- Rimfrost As v. Aker Biomarine Antarctic AsAll claims unpatentablePTAB · Apr 6, 2022 · IPR2020-01533 · APJ Jon B Tornquist · IPR · Final written decision
Claims 1–19 are unpatentable as obvious over the combined prior art, considered with the knowledge of a person of ordinary skill in the art.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Neither Patent Owner nor Dr. Jaczynski disputes Petitioner’s definition of a person of ordinary skill in the art. Ex. 2015 ¶ 8 (“For purposes of this proceeding, I will accept [Petitioner’s] definition of a [person of ordinary skill in the art].”). Upon review of the ’046 patent and the prior art of record, we find Petitioner’s uncontested definition reasonable and supported by the evidence of record. Accordingly, we adopt this definition of one of ordinary skill in the art for purposes of this Decision.” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Upon review of the parties’ arguments and supporting evidence, we determine that no terms of the ’046 patent require construction in order to resolve the disputes in this proceeding. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”)).” slip op. at 9
- PTAB / AIA Trials › §315(e) estoppelEstoppel does not applyDecided for patent owner
“Collateral estoppel protects a party from having to litigate issues that have been fully and fairly tried in a previous action and adversely resolved against a party-opponent.” Ohio Willow Wood Co. v. Alps South, LLC, 735 F.3d 1333, 1342 (Fed. Cir. 2013). In the context of patent claims, collateral estoppel applies “[i]f the differences between the unadjudicated patent claims and adjudicated patent claims do not materially alter the question of invalidity.” Id. Petitioner points to no prior decision of the Board where the issue of whether it would have been obvious to denature a krill product and then store it for 1 to 36 months before extraction was at issue. Moreover, to demonstrate that the added limitation would have been obvious, Petitioner relies heavily on the disclosures of Budziński, which was not at issue or analyzed in the prior proceedings. Pet. 39. Accordingly, Petitioner has not demonstrated that collateral estoppel applies to any issue in this proceeding. slip op. at 10
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner
“Breivik II’s disclosures would have understood that extraction of fresh krill is preferable over stored krill products, and that extraction should be performed on the fishing vessel as opposed to on land. PO Resp. 53. On this record, we agree with Patent Owner that Breivik II teaches or suggests a successful method of immediately processing and extracting fresh caught krill on-board a fishing vessel. We also agree that Breivik II suggests that its disclosed method may have advantages over conventional krill oil extraction processes. The disclosed advantages to immediately denaturing and extracting krill oil discussed in Breivik II, however, are only “expected,” not definitive, and we are directed to no disclosure in Breivik II to suggest that extraction from a stored, denatured krill meal was unlikely to result in a useful krill oil. See In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004) (noting that the case law “does not require that a particular combination must be the preferred, or the most desirable, combination described in the prior art in order to provide motivation for the current invention”); In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994) (explaining that a reference teaches away when it suggest that a particular course of action “is unlikely to be productive of the result sought by the applicant,” and that “[a] known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product of the same use”). Moreover, although, as noted in Breivik II, oxidation and enzymatic hydrolysis are of particular concern during krill processing procedures, Petitioner and Dr. Tallon persuasively demonstrate that the denatured and “stable” krill meal of Budziński was not subject to significant enzymatic hydrolysis or deterioration of krill lipid antioxidants, such as astaxanthin. Ex. 1006 ¶¶ 172, 421, 434; Ex. 1086 ¶¶ 50–51; see also Ex. 1010, 822–823 (Fricke disclosing storing denatured krill products for a period of time before extraction with a polar solvent). As such, we are not persuaded that Breivik II would have taught away from, or otherwise discouraged, one of ordinary skill in the art from extracting krill oil from a denatured and stable krill meal that has been stored from between 1 and 36 months. Patent Owner further argues that, consistent with Breivik II’s disclosures, Budziński instructs that krill should be “processed as soon as possible after capture” and that “[t]he only way to meet this requirement is to install processing facilities on-board the vessel.” PO Resp. 51 (citing Ex. 1008, 25). The required processing of Budziński, however, is to denature the problematic krill enzymes, not to extract krill oil. Ex. 1008, 25. And, once the krill products are denatured, Petitioner persuasively demonstrates that krill oil extraction could be successfully performed either on-board a vessel or on land after a storage period of up to 13 months. In view of the foregoing, we find that Breivik II and Budziński do not teach away from, or counsel against, extracting krill oil from a krill meal that had been denatured and stored for 1 to 36 months.” slip op. at 26
Patent outcomesUS 9,816,046 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,816,046 - Rimfrost As v. Aker Biomarine Antarctic AsAll claims unpatentablePTAB · Apr 6, 2022 · IPR2020-01532 · APJ Jon B Tornquist · IPR · Final written decision
Claims 1–20 are unpatentable as obvious over the asserted combinations of prior art, because the combined teachings establish every limitation and a reason to combine with a reasonable expectation of success.
