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 Group I, drawn to a polypeptide comprising an amino acid sequence that is at least 30% and less than 81% identical to or that has at least 4 and up to 14 amino acid additions or substitutions in SEQ ID NO: 77, in the reply filed on 11/10/25 is acknowledged. Election was made without traverse of SEQ ID NO: 15 (a double staples peptide), X is α-(4’pentneyl)alanine, the olefinic side chain from the first X is crosslinked to the olefinic side chain from the second X and the olefinic side chain from the third X is crosslinked to the olefinic side chain of the fourth X.
Claims 1, 4-5, 7-11, 13, 15-16, 18-19, 22-23, 25, 29-30, 34-36, 41, 45-51 are pending.
Please note that SEQ ID NO: 115 was found free of the art so the search was extended to additional stapled peptides where art was found (SEQ ID NO:17 and 100).
Claims 5, 11, 23 and 25, 29-30, 34-36, 41, 47-51 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim.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 1, 4, 7-10, 13, 15-16, 18-19, 22 and 45-46 read on Group I and elected species and are under consideration.
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 1, 8, 15, 16 and 19 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 1, 8, 15, 16 and 19 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
Claims 1 is drawn to a polypeptide comprising an amino acid sequence that is at least 30% and less than 81% identical to or that has at least 4 and up to 14 amino acid additions or substitutions in SEQ ID NO: 77. Claim 8 is drawn to the polypeptide of claim 1 which is not stapled or stitched. Claim 15 is drawn to the polypeptide of claim 1 wherein the polypeptide is not substituted at positions 1, 6, 10, 14, 15, 16 and 19 of SEQ ID NO: 77. Claim 16 is drawn to the polypeptide of claim 1 which is 20-50 amino acids on length. Claim 19 is drawn to a pharmaceutical composition comprising the polypeptide of claim 1 and a pharmaceutically acceptable carrier.
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, a polypeptide that is at least 30% and less than 81% identical or that has at least 4 and up to 14 amino acid additions or substitutions in SEQ ID NO: 77 is naturally occurring. As evidenced by GenBank: KAM5221909.1, a peptide that is 80% identical to SEQ ID NO: 77 is naturally occurring (see residues 23-42). GenBank KAM5221909.1 is ACE2 from C. gundi. Accordingly, the pending claims are directed to a naturally occurring 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, a polypeptide of claim 1 is naturally occurring and the claims do not recite additional elements that amount to significantly more. With respect to claim 15, the ACE2 from C. gundi is substituted at positions 1, 6, 10, 14, 15, 16 and 19. With respect to claim 16, the peptide is a fragment of a naturally occurring protein. Cleavage of peptide bonds does not create a composition that is significantly different than what occurs in nature. With respect to claim 19, a pharmaceutically acceptable carrier does not add significantly more because it does not add markedly different characteristics to the peptide.
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 1, 8, 15, 16 and 19 do not qualify as eligible subject matter.
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, 7, 8, 13, 15-16, 19, 22 and 45-46 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 1 is drawn to a polypeptide comprising an amino acid sequence that is at least 30% and less than 81% identical to or that has at least 4 and up to 14 amino acid additions or substitutions in SEQ ID NO: 77, wherein the polypeptide has the properties of (i)-(vii). The USPTO provides claim terms with broadest reasonable interpretation in light of the specification.
Assessment of whether species are support in the original specification
The complete structure of the following species was disclosed: SEQ ID NOs: 2-12,17-20, 78-111 and 113-133.
There was no disclosure of other peptide sequences that is at least 30% and less than 81% identical to or that has at least 4 and up to 14 amino acid additions or substitutions in SEQ ID NO: 77, wherein the polypeptide has the properties of (i)-(vii).
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 2-12,17-20, 78-111 and 113-133 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: 2-12,17-20, 78-111 and 113-133 is not representative of the genus. The disclosure of the sequences is not representative of the entire genus encompassed by peptide sequences that are at least 30% and less than 81% identical to or that has at least 4 and up to 14 amino acid additions or substitutions in SEQ ID NO: 77, wherein the polypeptide has the properties of (i)-(vii).
With the aid of a computer, one of ordinary skill in the art could identify all of the peptides with at least 30% identity to less than 81% identical to or that has at least 4 and up to 14 amino acid additions or substitutions in SEQ ID NO: 77. However, there is no teaching regarding which 70% of the amino acids can vary from SEQ ID NO: 77 and and still result in a polypeptide that has the claimed function. is able to specifically bind to the first and second β2GPI monomers. For example, SEQ ID NO:77 is 20 amino acids in length and can have 14 amino acid substitutions or deletions and still meet the criteria of 30% sequence identity to SEQ ID NO: 77. 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 30% sequence identity is quite large.
As disclosed in , there are exchangeability rate for each amino acid substitution (see Table 3) and each amino acid substitution will have an effect on the peptide activity (pp. 1465-1466).
