- 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 - Platform Science, Inc. v. Omnitracs, LLCNo claims unpatentablePTAB · Aug 29, 2022 · IPR2020-01612 · APJ Bart A Gerstenblith · IPR · Final written decision
Claims 1–4, 6–9, 11, 12, and 15 were not shown unpatentable because Coffee did not disclose the claimed copying, and Coffee combined with Heijden did not cure that deficiency.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for patent owner
“In our Initial and Rehearing Decisions, we noted that Patent Owner did not contest Petitioner’s proffered level of ordinary skill in the art at that stage of the proceeding and we found “Petitioner’s proposal consistent with the level of ordinary skill in the art reflected by the ’308 patent and the prior art of record.” Initial Dec. 13 (citing Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995); In re Oelrich, 579 F.2d 86, 91 (CCPA 1978)); Rehearing Dec. 16 (same). Therefore, we adopted Petitioner’s unopposed position as to the level of ordinary skill in the art. Initial Dec. 13; Rehearing Dec. 16. In its Patent Owner Response, Patent Owner states that “[f]or purposes of this proceeding, Patent Owner does not dispute Petitioner’s offered level of ordinary skill in the art.” PO Resp. 7. Accordingly, we maintain our preliminary finding by adopting Petitioner’s proposed level of ordinary skill in the art, as set forth above.” slip op. at 13
- Expert testimonyPetitioner expert discountedDecided for patent owner
“received message 7102 and the header of the response message 7202 are not the same. PO Resp. 25 (citations omitted); Pet. Reply 14. In the Petition, Petitioner argued that “header information” was the same in each message (received and response). Pet. 32 (citations omitted), 36–37. Petitioner relies on Tables 58 and 63, which show “Header.” Id. at 32–33, 37. Petitioner also relies on paragraphs 102 and 118 of Mr. Andrews’s Declaration. Neither the Petition nor Mr. Andrews’s Declaration, however, provide any sufficient basis to find that even a portion of the header or header information is copied from the received message to the response message. Mr. Andrews states his opinion as though it were fact without providing the underlying factual support for his opinion. See Ex. 1003 ¶¶ 102, 118; see 37 C.F.R. § 42.65(a) (“Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.”). In cross-examination, Mr. Andrews provided additional information explaining which portion of the headers he believes are the same, but he still does not provide any explanation as to why he believes the information is copied. See, e.g., Ex. 2007 at 111:3–25. The same is true of Petitioner’s Reply, which reiterates Mr. Andrews’s deposition testimony, but still fails to provide any reason as to why Coffee’s charts or Mr. Andrews’ testimony necessarily means that Coffee copies a portion of the header from the received message to the response message. See Continental Can Co. U.S.A., Inc. v. Monsanto Co., 948 F.2d 1264, 1269 (Fed. Cir. 1991) (“Inherency . . . may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient.”). And, despite Petitioner’s identification of a “Header” listed in Tables 58 and 63, Coffee does not expressly describe the header or part of the header as being copied from the received message to the response message. The Petition and Mr. Andrews also state that “if Coffee did not employ such copying, the response message would not automatically include information extracted from the received message.” Pet. 38 (citing Ex. 1003 ¶ 118). But, Coffee does not expressly describe the header as being “extracted from the received message” or describe automatically including the header in a response message to make the leap argued by Petitioner and Mr. Andrews. Accordingly, on the full record before us, we find that Petitioner has not established that Coffee explicitly or inherently discloses copying the header or header information and we do not credit Mr. Andrews’ testimony, discussed above, because he fails to provide the underlying factual basis for the opinions offered.” slip op. at 43
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“proceeding and on the full record before us, we do not find that Coffee’s silence is sufficient to support Petitioner’s argument. See Campbell Soup Co. v. Gamon Plus, Inc., 787 Fed. Appx. 731, 739 (Fed. Cir. 2019) (“We do not find any error in the Board changing its understanding of the teachings of [a prior art reference] from the institution decision to the final written decision. ‘The Board is not bound by any findings made in its Institution Decision. At that point, the Board is considering the matter preliminarily without the benefit of a full record. The Board is free to change its view of the merits after further development of the record, and should do so if convinced that its inclinations were wrong.’” (quoting Trivascular, Inc. v. Samuels, 812 F.3d 1056, 1068 (Fed. Cir. 2016))). Coffee does not explain the process by which the IOD of the received message is included in the response message; rather, Coffee just states that the response message “contains the IOD of the message being answered.” See, e.g., Ex. 1005, 56:63–67 (see full text quoted above). In particular, although Coffee attributes certain actions to the operator, the lack of attribution to the operator does not necessitate that the only viable possibility remaining is that Coffee copies the IOD from the received message to the response message. Even if it may be said that Coffee probably (or possibly) copies the IOD, that probability is not sufficient to find that Coffee necessarily copies the IOD. See Continental Can, 948 F.2d at 1269 (“Inherency . . . may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient.”).7 Additionally, on the full record before us, we determine that Mr. Andrews’s testimony, as with his testimony as to copying of the header and selected response, fails to provide any factual or underlying support for his opinions expressed therein. See Ex. 1003 ¶¶ 100–102. In particular, the leap occurs in paragraph 102, where Mr. Andrews takes the fact that some information (at least the IOD) from the received formatted message is included with the response message to opine that this means the information is “copied over.” Id. ¶ 102. But, again, Coffee is silent. And because Mr. Andrews did not provide any underlying factual basis for his opinion, we do not credit his testimony as to copying the IOD. 37 C.F.R. § 42.65(a) (“Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.”).” slip op. at 48
