- Samsung Bioepis Co. Ltd. v. Regeneron Pharmaceuticals, Inc.All claims unpatentablePTAB · Jun 14, 2024 · IPR2023-00442 · APJ John G New · IPR · Final written decision
Claims 1, 3–11, 13, 14, 16–24, and 26 are unpatentable as obvious over Dixon because Dixon anticipates them.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for petitioner
“We adopt the same reasoning here, and conclude that the evidence of record and the Specification of the ’681 patent support construing the preamble’s recitation of a “method for treating a patient with an angiogenic eye disorder” as meaning administering a compound, i.e., the recited VEGF antagonist, to a patient for the purpose of improving or providing a beneficial effect in their angiogenic eye disorder. We find that, as in Eli Lilly & Co. v. Teva Pharms. Int’l GmbH, although the claims “encompass a clinical result, they do not require such a result.” (emphasis added). 8 F.4th 1331, 1343 (Fed. Cir. 2021). We consequently reject Patent Owner’s proposed construction that the language of the preamble reciting a “method for treating an angiogenic eye disorder” requires not only an intent to treat, but, additionally, a high degree of efficacy on par with monthly Lucentis. See PO Resp. 9–10.” slip op. at 17
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“We adopt Petitioner’s proposed construction of the claim terms “initial dose,” “secondary dose,” and “tertiary dose.” Petitioner proposes adoption of the definitions expressly set forth in the Specification of the ’681 patent, viz., that the initial dose is the dose “administered at the beginning of the treatment regimen,” and is followed by the secondary doses that are “administered after the initial dose,” and the tertiary doses are “administered after the secondary doses” and may be distinguished from the secondary doses “in terms of frequency of administration.” Ex. 1001, col. 3, ll. 36–44. Patent Owner does not expressly dispute Petitioner’s construction, other than to argue that, by 2011, a person of ordinary skill in the art would have understood “initial” and “secondary” doses to correspond to loading doses and “tertiary” doses to correspond to maintenance doses. PO Resp. 13 (citing Ex. 2056 ¶ 66; Ex. 2349, 6–11. Patent Owner contends that the purpose (and expected effect) of loading doses was to achieve visual acuity gains and retina drying, and the goal of less frequent maintenance doses was to maintain the efficacy achieved with loading doses. Id. at 14 (citing Ex. 2056 ¶ 66). As we have explained above, we do not find persuasive Patent Owner’s argument that the definition of these terms requires a high, or otherwise defined, degree of efficacy. As we stated in the -00881 and -01225 Decisions: Based on those express definitions in the Specification, we do not find cause to construe the terms differently. In particular, we do not find that the Specification requires the “tertiary doses” to maintain any efficacy gain achieved after the initial and secondary doses, or that the term suggests any specific level of efficacy. The Specification unequivocally states that “[t]he terms ‘initial dose,’ ‘secondary doses,’ and ‘tertiary doses,’ refer to the temporal sequence of administration of the VEGF antagonist.”” slip op. at 18
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for patent owner
“If a claim limitation is directed to printed matter, the second step of the Praxair analysis is to determine whether the printed matter is functionally related to its “substrate.” Praxair, 890 F.3d at 1032. Printed matter that is functionally related to its substrate is given patentable weight. Id. (citing DiStefano, 808 F.3d at 850). However, “[w]here the printed matter is not functionally related to the substrate, the printed matter will not distinguish the invention from the prior art in terms of patentability.” Id. (quoting In re Ngai, 367 F.3d 1336, 1339 (Fed. Cir. 2004)). More specifically, printed matter is functionally related to its substrate when the language changes not mere thoughts or outcomes, but provides action steps that the method requires. See C R Bard Inc. v. AngioDynamics, Inc., 979 F.3d 1372, 1381 (Fed. Cir. 2020) (holding that the test for printed matter is whether it “merely informs people of the claimed information, or whether it instead interacts with the other elements of the claim to … cause a specific action in a claimed process.”); see also Bristol-Myers Squibb Co. v. Ben Venue Laboratories, Inc., 246 F.3d 1368, 1376 (Fed. Cir. 2001) (stating that language “is only a statement of purpose and intended result” where its “expression does not result in a manipulative difference in the steps of the claim”) (emphasis added).” slip op. at 21
- Skill levelSkill level petitioner adoptedDecided for petitioner
