- Celltrion, Inc. v. Genentech, Inc.Some claims unpatentablePTAB · Nov 29, 2018 · IPR2017-01374 · APJ Robert A Pollock · IPR · Final written decision
Claims 1, 2, 4, 25, 29–31, 33, 62–64, 66, 67, 69, 72, 78, 80, and 81 are unpatentable; the remaining challenged claims were not shown unpatentable because Kurrle and Queen 1990 were not prior art …
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“with respect to the ’213 patent. See Pet. 12–13; Prelim. Resp. 17–18; PO Resp. 17–18. In our institution decision, we adopted Patent Owner’s proposal that “[a] person of ordinary skill for the ’213 patent would have had a Ph.D. or equivalent in chemistry, biochemistry, structural biology, or a closely related field, and experience with antibody structural characterization, engineering, and/or biological testing, or an M.D. with practical academic or industrial experience in antibody development.” Dec. 10–11. Petitioner does not contest this definition in its Reply and we find no reason to revise our earlier determination. We further note that the prior art itself demonstrates this 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 on 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)). C.” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed patent owner constructionDecided for patent owner
“Patent Owner’s proposed construction derives from the ’213 patent’s definition of consensus sequence as “refer[ing] to an amino acid sequence which comprises the most frequently occurring amino acid residues at each location in all human immunoglobulins of any particular subclass or subunit structure.” Ex. 1001, 11:32–38. In the context of the patent as a whole, however, we do not understand the term to require a consensus of “all” human immunoglobulins in the literal sense because the embodiments in the patent were generated using the most common residue at each position identified in Kabat 1987.11 See id. at 10:34–63, 11:55–60; Ex. 2016 ¶¶ 25– 26. And though Patent Owner attempts to distinguish Queen 1990 as describing “a consensus framework from many human antibodies,’ not all as in the ’213 patent,’” it presents no argument as to why we should interpret the claim in this manner. See PO Resp. 47. Moreover, at oral argument, Patent Owner did not contest Petitioner’s assertion that the reference to “all sequences” in the patent, “refer[s] to all known sequences and there’s no dispute . . . that was really synonymous with Kabat 1987.” Tr. 15:4–16:4.12 Accordingly, we adopt the parties proposed construction, with a clarifying modification, specifically, “a human variable domain which comprises the most frequently occurring amino acid residues at each location in all human immunoglobulins of any particular subclass or subunit structure, as set forth in Kabat 1987.”” slip op. at 13
- Prior constructionDecided for patent owner
“We previously stated that the language of claim 63, “refer[s] to a humanized antibody having reduced immunogenicity in a human patient as compared to its non-humanized parent antibody.” IPR2017-01488, Paper 27 at 10–12. Patent Owner does not dispute this interpretation. See PO Resp. 19. Petitioner argues that the recited reduction in immunogenicity is both an inherent aspect of the claimed humanized antibodies, and “the stated goal of all humanization projects, including that of Queen 1990 and Kurrle.” Pet. Reply, 28, 43. Petitioner also contends that the term is not a claim limitation and “simply a statement of the intended result of the claimed compositions,” but, nevertheless, states: “For the purpose of the present petition only, Petitioner will assume that the preambles are limiting.” Pet. 13 n.3. On balance, we see no need to alter our prior determination that “[a] humanized antibody which lacks immunogenicity compared to a non-human parent antibody upon repeated administration to a human patient,” refers to a humanized antibody having reduced immunogenicity in a human patient as compared to its non-humanized parent antibody. Nevertheless, to the extent Petitioner is correct that the preambles should be accorded no weight, such a determination would not alter the outcome of this proceeding.” slip op. at 15
- Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference not prior artDecided for patent owner
