• Alivecor, Inc. v. Apple Inc.Some claims unpatentable
  PTAB · Dec 23, 2024 · IPR2023-00950 · APJ Josiah C Cocks · IPR · Final written decision

  Claims 1–14 were not shown unpatentable; claims 15–22 were shown unpatentable over Markel. The revised contingent motion to amend was dismissed as moot.

  RulingsFinal written decision

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

    “In carefully and faithfully wrangling the parties’ views and explanation as to the meaning of limitation [1.c.iii], we conclude that Petitioner’s “correct interpretation” of that limitation is that a first pad is recognized as a distinct structure or component from a first portion of an enclosure, and that the pad is positioned underneath that first portion in a manner such that the pad is concealed from a user. We adopt that interpretation. We determine that it is unnecessary to discuss an express construction for any other term to resolve this proceeding. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Matal, 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 19

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner’s proposed level of ordinary skill in the art is somewhat broader in both education and proposed work experience. Patent Owner’s proposed work experience is somewhat vague and potentially outside the scope of the claimed invention. For example, the requirement that the person of ordinary skill in the art have experience with the “capture and processing of data or information, including but not limited to physiological information,” would seemingly encompass data processing areas that do not relate to the scope of the claimed invention. We adopt Petitioner’s level of the level of ordinary skill in art because it is consistent with the level of ordinary skill reflected in the prior art references of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (recognizing that the prior art itself may reflect an appropriate level of skill in the art). Nevertheless, our analysis and the end result are the same under either proposed definition.” slip op. at 13

  • Expert testimonyPatent owner expert creditedPetitioner expert discountedDecided for patent owner

    “Patent Owner makes a more persuasive case as to what a person of ordinary skill in the art reasonably would have understood from Markel’s disclosure. In particular, we agree with Patent Owner that the record before us readily conveys that a skilled artisan would have followed Markel’s practice of forming or molding electrodes from conductive plastic rather than locating a separate electrode component underneath a conductive plaster layer. See, e.g., PO Resp. 30–31 (“[a] POSITA would find nothing in cited portions of Markel to inform or encourage placement of an electrode underneath an exterior layer.”). Indeed, as Patent Owner articulates, Petitioner “fails to provide any reasoning as to why a POSITA would have found Markel’s method of concealment to be deficient, or why a POSITA would have been motivated in light of Markel’s manner of concealment to nevertheless place an electrode underneath the exterior portion of the device.” Id. To that end, we credit Dr. Kenny’s supporting testimony as consistent with Markel’s express teachings. See, e.g., Ex. 2001 ¶¶ 77–83; Ex. 2004 ¶¶ 81–88. We credit that testimony over the countervailing testimony of Petitioner’s declarant, Dr. Berger (see, e.g., Ex. 1003 ¶¶ 122, 135–139), as we agree with Patent Owner that Dr. Berger’s testimony “is not supported by Markel’s actual disclosures.” PO Resp. 31.” slip op. at 33

  • Obviousness (§103) › Motivation to combine / reasonable expectation of success › HindsightNot shown unpatentableMotivation not foundNot shown unpatentable

