Barry v. Medtronic, Inc.
Opinion
Taranto, Circuit Judge.
Dr. Mark Barry brought this action against Medtronic, Inc., alleging that Medtronic induced surgeons to infringe U.S. Patent Nos. 7,670,358 and 8,361,121, which Dr. Barry owns and which name him as the sole inventor. The jury found infringement of method claims 4 and 5 of the '358 patent and system claims 2, 3, and 4 of the '121 patent, rejected Medtronic's several invalidity defenses, and awarded damages. In post-trial rulings on the jury issues,
Barry v. Medtronic, Inc.
,
*1317 I
A
Both patents at issue are entitled "System and Method for Aligning Vertebrae in the Amelioration of Aberrant Spinal Column Deviation Conditions." The patents claim methods and systems for correcting spinal column anomalies, such as those due to scoliosis, by applying force to multiple vertebrae at once. '358 patent, col. 2, line 63, through col. 3, line 6; '121 patent, col. 3, line 53, through col. 4, line 2. The '358 issued in 2010 from an application that Dr. Barry filed on December 30, 2004. The '121 patent issued in 2013 from an application-a continuation of an August 2005 application that was a continuation-in-part of the December 30, 2004 application-that Dr. Barry filed in 2010.
The asserted claims of the '358 patent are method claims 4 and 5. They depend ultimately on independent claim 1, which reads:
1. A method for aligning vertebrae in the amelioration of aberrant spinal column deviation conditions comprising the steps of:
selecting a first set of pedicle screws, said pedicle screws each having a threaded shank segment and a head segment;
selecting a first pedicle screw cluster derotation tool, said first pedicle screw cluster derotation tool having first handle means and a first group of pedicle screw engagement members which are mechanically linked with said first handle means, each pedicle screw engagement member being configured for engaging with, and transmitting manipulative forces applied to said first handle means to said head segment of each pedicle screw of said first set of pedicle screws,
implanting each pedicle screw in a pedicle region of each of a first group of multiple vertebrae of a spinal column which exhibits an aberrant spinal column deviation condition;
engaging each pedicle screw engagement member respectively with said head segment of each pedicle screw of said first set of pedicle screws; and
applying manipulative force to said first handle means in a manner for simultaneously engaging said first group of pedicle screw engagement members and first set of pedicle screws and thereby in a single motion simultaneously rotating said vertebrae of said first group of multiple vertebrae in which said pedicle screws are implanted to achieve an amelioration of an aberrant spinal column deviation condition;
selecting a first length of a spinal rod member; wherein one or more of said pedicle screws of said first set of pedicle screws each includes:
a spinal rod conduit formed substantially transverse of the length of said pedicle screw and sized and shaped for receiving passage of said spinal rod member therethrough; and
spinal rod engagement means for securing said pedicle screw and said spinal rod member, when extending through said spinal rod conduit, in a substantially fixed relative position and orientation;
extending said first length of said spinal rod member through said spinal rod conduits of one or more of said pedicle screws of said first set of pedicle screws ; and
after applying said manipulative force to said first handle means, actuating said spinal rod engagement means to secure said vertebrae in their respective and relative positions and orientations as achieved through application of said manipulative force thereto.
*1318
'358 patent, col. 6, lines 7-56. Claim 2, which depends on claim 1, adds steps requiring a second set of pedicle screws and a second derotation tool with a second group of engagement members and a second "handle means."
The asserted claims of the '121 patent are system claims 2-4. Claim 2, an independent claim, reads:
2. A system for aligning vertebrae in the amelioration of aberrant spinal column deviation conditions comprising:
a first set of pedicle screws, each pedicle screw having a threaded shank segment and a head segment; and
a first pedicle screw cluster derotation tool, said first pedicle screw cluster derotation tool having a first handle means for facilitating simultaneous application of manipulative forces to said first set of pedicle screws and a first group of three or more pedicle screw engagement members which are mechanically linked with said first handle means, said first handle means having a handle linked to each pedicle screw engagement member of the first group of three or more pedicle screw engagement members and a linking member to join together the handles linked to the pedicle screw engagement members, wherein the handle means is configured to move simultaneously each pedicle screw engagement member; wherein each pedicle screw engagement member is configured to engage respectively with said head segment of each pedicle screw of said first set of pedicle screws; and wherein each pedicle screw engagement member is configured to transmit manipulative forces applied to said first handle means to said head segment of each pedicle screw of said first set of pedicle screws;
a second set of pedicle screws, each pedicle screw having a threaded shank segment and a head segment;
a second pedicle screw cluster derotation tool, said second pedicle screw cluster derotation tool having a second handle means for facilitating simultaneous application of manipulative forces to said second set of pedicle screws and a second group of three or more pedicle screw engagement members which are mechanically linked with said second handle means, said second handle means having a handle linked to each pedicle screw engagement member of the second group of three or more pedicle screw engagement members and a handle linking member to join together the handles linked to the pedicle screw engagement members, wherein the handle means is configured to move simultaneously each pedicle screw engagement member; wherein each pedicle screw engagement member is configured to engage respectively with said head segment of each pedicle screw of said second set of pedicle screws; and wherein each pedicle screw engagement member is configured to transmit manipulative forces applied to said second handle means to said head segment of each pedicle screw of said second set of pedicle screws;
*1319 a cross-linking member that links the first handle means to the second handle means.
'121 patent, col. 7, line 57, through col. 8, line 45. The parties have highlighted the "cross-linking member" element in identifying the advance of the '121 patent claims over those of the '358 patent. Claim 3, which depends on claim 2, and claim 4, which depends on claim 3, add requirements that have had no material role in the arguments made to this court.
B
The following facts form the core of the background needed to understand the issues before us. Dr. Barry began working in late 2002 or early 2003 on trying to link derotation components (which grab screws in vertebrae to move the vertebrae) of devices for ameliorating spinal column deviation conditions. During 2003 he worked with a sales representative from the DePuy medical-device company, Mr. Pfefferkorn, to adjust standard DePuy tools for Dr. Barry's purposes and in accordance with Dr. Barry's ideas. Dr. Barry also spoke about his ideas with representatives from another company, SpineVision. By July 2003, Dr. Barry had a tool that allowed him to link the screw-grabbing, vertebrae-moving wrenches together.
Dr. Barry used that tool in three surgeries-on August 4, August 5, and October 14. Dr. Barry testified, without contradiction by any evidence the jury had to credit, that the three surgeries represent the three most common types of scoliosis-caused spinal deviation conditions that surgeons typically see. Between August 2003 and January 2004, the patients in those surgeries returned to Dr. Barry several times for follow-up appointments. During the follow-up appointments, Dr. Barry viewed x-rays of the patients' spines, after they had been able to stand up and walk following the three-month acute phase of recovery, to determine if the curvature conditions had been successfully ameliorated by the surgery.
