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 election without traverse of the required species in the reply filed on 10/13/2025 is acknowledged. The elected species is that of SEQ ID NO: 1.
Claims 8-11 and 16 are withdrawn from consideration as they recite non-elected species.
Claims 1-3, 14, 17, 23-27, 53 and 60-61 are examined on the merits. Claims 60 and 61 are newly presented.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 5/14/26 in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
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.
(Prior Rejection Maintained and extended to new claims) Claims 1-3, 14, 17, 23-27, 53, 60 and 61 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 following quotation from section 2163 of the Manual of Patent Examination Procedure is a brief discussion of what is required in a specification to satisfy the 35 U.S.C. 112 written description requirements for a generic claim covering several distinct inventions:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice .... 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 claimed genus... See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
Thus, when a claim covers a genus of inventions, the specification must provide written description support for the entire scope of the genus. Support for a genus is generally found where the applicant has provided a number of examples sufficient so that one in the art would recognize from the specification the scope of what is being claimed.
Claims 1-3, 14, 17, 23-27, 53, 60 and 61 are rejected as lacking adequate descriptive support for a generating a polypeptide comprising or consisting of: (a) an amino acid sequence at least 91% or 95% identical to the amino acid sequence of SEQ ID NO:1, wherein 1, 2, 3, 4, 5, 6, 7, 8, 9, or all 10 of the following mutations relative to SEQ ID NO:1 are present in the polypeptide: F32Y, H37D/E/K/N/Q/R, F43Q, F168D/E/K/N/Q/R/S/T/Y, K169D/E/N/Q, L173D/E/N/Q/S, A174S, S179D/E, K183D/E, and/or T185D/E/K/N/Q/S. The claims also can include that the polypeptide is at least 95% identical to an amino acid sequences selected from SEQ ID NO: 7-14.
Furthermore, SEQ ID NO:s 7-14 represent mutated versions of SEQ ID NO: 1, and amino acid 1 can be absent.
The claimed polypeptide of SEQ ID NO: 1 inherently possesses the ability to self- assemble into a nanoparticle (see claim 17) and the claimed polypeptide is part of a fusion protein with a second functional peptide (see claim 14).
Further, while the claims provide both a structure and a function, the application fails to draw any correlation between the two. I.e., there is no evidence that any mutant (other than those detailed below) of claim 1 (as it requires SEQ ID NO: 1) can still retain the ability of forming a nanoparticle or the second functional protein of claim 14 can also achieve this nanoparticle formation. Moreover, no correlation has been made to which portion of SEQ ID NO: 1 is required in order to maintain an ability to function as a nanoparticle forming polypeptide. Lastly, the specification states that SEQ ID NO: 1 was able to form nanoparticles, but mutants of SEQ ID NO: 1 needed assistance with a “second component” to form these nanoparticles (see Section F on page 21 of the specification.
Thus, in view of the above, there would have been significant uncertainty as to which mutants of the SEQ ID NO: 1 with or without a generic second functional protein, would be able form nanoparticles. In view of this uncertainty and the lack of any examples of the claimed genus, the claims are rejected for lack of adequate written description support.
Response to arguments:
Applicant presents the following arguments in traversal of the rejection:
Applicants argue that the claims are narrower in scope since they recite 91% identity and the amino acid mutations are specifically defined as presented in at least claim 1. Furthermore, the specification specifically provides methods for making these mutations, determining their secretion yields and determining if the resultant polypeptides form nanoparticles. See Specification, pp. 19-22. This includes results showing increased secretion while maintaining nanoparticle formation for different mutations. The specification provides the specific mutations to make in a sequence that has at least 91% identity to SEQ ID NO:1 and further provides guidance on how to fuse mutated nanoparticle polypeptides with a second functional polypeptide. The specification thus provides a clear roadmap to a person of ordinary skill in the art of the possession of the claimed subject matter. For at least this reason, the written description rejection should be withdrawn.
With regard to increased secretions of mutant proteins of SEQ ID NO: 1, the specification states that only single mutants H35D and L171Q significantly improve the yield of secreted protein. [see description of Figure 1(a)] Furthermore, the claimed invention permits 9% variation (91% identity) or 5% variation (95% identity) of SEQ ID NO:1, which includes up to 10 to 18 amino acids to be mutated. While claim 1 also lists specific mutations, the claim includes a broad genus of mutation combinations that applicants have not reduced to practice based on a representative number of species.
With regard to the claimed proteins being able to form nanoparticles, SEQ ID NO: 1 (I3-01) and variants (single mutant H35D or quad mutant H35D/L171Q/S177E/V180N) [see description for Figure 2a-b] are the species reduced to practice by applicant that can form nanoparticles, in relation to SEQ ID NO: 1.
