- Tiktok Inc. v. Cellspinsoft, Inc.InstitutedPTAB · Sep 30, 2024 · IPR2024-00770 · APJ Michael A Valek · IPR · Institution
The Board instituted IPR on claims 1, 2, 4–7, and 9–18 on all petitioned grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“In view of Petitioner’s Sotera stipulation, we will not exercise discretion to deny institution under 35 U.S.C. § 314(a). The Director has 8 Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 (Mar. 20, 2020) (precedential) (“Fintiv”). 9 Sotera Wireless, Inc. v. Masimo Corp., IPR2020-01019, Paper 12, 18–19 (Dec. 1, 2020) (“Sotera”). issued guidance stating that, when such a stipulation is presented, the PTAB will not discretionarily deny institution in view of the parallel litigation. Ex. 1034, 3. That guidance is unequivocal and dispositive of the Fintiv analysis here.” slip op. at 8
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“or substantially the same prior art or arguments previously were presented to the Office.” 35 U.S.C. § 325(d). The analyze this issue under the following two-part framework set forth in Advanced Bionics: (1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of [the] first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics, IPR2019-01469, Paper 6, 8.” slip op. at 10
- Other 314aDenied
“Patent Owner’s argument for discretionary denial under § 316(b) is unavailing. The statute provides that “[i]n prescribing regulations under this section, the Director shall consider the effect of any such regulation on the economy, the integrity of the patent system, the efficient administration of the Office, and the ability of the Office to timely complete proceedings instituted under this chapter.” 35 U.S.C. § 316(b). However, Patent Owner identifies no regulation, rule, or Office guidance that supports its argument here. In the absence of such, we decline to apply any discretion the Director may have under § 316(b) to deny the Petition, notwithstanding its merits, based on the policy considerations and concerns alleged by Patent Owner.” slip op. at 12
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“iii. Conclusion – Grounds 1A–B After considering the arguments and cited evidence of record, we determine that for purposes of institution, Petitioner sufficiently shows that both the combination of Hiroishi, Takahashi and Bluetooth in Ground 1A and the combination of Hiroishi, Kahn, and Bluetooth in Ground 1B teach or suggest each limitation of claims 1, 2, 4–7 and 9–18,20 and that a person of ordinary skill in the art would have had a reason to combine the teachings of these references with a reasonable expectation of success. See, e.g., Pet. 11– 68. Accordingly, on this record, Petitioner shows a reasonable likelihood of prevailing on Grounds 1A–B, and on this basis, we institute an inter partes review of all challenged claims. See 37 C.F.R. § 42.208(a). 19 While the term “WMTP” appears in these figures, it does not seem to be defined or discussed elsewhere in Kahn. 20 At this stage, Patent Owner does not make any additional arguments against Petitioner’s showing for the dependent claims.” slip op. at 42
Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 8,904,030 - PTAB · Sep 30, 2024 · IPR2024-00769 · APJ Gregg I Anderson · IPR · Institution
The Board instituted inter partes review of claims 1–15 on all asserted grounds, finding a reasonable likelihood that the claims are unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“In view of Petitioner’s Sotera stipulation, we will not exercise discretion to deny institution under 35 U.S.C. § 314(a). The Director has issued guidance stating that, when such a stipulation is presented, the PTAB will not discretionarily deny institution in view of the parallel litigation. Ex. 1034,8 3. That guidance is unequivocal and dispositive of the Fintiv analysis here.” slip op. at 11
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“Section 325(d) provides discretion to “reject the petition” if “the same or substantially the same prior art or arguments previously were presented to the Office.” 35 U.S.C. § 325(d). The analyze this issue under the following two-part framework set forth in Advanced Bionics: (1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of [the] first part of the framework is 9 Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 (PTAB Feb. 13, 2020) (precedential). satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics, IPR2019-01469, Paper 6, 8.” slip op. at 12
- Other 314aDecided for petitioner
“Patent Owner’s argument for discretionary denial under § 316(b) is unavailing. The statute provides that “[i]n prescribing regulations under this section, the Director shall consider the effect of any such regulation on the economy, the integrity of the patent system, the efficient administration of the Office, and the ability of the Office to timely complete proceedings instituted under this chapter.” 35 U.S.C. § 316(b). However, Patent Owner identifies no regulation, rule, or Office guidance that supports its argument here. In the absence of such, we decline to apply any discretion the Director may have under § 316(b) to deny the Petition, notwithstanding its merits, based on the policy considerations and concerns Patent Owner alleges.” slip op. at 15
- Skill levelSkill level petitioner adoptedDecided for petitioner
“A. Level of Ordinary Skill in the Art Petitioner alleges a person of ordinary skill in the art would have had at least a bachelor’s degree in electrical engineering, computer engineering, or computer science, and two years of experience in the field of consumer electronics, with exposure to digital camera technology and wireless communications. . . . Superior education could compensate for a deficiency in work experience, and vice-versa. Pet. 6 (citing Ex. 1030 ¶¶ 94–95). Patent Owner does not propose a level of ordinary skill. See Prelim. Resp. Petitioner’s proposal is supported by the Lett Declaration and is consistent with the ’766 patent. Accordingly, we apply Petitioner’s articulation.” slip op. at 15
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 9,900,766 - Resmed Corp. v. Cleveland Medical Devices, Inc.Institution deniedPTAB · Jun 24, 2024 · PGR2024-00012 · APJ Ulrike W Jenks · PGR · Institution