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable
“generally, including the alleged benefits of such and reasons why one of ordinary skill in the art would have been prompted to include field-mapping information in Coffee’s MDT. See id. at 62–70. None of Petitioner’s discussion, however, explains how the combination of Coffee and Heijden remedies the deficiencies that we identified regarding Petitioner’s challenge based on Coffee. In particular, Petitioner does not assert or explain how the teachings of Heijden would be applied to Coffee such that Coffee would then copy or fill in the specific information from Coffee’s received message to Coffee’s response message, particularly as pertains to the header, Response, and IOD fields (which Petitioner relied on in the first ground), or any other information field from Coffee. The same is true of Mr. Andrews’s testimony. See Ex. 1003 ¶¶ 214–231. Additionally, it appears that Petitioner’s analysis of the combination of Heijden and Coffee maintains the position that Coffee copies information fields. See Pet. 70 (“Given that Coffee’s system already implements field mapping to copy information fields . . . .”). And, Mr. Andrews’s testimony similarly maintains that Coffee copies information fields. See Ex. 1003 ¶ 229 (“Coffee also discloses (at least inherently) field mapping by describing that data is copied from fields in request messages into corresponding fields in response message.”). But, as we explain in detail in the context of Petitioner’s challenge based on Coffee, Petitioner has not shown sufficiently that Coffee copies or fills in information from a received message to a response message. Thus, we do not find and Petitioner does not allege that Ground “1B” fills the gaps identified in Petitioner’s Ground “1A.”10 Accordingly, we determine that Petitioner has not established, by a preponderance of the evidence, that the combination of Coffee and Heijden would have rendered the subject matter of claims 1–4, 7–9, and 12 unpatentable.” slip op. at 60
Patent outcomesUS 6,925,308 not shown unpatentable§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 6,925,308 - Thorne Research, Inc v. Trustees Of Dartmouth CollegeNo claims unpatentablePTAB · Aug 10, 2022 · IPR2021-00491 · APJ John E Schneider · IPR · Final written decision
Claims 1–3 were not shown unpatentable because the relied-upon portions of the Cell Article and PCT Publication were not shown to be the work of another and thus were not prior art.
RulingsFinal written decision- BurdenDecided for patent owner
“Having considered the evidence submitted by Patent Owner, we find Patent Owner has satisfied its burden of production to show the Cell Article is not prior art. We find the testimony of Dr. Brenner—as corroborated by the testimony and disclaimer of Dr. Bieganowski—to be persuasive evidence that the relied-upon portions of the Cell Article represent the work of Dr. Brenner alone. See In re Mathews, 408 F.2d 1393, 1396 (CCPA 1969) (finding applicant’s declaration and prior art inventor’s disclaimer sufficient to overcome a § 102(e) rejection).” slip op. at 19
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedDecided for patent owner
“Under § 120, a patent is entitled to the priority date of an earlier filed application if (1) the written description of the earlier filed application discloses the invention claimed in the later filed application sufficient to satisfy the requirements of § 112; (2) the applications have at least one common inventor; (3) the later application is filed before the issuance or abandonment of the earlier filed application; and (4) the later application contains a reference to the earlier filed application. In re NTP, Inc., 654 F.3d 1268, 1277 (Fed. Cir. 2011); see also 35 U.S.C. § 120 (2018). As discussed above, the ’807 patent meets all four criteria set forth above for each application in the priority chain of the PCT application listed on the face of the ’807 patent. Since the claim of priority arises under Section 120, the provisions of the Paris Convention and PCT do not apply.” slip op. at 12
- Novelty / Anticipation (§102) › Prior-art status of a reference › Applicant-admitted prior artReference not prior artNot shown unpatentable
“Having considered the evidence submitted by Patent Owner, we find Patent Owner has satisfied its burden of production to show the Cell Article is not prior art. We find the testimony of Dr. Brenner—as corroborated by the testimony and disclaimer of Dr. Bieganowski—to be persuasive evidence that the relied-upon portions of the Cell Article represent the work of Dr. Brenner alone. See In re Mathews, 408 F.2d 1393, 1396 (CCPA 1969) (finding applicant’s declaration and prior art inventor’s disclaimer sufficient to overcome a § 102(e) rejection).” slip op. at 19
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“We are not persuaded by Petitioner’s arguments. Although the laboratory techniques and starting materials used by Drs. Brenner and Bieganowski may have been known in the art, that is not the claimed invention. The invention as recited in claim 1 is directed a composition comprising isolated NR combined with one or more of tryptophan, nicotinic acid, or nicotinamide and one of the recited carriers, wherein the composition is formulated for oral administration and increases NAD+ biosynthesis upon oral administration. See Ex. 1001, col. 53. That the certain individual elements of the claimed composition may have been known elsewhere in the prior art does not lead to a conclusion that the relied-upon portions of the Cell Article are “by another.”” slip op. at 30
Patent outcomesUS 8,197,807 not shown unpatentable§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 8,197,807 - Laboratoire Francais Du Fractionnement Et Des Biotechnologies S.A. v. Novo Nordisk Healthcare AGNo claims unpatentablePTAB · Apr 13, 2022 · IPR2017-00028 · APJ Susan L C Mitchell · IPR · Final written decision
Claims 1–15 were not shown unpatentable under the remaining Tolo anticipation and Eibl ’023 combination grounds; Patent Owner’s motion to exclude was granted in part.
