- PTAB · Nov 17, 2023 · IPR2023-00894 · APJ Robert A Pollock · IPR · Institution
The Board instituted IPR on claims 1–15 on all petitioned grounds, finding a reasonable likelihood of prevailing and declining discretionary denial under Fintiv and § 325(d).
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Legal Standards “In an [inter partes review], the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (2012) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). This burden of persuasion never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in inter partes review).” slip op. at 7
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownNo construction neededOther
“to be construed.” 37 C.F.R. § 42.104(b)(3). But only those terms that are in controversy need be construed, and only to the extent necessary to resolve the controversy. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999); see also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (applying Vivid Techs. in the context of an AIA trial proceeding). For the purpose of this Decision, we need address only the terms “bore” and “at a terminal end.”” slip op. at 11
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“Contrary to Patent Owner’s analysis, we preliminarily construe a “bore” as “a hole or passage made by or as if by the turning or twisting movement of a tool such that its interior walls have a cylindrical cross-section, and which do not exclude and may include holes or passages having tapered or stepped longitudinal cross-sections.” See supra Section II.C.1. As such, and on the limited record before us, Cognet discloses a bore and further satisfies all elements of claim phrase 1[c][iii]. c) Conclusion as to Ground 1 In view of the above preliminary construction, Petitioner establishes sufficiently that Cognet discloses claim element 1[c][iii]. Patent Owner does not dispute any other element of Ground 1 in its Preliminary Response. Having considered the evidence of record, we determine that Petitioner has established sufficiently that these remaining elements are also disclosed in Cognet. According, and solely for the purpose of institution, Petitioner has demonstrated a reasonable likelihood that Cognet anticipates claim 1.” slip op. at 19
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“On the present record, we decline to speculate whether the pending motion to stay might be successful. Accordingly, Fintiv Factor 1 is neutral.” slip op. at 29
Claim construction§ 102 anticipationDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,298,166 - Masimo Corporation v. Apple Inc.InstitutedPTAB · Oct 16, 2023 · IPR2023-00745 · APJ Robert L Kinder · IPR · Institution
The Board instituted IPR on claims 1–4 and 8–22 for all asserted grounds, finding a reasonable likelihood of success on at least one challenged claim.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review, under 35 U.S.C. § 314 and 37 C.F.R. § 42.4. An inter partes review may not be instituted unless it is determined that “the information presented in the petition filed under section 311 and any response filed under section 313 shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314 (2018); see also 37 C.F.R. § 42.4(a) (“The Board institutes the trial on behalf of the Director.”). For the reasons provided below and based on the record before us, we determine that Petitioner has demonstrated a reasonable likelihood that Petitioner would prevail in showing the unpatentability of at least one of the challenged claims. Accordingly, we institute an inter partes review on all grounds set forth in the Petition.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“The parties’ recitations are similar in scope. Patent Owner’s proposed level of ordinary skill in the art is somewhat broader in both education and proposed work experience. This proposed work experience is somewhat vague and potentially outside the scope of the claimed invention. For example, the requirement that the person of ordinary skill in the art have experience with the “capture and processing of data or information, including but not limited to physiological information,” would seemingly encompass data processing areas that do not relate to the scope of the claimed invention. Petitioner’s definition is consistent with both the scope of the claimed invention and the level of ordinary skill reflected in the prior art references of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (recognizing that the prior art itself may reflect an appropriate level of skill in the art). For purposes of this Decision, we apply Petitioner’s definition of the person of ordinary skill in the art. We note, however, that our decision would be the same adopting either proposed level of ordinary skill in the art.” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner proposes constructions for the terms “embedded” (recited in claims 1, 9, and 15), “lead” (recited in the independent claims), “pad” (recited in claim 1 and some of its dependent claims), and “pocket” (recited in dependent claim 8). Pet. 7–12. Patent Owner, at this time, “discerns no need to construe explicitly any claim language because doing so would have no effect on analyses of Masimo’s asserted grounds, and would not assist in resolving the present controversy between the parties.” Prelim. Resp. 6.” slip op. at 13
- BurdenOther
“We agree with Patent Owner that Petitioner’s citation to Mills (Ex. 1006, 5:18–19), which is “[y]et another VLSI chip . . . SRAM chip 38,” does not necessarily disclose a processor standing alone. Petitioner’s position, however, does not rely just on SRAM chip 38, but instead a VLSI comprising other circuit components, including a distinct processor. See Pet. 31 (citing Ex. 1006, 2:3–6). Petitioner first cites to Mills column 2 to support its position that “housing 12 comprises a very-large scale integrated (VLSI) circuit chip that includes an ‘ECG signal and abnormal event detection circuitry, analog-to-digital (AD) and digital-to-analog (DA) conversion circuitry, memory and processor circuitry.’” Id. (quoting Ex. 1006, 2:3–6). Petitioner next relies on Mills’ disclosure that “microprocessor and associated electronics, including firmware executed thereby, employs a digital bandpass filter reliably to detect ECG signals.” Id. (quoting Ex. 1006, 2:20–23). Petitioner next cites to Mills (Ex. 1006, 4:55–5:3), which describes “circuitry shown schematically in FIG.4, including on [PCB 50’s] bottom side a microcontroller (with integral ROM) chip 42.” Pet. 31. It is unclear from