The Board denied institution of PGR on claims 1–20 because Petitioner did not show the patent was PGR-eligible, having failed to show inadequate written-description support or lack of enablement in the pre-AIA priority applications.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Petitioner has the burden of establishing eligibility for post-grant review. See Mylan Pharms. Inc. v. Yeda Res. & Dev. Co., PGR2016-00010, Paper 9 at 10 (PTAB Aug. 15, 2016). To show that the ’284 patent is eligible for post-grant review, Petitioner bears the burden of proving that the challenged claims lack the priority benefit of the filing date of an earlier 7 The ’284 patent issued from a transition application. A “transition application” is a patent application filed on or after March 16, 2013 (the effective date of the AIA), but which claims priority to an application that was filed prior to the effective date of the AIA. See, e.g., MPEP § 2159.04. challenged claims, or a claim pending during examination of the ’266 application, “was not disclosed in compliance with the written description and enablement requirements of § 112(a) in the earlier application for which the benefit of an earlier filing date prior to March 16, 2013 was sought.” Inguran, LLC v. Premium Genetics (UK) Ltd., PGR2015-00017, Paper 8 at 11 (PTAB Dec. 22, 2015).” slip op. at 9
- Disclosure Requirements (§112) › Written description (Ariad)Written description adequateNot shown unpatentable
“Thus, the ’284 patent specification explains that the system can adjust the positive airway pressure supplied to the subject without human intervention. The system gathers information from the sensors and uses it to “monitor the condition of the subject” and “determine a level of severity of the subject’s sleeping disorder.” Ex. 1001, 23:20–41. Based on this the subject,” for example by adjusting the positive airway pressure provided to the subject. See id. at 19:3–17, 3:37–55. In this way, the ’284 patent specification discloses generating “an index of treatment efficacy” where “the index [is] based in part on data of severity of sleep disorder symptoms of the subject and data of usage of the PAP device by the subject,” because the system uses data collected from the sensors to evaluate the severity of the subject’s sleeping disorder and efficacy of the current treatment, and can adjust the treatment without human intervention as needed. Accordingly, Petitioner has not demonstrated that it is more likely than not that the ’284 patent claims lack written description support in the pre-AIA priority applications for “an index of treatment efficacy” claim term.” slip op. at 13
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)EnabledNot shown unpatentable
“’284 patent claims are not enabled. Prelim. Resp. 24–30. We find that Petitioner has failed to demonstrate, more likely than not, that any experimentation would have been undue in view of the Wands factors. Prelim. Resp. 25 (citing Wands, 858 F.2d at 737). On this record, Petitioner has not demonstrated that the claimed subject matter is unpredictable or would require undue experimentation. Petitioner argues that “the challenged claims are not enabled regarding the ‘index of treatment efficacy’ claim elements.” Pet. 24. But as Patent Owner establishes, Petitioner acknowledges that determining treatment efficacies was merely applying a known technique. See Prelim. Resp. 26 (citing Pet. 36 (determining treatment efficacy “would amount to merely applying a known technique (i.e., determining treatment efficacy based on multiple factors) to a known device ready for improvement (e.g., CPAP treatment system comprising multiple devices) to yield predictable results (i.e., improve operation of CPAP treatment to better treat the patient and its disorder)”). On this record, Patent Owner further demonstrates that “it was well- known in the art [] how to determine indices of treatment efficacy based on breathing metric data over a period of time.” Prelim. Resp. 26; Ex. 2001 at 175 (“Efficacy, in the context of [obstructive sleep apnea] OSA, reflects the ability of treatment to prevent the occurrence of obstructive breathing events during periods when the treatment is being physically applied.”); Ex. 2002 at 1–2 (based on the apnea-hypopnea index (AHI) the severity of obstructive sleep apnea (OSA) can be calculated); Ex. 2003 at 1 (“ResLink presents this efficacy information along with integrated oximetry data for simultaneous onscreen viewing and analysis.”)). index of treatment efficacy on a cell phone or transmitting it to a remote internet site.” Pet. 25. Petitioner, however, has not demonstrated, more likely than not, that it would take undue experimentation to carry out such display or transmission. The Petition merely suggests that the specification lacks enablement of these claim limitations, but fails to provide any analysis of pertinent factors, such as the state of the prior art, the level of ordinary skill, or the level of predictability in the art with regard to displaying and transmitting data on a cell phone at the time of the invention. In sum, we conclude that Petitioner has failed to show that it is more likely than not that the challenged claims are not enabled.” slip op. at 23
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“In this post-grant review, we construe the claims of the ’284 patent “using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. § 282(b).” 37 C.F.R. § 42.200(b) (2019). Under that standard, the words of a claim are generally given their “ordinary and customary meaning,” which is the meaning the term would have to a person of ordinary skill at the time of the invention, in the context of the entire patent including the specification. Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). Petitioner contends that “[n]o claim term needs formal construction for purposes of evaluating the prior art in this Petition.” Pet. 16. Patent Owner also does not construe any claim terms. See generally Prelim. Resp. For purposes of this Decision, and based on the record before us, we determine that none of the claim terms requires an explicit construction to determine whether to institute post-grant review. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only 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))).” slip op. at 8