    “Petitioner does not appear to disagree that Markel, itself, does not convey that an electrode, or any structure identifiable as a “pad,” is positioned underneath any surface of any enclosure. Rather, Petitioner’s theory of unpatentability is premised on modification of Markel to so position such a pad. Although seemingly acknowledging that Markel contemplates a concealment technique involving molding an electrode into an exterior surface, Petitioner extrapolates from that disclosure that a skilled artisan would be motivated to try an alternative means of concealing an electrode pad by placing the pad underneath an outer layer or portion, i.e., “audio output portion 610.” See Pet. 20 (citing Ex. 1003 ¶ 135). Neither Petitioner, nor Dr. Kenny, however, meaningfully explains why a skilled artisan would have deviated from Markel’s express teachings of concealing an electrode via molding techniques to then arrive at an entirely different concealment approach of placing an electrode pad underneath the audio output portion. Petitioner’s modification proposal in that regard appears borne of hindsight bias based on the disclosure of the ’257 patent rather than any dutiful consideration of what Markel’s actual teachings would have conveyed to a skilled artisan. See Ex. 2004 ¶ 84 (Dr. Kenny explaining why Petitioner’s proposed modification to Markel to hide the electrode underneath a plastic conductive layer was based on improper hindsight). Such hindsight bias is impermissible. See, e.g., Metalcraft of Mayville, Inc. v. The Toro Co., 848 F.3d 1358, 1367 (Fed. Cir. 2017) (“[W]e cannot allow hindsight bias to be the thread that stitches together prior art patches into something that is the claimed invention.”). Patent Owner makes a more persuasive case as to what a person of ordinary skill in the art reasonably would have understood from Markel’s disclosure. In particular, we agree with Patent Owner that the record before us readily conveys that a skilled artisan would have followed Markel’s practice of forming or molding electrodes from conductive plastic rather than locating a separate electrode component underneath a conductive plaster layer. See, e.g., PO Resp. 30–31 (“[a] POSITA would find nothing in cited portions of Markel to inform or encourage placement of an electrode underneath an exterior layer.”). Indeed, as Patent Owner articulates, Petitioner “fails to provide any reasoning as to why a POSITA would have found Markel’s method of concealment to be deficient, or why a POSITA would have been motivated in light of Markel’s manner of concealment to nevertheless place an electrode underneath the exterior portion of the device.” Id. To that end, we credit Dr. Kenny’s supporting testimony as consistent with Markel’s express teachings. See, e.g., Ex. 2001 ¶¶ 77–83; Ex. 2004 ¶¶ 81–88. We credit that testimony over the countervailing testimony of Petitioner’s declarant, Dr. Berger (see, e.g., Ex. 1003 ¶¶ 122, 135–139), as we agree with Patent Owner that Dr. Berger’s testimony “is not supported by Markel’s actual disclosures.” PO Resp. 31.” slip op. at 32

  Patent outcomesUS 10,076,257 mixed
  Claim construction§ 103 obviousnesscites Phillips · KSR
  Patents in suitUS 10,076,257
• Masimo Corporation v. Apple Inc.Some claims unpatentable
  PTAB · Sep 23, 2024 · IPR2023-00634 · APJ Ken B Barrett · IPR · Final written decision

  Claims 1–5, 9, 10, 14, 15, and 17–20 are unpatentable as obvious; claims 6–8, 11–13, and 16 were not shown unpatentable.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We discern no material difference between the parties’ definitions. Cf. PO Resp. 16 (Patent Owner stating that “[t]he analysis presented [in the Response] remains unchanged even if [Petitioner’s proposed] skill level is applied.”). Petitioner’s definition is consistent with the level of ordinary skill reflected in the prior art references of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (recognizing that the prior art itself may reflect an appropriate level of skill in the art). For purposes of this decision, we apply Petitioner’s definition of the person of ordinary skill in the art. We note, however, that were we to adopt Patent Owner’s assessment, the outcome of this Decision would be the same.” slip op. at 11

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

    “We find Patent Owner’s position to be persuasive. Not only are the cover and biosensor module recited separately in the list of components of the device of claim 9, we also agree that the “disposed over” claim language establishes the configuration of two separate components relative to each other. Additionally, the claim language that requires the cover to be “configured to pass optical signals to and from the biosensor module” supports an interpretation where the cover is separate from the biosensor module, otherwise it seemingly would be passing signals to and from itself. The understanding that the cover is separate from the biosensor module in claim 9 is consistent with the Specification’s description of an embodiment that tracks the language of claim 9 and speaks of the two elements as separate, individual components, namely the statement that “[a] biosensor module may be disposed within the opening of the housing” and “[a] rear cover may be disposed over the biosensor module.” Ex. 1001, 2:59–62; see also id. at 2:56 (the same paragraph beginning with “Some embodiments . . .”). Petitioner asserts that its proposed construction is consistent with the claim language, arguing that “the word ‘cover’ naturally suggests that its role is to be ‘disposed over,’” and that “[a] cover can be part of a module just as a clear plastic lid can be both disposed over, and part of, a container, allowing a view of its contents.” Pet. Reply 4. We disagree with Petitioner’s analogy. Although a clear lid may be over a jar, it cannot be said to be “disposed over” the container consisting of both the jar and the lid because it then would be disposed over itself.” slip op. at 14

