- Biofrontera Inc. / Biofrontera Bioscience GmbH et al. v. Sun Pharmaceutical Industries, Inc.InstitutedPTAB · Feb 24, 2025 · IPR2024-01312 · APJ Erica A Franklin · IPR · Institution
The Board instituted review of claims 1, 2, 4-6, 16, 17, and 19-21 on all asserted grounds, finding a reasonable likelihood of unpatentability over Lundahl and Larsen.
RulingsInstitution decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“justification for requiring a POSITA to have both an engineering degree and a medical degree. We agree, insofar as Petitioner has not clearly set out any particular explanation or evidence in support of its dual-degree requirement. In all other respects, we note that the parties’ proposed definitions are largely similar. Because we determine that Patent Owner’s proposed definition is reasonable and consistent with the ’028 patent and the cited art, we adopt Patent Owner’s definition for purposes of this Decision. In any event, our decision whether to institute does not turn on this level of skill determination.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“used to construe the claim in a civil action under 35 U.S.C. § 282(b); 37 C.F.R. § 100(b). Under that standard, claim terms “are generally given their ordinary and customary meaning” as understood by a person of ordinary skill in the art at the time of the invention. Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc) (quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)). See 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)). Petitioner and Patent Owner assert that the Board need not construe any claims for the purpose of deciding whether to institute an inter partes review. Pet. 12; Prelim. Resp. 24. We agree.” slip op. at 10
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“Based on our review of the Petition, Petitioner explains that a driving motivation for a POSITA to modify Lundahl to include Larsen’s five panels is “to increase the flexibility of the device to ensure the light panels could be maintained at a distance of 2-4′′ from surface of the treatment area, whether the face, arm, or back, etc.” Pet. 29 (emphasis added). As Lundahl’s device is not flexible, and such flexibility would improve its ability to treat areas other than an average sized face, we determine, at this stage in the proceeding, that this motivation for the combination is sufficient.” slip op. at 20
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › HindsightInstituted
“would have been motivated to modify Lundahl’s device by incorporating Larsen’s use of LEDs on the surface of the light applicators in place of Lundahl’s fluorescent tubes with a reasonable expectation of success. Prelim. Resp. 55. Patent Owner argues that Petitioner’s modification is based on improper hindsight bias because “Petitioner cherry-picks Larsen’s LEDs (together with the five panels) and purports to arrange them according to the [sic] ‘the uneven spacing’ of Lundahl’s fluorescent tubes.” Id. at 56 (citing Pet. 46–49; Ex. 1015 ¶¶ 175–80). According to Patent Owner, “Petitioner cannot on the one hand argue that a ‘POSITA would have understood that Larsen’s applicator is configured to uniformly illuminate a treatment surface of the patient,’ while on the other ignore Larsen’s teaching that the ‘light sources 17 are placed in regular row arrangements.’” Id. Patent Owner asserts that Petitioner’s proposed modification “mish-mashes aspects of Lundahl and Larsen ([while] avoiding the overall teachings of [challenged] claims.” Id. at 56–57. As discussed above, based on our consideration of the current record, Petitioner has provided sufficient motivation for employing Larsen’s flexible five panel configuration. These panels in Larsen already use LEDs as their light source. So, in our view, Petitioner’s incorporation of the five panels includes the lighting source, i.e., LEDs, for those panels taught by Larsen. Further, we note that Petitioner has persuasively asserted that a skilled artisan would have been motivated to use Larsen’s LEDs as they are more cost-efficient and last longer. See Pet. 31.” slip op. at 20
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,697,028 - PTAB · Jan 16, 2025 · IPR2024-01088 · APJ Sharon Fenick · IPR · Institution
The Board instituted IPR on all challenged claims and grounds, finding a reasonable likelihood that Apple would prevail on its § 103 challenges.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“partes review. See 35 U.S.C. § 314(b); 37 C.F.R. § 42.4(a). Under 35 U.S.C. § 314(a), we may not authorize an inter partes review unless the information in the Petition “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.” For the reasons that follow, we institute inter partes review as to the challenged claims of the ’758 patent on all grounds of unpatentability presented.