RulingsFinal written decision- PTAB / AIA Trials › §315(e) estoppelEstoppel does not applyDecided for patent owner
“Collateral estoppel protects a party from having to litigate issues that have been fully and fairly tried in a previous action and adversely resolved against a party-opponent.” Ohio Willow Wood Co. v. Alps South, LLC, 735 F.3d 1333, 1342 (Fed. Cir. 2013). In the context of patent claims, collateral estoppel applies “[i]f the differences between the unadjudicated patent claims and adjudicated patent claims do not materially alter the question of invalidity.” Id. Petitioner points to no prior decision of the Board where the issue of whether it would have been obvious to denature a krill product and then store it for 1 to 24 months before extraction was at issue. Moreover, to demonstrate that the added limitation would have been obvious, Petitioner relies heavily on the disclosures of Budziński, which was not at issue or analyzed in the prior proceedings. Pet. 45; PO Resp. 13 (asserting that the prior art in the previous proceedings “did not include Budziński”). Accordingly, Petitioner has not demonstrated that collateral estoppel applies in this proceeding. slip op. at 10
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Neither Patent Owner nor Dr. Jaczynski dispute Petitioner’s definition of a person of ordinary skill in the art. Ex. 2015 ¶ 8 (“For purposes of this proceeding, I will accept [Petitioner’s] definition of a [person of ordinary skill in the art].”). Upon review of the ’169 patent and the prior art of record, we find Petitioner’s uncontested definition reasonable and supported by the evidence of record. Accordingly, we adopt this definition of one of ordinary skill in the art for purposes of this Decision.” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“oil,” “denature lipases and phospholipases,” “polar solvent,” “astaxanthin esters,” “krill meal,” and “freshly harvested.” Pet. 32–39. With respect to “krill meal,” Petitioner contends this term should be construed to mean “processed krill with reduced water content from which krill oil can be extracted.” Id. at 38. Patent Owner provides proposed constructions for the terms “krill meal” and “denature lipases and phospholipases.” PO Resp. 7–12. With respect to “krill meal,” Patent Owner contends Petitioner’s proposed construction of “krill meal” is overbroad and ignores the ordinary and customary meaning of a meal, which is a “powder formed by particle size reduction of a starting material.” Id. at 8 (citing Ex. 2015 ¶¶ 14–16). Thus, Patent Owner construes “krill meal” to mean “a krill powder resulting from the processing of krill.” Id. Upon review of the parties’ arguments and supporting evidence, we determine that no terms of the ’169 patent require construction in order to resolve the disputes in this proceeding. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”)).” slip op. at 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“As noted by Patent Owner, the evidence of record suggests that one of ordinary skill in the art would have known that krill processing—both denaturation and krill oil extraction—could be successfully performed on board a ship. Ex. 1037, 3–4; Ex. 2019, 49:18–25 (Dr. Tallon testifying 12 Because Patent Owner relies on various disclosures of Breivik II as potentially counselling against combining the references to arrive at the claimed subject matter, we will consider these teachings in our Decision. We do not, however, consider Breivik II or Petitioner’s arguments with respect to this reference in determining whether the prior art teaches or suggests every limitation of the challenged claims. during cross-examination that flammable solvents can be successfully managed on a ship). At the same time, Petitioner and Dr. Tallon explain that the dangers of using flammable solvents on a vessel are still a relevant consideration. Ex. 1086 ¶¶ 97–99; Ex. 2019, 49:18–25 (Tallon Deposition). Moreover, Dr. Tallon also persuasively identifies several other benefits of land-based krill oil extraction, such as the reduced costs of outfitting each ship with its own processing equipment (which is often essentially identical to that used on land), the ability to extract krill oil to meet specific demand in the market, and cheaper access to fuel. Pet. 61 (citing Ex. 1006 ¶¶ 173, 443); see KSR, 550 U.S. at 418 (noting that market forces and design needs can provide the reason to combine or modify prior art references). Patent Owner presents no argument or evidence to refute these additional benefits of land-based extractions, other than to note that Dr. Tallon does not cite any specific documents to support his assertions. PO Resp. 45 (Patent Owner noting the testimony of Dr. Tallon). Upon review of the evidence of record, we credit the testimony of Dr. Tallon that one of ordinary skill in the art would have understood that, in addition to avoiding the need to manage the use of flammable solvents at sea, there were a number of other benefits to land-based extractions of krill oil that would have motivated a skilled artisan to store the denatured krill products for between 1 and 24 months, as recited in claim 1.” slip op. at 25
Patent outcomesUS 9,644,169 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,644,169 - Medtronic Corevalve LLC / Edwards Lifesciences Corporation et al. v. Colibri Heart Valve LLCAll claims unpatentablePTAB · Mar 24, 2022 · IPR2021-00775 · APJ James A Tartal · IPR · Final written decision
Claims 1–5 are unpatentable as obvious over Garrison; the Board did not reach the Andersen/Limon grounds.
