- Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentablePTAB · Oct 2, 2026 · PGR2025-00046 · APJ Jeffrey N Fredman · PGR · Final written decision
Claims 1, 2, 5, and 7–33 are unpatentable because the Petitioner proved lack of written description and lack of enablement; the Board did not find the claims obvious.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“II. ANALYSIS A. Level of Ordinary Skill in the Art We consider the grounds of unpatentability in view of the” slip op. at 8
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“been able to use the data in the Specification to make reasonable predictions about the effect of multiple modifications on hyaluronidase activity, we view this testimony to at most describe a research plan (i.e., a “tool to engage in further modification”15) for finding the recited polypeptides rather than demonstrating the inventors were in possession of the full scope claimed. This is particularly so given the limits of the then-available analytical tools noted above and the fact that the structural connections and three dimensional modeling Patent Owner’s experts attempt to make (see, e.g., Ex. 2070 ¶¶ 129–213; Ex. 2068 ¶¶ 123–125) do not appear in the written description itself. To the extent the experts disagree on this point, we credit the testimony of Petitioner’s experts over that of Patent Owner’s. See Ex. 1133 ¶¶ 111–230 (identifying problems with the approaches proposed by Patent Owner’s experts). For these reasons, we find that a preponderance of the evidence of record better supports a finding that in the 2011–2012 timeframe, it would have been unpredictable to identify which multiple” slip op. at 54
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledUnpatentable
“6. Analysis Petitioner has the burden to identify how the Specification allegedly” slip op. at 74
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“E. Ground III - Obviousness 1. Principles of Law The Supreme Court in KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398” slip op. at 117
Patent outcomesUS 12,091,692 unpatentable§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 12,091,692 - Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentablePTAB · Oct 1, 2026 · PGR2025-00052 · APJ Cynthia M Hardman · PGR · Final written decision
Claims 1–17 are unpatentable for lack of written description, lack of enablement, and indefiniteness; the Board did not find them unpatentable as obvious.
RulingsFinal written decision- Skill levelOther
“II. ANALYSIS A. Level of Ordinary Skill in the Art We consider the grounds of unpatentability in view of the” slip op. at 7
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“Specification of the ’345 patent supports an understanding that some activity is required for a polypeptide to be a “modified PH20 polypeptide,” and it is the enzymatic activity of hyaluronidase specifically that is the most frequently identified activity recited in the Definitions section of the ’345 patent. Indeed, the definitions of “PH20” and “modified PH20 polypeptide” both require hyaluronidase activity. See Ex. 1001, 44:20–21, 49:4–7 (“PH20 refers to a type of hyaluronidase that . . . is neutral-active” and “neutral active refers to the ability . . . to enzymatically catalyze the cleavage of hyaluronic acid at neutral pH”); 47:8–11 (“A modified PH20 polypeptide can have up to 150 amino acid replacements so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity.”). Similar language is used later in the definition of a “conjugate” to explain that even when the modified PH20 polypeptide is linked to another polypeptide or chemical moiety it “retains hyaluronidase activity.” Id. at 61:60–67. In contrast, the discussion regarding the potential use of “modified PH20 polypeptides that are inactive” as antigens in contraception vaccines appears only in non-definitional sections of the ’345 patent. Id. at 71:16-18, 74:11–13. Accordingly, we find that this disclosure does not modify the definition’s explicit requirement that the claimed “modified PH20 polypeptide” exhibit hyaluronidase activity. Id. at 47:3–11.” slip op. at 20
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“description (see Capon, 418 F.3d at 1357–58), Patent Owner is trying to extend that to include that which is at most obvious from the prior art, as opposed to what is actually described. That is, it may have been obvious to a POSA to align PH20 sequences with other known hyaluronidase enzymes and to use the crystal structure of a different hyaluronidase (Hyal-1) in SWISS-MODEL to generate a three-dimensional structure, but none of that is described in the common disclosure itself. “[A] description that merely renders the invention obvious does not satisfy the [written description] requirement.” Ariad, 598 F.3d at 1352. While a POSA might be able to embark on their own research program to try to find suitable multiply-modified PH20 polypeptides, the four corners of the written description do not demonstrate possession of such. See id. at 1356‒57 (recognizing that “[p]erhaps one of ordinary skill could discover this information, but this does not alter our conclusion that the description . . . just represent[s] a wish or arguably a plan for future research”) (internal quotation omitted).” slip op. at 66
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledUnpatentable
“instances of epistasis are “rare” and an inactive PH20 polypeptide “will stay inactive . . . absent intentional ‘rescue’ mutations.” See Sur-reply 12–14. But the claims encompass far more than combinations of just two substitutions, and even Dr. Petsko concedes there are “billions” of sequences within the recited sequence space that will not properly fold. See Ex. 2070 ¶ 347; see also Ex. 1133 ¶ 237 (“While some [residues critical to protein structure] can be predicted (e.g., highly conserved positions), many others cannot without experimentation.”). Accordingly, we find Petitioner’s position more persuasive than Patent Owner’s competing position and evidence.” slip op. at 108
Patent outcomesUS 12,264,345 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham · NautilusPatents in suitUS 12,264,345 - Merck Sharp And Dohme LLC v. Halozyme, Inc.All claims unpatentablePTAB · Sep 25, 2026 · PGR2025-00033 · APJ Michael A Valek · PGR · Final written decision
Claims 1, 2, and 6–29 are unpatentable for lack of written description and enablement; the Board did not find them obvious over the ’429 patent and Chao.
