Functional Limitation, Claim Construction, and Obviousness: Bayer v. Mylan
Bo Xiao | September 24, 2025
BAYER PHARMA AKTIENGESELLSCHAFT, v. MYLAN PHARMACEUTICALS INC., TEVA PHARMACEUTICALS USA, INC., INVAGEN PHARMACEUTICALS INC.
Date of Decision: September 23, 2025
Before: MOORE, Chief Judge, CUNNINGHAM, Circuit Judge, and SCARSI, District Judge.
Summary
The Federal Circuit affirmed in part, vacated in part, and remanded the Patent Trial and Appeal Board’s decision invalidating claims of Bayer Pharma AG’s patent. The court upheld the invalidation of claims 1-4 but vacated and remanded with respect to claims 5-8.
Background
Bayer owns the ’310 patent (U.S. Patent No. 10,828,310), which claims methods for reducing the risk of cardiovascular events in patients with coronary artery disease (CAD) and/or peripheral artery disease (PAD) through administration of rivaroxaban and aspirin.
Independent claim 1 recites administration of rivaroxaban and aspirin in clinically proven amounts. Independent claim 5 recites once-daily administration of a first product comprising rivaroxaban and aspirin and a second product comprising rivaroxaban. Claims 1 and 5 are listed below with emphasis added:
1. A method of reducing the risk of myocardial infarction, stroke or cardiovascular death in a human patient with coronary artery disease and/or peripheral artery disease, comprising administering to the human patient rivaroxaban and aspirin in amounts that are clinically proven effective in reducing the risk of myocardial infarction, stroke or cardiovascular death in a human patient with coronary artery disease and/or peripheral arterial dis-ease, wherein rivaroxaban is administered in an amount of 2.5 mg twice daily and aspirin is administered in an amount of 75-100 mg daily.
5. A method of reducing the risk of myocardial infarction, stroke or cardiovascular death in a human patient with coronary artery disease and/or peripheral artery disease, the method comprising administering to the human patient rivaroxaban and aspirin in amounts that are clinically proven effective in reducing the risk of myocardial infarction, stroke or cardiovascular death in a human patient with coronary artery disease and/or peripheral arterial disease, wherein the method comprises once daily administration of a first product comprising rivaroxaban and aspirin and a second product comprising rivaroxaban, and further wherein the first product comprises 2.5 mg rivaroxaban and 75-100 mg aspirin and the second product comprises 2.5 mg rivaroxaban.
Mylan, Teva, and InvaGen filed substantively identical IPR petitions, arguing that a 2016 journal article by Foley (summarizing a trial which includes its dosing regimen of 2.5 mg rivaroxaban twice daily and 100 mg aspirin once daily without disclosing the trial results) and a 2014 journal article by Plosker (disclosing a dosing regimen of 2.5 mg rivaroxaban twice daily, co-administered with 75-100 mg aspirin) anticipated or rendered the claims obvious. The Board agreed and held all challenged claims unpatentable. Bayer appealed.
Discussion
The Federal Circuit addressed four disputes.
The first dispute is related to the phrase “clinically proven effective.” The Board had treated it as non-limiting or inherently anticipated. Bayer argued that the phrase should operate as a substantive limitation on the claims. According to Bayer, the language required that the claimed dosages of rivaroxaban and aspirin be supported by actual clinical trial evidence of efficacy, which in turn distinguished the claims from prior art references such as Foley. Bayer emphasized that Foley disclosed dosing regimens but did not provide trial results demonstrating that the regimens were effective and therefore could not anticipate or render the claimed methods obvious.
The Federal Circuit rejected this position, explaining that it did not decide whether the phrase “clinically proven effective” was a limiting element in claims 1-8. Even assuming it was limiting, the court reasoned that the phrase would not affect patentability because it merely described a characteristic of the treatment regimen rather than altering the steps of the claimed method. The court emphasized that the claims already specify the exact dosages of rivaroxaban and aspirin to be administered, and those dosages remain unchanged regardless of whether clinical trials later demonstrate efficacy. Accordingly, the limitation was deemed functionally unrelated to the claimed method and insufficient to distinguish the claims from the prior art.
