- PTAB · May 14, 2025 · IPR2025-00026 · APJ Deborah Katz · IPR · Institution
Instituted IPR of claims 1–10 on all asserted grounds after finding a reasonable likelihood that claim 1 is unpatentable over Porreca and declining § 325(d) denial.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Director determines that the information presented in the petition filed under section 311 and any response filed under section 313 shows that 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). We determine whether to institute inter partes review on behalf of the Director. See 37 C.F.R. § 42.4(a).” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“(1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims.” slip op. at 42
- Skill levelSkill level board ownOther
“Patent Owner asserts that Petitioner’s definition requiring a Ph.D. or a Master’s degree and several years of experience indicates higher than ordinary skill because by 2008 next generation sequencing was performed in laboratories according to published protocols and would have been accessible to experienced laboratory technicians and graduate students. (Prelim. Resp. 8.) Patent Owner proposes that, instead, the appropriate level of ordinary skill in the art was a Ph.D. in a field related to molecular biology, or a B.S. or M.S. degree with three to five years of experience working in a molecular biology lab. (See id.) On this preliminary record, having considered Dr. Metzker’s testimony and Patent Owner’s reasoning, we agree that one of ordinary skill in the art would have had experience with next generation sequencing, but are not persuaded that this would only be possible in the field of molecular biology. For the purposes of this Decision, we find a person of ordinary skill would have had a Ph.D. in the field of chemistry, molecular biology, or biochemistry or a B.S. or M.S. degree with three to five years of experience working in any of those fields. The person of ordinary skill would have had experience with next generation sequencing methods and a working knowledge of how those methods functioned. This definition of a person of ordinary skill is consistent with the skill level reflected in the disclosures of the ’357 patent and prior art. We further note that neither aspect of the dispute over the skill level affects our decision to institute review. C. Claim Construction” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“Petitioner argues that we should construe the claim term “adaptor” as “any oligonucleotide that is attached to the target sequence.” (See Pet. 9.) Petitioner cites the ’357 patent as referring to an “adaptor” as “an oligonucleotide sequence, the ligation of which to a target polynucleotide or a target polynucleotide strand of interest enables the generation of amplification-ready products of the target polynucleotide or the target polynucleotide strand of interest.” (Ex. 1002, 4:20-25; see Pet. 9–10.) According to Petitioner, this described function can be performed by any oligonucleotide. (See Pet. 10.) Petitioner also cites the Examiner’s reasoning during prosecution that “since any oligonucleotide can perform such function, any oligonucleotide is considered to anticipate this term.” (See Pet. 10 (citing Ex. 1013, 77).) Petitioner further cites the specification of the ’357 patent and claims of the ’241 patent, which is a continuation of the ’357 patent, in support of this construction. (See Pet. 9–10 (citing Ex. 1002, 9:43–46 (“appending the adaptor to the nucleic acid fragments generated by methods described herein can be achieved using a ligation reaction or a priming reaction.”) (emphasis omitted); Ex. 1001, claim 10).) Patent Owner does not dispute this construction at this stage, arguing only that the term need not be construed beyond its plain and ordinary meaning and reserving the right to propose constructions and identify terms needing construction later in the proceeding. (See Prelim. Resp. 9.) For the purposes of this decision, we adopt Petitioner’s construction of the term “adaptor,” although we note that it does not affect our decision to institute review. D. Ground I – Anticipation by Porreca” slip op. at 9
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,098,357 - PTAB · Sep 23, 2024 · IPR2024-00622 · APJ Sheridan K Snedden · IPR · Institution
The Board instituted IPR on claims 1, 6–11, 13–20, 22–24, and 26–28 on all petitioned grounds, finding a reasonable likelihood of success and declining discretionary denial.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“the . . . .” 35 U.S.C. § 102(a). To be anticipated, each and every element of the claim must be found, either expressly or inherently described, in a single prior art reference. See Atofina v. Great Lakes Chem. Corp., 441 F.3d 991, 999 (Fed. Cir. 2006). When claim elements are inherently taught, the result must be a necessary consequence of what was deliberately intended, but the prior art need not demonstrate that the authors appreciated the results. See Mehl/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1366 (Fed. Cir. 1999); see Schering Corp. v. Geneva Pharm., Inc., 339 F.3d 1373, 1377 (Fed. Cir. 2003) (“At the outset, this court rejects the contention that inherent anticipation requires recognition in the prior art.”).” slip op. at 11
