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  • Apple Inc. v. Masimo CorporationSome claims unpatentable
    PTAB · Jul 3, 2025 · IPR2024-00290 · APJ Richard H Marschall · IPR · Final written decision

    Claims 1–3, 6, 11–17, 21, 22, 27, 28, 32, 34, 36, 37, and 42–44 are unpatentable as obvious; claims 4 and 18–20 were not shown unpatentable.

    RulingsFinal written decision
    • Skill levelSkill level patent owner adoptedDecided for patent owner

      “In our Institution Decision, we deemed the differences in the parties’ proposals not material due to their substantial overlap, adopted Patent Owner’s proposal for purposes of that Decision, noted that the outcome of the Decision would not change if we adopted Petitioner’s proposal, and instructed the parties to “explain the differences and their relevance to the patentability issues in this case, and state whether any issue in the case turns on those differences” if either party continued to propose differing proposals during trial. Inst. Dec. 10–11. After institution, neither party has explained the materiality of the differences in their proposals or argued that any issues in this case turn on those differences. Based on our review of the parties’ proposals, we find Patent Owner’s proposal consistent with the level of skill exemplified by the prior art of record and the disclosure of the ’223 patent. Accordingly, we apply Patent Owner’s proposal in our analysis in this Decision. See Okajima, 261 F.3d at 1355 (“[T]he prior art itself” may reflect an appropriate level 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))). The outcome of this Decision would not change if we applied Petitioner’s proposed definition.” slip op. at 9

    • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner

      “persuasive and reject Patent Owner’s argument that we should construe the limitation as requiring the absence of one parameter from the display prior to the replacement and the absence of the other parameter after the replacement. We do not view either requirement proposed by Patent Owner as justified based on our review of the claims, specification, and prosecution history.” slip op. at 16

    • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableNot shown unpatentableMixed

      “preponderance of the evidence that the combination of Naghavi, Hochstedler, and Burnes discloses all of the limitations of claim 1 and that a POSITA would have been motivated to combine the references in the manner Petitioner proposes with a reasonable expectation of success. See Pet. 9–30. Accordingly, we determine that Petitioner proves by a preponderance of the evidence that claim 1 would have been obvious based on Naghavi, Hochstedler, and Burnes.” slip op. at 58

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner

      “proposed combination based on the argument that a POSITA would have been motivated to switch the layout responsive to a parameter value changing. Pet. 11–15 (citing Ex. 1003 ¶¶ 35–40, 47–52). For example, we agree with Petitioner that a motivation exists to change the layouts to “best suit the condition of [the] patient” because Naghavi expressly describes an “interactive and dynamic” GUI that “may automatically detect changes in health status . . . and automatically react and rearrange the available options to best suit the condition” of the patient. Ex. 1005 ¶ 63. The supporting expert testimony persuasively relies on this aspect of Naghavi when concluding that “such a change in the severity of a parameter can indicate a change in the patient’s health that may require close monitoring” and a POSITA “would have been motivated to implement this approach of the combination in order to achieve” Naghavi’s objectives. Ex. 1003 ¶ 48 (citing Ex. 1005 ¶ 63); see also Pet. Reply 23 (“[T]he rearrangement of parameters, as already suggested by Naghavi and implemented according to Hochstedler, advantageously ensures an easy-to-use user interface, e.g., by highlighting information that has changed to warrant user attention.” (citing Pet. 13–14; Ex. 1003 ¶¶ 42–43)); Ex. 1003 ¶¶ 42–43.” slip op. at 51

    Patent outcomesUS 8,190,223 mixed
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 8,190,223
  • Apple Inc. v. Masimo CorporationSome claims unpatentable
    PTAB · Jun 25, 2025 · IPR2024-00290 · APJ Richard H Marschall · IPR · Final written decision

    Claims 1–3, 6, 11–17, 19, 21, 22, 27, 28, 32, 34, 36, 37, and 42–44 are unpatentable as obvious; claims 4, 18, and 20 were not shown unpatentable.

    RulingsFinal written decision
    • Skill levelSkill level patent owner adoptedDecided for patent owner

      “In our Institution Decision, we deemed the differences in the parties’ proposals not material due to their substantial overlap, adopted Patent Owner’s proposal for purposes of that Decision, noted that the outcome of the Decision would not change if we adopted Petitioner’s proposal, and instructed the parties to “explain the differences and their relevance to the patentability issues in this case, and state whether any issue in the case turns on those differences” if either party continued to propose differing proposals during trial. Inst. Dec. 10–11. After institution, neither party has explained the materiality of the differences in their proposals or argued that any issues in this case turn on those differences. Based on our review of the parties’ proposals, we find Patent Owner’s proposal consistent with the level of skill exemplified by the prior art of record and the disclosure of the ’223 patent. Accordingly, we apply Patent Owner’s proposal in our analysis in this Decision. See Okajima, 261 F.3d at 1355 (“[T]he prior art itself” may reflect an appropriate level 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))). The outcome of this Decision would not change if we applied Petitioner’s proposed definition.” slip op. at 9

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed patent owner constructionDecided for petitioner
    • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
    • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable

      “preponderance of the evidence that the combination of Naghavi, Hochstedler, and Burnes discloses all of the limitations in claim 1. b. Motivation to Combine After summarizing its proposed combination, Petitioner provides a number of reasons for combining the references. Pet. 9–17. Petitioner breaks its motivation to combine arguments into three separate categories that we address below. See id. at 13–17. Patent Owner raises a number of arguments in support of its contention that “a POSITA would not have been motivated to combine the references to replace a measured value of one parameter with the measured value of another parameter,” which we address in the context of Petitioner’s arguments below. See PO Resp. 44–57. Many of Patent Owner’s arguments rely on Patent Owner’s proposed claim constructions for “replaced” and “measured value,” which we do not adopt for the reasons discussed above. For example, the first sentence in Patent Owner’s argument contends that “Naghavi, Hochstedler and Burnes do not disclose using the same screen area to display two currently measured parameters,” but we do not read the claims as requiring the display of “two currently measured parameters” consistent with Patent Owner’s construction for “measured values.” See id. at 44 (citing Ex. 2042 ¶ 125). Such arguments lack weight given that we have rejected their premise, and although Patent Owner’s arguments are suffused with references to its claim constructions, we attempt to identify where Patent Owner does not rely on those constructions in our analysis below.” slip op. at 47

    Patent outcomesUS 8,190,223 mixed
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 8,190,223
  • Apple Inc. v. Alivecor, Inc.Some claims unpatentable
    PTAB · Oct 26, 2023 · IPR2022-00872 · APJ Jeffrey N Fredman · IPR · Final written decision

    Claims 1, 2, 4–8, 10, 12, and 13 are unpatentable as obvious; claims 3, 9, and 11 were not shown unpatentable because the combinations lacked a persuasive reason to record spoken messages simultaneously with ECG …

    RulingsFinal written decision
    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Plain and ordinary meaningDecided for patent owner

      “PO Resp. 9. Patent Owner asserts “a POSA would have understood the plain and ordinary meaning of the term ‘acoustic signal’ [is] a signal that is transmitted as a sound wave through the ambient environment.” Id.; Ex. 2003 ¶ 25. Patent Owner therefore asserts a POSA would have understood the claimed “frequency modulated ECG acoustic signal” is a signal that is transmitted as a sound wave through the ambient environment, [and excludes] signals transmitted by electronic or wireless radio means, because claim 1 requires the acoustic signal to be “received from a built-in microphone of the smartphone.” PO Resp. 9; Ex. 2003 ¶ 26. Petitioner responds by asserting that “a POSITA would have understood that acoustic transmission is a form of wireless transmission.” Pet. Reply 24; Ex. 1021, 46:7–47:5 (citing the Jafari Deposition where Dr. Jafari stated “in the event of an acoustic signal, there is no need to connect a wire”) Having considered the entire record, we do not find there is a substantive dispute over the term “acoustic signal” as both Patent Owner and Petitioner agree that acoustic signals include wireless signals transmitted as a sound wave through the environment. We will apply this understanding in our further analysis.” slip op. at 7

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “A person of ordinary skill in the art (“POSITA”) would have had either (1) at least a bachelor of science in electrical engineering, mechanical engineering, or biomedical engineering, or a related discipline, with at least two years of relevant multidisciplinary work experience designing wearable devices and/or sensors for measuring physiological signals or parameters of mammals, or (2) a medical degree and at least five years of relevant work experience designing wearable devices and/or sensors for measuring physiological signals or parameters of mammals.” slip op. at 5

    • Expert testimonyPetitioner expert creditedPatent owner expert creditedDecided for petitioner

      “interference of sound waves was a known phenomenon at the time of the invention does not demonstrate that the ordinary artisan would have had reason to select particular carrier frequencies for the ECG acoustic signals that avoided human voice frequencies in the absence of any disclosure that such frequencies were known to interfere. Rather, we agree with Patent Owner that this is hindsight reasoning because until the ’882 patent pointed out this concern in the context of claim 1, there is no indication the prior art recognized that human voice interference was an issue.” slip op. at 26

    • Obviousness (§103) › Motivation to combine / reasonable expectation of success › HindsightMixed

      “that Vyshedskiy’s disclosure of a list of preferred carrier frequencies represents a permissible “obvious to try” situation. In KSR, the Supreme Court stated that a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103. KSR, 550 U.S. at 421. And simply because the prior art “discloses a multitude of effective combinations does not render any particular formulation less obvious.” Merck & Co. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989). The instant facts represent a situation where, at the time of invention in 2010, it would have been obvious to try the known carrier frequencies of Vyshedskiy for modulation of the acoustic ECG signal of Albert in the claimed frequency range of 6 kHz to 20 kHz because these carrier frequencies would have been obvious alternatives to try to address Vyshedskiy’s disclosed design need for simultaneous measurement of heart sound auscultation and ECG heart cycle. See Pet. 17 (citing Ex. 1005 ¶¶ 13– 15).” slip op. at 27

    Patent outcomesUS 8,509,882 mixed
    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 8,509,882
  • PTAB · May 18, 2023 · IPR2022-00044 · APJ Ulrike W Jenks · IPR · Final written decision

