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 and Claim Status
Applicant’s election without traverse of Group 1 and SEQ ID NO:62 in the reply filed on 9/15/26 is acknowledged.
Claims 19-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/15/26.
Since applicants elected SEQ ID NO:62 which is such that X2 is L, claims 2-4 and 8 are drawn to non-elected species. The elected species does read on generic sequence SEQ ID NO:54. Any relevant art that was uncovered during the search for the elected species is cited herein in order to advance prosecution.
Claims 2-4 and 8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/15/26.
Claims 16-18 have been canceled.
Claims 1, 5-7 and 9-15 are being examined.
Priority
The priority information is found in the filing receipt of 2/6/25.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/31/24 has been considered by the examiner.
Specification
The disclosure is objected to because of the following informalities:
37 CFR 1.831(c) recognizes that each occurrence of a sequence set forth in the sequence listing should include the corresponding sequence identifier. In the instant case, at least page 24 line 18, page 25 lines 2 and 20, page 26 lines 6 and 23, page 27 lines 10 and 24 and page 28 lines 13 and 27 for example do not include the corresponding sequence identifier.
Tables on pages 33-35 and 37 include numerous entries with commas. For example the first HPLC purity entry on page 33 is ’97,7%’. It would seem that periods should be used instead of commas at numerous locations.
Appropriate correction is required.
Claim Objections
Claim 7 is objected to because of the following informalities: claim 7 ends with 2 periods. Only one period is necessary at the end of a claim. Appropriate correction is required.
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 1, 5-7 and 9-15 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.
Claim 1 recites ‘-NR1R2, being R1 and R2…’. The meaning of such phrase is unclear. The term ‘-NR1R2’ seems to suggest that ‘-NR1R2’ is an option. However, the phrase being R1 and R2 seems to suggest that R1 or R2 alone are options. As such, what falls within the scope of the claim is unclear. None of the dependent claims clarify the claim scope.
Claim 7 recites ‘-NHC(O)R3, being R3…’. The meaning of such phrase is unclear. The term ‘NHC(O)R3’ seems to suggest that ‘NHC(O)R3’ is an option. However, the phrase being R3 seems to suggest that R3 alone is an option. As such, what falls within the scope of the claim is unclear.
Claim 1 recites that X2 can be a basic amino acid. The specification defines basic in terms of ‘resemble ammonia’. The term resemble is a relative term which renders the claim indefinite. The specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Dependent claims 5-7 and 10-15 do not clarify the claim scope.
Claim 1 recites ‘(X1)bD(X2)g’ and the elected species comprises ‘DLE’. The specification defines Laa as an amino acids having an L configuration and Daa as an amino acid having a D configuration. It is unclear if DL is the D-amino acid configuration of Leu or Asp-Leu. It is unclear if LE is the L-amino acid configuration of Glu or Leu-Glu. As such, the scope of the claims is unclear.
Claims 5-7 recite ‘particularly’. The phrase "particularly" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 14 recites ‘preferably’. The phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 6 recites SEQ ID NO:74. The sequence listing does not include any information for SEQ ID NO:74 nor does the specification define such sequence. Thus, it is unclear what falls within the scope of SEQ ID NO:74.
Claim 9 recites SEQ ID NOs: 63-65. The sequence listing recites the same sequence for SEQ ID NOs: 63-65. Page 35 of the specification appears to recite that the sequences have different masses. It is unclear if SEQ ID NOs: 63-65 are identical or different.
Although unclear, the claims have been given the broadest reasonable interpretation consistent with the specification. The elected species has been interpreted as being a heptapeptide. The last 4 lines of claim 1 refers to specifics about the terminal ends. Claim 1a refers to a peptide that ‘has a sequence length from 5 to 9 amino acids’. Thus, any peptide of claim 1a is interpreted as consisting of a length of 5 to 9 amino acids. Claim 1b refers to a peptide that is a particular sequence. Thus, any peptide of claim 1b is interpreted as being one of SEQ ID NO:39-46 or a salt thereof. The phrases ‘particularly’ and ‘preferably’ have been interpreted as being not further limiting.
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, 5, 7 and 10-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon (product of nature) without significantly more. The claim(s) recite(s) peptides/compositions which correspond to products of nature. This judicial exception is not integrated into a practical application because there is no additional elements that apply or use the judicial exception. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception as discussed below.
This 101 rejection is consistent with the most recent training provided by the office which will be referred to as 'guidance' (see MPEP 2106).
In comparison to the subject matter eligibility test as set forth in the guidance, the claims are drawn to peptides/compositions. Thus the answer to step 1 is yes.