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“the . . . .” 35 U.S.C. § 102(a). To be anticipated, each and every element of the claim must be found, either expressly or inherently described, in a single prior art reference. See Atofina v. Great Lakes Chem. Corp., 441 F.3d 991, 999 (Fed. Cir. 2006). When claim elements are inherently taught, the result must be a necessary consequence of what was deliberately intended, but the prior art need not demonstrate that the authors appreciated the results. See Mehl/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1366 (Fed. Cir. 1999); see Schering Corp. v. Geneva Pharm., Inc., 339 F.3d 1373, 1377 (Fed. Cir. 2003) (“At the outset, this court rejects the contention that inherent anticipation requires recognition in the prior art.”).” slip op. at 11
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“Petitioner contends that the MSI-H Study Record is prior art under 35 U.S.C. § 102(a) and is not covered by an exception under 35 U.S.C. § 102(b). Pet. 8. The parties agree that the MSI-H Study Record was publicly available by June 12, 2013. Id. at 7; Prelim. Resp. 19 (“JHU submitted the MSI-H Study Record on June 10, 2013, and it was posted on clinicaltrials.gov on approximately June 12, 2013”).” slip op. at 16
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“summarized above, we determine that the information presented in the Petition establishes that Petitioner has a reasonable likelihood of prevailing in showing that claim 1 would have been obvious in view of the MSI-H Study Record. We are persuaded that the MSI-H Study Record discloses the limitations of claim 1. Pet. 16–24. We are further persuaded that a person of ordinary skill in the art would have been motivated to modify the MSI-H Study Record with Pernot and Benson to benefit from the improved outcomes in treating MSI-H colorectal patients with the drug therapeutic. Id. at 41–44. We are also persuaded that a person of ordinary skill would have been motivated to test patients to determine their MSI-H status as such testing was routine in the art. Id. at 44–45. We are also persuaded that a person of ordinary skill would have been motivated to combine the teachings of the MSI-H Study Record and Benson to treat patients with metastatic and advanced disease. Id. at 46–47.” slip op. at 27
§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 10,934,356 - Coalition For Affordable Drugs V LLC / Hayman Credes Master Fund, L.P. et al. v. Biogen Ma Inc.Rehearing deniedPTAB · May 12, 2017 · IPR2015-01993 · APJ Richard E Schafer · IPR · Rehearing
The Board denied the petitioner's rehearing request, leaving intact its decision that claims 1-20 were not shown unpatentable because unexpected results supported nonobviousness.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“We considered Dr. Pleasure’s testimony in reaching our decision, but did not find it enlightening with respect to the unexpected results issue raised by Biogen. For the most part, Dr. Pleasure’s testimony is directed to the motivation and the reasonable expectation of success of the person having ordinary skill in the art to” slip op. at 2
- Obviousness (§103) › Objective indicia / secondary considerations › Unexpected resultsObjective indicia outweighedDecided for patent owner
“With respect to the unexpected results issue, Dr. Pleasure testified only that: As explained above, one of ordinary skill in the art would not have found it unexpected that dosages of 240 mg DMF given BID and TID were similarly efficacious in treating MS. Pleasure Dec., Ex. 1045, ¶ 75. Petitioner’s sole argument on the issue was: “[a]s demonstrated above, success was expected, not unexpected.” Pet. Reply, Paper 46, p. 24. Neither Petitioner’s Reply, nor Dr. Pleasure’s testimony addressed Biogen’s specific arguments and evidence of unexpected results. Thus, Petitioner’s argument and evidence failed to provide a basis for us to question the sufficiency of Biogen’s evidence to show that the degree of efficacy of the 480 mg/day dose would have been unexpected to one having ordinary skill in the art. As we noted in our Final Decision, “[o]bjective indicia of non-obviousness ‘may often establish that an invention appearing to have been obvious in light of the prior art was not.’” Institut Pasteur & Universite Pierre et Marie Curie v. Focarino, 738 F.3d 1337, 1346 (Fed. Cir. 2013).” slip op. at 4
§ 103 obviousnessPatents in suitUS 8,399,514 - PTAB · Mar 15, 2017 · IPR2016-00999 · APJ Jeffrey S Smith · IPR · Rehearing