“A Person of Ordinary Skill in the Art Petitioner notes that the Petitioner in the ’00881 IPR proposed that a person of ordinary skill in the art would have: (1) knowledge regarding the diagnosis and treatment of angiogenic eye disorders, including the administration of therapies to treat said disorders; and (2) the ability to understand results and findings presented or published by others in the field. Pet. 17–18 (quoting -00881 IPR, Paper 94 at 9–10). Furthermore, it was asserted that such a person would typically have an advanced degree, such as an M.D. or Ph.D. (or equivalent, or less education but considerable professional experience in the medical, biotechnological, or pharmaceutical field), with practical academic or medical experience in (i) developing treatments for angiogenic eye disorders, including through the use of VEGF antagonists, or (ii) treating of same, including through the use of VEGF antagonists. Id. at 18 (citing -00881 IPR Paper 94 at 10). Patent Owner does not expressly contest this definition of a person of ordinary skill in the art in its Response. In the -01225 IPR, we adopted the same definition of a person of ordinary skill in the art for the challenged claims of the ’681 patent, concluding that that definition was consistent with the level of skill in the art. See -01225 IPR, Paper 96 at 52–53. Having previously adopted this definition of the level of skill in the art for the claims of the ’681 patent, we do so again in the present proceeding.” slip op. at 25
Patent outcomesUS 10,130,681 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,130,681 - Life Spine, Inc. v. Globus Medical, Inc.All claims unpatentablePTAB · Jun 13, 2024 · IPR2022-01600 · APJ Devon Zastrow Newman · IPR · Final written decision
Claims 1–20 are unpatentable as obvious: claims 1–7 and 9–20 over Olmos and Varela ’774, and claim 8 over Olmos, Varela ’774, and Oglaza.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“invention. Graham, 383 U.S. at 17–18. Petitioner contends that a person of ordinary skill in the art (sometimes abbreviated herein as “POSITA”): would have had a bachelor’s degree in mechanical engineering or biomedical engineering and two or more years of experience in biomechanical engineering, biomedical engineering, and/or spinal implant devices. A person could also have qualified as a POSITA with some combination of more formal education (e.g., an M.D.) and less technical experience or less formal education and more technical or professional experience in the foregoing fields, and would have had further appreciation of various technical concepts in this field. Pet. 18 (citing Ex. 1002 ¶¶ 32–35). Patent Owner does not dispute Petitioner’s proposal. See Response 8. We adopt Petitioner’s proposed level of ordinary skill in the art because it is consistent with the cited prior art and is undisputed. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (indicating that the prior art itself may reflect an appropriate skill level).” slip op. at 13
- Expert testimonyPetitioner expert creditedPatent owner expert discountedMixed
“We credit Mr. Drewry’s testimony that it would have been well within the ordinary skill of a POSITA to make the proposed modifications. See Ex. 1002 (Drewry Decl.) ¶¶ 34, 56–71 (discussing the qualifications of a POSITA and the types of engineering concepts the POSITA would have understood); Ex. 1030 (Drewry Reply Decl.) ¶¶ 37, 48–56, 59–66. To the extent Mr. Culbert testifies otherwise, we do not find such testimony persuasive. Indeed, Olmos itself further supports Mr. Drewry’s testimony that a POSITA would have known how to modify dimensions to fit specific needs and make changes necessary to adapt features from one embodiment to fit another. See Ex. 1006 (Olmos) ¶¶ 153, 188 (providing a range of implant sizes and noting that “specific dimensions” of any disclosed 9 Patent Owner’s citation to Mr. Drewry’s deposition transcript at 87:13– 88:9 appears to be incorrect. We understand that the intended citation is 69:34–70:7. embodiment can be varied as is apparent to a POSITA and “all features discussed in connection with any one embodiment herein can be readily adapted for use in other embodiments herein to form various combinations and sub-combinations”). Given the POSITA’s ability to make the proposed modifications, we do not find that Patent Owner’s evidence regarding the number of modifications required undermines Petitioner’s articulated reasoning for the combination.” slip op. at 35
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner asserts that “no terms require constructions differing from their plain and ordinary meaning.” Pet. 19. Patent Owner states that it “takes no position on Petitioner’s assertion because the Board need not construe any claim term to find that the Challenged Claims are not unpatentable.” Response 8. We find that for purposes of this Decision, we need not construe any claim term. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 21
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
Patent outcomesUS 10,973,649 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,973,649 - PTAB · Jun 13, 2024 · IPR2024-00240 · APJ Deborah Katz · IPR · Institution
The Board instituted inter partes review of claims 1–42 on all asserted grounds, finding a reasonable likelihood of success and declining discretionary denial under §§ 314(a) and 325(d).