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Pet. 7 (internal citations omitted) (citing Ex. 1003 ¶¶ 41–53). For the purposes of institution, Patent Owner did not dispute this level of skill. Prelim. Resp. 6 (“Patent Owner does not necessarily agree with all aspects of Petitioner’s proposed level of ordinary skill, but does not believe that resolving that level is necessary to resolve the issues raised in this preliminary response.”) The portion of the definition proposed by the Petitioner requiring “a bachelor’s degree in computer science, computer engineering, or a comparable field and at least two years of professional experience working with graphical user interfaces and applications for computers” appears to be consistent with the problems and solutions in the ’758 patent and prior art of record and is supported by declarant testimony. We adopt this as the definition of one of ordinary skill in the art for the purposes of this Decision. We note that since it is unclear whether the bachelor’s degree in the proposed definition is considered by Petitioner to be “an advanced-level degree” we do not adopt the portion of the definition relating to the substitution of years of experience for a degree at this time. Additionally, we do not herein adopt Petitioner’s proposed additional requirement that one of ordinary skill “would have possessed extensive background knowledge and understanding of the pertinent technologies employed by the ’758 patent.” Pet. 7.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“Patent Owner also notes that in the pending District Court Litigation, Petitioner contends that eight claim terms found in the challenged claims are indefinite: “performing an operation [in connection with / on] the first application icon,” “application-launch criteria,” “action-option-display criteria,” “operation criteria,” “movement criteria,” “action options,” “action option objects,” and “evaluating the first single-finger touch input against at least one of a plurality of criteria, including evaluating a duration of the first single-finger touch input against at least one of: one or more application-launch criteria, one or more action-option-display criteria, or one or more operation criteria, and further including evaluating a movement of the first single-finger touch input against one or more movement criteria.” Prelim. Resp. 6–7 (citing Ex. 2003, 9–75). Patent Owner further notes that, contrary to its position in the pending District Court Litigation, Petitioner does not assert that any of these terms are indefinite in this proceeding. Id. For institution and on our present record, we determine that none of these claim terms require construction. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (only those terms that are in controversy need be construed, and only to the extent necessary to resolve the controversy) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). 3. Other Terms For institution and on our present record, no other claim terms require construction. See Nidec, 868 F.3d at 1017.” slip op. at 11
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner
“We determine that, on this record and for the purposes of institution, Petitioner has made a sufficient showing regarding motivation for its proposed combination of Chaudhri, Martyn, and Griffin. For the combination of Chaudhri and Martyn, we determine, on the present record and for the purposes of institution, that Petitioner has sufficiently shown support for the use of Martyn’s snap-shot menu with Chaudhri’s user interface. We acknowledge Patent Owner’s declarant’s examples of instances in which devices that incorporated “popular user interface features . . . did not achieve the same level of success because of poorly articulated design implementation.” Ex. 2001 ¶ 127 (cited at PO Resp. 23). However, on the present record, this evidence does not specifically address whether one of ordinary skill would have found such examples significant enough or relevant enough to the proposed combination to dissuade one of ordinary skill from considering such a combination to be reasonably likely to succeed, especially in light of the testimonial evidence before us that similar menus were often incorporated into GUIs similar to Chaudhri’s, which is adequately supported by reference to numerous examples. See Ex. 1003 ¶¶ 43–48, 64–65 (cited at Pet. 16). Additionally, we find compelling that Chaudhri describes a pop-up dialogue sub-menu for a different purpose (modifying the user interface object). See Ex. 1004 ¶¶ 274, 317, Figure 5LLL; Pet. 18–19; Ex. 1003 ¶ 69. On the present record, one of ordinary skill in the art would have found the use of the similar snap-shot menu from Martyn (offering different functionality) to be further prompted by this sub-menu, and not to have been redundant or “already solved” in Chaudhri, as Patent Owner argues (PO Resp. 26–27). See Pet. 18–19; Ex. 1003 ¶ 69. introduced to the combination of Chaudhri and Martyn to address a conflict that arises because Petitioner proposes a combination of Chaudhri and Martyn that “create[s] a conflict of assigning two functions to the same gesture.” PO Resp. 20. However, Petitioner provides a number of rationales to combine, and Petitioner’s argument that one of ordinary skill would have sought details from Griffin to implement Chaudhri’s teachings describing different user functionality being launched by user touches of different user durations (Pet. 19–21) adequately supports the use of the material from Griffin in the proposed combination. See Ex. 1004 ¶¶ 217, 218; Ex. 1002 ¶¶ 70–73, 75; see also PO Resp. 24 (describing “multiple types of gestures” used Chaudhri). While the proposed combination of Chaudhri and Martyn would, as Petitioner asserts, result in “three distinct operations invoked by duration-based touch gestures at an application icon” (Pet. 21), two of these distinct operations are found in Chaudhri’s teachings, and thus, on the present record, the motivation to look