RulingsFinal written decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“pursuant to 35 U.S.C. §§ 311–319, requesting an inter partes review of the Challenged Claims. Paper 2 (“Pet.”). On March 10, 2021, we instituted an inter partes review of the Challenged Claims on all grounds of unpatentability asserted in the Petition. Paper 11. Within one month of institution of review, on April 6, 2021, Edwards Lifesciences Corporation and Edwards Lifesciences LLC filed a petition in IPR2021-00775 substantively identical to the Petition in this proceeding, along with a motion for joinder to this proceeding. IPR2021-00775, Papers 2 and 3. We instituted trial in IPR2021-00775 and granted the motion joining Edwards Lifesciences Corporation and Edwards Lifesciences LLC as petitioner to this proceeding. Paper 17.” slip op. at 2
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“pursuant to 35 U.S.C. §§ 311–319, requesting an inter partes review of the Challenged Claims. Paper 2 (“Pet.”). On March 10, 2021, we instituted an inter partes review of the Challenged Claims on all grounds of unpatentability asserted in the Petition. Paper 11. Within one month of institution of review, on April 6, 2021, Edwards Lifesciences Corporation and Edwards Lifesciences LLC filed a petition in IPR2021-00775 substantively identical to the Petition in this proceeding, along with a motion for joinder to this proceeding. IPR2021-00775, Papers 2 and 3. We instituted trial in IPR2021-00775 and granted the motion joining Edwards Lifesciences Corporation and Edwards Lifesciences LLC as petitioner to this proceeding. Paper 17.” slip op. at 2
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
“with the features recited in claim 1, aside from the use of pericardial tissue. See generally Resp. Patent Owner also does not dispute that the use of fixed pericardial tissue in the construction of a valve means was well known in the art to a person of ordinary skill.9 Id. Because Petitioner’s arguments are supported by the cited evidence of record, which we adopt as our own findings, we are persuaded that a preponderance of the evidence shows that” slip op. at 41
- Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentable
“with the features recited in claim 1, aside from the use of pericardial tissue. See generally Resp. Patent Owner also does not dispute that the use of fixed pericardial tissue in the construction of a valve means was well known in the art to a person of ordinary skill.9 Id. Because Petitioner’s arguments are supported by the cited evidence of record, which we adopt as our own findings, we are persuaded that a preponderance of the evidence shows that” slip op. at 41
Patent outcomesUS 9,125,739 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,125,739 - Edwards Lifesciences Corporation / Edwards Lifesciences LLC v. Colibri Heart Valve LLCAll claims unpatentablePTAB · Mar 24, 2022 · IPR2020-01649 · APJ James A Tartal · IPR · Final written decision
Claims 1–5 are unpatentable as obvious over Bessler with Leonhardt and Klint, and Bessler with Teitelbaum and Klint; anticipation by Paniagua was not shown.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“A [person of ordinary skill in the art] as of January 4, 2002 ‘would have had a minimum of either a medical degree and experience working as an interventional cardiologist or a Bachelor’s degree in bioengineering or mechanical engineering (or a related field) and approximately two years of professional experience in the field of percutaneously, transluminally implantable cardiac prosthetic devices. Additional graduate education could substitute for professional experience, or significant experience in the field could substitute for formal education.’ Resp. 2 (quoting IPR2020-01454, Paper 1, 23); Ex. 2019 ¶¶ 21, 22. According to Patent Owner, Petitioner’s proposed definition does not allow for the “differentiation among those who possess ordinary skill in the art versus those who possess extraordinary skill in the art.” Resp. 2–3 (citing” slip op. at 15
- Expert testimonyPetitioner expert creditedDecided for petitioner
“one of extraordinary skill in the art,” because at his deposition “he testified that in forming his opinions, he applied all of his experience up until January 4, 2002.” Resp. 3 (citing Ex. 2020, 20:5–14). According to Patent Owner the “agreed upon definition of a person of ordinary skill required “two years of experience,” and in 2002 Dr. Goldberg had “been practicing in the relevant field for approximately 17 years.” Id. We find Patent Owner’s argument unpersuasive, because it misrepresents Dr. Goldberg’s testimony, as follows: Q. Did you apply all of the qualifications and experience that you set forth in your declaration up until January 4th, 2002, in reaching the opinions you set forth in your declaration, other than the Paniagua opinions? A. The phrasing of the question is slightly confusing, but I believe that what you're asking is, did I consider the perspective of somebody whose knowledge -- a person skilled in the art’s knowledge was January 4th, 2002, and before. And hopefully, I answered your question correctly, but if not, it was due to my misunderstanding.” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction needed
“related district court proceedings construing “‘flares at both ends in a trumpet-like configuration’ to mean ‘having, at each end, a widening that resembles the bell of a conventional musical trumpet.’” Resp. 12 (citing Ex. 2025, 46; Ex. 2026; Ex. 2019 ¶¶ 66, 67). We discern no dispute over the meaning of “flares at both ends in a trumpet-like configuration” that requires an express construction. See Reply 23–30. 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 Cir. 1999)).” slip op. at 17
