- Genus PLC v. Inguran, LLCAll claims unpatentablePTAB · Dec 8, 2022 · IPR2021-01027 · APJ Ulrike W Jenks · IPR · Final written decision
Claims 1–5 are unpatentable as obvious over Dekkers, Maxwell, Garner, and Kim; the Board did not reach the alternative obviousness grounds.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“Patent Owner agrees with Petitioner’s first portion of the definition, specifically, that a person of ordinary skill in the art would have had at least “an undergraduate or graduate degree in genetics, genomics, and/or animal breeding, along with several years of relevant applied research and/or industry work experience in the same fields, including in swine.” PO Resp. 16. Patent Owner, however, objects to the inclusion of the second portion of Petitioner’s definition because it is “improperly injecting a purported knowledge of the claimed invention into the definition of a” person of ordinary skill in the art. Id. at 17 (citing Arendi S.A.R.L. v. Apple Inc., 832 F.3d 1355, 1362 (Fed. Cir. 2016); In re Sang Su Lee, 277 F.3d 1338, 1345 (Fed. Cir. 2002)); Sur-reply 2–4. Petitioner responds, that its proposed definition reflects the level of skill in the art as supported by the various cited prior art. Pet. Reply. 5. Having considered the arguments and evidence, we agree with Patent Owner that Petitioner’s definition of one of ordinary skill in the art unnecessarily recites specific knowledge, whereas the art itself demonstrates the level of skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown”) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). Accordingly, we agree with Patent Owner and determine that one of ordinary skill in the art is a person having at least “an undergraduate or graduate degree in genetics, genomics, and/or animal breeding, along with several years of relevant applied research and/or industry work experience in the same fields, including in swine” and this definition is reasonably consistent with the ’734 patent and the prior art of record.” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for patent owner
“Having considered the record as a whole, we determine that Petitioner’s position with respect to the interpretation of “genetic nucleus” is reasonably supported within the record. At oral argument, however, Petitioner acknowledged that omitting the language “wherein certain offspring of the herd are used for breeding within the herd” from the claim construction would not change whether the challenged claims read on the applied references. See Tr. 14:6–16:28. Because the additional language proposed by Petitioner is unnecessary in order to resolve the disputed issues in this case, we do not adopt it here. We, therefore, construe “genetic nucleus” as an animal herd comprising one or more lines and positioned at the top of a multi-level pyramidal hierarchy of herds in a commercial herd breeding structure. 2. Remaining Claim Terms We find that it is unnecessary to expressly construe any remaining claim terms for purposes of this Decision. 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)). D. Ground 1A: Anticipation of Claims 1–5 by Dekkers, as evidenced by either Maxwell or Garner (claims 1–4), or Kim (claim 5)” slip op. at 13
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“We agree with Patent Owner that in an anticipation challenge under 35 U.S.C. § 102, Petitioner cannot rely upon specific disclosures in Maxwell or Gardner based on the generic reference to these publications cited Dekkers. Merely citing Maxwell or Gardner in association with sorting sperm as discussed in Dekkers is not incorporation by reference with any level of particularity. See PO Resp. 29 (citing Callaway Golf Co. v. Acushnet Co., 576 F.3d 1331, 1346 (Fed. Cir. 2009) (To incorporate matter by reference, “a host document must contain language clearly identifying the subject matter which is incorporated and where it is to be found; a mere reference to another application, or patent, or publication is not an incorporation of anything therein.” (internal quote and citations omitted, emphasis in original)); see also Cook Biotech Inc. v. Acell, Inc., 460 F.3d 1365, 1376 (Fed. Cir. 2006) (“To incorporate material by reference, the host document must identify with detailed particularity what specific material it incorporates and clearly indicate where that material is found in the various documents.”). The disclosure in Dekkers relied on by Petitioner recites: “The technique involves the separation of spermatozoa carrying either X or Y chromosomes (Maxwell et al., 2004; Garner, 2006).” Ex. 1004, 396. We note that Maxwell and Garner are review articles discussing the state of sperm sexting technology generally. See Ex. 1005; Ex. 1006. We agree with Patent Owner that the generic citation to these review articles as set out in Dekkers is not an incorporation by reference of any specific detail from these articles. Unlike the disclosures at issue in Callaway and Cook, Dekkers does not use language such as “reference is made to” (Callaway, 576 F.3d at 1346) or “the disclosure of which is expressly incorporated herein by reference” (Cook, 460 F.3d at 1376) in conjunction with identifying a particular portion of the cited reference that our reviewing court has held to be sufficient to indicate to one of skill in the art that the referenced material is fully incorporated in the host document. Because Dekkers does not incorporate by reference the level of sorting accuracy as required by the claims – at least 80% – the preponderance of evidence of record does not support Petitioner’s position the Dekkers anticipates claims 1–5 of the ’734 patent.” slip op. at 19
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“We find that Petitioner has the better position. Here, Patent Owner is identifying the scope of the invention as the commercial tier at the bottom of the pig production pyramid. However, the scope of the claimed invention is directed to the substantially smaller herd sitting at the top of the commercial pig breeding pyramid. As explained in Teva, “[t]he reasonable-expectationof-success analysis must be tied to the scope of the claimed invention. See Allergan, Inc. v. Apotex Inc., 754 F.3d 952, 966 (Fed. Cir. 2014) (“[F]ailure to consider the appropriate scope of the ... claimed invention in evaluating the reasonable expectation of success ... constitutes a legal error ....”); see also Intelligent Bio-Sys., Inc., 821 F.3d at 1367.” Teva, 18 F.4th at 1381. Above, we construed “genetic nucleus” as an animal herd comprising one or more lines and positioned at the top of a multi-level pyramidal hierarchy in a commercial herd breeding structure. See above II.C.1. The herd at the top of the pyramid comprises far fewer animals than the multiplication and production tiers. See Ex. 1097 ¶¶ 65 (“the relatively smaller herd size of the genetic nucleus (e.g., hundreds or thousands as compared to millions at the production level) makes the use of sexed semen far easier than in vastly larger multiplier and