- PTAB · Nov 16, 2023 · IPR2023-01035 · APJ Tina E Hulse · IPR · Institution
The Board instituted IPR on claims 1–6, 8–10, and 22–28, finding a reasonable likelihood that Petitioner would prevail on the asserted obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have authority under 35 U.S.C. § 314, which provides that an inter partes review may not be instituted “unless . . . 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(a). Upon considering the argument and evidence presented in the papers, we determine that Petitioner has established a reasonable likelihood that it would prevail in showing the unpatentability of at least one claim challenged in the Petition. Accordingly, we institute an inter partes review of the challenged claims of the ’048 Patent.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“of the invention (“POSITA”) would have had “a bachelor’s degree and two or more years of experience or a master’s degree in organic synthesis or chemical engineering, with education substituting for experience and vice versa.” Pet. 15 (citing Ex. 1002 ¶ 16). Patent Owner takes no position on” slip op. at 6
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“At this stage of the proceeding, we determine Petitioner’s construction is most consistent with the plain ordinary meaning of “about” and the intrinsic evidence. The claim recites that the carbon chain length of the resulting bio-alkene is “about 5 to about 20.” Ex. 1001, claim 1 (emphasis added). We agree with Petitioner that use of the term “about” indicates a lack of specificity with respect to the claimed range. See Cohesive Techs., Inc. v. Waters. Corp., 543 F.3d 1351, 1368 (Fed. Cir. 2008) (“When ‘about’ numeric boundary to the specified parameter.”) (internal quotations omitted). In other words, the claim term “about 5 to about 20” does not require precisely 5 to 20 carbons. Moreover, we agree that a carbon atom in a compound is not divisible. Keeping these principles in mind, we find “about 5” at the lower end of the range encompasses at least a carbon chain length of 4, and “about 20” at the upper end of the range encompasses at least a carbon chain length of 21. We also agree with Petitioner that the prosecution history of the parent application supports construing “about” to encompass one additional carbon atom, as evidenced by the amendment after allowance amending the term “carbon chain length of about 8” to “carbon chain length of 7.” See Ex. 1006, 335. Thus, the intrinsic evidence supports Petitioner’s construction and the plain ordinary meaning of “about.”” slip op. at 8
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsNot reached
“institution under 35 U.S.C. § 325(d) for only these grounds (i.e., Grounds 5 and 6). Prelim. Resp. 19–25. Specifically, Patent Owner argues that Wright was considered by the Office and Petitioner has failed to demonstrate that the Office erred in any material way. Id. Even if we found Patent Owner’s arguments persuasive, after the Supreme Court’s decision in SAS Institute, Inc. v. Iancu, 138 S. Ct. 1348 (2018), we are compelled to proceed with this inter partes review on all grounds raised in the Petition because we find above. See Guidance on the impact of SAS on AIA trial proceedings, available at https://www.uspto.gov/patents/ptab/trials/guidance-impact-sasaia-trial (“If the PTAB institutes a trial, the PTAB will institute on all challenges raised in the petition.”). Thus, we find Patent Owner’s § 325(d) arguments to be moot.” slip op. at 20
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSRPatents in suitUS 10,995,048 - PTAB · Oct 20, 2023 · IPR2023-00739 · APJ John G New · IPR · Institution
The Board instituted IPR on all challenged claims and grounds, finding a reasonable likelihood that claims 10–12, 18, 19, 21, and 26–28 are obvious over the 2009 Press Release and Shams.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Release nor Shams expressly teaches the dosing regimen of “2 mg approximately every 4 weeks for the first 5 injections followed by 2 mg approximately once every 8 weeks or once every 2 months,” as recited in the independent claims. However, the question guiding our analysis is not one of anticipation, but of obviousness. Specifically, the question is whether the differences between the claimed subject matter and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. KSR, 550 U.S. at 406. We therefore turn to that analysis.” slip op. at 32
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“We conclude that, on the record as presently developed, Petitioner has demonstrated a reasonable likelihood of success in demonstrating that a person of ordinary skill in the art would have found it obvious to modify the dosage regiment of the 2009 Press Release by adding a single dose at week twelve, in view of the teachings of Shams, to arrive at the claimed invention. We find that a person of ordinary skill in the art would have considered this addition of a single dose to be routine optimization to ensure, as Dr. Chaum relates, “to determine the optimal number of initial injections, before moving to eight-week dosing.” Ex. 1002 ¶ 151. Furthermore, and at this stage of the proceeding, we agree with Petitioner that a person of ordinary skill in the art would have had a reasonable expectation of success in modifying the 2009 Press Release dosing protocol to include an additional dose at week twelve to ensure sufficient “drying” of the inner wall of the retina prior to increasing the interval of the doses two eight weeks/two months.” slip op. at 36
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner