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“The Director may not authorize an inter partes review “unless the Director determines that the information presented in the petition filed under section 311 and any response filed under section 313 shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). We determine whether to institute a post grant review on behalf of the Director. See 37 C.F.R. § 42.4(a). The following findings of fact and conclusions of law are not final, but are made for the sole purpose of determining whether Petitioner meets the threshold for initiating review. Any final decision shall be based on the full trial record, including any response timely filed by Patent Owner. Upon considering the Petition, the Preliminary Response, and the evidence of record, we determine that Petitioner has demonstrated there is a reasonable likelihood that the petition would prevail in showing that at least one challenged is unpatentable. Accordingly, we institute inter partes review of all challenged claims on all asserted grounds. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1354, 1359–60 (2018); 37 C.F.R. § 42.108(a).” slip op. at 2
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“patient is MSI-H after enrollment in a study in which pembrolizumab is to be administered is not within the scope of the claim step “in response to determining that the colorectal cancer is microsatellite instability high or DNA mismatch repair deficient, treating the patient with a therapeutically effective amount of pembrolizumab.” At this point in the proceeding, though, we do not interpret the claim step as meaning anything other than the treatment of colorectal cancer patients after they have been determined to be microsatellite instability high or DNA mismatch repair deficient. Although the term “in response to” in claim 1 requires that treatment of the patient occur after the determination that the colorectal cancer is MSI-H, we do not interpret the term to mean that other patients are not treated or that the recruitment and enrollment of patients for a clinical trial has any bearing on the steps recited in claim 1. We interpret a claim “using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. 282(b).” 37 C.F.R. § 42.100(b) (2019). Under this standard, we construe the claim “in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” Id. Patent Owner has not directed us to evidence that one of ordinary skill in the art would have understood treating a patient “in response to” the determination that the patient has a condition excludes treatment of other patients without the condition, although it does require that treatment of the patient occur after the determination that the colorectal cancer is MSI-H. The language of claim 1 refers only to patients that are determined to have microsatellite instability high or DNA mismatch repair deficient colorectal cancer, not to other patients. (See Ex. 1001, 25:40–50.) At this point in the proceeding, the record does not indicate that the treatment of patients determined not to be MSI-H is be factored into whether the teaching of treating patients determined to be MSI-H anticipates the method of claim 1. At this point in the proceeding, we construe the “in response to” limitation of claim 1 to mean that pembrolizumab is administered to a patient after the patient has been determined to be microsatellite instability high or DNA mismatch repair deficient, regardless of whether pembrolizumab is also administered to other patients.” slip op. at 17
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“H Study Record teaches treating colorectal cancer patients after they were determined to be microsatellite instability high or DNA mismatch repair deficient with pembrolizumab. (See MSI-H Study Record, Ex, 1005, 4 (Arms and Interventions); see also id., 2 (Study Identification), 3 (Study Description), 4–5 (Outcome Measures), 5–6 (Eligibility); see Neugut Decl., Ex. 1003, ¶¶ 58–62.) At this point in the proceeding, Petitioner has sufficiently shown that there is a reasonable likelihood of a causal relationship in the MSI-H Study Record between treatment of colorectal cancer patients and the determination of their MSI status — all colorectal cancer patients determined to be microsatellite instability high or DNA mismatch repair deficient were treated. Whether or not other patients were treated or enrolled in the study does not detract from this teaching.” slip op. at 16
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“Furthermore, to the extent the MSI-H Study Record does not disclose the limitation of “in response to determining that the colorectal cancer is microsatellite instability high or DNA mismatch repair deficient, treating the patient with a therapeutically effective amount of pembrolizumab,” the record before us supports this limitation being rendered obvious by Pernot and the MSI-H Study Record. Specifically, because Pernot teaches that colorectal cancer patients are good candidates for immunotherapy, the evidence of the current record shows that one of ordinary skill in the art would have had a reason to use to PD-1 inhibitors to treat colorectal cancers. (See Ex. 1006, 3741.) Additionally, the focus in the MSI-H Study Record on a clinical study treating colorectal cancer patients who had been determined to be MSI-H with prembrolizumab indicates that it would have been obvious to test for this condition before treatment. The additional references discussed by Petitioner contribute further to a reasonable likelihood that Petitioner will prevail. For example, Libson reports the successful treatment of a colorectal cancer patient having MSI-H status with a PD- 1 inhibitor (see Ex. 1057, 463-64) and Champiat discusses evaluating the clinical activity of PD-1 agents in DNA mismatch repair, such as MSI+, colorectal cancer (see Ex. 1032, e27817-5). (See Pet. 44.) Thus, based on the entire record before us, Petitioner presents a reasonable likelihood that the method of claim 1 would have been considered obvious by one of ordinary skill in the art.” slip op. at 23