“The ’213 patent issued from application number 08/146,206 (“the ’206 application”), which is an application that entered the national stage on November 17, 1993, from a PCT application filed on June 15, 1992. Ex. 1001, (21), (22), (86). The ’206 application is also a continuation-in-part of the ’272 application, filed on June 14, 1991. Id. at (63). Kurrle was published on December 19, 1990 (Ex. 1071, (43)), and Queen 1990 was published on July 26, 1990 (Ex. 1050, (43)), both of which predate the earliest possible priority date, June 14, 1991, shown on the face of the ’213 patent. Accordingly, Petitioner has satisfied its initial burden of showing that Kurrle and Queen 1990, on their face, qualify as prior art to the challenged claims. We next consider whether Patent Owner has antedated these references.” slip op. at 18
Patent outcomesUS 6,407,213 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 6,407,213 - Pfizer, Inc. / Samsung Bioepis Co., Ltd. v. Genentech, IncSome claims unpatentablePTAB · Nov 29, 2018 · IPR2017-01489 · APJ Zhenyu Yang · IPR · Final written decision
The Board held claims 1, 2, 4, 12, 25, 29–31, 33, 42, 60, 62–64, 66, 67, 69, 71, 73, 74, 78, 80, and 81 unpatentable as obvious; claims 65, 72, 75–77, and 79 were not …
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“Level of Ordinary Skill in the Art In the Decision to Institute, we found the parties’ proposed definitions of a person of ordinary skill for the ’213 patent are similar. Dec. 7 (citing Pet. 16; Prelim. Resp. 17). We adopted Patent Owner’s proposed definition that “[a] person of ordinary skill for the ’213 patent would have had a Ph.D. or equivalent in chemistry, biochemistry, structural biology, or a closely related field, and experience with antibody structural characterization, engineering, and/or biological testing, or an M.D. with practical academic or industrial experience in antibody development.” Id. During trial, Patent Owner points out that Petitioner’s proposed definition “encompasses persons without advanced degrees but who have ‘knowledge gained through 4–5 years of work experience.’” PO Resp. 17. A person of ordinary skill in the art is a hypothetical person who is presumed to know the relevant prior art. Custom Accessories, Inc. v. Jeffrey–Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986). The artisan may gain such knowledge through either formal education or extensive work experience. Thus, we do not discern an appreciable difference in the parties’ respective definitions of the level of ordinary skill in the art, and any perceived distinction does not impact our Decision. Having considered the complete record developed at trial, we see no reason to change our assessment.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed patent owner constructionDecided for patent owner
“In the Decision to Institute, we agreed with Patent Owner that the ’213 patent expressly defined “consensus human variable domain,” which appears in claims 4, 33, 62, and 69, to mean “a human variable domain which comprises the most frequently occurring amino acid residues at each location in all human immunoglobulins of any particular subclass or subunit structure.” Dec. 9–10; Ex. 1501, 11:32–38. During trial, the parties did not argue otherwise, and we see no reason to change our position as to claim construction. See PO 17–18; Reply 5. We, however, clarify that “all” in the consensus of “all human immunoglobulins” is not in the literal sense. In fact, Patent Owner does not appear to argue otherwise.7 Dr. Wilson, the expert witness for Patent 7 In a parallel proceeding involving the same patent, counsel for Patent Owner acknowledged that the term “all human immunoglobulins” refers to Owner, testified that the consensus sequence of the ’213 patent was “derived from ‘all’ known antibody sequences of any particular subclass or subunit structure.” Ex. 2041 ¶ 210 (emphasis added); see also PO Resp. 52 (arguing the same); Ex. 1698, 59:22–60:1 (Dr. Carter testifying that the consensus sequence, as defined in the ’213 patent, “only describes what was known at that time or it’s only available sequences at that -- at that time”); Ex. 1699, 35:9–16 (Dr. Presta explaining that the consensus sequence of the ’213 patent had the most common residue at every position “for the sequences that were available”). And evidence of record shows that at the priority date of the ’213 patent, the sequences that were listed in Kabat 1987 “were the sequences available.” Ex. 1699, 35:9–20; see also Ex. 2016 ¶ 25 (Kabat 1987 “collected known sequence data of antibodies”); Ex. 1698, 60:13–25 (Dr. Carter explaining the consensus sequence was derived from Kabat 1987, which is what was available at the time of the ’213 patent); Ex. 1699, 27:19–25 (Dr. Presta stating that “Elvin Kabat had taken all known human/mouse/rabbit antibody sequences, published them in a government publication, and that there were human subgroups of sequences within the heavy and the light chains”).” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“For the purpose of this Decision, we see no need to expressly construe any other claim terms. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (stating claim terms need only be construed to the extent necessary to resolve the controversy).” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. KSR, 550 U.S. at 421. Here, Queen 1989 recognizes the need to substitute framework residues in order to “reduce immunogenicity while retaining high binding affinity.” See Ex. 1534, 3. Thus, even if Queen 1990 is not available as prior art, we find that an ordinary artisan would have identified the candidates for substitution, as recited in claims 12, 42, 60, 71, 73, and 74. Indeed, Dr. Wilson testified that he performed a “good analysis” and identified 19 amino acid positions in the light chain and 19 in the heavy chain, including 66L (recited in claims 12 and 42), 73H (recited in claim 71), 78H (recited in claims 60 and 73), 93H (recited in claim 74). Ex. 1697, 242:4–6; Ex. 2041 ¶ 186, Appendix 1. Claims 12, 66, 67, 71, 73, 74, and 78” slip op. at 22
Patent outcomesUS 6,407,213 mixedClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 6,407,213 - Celltrion, Inc. v. Genentech, Inc.Some claims unpatentablePTAB · Nov 29, 2018 · IPR2017-01373 · APJ Zhenyu Yang · IPR · Final written decision
Claims 1, 2, 4, 12, 25, 29–31, 33, 42, 60, 62–64, 66, 67, 69, 71, 73, 74, 78, 80, and 81 are unpatentable; claims 65, 72, 75–77, and 79 are not shown unpatentable.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedOther
“Level of Ordinary Skill in the Art In the Decision to Institute, we found the parties’ proposed definitions of a person of ordinary skill for the ’213 patent are similar. Dec. 10 (citing Pet. 12; Prelim. Resp. 17). We adopted Patent Owner’s proposed definition that “[a] person of ordinary skill for the ’213 patent would have had a Ph.D. or equivalent in chemistry, biochemistry, structural biology, or a closely related field, and experience with antibody structural characterization, engineering, and/or biological testing, or an M.D. with practical academic or industrial experience in antibody development.” Id. at 10–11. During trial, the parties did not dispute this finding. Having considered the complete record developed at trial, we see no reason to change our assessment. We further note that, in this case, the prior 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)).” slip op. at 10
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed patent owner constructionDecided for patent owner
“In the Decision to Institute, we agreed with Patent Owner that the ’213 patent expressly defined “consensus human variable domain,” which appears in claims 4, 33, 62, and 69, to mean “a human variable domain which comprises the most frequently occurring amino acid residues at each location in all human immunoglobulins of any particular subclass or subunit structure.” Dec. 7; Ex. 1001, 11:32–38. During trial, the parties did not argue otherwise, and we see no reason to change our position as to claim construction. We, however, clarify that “all” in the consensus of “all human immunoglobulins” is not in the literal sense. Indeed, counsel for Patent Owner acknowledged that the term refers to “all reasonably available[,] all known at the time of the invention.” Tr. 47:21–48:5. Dr. Wilson, the expert witness for Patent Owner, testified that the consensus sequence of the ’213 patent was “derived from ‘all’ known antibody sequences of any particular subclass or subunit structure.” Ex. 2041 ¶ 207 (emphasis added); see also PO Resp. 52 (arguing the same); Ex. 1140, 59:22–60:1 (Dr. Carter testifying that the consensus sequence, as defined in the ’213 patent, “only describes what was known at that time or it’s only available sequences at that -- at that time”); Ex. 1142, 35:9–16 (Dr. Presta explaining that the consensus sequence of the ’213 patent had the most common residue at every position “for the sequences that were available”). And evidence of record shows that at the priority date of the ’213 patent, the sequences that were listed in Kabat 1987 “were the sequences available.” Ex. 1142, 35:9–20; see also Ex. 2016 ¶ 25 (Kabat 1987 “collected known sequence data of antibodies”); Ex. 1140, 60:13–25 (Dr. Carter explaining the consensus sequence was derived from Kabat 1987, which is what was available at the time of the ’213 patent); Ex. 1142, 27:19–25 (Dr. Presta stating that “Elvin Kabat had taken all known human/mouse/rabbit antibody sequences, published them in a government publication, and that there were human subgroups of sequences within the heavy and the light chains”). Thus, although we reiterate our previous construction of “consensus” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“For the purpose of this Decision, we see no need to expressly construe any other claim terms. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (stating claim terms need only be construed to the extent necessary to resolve the controversy).” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“combination of Queen 1989 and the PDB database, together with the knowledge of an ordinary artisan, teaches or suggests each limitation of claims 12, 63, 66, 67, 71, 73, 74, and 78, and that a person of ordinary skill in the art would have had a reason to combine the references, and would have had a reasonable expectation of producing humanized antibodies with the substitutions and properties recited in those claims. We further determine that evidence of secondary considerations is not sufficient to outweigh the strong evidence of obviousness associated with the other Graham factors. As a result, we conclude that Petitioner has established by a preponderance of the evidence that claims 12, 63, 66, 67, 71, 73, 74, and 78 are unpatentable over Queen 1989 and the PDB database.” slip op. at 37
Patent outcomesUS 6,407,213 mixedClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 6,407,213 - Oracle America Inc. / Oracle Corporation et al. v. Intellectual Ventures I LLCSome claims unpatentablePTAB · Jan 8, 2018 · IPR2016-01434 · APJ Michael W Kim · IPR · Final written decision
Claims 11–13 and 15–20 are unpatentable as obvious; claim 14 was not shown unpatentable because the cited personal notes were not “content contributed.”
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“While the parties use slightly different language, we are unable to discern any substantive differences between the proffered levels of skill and basic qualifications of a person of ordinary skill in the art. Accordingly, we adopt Dr. Papakonstantinou’s articulation of the level of ordinary skill as our own, if for no other reason then for its conciseness, with the understanding that the differences between the proffered levels of ordinary skill are limited and inconsequential in our analysis.” slip op. at 23
- Expert testimonyPetitioner expert creditedPatent owner expert creditedDecided for patent owner
“above-identified single statement in the specification, which uses permissible language such as “can be” and “does not need to be,” is sufficient to justify Patent Owner’s assertions, which for all practical purposes, is a disavowal of claim scope. See Home Diagnostics, Inc. v. LifeScan, Inc., 381 F.3d 1352, 1358 (Fed. Cir. 2004) (“Absent a clear disavowal in the specification or the prosecution history, the patentee is entitled to the full scope of its claim language.”) We also credit the testimony of Dr. Almeroth over that of Dr. Papakonstantinou, because, among other reasons, Dr. Almeroth supports his testimony with relevant citations to the specification, while Dr. Papakonstantinou largely repeats that which is set forth in the Patent Owner Response, without further analysis. graphical fields that allow the input of administrative information without programming” are advantageous over “cumbersome programming performed in the past.” Ex. 2002 ¶¶ 44, 47. We treat this argument as subsumed within Patent Owner’s argument that the specification disparages prior art systems that require HTML programming to perform administrative tasks.” slip op. at 16