The Board denied rehearing, leaving in place its denial of institution for claims 1–28 because Petitioner did not show a reasonable likelihood that steered planar-array beams are necessarily asymmetrical.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. STANDARD OF REVIEW Under 37 C.F.R. § 42.71(c), “[w]hen rehearing a decision on petition, a panel will review the decision for an abuse of discretion.” An abuse of discretion may be determined if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors. See Star Fruits S.N.C. v. United States, 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000). The request must identify, with specificity, all matters that the moving party believes the Board misapprehended or overlooked. See 37 C.F.R. § 42.71(d). Section 42.71(d) further provides that the request must identify where each matter was previously addressed.” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Lastly, Petitioner contends the Decision overlooked or “misapprehended the facts showing that all steered planar array antennas inherently result in radiation patterns having at least one asymmetrical beam.” Req. 13–15. According to Petitioner, Figure 4 of U.S. Patent No. 5,929,823 (Exhibit 2010) and Figure 3 of U.S. Patent No. 6,198,434 (Exhibit 2011), relied upon in Patent Owner’s Preliminary Response as describing remedies for distortion effects due to asymmetrical beams (Prelim. Resp. 47–48), do not eliminate the inherent asymmetry of the main beam. Req. 14. However, our Decision relies on Paragraphs 151 to 156 of Mr. Cosgrove’s testimony (Ex. 2001), which cite additional sections of Exhibits 2010 and 2011, to determine that the steered beams of a planar array are not necessarily asymmetrical. Dec. 21–23 (citing Ex. 2001 ¶¶ 151–156). For example, Mr. Cosgrove addresses the asymmetric bulge shown in Figure 4 of Exhibit 2010 by citing to a description of Figure 6, which describes a lobe symmetry of main lobe 610 that presents a more slender beam mid-section than that of main lobe 410 of Figure 4. Ex. 2001 ¶ 152 (citing Ex. 2010, 7:65–8:6). Mr. Cosgrove also addresses the asymmetric bulge shown in Figure 3 of Exhibit 2011 by citing to a description of Figure 6, which describes main lobe 610 as substantially symmetric, and more suited than lobe 310 of Figure 3 to provide communications within a defined subsection of an area to be served. Ex. 2001 ¶ 156 (citing Ex. 2011, 10:13–16). Accordingly, the Decision did not misapprehend or overlook any arguments or evidence presented by Petitioner. We did not abuse our discretion in determining that the Petitioner did not adequately establish a reasonable likelihood that a steered beam of a planar array is necessarily asymmetrical.” slip op. at 5
NonePatents in suitUS 8,311,582 - Apple Inc. v. Fastvdo LLCRehearing deniedPTAB · Mar 15, 2017 · IPR2016-01203 · APJ Jeffrey S Smith · IPR · Rehearing
The Board denied FastVDO’s rehearing request, leaving institution of review of claims 7–11 and 22–26 in place because no overlooked or misapprehended matter was shown.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“argue that Petitioner provided a “sole theory” for the claimed “error protection means” based on indefiniteness. Rather, Patent Owner argued generally that “Petitioner does not describe the structure, materials, or acts corresponding to the terms that Petitioner contends are in means-plus-function format.” Prelim. Resp. 11. Because Patent Owner did not present its “sole theory” argument in the Preliminary Response, the Board could not have misapprehended or overlooked this argument. Even considering this argument, we are not persuaded. In our Decision, we disagreed with Petitioner’s indefiniteness arguments, but nonetheless found that the Petition identifies sufficient structure to support constructions of the means-plus-function limitations. Dec. 10–16. Rather than misapprehend or overlook Patent Owner’s arguments, we found that the Specification of the ’482 patent “discloses enough of an algorithm to allow a person of ordinary skill to discern the necessary structure for performing the claimed function of the ‘error protecting means.’” Dec. 12.” slip op. at 4
NonePatents in suitUS 5,850,482 - Sandisk Corporation v. Netlist, Inc.Rehearing deniedPTAB · Mar 6, 2017 · IPR2015-01020 · APJ Peter P Chen · IPR · Rehearing
The Board denied Patent Owner’s rehearing requests, finding no misapprehension or oversight in its decisions rejecting the challenge to claims 1–20 as obvious.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. STANDARD OF REVIEW Under 37 C.F.R. § 42.71(d), the request for rehearing “must specifically identify all matters the party believes the Board misapprehended or overlooked.” See 37 C.F.R. § 42.71(d). Section 42.71(d) further provides that the request must identify where each matter was previously addressed.” slip op. at 2
- Strike new argumentNew argument consideredDecided for petitioner