to Griffin does not arise only from the proposed combination of Chaudhri with Martyn. On the present record and for the purposes of institution, we determine that Petitioner has adequately shown that one of ordinary skill would have looked to Griffin to supply additional information regarding implementation of Chaudhri’s (and the Chaudhri and Martyn combination’s) use of parameters of a user’s touch, including duration, to enable different functionalities. Ex. 1006 ¶¶ 40, 53, Fig. 7; Ex. 1002 ¶¶ 70–73, 75. With respect to the use of the “press-and-hold” feature from Martyn, rather than other possibilities from Martyn for triggering its snap-shot menu and rather than adding a second touch point as Patent Owner suggests (PO Resp. 27–28, 32, 33 (citing Ex. 2001 ¶¶ 142–143, 156, 166, 172–173)), on to have been a suitable option. Pet. 15–16; Ex. 1003 ¶¶ 49–53, 63–64; Intel Corp. v. Qualcomm Inc., 21 F.4th 784, 799–800 (Fed. Cir. 2021) (determining that a showing of the obviousness in “predictable use of prior art elements according to their established functions” (as per KSR, 550 U.S. at 417) requires only a showing that the combination be a suitable option, rather than a showing that it is the best option).” slip op. at 20
Claim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,656,758 - PTAB · Jan 13, 2025 · IPR2024-00186 · APJ Jeffrey N Fredman · IPR · Institution
The Board instituted inter partes review on all challenged claims and all 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
“We have jurisdiction under 35 U.S.C. § 314, which provides that an inter partes review may not be instituted unless the information presented in the Petition “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.” A decision to institute under § 314 may not institute on fewer than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). In addition, if the Board institutes trial, it will “institute on all grounds in the petition.” PTAB Consolidated Trial Practice Guide, 5–6 (Nov. 2019); see also PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (interpreting the statute to require “a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition”). Having considered the arguments and evidence presented in the Petition and the Preliminary Response, for the reasons described below, we institute inter partes review.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“Office (“USPTO”) issued a Memorandum titled “Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings With Parallel District Court Litigation” (“Memorandum”)11, which states, among other things, that “the PTAB will not discretionarily deny institution in view of parallel district court litigation where a petitioner presents a stipulation not to pursue in a parallel proceeding the same grounds or any grounds that could have 11 Available at www.uspto.gov/sites/default/files/documents/interim_proc_ discretionary_denials_aia_parallel_district_court_litigation_memo_2022 0621_.pdf. reasonably been raised before the PTAB.” Memorandum 3 (citing Sotera Wireless, Inc. v. Masimo Corp., IPR2020-01019, Paper 12 (PTAB Dec. 1, 2020) (precedential as to § II.A)). By email dated November 25, 2024, Petitioner requested leave to file a Reply to Patent Owner’s Preliminary Response to address, inter alia, its proposed submission of a Sotera stipulation. Ex. 3001. We denied Petitioner’s request for briefing, but granted its request to submit the stipulation. Id. The Sotera stipulation avers that “if IPR Nos. IPR2024- 00183, IPR2024-00185, and IPR2024-00186 are instituted, National Beef will not pursue in the related district court proceeding, Inst. for Envtl. Health, Inc. v. Nat’ / Beef Packing Co., LLC, No. 1:23-cv-00826 (D. Del. Aug. 1, 2023), any ground National Beef raised or reasonably could have raised in the aforementioned IPRs,” and that the stipulation “binds National Beef in the related district court proceeding, Inst. for Envtl. Health, Inc. v. Nat'l Beef Packing Co., LLC, No. 1:23-cv-00826 (D. Del. Aug. 1, 2023).” Ex. 1064. Applying the guidance provided in the Memorandum, we decline to exercise our discretion to deny institution in this proceeding under Fintiv because Petitioner submitted a Sotera stipulation.” slip op. at 20
- BurdenInstituted
“Thus, Petitioner has accounted for each step/element of independent claims 1 and 37 as taught by the combination of ICMSF and Gombas, and has also provided a reason why, with rational underpinnings, the prior art would have been combined and modified, with a reasonable expectation of success. On the current record, including Patent Owner’s arguments that we considered and are addressed in detail below, Petitioner’s evidence for this ground is sufficient to provide a reasonable likelihood of success in demonstrating unpatentability of at least one claim.” slip op. at 31