    Claims 1–3, 5–7, 10–16, 18–20, and 23–30 are unpatentable as obvious; claims 4 and 17 were not shown unpatentable because the art did not establish expected Fab binding.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Level of Ordinary Skill in the Art In determining the level of skill in the art, we consider the type of problems encountered in the art, the prior art solutions to those problems, the rapidity with which innovations are made, the sophistication of the technology, and the educational level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Indus. Inc., 807 F.2d 955, 962 (Fed. Cir. 1986); Orthopedic Equip. Co. v. United States, 702 F.2d 1005, 1011 (Fed. Cir. 1983). Petitioner asserts that a person of ordinary skill in the art would have had (1) at least an advanced degree (e.g., a Master’s or Ph.D.) in biochemistry, process chemistry, protein chemistry, chemical engineering, molecular and structural biology, biochemical engineering, or similar disciplines; (2) several years of post-graduate training or related experience (including industry experience) in one or more of these areas; and (3) an understanding of the various factors involved in purifying proteins using chromatography.[] Such a person would have had multiple years of experience with affinity ligand design and protein purification. Pet. 9–10 (citing Ex. 1002 ¶¶ 13–14). Patent Owner does not dispute Petitioner’s definition of the person of ordinary skill. See generally PO Resp. Because Petitioner’s proposed definition is unopposed and appears consistent with the Specification and art of record, we apply it here.” slip op. at 12

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for patent owner

      “Petitioner contends that based on Patent Owner’s implicit construction in the district court litigation “that the term ‘the ligand comprising at least two polypeptides’ refers to a multimeric ligand (such as a tetramer) comprised of multiple polypeptides, each of which is a monomer.” Pet. 15 (citing Ex. 1020 ¶¶ 41, 50, 58, 62, 74, 87).” slip op. at 13

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableMotivation foundUnpatentable

      “knowledge that any one of the five SPA IgG binding domains are known to bind IgG and can function as a ligand for the purification of antibodies. Linhult and Abrahmsén both expressly suggest that the glycine codon at position 29 can be mutated for an alanine codon in any one of the SPA IgG binding domains E, D, A, B, or C. Ex. 1004, 2; Ex. 1005, 2:32–37. Here, the SPA IgG binding domains comprise a short list of 5 members: E, D, A, B, or C. Of these 5 members, the glycine at position 29 in domain B has already been mutated to an alanine to create a domain Z which has been shown to retain IgG binding activity. Ex. 1004, 6 (Fig. 3). Figure 1A of Linhult is reproduced below. Linhult’s Figure 1A, reproduced above, shows the amino acid alignments of the Z, Z(F30A) and the five homologous domains (E, D, A, B, and C). The three boxes show the α-helices. Ex. 1004, 2; Ex. 1005, Fig. 2. Here, Linhult and Abrahmsén show that the IgG binding domains of SPA – E, D, A, B, and C share many structural similarities. See Ex. 1004, 2 (Fig. 1(a) (reproduced above)); Ex. 1005, 3:25–35. As discussed in our Institution Decision (Dec. 30–31), there are a finite number—five (5)—SPA IgG binding domains and each possesses the dipeptide sequence Asp-Gly known to a be a target for alkaline protein degradation. Therefore, the solution of mutating the glycine at position 29 for an alanine to remove the alkaline sensitive sequence is not a product of innovation, but of ordinary skill and common sense. See Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356, 1364-65 (Fed. Cir. 2012) (quoting KSR, 550 U.S. at 421). It is well established that [s]tructural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds. For example, a prior art compound may suggest its homologs because homologs often have similar properties and therefore chemists of ordinary skill would ordinarily contemplate making them to try to obtain compounds with improved properties. In re Deuel, 51 F.3d 1552, 1558 (Fed. Cir. 1995).” slip op. at 37

    • Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner

      “Neither claim 1 nor claim 14 recite a need to bind the Fab region of an antibody or that the target molecule is Fab. All that is required by these claims is that they adsorb a target molecule and that you can elute the target molecule from the matrix. The target molecule, therefore, can reasonably encompass IgG. Petitioner’s articulated rationale is that there was an expectation that the composition binds antibodies, including monoclonal antibodies, and therefore, would be useful in a process of for isolating antibodies. Petitioner contends that: A POSA would have also reasonably expected such a combination to achieve a process for isolating one or more target compounds using the recited affinity chromatography matrix given the well-known fact that each individual SPA domain, including the C domain, has affinity for antibodies (Ex. 1004, [1]) as well as Abrahmsén’s confirmation that a G29A mutation on SPA “would not interfere with folding [of SPA] or binding to [antibodies]” (Ex. 1005, 5:13-16). (Ex. 1002 ¶131.) Pet. 25; Reply 8 (“‘A POSA would not have been motivated only by Fab-binding ability, as even Dr. Bracewell agreed that ‘a POSA would have understood that it was desirable to purify monoclonal antibodies for therapeutic use in 2006.’(Ex. 1057, 75:17-76:4, 113:23-114:11, 157:24- 158:9; Ex. 1061 ¶29)”). The law does not require that the teachings of the reference be combined for the reason or advantage contemplated by the inventor, as long as some suggestion to combine the elements is provided by the prior art as a whole. In re Beattie, 974 F.2d 1309, 1312 (Fed. Cir. 1992); In re Kronig, 539 F.2d 1300, 1304 (CCPA 1976); see In re Kemps, 97 F.3d 1427, 1430” slip op. at 44

    Patent outcomesUS 10,343,142 mixed
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 10,343,142
  • PTAB · May 18, 2023 · IPR2022-00041 · APJ Ulrike W Jenks · IPR · Final written decision