“claimed method. A reference teaches away when “a person of ordinary skill, upon reading the reference, would be discouraged from following the path set out in the reference, or would be led in a direction divergent from the path that was taken by the applicant.” In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). Patent Owner points to Shams’ Example 1, which it cites as representing Genentech’s PIER Phase IIIb study. See Prelim. Resp. 18. The PIER study, argues Patent Owner involved three monthly loading doses of a different VEGF antagonist (ranibizumab) followed by quarterly dosing, and, according to Patent Owner, was widely perceived as a failure. Id. Patent Owner contends that, based upon this single example, a person of ordinary skill in the art would have been discouraged from following the teachings of Shams. Id. We disagree. As we have explained above, the disclosures of Shams encompass a larger variety of regimen options than merely that embodied in Example 1. Shams is directed expressly to “methods including administering … a number of first individual doses of a VEGF antagonist, followed by administering … a number of second individual doses of the antagonist, wherein the second individual doses are administered less frequently than the first individual doses.” Ex. 1010, 4–5; see also id., claim 1. Furthermore, Shams expressly teaches that “[t]he doses may be administered according to any time schedule which is appropriate for treatment of the disease or condition.” Id. at 22. We find that these broad teachings of Shams would, rather than discouraging a skilled artisan from following its teachings, encourage a person of ordinary skill in the art to optimize the number of first and second individual doses to maximize the therapeutic effect of the regimen of VEGF antagonist dosage administration. Shams places no express limits upon the number of first individual doses and, as we have explained above, the addition of a single additional dose at week twelve would fall well within the scope of Shams’ disclosures.” slip op. at 38
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for petitioner
“A method for treating….” Petitioner initially accepts, for the purposes of this Decision, that the preamble of claim 1 is limiting, and agrees with the Board’s prior rejection, in the related IPR2021-00881 Final Written Decision, of Patent Owner’s position that the preamble requires a particular level of efficacy. Pet. 16 (citing Ex. 1002 ¶¶ 82–91). Specifically, Petitioner notes that the Board found that administering a compound—the recited VEGF antagonist—“to [a] patient for the purpose of improving or providing a beneficial effect on their angiogenic eye disorder” satisfies the “treating” portion of the preamble. Id. at 17 (quoting Ex. 1025, 19; and citing id. at 23; Ex. 1053, 9– 10; Ex. 1054). Patent Owner states that, for the purposes of this Decision only, it does not contest Petitioner’s proposed construction. Prelim. Resp. 11. Therefore, for the same reasons we explained in the Final Written Decision in related IPR2022-00881 concerning a related patent having claims with language similar to the presently challenged claims, and for the purposes of this Decision, we adopt Petitioner’s proposed construction of “a method for treating….” slip op. at 8
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 10,888,601 - PTAB · Oct 13, 2023 · IPR2023-00876 · APJ Michael J Fitzpatrick · IPR · Institution
Instituted IPR on claims 1–6; the Board found a reasonable likelihood that claim 1 would be unpatentable as obvious over Linnarsson and McCloskey.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“In sum, on the record presented, it appears that Petitioner is correct in stating that “no arguments were made during examination with respect to McCloskey or any similar reference disclosing an oligonucleotide with two tags.” Pet. 70 (underlining added).” slip op. at 16
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“4. Conclusion as to Claim 1 There is a reasonable likelihood that Petitioner would prevail in proving that claim 1 is unpatentable on this ground.” slip op. at 23
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“The Petition states that “Petitioner does not believe that any terms require explicit construction in view of the prior art being presented.” Pet. 36. Despite this stated position, Petitioner proposes constructions for “multiplex-identifier (MID)” and “providing a sample.” Id. Patent Owner, for its part, states that it “agrees that at this time, solely for purposes of an institution decision on the Petition, no terms require explicit construction.” Prelim. Resp. 45. On the record before us, and for purposes of institution, we find there is no need to provide an express construction of any claim term.” slip op. at 6
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Pet. 21–22 (citations omitted). At this stage of the proceeding, Patent Owner does not dispute the level of skill proposed by Petitioner. Because Petitioner’s formulation of the level of ordinary skill in the art appears consistent with the disclosure of the ’981 patent and the asserted prior art, and because there is no argument to the contrary at this stage of the proceeding, we apply Petitioner’s formulation in our analysis below.” slip op. at 7
Claim construction§ 103 obviousnessDiscretionary denialcites GrahamPatents in suitUS 10,155,981 - PTAB · Oct 13, 2023 · PGR2023-00022 · APJ Devon Zastrow Newman · PGR · Institution
The Board instituted PGR on claims 1–33 under all petition grounds, finding it more likely than not that at least one claim lacks written description and enablement.