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“224, 232 encompasses a “link to content.” In application, however, “what is a wireless LAN?” 224, 232 is actually two separate components: (1) the underlying technical set of computer instructions that, upon clicking the link associated with “what is a wireless LAN?” 232, transports a user to a web page associated with “what is a wireless LAN?” 232; and (2) the words “what is a wireless LAN?” 224 itself displayed on the computer display, but separate from the technical set of computer instructions set forth in (1). In this example, (1) is “link to content, but not itself ‘content,’” however, (2) is itself “content.” More precisely, when we now consider “what is a wireless LAN?” 224, 232 in relation to the aforementioned construction of “content” as “electronic data embodying information for an individual or individuals,” it becomes clear that “what is a wireless LAN?” 224, 232 is both “links to content” and “content.” Specifically, component (1) of “what is a wireless LAN?” 232 is “links to content,” but not “content” itself, because the underlying technical set of computer instructions is not “electronic data embodying information for an individual or individuals,” but for a computer. By contrast, component (2) of “what is a wireless LAN?” 224 is “content,” as it is clearly “electronic data embodying information for an individual or individuals,” in that the words “what is a wireless LAN?” are intended to convey information to an individual. So, as a practical matter, we discern that every disclosure of a “link to content” that includes “electronic data embodying information for an individual or individuals” (i.e., any information associated with a “link” that is separate from a generic indication of the “link” itself), is “content.” See also Ex. 3001, 6–16 (providing further analysis concerning construction, which we expressly incorporate herein). Accordingly, we determine that a proper construction of “content” is “electronic data embodying information for an individual or individuals,” and excluding “links to content,” but not excluding “content” associated with the “links to content.”” slip op. at 10
- Claim Construction › Intrinsic evidence (Phillips canons) › Specification disavowal / 'present invention' languageTerm construed petitioner constructionDecided for petitioner
“We agree with Petitioner. We are persuaded that “administrative interface” is broader than the “administrative page” mentioned in the specification, in that an “administrative interface” may encompass 9 While discussing “graphical user interface” during oral argument, Patent Owner stated that it was not disclaiming claim scope. Tr. 47:20–22 (“We’re not arguing that the claim terms have been disclaimed in some phrase.”). something other than an “administrative page.” We are also persuaded that the specification’s disclosure of a non-limiting embodiment, that of a highlyautomated and browser-based “administrative page,” does not require that a proper construction of “administrative interface” include “graphical user interface.” As admitted by Patent Owner, these pages are “example[s]” only, and, at best, merely “impl[y]” the presence of a “graphical user interface.” See PO Resp. 8–9 (citing Ex. 1002, 16:39–44; Ex. 2002 ¶ 40). We are persuaded that an “implied example” does not belong in a proper construction of a claim term. Indeed, Petitioner asserts that Patent Owner’s factual premise, concerning the above “implied example,” is flawed, as the specification’s “reference to automation and a browser provides no basis for restricting the claimed ‘administrative interface’ to a graphical user interface.” Pet. Reply 5–6 (citing Ex. 1033 ¶ 15) (Dr. Almeroth testifies that “automation of computer systems does not require a graphical user interface.”). More specifically, Dr. Almeroth identifies other automated “interfaces” in the specification, such as “a networked cash register, bar code scanner or electronic product code reader” (Ex. 1002, 13:8–15, 14:51–52) that do not require a “graphical user interface.” Ex. 1033 ¶ 14. We agree with Dr. Almeroth’s analysis of the specification. Dr. Almeroth asserts further, and we agree, again, that “[o]ne of ordinary skill would understand that that cash register could be connected to a server that is accessible only via a command line interface, and that administrators could use command-line tools . . . to group content on that server.” Ex. 1033 ¶ 14. Patent Owner cites In re Abbott Diabetes Care, Inc., 696 F.3d 1142, 1149–1150 (Fed. Cir. 2012) for its finding of an implicit definition of a” slip op. at 13
Patent outcomesUS 7,516,177 mixedClaim construction§ 103 obviousnesscites KSRPatents in suitUS 7,516,177 - Praxair Distribution, Inc. v. Mallinckrodt Hospital Products IP Ltd.Some claims unpatentablePTAB · Jul 7, 2016 · IPR2015-00529 · APJ Robert A Pollock · IPR · Final written decision
Claims 1–8 and 10–19 are unpatentable as obvious over the INOmax label, Bernasconi, Loh, and Goyal; claims 1, 7, 12, and 14 are also anticipated and obvious over the INOmax label.