production herds”), 84; Ex. 1096, 36:21–37:4; Ex. 2004, 39:6–22 (millions of animals at the production level). Petitioner contends that sperm sorting combined with lowdose insemination would have been practical for the much smaller herds found at the genetic nucleus. Pet. Reply 21. Both Maxwell and Garner reasonably suggest that deep-uterine insemination (DIU) allows for the use of sex sorted boar sperm. See Ex. 1005, 88; Ex. 1006, 952. Patent Owner admits that the use of sex-selected semen in the laboratory environment works. See PO Resp. 39. Even if the genetic nucleus (i.e. nuclear herd) comprises in excess of 100 or even 1000 animals it is not clear why using artificial insemination in conjunction with sex-selection would not work at the level of the genetic nucleus as argued by Patent Owner. See PO Resp. 39 (“sexed semen has not been implemented outside of a research setting”). Absolute predictability is not necessary to reach an obviousness determination; only a reasonable expectation of success is needed. Pharma Stem Therpeutic, Inc. v. ViaCell, Inc., 491 F.3d 1342, 1360 (2007); In re Kubin, 561 F.3d 1351, 1360 (Fed. Cir. 2009); In re O’Farrell, 853 F.2d 894, 903–904 (Fed. Cir. 1988) (“Obviousness does not require absolute predictability of success . . . . For obviousness under § 103, all that is required is a reasonable expectation of success.”). In particular, Dekkers teaches that sorted sperm can be used for artificial insemination. Specifically, acknowledging that “new developments in sperm sexing technology allow for the production of either male or female offspring for sire or dam lines, and this can be very useful for the nucleus and multiplication tiers.” Ex. 1004, 396; Ex. 1002 ¶ 48; see also Ex. 1055, 80 (“The main application by pig producers is for the use of sex-sorting technology in nucleus herds, particularly for producing female lines.”). Here, the evidence supports Petitioner’s contentions that given the” slip op. at 32
Patent outcomesUS 10,542,734 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 10,542,734 - Apple, Inc. v. Alivecor, Inc.All claims unpatentablePTAB · Dec 6, 2022 · IPR2021-00972 · APJ David Cotta · IPR · Final written decision
Claims 1–23 are unpatentable as obvious: claims 1, 5, 7–9, 11, 12, 16, 18–20, 22, and 23 over Shmueli and Osorio; remaining claims over combinations adding Lee-2013 or Chan.
RulingsFinal written decision- Skill levelSkill level board ownDecided for patent owner
“Patent Owner argues that we should reject our originally proposed definition in light of, for example, Petitioner’s proposed definition before the ITC, which required an engineering background and “at least two years of relevant work experience designing wearable devices and/or sensors for measuring physiological signals.” PO Resp. 27 (citing Ex. 2004, 6). As noted at oral argument, however, Patent Owner truncates the full extent of Petitioner’s ITC definition, which further states that “a hypothetical person of ordinary skill in the art could also be a person with a medical degree (MD or DO) and with at least two years of work experience using biomedical sensors and/or analyzing their data (in the context of industry, in biomedical academic research, or in practice treating patients).” Ex. 2004, 6; Tr. 40:13– 41:10. Patent Owner’s assertion that our originally proposed definition, would “classify all cardiologists as [persons of ordinary skill in the art],” is well taken. PO Resp. 25. Accordingly, we apply the following modified definition, which is consistent with Petitioner’s representation before the ITC. For the purpose of this proceeding, a person of ordinary skill in the art may be a member of an interdisciplinary team including persons with backgrounds in electrical engineering, mechanical engineering, biomedical engineering, computer science, and/or cardiology, and having at least two years of relevant work experience designing, using, or analyzing data from, cardiac monitoring devices.” slip op. at 24
- Expert testimonyPetitioner expert creditedPatent owner expert creditedMixed
“Dr. Efimov has extensive experience in the design of cardiac monitoring and related technologies, but Petitioner asserts that he “is unable to offer credible testimony on the meaning of [relevant] medical terminology,” because he is not a doctor. Reply 28; Sur-reply 22 (arguing that “Dr. Efimov is a recognized expert in the field of clinical cardiac electrophysiology”). Considering the totality of Dr. Efimov’s background, including extensive work on the physiology, diagnostics, and therapy of cardiac arrhythmias, we do not adopt Petitioner’s position. See, e.g., Ex. 2001 ¶¶ 2–15. In light of the above, we determine that Dr. Chaitman and Dr. Efimov are both qualified to testify as to the understanding of a person of ordinary skill in the art, we, nevertheless, consider the weight of both parties’ experts on a particular topic in light of the strengths and weaknesses of their respective background. C. Claim Construction” slip op. at 26
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” Id. “[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 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)). Petitioner offers a construction for the claim term “discordance,” proposing that it should be construed to mean “when a first sensed parameter value would not be expected to coincide with a second sensed parameter value.” Pet. 8–10. Patent Owner does not propose a competing construction and, in the ITC Investigation, proposed “[n]o construction required” for the term “discordance.” Ex. 2009, 4. Having reviewed the evidence and argument of record, we determine that we do not need to construe the term “discordance” in order to resolve this dispute. See Vivid Techs., 200 F.3d at 803 (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”). slip op. at 27
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“Patent Owner’s proposed construction is consistent with the intrinsic and extrinsic evidence. See e.g., Ex. 1047 (medical dictionary defining arrhythmias as “[a]n abnormal rate or rhythm of the heartbeat” caused by “a disturbance in the electrical impulses within the heart”); Ex. 1001, 4:4 (“Heart function is also measured in terms of regularity of rhythm. . . . When there is an abnormality of rhythm, the condition is typically referred to as an arrhythmia.”). Although it is not clear that the term is in dispute, for clarity, we understand the term “arrhythmia” as used in the context of the ’941 patent to mean: a cardiac condition in which the electrical activity of the heart is irregular or is faster (tachycardia) or slower (bradycardia) than normal.” slip op. at 28
Patent outcomesUS 10,638,941 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,638,941 - Apple, Inc. v. Alivecor, Inc.All claims unpatentablePTAB · Dec 6, 2022 · IPR2021-00971 · APJ Robert A Pollock · IPR · Final written decision
Claims 1–30 are unpatentable under § 103 over Shmueli alone or in combinations with Osorio, Li 2012, Kleiger, and Chan.
