- 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 - Mylan Pharmaceuticals Inc. / Teva Pharmaceuticals USA, Inc. et al. v. Bayer Pharma AktiengesellschaftAll claims unpatentablePTAB · Jul 28, 2023 · IPR2022-01513 · APJ Tina E Hulse · IPR · Final written decision
Claims 1–8 are unpatentable: claims 1–2 as anticipated by Foley, claims 1–2, 5, and 8 as obvious over Foley, and claims 3–4, 6–7 as obvious over Foley and Plosker.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“We find Petitioner has the better position. We agree with Petitioner and Dr. Zusman that an M.D. with experience treating patients who worked in consultation with a team of specialists would include the qualifications recited by Patent Owner. Ex. 1037 ¶¶ 7–11. We, therefore, adopt Petitioner’s definition of a POSA, which indicates a high level of skill in the relevant art and is consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))). Even if there were a distinction between the parties’ respective definitions of the level of ordinary skill in the art, Patent Owner’s expert, Dr. Weitz, notes that his opinion would not change regardless of which definition is applied. See Ex. 2060 ¶ 26. Moreover, we find both Dr. Zusman and Dr. Weitz qualified to opine from the perspective of a POSA for purposes of this Decision as both possess at least the level of ordinary skill in the art. See Ex. 1002 ¶¶ 1–11; Ex. 2060 ¶¶ 1–11; see also Kyocera Senco Indus. Tools Inc. v. Int’l Trade Comm’n, 22 F.4th 1369,” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“3. Remaining Claim Terms Patent Owner also offers constructions for “coronary artery disease,” and the preamble (PO Resp. 23–32, 39–40), but none of these claim phrases Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). We now turn to the patentability challenges presented by Petitioner.” slip op. at 21
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITADecided for petitioner
“construction and determine that the term “clinically proven effective” is nonlimiting, as Petitioner asserts. See Pet. 11; Pet. Reply 8–9, 16. We begin our analysis with the language of the claims, which recite administering rivaroxaban and aspirin in amounts that are “clinically proven effective,” “wherein rivaroxaban is administered in an amount of 2.5 mg twice daily and aspirin is administered in an amount of 75–100 mg daily.” Ex. 1001, claims 1 and 5. We are persuaded that a POSA would have understood from a plain reading of the claims that the specific recited “amounts” of 8 We also noted in our Institution Decision that in the Delaware MDL, the parties stipulated that claim 1 “does not require FDA approval.” Dec. Inst. 15 n.6 (quoting Ex. 2019, 2). That is, the independent claims expressly recite that the rivaroxaban is administered in an amount of 2.5 mg twice daily, and that aspirin is administered in an amount of 75–100 mg daily. Ex. 1001, claims 1 and 5. Because the claims expressly recite the amounts of rivaroxaban and aspirin, further identifying these amounts as “clinically proven effective” is redundant and unnecessary, and does nothing to alter the method steps of administering the pharmaceutical, as otherwise recited by these claims. See Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1375 (Fed. Cir. 2001) (finding claim term “antineoplastically effective” not limiting where express dosage amounts are material claim limitations that do not change based on the intended result).” slip op. at 13
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableInherency foundUnpatentable
“Patent Owner again, however, misses the point. The question is not whether clinical trials may exist where the disclosed dosing regimen may not be clinically proven effective, or whether a POSA would necessarily recognize clinical proof of efficacy from the COMPASS protocol taught by Foley. Id. at 53–54. On the contrary, the question is whether “the [prior art] disclosure is sufficient to show that the natural result flowing from the operation as taught would result in the performance of the questioned function.” King Pharms., Inc. v. Eon Labs, Inc., 616 F.3d 1267, 1275 (Fed. Cir. 2010) (citation omitted). If it is, the Federal Circuit has held that it is “well-settled that the disclosure should be regarded as sufficient.” Id. As such, here, we consider whether the disclosure in Foley is sufficient to show that the natural result of the disclosed dosing regimen would be “clinically proven effective” by the COMPASS study disclosed by Foley. In this case, we know that to be true because the claimed process was confirmed by the same COMPASS study disclosed by Foley. See Bristol- Myers, 246 F.3d at 1376; see also Abbott Labs. v. Baxter Pharm. Prods., Inc., 471 F.3d 1363, 1369 (Fed. Cir. 2006) (finding method claims anticipated where prior art method disclosed the same steps in furtherance of the same purpose, and all that was contributed by the patent claims is the the claim term were limiting, we find Foley inherently discloses “clinically proven effective” amounts of rivaroxaban and aspirin. Having considered the arguments and evidence presented at trial, we find Petitioner has shown by a preponderance of the evidence that claims 1 and 2 are anticipated by Foley.” slip op. at 26