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“Thus, in light of Applicants’ repeated statements during prosecution that the prosthetic heart valve cannot be collapsed onto a pusher member that terminates proximally to the valve, Petitioners’ proposed construction must fail. Petitioners’ construction of “collapsed onto” to mean “collapsed in contact with” specifically includes “collapsed onto” a pusher member that terminates proximally to the valve as in Bessler, which the prosecution history makes clear is not the meaning of “collapsed onto.” Id. at 17 (citing Ex. 2019 ¶¶ 75–77). In its Reply, Petitioner argues that Figure 8 of the ’739 patent is “inconsistent with the [S]pecification.” Reply 19. We disagree because Figure 8 is part of the Specification. Petitioner further argues that Figure 8 mislabels the distal end as the “proximal end” of the catheter, and, therefore, the entire figure should be “disregarded” because of such “obvious errors.” Id. at 21–23. Petitioner has shown no sufficient basis to “disregard” Figure 8, much less that Figure 8 is determinative of whether “onto” means “in contact with,” as Petitioner alleges. See Sur-reply 12–15. Likewise, Petitioner’s argument that Patent Owner “imposes an unsupported temporal limitation on ‘collapsed onto’” when Patent Owner addressed Klint provides no support for Petitioner’s proposed construction of “onto.” Reply 22–23. Consistent with our Decision on Institution, we determine on the full record that Petitioner fails to show sufficiently that “onto” means “in contact with.” See Inst. Dec. 23–27. Accordingly, a “delivery system . . . wherein the prosthetic heart valve is collapsed onto the pusher member” does not encompass a delivery system with a prosthetic heart valve only shown to be “in contact with” a pusher member. We find no further express construction” slip op. at 22
Patent outcomesUS 9,125,739 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,125,739 - Medtronic Vascular, Inc. / Medtronic Vascular Galway Unlimited Company et al. v. TMT Systems, Inc.InstitutedPTAB · Mar 22, 2022 · IPR2021-01532 · APJ Erica A Franklin · IPR · Institution
The Board instituted review of claims 1, 2, 4, 10, 11, and 26 on all asserted grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“Concerns about the degree of overlap may be mitigated where a petitioner agrees not to pursue in the parallel District Court litigation the grounds advanced in the petition. Sand Revolution II, Paper 24, 11. A petitioner stipulating not to pursue “any ground raised or that could have 8 Initially, the Petitioner in this proceeding was only Medtronic Vascular, a subsidiary of Medtronic, Inc. Patent Owner acknowledges that Petitioner’s counsel has requested that the Board include additional parties, including Medtronic, Inc., as a petitioner. See Prelim. Resp. 38 n.15 (citing Ex. 1056). We subsequently granted Petitioner’s unopposed request and added the additional parties as petitioners in this proceeding. See Paper 18. been raised” weighs strongly in favor of not exercising discretionary denial. Sotera, Paper 12, 18–19. Petitioner unequivocally stipulates that, if the Board here institutes an inter partes review, Medtronic, Inc. will not advance the grounds that are raised or reasonably could have been raised in the inter partes review in the co-pending District Court proceeding, thus eliminating any overlap between the inter partes review and the co-pending District Court proceeding. Pet. 88. Moreover, we have granted Petitioner’s unopposed request to include the real parties-in-interest as named petitioners in this proceeding, and that Order instructs Petitioner to file a power of attorney for the added parties. See Paper 18, 2. Although Petitioner has not yet filed its stipulation at the District Court, we consider Petitioner to be bound by any stipulation that it asserts to the Board in the proceeding for purposes of our Fintiv analysis. Considering that Petitioner has agreed to be bound by a stipulation that is substantively the same as the stipulation addressed in Sotera, we follow the Sotera precedent in finding that this factor weighs strongly against exercising discretion to deny institution under § 314(a). Sotera, Ex. 1038, 7–8.” slip op. at 18
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“At this stage in the proceeding, we determine that Petitioner’s foregoing assertions are supported by the cited references and the testimony of Petitioner’s declarant, Dr. Chaikof. Based on the current record, we determine that Petitioner has shown sufficiently for institution that a person of ordinary skill in the art would have been motivated to modify Quiachon’s attachment system to include the telescoping arms disclosed by Lazarus with a reasonable expectation of successfully providing an attachment device comprising each element recited in claim 1. In reaching these determinations, we have considered Patent Owner’s arguments. However, as explained in the following discussion, we do not find those arguments sufficiently supported at this stage in the proceeding to deny the Petition.” slip op. at 44
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner neither addresses Petitioner’s description of the level of ordinary skill in the art, nor provides its own description in the Preliminary Response. At this stage of the proceeding, we adopt Petitioner’s definition as we find it is unopposed on the current record and appears to be consistent with the level of skill in the art at the time of the invention as reflected by the prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 22
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction needed