Claim construction§ 112 disclosurePatents in suitUS 11,602,284 - Life Spine, Inc. v. Globus Medical, Inc.All claims unpatentablePTAB · Jun 11, 2024 · IPR2022-01602 · APJ Devon Zastrow Newman · IPR · Final written decision
Claims 1–14 are unpatentable: claims 1–3 and 8–10 are anticipated by Weiman, and claims 4–7 and 11–14 are obvious over Weiman and Mozeleski; the revised motion to amend is denied.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Pet. 11 (citing Ex. 1002 (Drewry Decl.) ¶¶ 76–79). Patent Owner does not dispute Petitioner’s proposal. See generally Response. We adopt Petitioner’s proposed level of ordinary skill in the art because it is consistent with the cited prior art and is undisputed on this record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (indicating that the prior art itself may reflect an appropriate skill level).” slip op. at 11
- Expert testimonyPetitioner expert creditedDecided for petitioner
“We find persuasive, and credit, Mr. Drewry’s testimony that (1) a POSITA would have appreciated that the proposed modification to replace Weiman’s screw/socket with Waugh’s angled version provides benefits including “avoiding selected muscular and abdominal anatomical structures,” and (2) such “benefits would have been desirable for certain applications, such as those where the patient’s anatomy dictates that OLIF would provide the patient with the best medical outcome.” Ex. 1044 (Drewry Second Supp. Decl.) ¶¶ 23–26; see also Ex. 1043 (Waugh), ¶¶ 54, 87–90 (describing use of angled screw holes to, e.g., “receive a fastener via a surgical pathway” and configured “to penetrate endplate tissue of a vertebral body”). We find the weight of evidence supports Petitioner’s articulation of a POSITA’s understanding of how to use angles to avoid anatomical features” slip op. at 61
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner asserts that no terms require construction “because they are shown to be anticipated and/or obvious regardless of construction.” Pet. 12. Patent Owner did not propose any terms for construction. See generally Response. We determine that no claim terms require express construction to render this Decision.” slip op. at 18
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“j. Conclusion on Claim 1 For the above reasons, we determine that Petitioner has shown by a preponderance of the evidence that Weiman discloses each and every limitation of claim 1, and therefore anticipates claim 1.” slip op. at 28
Patent outcomesUS 9,956,087 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 9,956,087 - PTAB · May 1, 2024 · PGR2024-00009 · APJ Tina E Hulse · PGR · Institution
The Board instituted PGR on claims 1–8, 12, and 20 on all asserted grounds, finding the petition showed a reasonable likelihood that at least one claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have authority under 35 U.S.C. § 324(a), which provides that a post-grant review may not be instituted “unless . . . the information presented in the petition . . ., if such information is not rebutted, would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” Upon considering the arguments and evidence presented by the parties, we determine Petitioner has shown that it is more likely than not that at least one of the claims challenged in the Petition is unpatentable.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner does not contest Petitioner’s definition of the level of ordinary skill in the art for purposes of its Preliminary Response. Prelim. Resp. 20. Although defining a person of ordinary skill in the art as a “team” of individuals is not conventional, because Patent Owner does not dispute the definition at this stage of the proceeding, we adopt Petitioner’s definition as it appears to be 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” slip op. at 7
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for petitioner
“Patent Owner “agrees that the preamble is limiting as a statement of the intentional purpose for which the method is performed—treating patients with CLL or SLL.” Prelim. Resp. 18. But Patent Owner disagrees with an “attempt to rewrite an express definition in the specification” and adds a safety requirement that is not recited in the definition of “therapeutically effective amount” in the Specification. Id. at 19. Patent Owner contends “therapeutically effective amount” should be construed according to its express definition in the Specification to mean “a sufficient amount of an agent or a compound being administered which will relieve to some extent one or more of the symptoms [of a] B-cell lymphoproliferative disorder (BCLD) . . . [or] reduction and/or alleviation of the signs, symptoms, or causes of BCLD.” Id. (citing Ex. 1001, 24:58–63). Notwithstanding its proposed construction, Patent Owner posits that “a precise construction of ‘therapeutically effective amount’ is not necessary to resolve the dispute here” and “[e]ven under Petitioner’s flawed construction of ‘therapeutically effective amount,’ Petitioner fails to meet its burden to warrant institution.” Id. at 20. Having considered the parties’ respective arguments at this stage of the proceeding, we agree that the preamble is limiting as a statement of intentional purpose. See Eli Lilly & Co. v. Teva Pharms. Int’l GmbH, 8 F.4th 1331, 1342 (Fed. Cir. 2021) (stating the Federal Circuit “has not hesitated to hold preambles limiting when they state an intended purpose for methods of using a compound”). Moreover, we find Patent Owner has the better position that the term “therapeutically effective amount” should be construed according to its express definition in the Specification and not according to the separate and distinct definition of “effective amount,” as Petitioner suggests. That is, we decline to import a safety limitation to the term “therapeutically effective amount” that only appears in the definition for “effective amount.” Compare Ex. 1001, 24:58–62 with id. at 24:66–25:2” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“an “attempt to rewrite an express definition in the specification” and adds a safety requirement that is not recited in the definition of “therapeutically effective amount” in the Specification. Id. at 19. Patent Owner contends “therapeutically effective amount” should be construed