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 polypeptide at least 30% identity to less than 81% identical to or that has at least 4 and up to 14 amino acid additions or substitutions in SEQ ID NO: 77 that results in a polypeptide with the properties of claim 1.
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 SEQ ID NOs: 2-12,17-20, 78-111 and 113-133.
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 13 and 15 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.
Claims 13 and 15 recite parenthetical expression “(where the position numbering is from the N-terminal (position 1) to the C-terminal Q (position 20))". The metes and bounds of claim 1 is rendered vague and indefinite by the parenthetical recitation because it is unclear as to whether the limitation is part of the instantly claimed subject matter. See MPEP § 2173.05(d).
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 1, 8, 9, 15-16 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Han et al. (“Computation Design of ACE2-Based Peptide Inhibitors of SARS-CoV-2” ACS Nano April 14, 2020, 14,5143-5147, cited on IDS).
Han et al. teach peptide inhibitors against SARS-Co-V coronavirus which are formed by two sequence self-supporting alpha helices extracted from the protease domain of ACE2 which bind to the SARS-Co-V receptor binding domains (Abstract). In particular, Han et al. teach the peptide inhibitor 1 (supplemental Table S1:
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Inhibitor 1 meets the limitation of claim 1, wherein the peptide has up to 14 amino acids additions in SEQ ID NO: 77. With respect to (i)-(vii), inhibitor 1 from Han et al. would inherently have all of the activities and properties of the polypeptide of claim 1. The MPEP § 2112 states: “Once a reference teaching product appearing to be substantially identical is made the basis of a rejection, and the Examiner presents evidence or reasoning tending to show inherency, the burden shifts to the Applicant to show an unobvious difference ‘[t]he PTO can require an Applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on inherency’ under 35 U.S.C. 102, on prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same…[footnote omitted].” The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzqerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (quoting In re Best, 562 F.2d 1252, 1255, 195 USPQ 430,433- 34 (CCPA 1977)).” In other words, Han et al. teach inhibitor 1 that anticipates the structural limitations of claim 1 as a peptide inhibitor of SARS-Co-V coronavirus. Therefore, the same peptide would inherently have the same properties as instantly claimed. Moreover, MPEP 2112.01 states: “Products of identical chemical composition cannot have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Importantly, MPEP 2112 states: “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer” and “There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference
With respect to claim 8, inhibitor 1 of Han et al. is not stapled or stitched.
With respect to claims 9 and 18, inhibitor 1 of Han et al. also meets the limitations of SEQ ID NO: 17.
With respect to claim 15, inhibitor 1 of Han et al. is not substituted at those positions.
With respect to claim 16, inhibitor 1 is 35 amino acids in length.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 8, 9, 15-16, 18-19, 22 and 45-46 are rejected under 35 U.S.C. 103 as being unpatentable over Han et al. (“Computation Design of ACE2-Based Peptide Inhibitors of SARS-CoV-2” ACS Nano April 14, 2020, 14,5143-5147, cited on IDS).
The teachings of Han et al. are presented in detail above. Han et al. does not teach an example of the inhibitor in a pharmaceutically acceptable carrier or a nanoparticle. However, the teachings of Han et al. are suggestive of the limitation.
With respect to claims 19 and 45, although Han et al. identifies inhibitor 1 thought molecular dynamics simulation, it does teach that peptide as a candidate inhibitor of SARS-Co-V-2. One of ordinary skill in the art would have understood that biologically active peptides against a virus are conventionally formulated in pharmaceutical formulation comprising pharmaceutically acceptable carriers. There is a reasonable expectation of success given that inclusion of a pharmaceutically acceptable carrier is routine in the art.
With respect to claims 22 and 46, Han et al. teach that the binding affinity of the inhibitors could be further enhanced by a multivalent binding of multiple peptides attached to surfaces of nanoparticles. One of ordinary skill in the art would have a motivation to create a nanoparticle composition comprising inhibitor 1 because Han et al. teach that binding affinity of the inhibitors could be enhanced by multiple peptides attached to the surface of a nanoparticle. There is a reasonable expectation of success given that methods of making and using nanoparticles comprising polypeptides are well known and routine in the art.
Claims 1, 4, 7-10, 13, 15-16, 18-19, 22 and 45-46 are rejected under 35 U.S.C. 103 as being unpatentable over Han et al. (“Computation Design of ACE2-Based Peptide Inhibitors of SARS-CoV-2” ACS Nano April 14, 2020, 14,5143-5147) in view of Debnath et al. (US20090281041) and Mangold et al. (Journal of the American Chemical Society, 2014, 136, 12469-12478).
The teachings of Han et al. are presented in detail above. In addition to the teachings above, Han et al. teach that inhibitor 1 was less stable (Conclusions). Han et al. does not teach stapled peptide with a, a-disubstituted non-natural amino acids with olefinic side chains. However, the teachings of Debnath et al. and Mangold et al. cure this deficiency.
