- Celltrion, Inc. / Pfizer, Inc. v. Biogen, Inc. And Genentech, Inc.No claims unpatentablePTAB · Feb 21, 2018 · IPR2016-01614 · APJ Erica A Franklin · IPR · Final written decision
Claims 1–3, 5–7, and 9–11 were not shown unpatentable under § 103 because the Rituxan Label was not established as prior art and the remaining references did not teach all claimed limitations.
RulingsFinal written decision- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“In the Petition, Petitioners assert that no terms of the challenged claims require construction. Pet. 22. However, Petitioners note that a person of skill in the art would have understood that “rituximab,” recited in claim 1, is “a CD20 antibody that binds to the CD20 antigen on human B lymphocytes.” Pet. 22–23. Indeed, claims 5 and 9 recite “an antibody that binds to the CD20 antigen on human B lymphocytes” and explain that “the CD20 antibody is rituximab.” Id. at 23. In the Institution Decision, we agreed with Petitioners that no claim terms required construction for purposes of that decision. Dec. 5 (citing See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (only terms which are in controversy need to be construed, and only to the extent necessary to resolve the controversy)). The parties do not assert otherwise in the Patent Owner Response or in Petitioners’ Reply. Accordingly, because the parties identify no controversy as to the scope of any claim terms, we conclude that, for the purpose of this Final Written Decision, no claim term requires express construction.” slip op. at 7
- Skill levelSkill level board ownOther
“The proposed definitions asserted by Petitioners and Patent Owner suggest that the level of skill in the art is considerably high. Petitioners’ definition is more limiting than Patent Owner’s definition in that it requires, for example, the person of ordinary skill in the art to have more years of experience in treating RA patients and an understanding of “all of the available and proposed methods of treating RA and other auto-immune disorders … and how they work to treat such disorders.” Pet. 24. Based on the record as a whole, we determine that a person of ordinary skill in the art is not so limited. The invention and the cited references are directed to standard and proposed methods of treating RA and not all “other auto-immune disorders.” In terms of years of experience, we recognize rheumatology as a specialized area of medicine, wherein acquiring at least three years of experience would be sufficiently significant. Accordingly, we find that the record as a whole supports defining the level of ordinary skill in the art as: a practicing rheumatologist with a medical degree (M.D. or equivalent) and: (i) at least three years of experience treating RA patients; (ii) an understanding of the immunology and the pathophysiology of RA; and (iii) an understanding of the available and proposed methods of treating RA, including relevant clinical trials for such treatment. We also note that the applied 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 9
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedNot shown unpatentable
“under 35 U.S.C. § 102(b). Even assuming that Exhibit 1056 authenticates Exhibit 1055 and establishes that the reference was online on January 23, 1998, our determination whether Exhibit 1055 was publicly accessible prior to the critical date requires further inquiry. That is, we must determine whether Petitioners made a satisfactory showing that the reference was “disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence, can locate it.” SRI Int'l, Inc., 511 F.3d at 1194. For example, the Federal Circuit has explained “evidence that a query of a search engine before the critical date, using any combination of search words, would have led to the [reference] appearing in the search results” is probative of public accessibility. Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331, 1350 (Fed. Cir. 2016). In this regard, Petitioners assert only that “Genentech’s website was organized such that the label could be easily located. Therefore the label was broadly disseminated and publicly accessible before May 1998 to anyone with a browser and an Internet connection.” Pet. 18 n.2. That assertion is not further explained or accompanied by citation to any evidence supporting Petitioners’ contention about Genentech’s website. Nor have Petitioners offered evidence indicating that persons interested and ordinarily skilled in treating rheumatoid arthritis would have identified and visited Genentech’s website before the critical date, and in doing so, would have searched for rituximab drug information, a product newly manufactured and indicated for the treatment of non-Hodgkin’s lymphoma. Ex. 1055, 3.” slip op. at 18
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“Petitioners do not rely on Edwards, O’Dell, or Kalden as teaching or suggesting “administering more than one intravenous dose of a therapeutically effective amount of” rituximab. See Pet. 34–35. Claims 2, 6, and 10 depend from claims 1, 5, and 9, respectively, and recite specific ranges for the dosage of rituximab. Ex. 1001, 30:1–3, 18–20, 35–37. Petitioners do not rely on Edwards, O’Dell, or Kalden as teaching or suggesting that limitation. Pet. 40–41. Claims 3, 7, and 11 also depend from claims 1, 5, and 9, respectively, and recite methods further comprising administering a glucocorticosteroid. Ex. 1001, 30:4–5, 21–22, 38–39. Petitioners do not rely on Edwards, O’Dell, or Kalden as teaching or suggesting that limitation. Pet. 41. In the Reply, Petitioners assert that “the dose of Rituxan that was approved by FDA to treat NHL, and [the] proposition that steroids effectively treat hypersensitivity reactions . . . were common knowledge in 1999 (Boers2 at ¶¶ 23–24).” Reply 24. This assertion is inadequate to supply the claim limitations not asserted to be taught or suggested by the combined prior art. Significantly, Petitioners have not shown that its assertion in the Reply was presented in the Petition. Further, the referenced testimony of Dr. Boers relates only to the use of glucocorticosteroids and not to the dose of Rituxan. Ex. 1064 ¶¶ 23–24. Moreover, Dr. Boers’ opinions relating to the use of glucocorticosteroids is unaccompanied by citation to any evidence. Id. Thus, those opinions are not entitled to persuasive weight.” slip op. at 22
Patent outcomesUS 7,820,161 not shown unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites GrahamPatents in suitUS 7,820,161 - Biodelivery Sciences International, Inc. v. Monosol RX, LLCNo claims unpatentablePTAB · Mar 24, 2016 · IPR2015-00165 · APJ Francisco C Prats · IPR · Final written decision
Claims 1, 4, 11, 12, 26, 27, 44, 51, 58, 65, 72, 82, and 125–127 were not shown unpatentable over Chen because the evidence did not establish the claimed active-component uniformity.