RulingsInstitution decision- Skill levelSkill level board ownOther
“Based on the information presented, we agree with Patent Owner that the asserted prior art itself is sufficient to demonstrate the level of skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (prior art itself can reflect the appropriate level of ordinary skill in the art). We do not find it necessary to define the level of skill in the art at the time of the invention at this time. However, for purposes of deciding whether to institute trial, we find that Dr. Silverstone is qualified to provide helpful opinion testimony on the issues regarding which we cite his testimony in this decision. See Ex. 1003 ¶¶ 6–15.” slip op. at 7
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“Based on the above, we agree with Patent Owner that many of the arguments raised by the Examiner are highly similar to the challenges in this proceeding, particularly the written description challenge. However, some arguments differ. For instance, Petitioner’s enablement argument identifies that, contrary to Applicant’s statement during prosecution reproduced above, amino acids and protein structure outside the disclosed AAD-12 motif can also affect the activity of the claimed dioxygenases to degrade phenoxy auxin and pyridyloxy auxin. See Ex. 1003 ¶¶ 42–50, 79 (Dr. Silverstone describing the mechanics of protein binding and explaining why the ’055 patent disclosure fails to provide sufficient information to the skilled artisan to know which amino acids could be changed while retaining the ability to enzymatically degrade both phenoxy and pyridyloxy auxin herbicides). See also Pet. 27–34 (asserting, e.g., 85% homology to AAD-12 motif alone is insufficient to predict enzymatic degradation activity). While the Examiner’s rejections regarded the disclosure corresponding to the ability to degrade herbicides, the Examiner plainly relied on Applicant’s statements that the AAD-12 motif’s structure alone was responsible when deciding to withdraw the rejection. Ex. 1002, 355. The Examiner did not have the additional testimony supplied by the Silverstone declaration explaining otherwise. See Ex. 1003 ¶¶ 42–50, 79. Petitioner, through Dr. Silverstone, also addresses the effort the skilled artisan would have needed to undertake to determine what proteins outside of the AAD-12 motif would affect the ability of homologues to enzymatically degrade the recited herbicides, and provides evidence for consideration regarding the lack of a clear link between the AAD-12 motif and the ability to enzymatically degrade both phenoxy and pyridyloxy auxin herbicides. Ex. 1003, 347. Therefore, the arguments are not entirely overlapping. And while these issues do in part overlap with Petitioner’s arguments pertaining to enablement, we agree with Petitioner that the Examiner did not complete a written Wands analysis. Although we conclude that the arguments are not entirely overlapping, we proceed to the second step in the analysis, for completeness.” slip op. at 13
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Because Petitioner has shown that it is more likely than not that Petitioner will prevail in showing that at least one claim lacks sufficient written description and is not enabled, we conclude the challenged claims are eligible for post-grant review. V. CONCLUSION After considering the evidence and arguments presently before us, we determine Petitioner has shown it is more likely than not that at least one challenged claim of the ’055 patent lacks written description and is unpatentable. Accordingly, we institute a post-grant review. VI. ORDER In consideration of the foregoing, it is hereby: ORDERED that, pursuant to 35 U.S.C. § 324(a), a post-grant review of claims 1–33 of the ’055 patent is instituted with respect to all grounds set forth in the Petition; and” slip op. at 57
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateOther
“85% identity as “highly identical” in this field and that the “conserved motif residues comprise ‘the active site that is essential for catalytic activity.’” Prelim. Resp. 31 (citing Ex. 1001, 11:1–6)). However, on the record before us, we are unpersuaded that this is sufficient because the Specification lacks disclosure supporting that a polypeptide of, for example, 86% identity to SEQ ID NO: 2 would retain the ability to degrade herbicides if the 5 amino acids in the general formula of HX109D(X)111-134 T(X)136-261H(X)263-272R, and the required chain lengths are present. In this regard we are persuaded by the testimony of Dr. Silverstone (Ex. 1003 ¶¶ 48–93) regarding the limitations of the disclosure of the ’055 patent and the lack of information supporting the skilled artisan in understanding that