According to Dr. Barry's testimony at trial, it was only in January 2004, after the three-month follow-up for the October 14, 2003 surgery, that he felt confident that his invention functioned for its intended purpose and was ready to publicize it in a professional forum. J.A. 1161-65, 1195-96. He prepared an abstract summarizing the development of his methods and submitted it, by February 1, 2004, for inclusion in the materials to be presented at a July 2004 International Meeting of Advanced Spinal Techniques-the selection committee for which accepted it in April. On December 30, 2004, he filed the application for what issued as the '358 patent, making December 30, 2003, the critical date for that patent for purposes of the public-use and on-sale bar issues under
Around the same time, Dr. Lawrence Lenke, a surgeon who works with Medtronic, was also working on a spinal derotation project. His work began in 2002. Medtronic contends that Dr. Lenke, through that work, was a prior inventor and that Dr. Barry's patents are therefore invalid under
By 2006, Medtronic introduced its Vertebral Column Manipulation (VCM) kit, which is used in conjunction with Medtronic's CD Horizon Legacy and Solera spinal-surgery systems. Dr. Barry alleges that surgeons' use of that combination infringes the asserted claims of the two patents at issue and that Medtronic has induced such *1320 infringement through its extensive training materials and instructions relating to its VCM kit. As to the latter, instructions appear on the lid of each kit. Medtronic employees have trained surgeons in how to use the VCM kit. Medtronic has included instructions for using the VCM kit in surgical guides, which Dr. Barry's expert, Dr. Walid Yassir, testified Medtronic "put ... out all of the time." J.A. 1782. And Dr. Lenke testified that he used the VCM kit when performing derotations, even after 2010, the year the '358 patent issued.
In this case, the jury found for Dr. Barry, and specifically did so on the key issues contested by Medtronic in this appeal-involving whether Dr. Barry's '358 invention was in public use or on sale before December 30, 2003; whether Dr. Lenke was a prior inventor for both patents; and whether, and to what extent, Medtronic induced infringement. As relevant here, the jury awarded Dr. Barry $15,095,970 for domestic infringement of the '358 patent and $2,625,210 for domestic infringement of the '121 patent. J.A. 135.
2
The district court denied Medtronic's post-trial challenges regarding induced infringement,
Barry
,
On appeal, Medtronic raises issues involving the § 102 statutory bars as to the '358 patent, Br. of Appellant at 26-41; inequitable conduct as to both patents,
id.
at 44-48; prior invention as to both patents,
id.
at 48-58; and induced infringement and associated damages as to both patents,
id.
at 58-67 (infringement), 67-69 (damages). We have jurisdiction under
II
We review the denial of judgment as a matter of law de novo, and we review the denial of a new trial as well as rulings on jury instructions for abuse of discretion.
i4i Ltd. P'ship v. Microsoft Corp.
,
A
We begin with Medtronic's argument for judgment as a matter of law that the '358 patent's asserted claims are invalid under § 102(b)'s statutory bar on patenting of inventions in "public use" in the United States more than one year before the application for the patent was filed. Here, the application was filed on December 30, 2004, so the critical date for an invalidating domestic public use is December 30, 2003. We reject Medtronic's challenge.
"The public use bar is triggered where, before the critical date, the invention is in public use
and
ready for patenting."
Polara Eng'g Inc v. Campbell Co.
,
We discuss "ready for patenting" first, then "in public use." We conclude that Medtronic's § 102(b) public-use challenge fails on two grounds, which are substantively related. First, the invention was not ready for patenting before the critical date. Second, there was no public use except for an experimental use, and "[p]roof of experimental use serves as a negation of the statutory bars,"
Polara
,
We place our discussion of experimental use within our discussion of the "public use" element. This placement fits the facts that commercial exploitation may sometimes satisfy that element,
Invitrogen
,
1
The jury could reasonably find facts that support rejection of Medtronic's contention that Dr. Barry's '358 invention was ready for patenting before December 30, 2003. Medtronic's contention required it to prove that, before that date, the method was " 'shown or known to work for
*1322
its intended purpose.' "
Polara
,
This court has long held that "the Supreme Court's 'ready for patenting test' " from
Pfaff
, involving the on-sale bar, also "applies to the public use bar under § 102(b)."
Invitrogen
,
Under the test for a reduction to practice, the challenger must show that "the inventor (1) constructed an embodiment or performed a process that met all the limitations and (2) determined that the invention would work for its intended purpose."
In re Omeprazole Patent Litig.
,
Here, Medtronic relied on the August and October 2003 surgeries as reductions to practice that immediately proved that the claimed invention of the '358 patent would work for its intended purpose. But the evidence allows a reasonable finding that Dr. Barry did not know that his invention would work for its intended purpose until January 2004, when he completed the follow-ups on those surgeries, which were on three patients who fairly reflected the real-world range of application of the inventive method.
We have already noted the evidence that the three surgeries involved "the three most common[ ] curve types of scoliosis" seen by surgeons, J.A. 1195, and that it was not until January 2004 that Dr. Barry completed the standard-practice follow-up on the third patient, at which point the three-month acute phase of recovery was over and the patient could stand up and walk. We also have noted Dr. Barry's testimony that only then did he conclude that the surgical method would work for its intended purpose, testimony confirmed by the fact that only then did he write up his development work for publication in a professional forum.
The record contains further supporting evidence. Dr. Lenke noted the range of scoliosis conditions. J.A. 2644. Evidence from several sources confirmed that, to evaluate the success of a spinal-deviation correction, it is important for the surgeon to evaluate the patient after some time has elapsed following the surgery, particularly once the patient can stand. See J.A. 1159-60, 1190-95, 1372, 5406, 5417, 13016. Dr. Barry's expert testified that "you know nominally if you have performed a correction of the spine"-agreeing to the "some amelioration" characterization by Medtronic's counsel only to that limited extent-and then immediately explained, starting in the same answer, that what happened afterward was crucial: "when the patient stands up, there are some changes that happen over time." J.A. 1959-60. As a result, he added, although "normally you can see the straightening" at the time of the surgery, "follow-up is absolutely required to determine that it lasts," J.A. 2906, and the follow-up appointments allowed Dr. Barry to conclude, " '[o]kay, this thing is holding up' and ... '[n]ow I know I've got a method that works,' " J.A. 2899. Both Dr. Barry and his expert indicated that at least that amount of follow-up is not just prudent but consistent with standards *1324 for peer-reviewed publications reporting new techniques.
That evidence suffices for the jury to have rejected Medtronic's contention that Dr. Barry is charged with knowing that the surgical technique worked for its intended purpose immediately upon completion of the surgical operation-at least the last operation, in October 2003. The evidence is not limited to Dr. Barry's own testimony, as just indicated. And credibility assessments, within a broad range, are for the factfinders, especially when they have seen the witnesses live, as the jurors in this case did.
See, e.g.
,
Cooper v. Harris
, --- U.S. ----,
To the extent that Medtronic contends, and the dissent concludes, that the patent claims compel narrowing the "intended purpose" determination to a single surgery, or even two surgeries, assessed for success immediately upon its completion, we disagree. The claims do not limit the intended purpose in that way. They are not limited to a particular type of curvature correction. Nor do they indicate that the intended purpose is limited to observing a straightening at the completion of surgery, without regard to the correction lasting so as to improve the patient's health. To the contrary, the preamble to the independent claim calls for "the amelioration of aberrant spinal column deviation conditions," '358 patent, col. 6, lines 8-9, which Medtronic argues is the intended purpose, Br. of Appellant at 30. See also '358 patent, col. 3, lines 10-34 (specification statement of first four objects of the invention using materially the same language). In a ruling not disputed on appeal, the district court concluded that the phrase would be given its "normal, customary meaning," without further construction, and that no indefiniteness problem would result because, in this medical context, a skilled artisan, focused on "benefit to a patient," would understand the scope of the phrase. J.A. 33. That common-sense approach to identifying the intended purpose is rooted in the preamble claim language as well as the specification. And it is properly understood, consistent with the specification's background discussion of patients' conditions beyond the end of surgery, '358 patent, cols. 1-2 (discussing patient health over time), as looking past the time of a surgery to evaluate the improvement in patients' conditions and allowing the withholding of judgment about the technique reliably working until follow-up on a small but representative range of "deviation conditions" surgeons would regularly encounter. 7
*1325
The "intended purpose" need not be stated in claim limitations that define the claim scope. Even in this case, the claim language that Medtronic treats as identifying the "intended purpose" is preamble language that, it is undisputed here, is not limiting,
i.e.