Patent outcomesUS 10,828,310 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,828,310 - Mylan Pharmaceuticals Inc. / Teva Pharmaceuticals USA, Inc. et al. v. Bayer Pharma AktiengesellschaftAll claims unpatentablePTAB · Jul 28, 2023 · IPR2022-01515 · APJ Tina E Hulse · IPR · Final written decision
Claims 1–8 are unpatentable: claims 1–2 as anticipated by Foley, claims 1–2, 5, and 8 as obvious over Foley, and claims 3–4, 6–7 as obvious over Foley and Plosker.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“We find Petitioner has the better position. We agree with Petitioner and Dr. Zusman that an M.D. with experience treating patients who worked in consultation with a team of specialists would include the qualifications recited by Patent Owner. Ex. 1037 ¶¶ 7–11. We, therefore, adopt Petitioner’s definition of a POSA, which indicates a high level of skill in the relevant art and is consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“construction and determine that the term “clinically proven effective” is nonlimiting, as Petitioner asserts. See Pet. 11; Pet. Reply 8–9, 16. We begin our analysis with the language of the claims, which recite administering rivaroxaban and aspirin in amounts that are “clinically proven effective,” “wherein rivaroxaban is administered in an amount of 2.5 mg twice daily and aspirin is administered in an amount of 75–100 mg daily.” Ex. 1001, claims 1 and 5. We are persuaded that a POSA would have understood from a plain reading of the claims that the specific recited “amounts” of 8 We also noted in our Institution Decision that in the Delaware MDL, the parties stipulated that claim 1 “does not require FDA approval.” Dec. Inst. 15 n.6 (quoting Ex. 2019, 2). That is, the independent claims expressly recite that the rivaroxaban is administered in an amount of 2.5 mg twice daily, and that aspirin is administered in an amount of 75–100 mg daily. Ex. 1001, claims 1 and 5. Because the claims expressly recite the amounts of rivaroxaban and aspirin, further identifying these amounts as “clinically proven effective” is redundant and unnecessary, and does nothing to alter the method steps of administering the pharmaceutical, as otherwise recited by these claims. See Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1375 (Fed. Cir. 2001) (finding claim term “antineoplastically effective” not limiting where express dosage amounts are material claim limitations that do not change based on the intended result).” slip op. at 13
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“2. Analysis “A claim is anticipated if each and every element as set forth in the claim is found, either expressly or inherently, in a single prior art reference.” Arbutus Biopharma Corp. v. ModernaTX, Inc., 65 F. 4th 656, 662 (Fed. Cir. 2023). The Federal Circuit explains that “[a]nticipation by inherent disclosure is appropriate only when the reference discloses prior art that must necessarily include the unstated limitation.” Monsanto Tech. LLC v. Inherent anticipation requires “merely that the disclosure of the prior art is sufficient to show that the natural result flowing from the operation as taught in the prior art would result in the claimed product.” SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331, 1343–44 (Fed. Cir. 2005) (internal quotes omitted).” slip op. at 23
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“In analyzing the obviousness of a combination of prior art elements, it can be important to identify a reason that would have prompted one of skill in the art “to combine . . . known elements in the fashion claimed by the patent at issue.” KSR, 550 U.S. at 418. A precise teaching directed to the specific subject matter of a challenged claim is not necessary to establish obviousness. Id. Rather, “any need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed.” Id. at 420. Accordingly, Petitioner must show that “a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1381 (Fed. Cir. 2016) (quotations and citations omitted).” slip op. at 28