As it relates to the elected SEQ ID NO: 1, these are the mutated proteins that applicants have reduced to practice and are in possession of in view of the claimed genus.
(Prior Rejection Withdrawn in view of Amendments) Claims 24, 25, 26, 48, 50 and 51 are rejected under 35 U.S.C. 112, first paragraph, as containing subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
(Prior Rejection Withdrawn in view of Amendments) Claims 1, 28 and 58 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
(Prior Rejection Withdrawn in view of Amendments) Claim 1 recites, “wherein optional residues may be present or may be absent in whole or in part.”
(Prior Rejection Withdrawn in view of Cancellation of Claim) A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 28 recites the broad recitation “synthetic”, and the claim also recites “degreased” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
(Prior Rejection Withdrawn in view of Cancellation of Claim) Claim 28 recite, “cryptic transmembrane domain”, however, the claim nor the specification explain or define what a renders a transmembrane domain cryptic. The claims nor the specification provide an explanation of what “the signature of a cryptic transmembrane domain” are. The state of the prior art also does not elaborate on what “the signature of a cryptic transmembrane domain” are. What renders a transmembrane domain cryptic and how does one of ordinary skill in the art know if it is a signature of a cryptic transmembrane domain.
(Prior Rejection Withdrawn in view of Cancellation of Claim) A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
(Prior Rejection Withdrawn in view of Cancellation of Claim) A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
(Prior Rejection Withdrawn in view of Cancellation of Claim) Claim 58 recites the limitation "Windows of dG_ins" in line 5. The claims nor specification provide an explanation of what “Windows of dG_ins” are. The state of the prior art also does not elaborate on what “Windows of dG_ins” are. Therefore, it is unclear what the metes and bounds of this limitation are.
(Prior Rejection Withdrawn in view of Cancellation of Claim) Claim 58 recites the limitation "the signature of a cryptic transmembrane domain" in lines 6-7. There is insufficient antecedent basis for this limitation in the claim.
(Prior Rejection Withdrawn in view of Cancellation of Claim) Claim 58 recites in lines 6-7, “the signature of a cryptic transmembrane domain”. The claims nor the specification provide an explanation of what “the signature of a cryptic transmembrane domain” are. The state of the prior art also does not elaborate on what “the signature of a cryptic transmembrane domain” are. What renders a transmembrane domain cryptic and how does one of ordinary skill in the art know if it is a signature of a cryptic transmembrane domain.
(Prior Rejection Withdrawn in view of Cancellation of Claim) Claim 58 recites the limitation "that domain" in line 9. There is insufficient antecedent basis for this limitation in the claim.
(Prior Rejection Withdrawn in view of Cancellation of Claim) Claim 58 recites, “…are allowed to adopt different rotamers but not mutate to other.” It is unclear what “but not mutate to other” refers to. Is “other” referring to amino acids, domains or peptides?
(Prior Rejection Withdrawn in view of Cancellation of Claim) A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
(Prior Rejection Withdrawn in view of Amendments) Claims 26 and 51 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
(Prior Rejection Withdrawn in view of Amendments) Claims 1 and 2 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a naturally-occurring element of nature that is not patent-eligible pursuant to the Supreme Court decision in Association for Molecular Pathology V. Myriad Genetics, Inc., -- U.S. -- (June 13, 2013) (hereafter "Myriad").
(Prior Rejection Withdrawn in view of Cancellation of Claim) Claim 58 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a naturally-occurring element of nature that is not patent-eligible pursuant to the Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, Inc., -- U.S.-- (June 13, 2013) (hereafter “Myriad”).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(Prior Rejection Withdrawn in view amendments) Claim(s) 1 and 2 are rejected under 35 U.S.C. 102a1 as being anticipated by GenBank Accession WP_038066850 (published 11/11/2018).
(Prior Rejection Withdrawn in view of Cancellation of Claims) Claim( 48, 50 and 51 are rejected under 35 U.S.C. 102a1 as being anticipated by He and Zhu (US PGPub 2020/0009244).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
(Prior Rejection withdrawn in view of amendments) Claim(s) 1-2, 14, 17, 23-27 and 53 are rejected under 35 U.S.C. 103 as being unpatentable over He and Zhu (supra) and GenBank Accession WP_038066850 (published 11/11/2018).
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN P BLUMEL whose telephone number is (571)272-4960. The examiner can normally be reached M-F 8-5 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Allen can be reached at (571) 270-3497. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BENJAMIN P BLUMEL/Primary Examiner, Art Unit 1671
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