RulingsFinal written decision- Skill levelSkill level board ownPetitioner expert creditedOther
“Patent Owner’s assertion that our originally proposed definition, would “classify all cardiologists as POSITAs,” is well taken. Accordingly, we apply the following modified definition, which is consistent with Petitioner’s representation before the ITC. For the purpose of this proceeding, a person of ordinary skill in the art may be a member of an interdisciplinary team including persons with backgrounds in electrical engineering, mechanical engineering, biomedical engineering, computer science, and/or cardiology, and having at least two years of relevant work experience designing, using, or analyzing data from, cardiac monitoring devices.” slip op. at 27
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for patent owner
“Patent Owner notes that the ITC applied the plain and ordinary meaning to the terms “arrhythmia” and “confirm” or “confirming.” PO Resp. 21 (citing Ex. 2010, 12–13). We understand “arrhythmia” as used in the context of the ’731 patent refers to “a cardiac condition in which the electrical activity of the heart is irregular or is faster (tachychardia) or slower (bradycardia) than normal.” See id. at 24–25 (quoting Ex. 1001, 1:40–42). This term does not appear to be in dispute. See Tr. 21:18-22:3 (“[Board”]: . . . Patent Owner raised the issue of claim construction for the term arrhythmia. Is there any dispute there? [Petitioner’s counsel]: Honestly, Your Honor, we considered that -- put a lot 23 of energy into considering it. We don’t believe so.”); see also, Tr. 53:24-54:2 (“[Board]: . . . Your claim construction of arrhythmia is merely a matter of precision and clarification rather than a contested point; is that correct? [Patent Owner’s counsel]: I believe that’s largely correct.”). Patent Owner also asserts, and we agree, that “confirm” and “confirming” are discrete requirements from “detect” in claims 3, 5, 6, 19, 21, and 22. See id. at 25. Accepting these clarifications, we apply the plain and ordinary meaning to all claim terms. D. Ground 1: Obviousness over Shmueli” slip op. at 30
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
“sensor and “detect, based on the PPG data, the presence of an arrhythmia.”11 According to Petitioner, although Shmueli does not explicitly use the term arrhythmia, one of ordinary skill in the art reading Shmueli would have found it obvious that the text “Detect Irregular Heart Condition,” in element 38 of Shmueli’s Figure 7, refers to detecting the presence of arrhythmia based on PPG data. See Pet. 22–24; Ex. 1003 ¶¶ 47–51. For the purpose of instituting trial, we determined that “one of ordinary skill in the art would have understood Shmueli’s use of ‘irregular heart condition’ as referring to—or at a minimum, encompassing— arrhythmia, and, thus, disclosing the detection of arrhythmia.” DI 33–34. As discussed below, the arguments and evidence adduced at trial confirm our initial understanding.” slip op. at 31
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“pages 17–18 of Petitioner’s Reply, which we adopt in full. In short, Osorio relates to medical device systems and methods capable of detecting a pathological body state of a patient. Ex. 1005 ¶ 2. As discussed above, we do not read Osorio as limiting “pathological state” to epilepsy or other neurological condition. To the contrary, one of ordinary skill in the art would have understood Osorio’s teachings applicable to “any pathological state,” including arrythmia. See e.g., id. at 44. As such, the references are not directed to different problems as Patent Owner urges. Further, even if one of ordinary skill in the art were to read Osorio as limited to the detection neurological events such as epilepsy, Osorio contains express teachings to monitor heart rate and heart rate variability for signs of arrhythmia. See Ex. 1005 ¶¶ 42, 43, 45, 46, 71; Ex. 1069, 58:23–59:3; 61:13–62:7. Whether Osorio’s detection of arrhythmias is viewed as a standalone goal, or as data for use in monitoring for epileptic seizures, does not materially affect the analysis. “Because Shmueli already renders arrhythmia detection obvious and Osorio motivates use of activity tracking to improve detection of any heart-related pathological conditions,” including arrhythmias, it is irrelevant whether Osorio’s ultimate goal is the detection of neurological events. Reply 18 (citing Pet. 23–24; Ex. 1004, 13:9–17, Fig. 7). With respect to Patent Owner’s reliance on Adidas, it is well established that a finding of obviousness does not require that all features of a secondary reference are “bodily incorporated into the structure of the primary reference.” In re Keller, 642 F.2d 413, 425 (CCPA 1981). Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. Id. “[I]f a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill.” KSR, 550 U.S. at 417. In the present case, we do not understand Petitioner to argue for the wholesale incorporation of Osorio into Shmueli’s device. Rather, Petitioner more narrowly argues that one of ordinary skill in the art would find it obvious to incorporate two elements of Osorio into Shmueli’s device: “using activity level monitoring to improve the accuracy of detecting a pathological event (e.g., arrhythmia), and (ii) determining HRV from HR and using HRV to detect the pathological event (e.g., arrhythmia),” because, for example, “HRV analysis is more robust . . . and is less affected by noise.” Pet. 30, 43–44, 48–49; see generally Ex. 1003 ¶¶ 151–167. Thus, even were Osorio ultimately limited to the detection of neurological events, Patent Owner’s suggestion that these targeted improvements would render Shmueli’s device inoperable for its intended purpose is unavailing. In view of the above, and all the argument and evidence adduced at trial, Petitioner has established sufficiently that one of ordinary skill in the” slip op. at 47
Patent outcomesUS 10,595,731 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,595,731 - Apple, Inc. v. Alivecor, Inc.All claims unpatentablePTAB · Dec 6, 2022 · IPR2021-00970 · APJ Robert A Pollock · IPR · Final written decision
Claims 1–20 are unpatentable: claims 1–6, 10–16, and 20 as obvious over Shmueli and Osorio; claims 7–9 and 17–19 as obvious over those references and Hu 1997.