RulingsFinal written decision- ExcludeMotion to exclude, grantedMotion to exclude, deniedGranted in part
“We agree that a motion to exclude is not the appropriate vehicle for consideration of whether a party has improperly raised new arguments. Our Trial Practice Guide delineates between a motion to exclude and a motion to strike, indicating that a motion to strike is the preferred mechanism “[i]f a party believes that a brief filed by the opposing party raises new issues, is accompanied by belatedly presented evidence, or otherwise exceeds the proper scope of reply or sur-reply . . . .” See Trial Practice Guide Update 17 (Aug. 2018); Patent Trial and Appeal Board Consolidated Trial Practice Guide 80 (Nov. 2019).10 Although a motion to exclude is pre-authorized in the Scheduling Order, see Paper 64, 4 (Supplemental Scheduling Order), a motion to strike is not, and Patent Owner did not request prior authorization to file its motion to strike. Petitioner did, however, have an opportunity to respond and did so respond to Patent Owner’s contentions that the allegedly new evidence and argument exceeded the proper scope of a reply. See Paper 87, 3–8. Therefore, we find that Petitioner had an appropriate opportunity, of which it took advantage, to respond to Patent Owner’s arguments regarding the alleged new arguments and evidence. Accordingly, we determine that Petitioner is not prejudiced by our consideration of Patent Owner’s motion to exclude as, in effect, a motion to strike.” slip op. at 11
- Skill levelSkill level board ownDecided for patent owner
“Owner’s proposed levels of skill in the art to be somewhat deficient. Paper 53, 8. We found that Petitioner’s proposed skill level does not address the specific problems concerning the nanofiltration of FVIIa that is the subject of the ’762 patent at issue in this proceeding. Id. We also found, however, that we were unaware of any basis in the record for Patent Owner’s contention that the hypothetical skilled artisan must be a “team” of scientists and engineers with two different areas of “expertise.” Id. Nonetheless, based on our consideration of the record, we found that the skilled artisan would need skills and knowledge with respect to both the biochemistry of coagulation factors (particularly FVII/FVIIa) and separation/purification/processing techniques used in the biotechnology industry for such proteins (particularly nanofiltration). Id. We agreed with both Petitioner and Patent Owner that such skills and knowledge may be obtained through some combination of education and industry/laboratory experience, wherein a skilled artisan with a doctorate degree (Ph.D.) could have fewer years of experience than required for a skilled artisan with a Master’s or Bachelor’s degree. Id. In general, we found that the “ordinary skill” level of a scientist or engineer in this art is relatively high. Id. As explained by Dr. Chtourou, “[e]xtensive academic training and laboratory experience are necessary for producing recombinant coagulation proteins and removing viruses from compositions of such proteins.” Id. at 8–9 (citing Ex. 1010 ¶ 27). We further took into account that this level of skill is also reflected in the prior art of record, see Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001), and we found that the parties’ declarants in this proceeding meet the requirements for this skill level. Id. at 8–9. The parties have not challenged these findings and we see no reason to depart from them for our analysis in this Decision.” slip op. at 22
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“As we stated in our Final Written Decision, Petitioner offered constructions for the following claim terms: “cell culture supernatant” and “Factor VII polypeptides.” See Paper 53, 9 (citing Pet. 10–15). We noted that Patent Owner did not disagree with Petitioner’s proposed construction for “cell culture supernatant,” and asserts that “Factor VII [poly]peptide[]” is expressly defined in the Specification of the ’762 patent. PO Resp. 6; see also Paper 67, 4. We previously found that no explicit construction of any claim term was necessary to resolve the issues in this case. No new claim construction issues have been raised in this proceeding, and we again find no explicit construction of any claim term is necessary in this proceeding. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 24
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“First, we begin with the unassailable fact that Tolo does not disclose expressly or inherently any particular concentration of FVII. See Ex. 1006, 7:25–34 (only mention of Factor VII in Tolo with no express statement concerning a concentration for FVII). In fact, we found in our Final Written Decision that: The record in this proceeding does not show persuasively that the skilled artisan would have reasonably expected that the same concentration disclosed in Example 3 of Tolo for IFN-α (0.04 mg/mL) could be successfully used for the nanofiltration of FVIIa. To the contrary, the evidence shows that IFN-α and FVIIa differ significantly in many respects, including molecular weight, size, and structure, such that the skilled [artisan] would not have necessarily considered them interchangeable in a nanofiltration process. Paper 53, 38 (citations omitted).” slip op. at 34
Patent outcomesUS 9,102,762 not shown unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites GrahamPatents in suitUS 9,102,762 - Intel Corporation v. Parkervision, Inc.No claims unpatentablePTAB · Jan 21, 2022 · IPR2020-01302 · APJ Bart A Gerstenblith · IPR · Final written decision
Claims 1, 3, 4, 7, and 9–11 were not determined unpatentable because the asserted Larson and Larson–Butler grounds did not teach sampling.