BLAST search of SEQ ID NO:62 (retrieved from https://blast.ncbi.nlm.nih.gov/Blast.cgi on 9/23/26, 34 pages) shows that the NDLEGLY sequence is present in many known naturally occurring proteins (pages 7-22 for example). NDLEGLY reads on instant SEQ ID NO:54 where X1 is N, X2 is L, X3 is L. Thus, instant SEQ ID NO: 54 can correspond to a fragment of a known protein. In relation to prong one of step 2a of the guidance the answer is yes because the peptides correspond to domains of proteins.
In relation to prong two of step 2a, the instant claims are product claims and do not require any additional elements that apply the judicial exception in a manner that imposes a meaningful limit on the judicial exception. Thus the answer to prong two of step 2a is no.
The instant claims recite SEQ ID NO:54 which can correspond to fragment of a known protein. The Myriad Supreme Court decision (Association for Molecular Pathology v. Myriad Genetics, 569 U.S. 12-398 (2013)) stated: “Myriad’s claims are not saved by the fact that isolating DNA from the human genome severs the chemical bonds that bind gene molecules together” (page 2 and 14). In the instant case, applicants’ claims are not saved by the fact that the peptides of the instant claims correspond to fragments (the protein with severed bonds).
Claim 6 is not included in the instant rejection because it requires a D-amino acid and there is no evidence that there are any such natural D-amino acid containing sequences as in claim 6.
In relation to step 2b, claims 10-15 recites a composition. The compositions can correspond to the peptide in water which itself is naturally occurring or with a vitamin that is naturally occurring. Thus claims 10-15 can correspond to a combination of naturally occurring components. The instantly claimed compositions are like the novel bacterial mixture of Funk Brothers which contained multiple naturally occurring components, which was held ineligible because each species of bacteria in the mixture (like each component in the peptide composition) continued to have “the same effect it always had”, i.e., it lacked markedly different characteristics. Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 131 (1948), discussed in Myriad Genetics, 133 S. Ct. at 2117 (explaining that the bacterial mixture of Funk Brothers “was not patent eligible because the patent holder did not alter the bacteria in any way”).
Further, there is no evidence of any markedly different characteristic. There is no indication that mixing of the peptide and an excipient (such as water) changes the structure, function or other properties of the peptide or the water. MPEP 2106.04(c) II C recognizes that a change cannot be an inherent or innate characteristic on the naturally occurring counterpart or an incidental change in a characteristic of the naturally occurring counterpart. Thus the answer to step 2b is no because there is not adequate evidence to conclude that the claims include significantly more than the judicial exception.
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.
Claim(s) 1, 5-7 and 9-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lindberg et al. (US 2003/0087827; ‘Lindberg’).
Lindberg teach peptide furin inhibitors (abstract). Lindberg teach a positional scanning hexapeptide library made solely of D-amino acids with amino terminal acetylation and carboxy terminal amidation (section 0028 and figure 5). Lindberg teach that at each position, 20 mixtures were surveyed each of which was defined by one of the 20 natural amino acids and the undefined positions were occupied by the amino acids except cysteine (section 0028). Lindberg teach that simultaneous multiple peptide synthesis methods were used (section 0028).
In relation to the peptide of claims 1, 5-7 and 9, Lindberg teach a positional scanning hexapeptide library made solely of D-amino acids with amino terminal acetylation and carboxy terminal amidation (section 0028 and figure 5). Lindberg teach that at each position, 20 mixtures were surveyed each of which was defined by one of the 20 natural amino acids and the undefined positions were occupied by the amino acids except cysteine (section 0028). Such library contains the peptide Ac-NDEGLY-NH2 (where all amino acids are D-amino acids) which is instant SEQ ID NO: 62 and is of SEQ ID NO:54 where X1 is N, X2 is L, X3 is L, a, d and e are 0, b, g, c and f are 1. Since a peptide as claimed is taught, it would function as claimed.
In relation to the compositions of claims 10-15, Lindberg teach a library which is a mixture of peptides (section 0028). Lindberg teach that simultaneous multiple peptide synthesis methods were used (section 0028) which is the form of a solution which is suitable for injection. Since Lidberg teach a library as discussed above additional lipolytic peptides of SEQ ID NO:54 would be present such as Ac-WDEGLY-NH2 (where all amino acids are D-amino acids)
Claim(s) 1, 5 and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bremel et al. (US 10,706,955; ‘Bremel’).
Bremel teach that the sequence listing is available in electronic form (columns 115-116). SEQ ID NO: 1197873 (retrieved from http://seqdata.uspto.gov/?pageRequest=docDetail&DocID=US10706955B2 on 9/28/26, 1 page) corresponds to SEQ ID NO: 1197873 of Bremel which is DPEGV.