this citation whether Petitioner is relying on microcontroller 42 (on PCB 50’s bottom side) as a processor because Petitioner then quotes Mills’ discussion of SRAM chip 38, which states “that the VLSI is surface-mounted on the top side of printed circuit board (PCB) 50.” Pet. 31 (quoting Ex. 1006, 5:18–19). We understand Petitioner’s position as relying on the “very-large scale integrated (VLSI) circuit chip that includes” several components, including “memory and processor circuitry.” Pet. 31 (quoting Ex. 1006, 2:3–6). Notably, this section of the specification is labeled, “Background and Summary of the Invention,” and the paragraph describing this VLSI circuit chip is “summarizing the invention.” Ex. 1006, 1:7–8, 1:60. This VLSI circuit chip does not appear to us to be the same as VLSI SRAM chip 38, which is characterized by Mills as “[y]et another VLSI chip.” Ex. 1006, 5:18. Mr. Oslan testifies that “the VLSI is a processor coupled to the heart sensor (first and second electrodes 14 and 16, respectively) and is configured to receive and process the detected cardiac signal.” Ex. 1003 ¶ 65. Mr. Oslan relies on Mills’ disclosure of a microprocessor and associated electronics, including firmware employing a digital bandpass filter for detecting ECG signals. Id. (citing Ex. 1006, 2:20–23). This cited sentence of Mills further discloses characterizing ECG signals (processing) based on QRS complexes or pacer and defibrillator pulses, but ignoring noise and motion artifacts. Ex. 1006, 2:20–25. Patent Owner makes additional arguments, such as alleging that the” slip op. at 28
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,076,257 - PTAB · Oct 4, 2023 · IPR2023-00724 · APJ Susan L C Mitchell · IPR · Institution
The Board instituted IPR on claims 1–10, finding a reasonable likelihood that claim 1 is anticipated by WO421 and Lovshin and obvious over the asserted combinations.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDecided for petitioner
“The Examiner’s statement that NCT657 “does not teach or disclose a higher amount of 1 mg semaglutide” is incorrect and also fails to consider the teachings of the dosing ranges of WO421 and Lovshin, and the maximum dose of 1.2 mg of semaglutide taught in NCT773. For these reasons, we determine that Petitioner has sufficiently demonstrated a material error on the part of the Examiner, and we therefore decline to exercise our discretion to deny institution of inter partes review under 35 U.S.C. § 325(d).” slip op. at 15
- Other 314aInstitution denied discretionary otherDecided for petitioner
“Petition under Section 314(a), “particularly in light of the significant §325(d) concerns regarding Grounds 1 and 2—which address only claims 1–3—and in view of the substantive infirmities of Ground 3–5.” Prelim. Resp. 66–67. Patent Owner does not address Petitioner’s assertions that a trial here would most likely conclude before the parallel Delaware litigation, and Petitioner’s stipulation “that if the Board institutes, Petitioner will not pursue in the district court any instituted grounds against the originally-issued claims unless a change in law otherwise permits.” Pet. 65–66 (citing Sand Revolution II, LLC v. Cont’l Intermodal Grp., IPR2019-01393, Paper 24, 12 (PTAB June 16, 2020)). We do not agree with Patent Owner’s assertions concerning Section 325(d) as set forth above, and find nothing here that would warrant the exercise of our discretion to deny institution based on 35 U.S.C. § 314(a) to deny institution of an otherwise meritorious petition.” slip op. at 16
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“VI. CONCLUSION Based on the current record, we determine Petitioner has shown a reasonable likelihood that it will prevail in establishing that at least one claim of the ’462 patent is unpatentable. Accordingly, we institute review of all claims challenged on all of the grounds in the Petition. See Patent Trial and Appeal Board Consolidated Trial Practice Guide (Nov. 2019), 64, available at https://www.uspto.gov/ sites/default/files/documents/tpgnov.pdf. At this stage of the proceeding, the Board has not made a final determination as to the patentability of any challenged claim. Our view with regard to any conclusion reached in the foregoing analysis could change upon completion of the record. VII. ORDER Accordingly, it is: ORDERED that pursuant to 35 U.S.C. § 314, an inter partes review is hereby instituted as to claims 1–10 of the ’462 patent based on the unpatentability challenges presented in the Petition; and” slip op. at 39
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for petitioner
“Here, we agree with the parties that the preamble of claim 1 is limiting. The preamble provides context for the requirement of claim 1 that administration of the semaglutide is “to a subject in need thereof.” See Ex. 1001, 35:42–44. The preamble, when read in the context of the entirety of claim 1, recites a limitation of administering semaglutide to a subject with type 2 diabetes. Based on the constructions of the preamble provided by the parties, it appears they agree that the preamble does not require any particular level of efficacy. We agree. The Specification of the ’462 patent makes clear that “treatment” or “treating” as used in the ’462 patent does not require any particular degree of efficacy as these terms include the “full spectrum” of treatments for a condition. See Ex. 1001, 5. For instance, the Specification of the ’462 patent provides: In one embodiment the term “treatment” or “treating” as used herein means the management and care of a patient for the purpose of combating a condition, such as a disease or a disorder. In one embodiment the term “treatment” or “treating” is intended to include the full spectrum of treatments for a given condition from which the patient is suffering, such as administration of the active compound to alleviate the symptoms or complications; to delay the progression of the disease, disorder or condition; to alleviate or relieve the symptoms and complications; and/or, to cure or eliminate the disease, disorder, or condition as well as to prevent the condition. Ex. 1001, 5:16–27.” slip op. at 23
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · GrahamPatents in suitUS 10,335,462 - Novartis Pharmaceuticals Corporation v. Shilpa Pharma, Inc.All claims unpatentablePTAB · Sep 29, 2023 · IPR2022-00886 · APJ John G New · IPR · Final written decision
Claims 1–4 are unpatentable under §102 over Mutz; the Board did not reach the §103 Mutz and Gidwani or §102 Gidwani grounds.