according to its express definition in the Specification to mean “a sufficient amount of an agent or a compound being administered which will relieve to some extent one or more of the symptoms [of a] B-cell lymphoproliferative disorder (BCLD) . . . [or] reduction and/or alleviation of the signs, symptoms, or causes of BCLD.” Id. (citing Ex. 1001, 24:58–63). Notwithstanding its proposed construction, Patent Owner posits that “a precise construction of ‘therapeutically effective amount’ is not necessary to resolve the dispute here” and “[e]ven under Petitioner’s flawed construction of ‘therapeutically effective amount,’ Petitioner fails to meet its burden to warrant institution.” Id. at 20. Having considered the parties’ respective arguments at this stage of the proceeding, we agree that the preamble is limiting as a statement of intentional purpose. See Eli Lilly & Co. v. Teva Pharms. Int’l GmbH, 8 F.4th 1331, 1342 (Fed. Cir. 2021) (stating the Federal Circuit “has not hesitated to hold preambles limiting when they state an intended purpose for methods of using a compound”). Moreover, we find Patent Owner has the better position that the term “therapeutically effective amount” should be construed according to its express definition in the Specification and not according to the separate and distinct definition of “effective amount,” as Petitioner suggests. That is, we decline to import a safety limitation to the term “therapeutically effective amount” that only appears in the definition for “effective amount.” Compare Ex. 1001, 24:58–62 with id. at 24:66–25:2 amount” but not “therapeutically effective amount”). Thus, we construe the term “therapeutically effective amount” to mean “a sufficient amount of an agent of a compound being administered which will relieve to some extent one or more of the symptoms [of] B-cell lymphoproliferative disorder (BCLD).”” slip op. at 9
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,672,803 - Atea Pharmaceuticals, Inc. v. Gilead Sciences, Inc.Institution deniedPTAB · Feb 21, 2024 · PGR2023-00046 · APJ Susan L C Mitchell · PGR · Institution
The Board denied institution because Atea did not show claim 1 was more likely than not unpatentable for lack of written description, lack of enablement, or anticipation.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Institution of post-grant review is authorized by statute only when “the information presented in the petition . . . demonstrate[s] that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324; see 37 C.F.R. § 42.4. Upon considering the Petition, Preliminary Response, and the cited evidence, we conclude that Petitioner has not satisfied its burden under 35 U.S.C. § 324 to show that it is more likely than not that claim 1 is unpatentable.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“The major differences between Petitioner’s and Patent Owner’s definitions of a skilled artisan include the number of years of drug discovery experience that is necessary and the breadth of the fields of endeavor with which a POSA should be familiar. We agree with Patent Owner that a POSA includes a team of skilled artisans with skill sets in the various aspects of drug development, but determine that Petitioner has addressed those necessary skill sets in its definition. We also determine on this record that Petitioner has assessed adequately the level of experience needed, and do not agree with Patent Owner that greater years of experience are necessary for a POSA in this instance. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007) (“A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.”). Because Petitioner’s definition of a person of skill in the art appears commensurate with the level of skill reflected in the asserted art in this case as well as the ’361 patent itself, we apply Petitioner’s proposed level of ordinary skill in the art to determine whether it is more likely than not that Petitioner would prevail on its challenges to claim 1. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (stating prior art itself can reflect the appropriate level of ordinary skill in the art).” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“C. Claim Construction We construe claims “using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. [§] 282(b).” 37 C.F.R. § 42.200. Therefore, we construe the challenged claims under the framework set forth in Phillips v. AWH Corp., 415 F.3d 1303, 1312–19 (Fed. Cir. 2005) (en banc). Under this framework, claim terms are given their ordinary and customary meaning, as would be understood by a person of ordinary skill in the art, at the time of the invention, in light of the language of the claims, the specification, and the prosecution history of record. Id. Only those terms that are in controversy need be construed, and only to the extent necessary to resolve the controversy. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). Both parties agree that we need not construe any claim terms here to resolve the issues in this proceeding. See Pet. 16; Prelim. Resp. 18–19. We agree with the parties that we need not construe any claim terms in this proceeding to resolve whether to institute a post-grant review.” slip op. at 11
- BurdenNot shown unpatentable
“In applying the rubric set forth in Ariad to determine whether claim 1 has appropriate written description support, we can look for structural features common to the members of the subgenus of claim 1 so that one of skill in the art can “visualize or recognize” the members of the subgenus. See Ariad, 598 F.3d at 1350. To do this, we look “for blaze marks within the disclosure that guide attention to the claimed species or subgenus.” See Regents of the Univ. of Minn., 61 F.4th at 1356. In this regard, the fourteenth aspect of the third embodiment is the blaze mark that points to the subgenus of claim 1. We do not need to find blaze marks that identify the fourteenth aspect of the third embodiment as the only formula of merit or the only one that should be claimed. Rather, we look to the written description to see if it describes sufficient structural features common to the members of the subgenus of claim 1 such that a POSA can visualize or recognize the members of that subgenus, thereby demonstrating that the inventors possessed the subject matter of the claim at the time they filed their application.” slip op. at 20