, it does not state a requirement that must be proved to establish infringement.
See
J.A. 152 (unchallenged jury instruction). The case law cited by the dissent (at 1340-41) looks to the claims and specification as a whole for guidance, without declaring strict requirements even as to those sources. We note that it is hardly surprising that intended purpose need not be stated in claim limitations, given that one typical way of claiming is simply to define the physical steps of the process, or the physical elements of a product, without building functional or purpose language into the claim limitations at all.
See
,
e.g.
,
In re Schreiber
,
Case law confirms this approach. For example, in
Corona Cord
, the Supreme Court, for its reduction-to-practice analysis, inferred the accelerate-curing purpose from the specification. And it described the main claims at issue (No. 1,411,231, claims 4, 8, and 12) as stating simple process steps without any reference to that purpose. 276 U.S. at 366,
In
Manville
, the patentee designed a light pole assembly that could be easily raised and lowered.
Similarly, in
Polara
, we agreed with Polara that it "needed to test the claimed invention at actual crosswalks of different sizes and configurations and where the prototype would experience different weather conditions to ensure that the invention would work for its intended purpose."
In
Honeywell International v. Universal Avionics Systems
, we likewise recognized that an invention might not be ready for patenting until the inventor ascertains how that invention will function in practical circumstances.
Honeywell Int'l Inc. v. Universal Avionics Systems Corp.
,
In
TP Laboratories, Inc. v. Professional Positioners, Inc.
,
The three types of curvature addressed by Dr. Barry's three surgeries are analogous to the different weather conditions in Manville and Polara , the different crosswalk dimensions in Polara , and the different types of terrain in Honeywell . And Dr. Barry's reliance on follow-up appointments is analogous to the role of follow-up appointments in TP Laboratories. We therefore affirm the determination that the claimed '358 patent invention was not ready for patenting before the critical date.
2
Although the foregoing discussion suffices to affirm the rejection of Medtronic's invalidity challenge under § 102(b)'s public-use bar, we think it worthwhile to address Medtronic's contentions regarding the other element of the test of invalidity under the public-use bar: whether the invention was "in public use." We conclude *1327 that Medtronic also fails under this element.
Medtronic sought to establish this element by showing that the invention was accessible to the public and that it was commercially exploited. We conclude, however, that the evidence permitted a reasonable finding that Dr. Barry's '358 patent invention was not accessible to the public before the critical date. We also conclude that the asserted acts of commercial exploitation, namely, the August and October 2003 surgeries, come within the experimental-use exception.
i
In assessing accessibility to the public, we have focused on several underlying facts: "the nature of the activity that occurred in public; the public access to and knowledge of the public use; [and] whether there was any confidentiality obligation imposed on persons who observed the use."
Dey, L.P. v. Sunovion Pharm., Inc.
,
Unlike in the classic case of
Egbert v. Lippmann
,
The evidence showed that very few of the people in the operating room had a clear view of the surgical field, where Dr. Barry was using his invention, because they were either not permitted near the sterile field or because there was a drape blocking the view. More dispositively, although sometimes (as in
Egbert
) even a limited disclosure can make an invention accessible to the public,
see
Dey,
ii
For commercial exploitation, as for public accessibility, Medtronic relies on the August and October surgeries. It rightly recognizes that "an inventor's own prior commercial use, albeit kept secret, may constitute a public use or sale under § 102(b), barring him from obtaining a patent."
Woodland Tr. v. Flowertree Nursery, Inc.
,
But regardless of the foregoing, the August and October surgeries come within the experimental-use exception. An inventor's use, while public in one sense, will not be considered a statutory public use if the use was experimental.
Electromotive
,
This court has identified a host of factors that can be relevant to assessing whether a use is experimental, including:
(1) the necessity for public testing, (2) the amount of control over the experiment retained by the inventor, (3) the nature of the invention, (4) the length of the test period, (5) whether payment was made, (6) whether there was a secrecy obligation, (7) whether records of the experiment were kept, (8) who conducted the experiment, (9) the degree of commercial exploitation during testing, (10) whether the invention reasonably requires evaluation under actual conditions of use, (11) whether testing was systematically performed, (12) whether the inventor continually monitored the invention during testing, and (13) the nature of contacts made with potential customers.
In this case, the evidence-including the evidence already discussed when addressing "ready for patenting"-shows that many of the above-recited factors point toward a conclusion of experimental use. Dr. Barry was not sure that the device would work on different types of scoliosis, so he performed surgeries on the three main types. He was not confident that the new procedure was effective until the January 2004 follow-up appointment for the third of those surgeries. In the context of
*1329
this medical patent, as we have discussed, it is reasonable, to truly determine whether a method works, to engage in such testing for a brief time on a small but representative range of expected circumstances of use and to rely on follow-up.
See
TP Labs.
,
Medtronic relies centrally on two factors as pointing against a finding of experimental use: that Dr. Barry charged his patients for the surgeries; and that Dr. Barry did not inform his patients that he was engaged in testing of his particular technique. The first factor is not by itself weighty in this case. Receipt of payment, if sufficiently incidental to an experiment, is not automatically disqualifying.
See
,
e.g.
,
Int'l Tooth Crown Co. v. Gaylord
,
Medtronic must rely, therefore, on the second factor, at least when present together with the first. Both circumstances were present in
Sinskey v. Pharmacia Ophthalmics, Inc.
,
The facts in Sinskey differ from the facts here in ways that we think are crucial. First, there was evidence here that not just Dr. Barry, but others, understood the surgeries to be experimental. In Sinskey , there was no such objective confirmation; and Dr. Sinskey himself, during his deposition, had stated that he did not consider his prior uses to be experimental. Id. at 497-98. Second, the nature of the invention and conduct is critically different in the two cases. Whereas Dr. Barry's invention is of a method, Dr. Sinskey's patent was for a physical product, i.e. , a lens. Id. at 496 ("The patent is directed to an intraocular lens."). And when Dr. Sinskey implanted the lens in a patient, he was surrendering control of his invention, whereas Dr. Barry did not surrender control of his invention when he performed the derotation surgeries.
The experimental-use inquiry asks whether the inventor's conduct would lead the " 'public' to reasonably believe the invention was in the public domain,"
Manville
,
This court stated the principle in
LaBounty Mfg., Inc. v. U.S. Int'l Trade Comm'n
: "When sales are made in an ordinary commercial environment and the goods are placed outside the inventor's control, an inventor's secretly held subjective intent to 'experiment,' even if true, is unavailing without objective evidence to support the contention. Under such circumstances, the customer at a minimum must be made aware of the experimentation."