RulingsFinal written decision- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“§ 6. This Final Written Decision is issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73. For the reasons set forth below, we determine that Petitioner Novartis Pharmaceuticals Corporation (“Petitioner”) has established, by a preponderance of the evidence of record, that challenged claims 1–4 of Patent Owner Shilpa Pharma Inc.’s (“Patent Owner”) U.S. Patent No. 9,266,816 B2 (Ex. 1001, the “’816 patent”) are unpatentable. Additionally, because we find that Petitioner has established that claims 1–4 are unpatentable, we dismiss as moot Petitioner’s Motion to Exclude Evidence (Paper 59). Furthermore, for the reasons we set forth below, Patent Owner’s Motion to Exclude Evidence (Paper 48) is dismissed-in-part as moot and denied-in-part. Both parties’ unopposed Motions to Seal are granted. See Papers 31, 33, 39, 40, 42, 46, 52, 56, 57, 60, 62, 68. Finally we deny Petitioner’s Motion for Sanctions against Patent Owner. (Paper 43).” slip op. at 2
- ExcludeMotion to exclude, grantedMixed
“§ 6. This Final Written Decision is issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73. For the reasons set forth below, we determine that Petitioner Novartis Pharmaceuticals Corporation (“Petitioner”) has established, by a preponderance of the evidence of record, that challenged claims 1–4 of Patent Owner Shilpa Pharma Inc.’s (“Patent Owner”) U.S. Patent No. 9,266,816 B2 (Ex. 1001, the “’816 patent”) are unpatentable. Additionally, because we find that Petitioner has established that claims 1–4 are unpatentable, we dismiss as moot Petitioner’s Motion to Exclude Evidence (Paper 59). Furthermore, for the reasons we set forth below, Patent Owner’s Motion to Exclude Evidence (Paper 48) is dismissed-in-part as moot and denied-in-part. Both parties’ unopposed Motions to Seal are granted. See Papers 31, 33, 39, 40, 42, 46, 52, 56, 57, 60, 62, 68. Finally we deny Petitioner’s Motion for Sanctions against Patent Owner. (Paper 43).” slip op. at 2
- PTAB / AIA Trials › Other PTAB motions (exclude, strike, seal, additional discovery, rehearing)Denied
“claims, Petitioner’s request that we do so as a sanction against Patent Owner is denied. Furthermore, having reviewed the arguments and evidence presented by Petitioner and Patent Owner, we conclude that the evidence is not sufficiently conclusive to warrant the additional imposition of financial sanctions. We consequently deny Petitioner’ Motion for Sanctions.” slip op. at 82
Patent outcomesUS 9,266,816 unpatentable§ 102 anticipationcites PhillipsPatents in suitUS 9,266,816 - Masimo Corporation v. Apple Inc.Institution deniedPTAB · Sep 18, 2023 · IPR2023-00635 · APJ Ken B Barrett · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that any challenged claim was unpatentable, principally because Rothkopf did not disclose an electrode positioned on the carrier member.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“A claim is anticipated only if each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference.” Verdegaal Bros., Inc. v. Union Oil Co. of Cal., 814 F.2d 628, 631 (Fed. Cir. 1987); see also Finisar Corp. v. DirecTV Group, Inc., 523 F.3d 1323, 1334 (Fed. Cir. 2008) (to anticipate a patent claim under 35 U.S.C. § 102, “a single prior art reference must expressly or inherently disclose each claim limitation”). Moreover, “[b]ecause the hallmark of anticipation is prior invention, the prior art reference—in order to anticipate under 35 U.S.C. § 102—must not only disclose all elements of the claim within the four corners of the document, but must also disclose those elements ‘arranged as in the claim.’” Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008) (quoting Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983)). Whether a reference anticipates is assessed from the perspective of one of ordinary skill in the art. See Dayco Prods., Inc. v. Total Containment, Inc., 329 F.3d 1358, 1368–69 (Fed. Cir. 2003) (“‘[T]he dispositive question regarding anticipation [i]s whether one skilled in the art would reasonably understand or infer from the [prior art reference’s] teaching’ that every claim element was disclosed in that single reference.” (second and third alterations in original) (quoting In re Baxter Travenol Labs., 952 F.2d 388, 390 (Fed. Cir. 1991))). slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“member.” On this record and for purposes of this decision, we determine that no claim terms require express construction.” slip op. at 14
- Claim Construction › Functional claiming / §112(f) means-plus-function › Whether §112(f) applies (Williamson, nonce words)§112(f) does not applyDecided for patent owner