RulingsFinal written decision- Skill levelSkill level board ownOther
“Neither party contends that the differences in proposals affect the outcome of this proceeding and we do not find that they do. Nonetheless, on the full record before us, we find that our identification of the level of ordinary skill in art from the Institution Decision as well as Patent Owner’s option (b) are supported by the prior art of record, the ’474 patent, and the opinions of Drs. Subramanian and Steer (which, as discussed above, recognize that additional work experience can compensate for the lack of a formal degree). Accordingly, we modify our preliminary finding to include the specifics from option (b) of Patent Owner’s proposal. Thus, we find that one of ordinary skill in the art would have at least a bachelor’s degree in electrical engineering or a related subject and two or more years of experience in the field of RF circuit design, or at least five years of work experience and training in the design and development of RF circuits and/or systems. We also find that less work experience may be compensated by a higher level of education, such as a master’s degree.” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Because the parties agree that the claims remaining in the trial require “sampling” and also agree that the prior art asserted in this case does not teach “sampling” (as discussed further below), we need not construe these terms expressly to resolve the controversy before us. See Vivid Techs., 200 F.3d at 803. sampling Although claim 1 does not recite “sampling” expressly, the post- institution briefs make clear that the parties agree that claim 1 and its dependent claims require sampling. In particular, Patent Owner contends, (1) “the ’474 patent pertains to a technique called sampling, which involves the use of a ‘switch’” (PO Resp. 2); (2) “all of the challenged claims are directed to a sampling system and, in particular, an energy sampling system (also known as an energy transfer system)” (id.); and (3) “[t]he challenged claims only cover energy sampling and the use of switches” (id. at 20). In its Reply, although Petitioner disagrees with Patent Owner’s interpretation of the claims as limited to energy sampling (i.e., energy transfer systems) (Pet. Reply 3–7), Petitioner contends that based on its “subsequent analysis of [Patent Owner’s] foundational ’551 patent—one of the multiple patents which the ’474 patent incorporates by reference—[Petitioner] now agrees with [Patent Owner] that the claims cover only systems that down-convert by sampling.” Pet. Reply 2. Thus, at a minimum, the parties agree that the claims at issue in this proceeding require sampling.” slip op. at 13
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“Discussion As discussed above, the parties now agree that (1) the claims at issue in this proceeding require “sampling” and (2) Larson alone or in combination with Butler do not disclose “sampling” and do not otherwise render the claims unpatentable. See Pet. Reply 2 (stating Petitioner agrees that “the claims cover only systems that down-convert by sampling”), 13 (stating that Larson and Butler do not disclose “down-conversion by sampling” and therefore agreeing that “Larson and Butler do not invalidate those claims”); see Ex. 2031, 6:20–22 (Patent Owner explaining, that “as the Board is aware, both parties agree that sampling is in the claims, and the claims are not invalid in view of all the cited prior art” (capitalization altered)). As such, based on Petitioner’s explicit admissions, Petitioner has not established by a preponderance of the evidence that (1) Larson anticipates claims 1, 3, 4, and 9–11 or (2) the combination of Larson and Butler would have rendered the subject matter of claims 1, 3, 4, 7, and 9–11 obvious to one of ordinary skill in the art at the time of the invention.” slip op. at 19
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableNot shown unpatentable
“Discussion As discussed above, the parties now agree that (1) the claims at issue in this proceeding require “sampling” and (2) Larson alone or in combination with Butler do not disclose “sampling” and do not otherwise render the claims unpatentable. See Pet. Reply 2 (stating Petitioner agrees that “the claims cover only systems that down-convert by sampling”), 13 (stating that Larson and Butler do not disclose “down-conversion by sampling” and therefore agreeing that “Larson and Butler do not invalidate those claims”); see Ex. 2031, 6:20–22 (Patent Owner explaining, that “as the Board is aware, both parties agree that sampling is in the claims, and the claims are not invalid in view of all the cited prior art” (capitalization altered)). As such, based on Petitioner’s explicit admissions, Petitioner has not established by a preponderance of the evidence that (1) Larson anticipates claims 1, 3, 4, and 9–11 or (2) the combination of Larson and Butler would have rendered the subject matter of claims 1, 3, 4, 7, and 9–11 obvious to one of ordinary skill in the art at the time of the invention.” slip op. at 19
Patent outcomesUS 7,539,474 not shown unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 7,539,474 - Pacific Biosciences Of California, Inc. v. Personal Genomics Taiwan, Inc.No claims unpatentablePTAB · Jan 18, 2022 · IPR2020-01200 · APJ Susan L C Mitchell · IPR · Final written decision
Petitioner failed to show claims 1, 2, 6, 7, 10–22, 24, and 27–36 unpatentable because the asserted references did not teach an apparatus capable of identifying a single biomolecule.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“We find Petitioner has the better argument. The claims at issue in this inter partes review involve a molecular sensor, its components, or a method of using or manufacturing the sensor. See Ex. 1001, 26:11–37, 27:64–30:6. An in-depth understanding of molecular sequencing would not be required to understand these claims, the ’441 patent, the prior art asserted against these claims, or the problems solved by the claimed apparatus and methods. Therefore, we will continue to apply Petitioner’s definition of one of skill in the art as set forth above. Moreover, even under Patent Owner’s proposal for the level of ordinary skill, we find that Dr. Neikirk is qualified to offer the opinions in his declaration. “There is . . . no requirement of a perfect match between the expert’s experience and the relevant field” and one need “not be a person of ordinary skill in the art in order to testify as an expert under Rule 702” so long as they are “qualified in the pertinent art.” PTAB Consolidated Trial Practice Guide (Nov. 2019) 34 (citing precedent). Here, the record demonstrates that Dr. Neikirk is qualified in the art of molecular sensors. See Ex. 1003 ¶¶ 4–20; Ex. 1004 (describing Dr. Neikirk’s technical background and expert qualifications). Therefore even if one of ordinary skill would have had experience in molecular sequencing, as Patent Owner proposes, it does not follow that all of the testimony in Dr. Neikirk’s declarations should be accorded “little or no weight.”” slip op. at 11
- Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner
“We find persuasive Dr. Harris’ analysis of Hassibi’s teachings set forth above describing BRC analysis and its sensitivity capability. Petitioner did not file a rebuttal declaration from Dr. Neikirk addressing Dr. Harris’ testimony here. We credit Dr. Harris’ testimony over Dr. Neikirk’s testimony that, as explained below, does not address the complete disclosure of Hassibi.” slip op. at 35
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“Here, we find that the preamble reciting “a single biomolecule” for claim 1 provides antecedent basis for the claim term “the biomolecule” that is affixed to a linker site and recited in the body of claim 1. See Ex. 1001, 26:11–18. Claims must also be read in view of the specification of which they are an integral part. See Phillips, 415 F.3d at 1315. The Specification of the ’441 patent, like the language of the preamble itself, repeatedly refers to the detection apparatus as identifying a “single” biomolecule. See, e.g., Ex. 1001, 1:67–2:6 (stating devices should be capable of sequencing single molecules), 2:16–17 (stating each sequencing reaction uses a single molecule as the template), 3:55–4:16 (stating each optical detection apparatus 20 may be operated independently to detect and identify a single biomolecule, and by integrating a huge number of optical detection apparatuses 20 on substrate 10, a huge number of single biomolecules can be detected and identified in parallel). Accordingly, both the claim language and the Specification support Patent Owner’s position that the preamble is limiting. We find Petitioner’s argument that the preamble is not limiting and that one can “identify” a single molecule from a signal from multiple copies of the same molecule is inapposite when the challenged claims are read in light of the Specification of the ’441 patent. See Reply 2–4. Although such a method for identification of a molecule exists and, as Petitioner identifies, is done by the Illumina sequencing platform, that is not what is described in the Specification of the ’441 patent and the claims at issue here. See Phillips, 415 F.3d at 1317 (“However, while extrinsic evidence ‘can shed useful light on the relevant art,’ we have explained that it is ‘less significant than the intrinsic record in determining “the legally operative meaning of claim language.”’”) (quoting C.R. Bard, Inc. v. U.S. Surgical Corp., 388 F.3d 858, 862 (Fed. Cir. 2004)). The Specification of the ’441 patent describes a bioassay system in which a very large number of the apparatuses described and claimed in the ’441 patent, in some embodiments over 10,000, are used in parallel “to determine, for example, the sequence of a genome or the profile of expressed genes in a tissue sample with high throughput.” Ex. 1001, 3:58– 65. In such a bioassay system, the Specification indicates that “[e]ach optical detection apparatus may sense the existence of a fluorophore on the single molecule by detecting photons emitted from the fluorophore.” Id. at 3:60–61 (emphasis added). The Specification of the ’441 patent contemplates running myriad optical detection apparatuses in parallel to detect a single or individual biomolecule in each such apparatus. The fact that other “Sequencing Modalities” are mentioned that may be used with the claimed apparatus of the ’441 patent, and which involve the detection of signal from multiple molecules of the same species, does not undercut this fulsome description of what is disclosed in the ’441 patent. See Reply 6–8.” slip op. at 17
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“Accordingly, we determine that the preamble of claim 1 is limiting, requires an apparatus capable of identifying a single biomolecule, and provides antecedent basis for “the biomolecule” as used in the body of the independent claims, which should be read as “the single biomolecule” introduced in the preamble.” slip op. at 21
Patent outcomesUS 7,767,441 not shown unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSRPatents in suitUS 7,767,441 - Eis GmbH v. Novoluto GmbHNo claims unpatentablePTAB · Sep 23, 2021 · IPR2020-00007 · APJ Susan L C Mitchell · IPR · Final written decision
Claims 1–3, 5, 7, 8, 11, 14, 15, and 17–26 were not shown unpatentable under the Taylor anticipation or Taylor-based obviousness grounds.
RulingsFinal written decision- Expert testimonyPatent owner expert creditedDenied
“disclosure of a suction cup “sealingly” receiving the vulva occurs when the vacuum is applied, not before. See Ex. 2034 ¶ 121. We disagree with Petitioner’s conclusion that “Taylor discloses that arm 26 ‘compresses . . . and then expands bellows 160’ after member 156 ‘sealingly’ engages the vulva.” Reply 9. The single statement in Taylor on which Petitioner relies states, with reference to Figure 3 set forth above in Section II.D.1, “[t]he first stimulator 154 includes a suction cup member 156 that conformingly and sealingly receives the upper portion of the vulva.” Ex. 1004, 5:29–31. We agree with Dr. Jensen that this does not support Petitioner’s conclusion that a seal is achieved before the vacuum is applied, and credit Dr. Jensen’s testimony that reads as follows as consistent with Taylor’s disclosure.” slip op. at 35
- ExcludeMotion to exclude, deniedDenied
“5. Conclusion For the reasons set forth above, we deny the portion of Petitioner’s” slip op. at 73
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“7 Petitioner presents argument that the term “pressure field generator” should be construed as a means-plus-function term limited to the following structure: at least one first chamber, at least one second chamber, and at least one connection element. Reply 25–26. As we find that it is not necessary to construe this term to resolve the issues before us, we do not address these arguments presented by Petitioner.” slip op. at 17
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“disclosure of a suction cup “sealingly” receiving the vulva occurs when the vacuum is applied, not before. See Ex. 2034 ¶ 121. We disagree with Petitioner’s conclusion that “Taylor discloses that arm 26 ‘compresses . . . and then expands bellows 160’ after member 156 ‘sealingly’ engages the vulva.” Reply 9. The single statement in Taylor on which Petitioner relies states, with reference to Figure 3 set forth above in Section II.D.1, “[t]he first stimulator 154 includes a suction cup member 156 that conformingly and sealingly receives the upper portion of the vulva.” Ex. 1004, 5:29–31. We agree with Dr. Jensen that this does not support Petitioner’s conclusion that a seal is achieved before the vacuum is applied, and credit Dr. Jensen’s testimony that reads as follows as consistent with Taylor’s disclosure.” slip op. at 35
Patent outcomesUS 9,849,061 not shown unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,849,061 - Baker Hughes Oilfield Operations, Inc. v. Smith International, Inc.No claims unpatentablePTAB · Feb 2, 2018 · IPR2016-01452 · APJ James A Tartal · IPR · Final written decision
Claims 22, 27, 46–52, 54, and 55 were not shown unpatentable over Myers, Myers and Bostock, or Anderson because the references did not disclose the claimed fluid-flow limitations.