Claim construction§ 102 anticipation§ 112 disclosurecites KSRPatents in suitUS 11,642,361 - Guardant Health, Inc. v. University Of WashingtonAll claims unpatentablePTAB · Jan 11, 2024 · IPR2022-01158 · APJ Zhenyu Yang · IPR · Final written decision
Claims 1–28 are unpatentable because Eltoukhy anticipates them; the Board found they were not entitled to a priority date before Eltoukhy’s publication.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Level of Ordinary Skill in the Art In determining the level of ordinary skill in the art, various factors may be considered, including the “type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field.” In re GPAC, Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995). Furthermore, the prior art itself can reflect the appropriate level of ordinary skill in the art. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). Here, Petitioner asserts that an ordinarily skilled artisan “would typically have an advanced degree, such as a Ph.D., with research experience in genomics, molecular biology, bioinformatics, or a related field, or could have less education but significant professional experience in one or more of these fields.” Pet. 8–9 (citing Ex. 1002 ¶ 38). Patent Owner states that for the purposes of this proceeding, it does not dispute Petitioner’s definition of the skill level. PO Resp. 2 (citing Ex. 2023 ¶¶ 21, 22). After reviewing the record, we adopt Petitioner’s definition as it is consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention.” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionOther
“1. “Sequence Reads” Petitioner argues that, for purposes of this Decision, no claim term needs specific construction beyond its plain and ordinary meaning. Pet. 10–11. Petitioner, however, seeks to provide context for understanding the scope of the term “sequence reads.” Specifically, Petitioner contends that “sequence reads” are produced by sequencing at least some of the tagged strands, whereas “consensus sequences” are generated by collapsing sequence reads. Id. at 11 (citing Ex. 1001, 4:45–47, 20:50–22:25, 23:29–57, 24:46–48, claim 1, claim 6). In the Decision to Institute, we agreed with Petitioner that “[t]he claims of the ’951 patent as well as the specification make clear that a ‘sequence read’ is different and distinct from a ‘consensus sequence.’” DI 7 (quoting Pet. 11). Patent Owner does not dispute Petitioner’s assertion. PO Resp. 12. Based on the complete record, we see no reason to change our determination of the scope of the term “sequence reads.”” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“We disagree with Patent Owner’s proposed construction of the terms “paired sequence reads” and “unpaired sequence reads.” Even though the ’951 patent Specification discloses grouping sequence reads “sharing a unique set of SMI tags” into paired families,4 “[t]he written description part of the specification itself does not delimit the right to exclude. That is the function and purpose of claims.” Phillips, 415 F.3d at 1312 (“[T]he claims of a patent define the invention to which the patentee is entitled the right to exclude.”). Here, claim 1 explicitly defines the terms “paired sequence reads” and “unpaired sequence reads.” Indeed, in the context of paired versus unpaired sequence reads, claim 1 specifies that the complementarity is related to the “original parent polynucleotide molecule,” and not the duplex tags. For example, claim 1 recites that “each unpaired read represents a first tagged strand having no second differently tagged complementary strand derived from an original parent polynucleotide molecule represented among said sequence reads in said set of sequence reads.” Ex. 1001, 37:50–55 (emphasis added). Thus, the plain claim language contradicts Patent Owner’s argument” slip op. at 11
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateDecided for petitioner
“Claim 1 defines the terms “paired sequence reads” and “unpaired sequence reads” based on the complementarity of the target sequence strands derived from the “original parent polynucleotide molecule.” Ex. 1001, 37:46–55. As explained above, we reject Patent Owner’s contention that a sequence read is considered unpaired solely based on the complementarity of the SMI tags. See supra Section II.C.2. Due to the “errors introduced during sample preparation and sequencing” (Ex. 1029 ¶ 5), there are four outcomes when determining the complementarity of the sequence reads of two strands of SMI-linked target sequence: (1) the first SMI tag and the first strand target sequence are complementary to the second SMI tag and the second strand target sequence, respectively; (2) the first SMI tag is complementary to the second SMI tag but the first strand target sequence is not complementary to the second strand target sequence; (3) the first SMI tag is not complementary to the second SMI tag but the first strand target sequence is complementary to the second strand target sequence; and (4) the first SMI tag is not complementary to the second SMI tag, and the first strand target sequence is not complementary to the second strand target sequence. It is undisputed that Schmitt groups sequence reads into paired families based on the SMI tags, and Schmitt only considers sequences in which “information from both DNA strands was in perfect agreement.” Ex. 1029 ¶¶ 14, 96; PO Resp. 18. Thus, among the four outcomes, only scenario (1), in which both the SMI tags and the target sequences are complementary, represents a “paired sequence read,” which claim 1 defines as corresponding to “sequence reads generated from a first tagged strand and a second differently tagged complementary strand derived from an original parent polynucleotide molecule.” Ex. 1001, 37:46–50. Contrary to Patent Owner’s argument (see PO Resp. 26), in Schmitt,” slip op. at 18
Patent outcomesUS 10,752,951 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites PhillipsPatents in suitUS 10,752,951 - PTAB · Dec 1, 2023 · PGR2022-00025 · APJ Susan L C Mitchell · PGR · Remand
The Board granted PGR of claims 1–19, finding claim 1 more likely than not anticipated by Grigoriadis and claims 1–19 more likely than not lacking written-description support.