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

    “Patent Owner argues that the proposed combination will result in a configuration “that is contrary to Honda’s teachings and its stated goals and purpose of achieving quick and efficient wireless charging.” PO Resp. 30– 31. Patent Owner’s focus on these properties is misplaced. We agree with Petitioner that characteristics such as charging speed and efficiency are not claimed. See Pet. Reply 1 (“[T]he ’783 patent does not disclose, let alone claim, sizing or other details [Patent Owner] Apple asserts are necessary for successful wireless charging.”); id. at 6 (“[C]harging speed [is] not claimed.”). Rather, the claim drafter utilized broad language to encompass a biosensor device having the capability to wireless charge through a cover— both good configurations and those that Patent Owner argues are inferior. And, even if the proposed combination does not yield a commercially viable product, as Patent Owner implies, the broad claim scope would hinder an innovating competitor’s ability to utilize and test that purported less desirable combination on the way to development of a better device. Patent Owner argues that a person of ordinary skill in the art would not have been motivated to make the proposed combination and would not have had a reasonable expectation of success in making that combination. See, e.g., PO Resp. 31. These arguments are not persuasive at least because Patent Owner’s motivation requirement and implied definition of success are not sufficiently tied to the claimed invention. See, e.g., Elekta Ltd. v. ZAP Surgical Sys., Inc., 81 F.4th 1368, 1375 (Fed. Cir. 2023) (“Reasonable expectation of success refers to the likelihood of success in combining references to meet the limitations of the claimed invention.”). Patent Owner would require a successful outcome to be “quick and efficient wireless charging.” See PO Resp. 31. In making these arguments, Patent Owner is improperly superimposing the purported goals and purpose of Honda, the secondary reference, onto the ordinary artisan. See, e.g., id. at 37–41. However, the intended purpose of a prior art reference does not control the obviousness inquiry. Intel Corp. v. Qualcomm Inc., 21 F.4th 784, 800 (Fed. Cir. 2021). Our reviewing court recently explained: The [motivation-to-combine] inquiry is not whether a relevant artisan would combine a first reference’s feature with a second reference’s feature to meet requirements of the first reference that are not requirements of the claims at issue. A contrary view would run counter to established principles, including that the claim defines the invention whose obviousness is being assessed and that a skilled artisan may be motivated to combine particular features of different references, e.g., to secure some benefits at the expense of others, even when bodily incorporation would be impossible or inadvisable. Axonics, Inc. v. Medtronic, Inc., 73 F.4th 950, 957 (Fed. Cir. 2023). Petitioner’s combination yields the benefit of the addition of wireless charging capability to a biosensor device. A person of ordinary skill in the art would find that benefit to be a motivating reason to make the combination. See, e.g., Ex. 1003 ¶ 121 (Dr. Duckworth’s motivation opinion based, in part, on “Kotanagi’s own statement that its rechargeable battery can be recharged ‘in a contactless state.’”); id. ¶ 127 (Dr. Duckworth’s describing a motivating factor in Honda’s explanation “that this [charging] station passes wireless power to the wireless charging receiving coil through a rear cover glass (similar to that of Kotanagi), using the physics of induced currents and magnetic flux.”); see also Ex. 1052, 45:16–46:2 (Dr. Anthony, on cross-examination and after being asked whether wireless charging is an improvement over wired charging for a consumer watch, responding that “in some instances it could be, and in others it may not be.”). And, as to a reasonable expectation of success, Patent Owner admits that “Petitioner has presented a device configuration in which a wireless charging coil could be provided in Kotanagi’s through hole 22.” PO Resp. 56; see also id. at 3 (Patent Owner arguing that “the size of coil that could be provided in this allegedly available space would be small and would significantly limit the amount of wireless power signal transmission,” but not arguing that even Patent Owner’s purported size-limited configuration would be inoperative); see, e.g., Ex. 1003 ¶¶ 130–133 (Dr. Duckworth credibly testifying that a person of ordinary skill in the art would have had a reasonable expectation of success in combining the teachings of Kotanagi and Honda).” slip op. at 31

  Patent outcomesUS 10,627,783 mixed
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,627,783
• Draftkings Inc., A Delaware Corporation v. AG 18, LLCSome claims unpatentable
  PTAB · Mar 12, 2024 · IPR2022-01446 · APJ George R Hoskins · IPR · Final written decision

  Claims 1–17 and 19–30 are unpatentable based on the listed anticipation and obviousness grounds; claim 18 was not shown unpatentable.

