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
1. The Election filed July 28, 2026 in response to the Office Action of May 28, 2026 is acknowledged. Applicant elected with traverse Group 1 and the species of SEQ ID NO: 16.
2. Applicants argue that the inventions of Groups I and V are linked by unity of invention under 37 C.F.R. 1.475(b)(2) as directed to product and process of use of said product.
The arguments have been considered and are persuasive. Thus, Group V and the claims 49-51 and 58-60 are rejoined to the claims 1, 3, 6, and 9 of Group I.
3. Applicants argue that the species election is an appropriate application of the 37 C.F.R. 1.141(a) directed to unreasonable numbers of species. In response, Examiner withdraws the species election and examined all listed SEQ ID NOs: 6-16.
4. Claims 1, 3, 6, 9, 13-14, 31-32, 40, 42, 49-51, 58-60, 67-68, and 72-74 are pending. Claims 13-14, 31-32, 40, 42, 67-68, and 72-74 have been withdrawn from further consideration by the examiner under 35 CFR 1.142(b) as being drawn to non-elected inventions. Claims 1, 3, 6, 9, 49-51, and 58-60 are currently under prosecution as drawn to the elected species.
Priority
5. Application claims the benefit and priority of PCT/US2022/029628 filed on 5/17/2022 which claims the benefit of provisional application 63/189,507 filed on 5/17/2021. Priority is granted to provisional application 63/189,507 and the effective filing date of 5/17/2021.
Specification
6. The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code on page 25 line 34. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
7. The disclosure is objected to because of the following informalities: inconsistent listing of SEQ ID NO: 3 which is a template peptide sequence that contains 29 amino acids but SEQ ID NOs: 6-8 and 10-16 which are derived from it only comprise 28 amino acids. Please correct the sequences in the specification to be consistent with each other. Additionally, please submit new sequence listings for the incorrect sequences. Pages that include these sequences are:
Page 2
Table 5 on pages 104-105
Sequence listings on pages 111-112
Appropriate correction is required.
Claim Interpretation
8. The examiner’s broadest reasonable interpretation of the claims is set forth below.
Claim 1 recites:
“A vasoactive intestinal peptide receptor (VIP-R) antagonist comprising KPRRPYX1X2X3X4TX5LRKQX6AVX7X8KYLX9X10ILN (SEQ ID NO: 3) or a fragment thereof,”.
From the specification on page 24, Applicant defines “fragments” as:
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Thus, the phrase “A VIP-R antagonist comprising… SEQ ID NO: 3 or a fragment thereof” is reasonably interpreted as comprising any fragment of the claimed sequence as small as two consecutive amino acids long including any insertions, deletions, substitutions, or modifications and still possess the function as a VIP-R antagonist.
Claim 3 recites:
“The VIP-R antagonist of claim 1 [[or 2]], wherein the VIP-R antagonist comprises the amino acid sequence:
KPRRPYADNYTRLRKQMAVNKYLNLILN (SEQ ID NO: 6),
KPRRPYAVNYTRLRKQIAVKKYLMSILN (SEQ ID NO: 7),
KPRRPYAVNYTRLRKQMAVNKYLMSILN (SEQ ID NO: 8),
KPRRPYADNCTRLRKQIAVNKKYLNSILN (SEQ ID NO: 9),
KPRRPYTVNYTSLRKQIAVKKYLMLILN (SEQ ID NO: 10),
KPRRPYTDNCTSLRKQIAVNKYLNLILN (SEQ ID NO: 11),
KPRRPYAVNCTSLRKQIAVNKYLNSILN (SEQ ID NO: 12),
KPRRPYAVNCTSLRKQIAVKKYLMSILN (SEQ ID NO: 13),
KPRRPYTVNCTSLRKQIAVKKYLMLILN (SEQ ID NO: 14),
KPRRPYTSDYTRLRKQMAVKKYLNSILN (SEQ ID NO: 15),
KPRRPYTSDYTRLRKQMAVKKYLNLILN (SEQ ID NO: 16), or a fragment thereof.”