RulingsFinal written decision- Expert testimonyPetitioner expert creditedDecided for petitioner
“structural connections and three-dimensional modeling Patent Owner’s experts attempt to make (see, e.g., Ex. 2070 ¶¶ 126–212, 297–342; Ex. 2068 ¶¶ 123–125, 245, 294–313, 318) do not appear in the written description itself. To the extent the experts disagree on this point, we credit the testimony of Petitioner’s experts over that of Patent Owner’s. See Ex. 1133 ¶¶ 111–230 (identifying problems with the approaches proposed by Patent Owner’s experts). For these reasons, we find that a preponderance of the evidence of record better supports a finding that in the 2011–2012 timeframe, it would have been unpredictable to identify which multiple mutants retained hyaluronidase activity, even with the single substitution data provided by the ’652 patent.” slip op. at 58
- Skill levelOther
“II. ANALYSIS A. Level of Ordinary Skill in the Art We consider the grounds of unpatentability in view of the” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Decided for petitioner
“exclude the use of modified PH20 polypeptides as contraceptives—the only other possible utility described in the ’652 patent—is unavailing. Resp. 39. First, “[t]he fact that a patent asserts that an invention achieves several objectives does not require that each of the claims be construed as limited to structures that are capable of achieving all of the objectives.” Phillips, 415 F.3d at 1327 (citing Liebel–Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 908 (Fed. Cir. 2004)). Second, unlike the definitions of “PH20” and “modified PH20 polypeptide” in the “Definitions” section of the Specification, the passages describing possible contraceptive use do not contain any characteristics suggesting they are definitional in nature. See Alnylam, 138 F.4th at 133 (enumerating “characteristics” such as the fact that the text appears in the “Definitions” section, sets the term off in quotation marks, and uses phrases like “refer to” that indicate that specification language is definitional in nature). Accordingly, the statement that “[a]lso provided are modified PH20 polypeptides that are inactive, and that can be used, for example, as antigens in contraception vaccines” (Ex. 1001, 75:56–58), does not redefine the term, nor otherwise void the definitional language in the Specification stating that a “modified PH20 polypeptide can have up to 150 amino acid replacements, so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity.” Id. at 48:47–49 (emphasis added).” slip op. at 26
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“1352. While a POSA might be able to embark on their own research program to try to find the genus of multiply-modified PH20 polypeptides recited in the challenged claims, the four corners of the written description here do not demonstrate the inventors were in possession of such. See id. at 1356–57 (recognizing that “[p]erhaps one of ordinary skill could discover this information, but this does not alter our conclusion that the description . . . just represent a wish or arguably a plan for future research”) (internal quotation omitted).” slip op. at 68
Patent outcomesUS 12,049,652 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 12,049,652 - Charles River Laboratories, Inc. v. Seikagaku CorporationAll claims unpatentablePTAB · Sep 8, 2026 · PGR2025-00023 · APJ Per Curiam · PGR · Final written decision
Claims 1–9 are unpatentable as anticipated by the ’629 publication; the claims are not entitled to the 2013 priority date.
RulingsFinal written decision- Skill levelSkill level board ownOther
“We find that a rigid requirement as to the subject of a POSITA’s doctoral degree (e.g., biochemical engineering, enzymology), or experience working specifically with horseshoe crab proteins, is not consistent with the evidence of record. See, e.g., Ex. 1067, 20:23–21:2 (Dr. Schaefer testifying that the fact the “name of [his] Ph.D. is immunology . . . does not change the fact that the core of [his] thesis training was really in molecular biology”), 22:3–15 (explaining that “the fact that the production of proteins recombinantly is mostly species agnostic”); Ex. 1069, 45:20–47:17 (Dr. Morris testifying that whether a person is a POSITA depends on the person’s “experience, [ ] publications,” and work done for the Ph.D. rather than the name of the Ph.D. program). We also find that evidence of record supports Petitioner’s assertion that, for purposes of defining a POSITA, “[m]ore education could substitute for experience, and vice versa.” See, e.g., Pet. 22; Ex. 1065, 99:14–100:3. Accordingly, based on the entirety of the trial record, we find a POSITA with respect to the claims of the ’109 patent would have had a two years of experience with cloning genes, expressing cloned genes as proteins, and/or characterizing such cloned genes and proteins, with more education being able to substitute for experience, and vice versa. A POSITA may also have collaborated with others, including those with specific experience in utilizing or assessing horseshoe crab Factor C for endotoxin detection and quantitation.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Neither party proposes an express construction of any claim term. See Pet. 22–23 (not proposing any constructions); PO Resp. 23 (“Patent Owner agrees that the terms can be afforded their plain and ordinary meaning.”). However, Patent Owner states that some of Petitioner’s arguments implicitly construe claim 1 in an erroneous manner. PO Resp. 23–28. “For example, Petitioner argues that ‘an adequate written description would have to either disclose representative examples of the possible working cascades of various proteins or some accurate structural feature of the claimed proteins that allow them to function in the claimed assay as a whole.’” Id. at 23 (quoting Pet. 35). Patent Owner argues that, contrary to what Petitioner’s argument allegedly implies, “Claim 1 is directed to a method for producing an endotoxin assay agent” and does not require the use – Owner that claim 1 does not require the use of endotoxin assay agent. However, the claimed endotoxin assay agent must be capable of performing the assay, as counsel for Patent Owner acknowledged. Tr. 83:5–9.” slip op. at 10