The second dispute concerned the proper construction of the phrase “first product comprising rivaroxaban and aspirin” in claim 5. The Board had construed this language broadly to encompass circumstances where rivaroxaban and aspirin were provided in separate dosage forms and administered together, not limited to a single dosage form, and, if administered separately, the dosage forms could be administered simultaneously or sequentially.
The Federal Circuit disagreed with that interpretation. Relying on both the plain language of the claim and the description in the specification, the court concluded that “a first product comprising rivaroxaban and aspirin” required a single dosage form containing both ingredients. The court emphasized that the specification describes that “combination therapy may be administered using separate dosage forms for rivaroxaban and aspirin, or using a combination dosage form containing both rivaroxaban and aspirin.” The court agreed with Bayer that “first product comprising rivaroxaban and aspirin” corresponds to the latter, which narrows the term.
Therefore, the Federal Circuit remanded for further consideration so that the Board’s analysis of the obviousness arguments would be under the correct construction of the “first product” term.
The third dispute concerned whether the Board adequately explained a skilled artisan’s motivation to combine the prior art references with a reasonable expectation of success. The Federal Circuit agreed with the Board’s decision and found it supported by substantial evidence. The court noted that the Board identified both an overlap in the disclosed dosage ranges and the established practice of administering aspirin within that range. The court further found that Foley and Plosker described similar motivations for combining rivaroxaban with aspirin in patients with cardiovascular risk, which supported the Board’s conclusion that a skilled artisan would have had reason to combine the references with a reasonable expectation of success. Accordingly, the Federal Circuit affirmed the Board’s determination of obviousness as to dependent claims 3-4 and 6-7.
The fourth dispute concerned Bayer’s argument that its own clinical trial provided clinical proof of efficacy was an unexpected result. The Federal Circuit rejected this position, holding that there was no nexus between the asserted unexpected property and the claimed invention. The court explained that the asserted results were tied only to the “clinically proven effective” limitation, which it had already deemed functionally unrelated to the actual treatment method. Without that nexus, the secondary consideration of unexpected results could not support nonobviousness.
Takeaways
- Claim language that merely recites a property or result, without further defining the claimed steps or structure, may be deemed functionally unrelated and insufficient to establish distinction over the prior art.
- Secondary considerations require a demonstrated nexus between the evidence presented and the claimed invention as construed.
The Federal Circuit’s First AIA Derivation Case
John Kong | September 10, 2025
Global Health Solutions LLC v. Selner
Date of Decision: August 26, 2025
Before: Stoll, Stark, Circuit Judges. Goldberg, District Judge.
Summary:
The Federal Circuit addressed a derivation proceeding under the AIA for the first time. While derivation issues arose in pre-AIA interference proceedings, AIA derivation does not require a showing of who is first-to-conceive. Independent conception by an accused inventor overcomes the derivation accusation.
Procedural History:
Global Health Solutions (GHS) petitioned for an AIA derivation proceeding against Selner. The Patent Trial and Appeal Board (“Board”) granted the petition because GHS identified at least one claim in GHS’ application that is (i) the same or substantially the same as Selner’s claimed invention and is also (ii) the same or substantially the same as the invention disclosed to Selner. After the derivation proceedings, the Board ruled in Selner’s favor. GHS appealed to the Federal Circuit.
Background:
In 2013, Selner and Burnam worked together, although unsuccessfully, to make and sell a novel emulsifier-free wound treatment ointment. Burnam later left and formed GHS. GHS and Selner each filed a patent application on a wound treatment ointment and method for making it, resulting in permanently suspended nanodroplets without the use of an emulsifier that can irritate a patient’s skin. Selner is the first-filer, and GHS is the second-filer. An AIA derivation proceeding provides a limited opportunity for a first-inventor second-filer to obtain a patent despite another person filing an application first (first-filer) in the situation where the first filer derived the invention from the second-filer. During the derivation proceedings, the Board found that Burnam conceived the invention and communicated it to Selner, but the Board also found that Selner proved conception earlier the same day Burnam contacted him.