RulingsFinal written decision- BurdenNot shown unpatentable
“In an inter partes review instituted under this chapter, the petitioner shall have the burden of proving a proposition of unpatentability by a preponderance of the evidence.” 35 U.S.C. § 316(e). We conclude that Petitioner has not proved by a preponderance of the evidence that claims 1, 4, 11, 12, 26, 27, 44, 51, 58, 65, 72, 82, and 125–127, of the ’167 patent are unpatentable for anticipation under 35 U.S.C. § 102(b) by Chen. slip op. at 3
- PTAB / AIA Trials › §315(e) estoppelEstoppel does not applyDecided for patent owner
“We find that the instant inter partes review under the AIA offers a significant procedural opportunity to the parties that was not available in the prior inter partes reexamination proceeding of the ’588 patent cited by Petitioner. Specifically, inter partes reexamination proceedings are conducted essentially by the same procedure as routine examination of patent applications. 37 C.F.R. § 1.937(b). Although normal examination procedure allows for submission of evidence in affidavit form (37 C.F.R. §§ 1.131, 1.132), the rules for inter partes reexaminations do not provide for cross-examination of those affiants. See 37 C.F.R. §§ 1.902–1.997. In contrast, in the instant proceeding, witnesses presenting direct testimony by affidavit are subject to cross-examination via deposition. 37 C.F.R. § 42.53. Indeed, as discussed herein below, the testimony on cross-examination of one of Petitioner’s witnesses uncovered facts significant to our evaluation of the issue of anticipation, resulting in a determination on that issue different from the prior ’588 reexamination appeal decision cited by Petitioner. Thus, the availability of cross-examination of witnesses in this inter partes review under the AIA is a significant procedural opportunity for Patent Owner that is not present in the prior inter partes reexamination proceeding, and that procedural distinction indeed yields a result different from that in the prior inter partes reexamination. In addition, we also find that the instant situation does not meet the requirements for applying issue preclusion, because resolution of the issue in this case was not essential to the final judgment in the ’588 decision. As to that requirement, in Freeman the court noted that “statements regarding the scope of patent claims made in a former adjudication should be narrowly construed.” In re Freeman, 30 F.3d at 1466. With that in mind, we note again that the limitation at issue in claim 1 of the ’167 patent states that the “substantially uniform distribution is measured by substantially equally sized individual unit doses which do not vary by more than 10% of said desired amount of said active component.” Ex. 1001, 41:19–22. In the prior ’588 decision, because Patent Owner had not argued any claims separately, the Board resolved the issue of whether Chen met the uniformity requirement based on claim 1 of the ’588 patent. Ex. 1027, 12 (the ’588 decision).5 In contrast to the language at issue here, claim 1 of the ’588 patent, as amended, required only “substantially uniform content of therapeutic active composition per unit of film.” Ex. 1027, 4. Thus, the ’588 decision did not resolve the issue of whether Chen met the 5 In citing to the ’588 decision we cite to the original page numbers of the decision, not the pages numbers entered by Petitioner as part Exhibit 1027. substantial uniformity requirement based on the claim language at issue in this proceeding. We acknowledge the statement in the ’588 decision that, as to claim 3 of the ’588 patent, the “weight deviation” described in Example 1 of Chen “is well within the less than 10% variation of active content per film unit requirement of claim 3” of the ’588 patent. Ex. 1027, 19. As noted immediately above, however, the ’588 decision resolved the uniformity issue based on claim 1 of the ’588 patent, not on claim 3, which depends from claim 1.” slip op. at 14
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownOther
“drying process,” claim 1 expressly recites that the controlled drying process, which produces the film, rapidly forms a viscoelastic matrix to lock-in the active component in place within the matrix to maintain the above-discussed substantially uniform distribution. Ex. 1001, 41:13–16. Accordingly, contrary to Petitioner’s contentions (see Pet. 10–11), we conclude that claim 1 does limit the conditions of the “controlled drying process.” As noted above, moreover, the ’167 patent discusses the advantages of the controlled drying process, including the faster drying times. Ex. 1001, 6:61–7:1. According to the Specification, “[d]esirably, the drying of the film will occur within about ten minutes or fewer, or more desirably within about five minutes or fewer.” Id. at 7:1–3. It further discloses that the initial film setting period, “during which a solid, visco-elastic structure is formed . . . can take place within the first few minutes, e.g. about the first 0.5 to about 4.0 minutes of the drying process.” Id. at 24:52–56. Thus, contrary to Petitioner’s contention, the ’167 patent does provide a standard for the term “rapidly” as recited in claim 1. Especially given the express language in the claims, we conclude that the claims encompass a film having a structure which would result from a controlled drying process which forms a viscoelastic matrix within a few minutes of the drying process to lock-in the active component within the matrix, the film having a substantially uniform distribution of the active component, measured by substantially equally sized individual unit doses which do not vary by more than 10% of the desired amount of the active component.” slip op. at 7
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureNot shown unpatentableInherency not foundNot shown unpatentable
“Because visual inspection is not the measure of uniformity recited in claim 1 of the ’167 patent, Petitioner does not persuade us that it is reasonable to construe the uniformity limitation at issue in claim 1 as being met by a visual evaluation, based on the ’292 patent’s disclosure that substantial uniformity (as opposed to the claimed uniformity of distribution with a variation of no more than 10%) can be verified visually. We acknowledge that the passage cited above in column 20 of the ’292 patent describes actual testing of the amount of active component as an “alternative” method of verifying substantial uniformity. Ex. 1035, 20:62. Petitioner does not persuade us, however, that it is reasonable to construe the measure of uniformity in claim 1 of the ’167 patent, which requires a determination of the amount of active component in equal size dosage units, as being met by a method (simple visual inspection) which no evidence has shown is capable of quantifying the active component amount.” slip op. at 19
Patent outcomesUS 8,765,167 not shown unpatentableClaim construction§ 102 anticipationcites PhillipsPatents in suitUS 8,765,167 - Oxford Nanopore Technologies Ltd. v. University Of Washington And Uab Research FoundationAll claims unpatentablePTAB · Feb 26, 2016 · IPR2015-00057 · APJ Francisco C Prats · IPR · Final written decision