“Independent claim 1 recites “a carrier member formed from a transparent material.” Ex. 1001, 56:13. Independent claim 9 recites “a carrier member having a circular carrier profile and positioned over the circular rear opening.” Id. at 57:20–21. Independent claim 15 recites “a carrier member protruding outward from an external surface of the housing member.” Id. at 58:10–11. None of these phrases is written in the form of a “means for” performing a function, the Petition does not identify a recited function,5 and Petitioner does not address the issue of whether the overall limitation recites adequate structure for performing any such function. See 5 On the conference call, Petitioner represented that “the Petition identifies carrying or supporting electrodes to be the function of the carrier member.” Ex. 1051, 49:3–10 (citing Pet. 10–12). The cited section of the Petition quotes the Specification, not the claim. Pet. 10. However, the focus of a means-plus-function analysis is the function recited in the claim. See 35 U.S.C. § 112(f). And, the Petition associates the function of supporting the electrodes with “carrier assembly” not “carrier member.” See Pet. 10–11 (“Petitioner interprets the claim term ‘carrier assembly’ according[ly] to mean any appropriate structure that supports the electrodes and, optionally, optical components.”). Dyfan, LLC v. Target Corp., 28 F.4th 1360, 1365 (Fed. Cir. 2022) (“The first step is to determine whether a claim limitation is drafted in means-plusfunction format, which requires us to construe the limitation to determine whether it connotes sufficiently definite structure to a person of ordinary skill in the art.”). Additionally, regardless as to whether “Courts have construed ‘member’ style claim terms as nonstructural” under the particular facts before those courts, it was incumbent upon Petitioner—particularly in light of the “carrier” modifier—to demonstrate that “carrier member” is a nonce term under the facts of the case before us, i.e. whether the term is a generic placeholder that a person of ordinary skill in the art of wearable electronic devices/watches would not recognize as a name for sufficiently definite structure. Pet. 11; Williamson, 792 F.3d at 1348 (“In making the assessment of whether the limitation in question is a means-plus-function term subject to the strictures of § 112, para. 6, our cases have emphasized that the essential inquiry is . . . whether the words of the claim are understood by persons of ordinary skill in the art to have a sufficiently definite meaning as the name for structure.”); see id. at 1350 (explaining that a nonce word is a generic term “that reflect[s] nothing more than verbal constructs [that] may be used in a claim in a manner that is tantamount to using the word ‘means’ because they ‘typically do not connote sufficiently definite structure’ and therefore may invoke § 112, para. 6.”); see also Kyocera, 22 F.4th 1380 (the court, in Petitioner’s cited case, determining, as part of its analysis, that “[a] person of ordinary skill in the art would not understand the claimed ‘lifter member’ to have ‘a sufficiently definite meaning as the name for a structure.’”). Accordingly, we determine that Petitioner has not shown persuasively that “carrier member” is a means-plus-function term.” slip op. at 15
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentable
“We find to be persuasive Patent Owner’s argument that “the Petition fails to cite anything in Rothkopf that describes electrodes attached to the ‘rear cover 608.’” Prelim. Resp. 23. Rothkopf discloses several embodiments of varying configurations. See, e.g., Ex. 1005 ¶¶ 4–27. Petitioner, in the block quoted contention above, stitches together several statements from various points in the Specification that individually are correct descriptions of an aspect of a particular embodiment or example but, together, fail to constitute a disclosure of an embodiment having electrodes positioned on the rear cover. For example, Rothkopf, in the paragraph 148 cited by Petitioner, states that “[i]n some embodiments, the biosensor module 710 includes the rear cover 608” and, “[a]s described in more detail . . . with respect to FIG. 16, the biosensor module 710 may include one or more light sources, one or more photodetectors, and one or more electrodes or conductive elements.” Ex. 1005 ¶ 148 (emphasis added). Thus, the biosensor module (mapped to the carrier assembly, not the carrier member) might include a rear cover and might include an electrode. It does not necessarily follow, however, that the electrode, when present, is positioned on the cover (mapped to the carrier member). Petitioner points to Rothkopf’s paragraph 201 as support for the proposition that “Rothkopf describes an embodiment where the electrodes are positioned on the cover 608.” Pet. 42 (citing Ex. 1005 ¶ 201). That paragraph provides that, “[a]s described above with respect to FIG. 6, in some embodiments, the biosensors are disposed relative to or attached to a rear cover 608 that is formed from an optically transparent material and is configured to be positioned with the opening of the housing 601.” Ex. 1005 ¶ 201. The paragraph does not describe an electrode as an exemplary biosensor in such embodiments. Rather, the paragraph goes on to describe the rear cover’s use with light sources 1611–1613 and detector 1614, i.e. optical sensor components. See id. (“The convex curved area of the rear cover 608 may include one or more windows or apertures that provide operational access to one or more internal components located within the housing. For example, the rear cover 608 may include an array of windows, each window including an aperture or opening for a respective light source 1611–1613 and/or the detector 1614.”). This description is consistent with Figure 16, which is relied on by Petitioner, where those optical sensor components are positioned on or under rear cover 608 (shaded orange in Petitioner’s annotated figure above) while electrodes 1601 and 1602 are positioned on the rear face of the housing (shaded in red) and thereby contact the user’s skin. See Ex. 1005 ¶¶ 190, 196 (“In this example [of Figure 16], a first electrode 1601 and second electrode 1602 are disposed on the rear face of the device 100. The first 1601 and second 1602 electrodes may be configured to make contact with the skin of the user’s wrist when the device is being worn.”). We determine that Petitioner has not shown adequately that a person of ordinary skill in the art would understand Rothkopf to disclose an electrode positioned on the carrier member, as recited in independent claims 9 and 15 and, by extension, claims 13 and 14, which depend from independent claim 9. Accordingly, Petitioner has not demonstrated a reasonable likelihood of prevailing on its anticipation challenge (Ground 1).” slip op. at 22