RulingsFinal written decision- Expert testimonyOther
“method of providing pharmaceutically acceptable nitric oxide gas requires providing information to the medical provider to safely administer the nitric oxide gas,” thus “confirm[ing] that the ‘providing . . . information’ step is functionally related to the steps in the claimed method.” PO Resp. 31–33. As an initial matter, whether the claims should be interpreted as requiring such a functional relationship is a legal conclusion. See PO Resp. 13. Patent Owner’s conclusion regarding functional relationship between claim terms is based, at least in part, on an overly-limited reading of “pharmaceutically acceptable nitric oxide gas,” as discussed above. See PO Resp. 27. Further, we do not read the transcript testimony relied on by Patent Owner as clearly admitting a functional relationship between the steps of “providing pharmaceutically acceptable nitric oxide gas” and the information of (ii). See PO Resp. 31–32 (citing Ex. 2022, 78:15–80:4, 81:11–22, 111:2–17)). To the contrary, Dr. Beghetti appears to have testified that the claim elements are not directly related. Ex. 2022, 86:10– 25. Although Patent Owner points to In re Distefano, 808 F.3d at 848, as evidence that a “printed matter analysis includes ‘factual findings’” (PO Sur Reply 4, n.6), which inform the ultimate legal conclusion, we do not find the evidence as a whole compelling.” slip op. at 19
- ExcludeMotion to exclude, deniedOther
“IV. PETITIONER’S MOTION TO EXCLUDE Petitioner moves to exclude certain portions of Ex. 2024 on the grounds that they “are declarations and supporting materials submitted during patent examination . . . in violation of 37 C.F.R. § 42.53(a)” and “lack foundation (FRE 602) and authentication (FRE 901) and constitute impermissible hearsay (FRE 901).” Paper 31, 2–3. Petitioner likewise moves to exclude Exhibit 2029 as not relied on in the Patent Owner Response or by Patent Owner’s expert. Id. at 3. As we do not rely on the objected-to materials in this opinion, we dismiss the motion as moot.” slip op. at 45
- Strike new argumentNew argument disregardedOther
“V. OBJECTIONS TO DEMONSTRATIVES The parties also submit competing objections to demonstrative exhibits used at trial. Papers 46, 47. Specifically, both parties object to certain slides as setting forth a new argument not previously made in any paper. Papers 46, 47. The parties are reminded that demonstrative exhibits are illustrative only and are not part of the trial record. Indeed, in accordance with our Order on requests for oral argument, neither party filed its demonstratives with the Board. See Paper 45, 2 (“Notwithstanding 37 C.F.R. § 42.70(b), the parties shall not file any demonstrative exhibits in this proceeding without prior authorization from the Board. 37 C.F.R. § 42.5(b). Demonstrative exhibits are intended to be visual aids to assist a party in making its oral presentation and will not be entered into the record of these proceedings.”). Nevertheless, in this Final Written Decision, we rely on the arguments presented properly in the parties’ briefs and the evidence of record and do not consider any new arguments not previously set forth in any paper. See Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,768 (Aug. 14, 2012). (“No new evidence or arguments may be presented at the oral argument.”).” slip op. at 45
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“The Applicant amended the preamble of the rejected independent claims to recite “[a] method of providing pharmaceutically acceptable nitric oxide gas,” as presently set forth in claims 1 and 7. Id. at 746–747. Subsequent to the amendment, the Examiner withdrew the objection. Id. at 765; see id. at 733 (“If all the priority issues are resolved then it appears that the primary reference in the 103 rejection will no longer be prior art.” (italics omitted)). On pages 19 and 20 of its Response, Patent Owner argues that the preamble is, therefore, limiting in light of Catalina Mktg. International, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002), which holds that “clear reliance on the preamble during prosecution to distinguish the claimed invention from the prior art transforms the preamble into a claim limitation because such reliance indicates the use of the preamble to define, in part, the claimed invention.” Although the prosecution history shows that amendment of the preamble only indirectly distinguished the claims over the prior art by establishing an earlier priority date, we conclude that both the Applicant and the Examiner treated the preamble as a claim limitation. Accordingly, we agree with Patent Owner that the preamble language “pharmaceutically acceptable nitric oxide gas” is limiting.” slip op. at 11
Patent outcomesUS 8,846,112 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,846,112
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.