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 with traverse of Group I, in the reply filed on 5/6/26 is acknowledged. The traversal is on the ground(s) that the Group I and II share the common technical feature of the composition of claim 80. Applicants argue that cited reference of Nongomierma does not teach the amino acid except for glycine are in the D-configuration. Election was made of a polypeptide, SEQ ID NO: 16, retro-inverso and the T-cel polypeptide is fused to the N-terminus.
This is not found persuasive because the claim is interpreted to require D-amino acids (except for glycine) in SEQ ID NO: 1-29 and 42-107 only. The broadest reasonable interpretation of the claim does not require fragments and variants to be in the D-configuration. Please see the 112 (b) rejection below for details. Therefore, the arguments are not persuasive as the technical feature is not a special technical feature in view of the prior art.
The requirement is still deemed proper and is therefore made FINAL.
Claims 80-100 are pending.
Claims 87 and 91-100 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim.
Claims 80-86 and 88-90 read on elected Group I and the elected species and are under consideration.
Claim Objections
Applicant is advised that should claim 83 be found allowable, claim 90 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim 80 is objected to because of the following informalities: grammatical error. The conjunctive “and” or “or” is missing from the limitation following “D-amino acid configuration”. Appropriate correction is required.
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 80-82, 84-86 and 88-89 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
MPEP § 2163 states that 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, 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. 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.
Scope of the claimed genus
Claim 80 is drawn a composition comprising a polypeptide comprising an amino acid sequence selected from the group consisting of SEQ ID NO: 1-29 and 42-107 and/or fragments and variants thereof and optionally 1 to 12 additional amino acids distributed in any ratio on the N and/or C-terminus of the polypeptides of SEQ ID NO: 1-29 and 42-107, wherein each of the amino acids of SEQ ID NO: 1-29 and 42-107 and optionally the extensions thereof, except for glycine are in the D-amino acid configuration. The USPTO provides claim terms with broadest reasonable interpretation in light of the specification.
The instant specification defines “variant” [PGPUB0110]:
As used herein, a “variant” polypeptide (including a variant retro-inverso Tregitope) can differ in amino acid sequence by one or more substitutions, deletions, insertions, inversions, fusions, and truncations or a combination of any of these. In aspects, a variant retro-inverso Tregitope can differ in amino acid sequence by one or more substitutions, deletions, insertions, inversions, fusions, and truncations or a combination of any of these provided said variants retain MHC binding propensity and/or TCR specificity, and/or regulatory T cell stimulating or suppressive activity.
Therefore, the broadest reasonable interpretation of variant includes any number of substitutions, deletions, inversions, fusions and truncations, wherein the variant has the function of retaining MHC binding propensity and/or TCR specificity and/or regulatory T cell stimulating or suppressive activity.
The instant specification does not define or limit the “fragment” to any particular amino acid length.
Assessment of whether species are support in the original specification
94 embodiment of the invention of the claims were reduced to practice at the time of filing. Applicants disclose SEQ ID NO: 1-29 and 42-107.
There was no disclosure of variants and fragments thereof. There was no disclosure of the polypeptides with an extension of 1 to 12 amino acids at the N and/or C-terminus.
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In summary, for these reasons, the skilled artisan would reasonably conclude that the inventor(s), at the time the application was filed, had possession of SEQ ID NO: 1-29 and 42-107 at the time the invention was filed.
Assessment of whether disclosed species are representative of the claimed genus
MPEP § 2163 states that 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.
In the instant case, the disclosure of SEQ ID NO: 1-29 and 42-107 are not representative of the genus of variants, fragments and extensions thereof.
There is no teaching regarding which amino acids can vary from the recited sequences and still result in a polypeptide that is able to retain MHC binding propensity and/or TCR specificity, and/or regulatory T cell stimulating or suppressive activity.
For example, the variants can vary by any number of amino acids and the fragment are not limited by amino acid length. If one considers that there are 20 natural amino acids and a great number of non-natural amino acids and the substitutions/deletions can occur at any position of the peptide, the number of peptides that meet the requirement of variants, fragments and extensions thereof is enormous.
Therefore, disclosure of SEQ ID NO: 1-29 and 42-107 are not representative of the genus.