RulingsRemand decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Institution of post-grant review is authorized by statute only when “the information presented in the petition . . . demonstrate[s] that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324; see 37 C.F.R. § 42.4. Upon considering the Petition, Patent Owner Preliminary Response, and the cited evidence in light of the Director’s Decision, we conclude that Petitioner has satisfied its burden under 35 U.S.C. § 324 to show that it is more likely than not that at least 1 of the claims challenged in the Petition is unpatentable. Therefore, we grant institution of a post-grant review.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“B. Person of Ordinary Skill in the Art Factual indicators of the level of ordinary skill in the art include “the various prior art approaches employed, the types of problems encountered in the art, the rapidity with which innovations are made, the sophistication of the technology involved, and the educational background of those actively working in the field.” Jacobson Bros., Inc. v. U.S., 512 F.2d 1065, 1071 (Ct. Cl. 1975); see also Orthopedic Equip. Co. v. U.S., 702 F.2d 1005, 1011 (Fed. Cir. 1983) (quoting with approval Jacobson Bros.).” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for petitioner
“Independent claim 1 recites a method of treating CAH by reducing an A4 level “from baseline” after administering a CRF1 receptor antagonist to a CAH patient. See Ex. 1001, 47:51–48:5. The Specification expressly teaches that, with respect to the clinical phase 2 trial described in Example 4, “Patients will have overnight [pharmacokinetic/pharmacodynamics] PK/PD assessments performed at baseline, which include an [sic] pre-dose overnight assessment and a post-dose overnight assessment for PK/PD following administration of the first dose.” Ex. 1001, 41:55–59. This is the same quotation and clinical trial relied upon by Dr. Barnes in his Declaration, and is the only definition of a “baseline” in the ’201 patent. See Ex. 1037, 36–37. We note that placebos were evidently not employed in the phase 2 clinical study of Example 4.5 Given the sole exemplary description of “baseline” in Example 4 of the Specification, we construe the claim term reciting “reduced from baseline” as meaning “a reduction in A4 level compared to an A4 level measurement made prior to, and/or at the beginning of, administration of the drug.”” slip op. at 10
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Reference is prior artInstituted
“A claim is unpatentable as anticipated under 35 U.S.C. § 102 only when “every element and limitation of the claim was previously described in a single prior art reference, either expressly or inherently, so as to place a person of ordinary skill in possession of the invention.” Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d 1075, 1082 (Fed. Cir. 2008). A reference may inherently anticipate if a claim limitation that is not expressly disclosed “is necessarily present, or inherent, in the single anticipating reference.” Verizon Servs. Corp. v. Cox Fibernet Va., Inc., 602 F.3d 1325, 1337 (Fed. Cir. 2010). Thus, the “very essence of inherency is that one of ordinary skill in the art would recognize that a reference unavoidably teaches the property in question.” Agilent Technologies, Inc. v. Affymetrix, Inc., 567 F.3d 1366, 1383 (Fed. Cir. 2009) (emphasis added).” slip op. at 23
Claim construction§ 102 anticipation§ 112 disclosureDiscretionary denialcites PhillipsPatents in suitUS 11,007,201 - PTAB · Oct 31, 2023 · PGR2022-00040 · APJ Cynthia M Hardman · PGR · Final written decision
The Board cancelled claims 1–17 and denied substitute claims 18–30 for lack of written-description support; it did not reach the remaining grounds against the substitute claims.