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 11,591,393 - Life Spine, Inc. v. Globus Medical, Inc.All claims unpatentablePTAB · Jun 11, 2024 · IPR2022-01602 · APJ Devon Zastrow Newman · IPR · Final written decision
Claims 1–14 are unpatentable: claims 1–3 and 8–10 are anticipated by Weiman, and claims 4–7 and 11–14 are obvious over Weiman and Mozeleski; the revised motion to amend is denied.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Pet. 11 (citing Ex. 1002 (Drewry Decl.) ¶¶ 76–79). Patent Owner does not dispute Petitioner’s proposal. See generally Response. We adopt Petitioner’s proposed level of ordinary skill in the art because it is consistent with the cited prior art and is undisputed on this record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (indicating that the prior art itself may reflect an appropriate skill level).” slip op. at 11
- Expert testimonyPetitioner expert creditedDecided for petitioner
“We find persuasive, and credit, Mr. Drewry’s testimony that (1) a POSITA would have appreciated that the proposed modification to replace Weiman’s screw/socket with Waugh’s angled version provides benefits including “avoiding selected muscular and abdominal anatomical structures,” and (2) such “benefits would have been desirable for certain applications, such as those where the patient’s anatomy dictates that OLIF would provide the patient with the best medical outcome.” Ex. 1044 (Drewry Second Supp. Decl.) ¶¶ 23–26; see also Ex. 1043 (Waugh), ¶¶ 54, 87–90 (describing use of angled screw holes to, e.g., “receive a fastener via a surgical pathway” and configured “to penetrate endplate tissue of a vertebral body”). We find the weight of evidence supports Petitioner’s articulation of a POSITA’s understanding of how to use angles to avoid anatomical features” slip op. at 61
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner asserts that no terms require construction “because they are shown to be anticipated and/or obvious regardless of construction.” Pet. 12. Patent Owner did not propose any terms for construction. See generally Response. We determine that no claim terms require express construction to render this Decision.” slip op. at 18
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“j. Conclusion on Claim 1 For the above reasons, we determine that Petitioner has shown by a preponderance of the evidence that Weiman discloses each and every limitation of claim 1, and therefore anticipates claim 1.” slip op. at 28
Patent outcomesUS 9,956,087 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 9,956,087 - Life Spine, Inc. v. Globus Medical, Inc.All claims unpatentablePTAB · Apr 18, 2024 · IPR2022-01435 · APJ Devon Zastrow Newman · IPR · Final written decision
Claims 1–11 are unpatentable: Chung anticipates claim 10, and the Olmos-based obviousness grounds establish unpatentability of claims 1–11.
RulingsFinal written decision- Skill levelOther
“B. Level of Ordinary Skill in the Art We consider the grounds of unpatentability in view of the” slip op. at 11
- Strike new argumentNew argument consideredDenied
“9 Patent Owner asserts that Petitioner’s Reply brief “presents copious new evidence and theories that exceed the scope of proper reply” and “[t]he Board should refuse to consider” it. Sur-reply 7–9. This generic objection to the entire Reply fails to provide adequate notice regarding which of Petitioner’s theories and arguments Patent Owner contends are allegedly new and improper. See, e.g., Rembrandt Diagnostics, LP v. Alere, Inc., 76 F.4th 1376, 1383 (Fed. Cir. 2023) (rejecting generic objection to alleged new theories in reply as failing to provide adequate notice of which theories are allegedly new). Accordingly, we reject Patent Owner’s request that we “refuse to consider” the entirety of the Reply. Where Patent Owner’s Sur-reply raises more particularized complaints regarding Petitioner’s allegedly improper new arguments, we address those complaints as appropriate below.” slip op. at 20
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningOther
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed
“Accordingly, we find Petitioner has not shown that claim 1 is unpatentable as anticipated by Chung.” slip op. at 65
Patent outcomesUS 10,137,001 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,137,001 - Dr. Reddy’S Laboratories, Inc. v. Genentech, Inc., Hoffman-La Roche AG, And Abbvie Inc.No claims unpatentablePTAB · Apr 16, 2024 · IPR2023-00052 · APJ Jeffrey N Fredman · IPR · Final written decision
The Board held claims 1–4, 8–14, and 18–26 not shown unpatentable because they were entitled to priority before the November 2018 Venclexta Label, which therefore was not prior art.