Identifying characteristics and structure/function correlation
In the absence of a reduction to practice of a representative number of species, the written description requirement for a claimed genus may be satisfied 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. To meet this requirement in the instant case, the specification must describe the structural, physical and/or chemical properties of a polypeptide that leads to the recited function.
The data do not suggest the physical basis for the claimed activity and therefore do not describe which substitutions, deletions or additions could be made while preserving function. This is an issue of written description. The specification does not make clear which proteins are in the genus and which are not because it does not describe the physical basis for the claimed activity. In other words, the specification does not describe which proteins to make.
In conclusion, for the reasons presented above, the skilled artisan would reasonably conclude that the inventors, at the time the application was filed had full possession of the neuropeptide analogs, SEQ ID NO: 1-29 and 42-107.
Claim Rejections - 35 USC § 112
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.
Claims 80-86 and 88-90 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.
Claim 80 is indefinite because the claim scope is unclear. Claim 80 recites a polypeptide comprising an amino acid sequence selected from the group consisting of SEQ ID NO: 1-29 and 42-107 and/or fragments and variants thereof….. wherein each of the amino acids of SEQ ID NO: 1-29 and 42-107 and optionally the extensions thereof, except for glycine are in the D-amino acid configuration. It is unclear if the requirement of D-amino acids (except for glycine) applies only to SEQ ID NO: 1-29 and 42-107 or also applies to the claimed fragments and variants thereof. The “wherein” clause expressly limits “each of the amino acids of SEQ ID NO: 1-29 and 42-107, and optionally the extensions thereof” to the D-amino acid configuration, but does not address the “and/or fragments and variants thereof”. Therefore, the claim is unclear if the D-amino acid requirement is intended to apply to the fragments and variants. The definition of “variant” in the specification [PGPUB0110] does not clarify the ambiguity. It is impossible to determine the metes and bounds of the claim. For purposes of examination, the claim is interpreted to require D-amino acids (except for glycine) in SEQ ID NO: 1-29 and 42-107 only. The broadest reasonable interpretation of the claim does not require fragments and variants to be in the D-configuration.
Claim 82 is indefinite because it is unclear how the recited “immune stimulating T-cell epitope polypeptides” can be “treatment with a vaccine” or “treatment with at least one antigen”. In particular, the “treatment with a vaccine” and “treatment with at least one antigen” appears to describe treatment method or therapeutic interventions rather that polypeptides. It is unclear what the limitations impose on the “one or more immune stimulating T-cell epitope polypeptides”. It is impossible to determine the metes and bounds of the claim. Please note that the specification defines “polypeptides” to include proteins [PGPUB0077].
Claim 86 recites the limitation "the retro-inverso T-cell polypeptide" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 1 does not recite a retro-inverso T-cell polypeptide.
Claims 81-86 and 88-90 do not clarify this point of confusion and are also rejected.
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.
Claims 80-82, 85-86 and 88-89 are rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter. Based upon an analysis with respect to the claim as a whole, claims 80, 85-86 and 88 do not recite something significantly different than a judicial exception. The rationale for this determination is explained below and is based on the analysis presented in the USPTO’s 2019 Revised Patent subject matter Eligibility Guidance (referred to as 2019 PEG) published January 2019 and the “PEG update” in October 2019.
Claim Interpretation
Claim 80 is drawn a composition comprising a polypeptide comprising an amino acid sequence selected from the group consisting of SEQ ID NO: 1-29 and 42-107 and/or fragments and variants thereof and optionally 1 to 12 additional amino acids distributed in any ratio on the N and/or C-terminus of the polypeptides of SEQ ID NO: 1-29 and 42-107, wherein each of the amino acids of SEQ ID NO: 1-29 and 42-107 and optionally the extensions thereof, except for glycine are in the D-amino acid configuration.
Subject Matter Eligibility Test for Products and Processes
Step 1: Is the claim to a process, machine, manufacture, or composition of matter (see, e.g., 79 FR 74621)?
Yes, the instant claims are directed to a statutory patent-eligible subject matter category, namely a composition of matter.
Step 2A (1): Is the claim directed to a law of nature, a natural phenomenon, or an abstract idea (see, e.g., 79 FR 74621)?