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,987,054 - Dr. Reddy’S Laboratories, Inc. v. Genentech, Inc., Hoffman-La Roche AG, And Abbvie Inc.Rehearing grantedPTAB · Aug 10, 2023 · PGR2022-00023 · APJ Jeffrey N Fredman · PGR · Rehearing
On Patent Owner’s rehearing request, the Board held claim 25 unpatentable under § 112(a) because it depends from claim 14, which lacks written description support.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“We therefore agree with Petitioner that we overlooked the correct dependency of claim 25. Claim 25, as a claim dependent from claim 14, lacks written descriptive support because claim 25 fails to cure the absence of descriptive support for claim 14.” slip op. at 4
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“In the Final Written Decision, we determined that claim 14 lacked descriptive support. We noted that Claim 14, in particular, recites a GDC-0199 dosing regimen “compris[ing] a dose of 20 mg per day for one week, a dose of 50 mg per day for one week, a dose of 100 mg per day for one week, a dose of 200 mg of GDC-0199 per day for one week, and a dose of 400 mg per day.” Unlike for claim 1, such disclosure is not found in a single example, but results from picking and choosing three separate selections from column 24. “The written description requirement is not met when, as here, the specification provides at best disparate disclosures that an artisan might have been able to combine in order to make the claimed invention.” Flash-Control, LLC v. Intel Corp., 2021 WL 2944592 *4 (Fed. Cir. 2021) (citing Ariad, 598 F.3d at 1352.)” slip op. at 3
§ 112 disclosurePatents in suitUS 10,993,942 - PTAB · Aug 8, 2023 · IPR2023-00546 · APJ Robert A Pollock · IPR · Institution
Instituted IPR on claims 1–5, 9–11, 13, 18, 19, and 28–30; Petitioner showed a reasonable likelihood of unpatentability under each asserted Ley and Newman anticipation and obviousness ground.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“In an IPR, the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). This burden of persuasion never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in inter partes review). slip op. at 13
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Relying on the testimony of Dr. Quackenbush, Petitioner asserts that a person of ordinary skill in the art (“POSA”) would have had: 1) an advanced degree (such as an M.D. or the equivalent of a Ph.D. in a life or physical sciences, engineering, or mathematics discipline) . . . 2) an understanding of various sequencing and next generation sequencing methods, sample preparation methods, targeted enrichment methods, bioinformatics methods for interpreting sequencing data, and methods for identifying genetic variants in a sample . . . . technology to conditions associated with nucleic acid variation, such as cancer, non-invasive prenatal testing, and transplant rejection . . . [and] 4) an understanding of cancer biology as it relates to mutations associated with tumor diagnosis, progression, and treatment, as well as awareness of the various types of mutations that can occur in and influence the course of a patient’s cancer. Pet. 4–5 (citing Ex. 1061 ¶ 37) (numbering added). Patent Owner does not presently challenge Petitioner’s definition. Prelim. Resp. 9. Based on the record before us, Petitioner’s proposed definition is consistent with the level of skill indicated in the cited references and the problems addressed in the ’611 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). For purposes of this Decision, we provisionally adopt Petitioner’s proposed definition of the person of ordinary skill in the art. C. Claim Construction” slip op. at 15
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner
“In general, “the preamble does not limit the claims.” Allen Eng’g Corp. v. Bartell Indus., Inc., 299 F.3d 1336, 1346 (Fed. Cir. 2002). Moreover, “where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation.” Rowe v. Dror, 112 F.3d 473, 478 (Fed. Cir. 1997). Considering the record before us, the preamble of claim 1 merely recites a purpose or intended use for the claimed method. In general, step (a) in the body of claim 1 entails obtaining sequence data from at least one biological sample from a subject. In step (b) the sequence data is used in to identify a set of genetic variants present in the biological sample. Step (c) entails creating a probe set corresponding to identified genetic variants. In step (d) the probe set is used to selectively enrich or amplify those variants if present in a second biological sample from the same or related individual, and thereby create a sequencing library. This library is sequenced in step (e) to identify the presence or absence of at least a subset of the genetic variants identified in step (b). As such, steps (a) through (e) define a complete invention, with the preamble merely stating a 4 To the extent Patent Owner maintains that the preamble is both limiting and distinguishes over the applied prior art, Patent Owner should clearly and explicitly identify during trial how it proposes the preamble should be construed—identifying evidentiary support for such construction according to well-established precedents. out the positively recited steps of the claim. As such, we do not presently view the preamble of claim 1 to be limiting and accord it no patentable weight.” slip op. at 18