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“We agree with Patent Owner that the term “lots” does not require construction because on the current record, there is no controversy over the meaning of the term, and neither Petitioner nor Patent Owner identify any way that claim construction may impact our decision. We also agree with Patent Owner that the ’771 patent provides definitions that guide the understanding of the term “lots” including: The term “test lot” or “reportable lot” as used herein to refer to an assemblage of one or more specimens of a medium or process (e.g. assemblage of specimens of air, water, solids or of products of a production process, etc.), where such assemblage can be sampled by taking portions of the one or more specimens thereof, and where the one or more specimens of the assemblage are operationally linked in a manner (e.g., proximity, time, process step, etc.) whereby information derived about sampled portions is operationally applicable to all specimens of the assemblage, and thus to the test lot. In particular instances, portions are synonymous with specimens. Ex. 1003, 5:43‒54. The ’771 patent similarly provides definitions for “product portion,” “test lot sample,” and “composite lot-unit” that provide significant guidance and clarity as to the meaning of these terms. Ex. 1003, 5:60‒6:4, 6:12‒29, 7:49‒63. 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)). We decline to expressly interpret this term at this time.” slip op. at 11
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 9,637,771 - Lenovo (United States) Inc. / Motorola Mobility LLC v. Theta IP, LLCNo claims unpatentablePTAB · Oct 16, 2024 · IPR2023-00697 · APJ Barbara A Benoit · IPR · Final written decision
Claims 1, 3, 4, and 8 were not proven unpatentable: Rauhala does not disclose the required simultaneous signal-strength determinations, and Masaaki does not cure the deficiency for claim 4.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Following institution, Patent Owner maintained the same level of ordinary skill proposed in its preliminary response and did not address our discussion of the level of ordinary skill in the art in the Institution Decision. PO Resp. 24–25; see also Prelim. Resp. 24. For the reasons discussed in the Institution Decision, we adopt and apply for this Decision the level of ordinary skill articulated by Petitioner and used previously in our Institution Decision. See Dec. 8–10. In light of our review of the complete record, we find that this formulation is consistent with the ’825 patent, the prior art of record, and is supported by the testimony of Dr. Baker. See Ex. 1002 ¶¶ 27– 31. Our decision would not change, however, if we had applied Patent Owner’s proposed level of ordinary skill.” slip op. at 12
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“We agree with Patent Owner that the desired signal and interferer signal must be received at the same time. The plain language of the claim requires the wireless transceiver to “receiv[e] a wireless signal having a desired signal and an interferer signal,” the determining of a signal strength of the interferer signal and the determining of a signal strength of the desired signal must be performed at the same time; otherwise, the determinations of signal strengths would not be of the same wireless signal. The specification supports this understanding. “When a receiver is actively receiving a desired signal, each block in the signal path has at its input the desired signal as well as noise and possibly interfering signals.” Ex. 1001, 5:20–22; see also id. at 5:31–33 (“FIGS. 2A and 2B illustrate examples of desired signals, interferers, and noise that may be received by one of the various circuits in a” slip op. at 21
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“We agree with Patent Owner that Rauhala does not state that the signal strengths are measured simultaneously or at the same time. Indeed, as discussed above, Rauhala indicates unequivocally in the same paragraph the opposite—that detector DET provides to control unit 42 “an indication about either the receive channel signal strength RSS or the strength of any signal on the reception band.” Ex. 1004 ¶ 17. Rauhala describes that “control unit 42 provides two one-bit control signals cA and cM” based on indications received from detector DET. Id. Importantly, Rauhala indicates that “at the same time as” describes how the control unit 42 uses the received inputs RSS and RSSn shown in Figure 4, which are described earlier in paragraph 17 as indications of either RSS or RSSn from detector DET. Id. (“Signal cA is 0 when signal RSS is greater than S4 and signal RSSn is at the 11 Dr. Baker’s reply declaration correctly quotes Rauhala paragraph 17 but cites to paragraph 18. We deem this harmless error. same time smaller than Sn. . . . Signal cM is 1 when signal RSS is not greater than S4 and signal RSSn is at the same time at least Sn. Otherwise, signal cM is 0.”). The burden remains on Petitioner to demonstrate by a preponderance of the evidence that Rauhala discloses the disputed limitations as arranged or combined in the claim. Petitioner does not persuasively reconcile these “either/or” statements regarding the functioning of detector DET with the “at the same time as” statements regarding control signals output by control unit 42 in paragraph 17. We do not find persuasive Petitioner counsel’s position expressed at the hearing that Rauhala’s “either/or” statements are “simply an imprecise description” (Tr. 16:22–24). We do not see a lack of precision in Rauhala’s “either/or” statements.” slip op. at 30
- Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner
“When asked at his deposition to explain Rauhala’s use of the word “or” regarding the functioning of detector DET, Dr. Baker asserted that “[detectors] can be designed to determine RSS or RSSn.” Ex. 2016, 85:5– 12. We find Dr. Baker’s testimony that “it’s reasonable that if you can design . . . the detector to detect one or the other, you can also design it to detect both” to be without factual support. Id. at 85:13–16. He points to no textbook or other independent evidence to support that would have led one of ordinary skill to design such a detector or to support that one of ordinary skill would have understood Rauhala’s detector to be so designed. Furthermore, Dr. Baker recognizes that “Rauhala doesn’t teach the details of what’s in the detector.” Id. at 91:6–7. We give little weight to Dr. Baker’s unsupported testimony that one could design a detector to detect both RSS and RSSn from the same wireless signal. See 37 C.F.R. 42.65(a) (“Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.”); see also Xerox Corp. v. Bytemark, Inc., No. IPR2022-00624, 2022 WL 3648989, at *6 (PTAB 2022) (precedential) (Director affirming because “the cited declaration testimony is conclusory and unsupported, adds little to the conclusory assertion for which it is offered to support, and is entitled to little weight”).” slip op. at 31
Patent outcomesUS 10,129,825 not shown unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,129,825 - Lenovo (United States) Inc. / Motorola Mobility LLC v. Theta IP, LLCNo claims unpatentablePTAB · Oct 16, 2024 · IPR2023-00698 · APJ Thomas L Giannetti · IPR · Final written decision
Claims 7–11, 13, and 19–21 were not shown unpatentable because Rauhala does not disclose simultaneous desired and interferer signal-strength determinations, defeating anticipation and the obviousness combination.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“The two proposals are materially similar in the education requirement, but differ marginally in professional experience required (three versus five years). See supra. While we were persuaded, on the preliminary record, that both Petitioner’s and Patent Owner’s proposals were consistent with the problems and solutions in the ’202 patent and the prior art of record, on balance, we determined that Petitioner’s proposal was a better reflection of the level of skill in the prior art, and we therefore adopted it for our Institution Decision. See Institution Dec. 12–13. For this Decision, we adopt the description of the person of ordinary skill articulated by Petitioner and used previously in our Institution Decision. In light of our review of the complete record, we find that this formulation is consistent with the ’202 patent, the prior art of record, and is supported by the testimony of Dr. Baker. See Baker I Decl. ¶¶ 28–32. Our Decision would not change, however, if we had applied Patent Owner’s proposed level of ordinary skill.” slip op. at 12
- Expert testimonyPetitioner expert discountedDecided for patent owner
“85:13–16. He admits that “Rauhala doesn’t teach the details of what’s in the detector.” Id. at 91:6–7. He points to no textbook or other independent evidence that would have led a person of ordinary skill to design such a detector. Our Trial Practice Guide cautions against crediting such unsupported testimony: The Board has broad discretion to assign weight to be accorded expert testimony. Yorkey v. Diab, 601 F.3d 1279, 1284 (Fed. Cir. 2010). However, the testimony must be based on sufficient facts and data. Fed. R. Evid. 702(b). “Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.” 37 C.F.R. § 42.65(a). Patent Trial and Appeal Board Consolidated Trial Practice Guide 35 (Nov. 2019).7 We therefore give Dr, Baker’s unsupported testimony on this issue little weight.” slip op. at 24
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“We construe claim terms only as relevant to the parties’ contentions and only to the extent necessary to resolve the issues in dispute. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999); Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017). Having considered the positions of the parties, we find that for the purpose of this decision, we do not need to construe these terms to resolve a dispute.” slip op. at 9
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“requirement.” Pet. Reply 5. We do not agree with Petitioner. We find that the language of the claims supports Patent Owner’s argument that the desired signal and the interferer signal are received together. As discussed infra, claim limitations 7.7 and 7.8 recite determining a signal strength of the interferer signal and determining a signal strength of the desired signal. These determinations must be performed at the same time; otherwise, the determinations of signal strengths would not be of the same wireless signal. See Larson II Decl. ¶ 70; Baker II Decl. ¶¶ 48–49 (explaining that consideration of signal strengths detected at the same time would be “essential”). The specification of the ’202 patent further supports this finding: “When a receiver is actively receiving a desired signal, each block in the signal path has at its input the desired signal as well as noise and possibly interfering signals.” Ex. 1001, 5:22–24; see also Figs. 2A, 2B (showing interferer signals and desired signals together).” slip op. at 17
Patent outcomesUS 10,524,202 not shown unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites GrahamPatents in suitUS 10,524,202 - Intuit Inc. v. Samesurf, Inc.No claims unpatentablePTAB · Jun 25, 2024 · IPR2023-00341 · APJ Barbara A Benoit · IPR · Final written decision