Yes, the claims are directed to a natural phenomenon, variants and fragments of SEQ ID NO: 1-29 and 42-107 are naturally occurring. As evidenced by Uniprot:
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A variant of SEQ ID NO: 12 is a fragment of a naturally occurring protein from Emmonsia. The protein from Emmonsia meets the limitations of a variant of SEQ ID NO: 12 and the limitations of claim 80. Accordingly, the pending claims are directed to a naturally occurring product.
Absent evidence to the contrary, the recitation of “recombinant” does not impart a different structure to the claimed FSH that would distinguish it from the natural product.
Step 2A (2): Does the Claim recite additional Elements that integrate the judicial Exception into a Practical Application?
No, the claim does not recite additional elements that integrate the judicial exception into a practical application.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception (see, e.g., 79 FR 74621)?
No, the claims do not recite additional elements that amount to significantly more than the judicial exception. As indicated above, the claimed fragments and variants are naturally occurring. The claims do not recited additional elements that amount to significantly more. With respect to claims 81-82 immune stimulating T-cell epitopes such as antigens and therapeutic proteins can be naturally occurring. A combination of naturally occurring agents does not constitute significantly more. With respect to claims 85-86, the rest of the protein meets the limitation of a heterologous polypeptide. With respect to claims 88-89, allergens and antigens are naturally occurring. Taken as a whole, the dependent claims do not add significantly more.
Factors for determining if the claim directed to a product of nature, as a whole, recites something significantly more than the judicial exception, are provided in the Guidance (74623; see esp. 79 FR 74623 at §I.A.3.b). see also, 79 FR.
In sum, when the relevant considerations are analyzed, they weigh against a significant difference. Accordingly, claims 80, 85-86 and 88 do not qualify as eligible subject matter.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 80 and 85-86 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Uniprot A0A0G2JAD4 (July 22, 2015).
Uniprot teaches a sequence that comprises a variant of SEQ ID NO: 12 at residues 54-62 (see below), anticipating the limitations of claim 80.
With respect to claims 85-86, the rest of the protein in Uniprot meets the limitations of a heterologous polypeptide fused the N-terminus.
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Claims 80-82, 85 and 88-89 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Grabowska et al. (EP2883550A1 published 6/17/2016).
With respect to claim 80, Grabowska et al. teach SEQ ID NO: 25 (claim 1 and [0009]). The bottom sequence is SEQ ID NO: 25 from Grabowska et al. and meets the limitation of a “variant” of SEQ ID NO: 12. Claim 12 of Grabowska et al. claim the peptides are antigens.
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SEQ ID NO: 26 from Grabowska et al. also meets the limitation of a “variant” of SEQ ID NO: 12 (Table A3 [0044]).
With respect to claims 81-82, Grabowska et al. teach the peptides in combination with an immune stimulating adjuvant or in combination with immune stimulatory cytokines or conjugated to keyhole limpet hemocyanin or mannan. Grabowski et al. also teach a vaccine comprising at least one peptide or all of the peptides in table A3 [0039-0044].
With respect to claims 85 and 88-89, Grabowski et al. teach the peptide can be part of a fusion protein or fusion molecule, for example with a TLR ligand [0041].
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 80 and 88-89 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22, 28 and 20 of copending Application No. 18/579,691(reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. SEQ ID NO: 2 and 3 of the copending application meet the limitations of a variant or fragment of SEQ ID NO: 1-29 and 42-107. The copending Application claim a cashew allergen in combination with the peptides (claims 18-20). Therefore, the copending application anticipates instant claims 80 and 88-89.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Examiner’s comment
SEQ ID NO: 1 and 16, wherein each of the amino acids except glycine are in the D-configuration are free of the art. The closest prior art is presented above. However, the references do not specifically teach SEQ ID NO: 1 or 16. However, variants and fragments of SEQ ID NO: 1 and 16 are not free of the art.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TARA L MARTINEZ whose telephone number is (571)270-1470. The examiner can normally be reached Mon-Fri 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko Garyu can be reached at (571)270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TARA L MARTINEZ/ Primary Examiner, Art Unit 1654
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