RulingsFinal written decision- Skill levelSkill level board ownOther
“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, which would encompass the blood cancers recited in the claims. Neither party identifies a difference in the analysis or conclusions that would be based on differences in the ordinary skill in the art analysis. 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))).” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“The parties do not identify any issue relating to the preamble that would impact our analysis. We recognize that Patent Owner is suggesting that Petitioner’s expert, at least, is reading the word “clinical” into the treatment language of claim 1. However, the plain language of the claim 1 preamble states “treating lymphoma or leukemia in a human patient” and is supported by a straightforward definition in the Specification of the ’087 patent, expressly limiting the invention to treatment of human patients. See Ex. 1001, 16:25–38. We therefore find that the preamble terms do not need claim construction because there is no actual dispute suggesting that, for example, claim 1 implicitly recites the term “clinical.” 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 5
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)EnabledEntitled to earlier dateDecided for patent owner
“d. Analysis Considering the Wands factors as a whole, we find that the limited breadth of the claims, presence of several working examples, significant amount of direction and guidance provided by the ’087 patent, predictability in treating blood cancers with Bcl-2 inhibitors like GDC-0199, and high level of skill in the art are balanced against a large quantity of experimentation. Based on our consideration of the entirety of the evidence, we find that a preponderance of the evidence supports the conclusion that undue experimentation would not have been required to make and use the invention commensurate in scope with the claims of the ’087 patent. One underlying theme of Petitioner’s contentions and Petitioner’s expert testimony is the repeated contention that clinical trials were not completed by Patent Owner. See, e.g., Pet. 48 (“venetoclax (GDC-0199) was not FDA-approved”); Ex. 1020 ¶ 193. We find these arguments unpersuasive as we agree with Patent Owner that “[i]t is well established that a patent may be secured, and typically is secured, before the conclusion of clinical trials.” In re Montgomery, 67 F.3d 1375, 1382 (Fed. Cir. 2012). Particularly as to the dependent claims, a preponderance of the evidence of record does not support a finding that undue experimentation would have been required to administer three different doses of GDC-0199 starting with 100 mg, to use multiple daily dosing cycles of one day, to continue until disease progression occurs, or to combine with other treatment compounds. We find that a preponderance of the evidence does not support Petitioner’s position that any of the dependent claims fail to comply with the enablement requirement.” slip op. at 23
- Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateDecided for patent owner
“Applying Rai and Wertheim to the instant facts, we agree with Patent Owner that, factually and legally, in the ’087 patent “the claimed dosages of 100 mg, 200 mg, and/or 400 mg of GDC-0199 are adequately supported.” PO Second Suppl. Brief 2 (citing PO Resp. 11, 27–29; PO Sur-reply 19, 21– 22; Ex. 1001, 24:20–29.) In particular, the ’087 patent describes all three specific dosage values 100 mg, 200 mg, and 400 mg in the context of an escalating drug dosage series and Petitioner points to no persuasive statements in the specification that dispute either the effectiveness or the operability of GDC-0199 at any of these dosages.” slip op. at 32
Patent outcomesUS 11,110,087 not shown unpatentableClaim construction§ 102 anticipation§ 112 disclosurePatents in suitUS 11,110,087 - Life Spine, Inc. v. Globus Medical, Inc.Some claims unpatentablePTAB · Mar 20, 2024 · IPR2022-01434 · APJ Cynthia M Hardman · IPR · Final written decision
Claims 1–9 and 15 are unpatentable over Chung and Olmos-based obviousness grounds; claims 10–14 were not shown unpatentable because the asserted references did not teach the claimed complementary relationship.
RulingsFinal written decision- Expert testimonyOther
“improperly incorporates-by-reference 12 pages of expert testimony via a single sentence.” PO Sur-reply 16 n.2 (citing Pet. Reply 17, which in turn cites Ex. 1026 (Hatch Decl.) ¶¶ 49–66). We find that many of the paragraphs within the cited range (i.e., Hatch Declaration paragraphs 49–66) appear to have a tenuous connection to the proposition for which Petitioner cites these paragraphs. See Pet. Reply 17. That said, we find that paragraphs 53–55 directly relate to Petitioner’s proposition in the Reply, i.e., that “Petitioner’s experts explain why a [person of ordinary skill in the art] would rely on a cross-sectional view over a perspective view for making the determination in question, because only the cross-sections provide the needed side view directly orthogonal to the positions of the yellow expansion portion and the end of the dovetail.” Id. Accordingly, we find that paragraphs 53–55—the only paragraphs we cite from Petitioner’s range in reaching our conclusion—are not improperly incorporated by reference into Petitioner’s Reply.” slip op. at 66