  RulingsFinal written decision

  • Claim Construction › Functional claiming / §112(f) means-plus-function › Whether §112(f) applies (Williamson, nonce words)§112(f) appliesTerm construed petitioner constructionDecided for petitioner

    “Module Terms each recite a “module” that is configured to perform or to oversee certain recited functionality, without reciting sufficient structure for performing that functionality. See Pet. 32. Further, as in Williamson, the word “module” in the context of the ’205 patent claims and specification is a “nonce” word, used “in a manner that is tantamount to using the word ‘means.’” Williamson, 792 F.3d at 1350–51. We therefore agree with Petitioner’s position that the rebuttable presumption against application of § 112 ¶ 6 is overcome in this case, because the Module Terms are not understood by persons of ordinary skill in the art to have a sufficiently definite meaning as the name for structure. See Williamson, 792 F.2d at 1349 (“The standard is whether the words of the claim are understood by persons of ordinary skill in the art to have a sufficiently definite meaning as the name for structure.”). Patent Owner’s and Dr. Lane’s apparent disagreement with this conclusion in the context of the ’205 patent is unaccompanied by any argument seeking to establish that the Module Terms might be understood to recite a sufficiently definite meaning as the name for structure. See PO Resp. 6; Ex. 2005 ¶ 28.” slip op. at 55

  • ExcludeMotion to exclude, deniedDenied

    “Petitioner filed a Motion to Exclude Evidence proffered by Patent Owner (Paper 31). Patent Owner filed an Opposition (Paper 32), and Petitioner filed a Reply (Paper 33). We deny Petitioner’s Motion to Exclude Evidence, for reasons provided below.” slip op. at 2

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed

    “k) Conclusion Regarding Claim 12 Thus, based on the record presented, we conclude Petitioner has” slip op. at 32

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableNot shown unpatentableMixed

    “Petitioner relies on Bryson as disclosing the subject matter recited in claim 1, except for limitations 1[g] and 1[h], in substantially similar fashion as discussed above in Ground One in relation to other claims. See Pet. 68–73. Patent Owner’s sole opposition in this regard is whether Bryson discloses the betting range limitation 1[j]. See PO Resp. 49–53 (Patent Owner’s opposition to Ground Four as to claim 1). We conclude a preponderance of the evidence establishes Bryson supports Petitioner’s unopposed contentions in this regard, for the reasons set forth in the Petition which we adopt as our own in this Decision. We accordingly find Bryson discloses the preamble 1[pre] and limitations 1[a]–1[f], 1[i], and 1[k]–1[m].” slip op. at 74

  Patent outcomesUS 9,978,205 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 9,978,205
• Draftkings Inc. v. AG 18, LLCSome claims unpatentable
  PTAB · Mar 12, 2024 · IPR2022-01448 · APJ Frances L Ippolito · IPR · Final written decision

  Claims 1–10 and 12–29 are unpatentable over the asserted anticipation and obviousness grounds; claim 11 was not shown unpatentable.