    Claims 1–3, 5–7, 10–16, 18–20, and 23–30 are unpatentable as obvious; claims 4 and 17 were not shown unpatentable because the art did not establish expected Fab binding.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner asserts that a person of ordinary skill in the art would have had (1) at least an advanced degree (e.g., a Master’s or Ph.D.) in biochemistry, process chemistry, protein chemistry, chemical engineering, molecular and structural biology, biochemical engineering, or similar disciplines; (2) several years of post-graduate training or related experience (including industry experience) in one or more of these areas; and (3) an understanding of the various factors involved in purifying proteins using chromatography.[] Such a person would have had multiple years of experience with affinity ligand design and protein purification. Pet. 9–10 (citing Ex. 1002 ¶¶ 13–14). Patent Owner does not dispute Petitioner’s definition of the person of ordinary skill. See generally PO Resp. Because Petitioner’s proposed definition is unopposed and appears consistent with the Specification and art of record, we apply it here.” slip op. at 13

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner

      “According to the Specification, “the present invention . . . relates to a multimeric chromatography ligand (also denoted a ‘multimer’) comprised of at least two Domain C units, or a functional fragments or variants thereof.” Ex. 1001, 7:27–30. The Specification additionally recites that a multimer containing only domain C units can, however, include linkers. Id. 7:39–41. In addition, the Specification describes that “the multimer comprises one or more additional units, which are different from Domain C.” Id. 7: 44–45. Based on these disclosures in the Specification, a multimer is composed of at least two or more monomers. Because Petitioner’s construction is consistent with the ’142 patent’s express construction of the term, and because Patent Owner agrees with Petitioner’s construction, we apply it here.” slip op. at 14

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundUnpatentable

      “knowledge that any one of the five SPA IgG binding domains are known to bind IgG and can function as a ligand for the purification of antibodies. Linhult and Abrahmsén both expressly suggest that the glycine codon at position 29 can be mutated for an alanine codon in any one of the SPA IgG binding domains E, D, A, B, or C. Ex. 1004, 2; Ex. 1005, 2:32–37. Here, the SPA IgG binding domains comprise a short list of 5 members: E, D, A, B, or C. Of these 5 members, the glycine at position 29 in domain B has already been mutated to an alanine to create a domain Z which has been shown to retain IgG binding activity. Ex. 1004, 6 (Fig. 3). Figure 1A of Linhult is reproduced below. Linhult’s Figure 1A, reproduced above, shows the amino acid alignments of the Z, Z(F30A) and the five homologous domains (E, D, A, B, and C). The three boxes show the α-helices. Ex. 1004, 2; Ex. 1005, Fig. 2. Here, Linhult and Abrahmsén show that the IgG binding domains of SPA – E, D, A, B, and C share many structural similarities. See Ex. 1004, 2 (Fig. 1(a) (reproduced above)); Ex. 1005, 3:25–35. As discussed in our Institution Decision (Dec. 30–31), there are a finite number—five (5)—SPA IgG binding domains and each possesses the dipeptide sequence Asp-Gly known to a be a target for alkaline protein degradation. Therefore, the solution of mutating the glycine at position 29 for an alanine to remove the alkaline sensitive sequence is not a product of innovation, but of ordinary skill and common sense. See Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356, 1364-65 (Fed. Cir. 2012) (quoting KSR, 550 U.S. at 421). It is well established that” slip op. at 37

    • Obviousness (§103) › KSR rationalesUnpatentable

      “Here, the teachings of Linhult, Abrahmsén, and Hober suggest mutating the glycine at position 29 for an alanine in any one of the IgG binding domains of E, D, A, B, or C of SPA in order to avoid protein degradation. Ex. 1004, 2; Ex. 1005, 5:4–9. We, therefore, agree with Petitioner that the art expressly suggests that the glycine codon can be mutated for an alanine codon in any one of the SPA IgG binding domains E, D, A, B, or C. Pet. 23 (citing Ex. 1002 ¶¶ 99–111). Attaching any one of SPA mutated IgG binding domains E D A B or C to a matrix using “known ligand-construction methods to yield a predictable result[] (e.g., the claimed affinity chromatography matrix)” would have been obvious. Pet. 25 (citing Ex. 1002 ¶ 130). As the Federal Circuit has explained, “[w]here a skilled artisan merely pursues ‘known options’ from ‘a finite number of identified, predictable solutions,’ the resulting invention is obvious under Section 103.” In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litig., 676 F.3d 1063, 1070 (Fed. Cir. 2012) (quoting KSR, 550 U.S. at 421). Accordingly, we agree with Petitioner that the combination of Linhult Abrahmsén, and Hober expressly suggests mutating the glycine codon for an alanine codon in any one of the SPA IgG binding domains E, D, A, B, or C. Pet. 23 (citing Ex. 1002 ¶¶ 99–111). We also agree that the cited art teaches using these mutant SPA domains in column chromatography for the isolation of antibodies.” slip op. at 36

    Patent outcomesUS 10,343,142 mixed
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 10,343,142
  • PTAB · May 18, 2023 · IPR2022-00045 · APJ Sheridan K Snedden · IPR · Final written decision

    Claims 1–10, 12–14, 16–28, 30–32, and 34–37 are unpatentable as obvious; claims 11 and 29 were not shown unpatentable because the art did not establish expected Fab binding.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner asserts that a person of ordinary skill in the art would have had (1) at least an advanced degree (e.g., a Master’s or Ph.D.) in biochemistry, process chemistry, protein chemistry, chemical engineering, molecular and structural biology, biochemical engineering, or similar disciplines; (2) several years of post-graduate training or related experience (including industry experience) in one or more of these areas; and (3) an understanding of the various factors involved in purifying proteins using chromatography.[] Such a person would have had multiple years of experience with affinity ligand design and protein purification. Pet. 9–10 (citing Ex. 1002 ¶¶ 13–14). Patent Owner does not dispute Petitioner’s definition of the person of ordinary skill. See generally PO Resp. Because Petitioner’s proposed definition is unopposed and appears consistent with the Specification and art of record, we apply it here. C.” slip op. at 12