“Patent Owner’s second argument is that Petitioner’s theory of the chip select signal generating another logic signal, as presented in its Reply, was an “entirely new rationale.” Req. Reh’g 4–7. We disagree. As noted above, there was no new rationale presented, and we found that Petitioner did not assert a new theory. Petitioner’s Reply was based on the same ground of obviousness, involving the same combination of references (Takeda, JEDEC, and Connolly), and proffering the same particular application of the Takeda reference, as set forth in the Petition. Therefore, we determine that we did not misapprehend or overlook the nature of Petitioner’s arguments in its Reply.” slip op. at 4
NonePatents in suitUS 7,881,150 - Sandisk Corporation v. Netlist, Inc.Rehearing deniedPTAB · Mar 6, 2017 · IPR2015-01021 · APJ Peter P Chen · IPR · Rehearing
The Board denied Patent Owner’s rehearing requests, finding no overlooked or misapprehended evidence or arguments in the Final Written Decisions.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. STANDARD OF REVIEW Under 37 C.F.R. § 42.71(d), the request for rehearing “must specifically identify all matters the party believes the Board misapprehended or overlooked.” See 37 C.F.R. § 42.71(d). Section 42.71(d) further provides that the request must identify where each matter was previously addressed.” slip op. at 2
- Strike new argumentNew argument consideredDecided for petitioner
“Patent Owner’s second argument is that Petitioner’s theory of the chip select signal generating another logic signal, as presented in its Reply, was an “entirely new rationale.” Req. Reh’g 4–7. We disagree. As noted above, there was no new rationale presented, and we found that Petitioner did not assert a new theory. Petitioner’s Reply was based on the same ground of obviousness, involving the same combination of references (Takeda, JEDEC, and Connolly), and proffering the same particular application of the Takeda reference, as set forth in the Petition. Therefore, we determine that we did not misapprehend or overlook the nature of Petitioner’s arguments in its Reply.” slip op. at 4
NonePatents in suitUS 8,081,536 - Sandisk Corporation v. Netlist, Inc.Rehearing deniedPTAB · Dec 12, 2016 · IPR2015-01020 · APJ Peter P Chen · IPR · Rehearing
The Board denied Patent Owner’s rehearing requests, finding no overlooked or misapprehended evidence or arguments in the final written decisions.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. STANDARD OF REVIEW Under 37 C.F.R. § 42.71(d), the request for rehearing “must specifically identify all matters the party believes the Board misapprehended or overlooked.” See 37 C.F.R. § 42.71(d). Section 42.71(d) further provides that the request must identify where each matter was previously addressed.” slip op. at 2
NonePatents in suitUS 7,881,150 - Sandisk Corporation v. Netlist, Inc.Rehearing deniedPTAB · Dec 12, 2016 · IPR2015-01021 · APJ Peter P Chen · IPR · Rehearing
The Board denied Patent Owner’s rehearing requests in IPR2015-01020 and IPR2015-01021, finding no overlooked or misapprehended evidence or arguments.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“106 of the first Jagannathan declaration, filed concurrently with the Petition, he testified, “[t]hus, when a chip-select output from the bank control unit is used to enable a particular DDR SDRAM device, it is also used to enable the bit switch.” Final Dec. 23 (citing Ex. 1002 ¶ 106) (emphasis added). This described Petitioner’s evidence on the chip select signal, namely, that Dr. Jagannathan did not testify that the chip select signal “is also the bit switch enable signal,” but rather, that the chip select signal “is used to” generate the enable signals to the bit switch. In Petitioner’s post-hearing brief (Paper 30), Petitioner cited to pages 35 and 36 of the Petition, and to Dr. Jagannathan’s deposition testimony: Q. So what I’m trying to understand is, in that paragraph, it seems that you’re saying it’s the same signal that’s being used. A. No, I don’t -- I disagree with that. What I am trying to say here is the chip select signal -- those signals that I talked about earlier in the sentence, they’re effectively being used to generate the enable signals. Paper 30 (citing Ex. 2002, 218:6–17). Petitioner asserted in its post-hearing brief, “[w]hen taken as a whole, in context, Dr. Jagannathan’s testimony supports the rationale in the Petition.” Paper 30, 4. As set forth in the Final Written Decision, we agree. Nothing argued by Patent Owner persuades us that in the Final Written Decision we misapprehended or overlooked the nature of Dr. Jagannathan’s testimony in his first declaration.” slip op. at 3
NonePatents in suitUS 8,081,536 - Par Pharmaceutical, Inc. / Lupin Ltd. et al. v. Horizon Therapeutics, LLCAll claims unpatentablePTAB · Sep 29, 2016 · IPR2016-00284 · APJ Deborah Katz · IPR · Final written decision
Claims 1–11 are unpatentable under § 103 over the three combinations of references identified in the decision.