RulingsFinal written decision- Skill levelSkill level board ownOther
“truncates the full extent of Petitioner’s ITC definition, which further states that “a hypothetical person of ordinary skill in the art could also be a person with a medical degree (MD or DO) and with at least two years of work experience using biomedical sensors and/or analyzing their data (in the context of industry, in biomedical academic research, or in practice treating patients)”. Ex. 2004, 6; Tr. 40:13–41:10. Patent Owner’s assertion that our originally proposed definition, would “classify all cardiologists as POSITAs,” is well taken. Accordingly, we apply the following modified definition, which is consistent with Petitioner’s representation before the ITC. For the purpose of this proceeding, a person of ordinary skill in the art may be a member of an interdisciplinary team including persons with backgrounds in electrical engineering, mechanical engineering, biomedical engineering, computer science, and/or cardiology, and having at least two years of relevant work experience designing, using, or analyzing data from, cardiac monitoring devices.” slip op. at 25
- Expert testimonyPetitioner expert creditedPatent owner expert creditedOther
“the art even under Patent Owner’s then-proposed definition. See DI 26–28. Despite Patent Owner’s subsequent position that the ordinarily skilled artisan should have an engineering degree and “design experience” in developing wearable cardiac sensors, the arguments and evidence adduced at trial do not alter our initial determination. See, e.g., PO Resp. 37–41; Reply 27–28; Sur-reply 22–24; see generally Tr. 40:25–46:19, 55:2–56:13. Rather, we agree with Petitioner’s argument in support of Dr. Chaitman’s qualifications, that this proceeding involves “piecing together known technologies and . . . the analysis of cardiac data” including PPG data, ECG data and activity level. Tr. 38:4–18. Thus, one of ordinary skill in the art with an understanding of cardiac monitoring technology “would understand how these types of data work, how they interplay and how the data could be processed on these devices.” Id.” slip op. at 26
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Plain and ordinary meaningOther
“meaning to the terms “arrhythmia,” “alert,” and “heart rate monitor.” PO Resp. 32 (citing Ex. 2010, 12–13). We understand “arrhythmia” as used in the context of the ’499 patent refers to “a cardiac condition in which the electrical activity of the heart is irregular or is faster (tachycardia) or slower (bradycardia) than normal.” Id. at 31–36 (quoting Ex. 1001, 1:31–33). This term does not appear to be in dispute. See Tr. 21:18–22:3 (“[Board”]: . . . Patent Owner raised the issue of claim construction for the term arrhythmia. Is there any dispute there? [Petitioner’s counsel]: Honestly, Your Honor, we considered that -- put a lot of energy into considering it. We don’t believe so.”); see also id. at 53:24–54:2 (“[Board]: . . . Your claim construction of arrhythmia is merely a matter of precision and clarification rather than a contested point; is that correct? [Patent Owner’s counsel]: I believe that’s largely correct.”). With the above understanding, we apply the plain and ordinary meaning to all claim terms. D. Ground 1: Obviousness over Shmueli and Osorio” slip op. at 27
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
“In light of the above, and all the evidence adduced at trial, we agree with Petitioner that one of ordinary skill in the art would have understood Shmueli to teach or disclose methods and systems for “determining the presence of an arrhythmia,” as required by the challenged claims.” slip op. at 36
Patent outcomesUS 9,572,499 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,572,499 - TCL Industries Holdings Co., Ltd. / LG Electronics Inc. v. Parkervision, Inc.All claims unpatentablePTAB · Nov 21, 2022 · IPR2022-00245 · APJ Bart A Gerstenblith · IPR · Final written decision
Claims 2–4 are unpatentable as obvious over Lam, Enz, and Tayloe; claims 2 and 3 are also unpatentable as obvious over Tayloe and the TI Datasheet.