Patent outcomesUS 10,828,310 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,828,310 - Mylan Pharmaceuticals Inc. / Teva Pharmaceuticals USA, Inc. et al. v. Bayer Pharma AktiengesellschaftAll claims unpatentablePTAB · Jul 28, 2023 · IPR2022-00517 · APJ Tina E Hulse · IPR · Final written decision
Claims 1–8 are unpatentable: claims 1–2 as anticipated by Foley, claims 1–2 and 5–8 as obvious over Foley, and claims 3–4 and 6–7 as obvious over Foley and Plosker.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner disagrees with Petitioner’s definition and contends that a POSA would have been a “clinician with experience in the design, conduct, analysis, and interpretation of results from clinical trials involving antithrombotic agents (anticoagulants and antiplatelet agents), as well as experience with the treatment of patients with anticoagulants and antiplatelet 7 Although we find certain of Patent Owner’s arguments not persuasive, this should never be taken as an indication that we have assigned Patent Owner the burden of proof on patentability. patients with coronary artery disease and/or peripheral artery disease.” PO Resp. 22 (citing Ex. 2060 ¶¶ 24–26). In response, Petitioner asserts that its definition encompasses Patent Owner’s definition, as the experience of an M.D. includes the ability to interpret the results of clinical trials to evaluate therapies. Pet. Reply 2–3 (citing Ex. 1037 ¶ 7). We find Petitioner has the better position. We agree with Petitioner and Dr. Zusman that an M.D. with experience treating patients who worked in consultation with a team of specialists would include the qualifications recited by Patent Owner. Ex. 1037 ¶¶ 7–11. We, therefore, adopt Petitioner’s definition of a POSA, which indicates a high level of skill in the relevant art and is consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“construction and determine that the term “clinically proven effective” is nonlimiting, as Petitioner asserts. See Pet. 11; Pet. Reply 8–9, 16. We begin our analysis with the language of the claims, which recite administering rivaroxaban and aspirin in amounts that are “clinically proven effective,” “wherein rivaroxaban is administered in an amount of 2.5 mg twice daily and aspirin is administered in an amount of 75–100 mg daily.” Ex. 1001, claims 1 and 5. We are persuaded that a POSA would have understood from a plain reading of the claims that the specific recited “amounts” of 8 We also noted in our Institution Decision that in the Delaware MDL, the parties stipulated that claim 1 “does not require FDA approval.” Dec. Inst. 15 n.6 (quoting Ex. 2019, 2). That is, the independent claims expressly recite that the rivaroxaban is administered in an amount of 2.5 mg twice daily, and that aspirin is administered in an amount of 75–100 mg daily. Ex. 1001, claims 1 and 5. Because the claims expressly recite the amounts of rivaroxaban and aspirin, further identifying these amounts as “clinically proven effective” is redundant and unnecessary, and does nothing to alter the method steps of administering the pharmaceutical, as otherwise recited by these claims. See Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1375 (Fed. Cir. 2001) (finding claim term “antineoplastically effective” not limiting where express dosage amounts are material claim limitations that do not change based on the intended result).” slip op. at 13
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableInherency foundUnpatentable
“Inherent anticipation requires “merely that the disclosure of the prior art is sufficient to show that the natural result flowing from the operation as taught in the prior art would result in the claimed product.” SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331, 1343–44 (Fed. Cir. 2005) (internal quotes omitted).” slip op. at 24
- Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableMotivation foundUnpatentable