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner

      “support, the ligand capable of binding the one or more target compound(s) and comprising at least two polypeptides.” Ex. 1001, 15:46–49; 17:28–31. Petitioner argues that “‘the ligand comprising at least two polypeptides’ refers to a multimeric ligand (such as a tetramer) comprised of multiple polypeptides, each of which is a monomer.” Pet. 19–20 (citing Ex. 1002 ¶¶ 43–45). Petitioner argues that this construction is consistent with Patent Owner’s implicit construction in the Delaware litigation between the parties. Id. Patent Owner does not challenge Petitioner’s claim construction. See generally PO Resp. According to the Specification, “the present invention . . . relates to a multimeric chromatography ligand (also denoted a ‘multimer’) comprised of at least two domain C units, or a functional fragments [sic] or variants thereof.” Ex. 1001, 7:35–38. The Specification additionally recites that a multimer containing only domain C units can, however, include linkers. Id. at 7:39–41. In addition, the Specification describes that “the multimer comprises one or more additional units, which are different from Domain C.” Id. at 7:52–53. Based on these disclosures in the Specification, a multimer is composed of at least two or more monomers. Because Petitioner’s construction is consistent with the ’007 patent’s express construction of the term, we apply that construction for the purposes of this decision.” slip op. at 13

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable

      “Petitioner’s articulated obviousness ground is premised on the knowledge that any one of the five SPA IgG binding domains are known to bind IgG and can function as a ligand for the purification of antibodies. Linhult and Abrahmsén both expressly suggest that the glycine codon at position 29 can be mutated for an alanine codon in any one of the SPA IgG binding domains E, D, A, B, or C. Ex. 1004, 2; Ex. 1005, 2:32–37. Here, the SPA IgG binding domains comprise a short list of 5 members: E, D, A, B, or C. Of these 5 members, the glycine at position 29 in domain B has already been mutated to an alanine to create a domain Z which has been shown to retain IgG binding activity. Ex. 1004, 6 (Fig. 3). Figure 1A of Linhult is reproduced below. Linhult’s Figure 1A, reproduced above, shows the amino acid alignments of the Z, Z(F30A) and the five homologous domains (E, D, A, B, and C). The three boxes show the α-helices. Ex. 1004, 2; Ex. 1005, Fig. 2. Here, Linhult and Abrahmsén show that the IgG binding domains of SPA – E, D, A, B, or C share many structural similarities. See Ex. 1004, 2 (Fig. 1(a) (reproduced above)); Ex. 1005, 3:25–35. As discussed in our Institution Decision (Dec. 30–31), there are a finite number – five (5) – SPA IgG binding domains and each possesses the dipeptide sequence Asp-Gly known to a be a target for alkaline protein degradation. Therefore, the solution of mutating the glycine at position 29 for an alanine to remove the alkaline sensitive sequence is not a product of innovation but of ordinary skill and common sense. See Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356, 1364-65 (Fed. Cir. 2012) (quoting KSR, 550 U.S. at 421). It is well established that” slip op. at 38

    • Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner

      “(c) No Teaching Away We are also not persuaded by Patent Owner’s contention that the art teaches away from the G29A substitution because it interferes with Fab binding. See PO Resp. 39–42; Sur-reply 9; Ex. 2009 at 2; Ex. 2010 at 25; Ex. 2012 at 25–26; Ex. 2029 at 7. None of claims 1, 2, or 20 recite a need to bind the Fab region of an antibody or that the target molecule is Fab. All that is required by these claims is that they adsorb a target molecule and that you can elute the target molecule from the matrix. The target molecule, therefore, can reasonably encompass IgG.” slip op. at 44

    Patent outcomesUS 10,875,007 mixed
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 10,875,007
  • PTAB · May 18, 2023 · IPR2022-00042 · APJ Sheridan K Snedden · IPR · Final written decision

    Claims 1–10, 12–14, 16–28, 30–32, and 34–37 are unpatentable as obvious; claims 11 and 29 were not shown unpatentable because Fab binding was not predictable.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “problems encountered in the art, the prior art solutions to those problems, the rapidity with which innovations are made, the sophistication of the technology, and the educational level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Indus. Inc., 807 F.2d 955, 962 (Fed. Cir. 1986); Orthopedic Equip. Co. v. United States, 702 F.2d 1005, 1011 (Fed. Cir. 1983). Petitioner asserts that a person of ordinary skill in the art would have had (1) at least an advanced degree (e.g., a Master’s or Ph.D.) in biochemistry, process chemistry, protein chemistry, chemical engineering, molecular and structural biology, biochemical engineering, or similar disciplines; (2) several years of post-graduate training or related experience (including industry experience) in one or more of these areas; and (3) an understanding of the various factors involved in purifying proteins using chromatography.[] Such a person would have had multiple years of experience with affinity ligand design and protein purification. Pet. 9–10 (citing Ex. 1002 ¶¶ 13–14). Patent Owner does not dispute Petitioner’s definition of the person of ordinary skill. See generally PO Resp. Because Petitioner’s proposed definition is unopposed and appears consistent with the Specification and art of record, we apply it here. C.” slip op. at 12