- BurdenNot shown unpatentable
“In this case, to show that the claims of the ’109 patent are unpatentable for lack of written description, Petitioner would have needed to show that the specification as filed (i.e., the ’420 application) fails to reasonably convey to those skilled in the art that Patent Owner had possession of the claimed subject matter as of the July 3, 2023, filing date. Petitioner did not. Pet. 23–24. Nor does Petitioner’s declarant offer testimony that could support such a showing. See Ex. 1003 ¶50 (“I have been asked to provide my opinions as to the state of the art in this field for purposes of determining what the inventors disclosed as their invention as of December 10, 2013.”), ¶51 (“Whenever I offer an opinion in this declaration about the knowledge of a POSA, the manner in which a POSA would have understood the claims of the ’109 patent or its description, the manner in have been led to do based on the prior art, I am referencing the December 10, 2013 timeframe.”). In our Institution Decision, we stated: Although the ’420 application is essentially identical to the ’767 application, the person of ordinary skill in 2013 is not the same as in 2023. See Ariad, 598 F.3d at 1351 (“[T]he [written description] test requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art.” (emphasis added)). Thus, the information presented in the Petition, which is limited to the perspective of a 2013 POSITA, does not demonstrate that it is more likely than not that at least 1 of the claims challenged in the Petition is unpatentable for lack of written description. Inst. Dec. 12 (alterations in original). During trial, Petitioner did not present any further arguments in support of Ground 1. See generally Pet. Reply. Petitioner has failed to prove that claims 1–9 are unpatentable for failing to meet the written description requirement set forth in 35 U.S.C. § 112(a).” slip op. at 12
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot shown unpatentable
“Although the evidence before us shows that, in 2013, a POSITA knew how to recombinantly express genes in expression systems such as CHO or HEK-293 cell lines, the evidence shows that this was true only for genes whose genetic sequences were known or readily available. See, e.g., Ex. 1069, 34:11–22 (“Q. Okay. So you would agree that the creation of the recombinant protein requires the underlying sequence of, as you said, the original animal? A. Of course.”) Because it is undisputed that, in 2013, the genetic sequence for Limulus polyphemus Factor C was unknown, or least not publicly available, Falko-Gunter does not support a finding of adequate written description here. See, e.g., Tr. 48:18–19 (“Patent Owner agrees that there had not been, as of 2013, the full length cDNA sequence for Limulus polyphemus Factor C published.”).” slip op. at 23
Patent outcomesUS 11,959,109 unpatentableClaim construction§ 102 anticipation§ 112 disclosurePatents in suitUS 11,959,109 - Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentablePTAB · May 12, 2026 · PGR2025-00003 · APJ Jeffrey N Fredman · PGR · Final written decision
Claims 1–4 and 8–21 are unpatentable for lack of written description and enablement; obviousness over the ’429 patent and Chao was not shown.
RulingsFinal written decision- Skill levelSkill level board ownOther
“VII. LEVEL OF ORDINARY SKILL IN THE ART We consider the grounds of unpatentability in view of the” slip op. at 7
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“term “modified PH20 polypeptide” in the ’600 patent supports the understanding that some type of activity is required for a polypeptide to be a “modified PH20 polypeptide”, and that the enzymatic activity of hyaluronidase is the most frequently identified activity recited in the definitions section of the ’600 patent. Id. at 48:38–53, 50:9‒17, 51:15‒18, 52:41–47, 55:9–23, 63:37–44, 64:14–19. In contrast, the discussion regarding the potential use of “modified PH20 polypeptides that are inactive” as antigens in contraception vaccines appears only in a non-definitional section of the ’600 patent. Id. at 75:56–58, 72:60–62. Accordingly, it does not modify the definition’s explicit requirement that the claimed “modified PH20 polypeptide” exhibit hyaluronidase activity. Id. at 48:38–53.” slip op. at 19
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“been able to use the data in the Specification to make reasonable predictions about the effect of multiple modifications on hyaluronidase activity, we view this testimony to at most describe a research plan (i.e., a “tool to engage in further modification”14) for finding the recited polypeptides rather than demonstrating the inventors were in possession of the full scope claimed. This is particularly so given the limits of the then-available analytical tools noted above and the fact that the structural connections and three dimensional modeling Patent Owner’s experts attempt to make (see, e.g., Ex. 2070 ¶¶ 129–213; Ex. 2068 ¶ 123) do not appear in the written description itself. To the extent the experts disagree on this point, we credit the testimony of Petitioner’s experts over that of Patent Owner’s. For these reasons, we find that a preponderance of the evidence of record better supports a finding that in the 2011–12 timeframe, it would have been unpredictable to identify which multiple mutants retained hyaluronidase activity, even with the single substitution data provided by the ’600 patent.” slip op. at 51
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledUnpatentable
“8. Conclusion We find that the balance of evidence supports a finding of undue” slip op. at 101
Patent outcomesUS 11,952,600 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 11,952,600 - Illumina, Inc. v. Molecular Loop Biosciences, Inc.No claims unpatentablePTAB · Apr 15, 2026 · IPR2024-01419 · APJ Susan L C Mitchell · IPR · Final written decision
Claims 1–9 were not shown unpatentable because the asserted references failed to disclose the claimed correcting step, and Chee was not prior art to claims 1–3 and 9.