“aspirin was taken with the first 2.5 mg dose of rivaroxaban, with the second 2.5 mg dose of rivaroxaban, or at a different time than either dose of rivaroxaban. Pet. 67 (citing Ex. 1002 ¶¶ 336–338). Nevertheless, Petitioner asserts that a POSA would have understood that “unless there is a cause for concern in terms of potential drug interactions, concomitant administration of multiple drugs in a dosing regimen is preferred for patient-compliance reasons.” Id. (citing Ex. 1002 ¶¶ 337–338). 13 We further note that we have considered, but are not persuaded that Patent Owner’s objective evidence of nonobviousness, discussed below, outweighs this strong evidence of obviousness. “first product,” Patent Owner does not argue that Foley does not teach a “first product.”14 See PO Resp. 51–56; PO Sur-reply 19–24. As set forth above, we agree with Petitioner’s construction of “first product” as not requiring, although allowing, a single combination dosage form. See supra Section II.B.2. We, therefore, find Petitioner has shown that a POSA considering Foley would have found it obvious to administer aspirin together with one of the rivaroxaban doses. We credit the testimony of Petitioner’s expert, Dr. Zusman, who notes that a POSA would have known that there were no concerns about administering rivaroxaban and aspirin together, and that it is easier for patients to take two drugs at the same time rather than at different times throughout the day. See Ex. 1002 ¶¶ 337–338; see also Ex. 1009,15 981 (noting “there is no clinically relevant interaction between rivaroxaban and aspirin and that the 2 drugs could be administered concomitantly”). We, therefore, find Petitioner has shown that Foley teaches or suggests each limitation of claims 5 and 8 and that a POSA would have had a reason to modify Foley to administer rivaroxaban together with aspirin with a reasonable expectation of success.” slip op. at 29
Patent outcomesUS 10,828,310 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,828,310 - Nextremity Solutions, Inc. / Zimmer Biomet Holdings, Inc. et al. v. Extremity Medical, LLCAll claims unpatentablePTAB · Jul 26, 2023 · IPR2022-00802 · APJ Jeffrey N Fredman · IPR · Final written decision
Claim 59 is unpatentable as anticipated by Brumfield, Marcus, and Chandran; the motion to amend proposing substitute claim 62 is denied because claim 62 is unpatentable.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“We find this argument unpersuasive. As Patent Owner notes, Petitioner’s expert provides a definition of POSITA that is very similar to that recited by Patent Owner in its Motion to Amend, substantively differing only in the number of years of experience of the engineer at issue. This congruity supports the conclusion that the level of ordinary skill in the art may be recognized in the prior art itself. Okajima, 261 F.3d at 1355 (“the absence of specific findings on the level of skill in the art does not give rise to reversible error ‘where the prior art itself reflects an appropriate level and a need for testimony is not shown’”).” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner
“In our Institution Decision, we agreed with Petitioner that the “portion of the preamble reciting ‘for compressing bone’ is not limiting to the claim” and found that other terms did not require construction. Dec. 8–9. We agreed with Petitioner that “[t]he phrase ‘for compressing bone’ merely identifies an intended use.” Pet. 20; Dec. 9. Patent Owner does not dispute this interpretation. See generally PO Resp. We agree with Petitioner that “the patentability of apparatus or composition claims depends on the claimed structure, not on the use or purpose of that structure.” Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed. Cir. 2002). Therefore, having considered the entire record developed during trial, we adhere to the preliminary construction that the limitation “for compressing bone” does not impose a structural limitation on claim 59 and that the other terms do not require construction.” slip op. at 11
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“Patent Owner disputes the Petition generally but Patent Owner does not identify any error in Petitioner’s foregoing arguments. Accordingly, we adopt the factual statements regarding the specific teachings of the references as findings of fact. See generally In re NuVasive, 841 F.3d 966, 974 (Fed. Cir. 2016) (explaining that the Board need not make specific findings as to claim limitations that Patent Owner does not dispute are disclosed in the prior art). We have reviewed Petitioner’s analysis and the underlying evidence cited in support and conclude that Petitioner has shown, by a preponderance of the evidence, that the limitations of claim 59 are disclosed by Brumfield.” slip op. at 26
- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, deniedDenied
“For the reasons discussed below, Patent Owner has shown that proposed substitute claim 62 meets the statutory and regulatory requirements set forth in 35 U.S.C. § 316(d) and 37 C.F.R. § 42.121. For the reasons discussed below, however, Petitioner has proven by a preponderance of the evidence that proposed substitute claim 62 is unpatentable over prior art. Therefore, we deny Patent Owner’s Revised Motion to Amend.” slip op. at 38