Debnath et al. teach a peptide comprising a sequence from 14 to 21 amino acids in length, wherein two of the amino acids are unnatural amino acids having either R or S stereochemistry at the a-carbon wherein the a-carbon of the unnatural amino acids comprises a methyl group and an olefinic group, where the two olefinic groups of the unnatural amino acids are on the same side of the a-helix and are joined to form a cross-link the two unnatural amino acids…(see claim 1), wherein said unnatural amino acid is (S)-a-2-(2’pentenyl)alanine or (R)-a-2-(2’-octenyl)alanine (see claim 2). Debnath et al teach:
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(see paragraph [0042]). Debnath et al. further teach that the peptides are anti-viral cell-penetrating peptides (see TITLE and abstract).
Additionally, Mangold et al. teach that olefin metathesis has emerged as a promising strategy for modulating the stability and activity of biologically relevant compounds (see abstract). Mangold et al. teach that peptide and protein modification using olefin metathesis has shown promise (p. 12472, left column, 1st full paragraph). Mangold et al. teach a peptide consisting of two sterochemically defined a,a-disubstituted olefinic amino acids separated by one turn of a helix (i.e., olefins positioned at residues 1 and I + 4, I +7) that, upon ring closure, would generate a 21-membered macrocycle p. 12474, right column, bottom).
With respect to claims 4, 7, 10 and 13, It would have been obvious to one of ordinary skill in the art to combine the teachings of Han et al., Debnath et al. and Mangold et al. to arrive at a structurally-stabilized polypeptide or a pharmaceutically acceptable salt thereof comprising a peptide sequence set forth in SEQ ID NO: 100, wherein amino acids at positions 5 and 12 (I, i+7) replaced by a,a-disubstituted non-natural amino acids with olefinic side chains, because both Han et al. and Debnath et al. teach antiviral peptides. One of ordinary skill in the art would be motivated to modify the peptide using non-natural amino acids capable of olefin metathesis as taught by Debnath et al. because i, i+7 hydrocarbon stapling of peptide stabilizes peptide secondary structure and improves resistance to degradation, thereby overcoming the tendency of isolated peptides to lose their function three dimensional structure. There is a reasonable expectation of success given that hydrocarbon stapling is routine in the art and is known to enhance stability of short peptides.
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.
Claims 1, 4, 7-10, 13, 15-16, 18-19, 22 and 45-46 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-99 of copending Application No. 19/162,577 (reference application) in view of Han et al, Debnath et al. and Mangold et al. Although the claims at issue are not identical, they are not patentably distinct from each other.
The copending application claims a dry powder comprising a peptide that binds to SARS-CoV-2 spike protein.
It would have been obvious to one of ordinary skill in the art to combine the teachings of the copending application, Han et al., Debnath et al. and Mangold et al. to arrive at a structurally-stabilized polypeptide or a pharmaceutically acceptable salt thereof comprising a peptide sequence set forth in SEQ ID NO: 100, wherein amino acids at positions 5 and 12 (I, i+7) replaced by a,a-disubstituted non-natural amino acids with olefinic side chains, because the copending application, Han et al. and Debnath et al. teach antiviral peptides. One of ordinary skill in the art would be motivated to modify the peptide using non-natural amino acids capable of olefin metathesis as taught by Debnath et al. because i, i+7 hydrocarbon stapling of peptide stabilizes peptide secondary structure and improves resistance to degradation, thereby overcoming the tendency to of isolated peptides to lose their function three dimensional structure. There is a reasonable expectation of success given that hydrocarbon stapling is routine in the art and is known to enhance stability of short peptides.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 4, 7-10, 13, 15-16, 18-19, 22 and 45-46 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-99 of copending Application No. 19/162,647 (reference application) in view of Han et al, Debnath et al. and Mangold et al. Although the claims at issue are not identical, they are not patentably distinct from each other.
The copending application claims a method of treating a coronavirus infection in a subject thereof comprising administering a therapeutically effective amount of a peptide that binds to SARS-CoV-2 spike protein.
It would have been obvious to one of ordinary skill in the art to combine the teachings of the copending application, Han et al., Debnath et al. and Mangold et al. to arrive at a structurally-stabilized polypeptide or a pharmaceutically acceptable salt thereof comprising a peptide sequence set forth in SEQ ID NO: 100, wherein amino acids at positions 5 and 12 (I, i+7) replaced by a,a-disubstituted non-natural amino acids with olefinic side chains, because the copending application, Han et al. and Debnath et al. teach antiviral peptides. One of ordinary skill in the art would be motivated to modify the peptide using non-natural amino acids capable of olefin metathesis as taught by Debnath et al. because i, i+7 hydrocarbon stapling of peptide stabilizes peptide secondary structure and improves resistance to degradation, thereby overcoming the tendency to of isolated peptides to lose their function three dimensional structure. There is a reasonable expectation of success given that hydrocarbon stapling is routine in the art and is known to enhance stability of short peptides.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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/TARA L MARTINEZ/Examiner, Art Unit 1654