Claims 1–16 were not shown unpatentable over Lebrun and Wang or over Prajapat and Wang because the combinations did not teach key invitation and webpage retrieval limitations.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for patent owner
“of the parties, we found that a person of ordinary skill in the art (“POSITA”) “would have had (1) at least a bachelor’s degree in computer science, 7 Patent Owner has not offered objective evidence of non-obviousness. See generally PO Resp.; PO Sur-reply; see also Pet. 21 (indicating Petitioner is not aware of any evidence of secondary considerations). least two years of work experience in software development and/or web-based software,” which reflected Petitioner’s proposal. Dec. 12; see Dec. 10–12 (discussing the respective proposals and level of ordinary skill reflected in the challenged patent and asserted prior art). Patent Owner accepts this level of ordinary skill in the art. PO Resp. 37. Accordingly, we apply this determination of the level of ordinary skill in the art for purposes of this Decision.” slip op. at 12
- Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner
“Petitioner’s citations in this regard to Dr. Lieberman’s declaration do not adequately support Petitioner’s “forwarding” contention. Pet. Reply 8 (citing Ex. 1003 ¶¶ 37, 149); Ex. 1003 ¶ 37 (indicating the challenged patent describes the invitation as being sent by email, instant message, or social network communication); Ex. 1003 ¶ 149 (describing the group-surfing server receiving the session-creation message, creating the group-surfing session, and “inform[ing] the participants in the group-surfing session”). Petitioner does not identify any testimony from Dr. Lieberman that supports Petitioner’s Reply position that Lebrun’s group-surfing server “forwards” the session-creation message to the group-surfing session participants, nor are we aware of any such testimony. See, e.g., Ex. 1003 ¶ 149 (The group-surfing server “responds to the group session request ‘by (1) creating a group-surfing session, and (2) informing the participants [web clients] in the group-surfing session.”); see generally Ex. 1034. Petitioner cannot satisfy its burden of proving obviousness by employing “mere conclusory statements.” In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1380 (Fed. Cir. 2016).” slip op. at 29
- Strike new argumentNew argument disregardedGranted in part
“surfing server as forwarding the session-creation message to the invited web client. PO Sur-reply 12. Although Lebrun describes the group-surfing server as “informing the participants in the group-surfing server session” after receiving the session-creation message and creating the group-surfing session, Lebrun does not describe forwarding or otherwise sending the session-creation message to the participants. Ex. 1005, 32:26–28, 44:12–14. Petitioner’s citations in this regard to Dr. Lieberman’s declaration do not adequately support Petitioner’s “forwarding” contention. Pet. Reply 8 (citing Ex. 1003 ¶¶ 37, 149); Ex. 1003 ¶ 37 (indicating the challenged patent describes the invitation as being sent by email, instant message, or social network communication); Ex. 1003 ¶ 149 (describing the group-surfing server receiving the session-creation message, creating the group-surfing session, and “inform[ing] the participants in the group-surfing session”). Petitioner does not identify any testimony from Dr. Lieberman that supports Petitioner’s Reply position that Lebrun’s group-surfing server “forwards” the session-creation message to the group-surfing session participants, nor are we aware of any such testimony. See, e.g., Ex. 1003 ¶ 149 (The group-surfing server “responds to the group session request ‘by (1) creating a group-surfing session, and (2) informing the participants [web clients] in the group-surfing session.”); see generally Ex. 1034. Petitioner cannot satisfy its burden of proving obviousness by employing “mere conclusory statements.” In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1380 (Fed. Cir. 2016).” slip op. at 29
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“receive webpage content from the website server in particular ways as identified in limitations [1e] and [1g]. Similarly, claim 1 requires the invitee device to retrieve data from the website server in response to receiving “the information related to the shared web browsing interaction from the synchronization server” (limitation [1f.iii]). For the reasons discussed above, Petitioner has not shown by a preponderance of the evidence its combination of Lebrun and Wang does so. For the required website server interaction, in its Petition, Petitioner relies on Lebrun’s description of an alternative embodiment applicable only when no cookies or other identity information are involved (Ex. 1005, 35:17–19). See, e.g., Pet. 30 (citing Ex. 1005, 35:17–19). As Patent Owner indicates, this alternative is not relevant to the subject matter recited in claim 1 which requires identity information. PO Resp. 45. Petitioner does not address this shortcoming in its Reply. See generally Pet. Reply. Rather, in its Reply, for website server interaction, Petitioner relies on Lebrun’s functionality of sending a web page from the web server to the web client as shown in Lebrun’s Figure 1. See, e.g., Pet. Reply 11 (citing Ex. 1005, 32:21–24, 31:27–30, Fig. 1). Specifically, Petitioner contends that Lebrun discloses that (i) a URL for the initial web page is included in session-creation message 151 (Ex. 1005, 32:21–24), (ii) the web site sends a web page directly to the web client (Fig. 1), and (iii) the web site delivers information 132 to web clients or the group-surfing server 140 “in response Pet. Reply 11. Although this shows the web site sending a web page directly to a web client, the prior art of Lebrun does not do so in the manner required by the claims (limitations [1e], [1f.i], [1f.iii], [1g]).” slip op. at 46