Medtronic cites several of our opinions that contain language that, taken out of context, might be read as making a necessary requirement for experimental use that the experimenter inform patients or customers of the experimental nature of the product. But the statements should not be taken out of context. Like
LaBounty
, which expressly tied the inform-customers statement to placing a product invention outside the inventor's control, every one of those cases in fact involved a device placed
*1331
into a patient's or customer's control, and out of the inventor's control.
See, e.g.
,
Electromotive
,
The experimental-use exception is properly applied in light of the recognized mix of § 102(b) policies-permitting experimental testing, protecting existing public domain knowledge, limiting extension of the statutory period of gaining revenues due to the invention, and encouraging prompt disclosure.
See
,
e.g.
,
Lough
,
B
The second asserted § 102(b) ground of invalidity of the asserted claims of the '358 patent is the on-sale bar. "A person shall be entitled to a patent unless ... the invention was ... on sale in this country, more than one year prior to the date of the application for patent in the United States[.]"
We have already concluded, in discussing the public-use bar, that the '358 patent's invention was not ready for patenting before the critical date and that the August and October 2003 surgeries come within the experimental-use exception. Those conclusions leave only one aspect of Medtronic's on-sale-bar challenge that requires discussion. 11
Medtronic argues on one ground for a new trial regarding experimental use. It challenges a jury instruction that informed the jury that "there is a difference between 'experimental use' in the context *1332 of patent law and the way that the word 'experiment' is used in the context of medicine." J.A. 160. We reject this challenge.
Although underlying questions of patent law are matters of this court's law, we generally apply regional-circuit law on the overall standards for setting aside a verdict because of asserted error in jury instructions.
See
KineticConcepts, Inc. v. Blue Sky Med. Grp., Inc.
,
The district court's instruction was not an abuse of discretion. In light of Medtronic's suggestions regarding the impropriety of medical experimentation without informed consent, it was reasonable for the court to address potential confusion about borrowing, for § 102(b), legal standards that govern experiments in quite different legal contexts. And what the court said on the subject was both modest and consistent with our holdings. This court has explained, specifically with regard to testing, that legal standards in other contexts do not control in the patent-validity context.
Pennwalt Corp. v. Akzona Inc.
,
C
Medtronic's final invalidity challenge, applicable to both patents at issue here, is that Dr. Lenke invented the claimed matter before Dr. Barry, rendering the asserted claims invalid under
Reduction to practice requires that the inventor prove that "(1) he constructed an embodiment or performed a process that met all the limitations ... and (2) he determined that the invention would work for its intended purpose."
*1333
We uphold the jury's rejection of Medtronic's § 102(g) challenge because there is substantial evidence to support a finding that Dr. Lenke did not reduce the claimed inventions to practice before February 2006, after Dr. Barry did so (for both patents at issue here). Weaknesses in Medtronic's evidence, including credibility issues, allowed the jury to reject Medtronic's assertion that Dr. Lenke, having worked on linked derotators since 2002, reduced the Barry-claimed inventions to practice before Dr. Barry did so in 2004.
See
Barry
,
D
Medtronic asserted in the district court that the two patents are unenforceable because Dr. Barry engaged in inequitable conduct during patent prosecution in the PTO. The district court found no such inequitable conduct. We affirm that determination.
"Inequitable conduct is an equitable issue committed to the discretion of the trial court and is, therefore, reviewed by this court under an abuse of discretion standard."
Energy Heating, LLC v. Heat On-The-Fly, LLC
,
The basis of the charge of inequitable conduct is Figure 6 of both patents, which Dr. Barry initially described incorrectly. Both patents describe Figure 6 as displaying "a three frame x-ray view showing 'before and after' views of a scoliosis patient who was treated in an investigational procedure using the system and method of the present invention." '358 patent, col. 4, lines 38-41; '121 patent, col. 4, lines 44-47. In January 2008, during the initial prosecution, the examiner requested clearer drawings than those originally submitted, including the x-rays that make up Figure 6. J.A. 5077 ("Figures 1-4 and 6-7 are objected [to] as they are unclear and do not distinctly show features which are pertinent to the understanding of the disclosed device. New corrected drawings are required."). In September 2008, Dr. Barry's counsel submitted a different set of x-rays for Figure 6. The evidence in this case indicates that counsel was not aware that, contrary to the description, the subject of the submitted x-rays actually was not a patient treated with the inventive methods, but instead was a patient treated on June 23, 2003, using a method that was not the invention claimed in the '358 patent (or the '121 patent's follow-on invention).
In March 2016, Dr. Barry sought to correct the description during this litigation. For the '121 patent, the PTO allowed the correction, issuing a Certificate of Correction in August 2016. Dr. Barry simultaneously requested the same correction of the '358 patent, but the '358 patent was the subject of an inter partes review proceeding at the time, so he withdrew the request in April 2016. Dr. Barry then filed a motion to correct under
*1334 granted the request and issued a Certificate of Correction in June 2017.
The district court found that there was no intent to deceive the PTO on the part of Dr. Barry and his counsel.
Inequitable Conduct Op.
,
E
Medtronic challenges the jury's finding that Medtronic directly infringed the patents and that it induced others to infringe. "Whoever actively induces infringement of a patent shall be liable as an infringer."
1
Substantial evidence supports the jury's finding of underlying direct infringement by surgeons. Dr. Barry presented the results of a survey-the Neal Survey-that asked spine surgeons questions about the spine derotation surgeries they had performed in the last two years. See J.A. 5449-57. 12 In particular, the survey asked doctors whether they had performed surgeries that included the following steps:
Insert 2 spinal rods through pedicle screws on multiple vertebrae (at any stage of the procedure)[.] Attach derotators to pedicle screws on 2 or more vertebrae. Mechanically link 2 or more derotators. Link 2 or more different derotators attached to screws in a second group of 2 or more vertebrae (the 2 groups may have vertebrae in common). Both sets of linked derotators are moved simultaneously[.] Engage pedicle screw locking mechanism to hold vertebrae in derotated position[.]
J.A. 5454.
Medtronic argues insufficiency, or even inadmissibility, of the Neal Survey because it did not specifically name the accused Medtronic VCM kit in asking doctors what *1335 they did. We do not think, however, that Medtronic has shown error in the admission of or reliance on the survey as reasonably indicating the amount of activity by surgeons that would infringe.
The steps recited in the survey's inquiry track the claim language in the patent. The patent claim language includes: "implanting ... each pedicle screw in a pedicle region of each ... first group of multiple vertebrae of a spinal column," '358 patent, col. 6, lines 22-23; "a first group of pedicle screw engagement members which are mechanically linked with said first handle means" of the "first pedicle screw cluster derotation tool,
The Neal Survey asked not only about specific steps but also about surgeons' use of Medtronic's Horizon System. J.A. 5451. According to Dr. Barry's expert, moreover, any use of the Horizon System to derotate a spine would have used the VCM kit. The jury could accept that testimony. Although Medtronic has argued that use of certain tube derotators might not infringe yet would have been captured by the Neal Survey about what surgeons actually used, the jury could reject that contention. There was evidence indicating that such derotators would not have worked as the claims require. Medtronic has also argued, in this court and in its post-trial motion, that the Neal Survey would have captured use of its SmartLink product, which it says would be non-infringing; but all evidence of SmartLink was excluded from the trial, with Medronic's agreement, so such evidence cannot support Medtronic's challenge to the verdict.