RulingsFinal written decision- ExcludeMotion to exclude, deniedDenied
“Petitioners argue that Patent Owner’s Exhibits 2022 and 2024 should be excluded because they are not prior art to the ’215 patent. Paper 25, 1–2. Even considering Exhibits 2022 and 2024, we are still persuaded that a preponderance of the evidence shows claims of the ’215 are unpatentable. Accordingly, Petitioners’ motion is dismissed as moot. Petitioners also argue that Patent Owner relies on attorney argument to rebut Petitioners’ challenges, effectively providing impermissible expert evidence, which Petitioners seek to exclude. (Paper 25, 2–6.) We dismiss Petitioners’ argument because attorney argument is not evidence. See Meitzner v. Mindick, 549 F.2d 775, 782 (CCPA 1977) (“Argument of counsel cannot take the place of evidence lacking in the record.”). Therefore, Petitioners’ argument is improperly presented in a motion to exclude evidence. Nevertheless, the issue of evidentiary support for Patent Owner’s arguments is addressed above. Patent Owner argues that evidence relied upon by Petitioners should be excluded. Paper 33. Specifically, Patent Owner seeks to exclude certain portions of Dr. Sondheimer’s cross-examination testimony and Exhibits 1031–1033. Patent Owner acknowledges that “[i]n its Reply (Paper 28), Petitioner has not attempted to rely upon the portions of Dr. Sondheimer’s deposition transcript or the documents Patent Owner seeks to exclude.” Paper 33, 2–3. We dismiss Patent Owner’s motion as being moot. Because Patent Owner cannot point to where Petitioners rely on the testimonial evidence, having apparently not relied on it, we have no basis on which to determine whether the evidence is inadmissible and no basis on which to exclude it. Furthermore, because Exhibits 1031–1033 have not been made of record in this proceeding (see Paper 33, 1), they cannot be excluded.” slip op. at 23
- Skill levelOther
- Expert testimonyPetitioner expert creditedOther
“Petitioners rely on the testimony of Neal Sondheimer, M.D., Ph.D. (Ex. 1002). Dr. Sondheimer testifies that he currently holds several positions at the Children’s Hospital of Philadelphia and the University of Pennsylvania, including Attending Physician in the Division of Biochemical Genetics, Training Director for the Clinical Biochemical Genetics Group, Program Director for Medical Genetics, and Assistant Professor of Pediatrics. Ex. 1002 ¶ 10. Dr. Sondheimer testifies that he has been involved in several research studies about the treatment of urea cycle defects and has co-authored several publications about the use of ammonia-scavenging medications. Id. ¶ 12. We find Dr. Sondheimer to be qualified to provide opinions on the subject matter at issue. Patent Owner does not present the testimony of its own witness to support its arguments.” slip op. at 5
- Claim Construction › Intrinsic evidence (Phillips canons) › Specification disavowal / 'present invention' languagePlain and ordinary meaningDecided for petitioner
“We look to the language of the claim itself and to language in the specification to determine the scope of a claim. To limit a claim beyond what its plain language appears to convey, the patentee “may demonstrate an intent to deviate from the ordinary and accustomed meaning of a claim term by including in the specification expressions of manifest exclusion or restriction, representing a clear disavowal of claim scope.” In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1365 (Fed. Cir. 2004) The plain language of independent claims 1–3 recites only the steps of “measuring,” “comparing,” and “administering.” The claims do not include a “targeting” step or steps such as repeated measuring, comparing, and administering, until the fasting blood ammonia level is less than half the upper limit of normal. See Pet. Reply 5–6. Although Patent Owner cites to evidence of the background of the invention, we have not been directed to evidence within the specification of the ’215 patent that clearly limits the claimed methods from being applied at any blood ammonia level greater than half the upper limit of normal. In addition, Patent Owner does not direct us to testimony or other evidence indicating that those skilled in the art would have considered the language of the claims to require “targeting” a certain blood ammonia level or to specify administering drug dosages only when the blood ammonia level is at about that targeted level. On the contrary, the plain terms of the claims contain no such limitations and are broad enough to embrace the administration of drug at higher blood ammonia levels. Accordingly, we conclude that the correct interpretation of Patent Owner’s claims is a method of measuring a fasting blood ammonia level, comparing this level to the upper limit of normal, and administering drug when the level is any level greater than half the upper limit of normal for blood ammonia level.” slip op. at 14
Patent outcomesUS 8,404,215 unpatentableClaim construction§ 103 obviousnesscites KSRPatents in suitUS 8,404,215
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.