Claim 10 is unpatentable as obvious over the ’782 patent and Butler; anticipation of claim 10 by Butler and claims 17–18 by the Wong Poster or Wong Abstract was not shown.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“substances, including ions. Ex. 1001, 8:45–49. Nonetheless, to detect an analyte, claim 1, from which claim 10 depends, requires its practitioner to compare (1) a first measured ion current obtained from the first liquid medium suspected of containing the analyte, with (2) a second measured ion current, obtained “without an analyte present,” that is, a known control containing no analyte. Id. at 103:42. As claim 1 states, the presence of the analyte is indicated by a reduction in the first measured ion current of 5% or more for at least 1.0 microsecond, as compared to the second measured ion current level without an analyte present. Id. at 103:40–44. Thus, as Patent Owner contends (PO Resp. 3–4), if the ions forming the first and second measured ion currents were considered “analytes,” the comparison required by claim 1, and its dependent claim 10, could not be performed, because removing the current-forming ions to prepare a sample “without an analyte present” (as recited in claim 1) would make it impossible to measure the ion current necessary to perform the required comparison. This conclusion is consistent with Examples 2, 3, and 6 of the ’550 patent, each of which is described as comparing ion current blockades “with and without [a]nalyte” (Ex. 1001, 41:55, 42:27, 45:49), yet each of which uses an ion-containing buffer including potassium and chloride ions to generate the measured current (id. at 41:15–16 (describing all ion conductance experiments as being performed in 1M KCl, 10 mM Hepes/KOH buffered at pH 8)). Accordingly, we conclude that, consistent with the Specification of the ’550 patent, the broadest reasonable interpretation of the term “analytes” in claim 10 encompasses only those substances detectable by measuring a reduction in ion current of 5% or more for at least 1.0 microsecond, as compared to an ion current level for the Msp without an analyte present, and does not encompass the ions forming the measured ion current, or other buffer components present in the liquid media used in the analyte detection process.” slip op. at 11
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“As discussed above, we agree with Patent Owner that the term “analytes” in claim 10 does not encompass the ions that produce the ion current that is measured in the claimed process. Petitioner does not dispute 9 Declaration of Steven A. Benner, Ph.D. (Declaration executed Dec. 5, 2014) (Ex. 2003; “Benner Declaration” or “Benner Decl.”). Patent Owner’s contention that the potassium ions in Butler’s experiments form the ion current that Butler measured. See Reply 1–6. Moreover, we discern no error in Patent Owner’s assertion, and supporting testimony of its witness, Dr. Benner, that Butler’s system is essentially identical to the system described in Examples 2, 3, and 6 of the ’550 patent, all of which use the potassium ions to generate the measured ion current. Accordingly, we agree with Patent Owner that the term “analytes” in claim 10 does not encompass the potassium ions in Butler’s experiments. Because Petitioner relies on the potassium ions in Butler’s experiments, along with the DNA in those experiments, as corresponding to the plurality of different analytes required by claim 10 (see Pet. 29), we agree with Patent Owner that Petitioner has not shown that Butler describes a process which includes all of the features of claim 10. We conclude, therefore, that Petitioner has not shown by a preponderance of the evidence that Butler anticipates claim 10 of the ’550 patent.” slip op. at 13
- Strike new argumentNew argument disregardedDecided for patent owner
“As provided in 37 C.F.R. § 42.23(b), a “reply may only respond to arguments raised in the corresponding opposition or patent owner response.” Thus, “a reply that raises a new issue or belatedly presents evidence will not be considered and may be returned.” Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,767 (Aug. 14, 2012). One indication that a new issue has been raised in a reply is where a petitioner submits “new evidence necessary to make out a prima facie case” of unpatentability of an original claim. Id. In contrast, where evidence submitted in support of a reply responded only to contentions presented in a Patent Owner response, and was not relied upon or necessary to the prima facie case of unpatentability, our reviewing court found no abuse of discretion by the Board in admitting the reply evidence. Belden Inc. v Berk-Tek LLC, 805 F.3d 1064, 1077–79 (Fed. Cir. 2015). Here, Petitioner contends that, in advancing its new contentions, its Reply merely responds to Patent Owner’s argument that the only substance in Butler’s liquid media that would be considered an analyte is the single stranded DNA tested by Butler. Reply 5, n.3; see also id. at 4 (citing Ex. 2003 ¶ 17 (Benner Decl.)). It might be true that Patent Owner’s Response argued that the DNA tested by Butler was the only analyte encompassed by claim 10. The basis for that argument, however, was Patent Owner’s response to contentions and evidence raised by Petitioner in its Petition. Specifically, Patent Owner responded that the potassium ions identified in the Petition as the second analyte were not reasonably considered “analytes” under the broadest reasonable construction of claim 10 consistent with the Specification. See PO Resp. 2–9. In its Reply, Petitioner now raises an entirely novel theory of unpatentability, a theory Patent Owner would not have addressed in its Response, as it was not raised in the Petition. We are not persuaded that presenting this novel theory of unpatentability, distinct from that originally presented in its Petition, truly responds to Patent Owner’s arguments about the reasonableness of considering potassium ions “analytes” as that term is used in claim 10. Rather, because the Reply presents new evidence in an effort to raise a new theory of anticipation, we conclude that the Reply exceeds its proper scope. See Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,767 (Aug. 14, 2012).” slip op. at 15
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedNot shown unpatentableNot shown unpatentable
“Thus, the poster session at issue plainly was not an unpublicized conference with no attendees. Nonetheless, because invitation to the session was based primarily on affiliation with a particular student, as opposed to interest or skill in any particular technical subject matter, we agree with Patent Owner that the poster session’s intended viewers were not comparable to the technology-specific or industry-specific audiences targeted in the professional conferences and trade show discussed in the Klopfenstein, MIT, and TypeRight cases.” slip op. at 28
Patent outcomesUS 8,673,550 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,673,550 - Oxford Nanopore Technologies Ltd. v. University Of Washington And Uab Research FoundationSome claims unpatentablePTAB · Feb 26, 2016 · IPR2014-00513 · APJ Francisco C Prats · IPR · Final written decision