Barry
,
The Neal Survey is not the only evidence of direct infringement. The jury could find that Dr. Lenke himself used the accused VCM kit. Dr. Lenke testified that when he performed derotations, the technique involving the VCM kit "would be the technique ... that [he] would use" and continued to use after 2010 (the year the '358 patent issued). J.A. 2706-08. He also continued to educate other surgeons on this technique after 2010.
Medtronic also makes an argument directed specifically to infringement of the '121 patent. It points to the requirement, stated in that patent's claim 2 as quoted above, of a cross-linking member connecting two handle means, each of which links three screw engagement members (for simultaneous manipulation). Medtronic contends that there was insufficient evidence, from the Neal Survey or otherwise, of surgeons' using such a three-by-three linking step with the VCM kit. We disagree. The Neal Survey asked about surgeons' using "6 or more derotators linked by lateral and transverse connections and moved simultaneously," J.A. 5454, and Dr. Barry's expert testified that the three-by-three linking step would be
*1336
carried out by surgeons following the instructions on the VCM kit's lid.
See
Barry
,
In sum, the jury could properly find that there was direct infringement of both patents at issue here, of a scope indicated by the Neal Survey.
2
Substantial evidence also supports the finding that Medtronic induced infringement after issuance of Dr. Barry's two patents. On appeal, Medtronic focuses on the timing of its inducing actions to contend otherwise, arguing that there was insufficient proof of inducement after the patents' issuance. We reject the contention, agreeing with the district court.
See
Barry
,
VCM was on the market four years before the '358 patent issued and seven years before the '121 patent issued. The Neal Survey asked whether surgeons "received any information or training (formal or informal) regarding derotation of multiple vertebrae using linked derotators from that source," without asking the dates of the information received. J.A. 5455. There was extensive evidence about the training materials provided by Medtronic and its sales representatives. Importantly, every VCM kit that went out had instructions on it, and the Medtronic sales force was constantly teaching surgeons the nuances of and techniques for using the devices. Dr. Lenke also testified that he was still instructing surgeons on using the VCM kit after 2010. On the evidence of record, we conclude, the jury could permissibly find inducement in the period after patenting.
F
Medtronic challenges the jury's damages award. But the challenge is dependent on our accepting Medtronic's challenges to use of the Neal Survey to establish infringement, which we have rejected. We add here only that the district court carefully considered Medtronic's challenges to the methodology of the Neal Survey and denied Medtronic's motion to exclude the survey, concluding that Medtronic's criticisms went to the weight of the evidence, not its relevance and reliability.
Barry
,
III
For the foregoing reasons, we reject Medtronic's challenges on appeal and affirm the judgment of the district court.
Costs to Dr. Barry.
AFFIRMED
Prost, Chief Judge, dissenting in part.
I join the majority's opinion regarding the '121 patent. I respectfully dissent, however, from its conclusion regarding the '358 patent.
The facts are simple. More than one year before filing for the '358 patent, Dr. Barry successfully performed his claimed surgical method on three different patients, charging each his normal fee. Dr. Barry's method was thus
prima facie
"on sale" or in "public use" before the critical date under
The majority concludes otherwise based on Dr. Barry's litigation testimony. Dr. Barry testified that, even though he charged his patients and successfully performed the claimed method three times before the critical date, he was not truly satisfied with his method until a follow-up after the third surgery-a follow-up that occurred just after the critical date. Never mind that Dr. Barry appreciated that his method worked as of a surgery's completion.
*1337 And never mind that successful follow-ups for the first two surgeries occurred before the critical date. Dr. Barry testified that he needed that third follow-up to be satisfied. On this basis, the majority concludes Medtronic failed to show that the asserted claims of the '358 patent are invalid under § 102(b)'s statutory bars.
Both the Supreme Court's and our precedent require invalidating the asserted claims under § 102(b) as a matter of law on this record. For this reason, I dissent.
I
A
Whether an invalidating sale or public use has occurred is a question of law reviewed de novo, based on underlying facts reviewed for substantial evidence following a jury verdict.
Leader Techs., Inc. v. Facebook, Inc.
,
The § 102(b) on-sale bar applies when, before the critical date, the claimed invention was (1) the subject of a commercial offer for sale; and (2) ready for patenting.
Pfaff v. Wells Elecs., Inc.
,
This case mostly concerns
Pfaff
's ready-for-patenting prong. This prong may be satisfied "in at least two ways": by proof of reduction to practice before the critical date; or by proof that before the critical date the inventor had prepared enabling drawings or other descriptions.
Even if a patent challenger makes out a
prima facie
case of the on-sale bar, a patentee may negate the bar's application with evidence that the sale was primarily for experimental purposes.
See
Electromotive Div. of Gen. Motors Corp. v. Transp. Sys. Div. of Gen. Elec. Co.
,
*1338 B
The majority provides two bases for its conclusion that the asserted claims are not invalid under § 102(b) and Pfaff . Majority Op. 1320-21. First, it says that the claimed methods were not ready for patenting before the critical date because they did not satisfy this court's reduction-to-practice test before that date. Majority Op. 1321-24. Second, it says that the three pre-critical-date surgeries were for experimental purposes, thus negating application of a § 102(b) bar. Majority Op. 1327-31.
Part II below concerns how Medtronic met Pfaff ' s two-prong test. Specifically, Part II.A shows that Pfaff ' s commercial-sale prong was satisfied. Part II.B shows that Pfaff ' s ready-for-patenting prong was satisfied because our reduction-to-practice test was satisfied. Part II.C shows that, regardless of whether the claimed methods were "reduced to practice," they were ready for patenting.
Part III concerns how the majority misapplies our reduction-to-practice test. This part also addresses a confusing aspect of our case law that the majority's opinion perpetuates. Part IV concerns the experimental-use doctrine.
II
The key facts are undisputed. The '358 patent's critical date is December 30, 2003. Dr. Barry performed three pre-critical-date surgeries that practiced all the limitations of the asserted '358 patent claims. These surgeries occurred on August 4, 2003; August 5, 2003; and October 14, 2003. Dr. Barry charged his normal fee for them.
A
The foregoing evidence establishes
Pfaff
' s commercial-sale prong for each of the three pre-critical-date surgeries.
See
Plumtree Software, Inc. v. Datamize, LLC
,
B
Medtronic also established that the inventions were reduced to practice no later than the second surgery's completion, and therefore were ready for patenting by then.
Pfaff
,
Reduction to practice is a question of law we review de novo.
DSL Dynamic Scis. Ltd. v. Union Switch & Signal, Inc.
,
The claims state the inventions' intended purpose: "the amelioration of aberrant spinal column deviation conditions." '358 patent col. 6 ll. 7-8. Dr. Barry testified that such amelioration happened during surgery:
*1339 Q. And there is a term that is used in the patent that is not a term that is familiar to me as a lay-person, but it's "amelioration." Does that mean correction?
A. Yes.
Q. Okay. So, it happens right there in the operating room, on the spot, true?
A. The surgical correction of the rotated vertebrae back to the midline, yeah, happens with that maneuver. Yes.
J.A. 1369-70. Dr. Barry's expert testified similarly. J.A. 1960 ("Q. And at least for the vertebrae, that derotation problem, you'll know if there was at least some amelioration when the surgery is over. A. Fair enough.")