RulingsFinal written decision- Skill levelSkill level board ownDecided for petitioner
“Neither party contends that the difference in their proposals affects the outcome of this proceeding and we do not find that it does. Nonetheless, on the full record before us, we find that our identification of the level of ordinary skill in art in the Institution Decision as well as Patent Owner’s option (b) are supported by the prior art of record, the ’444 patent, and the opinion of Dr. Steer. Accordingly, we modify our preliminary finding to include option (b) from Patent Owner’s proposal. Thus, we find that one of ordinary skill in the art would have had 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 12
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for petitioner
“To act as its own lexicographer, a patentee must ‘clearly set forth a definition of the disputed claim term’ other than its plain and ordinary meaning.” Thorner, 669 F.3d at 1366 (citing CCS Fitness, 288 F.3d at 1366). “It is not enough for a patentee to simply disclose a single embodiment or use a word in the same manner in all embodiments, the patentee must ‘clearly express an intent’ to redefine the term.” Id. (citing Helmsderfer v. Bobrick Washroom Equip., Inc., 527 F.3d 1379, 1381 (Fed. Cir. 2008); Kara Tech. Inc. v. Stamps.com, 582 F.3d 1341, 1347–48 (Fed. Cir. 2009)). That is precisely what the patentees did in the above-passage. Specifically, we find that they clearly set forth a definition that is different than the plain and ordinary meaning and, in so doing, clearly expressed an intent to redefine the term. That the patentees intended to redefine the term “storage module” is clearly expressed by the use of “as used herein”16 and “refers to” in the above-passage and is consistent with the patentees’ use of these same phrases when defining other terminology in the ’551 patent, as discussed above. slip op. at 18
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner
“Generally . . . the preamble does not limit the claims.” Am. Med. Sys., Inc. v. Biolitec, Inc., 618 F.3d 1354, 1358 (Fed. Cir. 2010). A term in the preamble is a limitation only if it “recites essential structure or steps, or if it is ‘necessary to give life, meaning, and vitality’ to the claim.” TomTom, 790 F.3d at 1323. We agree with Petitioners that “wireless modem apparatus,” as recited in the preambles of claims 2 and 3, is not limiting. In particular, “wireless modem apparatus” does not provide antecedent basis for any term subsequently recited in claims 2–4; it does not provide any essential structure because the body of the claim recites a structurally complete invention; and it is not necessary to give life, meaning, and vitality to the claim. Further, Patent Owner’s argument that the preamble is limiting because it makes clear that the input signal is input to a wireless modem apparatus is unavailing because the body of claims 2 and 3 expressly recite, as the first element, “a receiver for frequency down-converting an input signal.” See Ex. 1001, 60:48–49 (claim 2), 61:2–3 (claim 3). And, Patent Owner’s arguments make clear that its attempt to read “wireless modem apparatus” as limiting is solely for the purpose of arguing that claims 2–4 require a transmitter, which is a structural element that is not recited in the claims. See, e.g., PO Resp. 72 (arguing that Tayloe does not disclose a transmitter), 79 (raising the same arguments directed to Lam). When the patentees intended to limit a claim to a transmitter, they expressly recited a transmitter in the body of the claim. See, e.g., Ex. 1001, 61:25–57 (Claim 6 recites “[a] wireless modem apparatus, comprising,” and expressly recites “a receiver” and “a transmitter” in the body of the claim.). Accordingly, for each of these reasons, we find that “wireless modem apparatus” recited in the preambles of claims 2 and 3 is not limiting. slip op. at 23
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“On the full record before us, none of the parties’ arguments nor the outcome of this proceeding hinge on the construction of these additional terms. Accordingly, we need not construe them expressly to resolve the present disputes between the parties. See Nidec Motor Corp., 868 F.3d at 1017.” slip op. at 24
Patent outcomesUS 7,110,444 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 7,110,444 - TCL Industries Holdings Co., Ltd. / LG Electronics Inc. v. Parkervision, Inc.All claims unpatentablePTAB · Nov 21, 2022 · IPR2021-00990 · APJ Bart A Gerstenblith · IPR · Final written decision
Claims 2–4 are unpatentable under §103: claims 2–3 over Tayloe and the TI Datasheet, and claims 2–4 over Lam, Enz, and Tayloe.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner’s option (a) is substantially the same as Petitioners’ proposal—both require a bachelor’s degree in the same or a related subject and two additional years of related work experience. Patent Owner’s option (b) adds an additional option based on work experience in lieu of a formal degree. Neither party contends that the difference in their proposals affects the outcome of this proceeding and we do not find that it does. Nonetheless, on the full record before us, we find that our identification of the level of ordinary skill in art in the Institution Decision as well as Patent Owner’s option (b) are supported by the prior art of record, the ’444 patent, and the opinion of Dr. Steer. Accordingly, we modify our preliminary finding to include option (b) from Patent Owner’s proposal. Thus, we find that one of ordinary skill in the art would have had 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 12
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for petitioner
“The terms storage module and storage capacitance, as used herein, are distinguishable from the terms holding module and holding capacitance, respectively. Holding modules and holding capacitances, as used above, identify systems that store negligible amounts of energy from an under-sampled input EM signal with the intent of “holding” a voltage value. Storage modules and storage capacitances, on the other hand, refer to systems that store non-negligible amounts of energy from an input EM signal. Ex. 2029, 66:59–67 (emphases added); see Ex. 2016, 39–40 (discussing Patent Owner’s prior arguments to construe “storage module” in IPR2014- 00948). When defining certain terms in a section titled “General Terminology,” the ’551 patent repeatedly uses the phrase “when used herein” in combination with the phrase “refer(s) to.” See, e.g., Ex. 2029, 13:56–15:27 (mentioning a term followed by “when used herein,” followed by “refers to,” followed by a definition). For example, the ’551 patent states, “[t]he term digital signal, when used herein, refers to a signal that changes between discrete states, as contrasted to a signal that is continuous.” Id. at 15:7–9. As shown, the ’551 patent defines “digital signal” by stating “when used herein” followed by “refers to.” And, the same sentence also provides a comparison between “digital signal” and a signal that is continuous. Even though the passage describing “storage module” is not listed under the “General Terminology” section of the ’551 patent, the passage provides the same indications that the patentees clearly and unambiguously intended to define the term “storage module” by stating “as used herein” and “refer to”—hallmarks that the patentees were providing a lexicographic definition of the term. Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 679 (Fed. Cir. 2015) (“An applicant’s use of the phrase ‘refers to’ generally indicates an intention to define a term.”) (citing In re Imes, 778 F.3d 1250, 1252–53 (Fed. Cir. 2015); Microsoft Corp. v. Int’l Trade Comm’n, 731 F.3d 1354, 1360 (Fed. Cir. 2013); Linear Tech. Corp. v. Int’l Trade Comm’n, 566 F.3d 1049, 1054 (Fed. Cir. 2009)). Additionally, as with the term “digital signal,” the above-passage provides a comparison between “storage module” and “holding module” and uses the definitions of the terms to compare and contrast them. “To act as its own lexicographer, a patentee must ‘clearly set forth a definition of the disputed claim term’ other than its plain and ordinary meaning.” Thorner, 669 F.3d at 1366 (citing CCS Fitness, 288 F.3d at 1366). “It is not enough for a patentee to simply disclose a single embodiment or use a word in the same manner in all embodiments, the patentee must ‘clearly express an intent’ to redefine the term.” Id. (citing Helmsderfer v. Bobrick Washroom Equip., Inc., 527 F.3d 1379, 1381 (Fed. Cir. 2008); Kara Tech. Inc. v. Stamps.com, 582 F.3d 1341, 1347–48 (Fed. Cir. 2009)). That is precisely what the patentees did in the above-passage. Specifically, we find that they clearly set forth a definition that is different than the plain and ordinary meaning and, in so doing, clearly expressed an intent to redefine the term. That the patentees intended to redefine the term “storage module” is clearly expressed by the use of “as used herein”16 and “refers to” in the above-passage and is consistent with the patentees’ use of these same phrases when defining other terminology in the ’551 patent, as discussed above.” slip op. at 17
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner
“Generally . . . the preamble does not limit the claims.” Am. Med. Sys., Inc. v. Biolitec, Inc., 618 F.3d 1354, 1358 (Fed. Cir. 2010). A term in the preamble is a limitation only if it “recites essential structure or steps, or if it is ‘necessary to give life, meaning, and vitality’ to the claim.” TomTom, 790 F.3d at 1323. We agree with Petitioners that “wireless modem apparatus,” as recited in the preambles of claims 2 and 3, is not limiting. In particular, “wireless modem apparatus” does not provide antecedent basis for any term subsequently recited in claims 2–4; it does not provide any essential structure because the body of the claim recites a structurally complete invention; and it is not necessary to give life, meaning, and vitality to the claim. Further, Patent Owner’s argument that the preamble is limiting because it makes clear that the input signal is input to a wireless modem apparatus is unavailing because the body of claims 2 and 3 expressly recite, as the first element, “a receiver for frequency down-converting an input signal.” See Ex. 1001, 60:48–49 (claim 2), 61:2–3 (claim 3). And, Patent Owner’s arguments make clear that its attempt to read “wireless modem apparatus” as limiting is solely for the purpose of arguing that claims 2–4 require a transmitter, which is a structural element that is not recited in the claims. See, e.g., PO Resp. 72 (arguing that Tayloe does not disclose a transmitter), 79 (raising the same arguments directed to Lam). When the patentees intended to limit a claim to a transmitter, they expressly recited a transmitter in the body of the claim. See, e.g., Ex. 1001, 61:25–57 (Claim 6 recites “[a] wireless modem apparatus, comprising,” and expressly recites “a receiver” and “a transmitter” in the body of the claim.). Accordingly, for each of these reasons, we find that “wireless modem apparatus” recited in the preambles of claims 2 and 3 is not limiting. slip op. at 23
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“Additional Terms Petitioners propose that we construe the following three terms: “frequency down-conversion module,” “subtractor module,” and “under-samples.” Pet. 15–18. Patent Owner responds to Petitioners’ constructions for “frequency down-conversion module” and “subtractor module.” PO Resp. 39–41. On the full record before us, none of the parties’ arguments nor the outcome of this proceeding hinge on the construction of these additional terms. Accordingly, we need not construe them expressly to resolve the present disputes between the parties. See Nidec Motor Corp., 868 F.3d at 1017.” slip op. at 24
Patent outcomesUS 7,110,444 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 7,110,444 - TCL Industries Holdings Co., Ltd. / LG Electronics Inc. v. Parkervision, Inc.All claims unpatentablePTAB · Nov 17, 2022 · IPR2022-00246 · APJ Bart A Gerstenblith · IPR · Final written decision
Claims 1, 12–15, and 17–20 are unpatentable as obvious over the prior-art combinations; the Board did not reach the alternative grounds.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“the full record before us, we find that our identification of the level of ordinary skill in art in the Institution Decision as well as Patent Owner’s option (b) are supported by the prior art of record, the ’835 patent, and the opinion of Dr. Steer. Accordingly, we modify our preliminary finding to include option (b) from Patent Owner’s proposal. Thus, we find that one of ordinary skill in the art would have had 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 13
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner
“preamble of claim 1, is not limiting. In particular, “cable modem” does not provide antecedent basis for any term subsequently recited in claim 1, it does not provide any essential structure because the body of the claim recites a structurally complete invention, and “cable modem” is not necessary to give life, meaning, and vitality to the claim. Further, Patent Owner fails to raise any arguments on these issues to the contrary. Accordingly, for each of these reasons, we find that “cable modem” is not limiting.” slip op. at 24
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for petitioner
“the construction of “frequency translation module,” but that is inapposite because none of the parties’ arguments nor the outcome of this proceeding hinge on the construction of this term. Accordingly, we need not construe it expressly to resolve the present dispute between the parties. See Nidec Motor Corp., 868 F.3d at 1017.” slip op. at 26
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“differently than the Federal Circuit in ParkerVision. Accordingly, because this specific issue of what amounts to “non-negligible amounts of energy” was already decided by the Federal Circuit, we construe this term to mean “energy in amounts that are distinguishable from noise.”30” slip op. at 55
Patent outcomesUS 7,292,835 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 7,292,835 - TCL Industries Holdings Co., Ltd. / LG Electronics Inc. v. Parkervision, Inc.All claims unpatentablePTAB · Nov 17, 2022 · IPR2021-00985 · APJ Bart A Gerstenblith · IPR · Final written decision
The Board held claims 1, 12–15, and 17–20 unpatentable as obvious, including over Hulkko and Gibson and over Gibson and Schiltz.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner
“preamble of claim 1, is not limiting. In particular, “cable modem” does not provide antecedent basis for any term subsequently recited in claim 1, it does not provide any essential structure because the body of the claim recites a structurally complete invention, and “cable modem” is not necessary to give life, meaning, and vitality to the claim. Further, Patent Owner fails to raise any arguments on these issues to the contrary. Accordingly, for each of these reasons, we find that “cable modem” is not limiting.” slip op. at 24
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“the construction of “frequency translation module,” but that is inapposite because none of the parties’ arguments nor the outcome of this proceeding hinge on the construction of this term. Accordingly, we need not construe it expressly to resolve the present dispute between the parties. See Nidec Motor Corp., 868 F.3d at 1017.” slip op. at 26
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“differently than the Federal Circuit in ParkerVision. Accordingly, because this specific issue of what amounts to “non-negligible amounts of energy” was already decided by the Federal Circuit, we construe this term to mean “energy in amounts that are distinguishable from noise.”30” slip op. at 55
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“argument regarding the second alternative persuasive. In particular, the distinction Patent Owner seeks to draw between Hulkko and Gibson generally, does not undermine Petitioners’ argument and evidence that the particular structures proposed for combination are substantially similar, operate in a similar manner, and would have been expected, by one of ordinary skill in the art, to function predictably and with a reasonable expectation of success, once combined. Notably, we find particularly persuasive Hulkko’s teaching to use its switched capacitors as a mixer to perform down-conversion, which is the same function as Gibson’s mixers. See Ex. 1004, 5:39–49 (“switched capacitor switching elements . . . are used to implement the mixer 11 which directly demodulates the IF-signal into a base-frequency signal”). Accordingly, we find that the combination of Hulkko and Gibson teaches element [1B] and that one of ordinary skill in the” slip op. at 42
Patent outcomesUS 7,292,835 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 7,292,835 - Pfizer, Inc. v. Uniqure Biopharma B.V.All claims unpatentablePTAB · Nov 15, 2022 · IPR2021-00928 · APJ Robert A Pollock · IPR · Final written decision
Claims 1–6 are unpatentable as anticipated by Stafford and obvious over Stafford, alone or with Manno and Schuettrumpf.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“In our Decision on Institution, although we agreed with Patent Owner that the ordinarily skilled artisan would have experience in the treatment of coagulopathy, we applied a broader definition of a person of ordinary skill in the art, as articulated by Drs. Wang and Pedersen. See DI 11 (citing Ex. 1003 ¶ 48; Ex. 1094 ¶ 19). We determined a person of ordinary skill in the art would have the skill of a research team working to develop factor IX variants and gene therapies, where that team would include “(1) one or more researchers with experience in the fields of molecular biology and virology and the use of gene therapy for treatment of coagulopathies, working together with (2) one or more individuals with experience in protein structure or engineering; and where the individuals working on the team have an advanced degree and several years of experience in a relevant discipline. See id. Patent Owner states its positions on patentability of the challenged claims “would not change under that construction or Petitioner’s proposed definition ....” PO Resp. 13. Accordingly, we apply the definition of a person of ordinary skill in the art set forth supra and in our Decision on Institution.” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Plain and ordinary meaningOther
“In the Petition, Petitioner proposed constructions for five terms: “vector,” “percentage identity,” “promoter,” and “percentage homology,” and “polypeptide precursor.” Pet. 12–14. In our Decision on Institution, we determined that we did not need to explicitly construe any claim terms at that stage of the proceeding. DI 12. Patent Owner “does not believe any term requires construction for this proceeding.” PO Resp. 13. Considering the arguments and evidence of record, we agree with Patent Owner and apply the plain and ordinary meaning to all claim terms. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“we need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 12
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“In sum, Stafford discloses (and claims) preferred Factor IX variants for the treatment of hemophilia B, wherein arginine 338 is replaced with, at most, one of three amino acids having similar properties: alanine, leucine, or valine. Ex. 1004, 5, claims 3–5, 10, 14; Ex. 1094 ¶ 104. Stafford further discloses vectors and associated control elements that “may be used in gene therapy to administer the expression cassette to targeted [sic] cells within the patient and produce the Factor IX in the patient.” Ex. 1004, 6–7. In addition to listing various general classes of potential expression vectors, Stafford specifically names four DNA-based viruses including AAV for the construction of vectors: “papillomavirus, adenovirus, adeno-associated virus, [and] cytomegalovirus.” Id.; Ex. 1003 ¶¶ 41, 77–78, 315. Because Stafford’s claims 15 and 17–19 describe a DNA viral vector encoding a FIX variant (of which Stafford names four), and because Stafford specifies three (if not two) preferred amino acid variants, “a POSA would have faced twelve possible combinations of DNA vector and preferred FIX variant for gene therapy.” See Ex. 1003 ¶¶ 321–323.8 Moreover, crediting 8 As previously noted, Dr. Wang misstates, in part, the dependency of Stafford’s claims. See DI 27 (citing Ex. 1003 ¶ 323). Although Stafford’s Dr. Wang’s testimony that, as of the time of the invention, “AAV vectors were considered the leading candidate for useful human gene therapy vectors, and were being used routinely in the hemophilia B field” (Ex. 1003 ¶ 39; see also id. at ¶¶ 32–36, 88, 323), we find that one of ordinary skill in the art would read Stafford as disclosing all elements of claim 1, “arranged as in the claim.” See Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008). As noted above, Patent Owner does not separately argue dependent claims 3–6. We have reviewed Petitioner’s evidence and argument, and agree with Petitioner that Stafford discloses all limitations of claims 3–6.” slip op. at 26