“language itself, the written description, and the prosecution history. We begin by noting that the claim terms themselves indicate that the “telescoping arm(s)” must telescope, as the term “arm” or “arms” recited in the claims is modified by the term “telescoping.” We then look to the Specification description of the term “telescoping arm(s),” set forth in the passage referenced by both parties: The expandable attachment device comprises a plurality of telescoping arms that are attached to form an expandable ring. Each telescoping arm is similar to an expandable presentation pointer. Alternatively, each telescoping arm may function like an accordion. Ex. 1001, 2:36–40 (emphasis added). The parties dispute whether this disclosure contemplates only arms that individually telescope, or whether it also encompasses a group of arms that telescope collectively, i.e., “telescope[] like an accordion.” Prelim. Resp. 17; Pet. 24. However, for purposes of this Decision, we need not resolve that dispute, as the parties agree that the Specification expressly discloses that a telescoping arm includes embodiments wherein an arm is expandable similar to a presentation pointer. See Pet. 24–27; Prelim. Resp. 15–17. Whether an alternative form of a telescoping arm may exist, and what that form would be is not implicated in the challenges presented by Petitioner or the arguments raised by Patent Owner to those challenges, as Petitioner relies on the prior art as teaching this claim element by disclosing an arm that telescopes similar to an expandable presentation pointer. See, e.g., Pet. 38–39, 66–67. Accordingly, for purposes of this decision, we need not construe the full scope of the terms “telescoping arm” and “telescoping arms” as we agree with the parties that these terms at least include embodiments wherein each arm is individually expandable similar to a presentation pointer, which is the only embodiment relied upon by Petitioner for its grounds challenging the ’393 patent claims.9” slip op. at 26
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 7,101,393 - PTAB · Mar 3, 2022 · IPR2021-01542 · APJ Zhenyu Yang · IPR · Institution
The Board instituted IPR on claims 4, 5, and 12 on all asserted grounds, finding a reasonable likelihood that Petitioner would prevail on at least one claim.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have authority under 35 U.S.C. § 314, which provides that an inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). The Federal Circuit has interpreted the statute to require “a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition.” PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018). For the reasons provided below, we determine Petitioner has demonstrated a reasonable likelihood that it would prevail with respect to at least one claim challenged in the Petition. Thus, based on the information presented, we institute an inter partes review of claims 4, 5, and 12 of the ’264 patent on all grounds.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“an individual with an M.D. specializing in the treatment of autoimmune disorders and having several years of experience treating patients with such disorders, including rheumatoid arthritis, or having several years of experience researching treatments for autoimmune disorders, including rheumatoid arthritis.” Pet. 17 (citing Ex. 1002 ¶ 35). For purposes of its Preliminary Response, Patent Owner does not dispute this definition of the 8 Bonilla, Pharmacokinetics of Immunoglobulin Administered via Intravenous or Subcutaneous Routes, 28 Immun. and Allergy Clinics of N. America 803–19 (2008) (Ex. 1021, “Bonilla”). 9 Wang et al., Fixed Dosing Versus Body Size-Based Dosing of Monoclonal Antibodies in Adult Clinical Trials, 49 J. of Clin. Pharm. 1012–24 (2009) (Ex. 1022, “Wang”). ordinary skill level. Prelim. Resp. 13 n.4. For purposes of this Decision, we adopt Petitioner’s definition as it is consistent with the disclosures of the ’264 patent and the prior art of record.” slip op. at 7
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner
“Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). On this record, only the phrase “a method of treating rheumatoid arthritis in a patient” needs express construction. Each of claims 4 and 5 depends from claim 1. In claim 1, the preamble recites “[a] method of treating rheumatoid arthritis (RA) in a patient.” The parties dispute whether the preamble of claims 1 and 10 is limiting: Petitioner argues it is not (Pet. 18–19); whereas Patent Owner contends it is (Prelim. Resp. 13–17). The parties also disagree over whether “treating” or “treats” requires efficacy: Petitioner argues it does not (Pet. 19–20); whereas Patent Owner contends it does (Prelim. Resp. 17–23). We do not need to address whether preamble of claim 1 is limiting, because, as explained below, we agree with Petitioner that “[e]ven if the preamble was limiting,” “the plain and ordinary meaning of the phrase ‘treating rheumatoid arthritis . . . in a patient’ is ‘attempting to cause a therapeutic improvement in rheumatoid arthritis in a patient,’ and does not require actually causing a therapeutic benefit in a particular patient.” Pet. 19 (citing Ex. 1002 ¶ 105; Ex. 1027, 3; Ex. 1080, 3–4).” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“Thus, according to the claims and the Specification of the ’264 patent, DMARDs and TNF inhibitors, including etanercept and infliximab, are drugs that “have been used successfully to treat RA,” even though some patients “fail to respond,” or have “inadequate response” to these therapies. Id. at 1:47–50, 14:46–57. As a result, the term “treats the rheumatoid arthritis,” as used in claims 6 and 11, does not require that the administration result in an effective treatment for a particular patient. Because the same term in the same patent generally carries the same construed meaning (Omega Eng’g, Inc, v. Raytek Corp., 334 F.3d 1314, 1334 (Fed. Cir. 2003)), we similarly adopt Petitioner’s proposed construction for the preamble of claim 1, that is, “treating rheumatoid arthritis . . . in a patient” does not require actually causing a therapeutic benefit in a particular patient. Pet. 19.” slip op. at 12