the inventor possessed the entire claimed genus (e.g., lack of example at lower end of sequence identity and lack of information to assist the skilled artisan in predicting whether an α-ketoglutarate-dependent dioxygenase would interact with or degrade either phenoxy auxin herbicides and/or pyridyloxy auxin herbicides). Dr. Silverstone testifies, and we are persuaded on this record, that the skilled artisan would not have read the guidance in the disclosure and understood that the inventors possessed the ability to design a modified SEQ ID NO: 2 at the 85% identity level that retained the function of degrading the recited herbicides, let alone the full scope of the claimed genus. Id. Patent Owner argues that Dr. Silverstone’s testimony that conserved amino acids of the AAD-12 motif are present in other α- ketoglutarate-dependent dioxygenases but do not have the claimed dual activity (Ex. 1003 ¶ 48) is misplaced because it “ignores that the location and spacing of those residues in other αKG-dependent dioxygenases differ from those in the AAD-12 motif.” Prelim. Resp. 38. However, Patent Owner offers no evidence that supports its argument. Id. It is thus unpersuasive.” slip op. at 36
§ 112 disclosureDiscretionary denialPatents in suitUS 11,371,055 - 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 - PTAB · Sep 22, 2023 · IPR2023-00481 · APJ Timothy G Majors · IPR · Institution
The Board instituted IPR on claims 17, 19, 20, and 22–27 because Hopewell showed a reasonable likelihood that the claims would have been obvious over Bodor and Stelmasiak.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“5. Analysis: Claim 17 Based on the present record, Petitioner persuades us that it is reasonably likely to prevail in establishing that claim 17 would have been obvious over Bodor and Stelmasiak. We agree with Petitioner’s showing that Bodor teaches or suggests a method for treating MS, including RRMS, by orally administering cladribine tablets over a two-month induction period at a total dose of between 100 mg to 140 mg (equivalent to 1.4–2.0 mg/kg for the average patient) and, thus, satisfies claim 17’s preamble15 and step (i). See, e.g., Pet. 46–51. Bodor also expressly teaches such an” slip op. at 32
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“Because we agree that Bodor and Stelmasiak were presented previously to the Office, we turn to part two of the Advanced Bionics framework—whether there was a material error by the Office.” slip op. at 54
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Analogous artInstituted
“reasonably likely to prevail in establishing that claim 17 would have been obvious over Bodor and Stelmasiak. We agree with Petitioner’s showing that Bodor teaches or suggests a method for treating MS, including RRMS, by orally administering cladribine tablets over a two-month induction period at a total dose of between 100 mg to 140 mg (equivalent to 1.4–2.0 mg/kg for the average patient) and, thus, satisfies claim 17’s preamble15 and step (i). See, e.g., Pet. 46–51. Bodor also expressly teaches such an” slip op. at 32
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“maintenance period” or a secondary cladribine-free period, we find it logical, credible, and consistent with Dr. Miller’s testimony, that a POSA would have understood Bodor to suggest retreatment and that a POSA would know that retreatment is often needed given the chronic, incurable nature of MS. See, e.g., Ex. 1002 ¶¶ 86–87, 100–102 (testifying that a POSA would have thought to readminister cladribine according to Bodor’s initial treatment regimen, disclosed as suitable for MS treatment, and optimize if needed). Moreover, Petitioner provides evidence-backed reasoning supporting why it would have been routine and obvious to “tailor” the dosage, including by starting with a lower dose and “step-wise” increase it until a desired therapeutic effect is achieved. See, e.g., Ex. 1022, 24:1–9;16 Ex. 1002 ¶ 93. The POSA would have also been aware, from at least Stelmasiak, that it’s possible to give lower amounts of cladribine in a maintenance phase versus an induction phase, keeping lymphocyte counts in a suppressed state, and providing therapeutic benefits even over extended periods where no cladribine is administered. Ex. 1013, 5–7 (describing a decrease in relapse rate and EDSS improvements over a twenty-four month study period). That, combined with Bodor’s teachings and an expectation that a lower dose and intermittent cladribine-free periods would help manage 16 See also Ex. 1022, 26:2–8 (teaching that dosages are given with concomitant, continuous clinical evaluations by a skilled practitioner to “determine subsequent therapy” and “evaluating whether to increase, reduce