Patent outcomesUS 8,303,589 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · NautilusPatents in suitUS 8,303,589 - PTAB · Jul 19, 2023 · IPR2023-00442 · APJ John G New · IPR · Institution
The Board instituted IPR on all challenged claims and grounds, finding a reasonable likelihood that claim 1 is obvious over Dixon, CATT, MACTEL, and PIER.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 314, the Board “may not authorize an inter partes review to be instituted unless … the information presented in the petition … and any response … shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” Upon consideration of the Petition, Preliminary Response, Reply, Sur-Reply, and the evidence of record, we determine that the evidence presented demonstrates a reasonable likelihood that Petitioner would prevail in establishing the unpatentability of at least one challenged claim of the ’681 patent. We therefore institute inter partes review.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › General Plastic (serial petitions)Institution denied general plasticDenied
“deny a Petitioner successive attacks on the claims of a single patent, and profiting from those prior attempts by altering a petition’s strategy in response to Patent Owner’s and the Board’s responses. General Plastic, Paper 19 at 9–10. Patent Owner is quite correct, however, that, under Valve Corp., we can consider the relationship between different parties bringing successive challenges to a given patent. Valve Corp., Paper 11, at 2, 9. However, the facts of the present Petition render this present situation readily distinguishable from the facts in Valve Corp. In Valve Corp., we found that the parties bringing successive challenges to the patent-in-suit were “named as co-defendants in that lawsuit and were accused of infringing the ’934 patent based on [co-defendant] HTC’s VIVE devices that incorporate Valve’s technology.” Valve Corp., Paper 11, at 9–10. Furthermore, in that litigation, Valve represented that “HTC’s VIVE devices incorporate certain Valve technologies under a technology license from Valve,” and that “Valve employees did provide HTC with technical assistance during the development of the accused VIVE devices.” Id. at 10. The Board consequently concluded that “there is a significant relationship between Valve and HTC with respect to Patent Owner’s assertion of the ’934 patent. The complete overlap in the challenged claims and the significant relationship between Valve and HTC favor denying institution.” Id. No such facts obtain in the present instance. Petitioner is not a co- defendant with Mylan in the district court infringement action, Regeneron Pharms., Inc. v. Mylan Pharms. Inc., 1:22-cv-00061-TSK (N.D.W. Va.).11 There is no credible evidence of record that Petitioner and Mylan, potential business competitors, have developed any significant relationship, as in Valve Corp. Petitioner has joined the -01226 inter partes review as a “silent” slip op. at 44
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“skill in the art would have been motivated to adopt the exclusion criteria when administering aflibercept via intravitreal injection to minimize the risks of intravitreal infection and complications such as endophthalmitis and that adoption of these criteria reflected basic safety precautions developed to address the risks associated with intravitreal injections generally, regardless of the specific anti-VEGF agent injected. See Pet. 48–52. Petitioner has shown sufficient support on the record before us for such a view. Patent Owner also argues that Petitioner: (1) has not shown motivation to modify the exclusion criteria of PIER by adding the third exclusion criterion; and (2) has not shown motivation to modify the exclusion criteria of CATT and/or MACTEL. We disagree. We have explained above why we conclude that a person of ordinary skill in the art would have found exclusion criterion three to be obvious over not CATT and MACTEL individually and together. See KSR, 550 U.S. at 416. Moreover, Petitioner has, as we have also explained, asserted a persuasive reason why a skilled artisan would have been motivated to adopt the teachings of MACTEL and CATT to reduce the risk of intravitreal infection subsequent to injection of a VEGF receptor antagonist, such as aflibercept. Furthermore, Petitioner has persuasively argued that a person of ordinary skill in the art would also have had a reasonable expectation of success in adopting the exclusion criteria to the studies disclosed by Dixon, viz., that a person of ordinary skill in the art would therefore have reasonably expected that the exclusion criteria developed for prior art VEGF receptor antagonists could be successfully applied to aflibercept. Pet. 53 (citing Ex. 1002 ¶¶ 156–158).” slip op. at 39