Claim construction§ 103 obviousnesscites PhillipsPatents in suitUS 8,580,264 - PTAB · Feb 23, 2022 · IPR2021-01288 · APJ Zhenyu Yang · IPR · Institution
Instituted IPR of claims 1–3 and 6–11 on all asserted grounds; the Board found a reasonable likelihood of prevailing on anticipation by NCT00965653 and obviousness over Maini 2006, Bonilla, and Wang.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have authority under 35 U.S.C. § 314, which provides that an inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). The Federal Circuit has interpreted the statute to require “a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition.” PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018). For the reasons provided below, we determine Petitioner has demonstrated a reasonable likelihood that it would prevail with respect to at least one claim challenged in the Petition. Thus, based on the information presented, we institute an inter partes review of claims 1–3 and 6–11 of the ’264 patent on all grounds.” slip op. at 2
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“Thus, according to the claims and the Specification of the ’264 patent, DMARDs and TNF inhibitors, including etanercept and infliximab, are drugs that “have been used successfully to treat RA,” even though some patients “fail to respond,” or have “inadequate response” to these therapies. Id. at 1:47–50, 14:46–57. As a result, we agree with Petitioner that the term “treats the rheumatoid arthritis,” as used in claims 6 and 11, does not require that the administration result in an effective treatment for a particular patient. Pet. 24–25. Because the same term in the same patent generally carries the same construed meaning (Omega Eng’g, Inc, v. Raytek Corp., 334 F.3d 1314, 1334 (Fed. Cir. 2003)), we similarly adopt Petitioner’s proposed construction for the preamble of claims 1 and 10, that is, “treating rheumatoid arthritis . . . in a patient” does not require actually causing a therapeutic benefit in a particular patient. Pet. 22.” slip op. at 11
- Skill levelSkill level petitioner adoptedDecided for petitioner
“an individual with an M.D. specializing in the treatment of autoimmune disorders and having several years of experience treating patients with such disorders, including rheumatoid arthritis, or having several years of experience researching treatments for autoimmune disorders, including rheumatoid arthritis.” Pet. 20 (citing Ex. 1002 ¶ 33). For purposes of its Preliminary Response, Patent Owner does not dispute this definition of the with Rheumatoid Arthritis, 62(10) Arthritis & Rheumatism S467–68 (2010) (Ex. 1034, “Ohta 2010”). 6 Bonilla, Pharmacokinetics of Immunoglobulin Administered via Intravenous or Subcutaneous Routes, 28 Immun. and Allergy Clinics of N. America 803–19 (2008) (Ex. 1021, “Bonilla”). 7 Wang et al., Fixed Dosing Versus Body Size-Based Dosing of Monoclonal Antibodies in Adult Clinical Trials, 49 J. of Clin. Pharm. 1012–24 (2009) (Ex. 1022, “Wang”). ordinary skill level. Prelim. Resp. 27 n.10. For purposes of this Decision, we adopt Petitioner’s definition as it is consistent with the disclosures of the ’264 patent and the prior art of record.” slip op. at 6
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“Coalition for Affordable Drugs. Instead, Mr. Paarlberg has provided what is currently unrebutted testimony, that we determine, based on the current record, is credibly supported by disclosures on the ClinicalTrials.gov website. For example, Mr. Paarlberg explains how the records on ClinicalTrials.gov are managed and supports that testimony by referring to the webpage on that site that describes those practices. See, e.g., Ex. 1004 ¶¶ 17, 20–23. He also refers to the relevant provisions of the FDA Amendments Act of 2007 to support his testimony that the website was designed to “contain searchable categories, allowing the public to search for trials by the disease or condition, name of the intervention, location, age group, study phase, sponsor, recruitment status, or identification number.” Id. ¶ 16. Further, as discussed above, he demonstrates how a user may readily access current and archived records on the website, including records submitted by Petitioners as Exhibits 1028, 1038, and 1053. See, e.g., id. at ¶¶ 24–36. Regarding the date relied upon in those exhibits to address the prior art status of the printed publication, Mr. Paarlberg provides the meaning of the “First Posted” date by quoting the definition for the term set forth in the ClinicalTrials.gov Glossary. Id. ¶ 26 (quoting Ex. 1030, 7). Based on the foregoing testimony by Mr. Paarlberg, and the evidence that he cites, we determine on the current record that Petitioner has established sufficiently, for purposes of institution, that the “First Posted” NCT00965653 study record was sufficiently accessible to the public interested in the art and searchable on the ClinicalTrials.gov website such that a POSA could have found it with reasonable diligence. See Voter Verified, Inc. v. Premier Election Sols., Inc., 698 F.3d 1374, 1380 (Fed. Cir. 2012). In sum, based on this record and for purposes of this Decision, we determine that Petitioner has shown sufficiently that NCT00965653 is prior art.” slip op. at 23
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites PhillipsPatents in suitUS 8,580,264 - PTAB · Feb 23, 2022 · IPR2021-01336 · APJ Erica A Franklin · IPR · Institution
