The Berkeley brief in the CRISPR interference appeal
On July 31, Kevin Noonan at Patent Docs posted Berkeley Files Opening Brief in CRISPR Appeal, which included the text:
The brief also faults the Board for not considering a provisional application by Kim (U.S. Provisional Application No. 61/717,324, filed October 23, 2012, and later published as U.S. Application No. 14/685,568) as prior art under 35 U.S.C. §102(e). (In many ways this is the brief's strongest argument, because this reference is clearly prior art to the earliest-filed Broad provisional, and Berkeley has a strong argument that the Board not considering it was legal error.)
Finally, Berkeley argues that Broad had not shown that it was entitled to the December 12, 2012 filing date of its earlier provisional. According to the brief, the Board should have considered October 15, 2013 as the relevant "end date" for considering prior art; if it had done so, many of the references not considered by the Board (set forth in the table above) would have made it impossible for Broad to satisfy its burden of proof that its claims were not obvious. Instead, the brief contends that the Board "assume without analysis" that Broad was entitled to its December 12, 2012 first provisional filing date for its "hundreds of involved claims," a conclusion Berkeley contends was error.
Broad will have the opportunity to make its arguments in favor of the Board's decision in the coming months; oral argument should be scheduled for some time before the end of the year.
***Of the Kim reference mentioned by Noonan:
*One notes that US application 14/685,568 (published appl. 20150322457) has first published claim:
A composition for cleaving a target nucleic acid sequence in a eukaryotic cell, the composition comprising a Type II Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR)/Cas system in a eukaryotic cell, wherein the Type II CRISPR/Cas system comprises: a) a nucleic acid encoding a Cas9 polypeptide, and b) a nucleic acid encoding a guide RNA that hybridizes with the target nucleic acid sequence, wherein the Cas9 polypeptide and the guide RNA form a Cas9/RNA complex in the eukaryotic cell and wherein the guide RNA has sufficient sequence complementarity to the target nucleic acid sequence in the eukaryotic cell to allow the Cas9 polypeptide to mediate double stranded cleavage at the target nucleic acid sequence.
*This application derives from a PCT application, which in turn claims priority to more than one provisional: The present application is a continuation application of PCT/KR2013/009488 filed Oct. 23, 2013, which claims priority to U.S. Provisional Application No. 61/837,481 filed on Jun. 20, 2013, U.S. Provisional Application No. 61/803,599 filed Mar. 20, 2013, and U.S. Provisional Application No. 61/717,324 filed Oct. 23, 2012, the entire contents of each aforementioned application are incorporated herein by reference.
*It is not so clear that the saga of the Kim application is "good" for UC/Berkeley. In the rejection mailed November 7, 2016, the attached interview summary shows the applicant argued for unpredictability.
Dr. Bryan Cullen argued there was no expectation of success that the Doudna/Jinek system would work in eukaryotic cells, the same argument as that of Broad. Does UC/Berkeley want the Cullen material on the record?
Furthermore, in pre-AIA law, the granting of the provisional filing date to a later patent/published application is a bit tricky.
As William Valet pointed out in discussing Dynamic Drinkware v. National Graphics :
The ultimate issue during this appeal was whether Dynamic had satisfied its burden of proving that the claims of U.S. Patent No. 7,153,555 to Raymond (the “Raymond Patent”) were supported by the written description of Provisional Application No. 60/182,490 (the “Provisional Application”), thus permitting the use of the disclosure of the Provisional Application to anticipate the claims of U.S. Patent No. 6,635,196 (the “‘196 Patent”) to National Graphics, LLC (“National”).
(...)
Dynamic’s troubles did not end there. Since Dynamic was not entitled to a presumption that a non-provisional application claims priority to its provisional application, Dynamic had the burden of proving that the Raymond Patent was entitled to the benefit of the filing date of the Provisional Application. Unfortunately, Dynamic merely compared “the claims of the ‘196 patent to the disclosure of the Raymond Patent and claim 1 of the ‘196 patent to the disclosure of the Raymond provisional application,” and therefore failed to meet this burden. (Slip Op. at 11, citing Appellant’s Br. at 22).