Claim 10 is unpatentable as obvious over the ’782 patent and Butler; anticipation of claim 10 by Butler and claims 17–18 by the Wong Poster or Wong Abstract was not shown.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“substances, including ions. Ex. 1001, 8:45–49. Nonetheless, to detect an analyte, claim 1, from which claim 10 depends, requires its practitioner to compare (1) a first measured ion current obtained from the first liquid medium suspected of containing the analyte, with (2) a second measured ion current, obtained “without an analyte present,” that is, a known control containing no analyte. Id. at 103:42. As claim 1 states, the presence of the analyte is indicated by a reduction in the first measured ion current of 5% or more for at least 1.0 microsecond, as compared to the second measured ion current level without an analyte present. Id. at 103:40–44. Thus, as Patent Owner contends (PO Resp. 3–4), if the ions forming the first and second measured ion currents were considered “analytes,” the comparison required by claim 1, and its dependent claim 10, could not be performed, because removing the current-forming ions to prepare a sample “without an analyte present” (as recited in claim 1) would make it impossible to measure the ion current necessary to perform the required comparison. This conclusion is consistent with Examples 2, 3, and 6 of the ’550 patent, each of which is described as comparing ion current blockades “with and without [a]nalyte” (Ex. 1001, 41:55, 42:27, 45:49), yet each of which uses an ion-containing buffer including potassium and chloride ions to generate the measured current (id. at 41:15–16 (describing all ion conductance experiments as being performed in 1M KCl, 10 mM Hepes/KOH buffered at pH 8)). Accordingly, we conclude that, consistent with the Specification of the ’550 patent, the broadest reasonable interpretation of the term “analytes” in claim 10 encompasses only those substances detectable by measuring a reduction in ion current of 5% or more for at least 1.0 microsecond, as compared to an ion current level for the Msp without an analyte present, and does not encompass the ions forming the measured ion current, or other buffer components present in the liquid media used in the analyte detection process.” slip op. at 11
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“As discussed above, we agree with Patent Owner that the term “analytes” in claim 10 does not encompass the ions that produce the ion current that is measured in the claimed process. Petitioner does not dispute 9 Declaration of Steven A. Benner, Ph.D. (Declaration executed Dec. 5, 2014) (Ex. 2003; “Benner Declaration” or “Benner Decl.”). Patent Owner’s contention that the potassium ions in Butler’s experiments form the ion current that Butler measured. See Reply 1–6. Moreover, we discern no error in Patent Owner’s assertion, and supporting testimony of its witness, Dr. Benner, that Butler’s system is essentially identical to the system described in Examples 2, 3, and 6 of the ’550 patent, all of which use the potassium ions to generate the measured ion current. Accordingly, we agree with Patent Owner that the term “analytes” in claim 10 does not encompass the potassium ions in Butler’s experiments. Because Petitioner relies on the potassium ions in Butler’s experiments, along with the DNA in those experiments, as corresponding to the plurality of different analytes required by claim 10 (see Pet. 29), we agree with Patent Owner that Petitioner has not shown that Butler describes a process which includes all of the features of claim 10. We conclude, therefore, that Petitioner has not shown by a preponderance of the evidence that Butler anticipates claim 10 of the ’550 patent.” slip op. at 13
- Strike new argumentNew argument disregardedDecided for patent owner
“As provided in 37 C.F.R. § 42.23(b), a “reply may only respond to arguments raised in the corresponding opposition or patent owner response.” Thus, “a reply that raises a new issue or belatedly presents evidence will not be considered and may be returned.” Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,767 (Aug. 14, 2012). One indication that a new issue has been raised in a reply is where a petitioner submits “new evidence necessary to make out a prima facie case” of unpatentability of an original claim. Id. In contrast, where evidence submitted in support of a reply responded only to contentions presented in a Patent Owner response, and was not relied upon or necessary to the prima facie case of unpatentability, our reviewing court found no abuse of discretion by the Board in admitting the reply evidence. Belden Inc. v Berk-Tek LLC, 805 F.3d 1064, 1077–79 (Fed. Cir. 2015). Here, Petitioner contends that, in advancing its new contentions, its Reply merely responds to Patent Owner’s argument that the only substance in Butler’s liquid media that would be considered an analyte is the single stranded DNA tested by Butler. Reply 5, n.3; see also id. at 4 (citing Ex. 2003 ¶ 17 (Benner Decl.)). It might be true that Patent Owner’s Response argued that the DNA tested by Butler was the only analyte encompassed by claim 10. The basis for that argument, however, was Patent Owner’s response to contentions and evidence raised by Petitioner in its Petition. Specifically, Patent Owner responded that the potassium ions identified in the Petition as the second analyte were not reasonably considered “analytes” under the broadest reasonable construction of claim 10 consistent with the Specification. See PO Resp. 2–9. In its Reply, Petitioner now raises an entirely novel theory of unpatentability, a theory Patent Owner would not have addressed in its Response, as it was not raised in the Petition. We are not persuaded that presenting this novel theory of unpatentability, distinct from that originally presented in its Petition, truly responds to Patent Owner’s arguments about the reasonableness of considering potassium ions “analytes” as that term is used in claim 10. Rather, because the Reply presents new evidence in an effort to raise a new theory of anticipation, we conclude that the Reply exceeds its proper scope. See Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,767 (Aug. 14, 2012).” slip op. at 15
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency not foundNot shown unpatentable
“To show that Butler anticipates claim 10, Petitioner must show that Butler discloses “every limitation of the claimed invention, either explicitly or inherently.” In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997). Petitioner contends that, in addition to the dA50 molecules Butler tested, Butler also discloses two types of contaminants in its experiments that would be considered “analytes”: (1) divalent and trivalent ions, and (2) less than full-length oligonucleotides. Reply 5. Petitioner has not shown sufficiently that Butler explicitly or inherently discloses that those substances were present in the DNA experiments cited by Petitioner. As to the alleged divalent and trivalent ion impurities, Butler states only that “[i]f these hypothetical contaminant molecules are present in the dA50 aliquots that we add to the cis compartment, then we would observe the correlation between increased blockade rate and the presence of dA50.” Ex. 1003, 107 (emphasis added). Butler’s hypothetical guess at potential causes of ion current blockades does not equate to an explicit disclosure of the presence of those contaminants in its experiments. Moreover, because Butler’s disclosure, at best, suggests that such contaminants might possibly have been present, Butler does not inherently disclose the presence of those contaminants. See Agilent Techs., Inc. v. Affymetrix, Inc., 567 F.3d 1366, 1383 (Fed. Cir. 2009) (“The very essence of inherency is that one of ordinary skill in the art would recognize that a reference unavoidably teaches the property in question.”) (emphasis added); In re Oelrich, 666 F.2d 578, 581 (CCPA 1981) (“Inherency, however, may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient.”).” slip op. at 17
Patent outcomesUS 8,673,550 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,673,550 - Eli Lilly And Company v. Los Angeles Biomedical Research Institute At Harbor-Ucla Medical CenterNo claims unpatentablePTAB · Oct 22, 2015 · IPR2014-00693 · APJ Lora M Green · IPR · Final written decision
Claims 1–5 were not shown unpatentable because Whitaker did not anticipate the required continuous administration for at least 45 days.