Bremel teach a polypeptide of SEQ ID NO:1197873 (column 12 lines 34-39).
In relation to the peptide of claims 1, 5 and 7, Bremel teach a polypeptide of SEQ ID NO:1197873 (column 12 lines 34-39) which is DPEGV which meets the limitation of instant SEQ ID NO:54 since X2 is P, X3 is V, a, c, d, e and f are 0 and g and c are 1.
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.
Claim(s) 1, 5-7 and 10-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bremel et al. (US 10,706,955; ‘Bremel’) in view of Van Regenmortel et al. (‘D-peptides as immunogens and diagnostic reagents’ Current Opinion in Biotechnology v9 1998 pages 377-382; ‘Van Regenmortel’).
Bremel teach that the sequence listing is available in electronic form (columns 115-116). SEQ ID NO: 1197873 (retrieved from http://seqdata.uspto.gov/?pageRequest=docDetail&DocID=US10706955B2 on 9/28/26, 1 page) corresponds to SEQ ID NO: 1197873 of Bremel which is DPEGV.
Bremel teach a polypeptide of SEQ ID NO:1197873 (column 12 lines 34-39). Bremel suggest for use as a vaccine (column 12 lines 34-39 and column 65 lines 16-24). Bremel suggest a composition of the polypeptide with an adjuvant (column 10 lines 50-55 and column 66 lines 35-39). Bremel suggest surfactant based formulations (column 66 lines 35-39). Bremel suggest oral formulations (column 8 lines 57-60).
Bremel does not teach a specific example of a composition as claimed. Bremel does not teach the inclusion of D-amino acids.
Van Regenmortel teach that peptides made of D-amino acid are more stable than those made of L-amino acids and in many cases enhances their immunogenic activities (‘Conclusions’ page 381).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of Bremel because Bremel teach a finite number of polypeptides and suggest for use as a vaccine (column 12 lines 34-39 and column 65 lines 16-24) specifically with an adjuvant (column 10 lines 50-55 and column 66 lines 35-39) and suggest surfactant based formulations (column 66 lines 35-39). With respect to the peptide, Bremel teach a finite number of polypeptides including SEQ ID NO:1197873 (column 12 lines 34-39). Van Regenmortel teach that peptides made of D-amino acid are more stable than those made of L-amino acids and in many cases enhances their immunogenic activities (‘Conclusions’ page 381). Thus, one would have been motivated to make a D-amino acid version of SEQ ID NO:1197873 based on the advantages disclosed in Van Regenmortel. One would have had a reasonable expectation of success since methods of combining components and methods of peptide synthesis were known.
In relation to the peptide of claims 1, 5 and 7, Bremel teach a polypeptide of SEQ ID NO:1197873 (column 12 lines 34-39) which is DPEGV which meets the limitation of instant SEQ ID NO:54 since X2 is P, X3 is V, a, c, d, e and f are 0 and g and c are 1.
In relation to the peptide of claim 6, Van Regenmortel teach that peptides made of D-amino acid are more stable than those made of L-amino acids and in many cases enhances their immunogenic activities (‘Conclusions’ page 381). Thus, one would have been motivated to make a D-amino acid version of SEQ ID NO:1197873 based on the advantages disclosed in Van Regenmortel.
In relation to the compositions of claims 10-15, Bremel suggest for use as a vaccine (column 12 lines 34-39 and column 65 lines 16-24). Bremel suggest a composition of the polypeptide with an adjuvant (column 10 lines 50-55 and column 66 lines 35-39). Bremel suggest surfactant based formulations (column 66 lines 35-39). Bremel suggest oral formulations (column 8 lines 57-60).
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, 7 and 10-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4, 6, 8, 10, 12, 17, 23, 27-28, 30-33, 35, 37-41 of copending Application No. 19489417 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
19489417 recites SEQ ID NO:9 (TWDPEGVIFY) specifically with a D-amino acid (claim 1a). 19489417 recite compositions with carriers (claims 28 and 33).
In relation to the peptide of claims 1 and 7, 19489417 recites SEQ ID NO:9 (TWDPEGVIFY) specifically with a D-amino acid (claim 1a) which is instant SEQ ID NO:39.
In relation to the compositions of claims 10-25, 19489417 recite compositions with carriers (claims 28 and 33) and the inclusion of peptides (claim 1).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RONALD T NIEBAUER whose telephone number is (571)270-3059. The examiner can normally be reached M - F 6:30 - 2:30 EST.
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RONALD T. NIEBAUER
Primary Examiner
Art Unit 1658
/RONALD T NIEBAUER/Examiner, Art Unit 1658
Prosecution Insights