  RulingsFinal written decision

  • Skill levelOther

    “B. Level of Ordinary Skill in the Art In determining the level of skill in the art, we consider the type of” slip op. at 10

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Plain and ordinary meaningOther

    “C. Claim Construction In an inter partes review, we construe each claim “in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” 37 C.F.R. § 42.100(b). Accordingly, our claim construction standard is the same as that of a district court. See id. Under the standard applied by district courts, claim terms are generally given their plain and ordinary meaning as would have been understood by a person of ordinary skill in the art at the time of the invention and in the context of the entire patent disclosure. Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en banc). “There are only two exceptions to this general rule: 1) when a patentee sets out a definition and acts as his own lexicographer, or 2) when the patentee disavows the full scope of a claim term either in the specification or during prosecution.” Thorner v. Sony Comput. Entm’t Am. LLC, 669 F.3d 1362, 1365 (Fed. Cir. 2012).” slip op. at 11

  • Claim Construction › Functional claiming / §112(f) means-plus-function › Whether §112(f) applies (Williamson, nonce words)§112(f) appliesTerm construed petitioner constructionDecided for petitioner

    “generally takes issue with whether Petitioner has sufficiently explained its construction of means-plus-function limitations. See PO Resp. 24–35. Nonetheless, based on the complete record, we find that the Petition “identif[ies] the specific portions of the specification that describe the structure, material, or acts corresponding to each claimed function” of this means-plus-function limitation in claim 26. 37 C.F.R. § 42.104(b)(3); see Pet. 22 (citing Ex. 1001, 3:60–66). Moreover, we apply Petitioner’s construction for our prior-art analysis because it is consistent with and supported by the complete record.” slip op. at 38

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed

    “9–11, 20 102(e) Bryson 9, 10 11” slip op. at 110

  Patent outcomesUS 10,614,657 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,614,657
• Google LLC v. Nobots LLCSome claims unpatentable
  PTAB · Nov 29, 2023 · IPR2022-00940 · APJ Josiah C Cocks · IPR · Final written decision

  Claims 1–17 and 20 are unpatentable; claims 18 and 19 were not shown unpatentable, because the asserted grounds failed to establish the required limitations for those claims.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner contends that a person of ordinary skill in the art at the time of the invention of the ’008 patent “would have had a bachelor’s degree in computer science or a related field with coursework relating to computer science, plus two years’ academic and/or industry experience in computer security. More education could substitute for experience, and vice versa.” Pet. 4 (citing Ex. 1003 ¶¶ 36–40). Patent Owner does not dispute this proposed level of skill. PO Resp. 2. We adopt Petitioner’s proposal as reasonable and consistent with the prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art may reflect an appropriate level of skill in the art).” slip op. at 8

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

    “In considering Patent Owner’s explanation, and upon further reflection, we agree with Patent Owner’s reading of the pertinent sentence. In that regard, consistent with the remainder of the Specification of the ’008 patent, it follows that the noted sentence does not alter the contours of “acquired” data to also encompass “passive” data where that premise is entirely absent from other portions of the Specification. Rather, as Patent Owner explains, the sentence is consistent with the understanding that it is “active data” that is connected to the word “acquired” and “passive data” that is connected to the word “available.” See, e.g., id. Patent Owner’s explanation alleviates the ambiguity that was postulated in the Institution Decision. We have considered Petitioner’s views to the contrary (see, e.g., Pet. Reply 21–25) but find them unavailing. In particular, Petitioner does not reconcile its position that, although acknowledging that “acquired data” is defined in the ’008 patent, the term “acquiring” is not so defined and should be regarded as an “individual word” whose meaning is somehow entirely unconnected to “acquired.” See, e.g., Pet. Reply 21. We note, as we did in the Institution Decision, that the ’008 patent states that “acquired data” and “its equivalents and verb forms” is “a type of active data.” See Inst. Dec. 30 (citing Ex. 1001, 3:25–32). We are not persuaded by Petitioner’s view (see, identifiable as a verb form of “acquired.” See PO Sur-reply 8. We determine that, in the context of the ’008 patent, it clearly is. Having considered the competing views of Petitioner and Patent Owner, we conclude that Patent Owner’s construction of the term “acquiring interest data” is consistent with, and supported by, the Specification of the ’008 patent. In that regard, we conclude that, as is advanced by Patent Owner, “acquiring interest data” must encompass the retrieval of some active data.” slip op. at 16