RulingsFinal written decision- Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner
“to determine whether it further supports the contention that Myers discloses the “flowing a fluid” step. Mr. Shale’s declaration discusses the operation of Myers in a manner that is virtually identical in substance to the content of the Petition. Compare Ex. 1010 ¶¶ 49–53, with Pet. 21–24. Mr. Shale does not address directly the “flowing a fluid” step or otherwise explain how Myers discloses “flowing a fluid though an axial flowbore extending through the downhole tool.”7 Accordingly, we find Mr. Shale’s declaration fails to provide persuasive support for Petitioner’s contention that Myers discloses “flowing a fluid though an axial flowbore extending through the downhole tool while preventing the fluid from communicating with a different flowpath of the downhole tool,” as required by claim 22, beyond what Myers, itself, discloses.” slip op. at 17
- BurdenNot shown unpatentable
“Ex. 1021, 75:25 – 76:7. Mr. Underwood’s testimony does not support Petitioner’s contention that Myers discloses the “flowing a fluid” step. Mr. Underwood was asked whether there is “a fluid flowing within the Myers tool,” not whether Myers discloses “flowing a fluid though an axial flowbore extending through the downhole tool,” as required by claim 22. Id. Moreover, Mr. Underwood testified that “fluid doesn’t flow through the tool,” but rather just flows “into the tool.” Id. (emphases added)” slip op. at 20
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“claims 22, 27, 46, 47, 50–52, 54, and 55 of the ’099 patent. Inst. Dec. 22; see also Pet. 21–29. Anticipation under 35 U.S.C. § 102 requires “the presence in a single prior art disclosure of all elements of a claimed invention arranged as in the claim.” Therasense, Inc. v. Becton, Dickinson & Co., 593 F.3d 1325, 1332 (Fed. Cir. 2010). Specifically, “[f]or a claim to be anticipated, each claim element must be disclosed, either expressly or inherently, in a single prior art reference, and the claimed arrangement or combination of those elements must also be disclosed, either expressly or inherently, in that same prior art reference.” Id. at 1332–33. Inherent disclosure is established where the reference “must necessarily include the unstated limitation.” Id. (emphasis omitted); see Cont’l Can Co. USA v. Monsanto Co., 948 F.2d 1264, 1268 (Fed. Cir. 1991) (holding that inherency can be established by extrinsic evidence that “make[s] clear that the missing descriptive matter is necessarily present in the thing described in the reference, and that it would be so recognized by persons of ordinary skill”).” slip op. at 10
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableNot shown unpatentable
“C. ASSERTED OBVIOUSNESS OVER MYERS AND BOSTOCK Petitioner contends claim 22, and claims 48 and 49, which depend from claim 22, would have been obvious over Myers and Bostock. Pet. 29– 32. With regard to the “flowing a fluid” step of claim 22, Petitioner relies only on the contentions it set forth under its anticipation analysis with respect to claim 22. Pet. 31. Because Petitioner does not rely on Bostock to teach the recited “flowing a fluid” step, does not argue the step would have been obvious over the combination, and, for the reasons provided above, has not shown by a preponderance of the evidence that Myers discloses the step, Petitioner has not shown by a preponderance of the evidence that claims 22, 48, and 49 would have been obvious over Myers and Bostock.” slip op. at 25
Patent outcomesUS 7,314,099 not shown unpatentable§ 102 anticipation§ 103 obviousnessPatents in suitUS 7,314,099 - Baker Hughes Oilfield Operations, Inc. v. Smith International, Inc.No claims unpatentablePTAB · Feb 1, 2018 · IPR2016-01440 · APJ James A Tartal · IPR · Final written decision
Claims 1, 2, 4–20, and 28–42 were not shown unpatentable because Myers did not establish axial translation, and Myers with Bostock did not cure that deficiency.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“radially” in the Petition. In its Reply, Petitioner equates “radially” to “outwardly” and “axially” to “downwardly.” Pet. Reply 7. Patent Owner contends that “axially and radially” would have been understood by a person of ordinary skill in the art “to refer to movement relative the body and oriented relative to the axis of the body.” PO Resp. 19 (citing Ex. 2018 ¶ 82). In particular, Patent Owner contends that “axial” refers to “movement along or parallel to the axis of the body, and that “radial” refers to “the direction perpendicular to the axis of the body.” PO Resp. 20. Patent Owner contends its interpretation is consistent with the Specification of the ’099 patent and is supported by both its expert, Mr. Underwood, and Petitioner’s expert, Mr. Shale. Id. at 18–21 (citations omitted). For example, Mr. Shale testified that “‘[r]adially’ basically means left to right within the tubular body,” and “‘axially’ means up and down within the tubular body.” Ex. 2021, 189:5–7. Patent Owner further notes that Figures 4, 5, 11, and 12 of the ’099 patent illustrate arms 520 moving axially and radially relative to body 510. PO Resp. 20. In its Reply, Petitioner argues that “[c]ontrary to Patent Owner’s assertion, claim 1 of the ’099 [p]atent does not require that the body 10 be the frame of reference for the axial and radial movement.” Pet. Reply 13 n.3. Petitioner, however, cites no persuasive evidence to counter Patent Owner’s proposed construction. Contrary to Petitioner’s assertion, Mr. Shale agreed that “radially” corresponds to “outward from the body,” and that “axially” corresponds to “up and down of the body.” Ex. 2021 190:4–19. Consistent with Mr. Shale’s testimony, Petitioner’s analysis purports to show that Myers discloses movement of moveable arms (slips 30) “both axially and radially relative to the body 10 [of Myers].” Pet. 19– 20. Petitioner is not alleging movement of the slips of Myers relative to a feature other than the body of Myers or in some other frame of reference. See Tr. 10:1–21. Thus, based on the evidence discussed above, we determine “translates axially and radially,” as recited in claim 1, means “moves parallel to and perpendicular to the body” and does not encompass movement consisting of only rotation about a pivot point. slip op. at 9