Once this amelioration happened, Dr. Barry secured the derotated vertebrae in place with rods and screws, as the claims require:
Q. And can you explain for the jury, please, what happens once you get the vertebrae derotated into the proper alignment? How do you hold it there?
A. Well, as mentioned, you have screws up and down throughout that area of that curve. Once those vertebrae are rotated back into the midline and you have the correction that you are happy with, you are comfortable with , you lock down the screws to the two rods. ... So, that's at the end of the procedure where all of the implants-screws, rods, and the setscrews-are all tightened down, locked down.
J.A. 1158-59 (emphasis added); see '358 patent col. 6 ll. 52-56.
Thus, by no later than the second surgery's completion, Dr. Barry appreciated that his invention worked for its intended purpose-to ameliorate aberrant spinal column deviation conditions. 3 His inventions were reduced to practice by then as a matter of law.
C
Though sufficient, reduction to practice is not necessary for § 102(b)'s on-sale bar to apply.
Pfaff
,
The record demonstrates that, regardless of when his inventions were reduced to practice, Dr. Barry could have obtained a patent before the critical date. By August 5, 2003, he had already performed the claimed methods on what he contends were two different types of aberrant spinal column deviation conditions. There was at least some amelioration of those conditions by the end of the surgeries. At this point, Dr. Barry could have satisfied the enablement and written-description requirements of § 112 and credibly claimed utility under § 101.
See
Alcon Research Ltd. v. Barr Labs., Inc.
,
By focusing only on reduction to practice, the majority misses
Pfaff
's point-readiness for patenting is broader than reduction to practice and is meant to answer whether the inventor could have obtained a patent on his or her invention. This court captured a similar insight even before
Pfaff
. We noted that "the thrust of the on-sale inquiry is whether the inventor thought he had a product which could be and was offered to customers, not whether he could prevail under the technicalities of reduction to practice appropriate to determining priority of invention under interference law."
Paragon Podiatry Lab., Inc. v. KLM Labs., Inc.
,
The same insights apply here. Regardless of whether Dr. Barry satisfied our reduction-to-practice test as of the second surgery's completion, his inventions were ready for patenting by then.
III
The majority disagrees that Dr. Barry's inventions were ready for patenting before the critical date. The concept of an "intended purpose" is central to the majority's analysis and conclusion.
First, the majority reasons that Dr. Barry's claimed methods were not ready for patenting until they were reduced to practice, and that they were not reduced to practice until Dr. Barry knew that they would work for their intended purpose. The majority accepts that Dr. Barry needed the third follow-up to determine that the inventions worked for their intended purpose. Majority Op. 1321-22; see id. at 1322-25. This is error, because the majority asks more of the "intended purpose" than what the claims and specification define it to be.
Second, the majority finds support in cases where we have discussed "intended purpose" in the context of the experimental-use doctrine. But that doctrine contemplates a broader conception of "intended purpose" than what is required to show reduction to practice. Statements in our case law that loosely refer to an "intended purpose" are, regrettably, confusing. But the majority perpetuates the confusion in reaching its result. And its approach threatens to render superfluous a substantial body of law starting with the Supreme Court's seminal City of Elizabeth case.
I discuss these two problems in turn.
A
To know whether and when the inventor determined that the invention would work for its intended purpose for reduction to practice, we must first know what the "intended purpose" is. Although the testing necessary to determine whether an invention would work for its intended purpose is a factual question,
z4 Techs.
,
Here, the claims define the intended purpose as "the amelioration of aberrant spinal column deviation conditions." '358 patent col. 6 ll. 7-8. As both Dr. Barry and his expert testified, that amelioration is apparent and appreciated during a surgery *1341 when the surgeon rotates and straightens the vertebrae and then locks them into place. See supra Part II.B. That testimony, along with the undisputed fact that the pre-critical-date surgeries met all the claim limitations, should end the reduction-to-practice inquiry.
To conclude otherwise, the majority must conceive of a more exacting intended purpose-one that, based on Dr. Barry's testimony, includes clearing a follow-up at a certain time and working across three different types of conditions (not just two). In doing so, the majority legally errs by looking beyond the claims and the specification to effectively define the "intended purpose" for reduction to practice.
4
Conner v. Joris
,
To be sure, the majority suggests that the '358 patent describes follow-up time and the three-surgery requirement as part of the inventions' intended purpose. See Majority Op. 1324 (referencing a "common-sense approach to identifying the intended purpose [that] is rooted in the preamble claim language as well as the specification"). I am unpersuaded.
The claims say nothing about follow-up time. They say, "the amelioration of aberrant spinal column deviation conditions." '358 patent col. 6 ll. 7-8. The district court concluded that "amelioration" would be accorded its customary meaning, which a person of ordinary skill in the art would understand as "to improve." J.A. 33-34. Both Dr. Barry and his expert testified that the aberrant spinal column deviation conditions were ameliorated, or improved, as of a surgery's completion. And Dr. Barry testified that he appreciated as much at the time. Supra Part II.B.
The specification also says nothing relating follow-up time to the inventions' intended purpose. The majority references two portions of the specification in its discussion, but neither supports its position. First, it cites the background section. Majority Op. 1324 (citing '358 patent cols. 1-2). This section discusses prior-art treatment regimens and problems from untreated scoliosis ; it says nothing about follow-up criteria as it relates to the intended purpose of Dr. Barry's inventions. Second, the majority refers to the four "objects of the invention" articulated in the summary of the invention. Majority Op. 1324 (citing '358 patent col. 3 ll. 10-34). Again, these objectives say nothing about follow-up time. Quite the contrary; they describe what happens in the operating room-for example, (1) "facilitat[ing] the application of significant derotational forces to individual vertebra , with substantially reduced *1342 risk for fracture thereof upon application of such forces ," '358 patent col. 3 ll. 23-25 (emphasis added); and (2) "facilitat[ing] the application of forces to vertebrae of affected spinal column segments en bloc , thereby distributing otherwise potentially injurious forces in a manner for safely achieving over-all spinal column correction or derotation," id. at col. 3 ll. 30-33 (emphasis added).
Nor does the intended purpose contemplate working across three different types of curvatures, as opposed to just two. The claims' body requires amelioration of " an aberrant spinal column deviation condition," '358 patent col. 6 ll. 35-36 (emphasis added), and the preamble mentions only "amelioration of aberrant spinal column deviation conditions," id. at col. 6 ll. 7-8. The majority identifies nothing in the patent itself-whether in the claims or specification-that explains how working across three, not just two, curvatures is part of the inventions' intended purpose. Therefore, even if I were to accept that the '358 patent's language made follow-up time relevant to the inventions' intended purpose, I would still fail to understand the legal relevance of Dr. Barry's alleged need for the third surgery's follow-up, as opposed to just the first two, to determine whether his invention worked for its intended purpose (so as to establish reduction to practice).
The majority suggests that Medtronic "has not meaningfully presented, let alone supported" the argument that follow-ups on two surgeries (covering two conditions) were enough to establish reduction to practice. Majority Op. 1324-25 n.7. I disagree. The majority acknowledges that Medtronic's opening brief argued that the two follow-ups from the August surgeries were enough. Id. Dr. Barry responded that he needed to test his invention on "different anatomies" and that it was only after the third follow-up that he knew whether he had successfully treated the "three most common[ ] curve types." Dr. Barry's Resp. Br. 25-26 (alteration in original). Medtronic replied:
[A]n invention works for its intended purpose as long as there is some demonstration of the workability or utility of the claimed invention. A demonstration of its use in two patients certainly qualifies. After all, the claims are not confined to methods that ameliorate every patient's spinal deviation condition.