or continue a particular treatment dose”). ¶¶ 50–52, 91, 95, 103. Based on Petitioner’s evidence and reasoning, we find it reasonably likely that a POSA would have found it obvious to modify Bodor’s method to arrive at steps (iii) and (iv) of claim 17. We also find that the preliminary record, on balance, supports Petitioner’s contention that the POSA would have reasonably expected success in modifying the art to arrive at the subject matter of claim 17. Bodor discloses a method for treating MS with administration of oral cladribine and provides further guidance for adjusting the dosage or duration as needed to produce a desired therapeutic result. See, e.g., Ex. 1022, 22:18–22, 23:15–20, 24:1–9. Stelmasiak further evidences efficacy in treating RRMS with cladribine administration, including in oral and parenteral forms. Ex. 1013, 7. And neither Bodor nor Stelmasiak stands alone; as pointed out by Petitioner and Dr. Miller, several studies predating the ’903 patent describe the use of cladribine for treating MS, including RRMS, and such studies inform the POSA’s background knowledge—a necessary consideration in any obviousness analysis. See Pet. 19–21, 44; Ex. 1002 ¶¶ 35–49, 115; Randall Mfg. v. Rea, 733 F.3d 1355, 1362 (Fed. Cir. 2013) (“[T]he knowledge of such an artisan is part of the store of public knowledge that must be consulted when considering whether a claimed invention would have been obvious.”). Indeed, many of these studies are incorporated by reference into Bodor. Ex. 1022, 22:27–23:6 (incorporating, e.g., Romine (Ex. 1031) and Rice (Ex. 1018), after teaching that “various dosage amounts and dosing regimens have been reported in the literature for use in the treatment of multiple sclerosis”). slip op. at 33
§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 8,377,903 - PTAB · Sep 22, 2023 · IPR2023-00480 · APJ Timothy G Majors · IPR · Institution
The Board instituted IPR on claims 36, 38, 39, and 41–46, finding a reasonable likelihood that at least one claim would have been obvious over Bodor and Stelmasiak.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“5. Analysis: Claim 36 Based on the present record, Petitioner persuades us that it is reasonably likely to prevail in establishing that claim 36 would have been obvious over Bodor and Stelmasiak. We agree with Petitioner’s showing that Bodor teaches a method for treating MS by orally administering cladribine tablets over a two-month induction period at a total dose of between 100 mg to 140 mg (equivalent to 1.4–2.0 mg/kg for the average patient) and, thus, satisfies claim 36’s preamble14 and step (i). See, e.g., Pet. 45–49. Bodor also expressly teaches such an induction period is followed by a ten-month cladribine-free period—meeting claim 36’s step (ii) (reciting a cladribine-free period of between about 8–10 months), as argued by Petitioner. Id. at 49–50; Ex. 1022, 23:15–20. Although Bodor does not explicitly describe a subsequent “maintenance period” or a secondary cladribine-free period, we find it logical, credible, and consistent with Dr. Miller’s testimony, that a POSA would have understood Bodor to suggest retreatment and that a POSA would know that retreatment is often needed given the chronic, incurable nature of MS. See, e.g., Ex. 1002 ¶¶ 86–87, 100–102 (testifying that a POSA would have thought to readminister cladribine according to Bodor’s initial treatment regimen, disclosed as suitable for MS treatment, and optimize if 13 This paragraph is a high-level summary of Patent Owner’s argument (Prelim. Resp. 1–3, 51); we discuss Patent Owner’s argument in more detail in our analysis below but summarize here to reduce repetition. 14 We need not determine whether the preamble is limiting because, at this stage, there is no dispute that it is taught or suggested in the asserted art. supporting why it would have been routine and obvious to “tailor” the dosage, including by starting with a lower dose and “step-wise” increase it until a desired therapeutic effect is achieved. See, e.g., Ex. 1022, 24:1–9;15 Ex. 1002 ¶ 93. The POSA would have also been aware, from at least Stelmasiak, that it’s possible to give lower amounts of cladribine in a maintenance phase versus an induction phase, keeping lymphocyte counts in a suppressed state, and providing therapeutic benefits even over extended periods where no cladribine is administered. Ex. 1013, 5–7 (describing a decrease in relapse rate and EDSS improvements over a twenty-four month study period). That, combined with Bodor’s teachings and an expectation that a lower dose and intermittent cladribine-free periods would help manage potential side effects, supports Petitioner’s challenge. See, e.g., Ex. 1002 ¶¶ 50–52, 91, 95, 103. Based on