Decision:
Pre-AIA case law involving derivation often arose in the context of an interference to determine who was the first to invent under the previous first-to-invent law. However, when the AIA eliminated interferences and transformed 35 USC 135 from a law governing interferences to one governing derivation proceedings, Congress did not specify what a second-filer inventor must prove to show that the first-filer inventor derived the claimed invention from the second-filer inventor. However, the court concludes that “the required elements of a derivation claim have not changed other than to the extent necessary to reflect the transition from a first-to-invent to a first-to-file system of patent administration.”
Derivation in an AIA case requires the petitioner to “produce evidence sufficient to show (i) conception of the claimed invention, and (ii) communication of the conceived invention to the respondent prior to respondent’s filing of that patent application.” In a footnote, the Court sidestepped any decision regarding whether a party’s burden of proof in an AIA derivation proceeding is by a preponderance of evidence or by clear and convincing evidence (in pre-AIA interferences, proof of derivation was by clear and convincing evidence) since neither party raised this issue. But, a “respondent can overcome the petitioner’s showing by proving independent conception prior to having received the relevant communication from the petitioner.”
In particular, Selner need not prove that he was the first-to-conceive. Although the Board erred in focusing on whether Selner or Burnam was the first-to-invent or first-to-conceive, that was harmless error. “[A] first-to-file respondent like Selner need only prove that his conception was independent.” While the Board erroneously reached its decisions predicated on Selner being the first-to-conceive, the Board, in doing so, also indirectly determined that Selner independently conceived, and therefore, did not derive his invention from Burnam.
GHS argued that the Board erred by not requiring Selner to corroborate his inventorship with evidence independent of himself. The court found no such error. First, a “rule of reason test is used to determine whether an alleged inventor’s testimony is sufficiently corroborated.” Second, “the Board must consider ‘all pertinent evidence’ and then determine whether the ‘inventor’s story’ is credible.” More importantly, “[d]ocumentary or physical evidence that is made contemporaneously with the inventive process provides the most reliable proof that the inventor’s testimony has been corroborated.” Here, the corroboration was achieved through emails retrieved by Selner’s attorney’s law clerk from Selner’s AOL email account that were generated contemporaneously with the inventive process. And, such emails, whose authenticity was not challenged by GHS, do not require independent corroboration. In addition, the metadata generated by the web-based email server is independent of Selner’s own testimony and documents. Accordingly, the Board had substantial evidence for its findings of fact and there was no reversible error.
GHS argued that Selner did not show reduction to practice to prove conception. The court agreed with the Board that conception can occur without reducing the invention to practice. “Selner’s conception was complete at the point at which he was ‘able to define [the Invention] by its method of preparation’ or when he had formed ‘a definite and permanent idea of the complete and operative invention.’”
GHS argued that Burnam should be named as a co-inventor on Selner’s application. The court refused because GHS did not properly present this request to the Board and is thus forfeited. 37 CFR 42.22 requires a contested request for correction of inventorship in a patent application to be made in a separate motion, including a “statement of the precise relief requested” and a “full statement of the reasons for the relief requested, including a detailed explanation of the significance of the evidence including material facts, and the governing law, rules, and precedent.” No such separate motion was made to the Board, nor was any detailed explanation supporting joint inventorship and material facts relating thereto provided.
Takeaways:
In this case, even though the second-filer showed conception and communication of the invention to the first-filer, the first-filer’s independent conception was a complete defense over the derivation accusation. Unfortunately for Burnam (because GHS did not file a separate motion for correcting inventorship in Selner’s application), the “independent” nature of Selner’s conception was never really challenged despite all the interactions between him and Selner.
This case also provided good reminders that reduction to practice is not required for showing conception, and that contemporaneously generated evidence can corroborate the inventor’s story.