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“nucleic acid probe molecules” Claim step 1(c) recites “obtaining a probe set comprising a plurality of nucleic acid probe molecules . . . configured to selectively enrich or amplify sequences.” Relying on the testimony of Dr. Quackenbush and disclosure of the ’611 patent, Petitioner contends that one of ordinary skill in the art “would have understood that the claimed ‘nucleic acid probe molecules’ include PCR primers, hybrid capture baits, and other such nucleic acid probe molecules for selectively amplifying or enriching sequences.” Pet. 17–18 (citing Ex. 1061 ¶ 98; Ex. 1001, 4:54–55, 5:16–18, 6:64–67). At this stage of the proceeding, Patent Owner does not address the meaning of “nucleic acid probe molecules.” Although the term is not presently contested, Petitioner’s definition is reasonable in light of the present record, and we provisionally adopt it for clarity. slip op. at 20
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,450,611 - PTAB · Aug 8, 2023 · IPR2023-00545 · APJ Robert A Pollock · IPR · Institution
The Board instituted IPR on claims 1–9, 13–19, and 21–29 on all three grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“For the reasons provided below, we determine Petitioner has satisfied the threshold requirement set forth in 35 U.S.C. § 314(a). Because Petitioner has demonstrated a reasonable likelihood that at least one claim of the ’783 patent is unpatentable, we institute an inter partes review of all challenged claims on each of the grounds raised in the Petition. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018); see also Guidance on the Impact of SAS on AIA Trial Proceedings (April 26, 2018) (available at https://www.uspto.gov/patents-application-process/patent-trial-and-appeal-board/trials/guidance-impact-sas-aia-trial) (“Guidance”). C. Real Parties-in-Interest” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Relying on the testimony of Dr. Quackenbush, Petitioner asserts that a person of ordinary skill in the art (“POSA”) would have had: 1) an advanced degree (such as an M.D. or the equivalent of a Ph.D. in a life or physical sciences, engineering, or mathematics discipline) . . . 2) an understanding of various sequencing and next generation sequencing methods, sample preparation methods, targeted enrichment methods, bioinformatics methods for interpreting sequencing data, and methods for identifying genetic variants in a sample . . . . 3) an understanding of clinical applications of sequencing technology to conditions associated with nucleic acid variation, such as cancer, non-invasive prenatal testing, and transplant rejection . . . [and] 4) an understanding of cancer biology as it relates to mutations associated with tumor diagnosis, progression, and treatment, as well as awareness of the various types of mutations that can occur in and influence the course of a patient’s cancer. Pet. 4–5 (citing Ex. 1020 ¶¶ 35) (numbering added). Patent Owner does not presently challenge Petitioner’s definition. Prelim. Resp. 11. Based on the record before us, Petitioner’s proposed definition is consistent with the level of skill indicated in the cited references and the problems addressed in the ’783 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). For purposes of this Decision, we provisionally adopt Petitioner’s proposed definition of the person of ordinary skill in the art.” slip op. at 19
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner
“In general, “the preamble does not limit the claims.” Allen Eng’g Corp. v. Bartell Indus., Inc., 299 F.3d 1336, 1346 (Fed. Cir. 2002). Moreover, “where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation.” Rowe v. Dror, 112 F.3d 473, 478 (Fed. Cir. 1997). Considering the record before us, the preamble of claim 1 merely recites a purpose or intended use for the claimed method. In general, steps (a) through (c) in the body of claim 1 require the use of “a personalized probe set” to identify the presence or absence of genetic variants in a subject, whereupon this information is used to generate a report in step (d). We presently read the body of claim 1 to define a 7 Pointing to isolated passages in the Specification, Patent Owner further contends that, “methods that existed at the time of invention were specific to a particular disease or cancer rather than personalized to a specific subject’s family genetics,” whereas the claimed method “is directed to personalized genetic testing and is ‘better focused on the personal characteristics of the subject.’” Prelim. Resp. 20–21 (citing Ex. 1001, 4:37–47, 31:27–28). We find this argument confusing, as we do not presently read the challenged claims as limited to a “subject’s family genetics.” 8 To the extent Patent Owner maintains that the preamble is both limiting and distinguishes over the applied prior art, Patent Owner should clearly and explicitly identify during trial how it proposes the preamble should be construed—identifying evidentiary support for such construction according to well-established precedents. complete invention, with the preamble merely stating a purpose or intended use, or, in another sense, simply the result of carrying out the positively recited steps of the claim. As such, we do not presently view the preamble of claim 1 to be limiting and accord it no patentable weight.” slip op. at 21