Petitioner’s evidence and reasoning, we find it reasonably likely that a POSA would have found it obvious to modify Bodor’s method to arrive at steps (iii) and (iv) of claim 36. We also find that the preliminary record, on balance, supports Petitioner’s contention that the POSA would have reasonably expected success in modifying the art to arrive at the subject matter of claim 36. Bodor discloses a method for treating MS with administration of oral cladribine and provides further guidance for adjusting the dosage or duration as needed to produce a desired therapeutic result. See, e.g., Ex. 1022, 22:18–22, 23:15–20, 24:1–9. Stelmasiak further evidences efficacy in 15 See also Ex. 1022, 26:2–8 (teaching that dosages are given with concomitant, continuous clinical evaluations by a skilled practitioner to “determine subsequent therapy” and “evaluating whether to increase, reduce or continue a particular treatment dose”). forms. Ex. 1013, 7. And neither Bodor nor Stelmasiak stands alone; as pointed out by Petitioner and Dr. Miller, several studies predating the ’947 patent describe the use of cladribine for treating MS, and such studies inform the POSA’s background knowledge—a necessary consideration in any obviousness analysis. See Pet. 19–21, 44; Ex. 1002 ¶¶ 35–49, 115; Randall Mfg. v. Rea, 733 F.3d 1355, 1362 (Fed. Cir. 2013) (“[T]he knowledge of such an artisan is part of the store of public knowledge that must be consulted when considering whether a claimed invention would have been obvious.”). Indeed, many of these studies are incorporated by reference into Bodor. Ex. 1022, 22:27–23:6 (incorporating, e.g., Romine (Ex. 1031) and Rice (Ex. 1018), after teaching that “various dosage amounts and dosing regimens have been reported in the literature for use in the treatment of multiple sclerosis”).” slip op. at 32
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“interpreted to resolve Petitioner’s challenge. Patent Owner’s interpretation is broader and encompasses Petitioner’s interpretation. Nevertheless, to address the arguments made and give guidance for trial, we determine that the weight of the evidence on this preliminary record supports Patent Owner’s interpretation, and we conclude that the dosing of cladribine given during the “maintenance period” can be same as or lower than the total dose given during the induction period. We explain below. First, the language of the claims supports Patent Owner’s interpretation. Claim 36 expressly recites that the total dose reached at the end of the induction period (step (i)) “is from about 1.7 mg/kg to about 3.5 mg/kg.” See supra Section II(D). Claim 36, step (iii), recites that the total dose of cladribine reached at the end of the maintenance period “is about 1.7 mg/kg.” The plain language of claim 36, thus, indicates that the cladribine dosing given during the induction period and the maintenance period can be the same—each “about 1.7 mg/kg.” Claim 36 also encompasses regimens where the maintenance period dosing (e.g., 1.7 mg/kg) is lower compared to the induction period dosing (e.g., 3.5 mg/kg). But the plain language of the claims does not require a lower total dose in the maintenance period. Petitioner’s construction narrows the claims and, in effect, asks us to rewrite the lower bound of the range recited in claim 36’s induction period step to be some value higher than “about 1.7 mg/kg.” We decline to do so.” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“reasonably likely to prevail in establishing that claim 36 would have been obvious over Bodor and Stelmasiak. We agree with Petitioner’s showing that Bodor teaches a method for treating MS by orally administering cladribine tablets over a two-month induction period at a total dose of between 100 mg to 140 mg (equivalent to 1.4–2.0 mg/kg for the average patient) and, thus, satisfies claim 36’s preamble14 and step (i). See, e.g., Pet. 45–49. Bodor also expressly teaches such an induction period is followed by a ten-month cladribine-free period—meeting claim 36’s step (ii) (reciting a cladribine-free period of between about 8–10 months), as argued by Petitioner. Id. at 49–50; Ex. 1022, 23:15–20. Although Bodor does not explicitly describe a subsequent “maintenance period” or a secondary cladribine-free period, we find it logical, credible, and consistent with Dr. Miller’s testimony, that a POSA would have understood Bodor to suggest retreatment and that a POSA would know that retreatment is often needed given the chronic, incurable nature of MS. See, e.g., Ex. 1002 ¶¶ 86–87, 100–102 (testifying that a POSA would have thought to readminister cladribine according to Bodor’s initial treatment regimen, disclosed as suitable for MS treatment, and optimize if 13 This paragraph is a high-level summary of Patent Owner’s argument (Prelim. Resp. 1–3, 51); we discuss Patent Owner’s argument in more detail in our analysis below but summarize here to reduce repetition. 