Fumika Ogawa | August 27, 2025
Presumption of Validity Does Not Protect a Patent from Invalidity for Lack of Adequate Written Description
Case Name: MONDIS TECHNOLOGY LTD. v. LG ELECTRONICS INC.
Decided: August 8, 2025 (Precedential)
Panel: Taranto, Clevenger, and Hughes, Circuit Judges
Summary
The CAFC held that Mondis’s patent is invalid for lack of adequate written description for a claim limitation introduced by amendment to overcome a prior art rejection during prosecution, where the prosecution history itself clearly suggested a lack of written description so that Mondis could not rely solely on the presumption of validity; expert testimony on infringement issues did not provide substantive evidence of validity; and although the amendment was allowed by the Examiner, allowance alone did not prove written description compliance, where the prosecution history indicated contrary.
Details
Mondis owns U.S. Patent No. 7,475,180. The ’180 patent basically describes a technology using matching of identification information to prevent unauthorized control of a display unit by an external computer sending video signals to the display unit. For example, the patent’s specification describes an embodiment where one or more ID numbers are stored in the display unit’s database and the external computer is assigned a unique ID number. The computer’s ID number is compared against the display unit’s database and the computer is allowed to control the display unit only when there is a match between the ID numbers.
As originally filed, the underlying application recited the following claim language:
…
a memory in which at least display unit information is stored, said display unit information including an identification number for identifying said display unit and characteristic information of said display unit; and … .
During prosecution, the above claim language was amended by the applicant adding a phrase “at least a type of” to overcome an art-based rejection, to read:
…
a memory in which at least display unit information is stored, said display unit information including an identification number for identifying at least a type of said display unit and characteristic information of said display unit; and
… .
The Examiner allowed the application over the prior art in response to the amendment, including the above claim language—referred to as “the type limitation”—which is set forth in claim 14 of the resulting patent. The prosecution record includes the Examiner’s Interview Summary stating that the above amendment was proposed by the applicant during the interview so as “to more clearly specify identification number as a ‘type’ of display unit which examiner agree[d] will read over the previous art applied regarding … the claims.”
Mondis sued LG for infringement of the ’180 patent. In the district court proceeding, LG challenged the patent’s claim 14 and its dependent claim 15 as invalid for lacking written description for the type limitation. The jury determined that the ’180 patent was not proven invalid and was infringed by that LG’s accused products. Both parties appealed—Mondis dissatisfied with the district court vacating an original damages verdict and ordering retrial leading to a reduced damages award, and LG contesting the district court’s denial of its motion for judgment as a matter of law (JMOL) of invalidity and infringement, among other issues.
At issue on appeal is whether the type limitation complies with the written description requirement of 35 U.S.C. § 112, ¶ 1. The CAFC noted that the written description requirement is a question of fact, reviewed for substantial evidence. “Patents are presumed to be valid and overcoming this presumption requires clear and convincing evidence,” and the burden of persuasion was on LG.
Mondis conceded that there is no express support for the type limitation in the patent. Mondis’s main arguments were: (A) the presumption of validity frees it from the requirement to produce evidence of adequate written description support, and (B) substantial evidence of validity is provided by each of (B-1) Mondis’s expert testimony, (B-2) LG’s expert’s admissions, and (B-3) the patent’s prosecution history. The CAFC rejected each argument.
As to (A) the presumption of validity argument, the CAFC noted that some patents are “presumed valid at birth [such that] a patentee need submit no evidencein support of a conclusion of validity,” whereas others are themselves “clear enough that [the patent specification] establishes inadequacy of support in the written description for the full scope of the claimed invention unless there is contrary evidence.” The CAFC found that the ’180 patent falls under the second category, where the prosecution history made clear that the addition of the type limitation to overcome the art rejection changed the nature of the claimed ID number from one identifying a specific display unit to one identifying a type of display unit.