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner

      “According to the Specification, “the present invention . . . relates to a multimeric chromatography ligand (also denoted a ‘multimer’) comprised of at least two domain C units, or a functional fragments [sic] or variants thereof.” Ex. 1001, 7:35–38. The Specification additionally recites that a multimer containing only domain C units can, however, include linkers. Id. at 7:39–41. In addition, the Specification describes that “the multimer comprises one or more additional units, which are different from Domain C.” Id. at 7:52–53. Based on these disclosures in the Specification, a multimer is composed of at least two or more monomers. Because Petitioner’s construction is consistent with the ’007 patent’s express construction of the term, we apply that construction for the purposes of this decision. Having considered the parties’ positions and evidence of record, we determine that the express construction of any other claim term is unnecessary to resolve the disputed issues in this matter. 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))). To the extent further discussion of the meaning of any claim term is necessary to our decision, we provide that discussion below in our analysis of the asserted grounds of unpatentability.” slip op. at 14

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundUnpatentable

      “Petitioner’s articulated obviousness ground is premised on the knowledge that any one of the five SPA IgG binding domains are known to bind IgG and can function as a ligand for the purification of antibodies. Linhult and Abrahmsén both expressly suggest that the glycine codon at position 29 can be mutated for an alanine codon in any one of the SPA IgG binding domains E, D, A, B, or C. Ex. 1004, 2; Ex. 1005, 2:32–37. Here, the SPA IgG binding domains comprise a short list of 5 members: E, D, A, B, or C. Of these 5 members, the glycine at position 29 in domain B has already been mutated to an alanine to create a domain Z which has been shown to retain IgG binding activity. Ex. 1004, 6 (Fig. 3). Figure 1A of Linhult is reproduced below. Linhult’s Figure 1A, reproduced above, shows the amino acid alignments of the Z, Z(F30A) and the five homologous domains (E, D, A, B, and C). The three boxes show the α-helices. Ex. 1004, 2; Ex. 1005, Fig. 2. Here, Linhult and Abrahmsén show that the IgG binding domains of SPA – E, D, A, B, or C share many structural similarities. See Ex. 1004, 2 (Fig. 1(a) (reproduced above)); Ex. 1005, 3:25–35. As discussed in our Institution Decision (Dec. 30–31), there are a finite number – five (5) – SPA IgG binding domains and each possesses the dipeptide sequence Asp-Gly known to a be a target for alkaline protein degradation. Therefore, the solution of mutating the glycine at position 29 for an alanine to remove the alkaline sensitive sequence is not a product of innovation but of ordinary skill and common sense. See Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356, 1364-65 (Fed. Cir. 2012) (quoting KSR, 550 U.S. at 421). It is well established that [s]tructural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds. For example, a prior art compound may suggest its homologs because homologs often have similar properties and therefore chemists of ordinary skill would ordinarily contemplate making them to try to obtain compounds with improved properties. In re Deuel, 51 F.3d 1552, 1558 (Fed. Cir. 1995).” slip op. at 38

    Patent outcomesUS 10,875,007 mixed
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 10,875,007
  • PTAB · Feb 23, 2022 · IPR2020-01343 · APJ James A Tartal · IPR · Final written decision

    Claims 52 and 53 are unpatentable as anticipated by Ressemann; the other challenged claims were not shown unpatentable because Itou is not prior art.

    RulingsFinal written decision
    • ExcludeMotion to exclude, deniedDenied

      “Documents are authenticated by evidence “sufficient to support a finding that the item is what the proponent claims it is.” Fed. R. Evid. 901(a); see Fox Factory v. SRAM, LLC, IPR2016-01876, Paper 59 at 63 (PTAB Apr. 2, 2018) (quoting same). “Authenticity is, therefore, not an especially high hurdle for a party to overcome.” Fox Factory, Paper 59 at 63 (citing United States v. Patterson, 277 F.3d 709, 713 (4th Cir. 2002)). We determine that Exhibit 2024 has been authenticated under the low bar required under Federal Rule of Evidence 901 based on the evidence provided by Petitioner. See Mot. Opp. 2–11. In addition, Petitioner’s arguments go to the weight of the evidence and not its admissibility. Accordingly, we deny Petitioner’s Motion to Exclude. We note, however, that even if we were to exclude Exhibit 2024, it would not change the outcome or our general analysis of this case.” slip op. at 13

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner contends that a person of ordinary skill in the art at the time of the invention would have been either: (1) a medical doctor who would have had “(a) a medical degree; (b) completed a coronary intervention cardiologist;” or (2) an engineer who would have had “(a) an undergraduate degree in engineering, such as mechanical or biomedical engineering; and (b) at least three years of experience designing medical devices, including catheters or catheter-deployable devices.” Pet. 13–14. Additionally, Petitioner contends “[e]xtensive experience and technical training might substitute for education, and advanced degrees might substitute for experience.” Id. at 14. Further, according to Petitioner, a person of ordinary skill in the art “with a medical degree” and a person of ordinary skill in the art “with an engineering degree” may have had access to each other. Id. (citing Ex. 1005 ¶ 31; Ex. 1042 ¶¶ 18–19). Patent Owner does not dispute Petitioner’s proposed level of ordinary skill. PO Resp. 5. We adopt Petitioner’s proposed level of ordinary skill in the art as it is undisputed and consistent with the level of skill reflected in the prior art and the specification of the ’116 patent. 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 17