- Strike new argumentNew argument consideredDenied
“provide Petitioner an opportunity to respond under the new construction, and decline to strike Petitioner’s relevant argument and evidence. Cf. Axonics, 75 F.4th at 1383 (“[W]hen the Board adopts a new claim construction following institution, an IPR petitioner must have adequate notice and an opportunity to respond under the new construction.”). Like in Axonics, in its new arguments on Reply, Petitioner here relies on the same embodiment from the same prior art reference that it relies on in the Petition to support the same legal argument, i.e., that Olmos’s Figure 16 embodiment discloses the “complementary with one another” limitation of challenged claims 10– 14. See Axonics, 75 F.4th at 1384; see also Apple Inc. v. Andrea Elecs. Corp., 949 F.3d 697, 706 (Fed. Cir. 2020) (permitting petitioner to elaborate in reply on an unpatentability theory presented in the petition). Moreover, we permitted Patent Owner to file (and it indeed did file) a sur-reply brief and expert declaration that addressed Petitioner’s new obviousness theories. Accordingly, both parties had adequate notice of our preliminary construction and an opportunity to respond under that new construction. For these reasons, we deny Patent Owner’s motion to strike.” slip op. at 124
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed
“from the expansion portion. We agree with Patent Owner that the wording of this limitation as a whole requires that the “extension necessarily must protrude beyond a longitudinal end of the expansion portion.” Id. at 11. We also agree with Patent Owner that “[u]nder Petitioner’s tenuous theory, an extension in any direction except 90 or 180 degrees would satisfy the claim language since any such direction has a so-called ‘longitudinal component.’” Id. at 13. For these reasons, we disagree with Petitioner’s argument that the purported “longitudinal component” of Chung’s extension satisfies limitation 1[h].” slip op. at 55
- Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableNot shown unpatentableMixed
“would have been motivated to add an extension to the Figure 16 embodiment because “an integrally-formed extension advantageously requires fewer parts, which facilitates both manufacturing and use.” Pet. 118. We agree with Patent Owner that this argument is unavailing. PO Resp. 50. Petitioner’s combination entails adding an extension (from Figure 8) to an embodiment lacking one (Figure 16). We agree with Patent Owner that adding a new component (whether separately or integrally) can in some instances complicate manufacturing/assembly and increase costs. See id. (citing Ex. 2013 (Culbert Decl.) ¶ 115). Petitioner has not sufficiently demonstrated that the proposed combination in this instance would reduce complexity or facilitate the manufacturing process. Accordingly, we do not rely on this argument offered by Petitioner.” slip op. at 106
Patent outcomesUS 8,845,731 mixed§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,845,731 - PTAB · Mar 19, 2024 · IPR2024-00181 · APJ Timothy G Majors · IPR · Institution
The Board instituted inter partes review of claims 1–29 and granted Inari’s contingent motion to join the Bayer 1038 IPR.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Petition, and has not otherwise addressed Inari’s contentions. Inasmuch as Patent Owner raised counterarguments to the grounds in the preliminary response that it filed in the Bayer 1038 IPR, we addressed those arguments in our Institution Decision in that proceeding. Bayer 1038 IPR, Paper 12. From our review of the preliminary record, we are persuaded that Inari’s Petition challenges the same claims of the ’745 patent, based on the same grounds and substantially the same evidence, compared to the challenge in the Bayer 1038 IPR.” slip op. at 5
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“Furthermore, a motion for joinder should (1) set forth reasons why joinder is appropriate; (2) identify any new grounds of unpatentability asserted in the petition; (3) explain what impact (if any) joinder would have on the trial schedule for the existing review; and (4) address specifically how briefing and discovery may be simplified. See Kyocera Corp. v. Softview LLC, IPR2013-00004, Paper 15, 4 (PTAB Apr. 24, 2013); Patent Trial and Appeal Board, Consolidated Trial Practice Guide, 76 (Nov. 2019), https://www.uspto.gov/sites/default/files/ documents/tpgnov.pdf. Inari addresses these considerations in its Motion, and we generally agree with Petitioner’s assertions in favor of joinder. Mot. 3–10. We discuss below.” slip op. at 7
- Other 314aOther