Medtronic's Reply Br. 8 (citation and internal quotation marks omitted); see id. at 8-9 (citing Dr. Barry's testimony regarding the surgeries, their follow-ups, and the patients' curve types). This straightforward argument is before us. Not even Dr. Barry has urged otherwise.
If Dr. Barry wanted to claim or describe his inventions' intended purpose differently-for example, with reference to satisfying a standard of care that contemplates a certain amount of follow-up time, or versatility across more than two curvature types-he could have done so. But his claims and specification say nothing of the sort. Given his testimony that before the critical date he practiced his invention (as he later claimed it) and achieved its purpose (as he later described it), his invention was reduced to practice before then as a matter of law.
B
To find Dr. Barry's inventions not ready for patenting, the majority analogizes to several cases it says support its view of the inventions' intended purpose. Majority Op. 1325-26. Its analysis of Pfaff ' s ready-for-patenting prong reflects some confusion in our case law regarding the relationship among reduction to practice, an invention's intended purpose, and the experimental-use doctrine.
*1343
Again, reduction to practice requires proof that the inventor determined that the invention would work for its intended purpose.
In re Omeprazole
, 536 F.3d at 1373. Therefore, showing readiness for patenting (at least, via reduction to practice) requires proof that the inventor determined that the invention would work for its intended purpose. Yet we have also said that a use may be experimental if it is to "determine whether an invention will work for its intended purpose."
Polara Eng'g Inc. v. Campbell Co.
,
I am skeptical, however, of an approach that would render the experimental-use doctrine superfluous based upon the same considerations of an "intended purpose" being considered elsewhere. 5 Instead of rendering this doctrine superfluous, the better and more accurate view is that the considerations of an "intended purpose" are not really the same as between reduction to practice and experimental use.
The experimental-use doctrine exists to afford an inventor the ability to experiment with his or her invention via what would
otherwise
constitute a barring sale or public use. The focus is on the inventor's intent in making the sale or using the invention publicly; if it is for primarily experimental purposes, we do not consider the sale or use barring.
See
Electromotive Div.
,
Given these differences, a subjective, expansive understanding of an invention's "intended purpose"-one that accommodates the good-faith, perfectionist inventor-is considered as part of the experimental-use inquiry. This is the way the Supreme Court addressed the issue in the City of Elizabeth pavement case:
Durability was one of the qualities to be attained. [The inventor] wanted to know whether his pavement would stand, and whether it would resist decay. Its character for durability could not be ascertained without its being subjected to use for a considerable time. He subjected it to such use, in good faith, for the simple purpose of ascertaining whether it was what he claimed it to be.
City of Elizabeth v. Am. Nicholson Pavement Co.
,
In fact, most of the cases the majority analogizes to in its not-ready-for-patenting discussion actually analyze this subjective, outside-the-patent-language "intended purpose" as part of experimental use. Majority Op. 1325-26;
see
Polara
,
*1344
Manville Sales Corp. v. Paramount Sys., Inc.
,
Thus, if an inventor's pre-critical-date sale or public use is to test an unclaimed or undescribed, yet inherent, feature of an invention (e.g., durability, safety), such testing may support the inventor's overall claim of experimental use and thereby avoid invalidity.
See
Electromotive Div.
,
IV
Given my conclusion that Medtronic made a prima facie showing of both Pfaff prongs, I must address whether Dr. Barry presented enough evidence that he conducted the three surgeries with experimental purpose sufficient to negate an on-sale bar. Although the majority does not address the parties' respective burdens in this context, I address them briefly. I then address the evidence.
A
The Supreme Court addressed the burdens issue in Smith & Griggs Manufacturing Co. v. Sprague :
In considering the evidence as to the alleged prior use for more than two years of an invention, which, if established, will have the effect of invalidating the patent, and where the defense is met only by the allegation that the use was not a public use in the sense of the statute, because it was for the purpose of perfecting an incomplete invention by tests and experiments, the proof, on the part of the patentee , the period covered by the use having been clearly established, should be full, unequivocal, and convincing .
Over forty years later, the Second Circuit interpreted and applied this language. With Judge Learned Hand writing, the court concluded that, on the issue of experimental purpose, "the patentee has the burden, once the [prior] use is proved, and he must establish it by stronger proof than in ordinary civil suits."
Aerovox Corp. v. Polymet Mfg. Corp.
,
This court has, though. In
TP Laboratories, Inc. v. Professional Positioners, Inc.
, the court addressed the burdens applicable to a patent challenger's § 102(b) defense and a patentee's corresponding assertion of experimental use. It followed
Austin
*1345
and held that "the burden of proof [is] upon the party attacking the validity of the patent, and that burden of persuasion does not shift at any time to the patent owner."
The
TP Laboratories
court further opined that, even if
Smith & Griggs
expressed a contrary view-i.e., one that "impose[d] the ultimate burden of persuasion on the patent holder rather than merely the burden of going forward with countering evidence"-the Supreme Court's view would not be "tenable" in light of the subsequently enacted statutory presumption of validity in
Thus, in
TP Laboratories
, the patentee's burden of persuasion on experimental use became a burden of production: "[I]f a
prima facie
case is made of public use, the patent owner must be able to point to or
must come forward with convincing evidence
to counter that showing."
B
Even under the burden-of-production approach set forth in TP Laboratories , I conclude that Dr. Barry's evidence of experimental purpose was insufficient as a matter of law to negate a bar.
Most of Dr. Barry's evidence of experimental purpose as to the three pre-critical-date surgeries is just his own after-the-fact testimony.
See
Majority Op. 1328-29 (referencing Dr. Barry's testimony).
7
"[C]ertain
*1346
things are settled. Significantly, an inventor's subjective intent to experiment cannot establish that his activities are, in fact, experimental."
Electromotive Div.
,
Rather, we generally look to objective evidence to determine whether a sale was for experimentation.
Electromotive Div.
,
To begin, Dr. Barry kept no records reflecting any experimental intent as to these surgeries. We have observed that the absence of such records weighs against a finding of experimental use.
See
Lough
,
Dr. Barry also charged his normal fee for the surgeries. The majority concludes that this fact points toward a conclusion of experimental use. Majority Op. 1328-30. Yet I cannot see how charging one's normal fee makes the sale look like anything other than a normal sale.
See
Electromotive Div.
,
The majority places weight on the fact that Dr. Barry maintained control over his method, but I find it hard to do the same. Control can be a useful objective indicator of experimental intent when it serves to distinguish between a commercial sale and one that is experimental. For example, if an inventor sells his or her inventive product but retains some control over its use, that scenario looks different from a normal sale-thus, more likely experimental. Similarly, if an inventor sells his or her product but forgoes an opportunity to retain some control, that scenario looks more like a normal sale. In this case, however, the nature of the inventor (a practicing surgeon) and his invention (a surgical method) means the inventor was likely going to retain sole control over the method for as *1347 long as he was practicing it. Although Dr. Barry's control over his method is consistent with experimental intent, given these circumstances, I cannot place much weight on this consideration.