RulingsFinal written decision- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedReference not prior artDecided for patent owner
“We have considered both parties’ arguments and evidence and determine that Patent Owner has presented sufficient evidence of reasonable the invention to practice every day during the critical period in order to demonstrate reasonable diligence. See Perfect Surgical Techniques, Inc. v. Olympus America, Inc., 841 F.3d 1004, 1009 (Fed. Cir. 2016). “[D]iligence need not be perfectly continuous—only reasonably continuous.” Arctic Cat Inc. v. GEP Power Prods., Inc., 919 F.3d 1320, 1331 (2019). The key question is whether, “in light of the evidence as a whole, the invention was not abandoned or unreasonably delayed.” Id. (internal quotations omitted). Applying this standard, we determine that Patent Owner sufficiently demonstrates reasonably continuous diligence throughout the critical period.” slip op. at 32
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“introduced during said workflow by collapsing target:differentiator tag combinations observed more than once into a single count.” Ex. 1001, 131:46–48 (emphasis added). The “determining step” of claim 2 recites “determining a consensus base call for the target nucleic acid molecule sequences,” but performs “collapsing all sequence reads comprising a same differentiator tag into a single read,” before the “determining step.” Id. at 131:49–53. Patent Owner proposes an interpretation of these “collapsing” and “determining” steps recited in claims 1 and 2 and asserts that they should be construed as distinct steps performed in a particular order in which the “collapsing step” is performed before the “determining step.” PO Resp. 42–45. We agree. First, Patent Owner asserts a person of ordinary skill in the art would have understood that the “collapsing step” of claim 1 is distinct from, and must occur before, the “determining step” of claim 2 based on the plain language of claims 1 and 2. PO Resp. 42–43. Patent Owner argues that the “collapsing step” and the “determining step” are distinct steps because claims 1 and 2 use different terms to describe these distinct steps that are performed sequentially according to the claim language. Id. (citing Ex. 1001, 131:47–54; Ex. 2023 ¶ 133; Ex. 2024, 57:11–58:22). More specifically, Patent Owner explains that claim 1 recites a “collapsing step,” followed by claim 2, which depends from claim 1 and refers to “collapsing” before “determining a consensus base call” such that “claim 2 describes determining a consensus base call from collapsed reads, not performing ‘collapsing’ by determining a consensus base call.” Id. at 42 (citing Ex. 1001, 131:47–54). collapsing corrects for skewing, an issue related to over- or under-amplification, which is a separate and distinct problem from the sequence errors that a consensus base call is designed to address.” Id. at 43 (citing Ex. 1001, 27:47–50, 32:29–34). Patent Owner contends further that “‘[c]ollapsing’ is a different step, performed separately from determining any consensus base call, to provide even greater accuracy when subsequently determining a consensus base call” such that “if one were to collapse by determining the consensus base call, errors from amplification bias could still be represented in the consensus base call generated.” Id. at 43–44 (emphasis omitted, citing Ex. 2023 ¶¶ 134–37). Second, Patent Owner argues a person of ordinary skill in the art would have understood that the “collapsing step” of claim 1 is distinct from the “determining step” based on the specification of the ’730 patent. PO Resp. 43–45. For example, Patent Owner explains that the specification states that “[f]or any target:differentiator tag combination observed more than once, all such reads are ‘collapsed’ into a single read before consensus basecalls are determined. This will cancel the effect of bias on consensus basecall accuracy.” Id. at 43 (emphasis omitted) (quoting Ex. 1001, 72:63– 73:5) (citing Ex. 2023 ¶¶ 133, 138–142).” slip op. at 11
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“We have considered both parties’ arguments and evidence and agree with Patent Owner’s position. As discussed above, we agree with Patent Owner that the “collapsing step” recited in claim 1 and the “determining step” recited in claim 2 are two different steps required by the challenged claims such that “collapsing” does not mean determining a consensus base call or sequence, and must occur before any determining step. As a result, we determine Chee’s step of determining a consensus sequence does not disclose the “collapsing step” recited in claim 1 that requires collapsing “target:differentiator tag combinations.” We are also unpersuaded by Petitioner’s reliance on Chee’s process of correcting for amplification bias as disclosing the claimed collapsing step. As recognized by Patent Owner, the claim language of the “collapsing step” requires “collapsing target:differentiator tag combinations,” rather than collapsing only differentiator tags. In view of this requirement, Chee does not disclose the “collapsing step” because Chee teaches quantifying the starting nucleic acid molecules using their unique identifiers, rather than target:differentiator tag combinations. As Petitioner admits, “Chee’s technique for correcting amplification bias corrects quantitative errors without correcting sequencing errors” (Reply 15), whereas claim 1’s “collapsing step” corrects both quantitative errors and sequencing errors by using target:differentiator tag combinations. See Ex. 1001, 131:47–49 target:differentiator tag combinations).” slip op. at 41
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“Given this claim interpretation requiring collapsing target:differentiator tag combinations, it is undisputed that McCloskey, who uses unique barcodes alone, does not teach this limitation. Petitioner does not rely on Bignell as teaching this collapsing step. Accordingly, we conclude Petitioner has not shown that the combination of Bignell and McCloskey teaches the “collapsing step” recited in claim 1. Because claims 4 through 6 depend from claim 1, they also require the “collapsing step” of claim 1 that is not taught by the combination of Bignell and McCloskey.” slip op. at 54