Because Dynamic failed to meet its burden, the court ultimately agreed with National Graphics, noting that, “[a] reference patent is only entitled to claim the benefit of the filing date of its provisional application if the disclosure of the provisional application provides support for the claims in the reference patent in compliance with § 112, ¶ 1. (Slip Op. at 11, citing In re Wertheim, 646 F.2d 527, 537 (CCPA 1981).) The court included a reminder that “[a] provisional application’s effectiveness as prior art depends on its written description support for the claims of the issued patent of which it was a provisional.” (Slip Op. at 11). Ultimately, the court noted, by failing to “compare the claims of the Raymond patent to the disclosure in the Raymond provisional application,” “Dynamic did not make that showing.” (Id., citing Appellant’s Br. at 22, emphasis added).
To be specific, from the case, 800 F.3d 1375; 2015 U.S. App. LEXIS 15764; 116 U.S.P.Q.2D 1045 :
For a patent to claim priority from the filing date of its provisional application, it must satisfy 35 U.S.C. § 119(e)(1) (2006), which provides that:
An application for patent filed under section 111(a) or section 363 of this title for an invention disclosed in the manner provided by the first paragraph of section 112 of this title in a provisional application filed under section 111(b) of this title, by an inventor or inventors named in the provisional application, shall have the same effect, as to such invention, as though filed on the date of the provisional application filed under section 111(b) of this title . . . .
(emphases added). "In other words, the specification of the provisional must 'contain a written description of the invention and the manner and process of making and using it, in such full, clear, concise, and exact terms,' 35 U.S.C. § 112 ¶ 1, to enable an ordinarily skilled artisan to practice the invention claimed in the non-provisional application." New Railhead Mfg., L.L.C. v. Vermeer Mfg. Co., 298 F.3d 1290, 1294 (Fed. Cir. 2002) (emphases in original).
Of the Giacomini case:
As relevant here, we found that "[b]ecause Giacomini never argued before the Board that the Tran provisional failed to provide [page 1381] written description support for the claimed subject matter in accordance with [page 1050] section 119(e), Giacomini waived the argument by failing to raise it below." Id. at 1383 (citation omitted). We ultimately concluded that the Tran patent had the same "patent-defeating effect" as though it was filed on the date of the Tran provisional. Id. at 1385. Because Giacomini waived the argument that the Tran provisional application did not support the Tran patent, we did not reach the question whether the Tran patent was presumptively entitled to the benefit of the filing date of its provisional application.
Asserting that it carried that burden, Dynamic argues that it provided sufficient evidence to prove that the Raymond provisional application provided written description support for the claims of the Raymond prior art patent. Dynamic contends that, as part of its petition, it compared the claims of the '196 patent to the disclosure in the Raymond patent. According to Dynamic, it then provided a claim chart in its reply brief to the Board establishing anticipation of claim 1 of the '196 patent by the Raymond provisional application. Dynamic argues that the combination of the two charts demonstrates that the Raymond provisional application provides written description support for the claims [page 1382] of the Raymond patent.
National Graphics responds that Dynamic only made a conclusory assertion in its petition that Raymond was entitled to an earlier effective date, and the argument is therefore waived. National Graphics also argues that, even absent a determination of waiver, the Board's decision is supported by substantial evidence because Dynamic never compared the claims of the Raymond patent to the disclosure in the provisional application.
First, we find that Dynamic did not waive its argument that Raymond was entitled to an earlier effective date. As discussed supra, Dynamic did not have the burden of producing evidence relating to the Raymond provisional application until after National Graphics made its argument regarding reduction to practice. As a result, it was not necessary for Dynamic to prove in its petition that Raymond was entitled to the filing date of its provisional application. Thus, there was no waiver.
We ultimately agree with National Graphics, however, that the Board's decision was supported by substantial evidence because Dynamic failed to compare the claims of the Raymond patent to the disclosure in the Raymond provisional application. A reference patent is only entitled to claim the benefit of the filing date of its provisional application if the disclosure of the provisional application provides support for the claims in the reference patent in compliance with § 112, ¶ 1. In re Wertheim, 646 F.2d 527, 537 (CCPA 1981).2 As Dynamic acknowledges, it provided charts to the Board comparing the claims of the '196 patent to the disclosure of the Raymond patent and claim 1 of the '196 patent to the disclosure of the Raymond provisional application. See, e.g., Appellant's Br. at 22. Nowhere, however, does Dynamic demonstrate support in the Raymond provisional application for the claims of the Raymond patent. That was Dynamic's burden. A provisional application's effectiveness as prior art depends on its written description support for the claims of the issued patent of which it was a provisional. Dynamic did not make that showing.