Applying the same definition of “fragment” from the specification as listed above, the phrase “…or a fragment thereof” is reasonably interpreted as comprising any of the claimed sequences of SEQ ID NOs: 6-16 from above as small as two consecutive amino acids long including any insertions, deletions, substitutions, or modifications and still possess the function as a VIP-R antagonist.
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.
9. Claims 1, 3, 6, 9, 49-51, and 58-60 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 the VIP-R antagonist comprising the amino acid sequence of KPRRPYX1X2X3X4TX5LRKQX6AVX7X8KYLX9X10ILN (SEQ ID NO: 3) which is 29 amino acids long. Claim 3 then recites 11 amino acid sequences with 10 being 28 amino acids long and only 1 being 29 amino acids long (SEQ ID NO: 9). The sequence of SEQ ID NO: 3 listed above is listed the same way in the specification and in the submitted sequence listings. It is unclear and therefore indefinite whether the SEQ ID NO: 3 and 9 is incorrect or whether SEQ ID NOs: 6-8 and 10-16 are incorrect.
For the sake of compact prosecution, examiner will consider the K in SEQ ID NO: 3 as an error and interpret SEQ ID NO: 3 as drawn to:
“KPRRPYX1X2X3X4TX5LRKQX6AVX7X8YLX9X10ILN”
and SEQ ID NO: 9 as drawn to
“KPRRPYADNCTRLRKQIAVNKYLNSILN”.
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.
10. Claims 1, 3, 6, 9, 49-51, and 58-60 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. This is a WRITTEN DESCRIPTION rejection.
The claims are drawn to a peptide sequence comprising the amino acid sequence of SEQ ID NO: 3 comprising 10 wildcard positions that are further defined by 1-3 specific amino acids that can be located at the indicated positions and any fragments. As discussed above under claim interpretation “fragments” has been defined as any insertions, deletions, substitutions, or modifications and possess the function of binding vasoactive intestinal peptide receptor (VIP-R).
Claim 3 further draws the claims to 11 specific amino acid as shown below or fragments thereof;
KPRRPYADNYTRLRKQMAVNKYLNLILN (SEQ ID NO: 6),
KPRRPYAVNYTRLRKQIAVKKYLMSILN (SEQ ID NO: 7),
KPRRPYAVNYTRLRKQMAVNKYLMSILN (SEQ ID NO: 8),
KPRRPYADNCTRLRKQIAVNKKYLNSILN (SEQ ID NO: 9),
KPRRPYTVNYTSLRKQIAVKKYLMLILN (SEQ ID NO: 10),
KPRRPYTDNCTSLRKQIAVNKYLNLILN (SEQ ID NO: 11),
KPRRPYAVNCTSLRKQIAVNKYLNSILN (SEQ ID NO: 12),
KPRRPYAVNCTSLRKQIAVKKYLMSILN (SEQ ID NO: 13),
KPRRPYTVNCTSLRKQIAVKKYLMLILN (SEQ ID NO: 14),
KPRRPYTSDYTRLRKQMAVKKYLNSILN (SEQ ID NO: 15),
KPRRPYTSDYTRLRKQMAVKKYLNLILN (SEQ ID NO: 16), or a fragment thereof.
Thus, the claims identify the peptide by the function of binding VIP-R and a partial structure that comprises an amino acid chain with 10 wildcards with 1-3 specific amino acids located at the position and further 11 specific amino acid sequence structures and any “fragments” defined as any insertions, deletions, substitutions, or modifications that possess the function of binding VIP-R. Thus, the claims encompass a vast genus of peptide fragment variants that require the function of binding to VIP-R.
The instant specification discloses seventeen 28 amino acid long peptide sequences that demonstrate binding to VIP-Rs, VPAC1 and VPAC2 with 14 homologous species that correspond to the amino acid sequences represented by SEQ ID NO: 3 and the wildcard positions specifically indicated. (See pgs. 104-105 Table 5).