RulingsFinal written decision- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“Whitaker anticipates claim 1 by a preponderance of the evidence. To anticipate, a prior art reference “must not only disclose all elements of the claim within the four corners of the document, but must also disclose those elements ‘arranged as in the claim.’” Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008) (quoting Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983)).” slip op. at 8
- ExcludeOther
“1115–1116, 1118–1121, 1124, 1127, 1128–1130, 1131, 1135–1137, 1139– 1140, 1142, 1144, and portions of Dr. Bivalacqua’s deposition testimony (Ex. 1122). As we did not rely on any of those exhibits in this Decision, Patent Owner’s Motion to Exclude is dismissed as moot.” slip op. at 10
- PTAB / AIA Trials › Other PTAB motions (exclude, strike, seal, additional discovery, rehearing)Granted
“E. Objections to Demonstratives Each of Petitioner (Paper 42) and Patent Owner (Paper 43) objected to the other’s demonstratives. In view of those objections, we expunge the demonstratives from the record. Thus, Petitioner’s demonstratives (Paper 41) and Patent Owner’s demonstratives (Paper 40), are expunged.” slip op. at 10
Patent outcomesUS 8,133,903 not shown unpatentable§ 102 anticipationPatents in suitUS 8,133,903 - Eli Lilly And Company. v. Los Angeles Biomedical Research Institute At Harbor-Ucla Medical CenterAll claims unpatentablePTAB · Oct 22, 2015 · IPR2014-00752 · APJ Lora M Green · IPR · Final written decision
Claims 1–5 are unpatentable under § 103 over Montorsi, Whitaker, and Porst because their combination renders the claimed method obvious.
RulingsFinal written decision- Skill levelOther
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“Lederman, 355 F.3d 1343, 1348 (Fed. Cir. 2004); see 35 U.S.C. § 120. “In order to satisfy the written description requirement, the disclosure as originally filed does not have to provide in haec verba support for the claimed subject matter at issue.” Purdue Pharma L.P. v. Faulding, Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000). Nonetheless, the disclosure must convey with reasonable clarity to those skilled in the art that the inventor was in possession of the invention. Id. “Put another way, one skilled in the art, reading the original disclosure, must immediately discern the limitation at issue in the claims.” Id. However, “the question [of adequate written description] is not whether a claimed invention is an obvious variant of that which is disclosed in the specification.” Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997); see also Tronzo v. Biomet Inc., 156 F.3d 1154, 1158 (Fed. Cir. 1998) (“A disclosure in a parent application that merely renders the later-claimed invention obvious is not sufficient to meet the written description requirement; the disclosure must describe the claimed invention with all its limitations.”).” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for petitioner
“1257 (Fed. Cir. 2007). “[A] claim construction analysis must begin and remain centered on the claim language itself, for that is the language the patentee has chosen to ‘particularly point[ ] out and distinctly claim[ ] the subject matter which the patentee regards as his invention.’” Innova/Pure Water, Inc. v. Safari Water Filtration Sys,, Inc., 381 F.3d 1111, 1116 (Fed. Cir. 2004); see also Pitney Bowes, Inc. v. Hewlett–Packard Co., 182 F.3d 1298, 1305 (Fed. Cir. 1999) (“The starting point for any claim construction must be the claims themselves.”). Only terms which are in controversy need to be construed, and then only to the extent necessary to resolve the controversy. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999). 1. “continuous long-term regimen” In the Decision on Institution, we interpreted this claim phrase as: the administration of drug over a certain period of time without intermission such that the treatment is therapeutically effective. With regard to claims of the ’903 patent, the time period is not less than 45 days, as recited in claim 1.” slip op. at 6
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“2. “an individual with at least one of penile tunical fibrosis and corporal tissue fibrosis” Patent Owner contends that the term “should be construed to mean ‘an individual with fibrosis of either the tunica albuginea or corpora cavernosa of the penis, in which the fibrosis is clinically significant.’” PO Resp. 22 (emphasis removed). In particular, Patent Owner contends that “a person of ordinary skill in the art would understand the claims of the ’903 patent to concern treatment of penile fibrosis, a disease.” Id. According to Patent Owner, Petitioner’s proposed interpretation of a patient having any degree of fibrosis “risks encompassing not only men with subclinical penile fibrosis, but men with no penile fibrosis at all.” Id. at 22–23. Petitioner responds that the term “clinically significant” “is largely subjective—what is clinically significant to one patient or doctor may not be clinically significant to another.” Reply 11. The ’903 patent teaches that there is a need “to treat and/or ameliorate the symptoms of a variety of fibrotic disease, such as PD, ED and arteriosclerosis.” Ex. 1001, 2:42–46. Thus, although the claim requires the patient to have penile tunical fibrosis or corporal tissue fibrosis, we conclude that the broadest reasonable interpretation of “an individual with at least one of penile tunical fibrosis and corporal tissue fibrosis,” in view of the Specification of the ’903 patent, requires that the individual have symptoms that may be associated with penile fibrosis, such as ED, but not that the patient be specifically diagnosed as having penile tunical fibrosis or corporal tissue fibrosis.” slip op. at 7
Patent outcomesUS 8,133,903 unpatentableClaim construction§ 103 obviousness§ 112 disclosurePatents in suitUS 8,133,903 - LG Chem, Ltd. v. Celgard, LLCSome claims unpatentablePTAB · Oct 5, 2015 · IPR2014-00692 · APJ Donna M Praiss · IPR · Final written decision
Claims 1–11 are unpatentable as obvious: claims 7–10 over Tojo and claims 1–6 and 11 over Tobishima and Tojo; the other instituted grounds were not proven.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Specification disavowal / 'present invention' languageTerm construed board ownDecided for petitioner
