DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s response 3/17/25 has been considered. Applicant has amended the claims and the restriction requirement 5/15/24 is withdrawn.
Claim Amendment Formalities
Applicant should submit only one set of amended claims that show the current amendments and status.
Rejections Necessitated by Amendment
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and 3-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are drawn to a genus of polymerization modules, a genus of target peptide presentation molecules, a genus of insertions between beta sheet 8 and 9 in green fluorescent protein, and high affinity antibodies.
The specification only discloses a modified influenza M2 peptide as polymerization domain and the presentation module of superfolder green fluorescent protein or superfolder mCherry protein with an insert between beta sheet 8 and 9.
The guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112, § 1 "Written Description" Requirement make clear that if a claimed genus does not show actual reduction to practice for a representative number of species, then the Requirement may be alternatively met by reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the Applicant was in possession of the genus (Federal Register, Vol. 66, No. 4, pages 1099-1111, Fri. January 5, 2001, see especially page 1106 column 3).
The specification does not provide adequate written description of the claimed invention. The legal standard for sufficiency of a patent's (or a specification's) written description is whether that description "reasonably conveys to the artisan that the inventor had possession at that time of the. . .claimed subject matter", Vas-Cath, Inc. V. Mahurkar, 19 USPQ2d 1111 (Fed. Cir. 1991). In the instant case, the specification does not convey to the artisan that the Applicant had possession at the time of invention of the claimed invention, the genus of polymerization modules, genus of target peptide presentation molecules, and the genus of insertions between beta sheet 8 and 9 in green fluorescent protein. These are claimed by function, the ability to polymerize and present peptide antigens. The Federal Circuit addressed the application of the written description requirement to DNA-related inventions in University of California v. Eli Lilly and Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997). The court stated that “[a] written description of an invention involving a chemical genus, like a description of a chemical species, requires a precise definition, such as by structure, formula, [or] chemical name, of the claimed subject matter sufficient to distinguish it from other materials.” Id. At 1567, 43 USPQ2d at 1405. The court concluded that “naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of, is not a description of that material.” Id.
The Federal Circuit clarified that a molecule can be adequately described without disclosing its complete structure. See Enzo Biochem, Inc. V. Gen-Probe Inc., 296 F.3d 1316, 63 USPQ2d 1609 (Fed. Cir. 2002). The Enzo court adopted the standard that the written description requirement can be met by “show[ing] that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics ....i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics. “ Id. At 1324, 63 USPQ2d at 1613 (emphasis omitted, bracketed material in original).
Furthermore The Board in Ex Parte Kubin found that the written description of 35 USC 112 was not met, stating that
Without a correlation between structure and function, the claim does little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (“definition by function … does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is”).
The Board in Ex Parte Kubin further stated on page 16 that
Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features. See University of Rochester, 358 F.3d at 927, 69 USPQ2d at 1895.
Thus, the specification does not provide an adequate written description of the genus of the ability to polymerize and present peptide antigens that is required to practice the claimed invention. Applicants have not described the genus of polymerizing, presenting, and making high affinity antibodies sufficiently to show they had possession of the claimed genus. Since the disclosure fails to provide sufficient relevant identifying characteristics, and because the genus is highly variant, one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus as broadly claimed.
Applicant argues for the polymerization domain that applicant points to portions of SEQ ID# 32 that function in conjunction with GFP including those in Figure 3a. (para 12). Applicant goes into detail about the results of Figures 3A-3D. Applicant points to para 0004 that discusses fluorescent proteins, and presents scientific references that support the insertion of peptide in the structure between beta sheets 8 and 9 and provides explanation and a table of examples.
Applicant’s arguments have been fully considered and not found persuasive.
Applicant’s argument on the polymerization module support 75% of SEQ ID# 32 fused to a fluorescent protein. That does not show possession of any other polymerization module or target peptide presentation module. There are no dependent claims that include both the elements of 75% of SEQ ID# 32 fused to a fluorescent protein.
Applicant’s argument on the target peptide presentation module are not persuasive because the target peptide presentation module is not limited to fluorescent proteins with an insert between beta sheets 8 and 9.
Applicant’s arguments refer to fluorescent protein fused to SEQ ID# 32 or 75% of it. Claim 1 does not require either of these. Claims 3-13 do not have structures for both functions in one claim and so do not meet the written description requirements.
Claims 1 and 3-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a modified influenza M2 peptide as polymerization domain and the presentation module of superfolder green fluorescent protein or superfolder mCherry protein with an insert between beta sheet 8 and 9., does not reasonably provide enablement for any polymerization module or any target peptide presentation module. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The specification teaches a modified influenza M2 peptide as polymerization domain and the presentation module of superfolder green fluorescent protein or superfolder mCherry protein with an insert between beta sheet 8 and 9.
The post filing reference shows that certain features are required for function as the self-assembled protein. Wong et al. (Vaccines 2023, 11(2), 426; https://doi.org/10.3390/vaccines11020426) teach that “This novel application is restricted to conditions when an AH3 peptide is fused with a fast-folding protein such as a fluorescent protein. Fusing amphipathic helical peptide to other slow-folding proteins causes fusion protein misfolding, which appears to be due to aggregation of slow-folding fusion proteins in the presence of AH3” and “Through protein modeling, we went further to identify two point mutations in the AH3 peptide, I9L and K14E, which act synergistically to stabilize protein nanoparticles“ (page 17 lower part).
Thus, it would require undo experimentation to use the broadly claimed polymerization module and target peptide presentation module.
Applicant argues that the reference is post-filing and is used to show lack of written description [the rejection is enablement]. Applicant argues that the postdated reference shows the importance of claimed invention. That only when the AH3 peptide is fused to the fast-folding fluorescent protein does it not mis-fold. Lastly, that claim 1 states the invention and claims 3-10 add more details.
Applicant’s arguments have been fully considered and not found persuasive.
Applicant’s argument on post-dated reference is not persuasive because the reference is not used as prior art but to show the state of the art. This type of reference does not have to be before the filing date. The reference shows what failed and if it failed after the filing date, it would fail before the filing date absent some structure that overcomes the failure. The present claims do not exclude those structures. The combination that did work are not found in one claim or in a claim that depends on one that has the other limitation. Claims 3-10 recite the structure limitations separately. Only claim 7 includes super folders with insertion between betasheets 8-9 but does not require AH3 or 75% of SEQ ID # 32.
Allowable Subject Matter
The sequence in claim 14 (SEQ ID# 32) is free of the prior art.
Suggested claim language of an allowable claim. A very similar version was previously offered but no agreement was reached.
1. (Currently amended) A recombinant protein, comprising a polymerization module and a target peptide presentation module, wherein the polymerization module is fused in frame to the target peptide presentation module and is polymerized into a self-assembled protein nanoparticle[ when it is expressed in a host.], wherein the polymerization module comprises a peptide with more than 75% identity to Sequence ID No. 32, and wherein the target peptide presentation module comprises a fluorescent protein.
Citation of Closest Prior Art
Ravin et al. (Vaccine Volume 33, Issue 29, 26 June 2015, Pages 3392-3397) teach a polymerization domain of HBV core protein in fusion with Influenza M2e as the target peptide (abstract).
The reference does not teach or make obvious using a different part of M2 as the basis for a polymerization module or use a green fluorescent protein to display the target.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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MYRON G. HILL
Examiner
Art Unit 1671
/M.G.H/Examiner, Art Unit 1671
/Shanon A. Foley/Primary Examiner, Art Unit 1671
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