14 We need not determine whether the preamble is limiting because, at this stage, there is no dispute that it is taught or suggested in the asserted art. supporting why it would have been routine and obvious to “tailor” the dosage, including by starting with a lower dose and “step-wise” increase it until a desired therapeutic effect is achieved. See, e.g., Ex. 1022, 24:1–9;15 Ex. 1002 ¶ 93. The POSA would have also been aware, from at least Stelmasiak, that it’s possible to give lower amounts of cladribine in a maintenance phase versus an induction phase, keeping lymphocyte counts in a suppressed state, and providing therapeutic benefits even over extended periods where no cladribine is administered. Ex. 1013, 5–7 (describing a decrease in relapse rate and EDSS improvements over a twenty-four month study period). That, combined with Bodor’s teachings and an expectation that a lower dose and intermittent cladribine-free periods would help manage potential side effects, supports Petitioner’s challenge. See, e.g., Ex. 1002 ¶¶ 50–52, 91, 95, 103. Based on Petitioner’s evidence and reasoning, we find it reasonably likely that a POSA would have found it obvious to modify Bodor’s method to arrive at steps (iii) and (iv) of claim 36. We also find that the preliminary record, on balance, supports Petitioner’s contention that the POSA would have reasonably expected success in modifying the art to arrive at the subject matter of claim 36. Bodor discloses a method for treating MS with administration of oral cladribine and provides further guidance for adjusting the dosage or duration as needed to produce a desired therapeutic result. See, e.g., Ex. 1022, 22:18–22, 23:15–20, 24:1–9. Stelmasiak further evidences efficacy in 15 See also Ex. 1022, 26:2–8 (teaching that dosages are given with concomitant, continuous clinical evaluations by a skilled practitioner to “determine subsequent therapy” and “evaluating whether to increase, reduce or continue a particular treatment dose”). forms. Ex. 1013, 7. And neither Bodor nor Stelmasiak stands alone; as pointed out by Petitioner and Dr. Miller, several studies predating the ’947 patent describe the use of cladribine for treating MS, and such studies inform the POSA’s background knowledge—a necessary consideration in any obviousness analysis. See Pet. 19–21, 44; Ex. 1002 ¶¶ 35–49, 115; Randall Mfg. v. Rea, 733 F.3d 1355, 1362 (Fed. Cir. 2013) (“[T]he knowledge of such an artisan is part of the store of public knowledge that must be consulted when considering whether a claimed invention would have been obvious.”). Indeed, many of these studies are incorporated by reference into Bodor. Ex. 1022, 22:27–23:6 (incorporating, e.g., Romine (Ex. 1031) and Rice (Ex. 1018), after teaching that “various dosage amounts and dosing regimens have been reported in the literature for use in the treatment of multiple sclerosis”).” slip op. at 32
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner
“weight-based dosing. Prelim. Resp. 29–30. According to Patent Owner, Stelmasiak remarks on there being “no correlation” between the magnitude of lymphocyte reduction and the drug dose expressed per kg of body weight; similarly, Patent Owner cites Stelmasiak’s disclosure that “there was no indication that a ‘good response’ is related to the actual cladribine dose per body weight.” Id. (citing Ex. 1013, 6–7) (emphasis omitted). We do not agree that this rises to a teaching away. These cited disclosures relate to Stelmasiak’s attempt to explain the observed variance in lymphocyte counts among its patients, and to identify “any factor” that might have differentiated between those patients that were responders versus the non-responders. Ex. 1013, 6–7. Stelmasiak was “unable” to identify such a factor. But Stelmasiak nowhere teaches that expressing dosages in mg/kg and administering those dosages would result in a less effective or ineffective MS treatment. To the contrary, at most, Stelmasiak suggests that doing so would not have changed the results for its study and patient group. We also note that other technical literature of record describes cladribine studies where dosages are expressed in mg/kg form and recognizes a dose-dependent effect, including on the level of lymphocyte reduction. See, e.g., Ex. 1002 ¶¶ 91–92 (discussing Rice (Ex. 1018) (noting dose-dependent reduction in lymphocyte counts and lesion volume) and Selby (Ex. 1047)). Patent Owner’s “teaching away” argument is also weakened by Bodor, which, while teaching a regimen based on an alleged “flat” dosing (10 mg/day), defines “effective amount[s]” for MS treatment by referencing dosages expressed on a mg/kg basis—“from about 0.04 to about 1.0 mg/kg/day.” Ex. 1022, 22:17–22, 23:15–20. Whatever distinction Patent Owner seeks to erect between so-called “flat” and “weight-based” dosing is differentiator.” slip op. at 43