The Board instituted IPR on claims 1–8 over all asserted grounds, finding a reasonable likelihood of unpatentability based on NCT00965653 and the other asserted combinations.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review. 35 U.S.C. § 314 (2018). Upon considering the parties’ arguments and evidence, we determine that Petitioners have demonstrated a reasonable likelihood that they would prevail in showing the unpatentability of the one claim challenged in the Petition. Accordingly, we institute an inter partes review.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioners assert that a person of ordinary skill in the art at the time of the invention (also referred to as “POSA”) “would have had been an individual with an M.D. specializing in the treatment of autoimmune disorders and having several years of experience treating patients with such disorders, including rheumatoid arthritis, or having several years of experience researching treatments for autoimmune disorders, including rheumatoid arthritis.” Pet. 19 (citing Ex. 1002 ¶ 34). At this stage in the proceeding, Patent Owners do not dispute Petitioners’ definition of the person of ordinary skill in the art. Prelim. Resp. 16 n.4. Because Petitioners’ uncontested definition of one of ordinary skill in the art is reasonable and consistent with the ’677 patent and the cited art, we adopt Petitioners’ definition for purposes of this Decision.” slip op. at 6
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“1. “fixed dose” Petitioners address the term “fixed dose” by asserting that the term is defined in the Specification as “a dosage of a drug, such as an anti-IL-6R antibody which is administered without regard to the patient’s weight or body surface area (BSE), i.e., it is not administered as either a mg/kg or mg/m2 dose.” Pet. 20 (quoting Ex. 1006, 15:15–18). Patent Owners assert that it agrees with Petitioners’ proposed construction for the term. Prelim. Resp. 16. Because the term “fixed dose” is defined by the Specification and is not disputed by the parties, we determine, based on the current record, that the term requires no further construction. “subcutaneous administration device” Petitioners address the term “subcutaneous administration device” by asserting that the term is defined in the Specification as “a device, such as syringe, injection device, infusion pump, injector pen, needleness device, patch delivery system, etc, which is adapted or designed to administer a drug or pharmaceutical formulation by the subcutaneous route.” Pet. 20 (quoting Ex. 1006, 20:7–11). Patent Owners assert that it agrees with Petitioners’ proposed construction for the term. Prelim. Resp. 16. Because the term “subcutaneous administration device” is defined by the Specification and is not disputed by the parties, we determine, based on the current record, that the term requires no further construction.” slip op. at 7
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“Based on our review of the Specification and consideration of the arguments and the evidence, we find that Petitioners have the better position. As Petitioners assert, the claims are directed to a device and not to a method of treatment. The claim recitation that the device contains and delivers to a patient the recited fixed dosage of tocilizumab is achieved by the structure of the device, and not by the patient status of the individual for whom the device is intended. Additionally, we do not find that Patent Owners have demonstrated that the Specification limits the term “patient” to individuals with IL-6 mediated disorders. Rather, the references to “patient” in the Specification, cited by Patent Owners, demonstrate that the term is used broadly and then modified in some instances to refer to a specific type of patient, e.g., “[a] patient with ‘active rheumatoid arthritis’” (Ex. 1006, 14:30) or “an IL-6- mediated disorder in a patient” (id. at 25:22). The challenged claims, term “patient.” Nor do the claims recite an IL-6 mediated disorder. Further, we find that the Specification uses the term “patient” and “subject” interchangeably. For example, the Specification refers to “[t]he subject who is a ‘TNF inhibitor inadequate responder’ has experienced an inadequate response to previous or current treatment with one or more TNF inhibitors,” and thereafter immediately refers to that subject by explaining that “such patient has received, for example, etanercept.” Ex. 1006, 15:1–5. Thus, we do not find that the Specification supports Patent Owners’ assertion that the Specification only uses the term “patient” when it discusses treatment. See PO Sur-reply 9–10. Accordingly, at this stage in the proceeding, we preliminarily construe” slip op. at 9
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 10,874,677 - Boehringer Ingelheim Animal Health USA Inc. v. Kansas State University Research FoundationAll claims unpatentablePTAB · Jan 31, 2022 · PGR2020-00076 · APJ Erica A Franklin · PGR · Final written decision
Claims 1–16 are unpatentable under § 112(a) for lack of written description; the Board did not reach the remaining grounds.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“As noted by the Drs. Nordgren and HogenEsch, the differences in these descriptions are “relatively minor.” See Ex. 1038, 238:21–24; Ex. 1039 ¶ 42. Dr. Nordgren explains that even under the higher skill level required by Patent Owner’s description of a POSITA, his opinions would not change. Id. at 1039 ¶ 42. Based upon our review, the differences in Petitioner’s and Patent Owner’s proposed definitions do not impact Petitioner’s grounds for unpatentability or Patent Owner’s responsive arguments. Nor does our consideration of the issues presented turn on which proposed definition is applied. In any event, having considered the evidence and the arguments, we find Patent Owner’s rationale for its more narrow description of the level of ordinary skill in the art to be persuasive and Patent Owner’s description of a person of ordinary skill in the art, while maintaining that the prior art reflects the appropriate level of skill at the time of the claimed invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 10