As to (B-1) Mondis’s expert testimony, the expert presented an infringement theory pointing to the patent’s disclosure of an embodiment where an ID number is sent from the display to a computer:
Namely, an ID number is sent to the computer 1 from the display device 6 so that the computer 1 identifies that the display device 6 having a communication function is connected and the computer 1 compares the ID number with the ID number registered in the computer 1.
The Mondis’s expert explained to the jury that the above passage to mean that “the communication function [disclosed in the specification] is an actual video format [such that] the ID number is defining what video format the display is capable of receiving.”
The CAFC noted that the above testimony was “about infringement rather than validity,” and that the plain words of the specification, read in the context of the surrounding disclosure, would convey that the patent discloses a specific display unit, as opposed to a specific type of display unit.
As to (B-2) LG’s expert’s admissions, Mondis asserted that LG’s noninfringement testimony provides substantial evidence that serial numbers could be used to identify a particular display unit, and could hypothetically be a type ID.
The CAFC noted that to meet the written description requirement, “it is the specification itself that must demonstrate possession.” Nothing in the patent specification describes a serial number that identifies any type of display unit, and the expert testimony—which was again about infringement rather than validity—does not address whether a skilled artisan would find support in the specification for the type limitation.
As to (B-3) the patent’s prosecution history, Mondis argued that the fact that the claim amendment was entered without objection led to “an especially weighty presumption of correctness,” citing Commonwealth Sci. & Indus. Rsch. Org. v. Buffalo Tech., Inc. (USA), 542 F.3d 1363, 1380 (Fed. Cir. 2008). That is, Modis argued that “when the examiners allowed the amendment, they agreed to the type limitation because they understood that it was supported by written description.”
The CAFC clarified that Commonwealth Science, while finding a “presumption of validity based on the PTO’s issuance of the patent despite the amendments,” “does not hold that the examiner’s allowance of claims by itself provides substantial evidence that the claims comply with the requirements of § 112.” “If it did, there would rarely be a situation where an issued patent could later be invalidated for lack of written description.”
Further, the CAFC pointed to the Examiner’s interview summary explaining the nature of the claim amendment as overcoming the art rejection, but silent as to whether the Examiner considered compliance with the written description requirement. As such, the prosecution history fell short of substantial evidence.
Takeaways
This case provides a reminder that allowance of claim amendments and presumption of validity of patents alone do not constitute substantial evidence that the claims comply with the written description requirement. Care should be taken when adding a claim limitation that is not expressly supported by the specification, even if the amendment would successfully overcome an art-based rejection.
Stephen G. Adrian | August 13, 2025
Shocking-Applicant Admitted Prior Art Sinks Own Patent
Case Name: SHOCKWAVE MEDICAL, INC. v. CARDIOVASCULAR SYSTEMS, INC.
Decided: July 14, 2025
Before: LOURIE, DYK, and CUNNINGHAM, opinion by DYK
Background
Shockwave owns US patent no. 8,956,371 directed to treatment of atherosclerosis through intravascular lithotripsy. Lithotripsy is a technique used to break up kidney stones by using shockwaves induced by plasma. Atherosclerosis is a buildup of fatty deposits in blood vessels. Balloon angioplasty is a method of treating atherosclerosis by guiding a balloon catheter to the location of a blood vessel containing calcified plaque buildup.
Shockwave’s claimed device uses a typical over-the-wire angioplasty balloon catheter and adds electrodes within a fluid-filled balloon with a pulse generator to generate shockwaves to break up calcified plaque deposits. Claims 1 and 5 state:
1. An angioplasty catheter comprising: an elongated carrier sized to fit within a blood vessel,
said carrier having a guide wire lumen extending there through;
an angioplasty balloon located near a distal end of the carrier with a distal end of the balloon being sealed to the carrier near the distal end of the carrier and with a proximal end of the balloon defining an annular channel arranged to receive a fluid therein that inflates the balloon; and
an arc generator including a pair of electrodes, said electrodes being positioned within and in non-touching relation to the balloon,
said arc generator generating a high voltage pulse sufficient to create a plasma arc between the electrodes resulting in a mechanical shock wave within the balloon that is conducted through the fluid and through the balloon and wherein the balloon is arranged to remain intact during the formation of the shockwave.