RulingsFinal written decision- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend granted in partGranted in part
“For the reasons discussed below, on the full trial record, we find that Patent Owner has not carried its burden of showing by a preponderance of the evidence that the proposed substitute claims introduce no new matter relative to the original disclosure. 35 U.S.C. § 326(d)(3); 37 C.F.R. § 42.221(d)(1); see also Paper 58, 2 (Patent Owner acknowledging that it “bears the burden to meet the regulatory and statutory requirements” for a motion to amend, including demonstrating that the substitute claims do not “introduce new matter”). Importantly, we note that Patent Owner fails to explain how the material cited in the claim chart supports the claims. See Mot. 15–16. Instead, Patent Owner provides only a claim chart with bare citations, leaving it to the panel to discern how the cited material supports the claim limitations. See id. Patent Owner’s failure to explain the citations constitutes a fatal error, as we have reviewed the passages cited by Patent Owner and are unable to discern where support is found for several of the substitute claim limitations. Where, as here, “the Board is unable to determine how the specification and drawings support the proposed substitute claims, the motion to amend may be denied.” Patent Trial and Appeal Board Consolidated Trial Practice Guide (Nov. 2019) (“TPG”),6 71.” slip op. at 15
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“Petitioner persuades us that the ’418 Application lacks adequate written description support for the formulation limitations of proposed substitute claim 18 [limitations 18a–8c]. As outlined by Petitioner and its declarants, the ’418 Application, including the Abstract, Field of the Invention, Summary of the Invention, and Detailed Description of the Invention sections, uniformly focuses on phosphate prodrugs of levodopa and carbidopa. See, e.g., Ex. 1004 (Sloan Decl.) ¶¶ 38–55, 64–69; Ex. 1003 (LeWitt Decl.) ¶¶ 89–97; Ex. 1047 (Forrest Decl.) ¶¶ 40–74, 80–92; Opp. 6– 10; Pet. 23–26, 49–55. We agree with Petitioner that “nothing in the specification suggests that the invention includes methods of subcutaneous infusion with anything other than the carbidopa prodrugs and L-dopa prodrugs of Formulas (I) and (II), respectively, or teaches how to get sufficient amounts of either L-dopa or carbidopa into solution, or achieve particular L-dopa plasma levels, without those particular prodrugs.” Pet. 27. Petitioner persuades us that the ’418 Application fails to contain “[so] much as a single generic sentence, anywhere in the application, suggesting the inventors possessed the claimed formulations.” Sur-reply 3. Additionally, the ’418 Application contains no example teaching administration of an aqueous formulation comprising carbidopa itself with levodopa itself or one of the three claimed levodopa prodrugs, let alone one that is suitable for continuous subcutaneous administration. See Ex. 1047 (Forrest Decl.) ¶¶ 61–72, 82–92. Patent Owner is correct that to establish written description support, neither “an actual reduction to practice,” nor a verbatim recitation of the claims is required. Sur-reply 4. Nevertheless, “[a]lthough examples are not always required to satisfy the written description requirement, the lack of any disclosure of examples may be considered when determining whether the claimed invention is adequately described.” Bos. Sci. Corp. v. Johnson & Johnson, 647 F.3d 1353, 1364 (Fed. Cir. 2011). Here, the lack of an actual reduction to practice or verbatim description of a formulation that falls within the scope of the claims is relevant, because we also see no other description or material in the ’418 Application that suggests the claimed methods extend to continuous subcutaneous administration of a composition comprising levodopa or one of the three claimed levodopa prodrugs, together with carbidopa, in an aqueous carrier.” slip op. at 28
- ExcludeMotion to exclude, deniedDenied
“All of the exhibits that are the subject of Patent Owner’s motion to exclude relate to the prior-art status and/or authenticity of Yacoby-Zeevi and ancillary related documents underlying Petitioner’s prior art-based challenges to the proposed substitute claims. See generally MTE. Because we deny Patent Owner’s request to enter proposed substitute claims 18–30 based on lack of written description support and do not reach Petitioner’s prior-art based challenges to the patentability of these claims, we do not rely on Exhibits 1005, 1007, 1040–1044, 1046, or 1048–1050 in this Decision. Accordingly we dismiss Patent Owner’s Motion to Exclude as moot.” slip op. at 49
- Strike new argumentNew argument consideredDenied
“On the other hand, Petitioner shows that Patent Owner took positions in its Motion to Amend that it only later sought to support with technical declarations. For example, in the Motion to Amend, Patent Owner elected to assert “that levodopa and carbidopa could be ‘interchanged’ in a formulation with their prodrugs, and that a skilled artisan could ‘perform a pharmacokinetic analysis to predict steady state levodopa plasma levels’ using the ‘parent compounds’ based on Example 24.” MTS 2 (citing Mot. 12–13). Patent Owner, however, “chose to forgo any expert support” on these issues at the time it filed its Motion to Amend, and instead waited until the Reply to submit technical declarations in support of these arguments. Id. We agree with Petitioner that although Patent Owner “was not required to anticipate the arguments that [Petitioner] would make in its Opposition” to the Motion to Amend, if Patent Owner “wanted to provide expert testimony to support the positions it actually took” in that Motion, “the TPG required [Patent Owner] to do so at that time, instead of waiting until [Petitioner] had limited ability to respond.” Id. at 5. Accordingly, we agree with Petitioner that in this respect at least some portions of Patent Owner’s