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“The steps discussed above address how slips 30 of Myers are deployed, but do not explain expressly whether slips 30 move axially relative to body 10 during deployment. With regard to the slips, Myers further provides that: [Slips 30] are positively movable laterally relative to the expander upon relative longitudinal movement between the expander and slips by inclined spline connections between the slips and expander, provided by oppositely directed side tongues 32 on each slip sliding in companion grooves 33 in the expander on opposite sides of slots 34 in the expander in which the slips are disposed. The lower ends of the slips 30 are coupled for movement longitudinally with one another by being connected to a slip ring 35 having generally T-shaped slots 36 therein receiving companion T-shaped heads 37 on the lower portions of the slips. Thus, the slips 30 move longitudinally jointly with the slip ring 35, although they are still permitted to move radially or laterally inwardly and outwardly of the slip ring, upon relative longitudinal movement between the slips 30 and expander 26. Ex. 1004, 3:2–17. In this passage, the movement of the slips includes “longitudinal movement,” which we understand generally corresponds to a vertical direction, as opposed to lateral movement in a horizontal direction. However, the movement is described relative to expander 26, not relative to body 10. See Pet. 13 (using “lateral” consistent with the horizontal extent and “longitudinal” consistent with the vertical extent). Thus, this passage also does not explain expressly whether slips 30 move axially relative to the body during deployment.” slip op. at 18
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable
“C. ASSERTED OBVIOUSNESS OVER MYERS AND BOSTOCK Petitioner contends claims 4, 33, and 34, each of which depends from claim 1, would have been obvious over Myers and Bostock. Pet. 24–26. According to Petitioner, “[e]ach of claims 4, 33, and 34 recites biasing either a sleeve or a movable arm to a collapsed position.” Id. at 24. Petitioner relies on Bostock as disclosing a spring for biasing. Id. As to the limitations of claim 1 from which claims 4, 33, and 34 depend, including the requirement of “one moveable arm translates axially and radially,” Petitioner relies only on the contentions it set forth under its anticipation analysis with respect to claim 1. Because Petitioner does not rely on Bostock to teach the recited feature “one moveable arm translates axially and radially,” does not argue the feature would have been obvious over the combination, and, for the reasons provided above, has not shown by a preponderance of the evidence that Myers teaches the feature, Petitioner has not shown by a preponderance of the evidence that claims 4, 33, and 34 of the ’099 patent would have been obvious over Myers and Bostock.” slip op. at 25
- Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner
“Mr. Shale expresses the opinion that “slips 30 move both axially and radially relative to the body 10, along ‘generally T-shaped slots 36’ that are linear and angled relative to the axial direction,” we find that testimony to be conclusory and entitled to little weight, in part because this testimony does not account for the upward movement of setting sleeve 40. See Ex. 1010 ¶ 53 (quoting Ex. 1004, 3:11); see also In re Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004) (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”); 37 C.F.R. § 42.65(a) (“Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.”). Accordingly, we find Mr. Shale’s declaration fails to provide persuasive support for Petitioner’s contention that Myers discloses “one moveable arm translates axially and radially,” as required by claim 1, beyond what Myers, itself, discloses. We find more persuasive Mr. Underwood’s testimony, on behalf of Patent Owner, that Myers fails to disclose axial movement of slips 30. Ex. 2018 ¶¶ 90–107. According to Mr. Underwood: slots [36 of Myers] are shown as angled relative to the slip ring 35. However, though the slips may move downward (axially) relative to the slip ring 35 as the slips move outward (radially), the slip ring 35 at the same time moves upward (axially) relative to the body. As such, the angle of the slots 36 within the slip ring 35 is not, itself, indicative of the overall movement of the slips. Id. ¶ 91. Mr. Underwood further reasons that “as the slip ring moves upwardly, the movement of the slips relative to the body in the axial direction is zero due to the slips sliding downward in the slots 36 relative to the slip ring 35 in equal proportion.” Id. ¶ 94. Mr. Underwood also” slip op. at 20
Patent outcomesUS 7,314,099 not shown unpatentableClaim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialPatents in suitUS 7,314,099 - Coalition For Affordable Drugs (Adroca) LLC v. Acorda Therapeutics, Inc.No claims unpatentablePTAB · Mar 9, 2017 · IPR2015-01853 · APJ Susan L C Mitchell · IPR · Final written decision
Claims 1–52 of the ’703, claims 1–3, 5–8, and 10–41 of the ’826, claims 1–8 of the ’685, and claims 1–40 of the ’437 were not shown unpatentable under § 103.