5. The catheter of claim 2, wherein the pair of electrodes is disposed adjacent to and outside of the guide wire lumen.
Claim 2 requires that the “pair of electrodes” include a “pair of metallic electrodes.
CSI filed an inter partes review (IPR) petition challenging all claims of Shockwave’s ‘371 patent as obvious over EP 0571306 to Levy. The EP patent describes using laser-generated pulses to disintegrate plaque in blood vessels. CSI’s petition pointed to Shockwave’s ‘371 patent disclosure discussing “typical prior art over-the-wire angioplasty balloon catheter[s] … [that] are usually non-compliant with a fixed maximum dimension when expanded with a fluid such as saline.” The petition argued that it would have been obvious to modify Levy with the well-known angioplasty balloon catheter disclosed by the applicant admitted prior art (AAPA). (Keep in mind that a rejection in an IPR petition can only be based on patents and printed publications).
The Patent Trian and Appeal Board (PTAB) issued a final decision finding claims 1-4 and 6-17 were unpatentable as obvious. The PTAB stated that AAPA qualified as “prior art consisting of patents or printed publications.” After the decision, the USPTO issued “AAPA Guidance” stating that AAPA is not “prior art consisting of patents or printed publications.” The PTAB thereafter initiated rehearing, relying on AAPA only as evidence of the background knowledge in the art to typical over-the-wire balloon catheters. The PTAB then again concluded that claims 1-4 and 6-17 had been shown to be unpatentable as obvious.
Shockwave appealed the finding of unpatentability while CSI appealed the finding that claim 5 was not unpatentable.
Discussion
AAPA as a basis vs. evidence in an IPR petition
Shockwave argued that both CSI and the PTAB improperly relied on AAPA as a basis for the IPR petition. As set forth in 35 U.S.C. 311(b), a petitioner in an inter partes review may request to cancel as unpatentable 1 or more claims of a patent only on a ground that could be raised under section 102 or 103 and only on the basis of prior art consisting of patents and printed publications. The Federal Circuit has explained that “[a]lthough the prior art that can be considered in [IPRs] is limited to patents and printed publications, it does not follow that we ignore the skilled artisan’s knowledge when determining whether it would have been obvious to modify the prior art.” Koninklijke Philips N.V. v. Google LLC, 948 F.3d 1330, 1337 (Fed. Cir. 2020). This is because the obviousness analysis “requires an assessment of the . . . ‘background knowledge possessed by a person having ordinary skill in the art.’” Dow Jones & Co. v. Ablaise Ltd., 606 F.3d 1338, 1349 (Fed. Cir. 2010) (quoting KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 401 (2007)).
As set forth in Qualcomm Incorporated v. Apple Inc., 24 F.4th 1367 (Fed. Cir. 2022) (“Qualcomm I”), AAPA can be used as evidence of background knowledge of an ordinarily skilled artisan, but that AAPA cannot be the “basis” of a ground in an IPR petition. Shockwave had noted that the PTAB’s written decision included a table with a column labeled Relevance/Basis to assert that the AAPA was the basis of the ground of rejection. The CAFC, however, distinguished the reference to “basis” by noting that it is an IPR petitioner, not the PTAB, that must comply with what defines the metes and bounds of an IPR. Here, CSI properly relied on general background knowledge to supply missing claim limitations and used AAPA as evidence of that general background in the IPR petition. As such, the IPR petition did not violate section 311(b).
Claim construction of “angioplasty balloon”
Shockwave argues that the Board erred in denying its construction for “angioplasty balloon” as “a balloon that displaces the plaque into the vessel wall to expand the lumen of the vessel” and adopting CSI’s construction of the term as “an inflatable sac that is configured to be inserted into a blood vessel for use in a medical procedure to widen narrowed or obstructed blood vessels.” This argument was dismissed because there is nothing in the language of the claims or specification which supports requiring that an angioplasty balloon press plaque into the vessel wall.