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Not reached

      “Petitioner proposes the following constructions: (1) “substantially rigid” as “rigid enough to allow the device to be advanced within the guide catheter,” (2) “side opening” needs no construction and should be given its plain and ordinary meaning, (3) “lumen” as “the cavity of a tube,” and (4) “flexural modulus” as “[a] measure of resistance . . . to bending.” 7 Patent Owner argues that Dr. Hillstead does not meet the definition of a person of ordinary skill in the art because he lacks a four-year undergraduate degree in engineering. PO Resp. 5 n.1 (citing, e.g., Ex. 2137, 462:8–13). As noted above, however, it is undisputed that “[e]xtensive experience and technical training might substitute for education.” Pet. 14. Patent Owner does not address Dr. Hillstead’s significant professional experience, which we find sufficient to show he is qualified to opine on the issues in this proceeding from the perspective of a person of ordinary skill in the art. See Ex. 1043 (curriculum vitae of Dr. Hillstead). does not dispute at this stage of the proceeding Petitioner’s proposed construction of these terms. See generally PO Resp. In view of the issues we address below, we determine it is not necessary to address the express interpretation of any claim term. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017); Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy”).” slip op. at 19

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable

      “Ressemann. Pet. 23–31. Petitioner provides a detailed explanation of how it contends Ressemann discloses each of the limitations of claims 52 and 53. Id. In particular, Petitioner explains how Ressemann’s disclosures of the use of features including guide catheter 160, evacuation sheath assembly 100, intermediate shaft portion 120, distal shaft portion 130, lumen 140, and stent delivery system 194 correspond to the recited methods of claims 52 and 53. Id. Petitioner’s contentions are supported by Dr. Brecker and Dr. Hillstead. Ex. 1005 ¶¶ 164–174; Ex. 1042 ¶¶ 36–39, 58–62. Patent Owner does not dispute that claims 52 and 53 are anticipated by Ressemann. See generally PO Resp; PO Sur-reply; see also Pet. Reply 2 (Petitioner arguing that Patent Owner did not dispute that Ressemann anticipates claims 52 and 53). After reviewing the record, we find Petitioner shows by a preponderance of the evidence that Ressemann discloses each limitations (Pet. 23–31) as our own findings. Accordingly, Petitioner shows by a preponderance of the evidence that Ressemann anticipates claims 52 and 53 of the ’116 patent.” slip op. at 26

    Patent outcomesUS RE46,116 mixed
    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  • PTAB · Feb 16, 2022 · IPR2020-01258 · APJ Christopher G Paulraj · IPR · Final written decision

    Claims 1–6, 8, 10, 13–16, 19, and 20 are unpatentable as obvious; claims 11, 12, 17, and 18 were not shown unpatentable.

    RulingsFinal written decision
    • PTAB / AIA Trials › Real party in interest / privityDecided for petitioner

      “We declined to decide whether Dropbox should have been named an RPI in the Petition in the Institution Decision. Inst. Dec. 2–4. Patent Owner did not raise the RPI issue in its post-institution Response. We agree with Petitioner that Patent Owner has thus forfeited any RPI arguments. Reply at 24 (citing Unified Patents, LLC v. Mobility Workx, LLC, IPR2018- 00150, Paper 26 at 3 (PTAB Dec. 2, 2019) (RPI arguments waived if not in Response)). Therefore, we need not address this issue further.” slip op. at 3

    • Skill levelSkill level patent owner adoptedDecided for patent owner

      “In our Institution Decision, we adopted Patent Owner’s definition as being consistent with the level of skill in the art reflected by the prior art. Dec. 10–11; 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 6 Patent Owner also submitted a supplemental declaration by Dr. Brogioli (Ex. 2031) with its Sur-Reply. We expunged that document from the record along with certain other exhibits (Exs. 2023–2030) as untimely presented under 37 C.F.R § 42.23(b). Paper 37. Therefore, we do not take those documents into consideration for our analysis in this Decision. Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))). We continue to apply that same definition for our analysis in this Final Written Decision. We note, however, that there does not appear to be a significant difference between the parties’ respective definitions, so our analysis would not substantially differ under Petitioner’s definition.” slip op. at 9

    • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

      “Additionally, we are not persuaded by Patent Owner’s argument that Walker is not enabled, or that a POSITA would not have a reasonable expectation of success in combining Prust with Walker, because those arguments focus on features not required by the challenged claims of the ’868 patent. See Raytheon Tech. Corp. v. General Electric Co., 993 F.3d 1374) (Fed. Cir. 2021) (“In general, a prior art reference asserted under § 103 does not necessarily have to enable its own disclosure, i.e., be ‘self-enabling,’ to be relevant to the obviousness inquiry.”). Dr. Brogioli acknowledged that he never even analyzed whether the features of Walker that he argues are not enabling are required in the claims of the ’868 patent. Ex. 1032, 84:1-85:22 (testifying that he did not recall performing an analysis about whether the claims of the ’868 patent required allowing users to edit different parts of the same file at the same time, user collaboration, concurrency among user actions and editing, or locking a document). Moreover, other than pointing to the allegedly deficient teachings of Walker itself, Dr. Brogioli cites to no evidence of record in support of his testimony that a POSITA would not have a reasonable expectation of success in implementing Walker. See Ex. 2022 ¶¶ 66–74. But Walker itself is presumed to be enabling for what it teaches. See In re Antor Media Corp., 689 F.3d 1282, 1288 (Fed. Cir. 2012) (“[A] prior art printed publication . . . is presumptively enabling barring any showing to the contrary by [the] patentee.”). Rather than the unsupported testimony of Dr. Brogioli, we credit the testimony of Dr. Long, which is corroborated by other prior art, that the concepts disclosed in Walker, such as indicating that downloaded files are currently locked and unavailable to other users and multi-user editing, would have been familiar to programming students before 2005, and a POSITA would have been able to apply these well-known techniques with a reasonable expectation of success. Ex. 1008 ¶¶ 36–40, 67 (citing Ex. 1011–1017); Ex. 1033 ¶¶ 4–5.” slip op. at 39

    • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner

      “we are not persuaded by Patent Owner’s claim construction position that the claims require the virtual server to transmit information about files locally stored on the client device (in addition to virtual server files) as part of the fourth claim element. With regard to the claim language, we agree with Patent Owner that “the one or more files associated with the particular user storage account” recited in the fifth claim element finds antecedent basis in the prior recitation of “information relating to one or more files associated with the particular user storage account” in the fourth claim element. By its plain language, what this means is that at least some of the “information” that is transmitted from the virtual server under the fourth element must be related to the “userselected file” that is subsequently uploaded from the client device under the fifth element. Cf. Yamaha Corp. v. ESS Tech., Inc., 82 F.3d 435, 1996 WL 146499, *3 (Fed. Cir. 1996) (“By using a definite article ‘the’ to describe ‘output’ in the last phrase, Yamaha raises the inference that the term refers to the same value as in the first step.”). Thus, contrary to Petitioner’s arguments, we are not of the view that files referenced in the fourth and fifth elements are completely “distinct.” But this does not necessarily imply, as Patent Owner suggests, that the virtual server must already be in possession of information relating to locally stored files at the point of the transmitting step of the fourth element and prior to the uploading step of the fifth element. Indeed, there is nothing recited in the claims to suggest how the virtual server would come to know about files stored on the client device.” slip op. at 16

    Patent outcomesUS 10,476,868 mixed
    Claim construction§ 103 obviousness
    Patents in suitUS 10,476,868
  • PTAB · Jan 4, 2022 · IPR2020-01113 · APJ Michael A Valek · IPR · Final written decision

    Claims 1–4 are unpatentable as obvious over Misselbrook, CN ’588, and JP ’902; claims 7–12 were not shown unpatentable because the grounds did not establish motivation to add a disintegrating agent.

    RulingsFinal written decision
    • Skill levelSkill level patent owner adoptedDecided for patent owner

      “relevant to determining the level of ordinary skill in the art include the type of problems encountered in the art and prior art solutions to those problems. See Envtl. Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696–97 (Fed. Cir. 1983). The prior art itself may also reflect an appropriate level of skill. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 7

    • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for patent owner

      “We also adopt the parties’ position that the preamble of claims 1 and 7 is not limiting beyond the term “granule.” Claims 1 and 7 each recite “[a] chemically stable dry flow, low compact, dust free soluble phosphoramidothioate granule consisting of” the set of ingredients recited in body of those claims. Ex. 1001, 7:44–45, 8:19–20. While the wherein clause describing the dimensions of “said granule” relies on “granule” in the preamble for antecedent basis, none of the other preamble language appears to be necessary to breathe life and meaning into the claim, and the claim body recites a structurally complete invention. See Catalina Marketing Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002) (explaining that a preamble is limiting if it is “necessary to give live, meaning, and vitality to the claim,” but “is not limiting where a patentee defines a structurally complete invention in the claim body”) (internal quotations omitted). Thus, we agree with the parties, and the district court in the related litigation, that the preamble language other than “granule” is not limiting.” slip op. at 10

    • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner

      “Moreover, we agree that the transitional phrase “consisting of” in claims 1 and 7 creates a “very strong presumption that the claim element is ‘closed’ and therefore exclude[s] any elements, steps, or ingredients not specified in the claim.” Pet. 5; Resp. 12 (both quoting Multilayer Stretch Cling Film Holdings, Inc. v. Berry Plastics Corp., 831 F.3d 1350, 1358 (Fed. Cir. 2016)). Neither party seeks to overcome that presumption, nor do we see any basis for doing so based on the record before us. Accordingly, we construe the challenged claims to be limited to granule compositions containing only those ingredients recited in the claims. There are no other terms that need to be construed to resolve the issues presented in this proceeding. Therefore, we do not construe any additional terms. See, e.g., Nidec Motor Corp. 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 11

    • Expert testimonyPetitioner expert creditedPatent owner expert creditedMixed

      “demonstrating that the “general conditions” regarding the use of these ingredients in such compositions was known. In re Applied Materials, Inc., 692 F.3d 1289, 1295 (Fed. Cir. 2012) (noting that any overlap between the claimed and disclosed ranges serves to disclose the “general conditions” of the claim). “Such overlap itself provides sufficient motivation to optimize the ranges.” Id. Moreover, we credit Mr. Geigle’s testimony that a POSITA would have understood because the concentration of acephate was increased the concentration of the other ingredients would necessarily decrease and that a POSITA would have been able optimize these amounts using standard techniques and testing. Ex. 1003 ¶¶ 85–113. Thus, Petitioner has demonstrated that these ingredient concentrations are result-effective variables that would have been obvious to optimize through routine experimentation.” slip op. at 24

    Patent outcomesUS 7,473,685 mixed
    Claim construction§ 103 obviousnesscites Graham
    Patents in suitUS 7,473,685
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