Of published applications (rather than issued patents) see also Amgen, 2016 U.S. Dist. LEXIS 26049 :
3. Because I asked the parties to identify the case that best supports their respective positions, I assume that there is no case on point, that is, a case where defendants are relying for their obviousness defense on a published application (as opposed to a patent) which is only prior art by claiming priority to an earlier filed unpublished application, neither of which have claims that have been examined. I recognize that the references at issue may change; nevertheless, I believe the law is more accurately described in Dynamic Drinkware. However, because plaintiffs did not object to the two prior art references at issue until the conclusion of expert discovery through the Daubert motion exercise, I decline to grant plaintiffs' motion to preclude defendants from presenting their obviousness defense and will, instead, give defendants the opportunity to supplement their expert reports to appropriately address the question of whether the Schering and Novartis references constitute prior art by comparing their claims to the prior disclosures. (D.I. 247 at 62) If the parties need a short postponement of the trial date to accommodate this order, I will make it so.
See also VERINATA HEALTH, INC., 2017 U.S. Dist. LEXIS 7728 :
Ariosa is correct that the PTAB never specifically compared Fan with the challenged claims of the '794 Patent in its final written decision. See Decl. Wathen (Dkt. No. 301), Ex. 18. Rather, the PTAB found that, under the Federal Circuit's decision in Dynamic Drinkware, LLC v. National Graphics, Inc., 800 F.3d 1375 (Fed. Cir. 2015), Ariosa failed to carry its burden to demonstrate that Fan was prior art under § 102. Establishing priority is one of the elements of a claim that the patent is invalid on anticipation grounds, not an evidentiary "technicality."
***Pre-AIA law is NOT what one intuitively expects (did the provisional provide DISCLOSURE rendering the later challenged claims not patentable?) but rather is claim-centric (did the written description of the provisional support the claims of the patent/application arising from the provisional?). Intuitively, Dynamic had a good case; legally, under pre-AIA, it did not.
link to Valet piece: http://www.cdfslaw.com/publications/think-provisional-application-qualifies-prior-art-better-think/
Also:
http://ipr-pgr.com/provisional-application-not-%C2%A7-102e-prior-art-in-ipr/
The brief also faults the Board for not considering a provisional application by Kim (U.S. Provisional Application No. 61/717,324, filed October 23, 2012, and later published as U.S. Application No. 14/685,568) as prior art under 35 U.S.C. §102(e). (In many ways this is the brief's strongest argument, because this reference is clearly prior art to the earliest-filed Broad provisional, and Berkeley has a strong argument that the Board not considering it was legal error.)
Finally, Berkeley argues that Broad had not shown that it was entitled to the December 12, 2012 filing date of its earlier provisional. According to the brief, the Board should have considered October 15, 2013 as the relevant "end date" for considering prior art; if it had done so, many of the references not considered by the Board (set forth in the table above) would have made it impossible for Broad to satisfy its burden of proof that its claims were not obvious. Instead, the brief contends that the Board "assume without analysis" that Broad was entitled to its December 12, 2012 first provisional filing date for its "hundreds of involved claims," a conclusion Berkeley contends was error.
Broad will have the opportunity to make its arguments in favor of the Board's decision in the coming months; oral argument should be scheduled for some time before the end of the year.
***Of the Kim reference mentioned by Noonan:
*One notes that US application 14/685,568 (published appl. 20150322457) has first published claim:
A composition for cleaving a target nucleic acid sequence in a eukaryotic cell, the composition comprising a Type II Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR)/Cas system in a eukaryotic cell, wherein the Type II CRISPR/Cas system comprises: a) a nucleic acid encoding a Cas9 polypeptide, and b) a nucleic acid encoding a guide RNA that hybridizes with the target nucleic acid sequence, wherein the Cas9 polypeptide and the guide RNA form a Cas9/RNA complex in the eukaryotic cell and wherein the guide RNA has sufficient sequence complementarity to the target nucleic acid sequence in the eukaryotic cell to allow the Cas9 polypeptide to mediate double stranded cleavage at the target nucleic acid sequence.