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“2) “nucleic acid probe molecules” Claim 1 recites the use of “nucleic acid probe molecules . . . configured to selectively enrich or amplify sequences.” Relying on the testimony of Dr. Quackenbush and disclosure of the ’783 patent, Petitioner contends that one of ordinary skill in the art “would have understood that the claimed ‘nucleic acid probe molecules’ include PCR primers, hybrid capture baits, and other such nucleic acid probe molecules for selectively amplifying or enriching sequences.” Pet. 15 (citing Ex. 1020 ¶ 95; Ex. 1001, 4:60–61, 5:23–25, 7:5–8, 7:25–26). At this stage of the proceeding, Patent Owner does not address the meaning of “nucleic acid probe molecules.” Although the term is not presently contested, Petitioner’s definition is reasonable in light of the present record, and we provisionally adopt it for clarity.” slip op. at 23
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,299,783 - Mylan Pharmaceuticals Inc. / Teva Pharmaceuticals USA, Inc. et al. v. Bayer Pharma AktiengesellschaftAll claims unpatentablePTAB · Jul 28, 2023 · IPR2022-01513 · APJ Tina E Hulse · IPR · Final written decision
Claims 1–8 are unpatentable: claims 1–2 as anticipated by Foley, claims 1–2, 5, and 8 as obvious over Foley, and claims 3–4, 6–7 as obvious over Foley and Plosker.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“We find Petitioner has the better position. We agree with Petitioner and Dr. Zusman that an M.D. with experience treating patients who worked in consultation with a team of specialists would include the qualifications recited by Patent Owner. Ex. 1037 ¶¶ 7–11. We, therefore, adopt Petitioner’s definition of a POSA, which indicates a high level of skill in the relevant art and is consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))). Even if there were a distinction between the parties’ respective definitions of the level of ordinary skill in the art, Patent Owner’s expert, Dr. Weitz, notes that his opinion would not change regardless of which definition is applied. See Ex. 2060 ¶ 26. Moreover, we find both Dr. Zusman and Dr. Weitz qualified to opine from the perspective of a POSA for purposes of this Decision as both possess at least the level of ordinary skill in the art. See Ex. 1002 ¶¶ 1–11; Ex. 2060 ¶¶ 1–11; see also Kyocera Senco Indus. Tools Inc. v. Int’l Trade Comm’n, 22 F.4th 1369,” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“3. Remaining Claim Terms Patent Owner also offers constructions for “coronary artery disease,” and the preamble (PO Resp. 23–32, 39–40), but none of these claim phrases Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). We now turn to the patentability challenges presented by Petitioner.” slip op. at 21
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITADecided for petitioner
“construction and determine that the term “clinically proven effective” is nonlimiting, as Petitioner asserts. See Pet. 11; Pet. Reply 8–9, 16. We begin our analysis with the language of the claims, which recite administering rivaroxaban and aspirin in amounts that are “clinically proven effective,” “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.” Ex. 1001, claims 1 and 5. We are persuaded that a POSA would have understood from a plain reading of the claims that the specific recited “amounts” of 8 We also noted in our Institution Decision that in the Delaware MDL, the parties stipulated that claim 1 “does not require FDA approval.” Dec. Inst. 15 n.6 (quoting Ex. 2019, 2). That is, the independent claims expressly recite that the rivaroxaban is administered in an amount of 2.5 mg twice daily, and that aspirin is administered in an amount of 75–100 mg daily. Ex. 1001, claims 1 and 5. Because the claims expressly recite the amounts of rivaroxaban and aspirin, further identifying these amounts as “clinically proven effective” is redundant and unnecessary, and does nothing to alter the method steps of administering the pharmaceutical, as otherwise recited by these claims. See Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1375 (Fed. Cir. 2001) (finding claim term “antineoplastically effective” not limiting where express dosage amounts are material claim limitations that do not change based on the intended result).” slip op. at 13
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableInherency foundUnpatentable