Patent outcomesUS 11,840,730 not shown unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites GrahamPatents in suitUS 11,840,730 - Alamar Biosciences, Inc. v. Olink Proteomics ABNo claims unpatentablePTAB · Mar 4, 2026 · IPR2024-01353 · APJ Tawen Chang · IPR · Final written decision
Claims 1–20 were not shown unpatentable: the asserted obviousness grounds failed, including because Kanan and Neri did not teach selecting the claimed cis-reactive cells.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Accordingly, for purposes of this decision we adopt Petitioner’s proposal of a person of ordinary skill in the art, with the following changes noted in italics below: A person with “an advanced degree, such as a Ph.D., in organic chemistry, molecular biology, biochemistry, or a related field; and about two years of experience in industry and/or laboratory experience relating to small molecules and proteins and would have been familiar with nucleic acid chemistry and conventional hybridization techniques; and (b) access to one or more team members having an advanced degree, such as a Ph.D., in organic chemistry, molecular biology, biochemistry, or a related field; and about two years of experience in industry and/or laboratory experience relating to high throughput screening techniques such as nucleic acid sequencing. A person could also have qualified as a POSA with less formal education and more technical or professional experience.11 We emphasize, however, that our decision would not change if we instead used Patent Owner’s proposed definition of a POSA.” slip op. at 13
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“Because the parties have placed the limitation “selecting all cis- reactive cells exhibiting the detectable trace” into controversy, we construe the term below, but only to the extent necessary to resolve the controversy. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those 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)). For the reasons discussed below, we agree with Patent Owner that the plain and ordinary meaning of this phrase, in light of the language of the claims, the Specification, and the prosecution history of record, requires “selecting all of the [molecular complexes or structures] meeting the defined criteria for [cis-reactive cells (CRCs)] and exhibiting the detectable trace.” Sur-reply 8 (citing Ex. 2008 ¶¶ 94, 98–119). We further agree that cis-reactive cells should be construed to mean “an association of at least two interactor moieties, joined by an associated oligonucleotide.” (PO Resp. 9 (quoting Ex. 1001, 9:35-37)). Accordingly, we determine that, properly construed, the claims require that what is “selected” at step 1(d) — what is differentiated or set apart from other molecular complexes or structures in the reaction mixture at the conclusion of step 1(d) — to be “an association of at least two interactor moieties joined by an associated oligonucleotide” that exhibits the detectable trace.” slip op. at 16
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“We agree that Petitioner has not shown that the combination of Kanan and Neri teaches “selecting all cis-reactive cells exhibiting the detectable trace,” as we have construed that phrase above. In particular, we determine that, properly construed, the limitation requires the selection of “all associations of at least two interactor moieties joined by an associated oligonucleotide and exhibiting the detectable trace.” Instead, as described in Kanan, what is “selected” is the molecules of interest joined by bond formation, with only one of the molecules of interest coupled to a nucleic acid moiety. Thus, the selected molecular complex or structure does not comprise two interactors (i.e., two molecules of interest coupled to NAMs). Moreover, to the extent there are two interactors, they are joined by the bond between the molecules of interest rather than an associated oligonucleotide.” slip op. at 35
- ExcludeMotion to exclude, deniedDenied
“III. PATENT OWNER’S MOTION TO EXCLUDE EVIDENCE Patent Owner moved to exclude Exhibit 1008, on the ground that it contains settlement statements and that Rule 408 of the Federal Rule of Evidence prohibits Petitioner from using the statements to impeach or contradict Patent Owner. Mot. 5. Because we do not rely in our analysis on this exhibit, we dismiss the Motion to Exclude as moot.” slip op. at 43
Patent outcomesUS 7,883,848 not shown unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 7,883,848 - Illumina Inc. v. Molecular Loop Innovations LLCNo claims unpatentablePTAB · Jan 13, 2026 · IPR2024-00964 · APJ Annette R Reimers · IPR · Final written decision
Claims 1–8 were not shown unpatentable over either asserted §103 combination because the prior art did not teach the discarding step or establish a reasonable expectation of success.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“specification to interpret the meaning of a claim and importing limitations from the specification into the claim can be a difficult one to apply in practice.” Phillips, 415 F.3d at 1323. “[T]he line between construing terms and importing limitations”, however, “can be discerned with reasonable certainty and predictability if [our] focus remains on understanding how a person of ordinary skill in the art would understand the claim terms.” Id. Ultimately, we construe claim terms to “capture the scope of the actual invention more accurately than either strictly limiting the scope of the claims to the embodiments disclosed in the specification or divorcing the claim language from the specification.” Id. at 1324. Here, we are tasked with resolving the dispute between the parties as to the scope of the source of the claimed cross-over error. See Sur-reply 2. Although claim 1 does not explicitly recite cross-over error is created during cluster amplification, the specification shows otherwise. It repeatedly, consistently, and exclusively describes cross-over errors as arising from the formation of chimeric molecules during the amplification step of the sequencing workflow. See Ex. 1001, Fig. 1, Fig. 2, 4:29–52 (describing “improper molecular overlap via formation of a heteroduplex between patient A’s nucleic acid template and patient B’s nucleic acid template” “[w]hen the amplification process begins”), 5:29–58 (the same), 6:25–44 (the same), 6:64–7:23 (the same).” slip op. at 15