“prevailing, as it is substantively identical to the successful petition upon which we instituted the Bayer 1038 IPR. However, institution of an inter partes review is discretionary. See 35 U.S.C. § 314(a) (authorizing institution of an inter partes review under particular circumstances, but not requiring institution under any circumstances); Cuozzo Speed Techs., LLC v. Lee, 579 U.S. 261, 273 (2016) (“[T]he agency’s decision to deny a petition is a matter committed to the Patent Office’s discretion.”); SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348, 1356 (2018) (“[Section] 314(a) invests the Director with discretion on the question whether to institute review . . . .” (emphasis omitted)); Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1367 (Fed. Cir. 2016) (“[T]he PTO is permitted, but never compelled, to institute an IPR proceeding.”). I would exercise that discretion here and deny the Petition. The Bayer 1038 IPR is governed by the petition filed by Bayer. See Facebook, Inc. v. Windy City Innovations, LLC, 973 F.3d 1321, 1336 (Fed. Cir. 2020) (“The already-instituted IPR to which a person may join as a party is governed by its own petition and is confined to the claims and grounds challenged in that petition.”). However, “[t]he instant Petition is substantively identical to the petition filed by Bayer, challenging the same claims of the ’745 patent on the same grounds and relying on substantively identical expert testimony.” Pet. 3. Thus, institution based on the instant Petition creates a second inter partes review that is duplicative of the Bayer 1038 IPR. As we are already granting Inari’s request to join the Bayer 1038 IPR as a petitioner, I see no benefit to granting Inari’s Petition to institute a second inter partes review. I would deny Inari’s Petition.” slip op. at 11
Discretionary denialPatents in suitUS 11,299,745 - Parse Biosciences, Inc. v. 10x Genomics, Inc.Rehearing grantedPTAB · Feb 5, 2024 · IPR2023-00958 · APJ Michael J Fitzpatrick · IPR · Rehearing
Rehearing was granted and IPR instituted on claims 1–28 because the petition showed a reasonable likelihood that claim 1 was obvious over Linnarsson, McCloskey, and ordinary skill.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“III. WHETHER REHEARING IS WARRANTED Petitioner argues that we misconstrued the claims “as requiring one to add tags in a way that can provide a distinction based on a ‘polynucleotide sequence.’” Req. 6 (quoting Dec. 14 (Petitioner’s emphasis)). Petitioner is correct. More specifically, we implicitly construed the claim language reciting “a second tag sequence distinguishing said sample polynucleotide from other sample polynucleotides from said cell,” as requiring said “distinguishing” to be based on the sequences of the sample polynucleotides. See, e.g., Dec. 14 (“[E]ach strand of cDNA that is tagged in Linnarsson is tagged regardless of the polynucleotide sequence of the cDNA or its corresponding mRNA. Thus, Linnarsson’s tags do not distinguish between ‘sample polynucleotides,’ whether cDNA or mRNA, of different sequences.”). Based on that misunderstanding, we erroneously determined that the proposed modification could not achieve the claim language, stating the following: Petitioner’s proposal appears to defeat satisfaction of another portion of claim 1, namely a “second tag sequence distinguishing said sample polynucleotide from other sample polynucleotides from said cell.” Ex. 1001, 30:62–64. For if the second tag is “added to the CDS or TSO after extension,” as opposed to the sample polynucleotide, as Petitioner argues (Pet. 39 (emphasis added)), it would appear that the second tag would be incapable of distinguishing any sample polynucleotide from other sample polynucleotides. Rather, the second tag would be ligated to each and every extension product bearing a CDS or TSO without regard to the sequence of any sample polynucleotide. Dec. 16. We now reconsider whether to institute.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“Cited”). Because we find that the same or substantially the same art was previously presented to the Office, we proceed to part two of the analysis. 2. Advanced Bionics Part Two Patent Owner argues that the Petition “fails to show any error in the Examiner’s application during prosecution of the prior art teachings Petitioner now purports to invoke from . . . McCloskey.” Prelim Resp. 23; see also id. at 24–25 (“Revisiting the same art and arguments already overcome during prosecution is a waste of the Board’s limited resources and would unfairly burden PO.”). However, Petitioner argued that “the Examiner committed major error in Examination by erroneously stating that the prior art fails to teach a dual tagging approach when, in fact, this approach is plainly taught in both McCloskey and McCloskey II.” Pet. 67. The record supports Petitioner’s position, and we agree that the error was material to patentability. See Ex. 1005, 131 (Notice of Allowance). Accordingly, and having considered all of the Becton, Dickinson factors, we do not exercise discretionary denial.” slip op. at 12
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We are persuaded there is a reasonable likelihood that Petitioner would prevail in demonstrating that a person of ordinary skill in the art would have had a reasonable expectation of success in combining the teachings of Linnarsson and McCloskey with the knowledge of a person of ordinary skill in the art to obtain the claimed subject matter. 8. Conclusion as to Claim 1 There is a reasonable likelihood that Petitioner would prevail in proving that claim 1 is unpatentable.” slip op. at 21
- Obviousness (§103) › Analogous artNot reached