“Our reviewing court, however, has “cautioned against reading limitations into a claim from the preferred embodiment described in the specification, even if it is the only embodiment described, absent clear disclaimer in the specification.” In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1369 (Fed. Cir. 2004). Patent Owner does not direct us to any specific disclosure in the Specification of the ’586 patent clearly limiting or defining dendrite blocking as impeding dendrite growth for the entire intended life of a rechargeable battery. Accordingly, because the ’586 patent does not clearly disclaim the scope of dendrite blocking in the manner Patent Owner advances, we are not persuaded that we should limit the claims to the asserted primary goal, or preferred result, of the ’586 patent. We, therefore, decline to adopt Patent Owner’s proffered claim construction.” slip op. at 9
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureNot shown unpatentableInherency not foundNot shown unpatentable
“and Dr. Abraham, as well as the Handbook’s disclosure that separator pores as small as 0.1 µm are effectively barn doors, which cannot prevent electronic shorts caused by dendrite growth, Patent Owner persuades us that Tojo’s porous ceramic composite layer is not capable of hindering, interrupting, or delaying the passage, progress, or course of dendrite growth, with any degree of effectiveness that prevents electronic shorting. That is, Patent Owner persuades us that Tojo’s separators do not include a ceramic composite layer that is adapted to at least block dendrite growth and to prevent electronic shorting, as recited in claim 1 of the ’586 patent.” slip op. at 16
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable
“As discussed above, Petitioner does not persuade us that it has established that Tojo’s separator includes that feature, because of the pores in Tojo’s ceramic composite layer. Because Petitioner relies on this limitation being inherently present in Tojo as argued with respect to claim 1 (Pet. 19, 23), Petitioner does not provide any evidence to support the obviousness of this limitation. In the context of an obviousness analysis, inherency “‘may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient.’” In re Oelrich, 666 F.3d 578, 581 (C.C.P.A. 1981) (quoting Hansgirg v. Kemmer, 102 F.2d 212, 214 (CCPA 1939)). An inherent disclosure is one that is “sufficient to show that the natural result flowing from the operation as taught would result in the performance of the questioned function.” Id.; Par Pharm., Inc. v. TWI Pharm., Inc., 773 F.3d 1186, 1195 (Fed. Cir. 2014) (“[T]he concept of inherency must be limited when applied to obviousness, and is present only when the limitation at issue is the ‘natural result’ of the combination of prior art elements.”) (quoting In re Oelrich, 666 F.2d at 581). As discussed above, the preponderance of the evidence leads us to conclude that Tojo’s disclosure would not necessarily produce pores with a tortuosity sufficient to block dendrite growth. Thus, even if an ordinary artisan were to find it obvious to try one of the specific matrix materials recited in dependent claim 4 (id. at 19), the resulting ceramic composite layer required by both claim 4 and claim 12 would, nonetheless, have the pores that Tojo teaches should be present in that layer. Therefore, a preponderance of the evidence does not support a finding that it would have been obvious that the separator disclosed by Tojo would result in a separator having the dendrite-blocking feature required by claims 4 and 12. Accordingly, because Petitioner has not shown that Tojo teaches or suggests all of the features required by claims 4 and 12, we conclude that Petitioner has not established by a preponderance of the evidence that claims 4 and 12 are unpatentable under 35 U.S.C. § 103 as obvious over Tojo.” slip op. at 21
- Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner
“Even disregarding the procedural infirmities in Patent Owner’s Response, however, Petitioner persuades us that the evidence of secondary considerations is not entitled to substantial weight, because Patent Owner has not established a sufficient nexus between the merits of the claimed subject matter and that evidence. Petitioner persuades us also that the evidence of secondary considerations is not reasonably commensurate in scope with the claimed subject matter.” slip op. at 33
Patent outcomesUS 6,432,586 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 6,432,586 - SK Innovation Co., Ltd. v. Celgard, LLCSome claims unpatentablePTAB · Sep 25, 2015 · IPR2014-00679 · APJ Francisco C Prats · IPR · Final written decision
Claims 7–9 are unpatentable as obvious over Tojo and Lundquist, and claim 10 as obvious over Tojo and Kejha; claims 1–6, 11, and 12 were not shown unpatentable.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Specification disavowal / 'present invention' languageTerm construed board ownDisclaimer not foundDecided for petitioner
“Our reviewing court, however, has “cautioned against reading limitations into a claim from the preferred embodiment described in the specification, even if it is the only embodiment described, absent clear disclaimer in the specification.” In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1369 (Fed. Cir. 2004). Patent Owner does not direct us to any specific disclosure in the Specification of the ’586 patent clearly limiting or defining dendrite blocking as impeding dendrite growth for the entire intended life of a rechargeable battery. Accordingly, because the ’586 patent does not clearly disclaim the scope of dendrite blocking in the manner Patent Owner advances, we are not persuaded that we should limit the claims to the asserted primary goal, or preferred result, of the ’586 patent. We, therefore, decline to adopt Patent Owner’s proffered claim construction.” slip op. at 10
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureNot shown unpatentableInherency not foundNot shown unpatentable