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“In the Patent Owner Response, Patent Owner asserts that Petitioner’s proposed construction is actually a subject matter eligibility argument. PO Resp. 23. According to Patent Owner, “[t]he term ‘porcine circovirus type 3 recombinant protein’ has a plain and ordinary meaning of ‘genetically engineered PCV3 protein.’” Id. (citing Ex. 2052 ¶¶ 91–92). Having considered the positions of both parties, and the evidence of record, we find that for purposes of this Decision, the ordinary and customary meaning of the claim term “porcine circovirus type 3 recombinant protein,” is a PCV3 protein obtained by genetic engineering, and specifically by recombinant technology, wherein the recombinant protein may either have the same structure and same amino acid sequence as variation therein. See Ex. 1026 ¶¶ 217–218; Ex. 1038, 264:2–9, 266:13– 267:3). 2.” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed patent owner constructionDecided for patent owner
“In the Patent Owner Response, Patent Owner asserts that “[a] POSITA would have understood ‘the nucleotide sequence encoding [ORF1, ORF2 or ORF3]’ to mean ‘a nucleotide sequence having at least 90% sequence homology with SEQ ID NOS. 3, 5, or 7 or encoding a sequence having at least 90% sequence homology with SEQ ID NOS. 4, 6 or 8.’” PO Resp. 24 (citing Ex. 2052 ¶¶ 93–96). In support of that position, Patent Owner refers to the following Specification description: [a] preferred PCV3 ORF2 protein is that of SEQ ID NO. 6, but it is understood by those of skill in the art that this sequence, as well as those for ORF1 and ORF3 could vary by as much as 10% in sequence homology and still retain the antigenic characteristics that render it useful in immunogenic compositions. Patent Owner asserts, according to that Specification description, “the sequences described and identified by SEQ ID Nos. in the patent for PCV3 ORF1, ORF2 and ORF3 are representative sequences, and ‘ORF1,’ ‘ORF2’ and ‘ORF3’ in the patent also refers to those sequences with at least 90% sequence homology.” Id. (citing Ex. 2052 ¶ 95; Ex. 2006, 107:9–17). Further, Patent Owner asserts this interpretation is consistent with the language of the other claims. In particular, Patent Owner refers to the limitation in claim 1 reciting that the composition comprises a PCV3 recombinant protein selected from “ORF1, ORF2 and ORF3, wherein said protein is encoded by a nucleotide sequence having at least 90% sequence homology with a sequence selected from the group consisting of SEQ ID NO. 3, SEQ ID NO. 5, SEQ ID NO. 7.” Id. (quoting Ex. 1001, 71:14–21). Having considered the positions of the parties, and the evidence of record, we agree with Patent Owner that the Specification provides clarity and meaning for the use of the terms ORF1, ORF2, and ORF3, which are not set forth or defined in claim 4, from which claim 5 depends, or in claim 5. Petitioner, in its alternative argument regarding the construction of the phrase involving those terms in claim 5, agrees to some extent. See Pet. 26. For purposes of this Decision, and for the reasons discussed by Patent Owner, we construe the claim phrase “nucleotide sequence encoding ORF1, . . . ORF2, and . . . ORF3” recited in claim 5 as meaning “a nucleotide sequence having at least 90% sequence homology with SEQ ID NOS. 3, 5, or 7 or encoding a sequence having at least 90% sequence homology with SEQ ID NOS. 4, 6 or 8.”” slip op. at 13
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“We do not find that description to be adequate. Essentially, the Specification description that the sequences for PCV3 ORF 1, 2, and 3, could vary by as much as 10% sequence homology just rephrases what is claimed in terms of those sequences having at least 90% sequence homology, adding only that antigenic characteristics are retained that render it useful for immunogenic compositions. A claim, however, “does not become more descriptive by its repetition,” see Ariad, 598 F.3d at 1350 (quoting Eli Lilly, 119 F.3d at 1568), and “a definition of a useful result rather than a definition of what achieves that result” does not sufficiently Inc. v. Gen-Probe Inc., 323 F.3d 956, 969 (Fed. Cir. 2002)). As noted by Petitioner and Dr. Nordgren, the ’351 patent discloses nucleotide and amino acid sequences corresponding only to the naturally-occurring PCV3 ORFs 1–3. PO Resp. 52; Ex. 1026 ¶ 168. While those sequences may be characterized as “reference” sequences, as they reflect sequences with 100% homology with PCV3 ORFs 1–3, Patent Owner has not demonstrated that they are “representative” sequences for the broad range of sequences claimed. We find that the Specification does not reasonably convey that the inventor made or was otherwise in possession of any of the remaining members of the genus with at least 90% sequence or amino acid homology with ORFs 1–3. PO Resp. 53; Ex. 1026 ¶ 168. We find that Dr. Nordgren credibly characterizes the Specification, as follows: [T]he ’351 Patent outlines a preliminary research plan to eventually make and use the broad range of claimed proteins. That is, the inventor provides a number of DNA and primer sequences that could be used to clone homologous DNA sequences into an expression vector, and theorizes that proteins expressed from sequences having 90% sequence homology will be antigenic. Critically, however, the ’351 Patent does not disclose which of the thousands of different claimed homologous sequences, if any, the inventor possessed, much less had discovered to be antigenic. Instead, the inventor merely proposes, without any factual support, that PCV3-derived amino acid sequences “could vary by as much as 10% in sequence homology and still retain the[ir] antigenic characteristics.” Ex. 1001 at 8:49-56. A POSITA would not credit that unsupported speculation, and therefore would not believe that the inventors possessed such a wide range of proteins.” slip op. at 33
Patent outcomesUS 10,450,351 unpatentableClaim construction§ 112 disclosurecites GrahamPatents in suitUS 10,450,351 - 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
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.