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner disagrees with Petitioner’s definition of a person of ordinary skill in the art, arguing that the skilled artisan is an ophthalmologist experienced in treating angiogenic eye disorders, including with VEGF antagonists. Prelim. Resp. 11. Patent Owner acknowledges, however, that the parties’ differing definitions of a person of ordinary skill in the art do not affect any argument presented with respect to our present Decision to Institute. Id. As we explain below, with the exception of the exclusion criteria, claim 1 of the ’681 patent is identical to claim 1 of the ’388 patent in the -00881 IPR. We again determine that our definition of a person of ordinary skill in the art is reasonable and consistent with the prior art of record at this stage of the proceeding. For the purposes of this decision, and for the sake of consistency, we adopt our prior definition, quoted above, as the definition of a person of ordinary skill in the art.” slip op. at 10
§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 10,130,681 - Dr. Reddy’S Laboratories, Inc. v. Genentech, Inc., Hoffman-La Roche AG, And Abbvie Inc.Some claims unpatentablePTAB · Jul 5, 2023 · PGR2022-00023 · APJ Robert A Pollock · PGR · Final written decision
The Board held claims 2, 3, 5, 14, 26, 27, and 30 unpatentable for lack of written description, but did not find claims 1, 6, and 25 unpatentable.
RulingsFinal written decision- Skill levelSkill level board ownDecided for patent owner
“We do not discern a substantive difference between the parties’ respective definitions for the level of ordinary skill in the art. Although Petitioner did not expressly recite hematological malignancies, Petitioner did refer to expertise in clinical oncology and cancer biology, which would encompass the blood cancers recited by Patent Owner. Accordingly, we find the parties’ respective definitions to be equivalent and consistent with the level of ordinary skill in the art as reflected by the prior art in this proceeding. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))). We find that Dr. Gordon and Dr. Sharman are both qualified to opine from the perspective of a skilled artisan as both are persons of at least ordinary skill in the art, based on either party’s definition. Ex. 1020, ¶¶ 8– 19; Ex. 2008, ¶¶ 11–24.” slip op. at 7
- Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner
“We find Dr. Sharman’s statements and deposition testimony have substantially greater credibility than Dr. Gordon’s statements and deposition testimony based on Dr. Sharman’s significantly greater relevant experience in treatment and study of hematological cancers using chemotherapeutic agents and based on Dr. Sharman’s superior recollection and more complete analysis of the record found in the ’942 patent. In particular, we found Dr. Gordon’s statement that no example “includes” every element of claim 1 factually incorrect as contradicted by at least Figure 2 of the ’942 patent where the ordinary understanding of includes to mean encompasses is used. See Ex. 1020 ¶ 131. Ebit Sys. Am., LLC v. Thales Visonix, Inc., 881 F.3d 1354, 1358 (Fed. Cir. 2018) (“The PTAB [i]s entitled to weigh the credibility of the witnesses ....”).” slip op. at 16
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“The parties do not identify any issue relating to the preamble that needs to be addressed to resolve the sole written description challenge and the parties do not dispute that the transitional term “comprising” is “inclusive or open-ended and does not exclude additional, unrecited elements or method steps.” Georgia-Pacific Corp. v. US. Gypsum Co., 195 F.3d 1322, 1327 (Fed. Cir. 1999). We therefore find that there are no terms that need claim construction. See, e.g., Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 8
- Disclosure Requirements (§112) › Written description (Ariad)Written description adequateWritten description inadequateMixed