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

    “1–3 and 6–17 are found in Willner. Pet. 9–26. During trial, Patent Owner presented no arguments challenging Petitioner’s proposed ground of unpatentability of claims 1–3 and 6–17 based on Willner. During oral argument, upon questioning, counsel for Patent Owner expressed that “We did not present any arguments on Claims 1 to 3, 6 to 17 on Ground 1.” Tr. 30:3–4. We determine that Petitioner, via its Petition, has established adequately where all the features of claims 1–3 and 6–17 are present in Willner. See Pet. 9–26. Given that determination, and in the absence of any argument during trial challenging Petitioner’s ground of unpatentability based on Willner as to those claims, we conclude that Petitioner has shown by a preponderance of the evidence that claims 1–3 and 6–17 are unpatentable under 35 U.S.C. § 102 based on Willner.” slip op. at 19

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

    “Here, we conclude that: (1) the parties’ recognized level of ordinary skill in the art (see Pet. 4; PO Resp. 2); (2) the knowledge of a skilled artisan as set forth by record evidence, including the teachings of Willner and Kitts; and (3) the nature of the problem addressed in both of those references, i.e., click fraud detection, all support a determination that a skilled artisan would have had adequate reasons to combine Willner and Kitts, and would have had a reasonable expectation in doing so. To that end, we find persuasive Petitioner’s arguments in the Petition as to the proposed reasoning to combine Willner and Kitts, and also credit Dr. Lopresti’s supporting testimony. See Pet. 28–29; Ex. 1003 ¶ 118. We are mindful of the contrasting testimony referenced by Patent Owner’s declarant, Dr. Russ. See, e.g., PO Resp. 38 (citing Ex. 2011 ¶¶ 107–110). Dr. Russ testifies that, in his view, there are “practical” and “technical” “considerations” in combining Willner and Kitts that a “POSA would have had to consider in determining whether a reasonable expectation of success exists, none of which are addressed or discussed in the Petition.” See Ex. 2011 ¶¶ 107–110. The example considerations listed by Dr. Russ are reproduced below: 1. How Kitts’ passive data could be collected and stored in conjunction with the mouse vector data already being collected by Willner; 2. How to collectively analyze fundamentally different types of data—Willner’s mouse vector data on one hand, and Kitts’ passive data on the other; 3. How to generate a useful confidence score that is more accurate than the scores already generated by Willner, again taking into consideration that passive data is a fundamentally different type of data than active data; assessment using the complex statistical model of Kitts; and 5. To what extent additional computer hardware would be necessary to enable the combined system to effectively operate and whether such hardware could be reasonably implemented, taking into consideration both cost and feasibility. Ex. 2011 ¶ 108. Those considerations are generally directed to collection and use of” slip op. at 36

  Patent outcomesUS 9,595,008 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 9,595,008
• JSR Corporation / JSR Life Sciences, LLC v. Cytiva Bioprocess R&D ABSome claims unpatentable
  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
• JSR Corporation / JSR Life Sciences, LLC v. Cytiva Bioprocess R&D ABSome claims unpatentable
  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
• JSR Corporation / JSR Life Sciences, LLC v. Cytiva Bioprocess R&D ABSome claims unpatentable
  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
• JSR Corporation / JSR Life Sciences, LLC v. Cytiva Bioprocess R&D ABSome claims unpatentable
  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
• C.R. Bard, Inc. v. Medline Industries, Inc.Some claims unpatentable
  PTAB · Nov 23, 2022 · IPR2019-00035 · APJ Mitchell G Weatherly · IPR · Remand

  Claims 1, 2, 6, 8–10, 16, 25–27, 29–37, and 39–44 are unpatentable as obvious; claims 7, 17–19, 28, and 38 were not shown unpatentable.