“Patent Owner again, however, misses the point. The question is not whether clinical trials may exist where the disclosed dosing regimen may not be clinically proven effective, or whether a POSA would necessarily recognize clinical proof of efficacy from the COMPASS protocol taught by Foley. Id. at 53–54. On the contrary, the question is whether “the [prior art] disclosure is sufficient to show that the natural result flowing from the operation as taught would result in the performance of the questioned function.” King Pharms., Inc. v. Eon Labs, Inc., 616 F.3d 1267, 1275 (Fed. Cir. 2010) (citation omitted). If it is, the Federal Circuit has held that it is “well-settled that the disclosure should be regarded as sufficient.” Id. As such, here, we consider whether the disclosure in Foley is sufficient to show that the natural result of the disclosed dosing regimen would be “clinically proven effective” by the COMPASS study disclosed by Foley. In this case, we know that to be true because the claimed process was confirmed by the same COMPASS study disclosed by Foley. See Bristol- Myers, 246 F.3d at 1376; see also Abbott Labs. v. Baxter Pharm. Prods., Inc., 471 F.3d 1363, 1369 (Fed. Cir. 2006) (finding method claims anticipated where prior art method disclosed the same steps in furtherance of the same purpose, and all that was contributed by the patent claims is the the claim term were limiting, we find Foley inherently discloses “clinically proven effective” amounts of rivaroxaban and aspirin. Having considered the arguments and evidence presented at trial, we find Petitioner has shown by a preponderance of the evidence that claims 1 and 2 are anticipated by Foley.” slip op. at 26
Patent outcomesUS 10,828,310 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,828,310 - Mylan Pharmaceuticals Inc. / Teva Pharmaceuticals USA, Inc. et al. v. Bayer Pharma AktiengesellschaftAll claims unpatentablePTAB · Jul 28, 2023 · IPR2022-01515 · APJ Tina E Hulse · IPR · Final written decision
Claims 1–8 are unpatentable: claims 1–2 as anticipated by Foley, claims 1–2, 5, and 8 as obvious over Foley, and claims 3–4, 6–7 as obvious over Foley and Plosker.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“We find Petitioner has the better position. We agree with Petitioner and Dr. Zusman that an M.D. with experience treating patients who worked in consultation with a team of specialists would include the qualifications recited by Patent Owner. Ex. 1037 ¶¶ 7–11. We, therefore, adopt Petitioner’s definition of a POSA, which indicates a high level of skill in the relevant art and is consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“construction and determine that the term “clinically proven effective” is nonlimiting, as Petitioner asserts. See Pet. 11; Pet. Reply 8–9, 16. We begin our analysis with the language of the claims, which recite administering rivaroxaban and aspirin in amounts that are “clinically proven effective,” “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.” Ex. 1001, claims 1 and 5. We are persuaded that a POSA would have understood from a plain reading of the claims that the specific recited “amounts” of 8 We also noted in our Institution Decision that in the Delaware MDL, the parties stipulated that claim 1 “does not require FDA approval.” Dec. Inst. 15 n.6 (quoting Ex. 2019, 2). That is, the independent claims expressly recite that the rivaroxaban is administered in an amount of 2.5 mg twice daily, and that aspirin is administered in an amount of 75–100 mg daily. Ex. 1001, claims 1 and 5. Because the claims expressly recite the amounts of rivaroxaban and aspirin, further identifying these amounts as “clinically proven effective” is redundant and unnecessary, and does nothing to alter the method steps of administering the pharmaceutical, as otherwise recited by these claims. See Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1375 (Fed. Cir. 2001) (finding claim term “antineoplastically effective” not limiting where express dosage amounts are material claim limitations that do not change based on the intended result).” slip op. at 13
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“2. Analysis “A claim is anticipated if each and every element as set forth in the claim is found, either expressly or inherently, in a single prior art reference.” Arbutus Biopharma Corp. v. ModernaTX, Inc., 65 F. 4th 656, 662 (Fed. Cir. 2023). The Federal Circuit explains that “[a]nticipation by inherent disclosure is appropriate only when the reference discloses prior art that must necessarily include the unstated limitation.” Monsanto Tech. LLC v. Inherent anticipation requires “merely that the disclosure of the prior art is sufficient to show that the natural result flowing from the operation as taught in the prior art would result in the claimed product.” SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331, 1343–44 (Fed. Cir. 2005) (internal quotes omitted).” slip op. at 23
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“In analyzing the obviousness of a combination of prior art elements, it can be important to identify a reason that would have prompted one of skill in the art “to combine . . . known elements in the fashion claimed by the patent at issue.” KSR, 550 U.S. at 418. A precise teaching directed to the specific subject matter of a challenged claim is not necessary to establish obviousness. Id. Rather, “any need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed.” Id. at 420. Accordingly, Petitioner must show that “a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1381 (Fed. Cir. 2016) (quotations and citations omitted).” slip op. at 28
Patent outcomesUS 10,828,310 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,828,310
Holdings, summaries, rulings, issues, outcomes, winners and claim constructions shown for a decision were generated by a large language model reading the opinion. They are a guide to the decision, not the decision. Confirm every one against the court's own text before relying on it. Outcomes read from the patent owner’s side. Party names are extracted from the decision and are missing on about 900 short Director denials and scans, which carry the trial number instead.