Claim construction§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 7,713,947 - 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 - Apotex Inc. v. Cellgene CorporationInstitutedPTAB · Jul 20, 2023 · IPR2023-00512 · APJ Ryan H Flax · IPR · Institution
The Board instituted IPR on claims 1, 2, 6–9, 11–28, 32–36, and 38–43 on all asserted grounds, finding a reasonable likelihood of success on obviousness.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“IV. CONCLUSION Petitioner demonstrates a reasonable likelihood of prevailing at trial in showing that at least one of claims 1, 2, 6–9, 11–28, 32–36, and 38–43 of the ’628 patent is unpatentable over the cited prior art. Our decision derives from our review of the preliminary record before us. Accordingly, we institute inter partes review of each challenged claim the ’628 patent on each of the grounds asserted by Petitioner. This decision does not reflect a final determination on the patentability of the claims. ORDER Accordingly, it is hereby: ORDERED that the Petition is granted and we institute inter partes review of claims 1, 2, 6–9, 11–28, 32–36, and 38–43 of the ’628 patent based on the grounds asserted in the Petition.” slip op. at 53
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for petitioner
“patentee that differs from the meaning it would otherwise possess. In such cases, the inventor’s lexicography governs.” Phillips, 415 F.3d at 1316 (citing CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366 (Fed. Cir. 2002)). Moreover, “[w]hen the specification explains and defines a term used in the claims, without ambiguity or incompleteness, there is no need to search further for the meaning of the term.” Multiform Dessicants, Inc. v. Medzam Ltd., 133 F.3d 1473, 1478 (Fed. Cir. 1998). We agree with the parties that the ’628 patent expressly defines this term in stating “[t]he term ‘non-enteric-coated,’ when used herein, refers to a pharmaceutical composition, formulation, or dosage form that does not comprise a coating intended to release the active ingredient(s) beyond the stomach (e.g., in the intestine),” and we adopt this express definition herein with regard to “nonenteric coated tablet.”9 Ex. 1001, 11:42–48 (emphasis added).” slip op. at 14
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“to, and sometimes associated with, but not identical to the claim term “subject”), which appears in claims 11, 12, 18–22, and 38–43, means “a human or other animal who received the recited pharmaceutical composition in connection with a test of the recited parameter.” Prelim. Resp. 18–19 (also asserting Petitioner does not appear to dispute this construction). We first note that the term “test subject” appears in the ’628 patent only in the claims. See generally Ex. 1001. However, we find Patent Owner’s definition comports with the Specification’s express definition of “subject,” a term the Specification appears to use synonymously with the claim term “test subject” and the word patient, and that Patent Owner’s definition adds that the subject received the pharmaceutical composition in connection with a test of the recited parameter, which we find to be a reasonable interpretation of the claim term “test subject,” in accordance with the plain language of the claims on their face, and as supported by the relevant portions of the Written Description that describe testing parameters relating to drug administration. Ex. 1001, 35:45–36:62, 67:61–81:48. We adopt Patent Owner’s definition herein.” slip op. at 16
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureNot shown unpatentableInherency not foundNot shown unpatentable
“A single prior art reference may anticipate without disclosing a feature of the claimed invention if such feature is necessarily present, or inherent, in that reference.” Allergan, Inc. v. Apotex Inc., 754 F.3d 952, 958 (Fed. Cir. 2014). However, “‘[i]nherency . . . may not be established by probabilities or possibilities.’” In re Montgomery, 677 F.3d 1375, 1379–80 (Fed. Cir. 2012) (citations omitted, alterations in original). “The mere fact that a certain thing may result from a given set of circumstances is not sufficient to establish inherency.” Scaltech Inc. v. Retec/Tetra L.L.C., 178 F.3d 1378, 1384 (Fed. Cir. 1999). slip op. at 38
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 8,846,628
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.