Patent outcomesUS 9,483,448 not shown unpatentable§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 9,483,448 - Forte Biosciences, Inc. v. University Of MassachusettsAll claims unpatentablePTAB · Jun 24, 2024 · PGR2023-00014 · APJ Georgianna W Braden · PGR · Final written decision
Claims 1–5 are unpatentable for lack of written description and enablement under § 112(a); the Board did not reach the § 103 challenge.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner does not contest Petitioner’s proposed definition, except to modify the level such that an ordinarily skilled artisan “would have been familiar with well-known inhibitors of IL-15 and IL-15R as described in the ’505 patent and recognized in the art as of April 2017.” Resp. 26–27 (citing Ex. 2005 ¶ 94). We adopt Petitioner’s level of ordinary skill in the art with Patent Owner’s proposed modification 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)No construction neededDecided for patent owner
“this stage of the proceeding and that all terms are to given their plain and ordinary meaning. Pet. 23; Resp. 38. 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 F.3d 795, 803 (Fed. Cir. 1999)). Here, we determine that no claim construction is necessary.” slip op. at 8
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“Finally, we are reminded that “a sufficient description of the genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Ariad, 598 F.3d at 1350. “[F]unctional claim language can meet the written description requirement when the art has established a correlation between structure and function.” Id. Here, however, the challenged claims are directed to methods using a wide range of different types of compounds purported to be “IL-15/IL-15R inhibitors” that are not part of a known or readily identifiable class, do not target the same biological pathway, do not have any common structural features, and do not appear to always function as inhibitors. See Ex. 1018, Abstr., 1575–77, 1579; Ex. 1046, 189:4–19, 191:15–192:15, 193:18–196:22, 198:21–199:21, 197:12–198:19, 200:1–8, 207:11–14, 203:3–10, 207:15–21, 236:12–24; Ex. 1047 ¶¶ 19–23, 56, 63–64, 80–85. Therefore, we find there is neither a representative number of species disclosed, nor a sufficient” slip op. at 21
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledUnpatentable
“598 U.S. at 610. A “specification may call for a reasonable amount of experimentation to make and use a patented invention. What is reasonable in any case will depend on the nature of the invention and the underlying art.” Id. at 613. But the person of ordinary skill in the art cannot be left with merely “a hunting license” or obligated to engage in “painstaking experimentation” or “trial and error” to “see what works.” Id. at 614. Patent Owner argues that “the IL-15/IL-15R inhibitors disclosed in the specification were known in the art and “share the common ‘general quality’ of inhibiting a pathway known to be relevant to and having ‘particular fitness for the particular purposes’ of (id.) treating certain autoimmune diseases by blocking IL-15 signaling.” Sur-reply 14 (citing Ex. 1011, 22; Ex. 2013, 3; Ex. 2017, Abstr.; Ex. 2024, 17; Ex. 2025, 2–3, 6; Ex. 2027, 4; Ex. 2028, 9; Ex. 2029, 4; Ex. 2031, 23; Ex. 2118, 53:22–54:9; Ex. 1018, 1; Ex. 2005, ¶¶ 52–63, 80–83, 130; Ex. 1046, 231:20–25). Patent Owner’s argument is unavailing, however, because the record shows that different IL-15-specific inhibitors may operate in different ways that may result in differential effects, some of which may not include inhibition at all. See Ex. 1047 ¶¶21, 23, 40, 71; Ex. 1018, Abstr., 1576, 1579; Ex. 2013, 4:1– 8; Ex. 2014, 4:9–15; Ex. 2015 ¶ 22; Ex. 2025, 4:34–5:2; Ex. 1046, 166:21– 24, 168:25–169:5, 207:23–209:22, 210:4–17, 210:24–211:6; Ex. 1011, 1:67–2:4; Ex. 2005 ¶¶ 116, 134. Thus, we find that the record supports Drs. Abbas and Plott’s testimony, which we credit, that a person of ordinary skill in the art would be forced to hunt down and test every compound through painstaking Ex. 1002 ¶¶ 85–90, 92; Ex. 1047 ¶ 53 (Dr. Plott’s testimony that the “specification of the ’505 patent is essentially a black box (so far as which aspects of IL-15 signaling it inhibits and how it operates), leaving the reader to guess through trial and error which molecules might operate similarly to ChMBC7 and which do not.”); Ex. 1004 ¶ 61 (Dr. Plott’s testimony that “from the perspective of a clinician, the amount of experimentation required would be extremely burdensome and success would be speculative.”); Ex. 2007, 93:16–97:25, 38:208; Ex. 1046, 234:20–236:11. This is due to the fact that the claims (without limit) encompass any inhibition of any one of the various types of IL-15 signaling and various versions of the receptor, and even implicate other compounds that act on different targets but which inhibit the IL-15 signaling pathway. See Ex. 1047 ¶¶ 10, 53, 68; Ex. 2005 ¶ 71; Ex. 1046, 254:4–255:11, 158:12–160:20. The evidence has shown that IL-15/IL-15R inhibition is complicated and unpredictable, with some inhibitors also capable of enhancing forms of IL-15 signaling rather than preventing it. See Ex. 1047 ¶¶ 10, 25–26, 53; Ex. 2013, 2:10–18; Ex. 2014, 2:12–20; Ex. 2015 ¶ 3; Ex. 2025, 2:10–18; Ex. 2078, 267.” slip op. at 32