“the three references is analogous art to the ’013 patent as opposed to each other. Prelim. Resp. 46 (citing Pet. 35; Sanofi-Aventis Deutschland GmbH v. Mylan Pharms. Inc., 66 F.4th 1373, 1374 (Fed. Cir. 2023)). As Sanofi- Aventis holds, a petitioner bears the burden of persuasion to establish that an asserted prior art reference is analogous art to the claimed invention. See Sanofi-Aventis, 66 F.4th at 1377 (“We agree with [the patent owner] that [the petitioner] did not carry its burden to argue that de Gennes is analogous to the [challenged] patent.”); id. (“In evaluating whether a reference is analogous, we have consistently held that a patent challenger must compare the reference to the challenged patent.”); id. at 1378–79 (“We have routinely held that the petitioner has the burden of proving unpatentability.”). However, the Petition should not be denied for failing to state explicitly that the cited prior art references are analogous art to the ’013 patent. Rather, as Sanofi-Aventis further held: “A petitioner is not required to anticipate and raise analogous art arguments in its petition; instead a petitioner can use its reply to ‘respond to arguments raised in the corresponding opposition, patent owner preliminary response, patent owner response, or decision on institution.’” Sanofi-Aventis, 66 F.4th at 1379 (quoting 37 C.F.R. § 42.23). Accordingly, we need not address this issue for purposes of deciding whether to institute trial.” slip op. at 15
§ 103 obviousnessDiscretionary denialPatents in suitUS 10,697,013 - Parse Biosciences, Inc. v. 10x Genomics, Inc.Rehearing grantedPTAB · Feb 5, 2024 · IPR2023-00955 · APJ Michael J Fitzpatrick · IPR · Rehearing
Rehearing granted and IPR instituted on claims 1–26; the Board found a reasonable likelihood that claim 1 would have been obvious over Linnarsson and McCloskey.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“III. WHETHER REHEARING IS WARRANTED Petitioner argues that we misconstrued the claims “as requiring one to add tags in a way that can ‘provide a distinction based on a polynucleotide’s sequence.’” Req. 6 (quoting Dec. 15 (Petitioner’s emphasis)). Petitioner is correct. More specifically, we implicitly construed the claim language reciting “a second tag sequence distinguishing said sample polynucleotide from other sample polynucleotides from said cell,” as requiring said “distinguishing” to be based on the sequences of the sample polynucleotides. See, e.g., Dec. 14 (“[E]ach strand of cDNA that is tagged in Linnarsson is tagged regardless of the polynucleotide sequence of the cDNA or its corresponding mRNA. Thus, Linnarsson’s tags do not distinguish between ‘sample polynucleotides,’ whether cDNA or mRNA, of different sequences.”). Based on that misunderstanding, we denied the Petition because “adding a second tag sequence to Linnarsson’s CDS and/or TSO would do nothing to achieve such a distinction,” i.e., “a distinction based on a polynucleotide’s sequence.” Id. at 15. That was error. We now reconsider whether to institute.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDecided for petitioner
“the ’197 patent. See Ex. 1001, code (56) (listing McCloskey II under “References Cited”). Because we find that the same or substantially the same art was previously presented to the Office, we proceed to part two of the analysis.” slip op. at 11
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We are persuaded there is a reasonable likelihood that Petitioner would prevail in demonstrating that a person of ordinary skill in the art would have had a reasonable expectation of success in combining the teachings of Linnarsson and McCloskey to obtain the claimed subject matter. 6. Conclusion as to Claim 1 There is a reasonable likelihood that Petitioner would prevail in proving that claim 1 is unpatentable.” slip op. at 18
- Obviousness (§103) › Analogous artNot reached
“GmbH v. Mylan Pharms. Inc., 66 F.4th 1373, 1374 (Fed. Cir. 2023)). As Sanofi-Aventis holds, a petitioner bears the burden of persuasion to establish that an asserted prior art reference is analogous art to the claimed invention. See Sanofi-Aventis, 66 F.4th at 1377 (“We agree with [the patent owner] that [the petitioner] did not carry its burden to argue that de Gennes is analogous to the [challenged] patent.”); id. (“In evaluating whether a reference is analogous, we have consistently held that a patent challenger must compare the reference to the challenged patent.”); id. at 1378–79 (“We have routinely held that the petitioner has the burden of proving unpatentability.”). However, the Petition should not be denied for failing to state explicitly that the cited prior art references are analogous art to the ’197 patent. Rather, as Sanofi-Aventis further held: “A petitioner is not required to anticipate and raise analogous art arguments in its petition; instead a petitioner can use its reply to ‘respond to arguments raised in the corresponding opposition, patent owner preliminary response, patent owner response, or decision on institution.’” Sanofi-Aventis, 66 F.4th at 1379 (quoting 37 C.F.R. § 42.23). Accordingly, we need not address this issue for purposes of deciding whether to institute trial.” slip op. at 15
§ 103 obviousnessDiscretionary denialPatents in suitUS 10,240,197
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.