Challenge to Fact Findings
Shockwave challenges three of the PTAB’s fact findings: (1) that an ordinarily skilled artisan would have been motivated to incorporate Levy’s shockwave system into the over-the-wire balloon catheter, (2) that Levy discloses shockwaves, and (3) that Shockwave’s secondary considerations evidence did not outweigh CSI’s obviousness showing. The standard of review for fact findings is substantial evidence. The CAFC found that substantial evidence supports each of the findings.
CSI’s Cross-Appeal
CSI cross-appeals the PTAB’s conclusion that claim 5 had not been shown to be unpatentable as obvious over Levy implemented in an over-the-wire balloon catheter in view of Uchiyama. The PTAB found that the prior art combination did not disclose claim 5’s limitation relating to the placement of electrodes.
Initially, Shockwave argued that CSI lacks Article III standing. As we have discussed in other decisions related to Article III standing, a party does not need Article III standing to receive a PTAB decision, but does need Article III standing to seek review of a PTAB decision. Parties seeking relief before the CAFC have the burden of establishing the existence of an Article III case or controversy. Regarding this, when a party challenging an IPR decision “relies on potential infringement liability as a basis for injury in fact, but is not currently engaging in infringing activity, it must establish that it has concrete plans for future activity that creates a substantial risk of future infringement or would likely cause the patentee to assert a claim of infringement.” Gen. Elec. Co. v. Raytheon Techs. Corp., 983 F.3d 1334, 1341 (Fed. Cir. 2020) (quoting JTEKT Corp. v. GKN Auto, LTD., 898 F.3d 1217, 1221 (Fed. Cir. 2018)).
CSI says it has standing because it has developed an intravascular lithotripsy (IVL) device, and Shockwave’s President publicly commented that the company would aggressively assert claim 5:
We are very pleased that the [Board] validated claim 5 of our ’371 patent, which protects the broad embodiment of our IVL technologies. Specifically, claim 5 describes a device that is delivered over a guidewire and generates shockwaves with electrodes inside of a balloon catheter. We believe that any viable, much less commercially viable, IVL device must contain these elements[.] . . . We believe that our robust portfolio of 40 issued U.S. patents and 50 issued foreign patents captures and protects the truly unique and sophisticated IVL technology[.]
The CAFC found that CSI’s circumstances had constituted sufficiently concrete plans coupled with a substantial likelihood of a suit of infringement of claim 5. Shockwave’s President’s statement reflected the company’s view of claim 5 as reading broadly on IVL technology, and that CSI had sufficiently shown that it was engaging in activity that creates a substantial risk of future infringement to likely cause the patentee to assert infringement.
Regarding obviousness of claim 5, the CAFC found that the PTAB’s analysis was predicated on the teaching of a prior art reference Uchiyama alone as not disclosing electrodes positioned adjacent to and outside of the guidewire lumen. The standard of obviousness requires consideration of the prior art combination as a whole (that is, the combination of Levy with Uchiyama). CSI’s expert had testified that it would have been obvious to implement the features of Uchiyama as a routine design choice. Shockwave did not present contrary evidence. Since there was no evidence in the record supporting the finding as to claim 5, the PTAB is reversed.
Takeaways
- Avoid having an admission of prior art in your specification. If there is prior art disclosing a certain aspect that serves as a background of the invention, refer to that prior art itself instead of creating an admission.
- AAPA cannot be used as a basis of an IPR petition, but can be used as evidence of the state of art.
- Advise your clients to refrain from making statements following a PTAB decision. The President’s statement allowed CSI to establish standing to file the cross appeal which ultimately struck down the last standing claim.
- Expert testimony is important in any IPR petition. CSI had expert testimony regarding obviousness of claim 5 which was not refuted by testimony from Shockwave.