  RulingsRemand decision

  • PTAB / AIA Trials › §315(e) estoppelEstoppel does not applyDecided for patent owner

    “IPR2019-00208 and this proceeding do not involve an “identical issue” despite Patent Owner relying on essentially the same body of objective evidence of nonobviousness in both proceedings. The challenged claims in this proceeding materially differ from those at issue in IPR2019- 00208. Compare Ex. 1001, 27:47–30:57, with IPR2019-00208, Ex. 1001, 11:47–12:28; see also PO Remand Br. 23. The material differences in the claims, alone, and thus the issues previously decided, precludes a finding of collateral estoppel. Therefore, we conclude that Patent Owner is not collaterally estopped from relying upon its objective evidence of nonobviousness. Rather, we consider and weigh that evidence as it applies to the claims at issue in this proceeding below.” slip op. at 54

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

    “However, we disagree with Patent Owner’s interpretation of limitation 1a as requiring that the compartment for receiving the medical assembly be “distinct” from the first compartment or that the medical assembly be disposed within the “compartment” of limitation 1a. Limitation 1f requires “at least two compartments,” but expressly recites a functional limitation for only “a first compartment” among the “at least two compartments.” Ex. 1001, 27:60–62. Claim 1 does not further limit the unspecified compartment among the “at least two compartments” or specify what items, if any, are placed within it. See id. at 27:47–67. Two unchallenged dependent claims, claims 4 and 11, further recite that “the at least two compartments” further comprise “a second compartment.” Claim 4 depends directly from claim 1 and further recites, in pertinent part: “the at least two compartments further comprising a second compartment separated from the first compartment by a wall with an opening, further comprising a catheter assembly disposed within the second compartment, the catheter assembly comprising a fluid bag.” Id. at 28:21–25 (emphasis added). Claim 11 depends from claim 10, which depends from claim 1, and similarly recites: “the at least two compartments further comprising a second compartment separated from the first compartment by a wall with an opening, further comprising a catheter assembly disposed within the second compartment.” Id. at 28:47–51 (emphasis added).” slip op. at 18

  • Skill levelSkill level board ownDecided for petitioner

    “skill in the relevant art would have a bachelor’s degree in packaging engineering, mechanical engineering, or industrial design. Pet. 18 (citing Ex. 1002 ¶¶ 14–16); PO Resp. 15 (citing Ex. 2026 ¶ 38). Alternatively, such a person could have an engineering degree in another technical field along with about two years of experience designing medical packaging. Pet. 18 (citing Ex. 1002 ¶¶ 14–16); PO Resp. 15 (citing Ex. 2026 ¶ 38). Neither party contends that a person of ordinary skill needs to be a medical practitioner, but both parties agree that the person of ordinary skill would consult with medical practitioners familiar with catheterization procedures. Pet. 18; PO Resp. 15 (citing Ex. 2027 ¶ 78). Slight differences exist in the formulation of the level of ordinary skill between the parties. We, however, discern no meaningful difference because none of those differences would affect the outcome of our analysis. Accordingly, we apply the level of skill set forth in the preceding paragraph.” slip op. at 10

  • Expert testimonyPatent owner expert creditedPetitioner expert creditedMixed

    “Petitioner argues that shallow area 11B “facilitates easy lubrication of the catheter” simply because it is shallow and “it was well-known to ‘(a) apply lubricant directly on the catheter; and (b) use the same compartment where lubricant is stored to lubricate the catheter.’” Pet. Remand Br. 28–29 (citing Pet. 32, 34; Ex. 1002 ¶ 231). Patent Owner persuasively responds, however, that a practitioner would not use the same compartment to collect urine and lubricate the catheter because the lubricant would contaminate the urine specimen collected in the compartment. PO Remand Br. 3–4 (citing PO Resp. 36; Op. *8); see also Ex. 2027 ¶ 175 (Ms. Chiappetta testifying that “lubrication in the portion of the tray that collects urine will contaminate the urine,” which would invalidate any testing of the patient’s urine). Although it may be easier to lubricate a catheter in shallow area 11B than in deep area 11A, we find that Solazzo’s shallow area 11B is not well-suited, configured, or intended for lubricating a catheter; rather, Solazzo recommends using lubricating wells 31 and 33 for that purpose. We credit Ms. Chiappetta’s supporting testimony to that effect. See Ex. 2027 ¶ 175. Accordingly, we conclude that Petitioner has failed to prove by a preponderance of evidence that the combined teachings of Solazzo and Serany render claim 7 unpatentable as obvious.” slip op. at 31

  Patent outcomesUS 9,745,088 mixed
  Claim construction§ 103 obviousnesscites Graham
  Patents in suitUS 9,745,088

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.