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner asserts that a person of skill in the art (“POSA”) “would have had (i) a Ph.D. in molecular biology, genetics, bioinformatics, or a related field and at least two years of experience in high-throughput sequencing technologies or (ii) a Master’s degree in one of the same fields with at least four years of experience in high-throughput sequencing technologies.” Pet. 17 (citing Ex. 1003 ¶¶ 19–20). Patent Owner states that it adopts Petitioner’s proposal for a POSA for purposes of this proceeding. PO Resp. 13 (citing Ex. 2001 ¶¶ 19–22). We adopt Petitioner’s proposed definition of the skill level as it is consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention. We find both Dr. Spellman and Dr. Adalsteinsson are qualified to opine from the perspective of a POSA, because each has at least ordinary skill in the art. See Ex. 1003 ¶¶ 4–15; Ex. 2001 ¶¶ 4–9.” slip op. at 8
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableReasonable expectation not foundNot shown unpatentable
“The reasonable expectation of success requirement refers to the likelihood of success in combining references to meet the limitations of the claimed invention.” Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 9 Because, as explained below, we find Petitioner has not met its burden to show reasonable expectation of success, we do not need to address whether Petitioner has shown sufficient reason to combine the asserted references. 821 F.3d 1359, 1367 (Fed. Cir. 2016); see also Allergan, Inc. v. Apotex Inc., 754 F.3d 952, 966 (Fed. Cir. 2014) (stating that “failure to consider the appropriate scope of the . . . patent’s claimed invention in evaluating the reasonable expectation of success . . . constitutes a legal error”). Here, the claimed invention is a method for reducing template cross-over error. Thus, we must determine whether, in December 2010, an ordinarily skilled artisan would have reasonably expected that the combination of Parameswaran and Gloor would reduce template cross-over error. slip op. at 26
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“Thus, on this record, we are persuaded by Patent Owner’s argument that Parameswaran’s “unexpected perfect pairings of unmatched forward and reverse barcodes” are not cross-over error. PO Resp. 31 (citing Ex. 2001 ¶¶ 116–123). In addition, as Petitioner acknowledges, Parameswaran merely “distinguished,” but did not “discard” sequences with mismatches. Pet. 34. Parameswaran states that “[t]he low false-discovery rate for perfect matches strengthens the argument that any sequence with both 5’ and 3’ barcode motifs will be placed with reasonable accuracy into the correct bin.” Ex. 1004, 8. But, because Parameswaran achieved a “remarkably low misassignment rate,” it did not discard, but included any sequence with a matched barcode. Id. Indeed, Parameswaran explains that “[f]or our purposes, all sequences with a match to one of the two expected sequence motifs were considered as true members of the corresponding dataset.” Id. In its Reply, Petitioner emphasizes Parameswaran’s language “[f]or our purposes.” Reply 14 (citing Ex. 1004, 8). According to Petitioner, “[a] POSA would have understood from Parameswaran that chimeric sequences could be kept or discarded, depending on the sequencing ‘purpose.’” Id. (citing Ex. 1054 ¶¶ 79–82). Petitioner is asking us to deem unpatentable a claim based on its reading of “for our purposes,” a broad, undefined statement, to mean something specific—a suggestion to discard perfect unexpected pairings, which Parameswaran explicitly did not do. See Ex. 1004, 8. Petitioner has not presented sufficient evidence and persuasive argument for us to do so.” slip op. at 24
Patent outcomesUS 11,041,852 not shown unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,041,852 - Google LLC v. Eyesmatch Ltd.Some claims unpatentablePTAB · Nov 21, 2025 · IPR2025-00296 · APJ Neil T Powell · IPR · Final written decision
Claims 1–18 are unpatentable: claims 1–6 and 10–12 over Rosenberg and Park, and claims 3, 4, 7–9, and 11–18 over Rosenberg, Park, and Geisner.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“December 18, 2012, would have a bachelor’s degree in electrical or computer engineering, or a closely related field such as computer science, and two years of work experience with image capture and processing systems or related fields.” Pet. 7 (citing Karam Decl. ¶ 91). Petitioner adds that “[a] person with less and/or different education, but more relevant practical experience, or vice versa, may also meet this standard.” Id. According to Petitioner, [t]he prior art also evidences such level of skill.” Id. Patent Owner states that it “applies Petitioners’ proposed level of skill for purposes of this Response.” PO Resp. 9 (citing Forsyth Decl. ¶¶ 53–54). For this Decision, we adopt the formulation of the level of ordinary skill in the art proposed by Petitioner and applied by Patent Owner as consistent with the prior art before us in this proceeding.10” slip op. at 9
- Prior constructionPrior construction adoptedDecided for patent owner
“Turning to the substantive issues, we find the District Court’s “mirror tracking mode” construction to be well-reasoned and supported by the record, and we therefore adopt that construction and its reasoning. As the District Court points out, both the “double the distance” and “same size” aspects of its construction are expressly discussed in the ’109 patent, which is incorporated in the ’110 patent. See Ex. 2008, 16 (citing Ex. 1021, 2:5–27, Figs. 5A, 5B), 40 (citing “same reasons set forth regarding the term ‘it appears to mimic a reflection of a mirror’” in support of construction of “mirror tracking mode”). So, too, is “flipping” or reversing of the image disclosed. Id. at 17 (citing Ex. 1021, 14:46–51, 15:41–47), 40.” slip op. at 14
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“Post-institution, Patent Owner invites us to construe limitation 1[f]’s recitation of “mirror tracking mode” and limitation 1[c]’s recitation of “adaptive transformation mapping.” PO Resp. 9–14. Regarding the latter, Patent Owner explains that “[i]n the District Court Litigation, ‘adaptive transformation mapping’ was construed as ‘continuously variable transformation mapping’ and ‘transformation mapping’ was construed as a ‘selected set of image transformations.’” Id. at 14 (citing Ex. 2008, 14, 37; Ex. 2013 ¶¶ 25, 27). Patent Owner does not, however, identify any way that those claim constructions affect our analysis of the parties’ patentability disputes. We find it unnecessary in resolving the parties’ patentability disputes to construe expressly limitation 1[c]’s recitation of “adaptive transformation mapping.”” slip op. at 11