*This application derives from a PCT application, which in turn claims priority to more than one provisional: The present application is a continuation application of PCT/KR2013/009488 filed Oct. 23, 2013, which claims priority to U.S. Provisional Application No. 61/837,481 filed on Jun. 20, 2013, U.S. Provisional Application No. 61/803,599 filed Mar. 20, 2013, and U.S. Provisional Application No. 61/717,324 filed Oct. 23, 2012, the entire contents of each aforementioned application are incorporated herein by reference.
*It is not so clear that the saga of the Kim application is "good" for UC/Berkeley. In the rejection mailed November 7, 2016, the attached interview summary shows the applicant argued for unpredictability.
Dr. Bryan Cullen argued there was no expectation of success that the Doudna/Jinek system would work in eukaryotic cells, the same argument as that of Broad. Does UC/Berkeley want the Cullen material on the record?
Furthermore, in pre-AIA law, the granting of the provisional filing date to a later patent/published application is a bit tricky.
As William Valet pointed out in discussing Dynamic Drinkware v. National Graphics :
The ultimate issue during this appeal was whether Dynamic had satisfied its burden of proving that the claims of U.S. Patent No. 7,153,555 to Raymond (the “Raymond Patent”) were supported by the written description of Provisional Application No. 60/182,490 (the “Provisional Application”), thus permitting the use of the disclosure of the Provisional Application to anticipate the claims of U.S. Patent No. 6,635,196 (the “‘196 Patent”) to National Graphics, LLC (“National”).
(...)
Dynamic’s troubles did not end there. Since Dynamic was not entitled to a presumption that a non-provisional application claims priority to its provisional application, Dynamic had the burden of proving that the Raymond Patent was entitled to the benefit of the filing date of the Provisional Application. Unfortunately, Dynamic merely compared “the claims of the ‘196 patent to the disclosure of the Raymond Patent and claim 1 of the ‘196 patent to the disclosure of the Raymond provisional application,” and therefore failed to meet this burden. (Slip Op. at 11, citing Appellant’s Br. at 22).
Because Dynamic failed to meet its burden, the court ultimately agreed with National Graphics, noting that, “[a] reference patent is only entitled to claim the benefit of the filing date of its provisional application if the disclosure of the provisional application provides support for the claims in the reference patent in compliance with § 112, ¶ 1. (Slip Op. at 11, citing In re Wertheim, 646 F.2d 527, 537 (CCPA 1981).) The court included a reminder that “[a] provisional application’s effectiveness as prior art depends on its written description support for the claims of the issued patent of which it was a provisional.” (Slip Op. at 11). Ultimately, the court noted, by failing to “compare the claims of the Raymond patent to the disclosure in the Raymond provisional application,” “Dynamic did not make that showing.” (Id., citing Appellant’s Br. at 22, emphasis added).
To be specific, from the case, 800 F.3d 1375; 2015 U.S. App. LEXIS 15764; 116 U.S.P.Q.2D 1045 :
For a patent to claim priority from the filing date of its provisional application, it must satisfy 35 U.S.C. § 119(e)(1) (2006), which provides that:
An application for patent filed under section 111(a) or section 363 of this title for an invention disclosed in the manner provided by the first paragraph of section 112 of this title in a provisional application filed under section 111(b) of this title, by an inventor or inventors named in the provisional application, shall have the same effect, as to such invention, as though filed on the date of the provisional application filed under section 111(b) of this title . . . .
(emphases added). "In other words, the specification of the provisional must 'contain a written description of the invention and the manner and process of making and using it, in such full, clear, concise, and exact terms,' 35 U.S.C. § 112 ¶ 1, to enable an ordinarily skilled artisan to practice the invention claimed in the non-provisional application." New Railhead Mfg., L.L.C. v. Vermeer Mfg. Co., 298 F.3d 1290, 1294 (Fed. Cir. 2002) (emphases in original).
Of the Giacomini case:
As relevant here, we found that "[b]ecause Giacomini never argued before the Board that the Tran provisional failed to provide [page 1381] written description support for the claimed subject matter in accordance with [page 1050] section 119(e), Giacomini waived the argument by failing to raise it below." Id. at 1383 (citation omitted). We ultimately concluded that the Tran patent had the same "patent-defeating effect" as though it was filed on the date of the Tran provisional. Id. at 1385. Because Giacomini waived the argument that the Tran provisional application did not support the Tran patent, we did not reach the question whether the Tran patent was presumptively entitled to the benefit of the filing date of its provisional application.