RulingsFinal written decision- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner asserts constructions for the following claim terms, “less than 15 milligrams,” “release profile,” “matrix,” “improving walking,” and “initiating treatment.” Pet. 18–19. Patent Owner contends that Petitioner has failed to provide an explanation as to why the identified claim terms require construction and why the Board should depart from the plain and ordinary meaning of the terms. Prelim. Resp. 17, n.4. In the Institution Decision, we agreed with Patent Owner and determined that it was unnecessary to construe explicitly the claim terms for purposes of the Institution Decision. See Dec. Instit. 6 (citing Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). We also determine here that we need not construe expressly any claim term in order to issue a Final Written Decision regarding the patentability of the challenged claims.” slip op. at 7
- Skill levelSkill level petitioner adoptedDecided for petitioner
“1. Level of Skill Petitioner’s declarants, Drs. Pleasure and Polli, testify that a person of ordinary skill in connection with the ’703 patent would have had an M.D. or Ph.D. in neuroscience or a related field with an understanding of pharmacokinetics and at least some experience in providing drug therapy to MS patients. Ex. 1023 ¶ 16, Ex. 1044 ¶ 13. Additionally, Drs. Pleasure and Polli testify that a person of ordinary skill in the art would have had access to a person having an advanced degree in pharmaceutics or pharmaceutical formulation, specifically oral sustained release formulations, or at least five years of experience in formulating sustained oral release drug products and may work as part of a multi-disciplinary team. Ex. 1023 ¶¶ 16–17; Ex. 1044 ¶¶ 13–14. Patent Owner does not dispute this recitation of the level of ordinary skill in the art. See Ex. 2042 ¶ 68 n.5. We adopt the level of ordinary skill in the art identified by Drs. Pleasure and Polli as it is consistent with the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (stating level of ordinary skill in the art may be reflected by the prior art of record); In re GPAC Inc., 14 57 F.3d 1573, 1579 (Fed. Cir. 1995); In re Oelrich, 579 F.2d 86, 91 (CCPA 1978).” slip op. at 14
- Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateDecided for patent owner
“In order for claims of the ’703 patent to be entitled to benefit of the filing date of the Provisional, the Provisional must provide written description support for those claims. See 35 U.S.C. § 120. To satisfy the written description requirement of 35 U.S.C. § 112, first paragraph, and provide support for the challenged claims of the ’703 patent under 35 U.S.C. § 120, the Provisional must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See In re Wertheim, 541 F.2d 257, 261, 262 (CCPA 1976); Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563– 64 (Fed. Cir. 1991). The primary consideration in determining whether appropriate written description support exists “is factual and depends on the nature of the invention and the amount of knowledge imparted to those skilled in the art by the disclosure.” Union Oil Co. of Cal. v. Atlantic Richfield Co., 208 F.3d 989, 996 (Fed. Cir. 2000).” slip op. at 27
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedDecided for patent owner
“We are persuaded by Dr. Hayes’ testimony as confirmed by testimony from Drs. Pleasure and Polli, and conclude that the Provisional supports the CavSS ranges in claims 14–15 and 35–36. Dr. Hayes offers credible 34 testimony concerning how one of skill in the art would interpret Table 7 of the Provisional, which depicts essentially the same data as Table 3 of Hayes. See Ex. 2041 ¶ 17. Dr. Hayes interpretation of the data in Table 7 is supported by testimony from Drs. Pleasure and Polli that about two thirds of the measured data fall within one standard deviation and approximately 95 percent of measured values are within two standard deviations from the mean. Id. at 20–22 (citing deposition testimony from Drs. Pleasure and Polli confirming such an understanding). We agree with Dr. Hayes that “[i]n light of the fact that a POSA would immediately recognize that Table 7 of the ’894 Provisional (Ex. 1007-00045) shows possession of measured data beyond even two standard deviations from its reported mean values, a more complete view of the information reported in Table 7 would consider data dispersed beyond two standard deviations from the mean” to encompass a CavSS range from 3.7–37.8 ng/ml. Ex. 2041 ¶ 23. We are not persuaded by Dr. Fairweather’s testimony that Table 7 supports a CavSS of only 15.1 ng/ml to 26.5 ng.ml. See Ex. 1066 ¶ 21. Dr. Fairweather was asked if he could identify where “range” is defined as plus or minus one standard deviation, and he replied that he could not identify where he found such a definition, Ex. 2176, 44:13–22, but Dr. Fairweather confirmed such a definition is not how he would define “range” in his usual practice, Id. at 92:20–93:21. See also id. at 108:5–11 (conceding there may not be any document that defines “range” as one 35 standard deviation from the mean). When asked whether he could justify the range that he provided for CavSS in his declaration, Dr. Fairweather stated that he could not. Id. at 104:25–105:2. He testified that he conceded the smallest range so as to avoid a discussion of what’s the proper definition for range. Id. at 104:16–20. Dr. Fairweather stated twice that he was not a person of skill in the art and would not be able to answer what assumptions such a person would make when reviewing Table 7 of the Provisional. Id. 136:16–23, 138:14–139:7. Finally, Dr. Fairweather also testified that he could not rule out whether the CavSS data for the 10 mg b.i.d. dose described in Table 7 of the Provisional had a range of at least 15 to 35 ng/ml. Id. at 90:9–92:19. In light of these statements, we do not credit Dr. Fairweather’s testimony.” slip op. at 34
Patent outcomesUS 8,007,826 not shown unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 8,007,826
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.