“It is well settled that the “very essence of inherency is that one of ordinary skill in the art would recognize that a reference unavoidably teaches the property in question.” Agilent Techs., Inc. v. Affymetrix, Inc., 567 F.3d 1366, 1383 (Fed. Cir. 2009) (emphasis added); see also In re Oelrich, 666 F.2d 578, 581 (CCPA 1981) (“Inherency, however, may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient.”). Given the evidence discussed above that the pores in Tojo’s ceramic composite layer would allow dendrite growth, Petitioner does not persuade us that, because Tojo’s ceramic composite layer contains the inorganic particles and matrix material required by claim 1, Tojo unavoidably teaches that its ceramic composite layer is adapted to block dendrite growth enough to prevent electronic shorting. See Reply 4–6. Moreover, even assuming for argument’s sake that larger dendrites would be blocked by Tojo’s pores (see id. at 8), Petitioner concedes that dendrites may grow at an atomic scale (id. at 7), and the evidence discussed above supports a finding that Tojo’s pores would not block dendrites of that size from producing an electronic short.” slip op. at 18
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayMotivation foundTeaching away not foundDecided for petitioner
“A reference does not teach away, however, “if it merely expresses a general preference for an alternative invention but does not ‘criticize, discredit, or otherwise discourage’ investigation into the invention claimed.” DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1327 (Fed. Cir. 2009) (citing In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004)). Patent Owner does not direct us to disclosures in Tojo that clearly or specifically criticize or discredit the use of fluoropolymers as the matrix material in its ceramic composite layer. Moreover, as noted above, and as Petitioner points out (Reply 13–14), Tojo’s teaching regarding its matrix material is rather expansive. See 1007 ¶ 22 (“The binders are not particularly limited, as long as they are conventionally in use, and examples include various polyesters, polyolefins, rubbers, acrylic resins, or the like . . . .”) (emphases added). Given this expansive disclosure, we agree with Petitioner that an ordinary artisan would not have viewed Tojo’s failure to include fluoropolymers in its list of binder materials as a teaching away, even in light of the earlier mention of fluoropolymers as known separator materials.” slip op. at 26
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner
“Because Tojo teaches that essentially any conventional polymeric material used in batteries can be used as its inorganic particle binder material, and because Lundquist, in turn, teaches that PTFE copolymers are useful as a binder material for inorganic particles in a battery separator containing the same two layers contained in Tojo’s separator, we find that that an ordinary artisan would have been prompted to use Lundquist’s PTFE copolymers as the binder material in Tojo’s separator. Patent Owner’s arguments and evidence do not persuade us to the contrary.” slip op. at 26
Patent outcomesUS 6,432,586 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 6,432,586 - Boehringer Ingelheim International GmbH / Boehringer Ingelheim Pharmaceuticals, Inc. v. Biogen Inc.Institution deniedPTAB · Jul 13, 2015 · IPR2015-00418 · APJ Francisco C Prats · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood of prevailing on any challenge to claim 1.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied
“An inter partes review may be instituted only if “the information presented in the [Petition and Preliminary Response] 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). Upon consideration of the Petition and Preliminary Response, we conclude that Petitioner has not established a reasonable likelihood that it would prevail in its challenges to claim 1 of the ’172 patent. Accordingly, we decline to institute an inter partes review.” slip op. at 2
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedNot shown unpatentable
“The Federal Circuit has held that “public accessibility” is “the touchstone” in determining whether a reference is a printed publication. In re Hall, 781 F.2d 897, 899 (Fed. Cir. 1986). “A given reference is ‘publicly accessible’ upon a satisfactory showing that such document has been disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence, can locate it.” SRI Int’l, Inc. v. Internet Sec. Sys., Inc., 511 F.3d 1186, 1194 (Fed. Cir. 2008) (quoting Bruckelmyer v. Ground Heaters, Inc., 445 F.3d 1374, 1378 (Fed. Cir. 2006)). We agree with Patent Owner that Petitioner has not shown that either ECOG 1496 or ECOG 4494 was publicly accessible to the extent required to establish its status as a printed publication under either § 311(b) or § 102(b).” slip op. at 8
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“We agree with Patent Owner that McNeil differs from claim 1 of the ’172 patent in at least three respects: (1) McNeil treats patients with intermediate grade NHL (IG-NHL), rather than the low grade NHL (LG- NHL) treated in claim 1, (2) McNeil does not teach rituximab maintenance therapy following CVP induction therapy as required by claim 1, but instead teaches CHOP induction therapy, and (3) McNeil is silent as to the dosing for maintenance therapy and, therefore, does not teach claim 1’s rituximab maintenance regimen of four weekly doses of 375 mg/m2. See Prelim. Resp. 31.” slip op. at 15
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency not foundNot shown unpatentable
“We acknowledge that the Rituxan® label discloses that, “for the treatment of relapsed or refractory low-grade or follicular, CD20 positive, B- cell non-Hodgkin’s lymphoma, the “recommended dosage of RITUXAN is 375mg/m2 given as an IV infusion once weekly for four doses (days 1, 8, 15, and 22).” Ex. 1008, 1, 2. However, that the FDA-approved/recommended weekly rituximab dosage for relapsed or refractory LG-NHL might be the same as the dosage recited in claim 1 does not demonstrate that a skilled artisan would have understood that those dosages were necessarily given in McNeil’s study of intermediate grade NHL, a different patient population. Because Petitioner directs us to no clear or specific evidence showing that the dosage used in McNeil’s study was the same as that recited in claim 1 of the ’172 patent, we are not persuaded that McNeil inherently describes administering the weekly dosage required by claim 1.” slip op. at 20
§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 8,329,172 - Olympus America Inc. / Olympus Medical Systems Corporation v. Perfect Surgical Techniques, Inc.All claims unpatentablePTAB · Jun 8, 2015 · IPR2014-00233 · APJ James B Arpin · IPR · Final written decision
Claims 1, 4–6, 8, 9, 11, 12, 38, 41–44, 46, 47, and 49 are unpatentable over JP’551; claims 1, 4–6, 8, 9, 11, 12, 43, 44, 46, and 47 also over JP’551 and FR’149.