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“persuasively address limitation 1[f]’s “mirror tracking mode.” In particular, Petitioner does not address persuasively the requirement, as explained in Section II.B above, that mirror tracking mode involves processing camera-captured images in a way that “maintains roughly the same size regardless of the user movement.” At odds with this requirement, Petitioner founds its case on an assertion that “Haan teaches the claimed mirror tracking mode” because “if the viewer is within 35 cm of the camera, a tracking mode is entered, applying resizing transformation.” Pet. 44 (emphasis added) (citing Ex. 1005 ¶¶ 75–76, 80–82, 90–94, 97; Ex. 1003 ¶¶ 205–210). The resizing transformation Petitioner references actually involves magnifying the user’s image by an amount that changes based on the user’s position relative to the camera, quite the opposite of maintaining image size regardless of the user movement. Ex. 1005 ¶¶ 75–76, Fig. 8. Thus, Petitioner’s initial position is unpersuasive. Petitioner’s shift to Haan’s “reflective mirror mode and conventional mirror period in the dual mode” is also unavailing. Reply 8. Consistent with Patent Owner’s arguments, Petitioner does not provide persuasive evidence that these operating states of Haan’s device involve any processing of camera-captured images. Sur-reply 13–14. To the contrary, Haan suggests that anytime its device provides an unmagnified image, it comes from a reflection off a physical reflective surface. See, e.g., Ex.1005 ¶ 76 (“This can be done for instance by using the device as a simple mirror, i.e. not displaying an image on the display device, but using the device in the reflective mode.”) (emphasis added), ¶ 92 (“a simple reflective mode, to act as a mirror”), ¶ 29 (“for a first range of positions, no image is displayed, whereby the reflective layer acts as a mirror, and for a second range of positions, the recorded image is displayed.”) (emphasis added). We also find unpersuasive Petitioner’s Reply arguments based on Haan’s disclosure of smoothly transitioning from “using the device as a simple mirror” (i.e., using a physical reflecting surface) to displaying a magnified image. Reply 11 (citing Ex. 1005 ¶¶ 76, 80). To the extent this may establish a point around the transition at which Haan’s system displays an image with relatively little magnification, it does not establish that Haan teaches, suggests, or renders obvious holding the displayed size roughly constant, “regardless of the user movement.” Indeed, given Haan’s focus on helping the user see things more clearly with image magnification, Petitioner’s argument that it would have been obvious to hold the size of the image constant is not persuasive. See, e.g., Ex. 1005 ¶ 4.” slip op. at 23
Patent outcomesUS 8,982,110 mixedClaim construction§ 103 obviousnesscites PhillipsPatents in suitUS 8,982,110 - Samsung Electronics Co., Ltd. / Samsung Electronics America, Inc. et al. v. Eyesmatch Ltd.All claims unpatentablePTAB · Nov 21, 2025 · IPR2024-00810 · APJ Neil T Powell · IPR · Final written decision
Claims 1–18 are unpatentable: claims 1–6 and 10–12 over Rosenberg and Park, and claims 3, 4, 7–9, and 11–18 over Rosenberg, Park, and Geisner.
RulingsFinal written decision- Prior constructionPrior construction adoptedDecided for patent owner
“Turning to the substantive issues, we find the District Court’s “mirror tracking mode” construction to be well-reasoned and supported by the record, and we therefore adopt that construction and its reasoning. As the District Court points out, both the “double the distance” and “same size” aspects of its construction are expressly discussed in the ’109 patent, which is incorporated in the ’110 patent. See Ex. 2008, 16 (citing Ex. 1021, 2:5–27, Figs. 5A, 5B), 40 (citing “same reasons set forth regarding the term ‘it appears to mimic a reflection of a mirror’” in support of construction of “mirror tracking mode”). So, too, is “flipping” or reversing of the image disclosed. Id. at 17 (citing Ex. 1021, 14:46–51, 15:41–47), 40.” slip op. at 14
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“persuasively address limitation 1[f]’s “mirror tracking mode.” In particular, Petitioner does not address persuasively the requirement, as explained in Section II.B above, that mirror tracking mode involves processing camera-captured images in a way that “maintains roughly the same size regardless of the user movement.” At odds with this requirement, Petitioner founds its case on an assertion that “Haan teaches the claimed mirror tracking mode” because “if the viewer is within 35 cm of the camera, a tracking mode is entered, applying resizing transformation.” Pet. 44 (emphasis added) (citing Ex. 1005 ¶¶ 75–76, 80–82, 90–94, 97; Ex. 1003 ¶¶ 205–210). The resizing transformation Petitioner references actually involves magnifying the user’s image by an amount that changes based on the user’s position relative to the camera, quite the opposite of maintaining image size regardless of the user movement. Ex. 1005 ¶¶ 75–76, Fig. 8. Thus, Petitioner’s initial position is unpersuasive. Petitioner’s shift to Haan’s “reflective mirror mode and conventional mirror period in the dual mode” is also unavailing. Reply 8. Consistent with Patent Owner’s arguments, Petitioner does not provide persuasive evidence that these operating states of Haan’s device involve any processing of camera-captured images. Sur-reply 13–14. To the contrary, Haan suggests that anytime its device provides an unmagnified image, it comes from a reflection off a physical reflective surface. See, e.g., Ex.1005 ¶ 76 (“This can be done for instance by using the device as a simple mirror, i.e. not displaying an image on the display device, but using the device in the reflective mode.”) (emphasis added), ¶ 92 (“a simple reflective mode, to act as a mirror”), ¶ 29 (“for a first