Dr. Barry also did not inform his patients that he was performing his surgical method for experimental purposes. The majority dedicates considerable discussion to minimizing the importance of this fact. It carefully parses a statement in one of our prior cases, LaBounty , and finds that informing a customer of experimental intent is only relevant or necessary if at least two premises exist: (1) the absence of other objective evidence of experimentation; and (2) the placement of the invention outside of the inventor's control. Majority Op. 1330-31. Respectfully, I believe the majority's two-necessary-premises requirement over-reads LaBounty and overcomplicates what should be a simple observation: if an inventor tells his or her customer that the invention is for experimental purposes, it is more likely that the inventor's intent was experimental; if he or she does not, it is less likely. Regardless, even if I were to accept that informing customers of experimental intent is more important when control is lost, that would not mean it is irrelevant when control is maintained. It remains useful as an objective indicator of the inventor's contemporaneous intent.
In Dr. Barry's case, all of the foregoing considerations-the lack of records indicating experimentation, the normal fee charged, the control exercised, and the failure to inform customers of experimental purpose-would look the same if the surgeries were for commercial purposes. The only thing that affirmatively suggests these surgeries were experimental is that Dr. Barry said they were-after the fact, during litigation. As a matter of law, that is insufficient to show experimental purpose.
* * *
The record in this case shows that Dr. Barry waited too long to file for the '358 patent and that the on-sale bar applies. I respectfully dissent from the majority's contrary conclusion.
We refer throughout this opinion to the Title 35 provisions in effect before the changes made by the Leahy-Smith America Invents Act (AIA), Pub. L. No. 112-29,
The district court eliminated non-domestic infringement and damages from the judgment, a ruling not on appeal here.
Barry
,
The dissent proposes several changes to the legal standards stated in governing case law, such as a change to impose a (high) burden of persuasion on the patent owner to establish experimental use. Dissent at 1342-45. Medtronic has not argued for such changes. We follow existing case law. We also note that we see nothing in the dissent's proposed changes that would alter our § 102(b) result-at the least on the sufficient ground that Medtronic failed to establish readiness for patenting.
The dissent states that readiness for patenting might be shown in some other way. Dissent at 1339-40. We have no such alternative before us. Reduction to practice and enabling drawings or descriptions are the sole bases on which Medtronic argues for readiness for patenting. Br. of Appellant at 29-34. The jury instructions, not challenged here, are similarly limited. J.A. 158-61.
On appeal, Medtronic also points to drawings prepared in November 30, 2003, by a device company, SpineVision, based on conversations with Dr. Barry, and argues that the drawings show that "prior to the critical date the inventor [Dr. Barry] had prepared drawings or other descriptions of the invention that were sufficiently specific to enable a person skilled in the art to practice the invention."
Pfaff
,
Pfaff
supports the "intended purpose" standard in several ways. In a footnote,
see
The dissent suggests that at most two surgeries, not three, were needed for the plural "conditions." Dissent at 1341-42. But Medtronic has not meaningfully presented, let alone supported, such a rationale for reversal. Only a single sentence in Medtronic's opening brief, where arguments must be made, is of even possible relevance. After reciting the district court's reliance on Dr. Barry's testimony that "he wanted to follow up with his patients three months after the surgery," citing J.A. 215, 1196, Medtronic said: "That reasoning fails even on its own terms: three months after surgeries on August 4 and 5, 2003, would mean reduction to practice in early November, which is still nearly two months before the December 30, 2003 critical date." Br. of Appellant at 30, lines 6-9. If the dissent's point is one about the claim preamble's plural language, Medtronic's sentence says nothing about that. If the dissent's point is a medical-judgment point about the need for three rather than two surgeries, Medtronic's sentence is doubly deficient. The testimony Medtronic says it is answering is not about three versus two, but merely about the length of follow-up time, as confirmed by the citations to J.A. 215, 1196. In any event, and decisively, a medical-judgment point must be supported by evidence, but Medtronic's sentence is unaccompanied by any citation to the record at all. Specifically, there is no citation to evidence contrary to Dr. Barry's testimony as a factual matter about the need for follow-ups of three surgeries, much less evidence that compelled a determination in Medtronic's favor on this point.
In the related context of experimental use, we have likewise recognized that sometimes testing for a property can fall outside the statutory bars even if that property is not required by a claim limitation.
See
Electromotive
,
Contrary to the dissent (at 1346-47), this fact reduces the "degree of commercial exploitation,"
Clock Spring
,
We discuss Medtronic's new-trial challenge to a jury instruction regarding experimental use in our discussion of the on-sale bar next.
We need not discuss whether certain pre-critical-date communications between Dr. Barry and two device makers, DePuy and SpineVision, would constitute offers for sale under "traditional contract law principles."
Allen Eng'g
,
The parties have not specified precisely when the Neal Survey was conducted. But the district court said that it was not completed when Dr. Barry filed a motion concerning non-VCM products, a motion filed in late February 2016. J.A. 15168 n.8.
All citations to sections of Title 35 are to their pre-AIA version.
I focus the rest of my discussion on § 102(b)'s on-sale bar as opposed to its public-use bar, though my ultimate conclusion is the same for each. The public-use bar applies when, before the critical date, the claimed invention was (1) in public use; and (2) ready for patenting.
Invitrogen Corp. v. Biocrest Mfg., L.P.
,
Because the claims' preamble refers to the amelioration of "aberrant spinal column deviation conditions" (plural), and because Dr. Barry testified that his patients had different types of conditions, I place the time of reduction to practice at the completion of the second surgery-not the first. Given that both of the first two surgeries (and their respective follow-ups) occurred before the critical date, the difference is immaterial here.
The majority also references Dr. Barry's expert's testimony as supporting Dr. Barry. Majority Op. 1323-24. But much of that testimony concerns what the expert thought Dr. Barry was thinking, J.A. 2899, which adds very little to an objective, patent-based assessment of what the inventions' intended purpose is. And, insofar as the majority relies on standards for peer-reviewed publications as they relate to follow-up time, Majority Op. 1323-24, I am not convinced that those standards are, or should be, relevant to reduction to practice or readiness for patenting under the U.S. patent laws. For instance, Dr. Barry's expert testified that such publications require two years' follow-up time, J.A. 2900, but Dr. Barry successfully filed for a patent well before that.
I am all the more skeptical given that
Pfaff
explicitly reaffirmed the continued vitality of the experimental-use doctrine.
E.g.
, William C. Rooklidge & Stephen C. Jensen,
Common Sense, Simplicity and Experimental Use Negation of the Public Use and On Sale Bars to Patentability
,
The majority suggests that other people were aware that Dr. Barry was experimenting, Majority Op. 1328-30, but its record citations do not withstand scrutiny. Dr. Barry's doctor colleague testified that she understood him to be working on a technique sometime "in the 2002-2004 time frame." J.A. 1733. This testimony is vague and says nothing about these particular surgeries, much less their experimental purpose. Dr. Barry's nurse colleague said that it was "exciting when [the] team uses [the] levers to correct the curve," but said nothing about whether she understood the procedure to be experimental. J.A. 1370. And testimony concerning the DePuy medical-device representative relates only to the development of surgical tools, not these particular surgeries or whether they were experimental. J.A. 1178-79.
Reference
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