“We find that Figure 2 of the ’942 patent and the associated example provide literal and express descriptive support for claim 1 of the ’942 patent. As descriptive support for claim 1, the ’942 patent teaches treatment of leukemia or lymphoma, including chronic lymphocytic leukemia and small lymphocytic lymphoma (Ex. 1001, 16:21–22), by orally administering the Bcl-2 inhibitor GDC-0199 (Ex. 1001, 17:16) in escalating doses of 50 mg per day during a first week and 100 mg per day during a second week (Ex. 1001, Figure 2). Claim 1 of the ’942 patent, as written, does not exclude performance of the complete combination therapy shown in Figure 2. Rather, the reasonable understanding of the term “comprising” in claim 1 encompasses monotherapy with GDC-0199 alone and combination therapy with obinutuzumab. Both embodiments are described in the Specification. As Patent Owner points out, the ’942 Specification is replete with disclosures to administer GDC-0199 by itself to a patient, stating” slip op. at 16
Patent outcomesUS 10,993,942 mixedClaim construction§ 112 disclosurePatents in suitUS 10,993,942 - PTAB · Jul 3, 2023 · PGR2023-00014 · APJ Georgianna W Braden · PGR · Institution
The Board instituted PGR on claims 1–5 and all asserted challenges, finding written description and enablement challenges met the threshold but the Harris–Xing obviousness challenge did not.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“Patent Owner’s argument is unpersuasive because the combination of Harris with Xing is not cumulative of Pavlakis, Harris-2015, and Damsky. Here the combination of Harris with Xing is argued in different ways compared to what was made to the Examiner. Additionally, we agree with Petitioner that Xing discloses information the Examiner indicated were absent from the prior art. See Ex. 1010, 14–15. For example, Xing teaches administering a therapeutically effective amount of an inhibitor of IL-15 or the IL-15 receptor is administered to the subject. Compare id. at 15, with Ex. 1007, 3. Xing also teaches that TM-β1-mediated blockade of CD122 prevented disease development and progression and that inhibiting IFN-γ production downstream of IL-15 through topical administration of JAK inhibitors effectively eliminated existing lesions. Thus, we do not find that the same or substantially the same arguments were presented previously to the Office, nor do we find that the same or substantially the same art was previously presented to the Office. Thus, the first part of the Advanced Bionics framework is not satisfied for Petitioner’s § 103 challenge, and we decline to exercise our discretion under 35 U.S.C. § 325(d) to deny institution of a trial proceeding on this challenge.” slip op. at 12
- Skill levelSkill level petitioner adoptedOther
“At this stage of the proceeding, Patent Owner does not assert a different level of skill in the art at the time of the alleged invention and uses Petitioner’s proposed level of skill. Prelim. Resp. 16. For the purposes of this Decision, we too adopt Petitioner’s level of ordinary skill in the art because it appears consistent with the problems addressed in the ’505 patent and the prior art of record.” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Plain and ordinary meaningOther
“Both parties state that express claim construction is unnecessary at this stage of the proceeding and that all terms are to given their plain and ordinary meaning. Pet. 23; Prelim. Resp. 17. We agree. Construction is needed only for those terms “that are in controversy, and only to the extent necessary to resolve the controversy.” See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 terms for purposes of institution.” slip op. at 7
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review under 35 U.S.C. § 324 and 37 C.F.R. § 42.4. A post-grant review may not be instituted unless it is determined that “the information presented in the petition filed under section 321, 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.” 35 U.S.C. § 324 (2018); see also 37 C.F.R § 42.4(a) (2022) (“The Board institutes the trial on behalf of the Director.”). The “more likely than not” standard requires greater than 50% chance of prevailing. Consolidated Trial Practice Guide 58 (Nov. 2019), available at https://www.uspto.gov/TrialPracticeGuideConsolidated. For the reasons provided below and based on the record before us, we determine Petitioner has demonstrated that it is more likely than not that it would prevail in showing the unpatentability of at least one of the challenged claims. We decline to deny the Petition on a discretionary basis as requested by Patent Owner. Accordingly, we institute a post-grant review of the ’505 patent and all of the asserted challenges to patentability.” slip op. at 2
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,278,505
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.