Asserting that it carried that burden, Dynamic argues that it provided sufficient evidence to prove that the Raymond provisional application provided written description support for the claims of the Raymond prior art patent. Dynamic contends that, as part of its petition, it compared the claims of the '196 patent to the disclosure in the Raymond patent. According to Dynamic, it then provided a claim chart in its reply brief to the Board establishing anticipation of claim 1 of the '196 patent by the Raymond provisional application. Dynamic argues that the combination of the two charts demonstrates that the Raymond provisional application provides written description support for the claims [page 1382] of the Raymond patent.
National Graphics responds that Dynamic only made a conclusory assertion in its petition that Raymond was entitled to an earlier effective date, and the argument is therefore waived. National Graphics also argues that, even absent a determination of waiver, the Board's decision is supported by substantial evidence because Dynamic never compared the claims of the Raymond patent to the disclosure in the provisional application.
First, we find that Dynamic did not waive its argument that Raymond was entitled to an earlier effective date. As discussed supra, Dynamic did not have the burden of producing evidence relating to the Raymond provisional application until after National Graphics made its argument regarding reduction to practice. As a result, it was not necessary for Dynamic to prove in its petition that Raymond was entitled to the filing date of its provisional application. Thus, there was no waiver.
We ultimately agree with National Graphics, however, that the Board's decision was supported by substantial evidence because Dynamic failed to compare the claims of the Raymond patent to the disclosure in the Raymond provisional application. A reference patent is only entitled to claim the benefit of the filing date of its provisional application if the disclosure of the provisional application provides support for the claims in the reference patent in compliance with § 112, ¶ 1. In re Wertheim, 646 F.2d 527, 537 (CCPA 1981).2 As Dynamic acknowledges, it provided charts to the Board comparing the claims of the '196 patent to the disclosure of the Raymond patent and claim 1 of the '196 patent to the disclosure of the Raymond provisional application. See, e.g., Appellant's Br. at 22. Nowhere, however, does Dynamic demonstrate support in the Raymond provisional application for the claims of the Raymond patent. That was Dynamic's burden. A provisional application's effectiveness as prior art depends on its written description support for the claims of the issued patent of which it was a provisional. Dynamic did not make that showing.
Of published applications (rather than issued patents) see also Amgen, 2016 U.S. Dist. LEXIS 26049 :
3. Because I asked the parties to identify the case that best supports their respective positions, I assume that there is no case on point, that is, a case where defendants are relying for their obviousness defense on a published application (as opposed to a patent) which is only prior art by claiming priority to an earlier filed unpublished application, neither of which have claims that have been examined. I recognize that the references at issue may change; nevertheless, I believe the law is more accurately described in Dynamic Drinkware. However, because plaintiffs did not object to the two prior art references at issue until the conclusion of expert discovery through the Daubert motion exercise, I decline to grant plaintiffs' motion to preclude defendants from presenting their obviousness defense and will, instead, give defendants the opportunity to supplement their expert reports to appropriately address the question of whether the Schering and Novartis references constitute prior art by comparing their claims to the prior disclosures. (D.I. 247 at 62) If the parties need a short postponement of the trial date to accommodate this order, I will make it so.
See also VERINATA HEALTH, INC., 2017 U.S. Dist. LEXIS 7728 :
Ariosa is correct that the PTAB never specifically compared Fan with the challenged claims of the '794 Patent in its final written decision. See Decl. Wathen (Dkt. No. 301), Ex. 18. Rather, the PTAB found that, under the Federal Circuit's decision in Dynamic Drinkware, LLC v. National Graphics, Inc., 800 F.3d 1375 (Fed. Cir. 2015), Ariosa failed to carry its burden to demonstrate that Fan was prior art under § 102. Establishing priority is one of the elements of a claim that the patent is invalid on anticipation grounds, not an evidentiary "technicality."
***Pre-AIA law is NOT what one intuitively expects (did the provisional provide DISCLOSURE rendering the later challenged claims not patentable?) but rather is claim-centric (did the written description of the provisional support the claims of the patent/application arising from the provisional?). Intuitively, Dynamic had a good case; legally, under pre-AIA, it did not.
link to Valet piece: http://www.cdfslaw.com/publications/think-provisional-application-qualifies-prior-art-better-think/
Also:
http://ipr-pgr.com/provisional-application-not-%C2%A7-102e-prior-art-in-ipr/
posted by Lawrence B. Ebert at 6:09 AM
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