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“recited in the challenged claims. In sum, considering the record as a whole, we agree with Dr. Wang’s testimony that one of ordinary skill in the art would have found the challenged claims obvious in view of Stafford. Ex. 1003 ¶¶ 348–370. We also do not find persuasive Patent Owner’s argument that a person of ordinary skill in the art reading Stafford would have had serious concerns regarding whether R338L would be expressed. As discussed above, Stafford discloses successful expression of R338A in vitro. As Dr. Wang explains, given that Stafford demonstrated in vitro expression for numerous other variants in the 330–338 helix region of FIX, only R338P showed reduced expression, and unlike leucine, “proline [P] is a known ‘helix breaker.’” Ex. 1004, 14–15; Ex. 1100 ¶¶ 113–116, 225; see also Ex. 1100 ¶¶ 117–121. As such, we agree with Dr. Wang that one of ordinary skill in the art would not have expected difficulties in the expression of R338L. We also find unavailing Patent Owner’s argument that a person of ordinary skill would not have expected in vivo expression of FIX-R338L at levels similar to that of wild-type FIX. To the contrary, Schuettrumpf supports a conclusion that a person of ordinary skill would have expected that gene therapy with FIX-R338A expressed in vivo from liver cells at levels similar to wild-type FIX. See Reply 13 (citing Ex. 1005, 2, 4; Ex. 2114, 53:13–55:14; Ex. 1100 ¶¶ 113–116, 225). As Dr. Wang testified, this would have suggested to a person of ordinary skill that FIX-R338L would express at a similar level. Ex. 2114, 53:13–55:14; Ex. 1100 ¶¶ 113– 16; see also Ex. 1001, 4:45–58 (’180 patent’s teaching that it was expected that conservative amino acid substitutions (e.g. alanine and leucine) “would not change phenotype of the proteins”). We do not find persuasive Patent Owner’s argument that a person of ordinary skill in the art reading Stafford would have had serious concerns regarding whether R338L would be active. To the contrary, we credit Dr. Wang’s testimony that one of ordinary skill in the art would have expected the R338L variant to exhibit higher activity than wild-type Fix based, for example, on Stafford and Schuettrumpf showing that R338A exhibited higher activity in vitro and in vivo, respectively, and the similarities between alanine and leucine. See, e.g., Ex. 1003 ¶¶ 40, 42, 158, 219, 383, Ex. 1100 ¶¶ 101–112; see also Ex. 1094 ¶¶ 41–45, Ex. 1100 ¶¶ 23–36 (Dr. Pederson’s explanation of why one of ordinary skill would have expected replacing arginine 338 with leucine would have a similar effect as replacing it with alanine). Stafford’s disclosure that numerous mutations in the FIX 330–337” slip op. at 44
Patent outcomesUS 10,465,180 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,465,180 - Pfizer, Inc. v. Uniqure Biopharma B.V.All claims unpatentablePTAB · Nov 15, 2022 · IPR2021-00926 · APJ Julia Heaney · IPR · Final written decision
Claims 2, 4–6, 11–13, 17, and 18 are unpatentable as obvious over Stafford and Manno; claims 2, 5, 6, 11–13, 17, and 18 are also anticipated or obvious over Monahan.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“In our Decision on Institution, although we agreed with Patent Owner that the ordinarily skilled artisan would have experience in the treatment of coagulopathy, we applied a broader definition of a person of ordinary skill in the art, as articulated by Drs. Wang and Pedersen. See Ex. 1003 ¶ 48; Ex. 1094 ¶ 19. We determined a person of ordinary skill in the art would have the skill of a research team working to develop factor IX variants and gene therapies, where that team would include “(1) one or more researchers with experience in the fields of molecular biology and virology and the use of gene therapy for treatment of coagulopathies, working together with (2) one or more individuals with experience in protein structure or engineering;” and where the individuals working on the team have an advanced degree and several years of experience in a relevant discipline. See id. Patent Owner states its positions on patentability of the challenged claims “would not change under that construction or Petitioner’s proposed definition ....” PO Resp. 13. Accordingly, we apply the definition of a person of ordinary skill in the art set forth supra and in our Decision on Institution.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“We agree with Petitioner that the ’248 patent provides an express definition of “treat” and “treatment.” The Specification states, “[i]n the present text the term ‘treat’ or ‘treatment’ of a pathology means the prophylaxis and/or therapy and/or cure of this pathology.” Ex. 1001, 5:19– 21. This definition includes “cure” as a separate concept from therapy, and further provides that therapy includes “partial or total” alleviation of symptoms. Id. at 5:21–24. The ’248 patent does not define or otherwise describe “treating a coagulopathy” as requiring any specific duration of therapeutic efficacy; therefore, a person of ordinary skill in the art would understand that partial alleviation of symptoms and a shorter duration of therapeutic efficacy is encompassed in “treating a coagulopathy” as recited in claim 1. Claim 16, which depends from claim 1, supports a construction of “treating a coagulopathy” that does not require complete alleviation of symptoms or permanent therapeutic efficacy. Claim 16 recites the “modified FIX polypeptide is expressed at a level that reduces and/or prevents hemorrhages.” Ex. 1001, 46:34–36. Because claim 16 depends from claim 1, this means that “treating a coagulopathy” as recited in claim 1 encompasses merely reducing hemorrhages, i.e., partial alleviation of symptoms. Accordingly, based on the intrinsic evidence, including the express definition of the terms “treat” and “treatment,” we construe “treating a coagulopathy” as prophylaxis and/or therapy and/or cure of the coagulopathy which includes partial alleviation of symptoms, for any duration of therapeutic efficacy. We determine that we need not explicitly construe any other claim terms.” slip op. at 11
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateDecided for petitioner
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date, deniedReference is prior artDecided for petitioner
“the earlier application must disclose the claimed invention “in the manner provided by § 112(a) (other than the requirement to disclose the best mode).” 35 U.S.C. §§ 119(e), 120. Section 112(a) requires that the specification contain a written description of the claimed invention. 35 U.S.C. § 112(a). “[T]he hallmark of written description is disclosure.” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). The written description requirement is met when the specification “conveys to those skilled in the art that the inventor had possession of” and “actually invented” the claimed subject matter. Id. The purpose of the written description requirement is to ensure that a patent’s claims “do[] not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification.” Reiffin v. Microsoft Corp., 214 F.3d 1342, 1345 (Fed. Cir. 2000). The Federal Circuit has stated: The question is not whether a claimed invention is an obvious variant of that which is disclosed in the specification. Rather, a prior application itself must describe an invention, and do so in sufficient detail that one skilled in the art can clearly conclude that the inventor invented the claimed invention as of the filing date sought. Lockwood v. Am. Airlines, 107 F.3d 1565, 1572 (Fed. Cir. 1997).” slip op. at 21
Patent outcomesUS 9,982,248 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 9,982,248
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.