range of positions, no image is displayed, whereby the reflective layer acts as a mirror, and for a second range of positions, the recorded image is displayed.”) (emphasis added). We also find unpersuasive Petitioner’s Reply arguments based on Haan’s disclosure of smoothly transitioning from “using the device as a simple mirror” (i.e., using a physical reflecting surface) to displaying a magnified image. Reply 11 (citing Ex. 1005 ¶¶ 76, 80). To the extent this may establish a point around the transition at which Haan’s system displays an image with relatively little magnification, it does not establish that Haan teaches, suggests, or renders obvious holding the displayed size roughly constant, “regardless of the user movement.” Indeed, given Haan’s focus on helping the user see things more clearly with image magnification, Petitioner’s argument that it would have been obvious to hold the size of the image constant is not persuasive. See, e.g., Ex. 1005 ¶ 4. Thus, on the whole, Petitioner’s shifting, scattered arguments do not persuasively address limitation 1[f]. Accordingly, Petitioner has not shown by a preponderance of the evidence that claim 1 would have been obvious over Haan and Francois. And Petitioner’s arguments and evidence addressing claims 2–6, 10–12, 16, and 17 do not cure the foregoing deficiencies in the challenge of claim 1. Pet. 46–52. Accordingly, Petitioner has not shown by a preponderance of the evidence that any of claims 1–6, 10–12, 16, and 17 would have been obvious over Haan and Francois.” slip op. at 23
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner
“We do not agree. Petitioner demonstrates persuasively that a person of ordinary skill would have combined these references “to correct image distortions and provide a more realistic mirror image.” Pet. 52–55; Ex. 1003 ¶¶ 242–249. We are not persuaded by Patent Owner that by specifically disclosing “flipping” the image, Rosenberg is discouraging or teaching away from performing other transformations to achieve its objective of “replicat[ing] the performance of a standard household mirror.” See PO Resp. 35, 38–39 (Patent Owner asserting lack of motivation to combine the references). A reference may be said to “teach away” “when a person of ordinary skill, upon reading the reference, would be discouraged from following the path set out in the reference, or would be led in a direction divergent from the path that was taken by the applicant.” Galderma Lab'ys, L.P. v. Tolmar, Inc., 737 F.3d 731, 738 (Fed. Cir. 2013) (quoting DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1327 (Fed.Cir.2009)). “A reference does not teach away, however, if it merely expresses a general preference for an alternative invention but does not criticize, discredit, or otherwise discourage investigation into the invention claimed.” Id. Further, when conducting an obviousness analysis, the Board must consider a prior art reference “not only for what it expressly teaches, but also for what it fairly suggests.” Bradium Techs. LLC v. Iancu, 923 F.3d 1032, 1049 (Fed. Cir. 2019) (quoting In re Baird, 16 F.3d 380, 383 (Fed. Cir. 1994)). We are not convinced that the references before us “teach away” from performing the other transformations. In sum, we find for the reasons given that Petitioner has demonstrated by a preponderance of evidence that to a person of ordinary skill, Rosenberg alone or with Park teaches or suggests limitation 1[f].” slip op. at 44
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
“shows by a preponderance of the evidence that limitations 1[c] and 1[e] are taught or suggested by Rosenberg and Park, in combination. Pet. 58–64; PO Resp. 39–40; Reply 19–20; Sur-reply 19. Petitioner persuades us that limitations 1[c] and 1[e], would have been obvious over Rosenberg and Park, in combination. Pet. 58–64; Reply 19–20. Patent Owner’s counter arguments are unavailing for multiple reasons. Patent Owner’s arguments fail because they improperly attack Rosenberg’s teachings individually, rather than addressing Petitioner’s combination of the references. PO Resp. 39–40; Sur-reply 19. This is fatal to Patent Owner’s arguments. In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986). Moreover, Petitioner presents persuasive arguments and evidence that the references, in combination, teach limitations 1[c] and 1[e], including persuasive evidence that the references’ tilting, resizing, and zooming meet the claim limitations’ “adaptive transformation mapping . . . to generate modified images that appear to be captured from a different point of view” that “corresponds to an image taken from a different angle and a different distance.” Pet. 58–64 (citing Ex. 1001, 3:26–28; Ex. 1003 ¶¶ 65–67, 253–268; Ex. 1006 ¶¶ 26–28, 50, 52, 61, 75 ; Ex. 1011 ¶¶ 50–51, 59, Figs. 6A–6B, 7, 8, 14, 15; Ex. 1019, 16–20; Ex. 1021, 2:19–27, 17:19–24, 21:60, 23:65–24:9, 25:46–48, 30:4–11, Fig. 11); Reply 19–20 (citing Ex. 1003 ¶¶ 253–268; Ex. 1021, 17:17–23; Ex. 2012, 63:13–22, 111:13–21). Regarding tilting, after noting the ’110 patent’s disclosure (incorporated from the ’109 patent) of performing tilt transformations (Pet. 10–11), Petitioner advances persuasive evidence that Park discloses such a tilting transformation, thereby teaching the claimed “different angle” (id. at 61–63). Regarding resizing and zooming, citing extensive discussion in the ’110 patent (incorporated from the ’109 patent) of resizing and/or zooming to address the effects of varying distance between an object and a camera, Petitioner and Dr. Karam explain that the prior art’s zooming and resizing meet the claimed “different distance.” Pet. 63 (Ex. 1001, 3:26–28; Ex. 1021, 17:19–23, 21:57–60, 23:65–24:9, 25:46–48, 30:4–11, Fig. 11); Ex. 1003 ¶ 265 (citing Ex. 1001, 3:26–28; Ex. 1021, 17:19–23, 21:57–60, 23:65–24:9, 25:46–48, 30:4–11, Fig. 11). In its counterarguments, Patent Owner suggests that zooming and resizing do not account for “occlusion effects,” but Patent Owner does not persuasively tie this argument to the ’110 patent, failing to cite any portion of the ’110 patent that evinces its invention addresses such effects. PO Resp. 23–25, 39–40.” slip op. at 39
Patent outcomesUS 8,982,110 unpatentableClaim construction§ 103 obviousnesscites PhillipsPatents in suitUS 8,982,110
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.