RulingsFinal written decision- BurdenDecided for petitioner
“2. Translation of JP’551 Pursuant to 37 C.F.R. § 42.63(b), “[w]hen a party relies on a document or is required to produce a document in a language other than English, a translation of the document into English and an affidavit attesting to the accuracy of the translation must be filed with the document.” In support of its challenges to the claims of the ’384 patent, Petitioner filed a Japanese language copy of JP’551; an English language translation of JP’551, and a certification, signed by the translator, attesting to the accuracy of the English language translation of JP’551 and stating that JP’551 was “published on February 10, 1998.”5 Ex. 1013.” slip op. at 12
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportDecided for petitioner
“unpatentable, which includes the burden of establishing that any reference upon which it relies constitutes prior art under 35 U.S.C. § 102. 35 U.S.C. § 316(e); see Mahurkar v. C.R. Bard, Inc., 79 F.3d 1572, 1576 (Fed. Cir. 1996) (holding that the challenger “bore the burden of persuasion . . . on all issues relating to the status of [the asserted reference] as prior art”). However, because Petitioner offered into evidence JP’551, which was published before the ’384 patent’s filing date, Patent Owner bears a burden of producing evidence supporting a date of invention before JP’551’s publication date. Mahurkar, 79 F.3d at 1576–77. An inventor may antedate a reference if the inventor was the first to conceive of a patentable invention, and then connects the conception of the invention with its constructive reduction to practice by reasonable diligence on the inventor’s part, such that conception and diligence are substantially one continuous act. Id. at 1577. 7 In view of Petitioner’s erroneous reference to February 2, 1998, as JP’551’s publication date (see supra 12 n.5), Patent Owner proposes to show conception prior to February 2, 1998, and reasonable diligence from February 1, 1998, until May 1, 1998. PO Resp. 12. We do not analyze Patent Owner’s arguments based on Petitioner’s admitted typographical error. However, an inventor’s testimony, standing alone, is insufficient to carry the inventor’s burden of production with respect to conception and diligence, as some form of corroboration is required. Id.; Price v. Symsek, 988 F.2d 1187, 1194 (Fed. Cir. 1993). A rule of reason applies to determine whether the inventor’s testimony has been corroborated. Price, 988 F.2d at 1194. During the period in which reasonable diligence must be shown, there must be continuous exercise of reasonable diligence. In re McIntosh, 230 F.2d 615, 619 (CCPA 1956); see also Burns v. Curtis, 172 F.2d 588, 591 (CCPA 1949) (referring to “reasonably continuous activity”). The party alleging diligence must account for the entire critical period. Griffith v. Kanamaru, 816 F.2d 624, 626 (Fed. Cir. 1987); Gould v. Schawlow, 363 F.2d 908, 919 (CCPA 1966). Even a short period of unexplained inactivity may be sufficient to defeat a claim of diligence. Morway v. Bondi, 203 F.2d 742, 749 (CCPA 1953); Ireland v. Smith, 97 F.2d 95, 99–100 (CCPA 1938). In In re Mulder, 716 F.2d 1542, 1542–46 (Fed. Cir. 1983), for example, the Federal Circuit affirmed a determination of lack of reasonable diligence, where evidence of record demonstrating any diligence was absent for a two-day critical period. A party alleging diligence also must provide corroboration with evidence that is specific both as to facts and dates. Gould, 363 F.2d at 920; Kendall v. Searles, 173 F.2d 986, 993 (CCPA 1949). The rule of reason does not dispense with the need for corroboration of diligence that is specific as to dates and facts. Gould, 363 F.2d at 920; Kendall, 173 F.2d at 993; see also Coleman v. Dines, 754 F.2d 353, 360 (Fed. Cir. 1985) (“The rule of reason . . . does not dispense with the requirement for some evidence of independent corroboration.”). Consequently, in order to antedate JP’551, Patent Owner must show conception prior to the publication date of JP’551 and continuous and corroborated diligence from prior to JP’551’s publication date, i.e., February 10, 1998, until the date of constructive reduction to practice of the ’384 patent, i.e., May 1, 1998.” slip op. at 15
- Skill levelSkill level patent owner adoptedDecided for patent owner
“Patent Owner contends that a person of ordinary skill in the art possesses: a Bachelor’s Degree in either Physics, Electrical Engineering, or Mechanical Engineering and two to three years’ experience working in the field of electrosurgery. A person of ordinary skill in the art would be familiar with electrode designs and heating biological tissue through the application of various forms of electromagnetic energy, including RF energy. PO Resp. 33 (citing Ex. 2014 ¶¶ 14–17). For purposes of the Decision on Institution, we determined that the prior art adequately reflects a level of ordinary skill in the art. Dec. on Inst. 20 (citing Litton Indust. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163–64 (Fed. Cir. 1985)). Petitioner’s declarant meets or exceeds the qualifications set forth in Patent Owner’s definition of a person of ordinary skill in the art. See Ex. 1018 ¶ 7; Ex. 2022, 42:18–24. Further, Mr. Odell, as a person of equal or greater skill in the art, may testify as to what a person of 9 Patent Owner does not contend in the Patent Owner Response that secondary considerations are present, which would render the challenged claims patentable over JP’551, alone or in combination with FR’149. ordinary skill in the art would know or understand. See Ex. 2022, 41:12–42:11. Therefore, to the extent that it is necessary, for purposes of this Decision, we adopt Patent Owner’s definition of a person of ordinary skill in the art.” slip op. at 23
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for patent owner
“Contrary to Petitioner’s suggestion, we remain unpersuaded that the phrase “to permit the release of steam during use” may be ignored in construing this limitation. Pet. 18. Even if the phrase “to permit the release of steam during use” describes a function of the perforations, functional language may not be ignored in construing the claims. Id. A patent applicant is free to recite features of an apparatus either structurally or functionally. See In re Swinehart, 439 F.2d 210, 212 (CCPA 1971). A relevant definition of “steam” is “[w]ater vapor or water in its gaseous state.” MCGRAW-HILL DICTIONARY OF SCIENTIFIC AND TECHNICAL TERMS, 1817. Because claim 38 recites that “at least one of the jaws is perforated to permit the release of steam during use,” we understand that claim 38 requires only a single perforation or passage formed through either jaw. Thus, the at least one perforation or passage must pass through the jaw, such that the steam may be released from the tissue between the jaws. Patent Owner contends that the term “perforations” does not include “passages,” and that we erred in construing a “perforated” jaw to include at least one jaw having “one or more perforations or passages formed therethrough.” PO Resp. 19–20. Although Patent Owner contends that the Specification distinguishes perforations from passages, Patent Owner does not suggest how each term is to be understood, such that a person of ordinary skill in the art would distinguish between them. Id.; see Tr. 45:14–16 (perforations as “small holes”). A “passage” is “an opening or entrance into, through, or out of something.” RANDOM HOUSE WEBSTER’S COLLEGE DICTIONARY, 964 (Random House ed. 1999) (Ex. 3003). Consequently, we conclude that Patent Owner does not explain adequately why a perforation excludes a passage. Within the context of the Specification of the ’384 patent and in view of ordinary and customary meanings of the relevant words, as evidenced by the cited definitions, we interpret a perforation formed through a jaw and a passage formed through a jaw as alternative expressions of the same concept. Therefore, we maintain that this limitation is construed properly to mean “at least one jaw has one or more perforations or passages formed therethrough, so that steam generated between that jaw and tissue is released through the one or more perforations or passages.” Because the parties agree with our constructions for the remaining claim terms construed in the Decision on Institution, to the extent necessary, we adopt these constructions for the Final Written Decision. Tr. 12:19–13:8; 45:24–46:8. Because no other claim terms are in controversy, no other claim terms need to be construed.” slip op. at 10
Patent outcomesUS 6,030,384 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 6,030,384
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.