Patent outcomesUS 11,278,505 unpatentableClaim construction§ 112 disclosurecites PhillipsPatents in suitUS 11,278,505 - 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 - PTAB · May 28, 2024 · IPR2024-00170 · APJ Robert A Pollock · IPR · Institution
The Board instituted IPR of claims 1–13 on all five asserted 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
“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 14
- Skill levelSkill level petitioner adoptedDecided for petitioner
“According to Patent Owner, Petitioner’s proposed definition “attempts to imbue the POSA with an array of different skills and competencies that do not accurately reflect the state of the field at the time of the October 2014 priority date.” Prelim. Resp. 10. Patent Owner does not offer a competing definition in the Preliminary Response, but notes that we adopted the above definition in the 00224, 00317, 00545, and 00546 IPRs. Insofar as the prior art of record appears to support Petitioner’s definition, we apply our earlier definition here as Petitioner urges. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). Patent Owner is, nevertheless, welcome to provide argument and evidence for an alternative definition at trial.” slip op. at 17
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“In general, a preamble limits the invention if it recites essential structure or steps, or if it is necessary to give life, meaning, and vitality to the claim.” Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002) (quotation marks omitted). On its face, the preamble of claim 1 includes a “wherein” clause requiring that the biological sample be obtained “from a non-fetal source.” Because Petitioner does not explain how this limitation is either understood from the body of the claim, or severable from the remainder of the preamble, we do not find Petitioner’s argument persuasive. See Cochlear Bone Anchored Sols. AB v. Oticon Med. AB, 958 F.3d 1348, 1355 (Fed. Cir. 2020) (“A conclusion that some preamble language is limiting does not imply that other preamble language, or the entire preamble, is limiting.”). Absent further argument and evidence, and solely for the purpose of this Decision, we construe the preamble as limiting. slip op. at 19
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“Specification provides little guidance regarding how much of the genome must be sequenced under Patent Owner’s construction. See generally 00224 IPR, Paper 11 at 19–23. As discussed in detail on pages 15–16 of the Preliminary Response, however, the instant Specification does make a clear distinction between “untargeted sequencing (e.g., whole genome sequencing)” as compared to targeted sequencing approaches such as “whole exome sequencing,” or “deep sequencing over a fraction of the genome.” See e.g., Ex. 1001, 17:36–49, 25:64–34, 27:16–19, 43–46; cf. 00224 IPR, Paper 11 at 22 (“tak[ing] particular note of the [’394] Specification’s distinction between whole genome sequencing and targeted sequencing of the exome or other sub-genomic regions (e.g., Ex. 1001, 5:38–59, 24:35– 58), as well as the Specification’s acknowledgement that whole genome sequencing may encompass “low mean coverage regions” and “zero mean coverage regions,” (id. at 24:59–62, 28:33–42)”). As we read the Specification, the phrase “sequencing all or almost all of a genome,” speaks more tot the untargeted nature of the process rather than to an end result of the sequencing effort. In this respect, the instant Specification’s references to “high coverage whole genome sequencing,” “low coverage whole genome sequencing,” and “low” and “zero mean coverage regions from WGS,” indicate that whole genome sequencing does not mean that all or almost all of the nucleotide bases in a genome must be determined, but that “all or almost all” of the genome is available for sequencing.12 See e.g., id. at 25:64–67, 26:6–14, 27:16–19, 28:57–60; 32:37–45; see also 00224 IPR, Paper 11 at 19–23 (preliminarily determining that Leary disclosed whole genome sequencing despite evidence that the authors sequenced only about half of the genome). With the above explanation, we provisionally construe “whole genome sequencing as “a non-targeted approach to sequencing all or almost all of a genome.” We leave for later, and to the extent necessary, any 12 Consistent with Owner’s argument that “WGS has taken on many different flavors of meaning,” we presently understand the Specification’s recognition of “high” and “low” coverage whole genome sequencing as species of the generic term. See Prelim Resp. 12–13 (citing Ex. 2018, 155:15–20, 161:21–162:1, 156:20–157:22). determination of the lower limit (if any) one of ordinary skill would attach to the number sequencing reads, extent of genomic coverage, or nucleotide bases that must be determined to qualify as whole genome sequencing, and whether any particular experimental approach would have been understood to comprise whole genome sequencing.” slip op. at 22
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,584,968 - 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
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.