Declarations are untimely, because it is “improper for a reply to present new evidence (including new expert testimony) that could have been presented in a prior filing.” TPG 74. Nevertheless, an order striking arguments and evidence in their entirety is an “exceptional remedy,” particularly under the circumstances here, where some portions of the Declarations are proper, while other portions are untimely. TPG 80. Moreover, “there is a strong public policy for making all information filed in an administrative proceeding available to the public.” Liberty Mut. Ins. Co. v. Progressive Cas. Ins. Co., CBM2012- 00010, Paper 59 at 40 (PTAB Feb. 24, 2014). Under the facts of this case, Patent Owner was permitted to file evidence to respond to Petitioner’s unpatentability claims, but also belatedly supported positions it made in earlier attorney argument. Petitioner’s Motion to Strike, however, challenges all of Patent Owner’s evidence, without acknowledging that some portions constitute proper reply. Although “[t]he Board is not required to attempt to sort proper from improper portions of the reply” (TPG 74, emphasis added), under the circumstances here, we agree with Patent Owner that Petitioner’s lack of specificity as to what it seeks to strike is fatal to Petitioner’s motion. Accordingly, we decline to strike the Declarations in their entirety as untimely.” slip op. at 46
§ 112 disclosurePatents in suitUS 11,091,507 - Life Spine, Inc. v. Globus Medical, Inc.InstitutedPTAB · Jun 15, 2023 · IPR2022-01600 · APJ Kristi L R Sawert · IPR · Institution
Instituted IPR on all grounds for claims 1–20; the Board found a reasonable likelihood of obviousness over Olmos and Varela ’774 for claims 1–7 and 9–20, and over Varela ’357 and Oglaza for claim 8.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“the same or substantially the same prior art or arguments previously were presented to the Office.” The Board analyzes this issue under a two-part framework: (1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of [the] first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. slip op. at 11
- Other 314aDenied
“1. Legal Standard As noted above, institution of an inter partes review is discretionary. See 35 U.S.C. § 314(a) (authorizing institution of an inter partes review under particular circumstances, but not requiring institution under any circumstances); Cuozzo Speed Techs., LLC v. Lee, 579 U.S. 261, 273 (2016) (“[T]he agency’s decision to deny a petition is a matter committed to the Patent Office’s discretion.”); SAS, 138 S. Ct. at 1356 (stating that “[section] 314(a) invests the Director with discretion on the question whether to institute review” (emphasis omitted)). 2. Analysis Patent Owner contends that “[s]hould the Board agree that all Grounds fail except for Ground 2, then Patentee requests the Board discretionarily deny this Petition under §314(a).” Prelim. Resp. 77. Patent Owner contends that it would be “a waste of Board and party resources to proceed with an IPR here on a single dependent claim, if Petitioner has not met its burden with respect to the nineteen (19) other claims.” Id. at 78 (citing Deeper, UAB v. Vexilar, Inc., IPR2018-01310, Paper 7 at 42–43 (PTAB Jan. 24, 2019) (informative)). We do not agree with Patent Owner that all grounds of unpatentability fail except for Petitioner’s second asserted ground. Instead, for the reasons discussed below, we determine that Petitioner has met its burden in showing a reasonable likelihood of unpatentability based on all asserted grounds of unpatentability except for Ground 1. Infra §§ G–I. Asserted Grounds 2, 3, and 4 cover all twenty claims of the ’649 patent. Pet. 3. Thus, we decline to exercise our discretion to deny institution under § 314(a) as Patent Owner requests. See Prelim. Sur-reply 6 (contending that “if the Board agrees that all Grounds fail except for Ground 2, then the Board should discretionarily deny the Petition under §314(a)”).” slip op. at 18
- Skill levelSkill level petitioner adoptedDecided for petitioner
“understanding of a person of ordinary skill in the art at the time of the invention. Graham, 383 U.S. at 17–18. Petitioner contends that a person of ordinary skill in the art (sometimes abbreviated herein as “POSITA”): would have had a bachelor’s degree in mechanical engineering or biomedical engineering and two or more years of experience in biomechanical engineering, biomedical engineering, and/or spinal implant devices. A person could also have qualified as a POSITA with some combination of more formal education (e.g., an M.D.) and less technical experience or less formal education and more technical or professional experience in the foregoing fields, and would have had further appreciation of various technical concepts in this field. Pet. 18 (citing Ex. 1002 ¶¶ 32–35). Patent Owner does not presently dispute Petitioner’s proposal. Prelim. Resp. 8. Because Petitioner’s proposed level of ordinary skill in the art appears to be consistent with the cited prior art and is undisputed on this record, we adopt it for purposes of this Decision. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (indicating that the prior art itself may reflect an appropriate skill level).” slip op. at 21
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner asserts that “no terms require constructions differing from their plain and ordinary meaning.” Pet. 19. Patent Owner “currently takes no position on Petitioner’s assertion” but “reserves the right to propose specific constructions in this proceeding, if necessary.” Prelim. Resp. 7–8. We determine that no claim terms require express construction for this Decision. Any final written decision entered in this case may include a final claim construction based on the full trial record that differs from any discussion of claim scope provided in our analysis below.” slip op. at 22
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 10,973,649
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.