Thus, the instant specification identifies 17 structurally distinct 28 amino acid peptide sequences that function to bind VIP-R. Other than the listed amino acid substitutions for the wild card positions, the specification fails to disclose any fragments of the disclosed peptide sequences as defined as any insertions, deletions, substitutions or modifications that could be made to the peptides already disclosed and retain the function of binding to VIP-R.
To provide adequate written description and evidence of possession of the claimed peptide genus, the instant specification can structurally describe representative peptide fragment variants that function to bind VIP-R or describe structural features common to the members of the genus, which features constitute a substantial portion of the genus. Alternatively, the specification can show that the claimed invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics (see University of California v. Eli Lilly and Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997) and Enzo Biochem, Inc. V. Gen-Probe Inc.). A disclosure that does not adequately describe a product itself logically cannot adequately describe a method of using that product.
In this case, the only factor present in the claims is a recitation of the function “a VIP-R antagonist”, and partial sequence structure as stated above. The instant specification fails to describe structural features common to the members of the peptide fragment genus, which features constitute a substantial portion of the genus because the instant specification fails to disclose representative peptide fragment variant sequences that function as claimed. A definition by function does not suffice to define the genus because it is only an indication of what the peptide does not what it is. Other than the peptides disclosed in Table 5, the specification fails to provide amino acid structural features coupled to the claimed functional characteristics. The instant specification fails to describe a representative number of peptide sequence variants for the genus of peptide fragments that function as claimed. Accordingly in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus required to make the claimed peptide fragments.
The claims broadly encompass any sequence variant of SEQ ID NO: 3 and its associated wildcard amino acids including any fragments as defined as any insertions, deletions, substitutions, or modifications that function to bind VIP-R. Applicants have not established any reasonable structure-function correlation with regards to the sequences in the peptide sequence of SEQ ID NO: 3, outside of the wildcard amino acids and their associated specific substitutions, that can be altered and still maintain VIP-R binding function. Tang, et al. (International Journal of Oncology, 2014, 44:1023-1031) teaches that the VIP-R antagonist VIPhyb, which is represented in the present application by SEQ ID NO: 1, consists of a N-terminal Lys-Pro-Arg-Arg-Pro-Tyr (KPRRPY) that is designed to increase membrane permeability and the 22 amino acids of the C-terminal of the VIP which is the portion of the VIP that recognizes the receptor binding site. (See Tang, pg. 1028 “8. Targeting VIP receptor for Cancer Molecular Therapy”, paragraph 1, also pg. 1024 column 1 “2. Structural and Functional Features of VIP/PACP and VIPRs” paragraph 1). Given the well-known high level of polymorphism of binding sequences and structure, the skilled artisan would not have been in possession of the vast repertoire of peptide fragments encompassed by the claimed invention. One could not reasonably or predictably extrapolate the structure of a single peptide fragment comprising an amino acid sequence from SEQ ID NO: 3 to the structure of any variants required to bind VIP-R as broadly claimed. Therefore, one could not reasonably envision members of the broadly claimed genus.
Although Applicants may argue that it is possible to screen for peptide fragment variants that bind VIP-R and function as claimed, the court found in (Rochester v. Searle, 358 F.3d 916, Fed Cir., 2004) that screening assays are not sufficient to provide adequate written description for an invention because they are merely a wish or plan for obtaining the claimed chemical invention. “As we held in Lilly, “[a]n adequate written description of a DNA … ‘requires a precise definition, such as by structure, formula, chemical name, or physical properties,’ not a mere wish or plan for obtaining the claimed chemical invention.” 119 F.3d at 1566 (quoting Fiers, 984 F.2d at 1171). For reasons stated above, that requirement applies just as well to non-DNA (or RNA) chemical inventions.” Knowledge of screening methods provides no information about the structure of any future peptides yet to be discovered that may function as claimed. The VIP-R antigen provides no information about the structure of a peptide fragment that binds to it.
Given the lack of representative examples to support the full scope of the claimed variant peptides, and lack of reasonable structure-function correlation with regards to the unknown variable sequences in the peptides that provide VIP-R-binding function, the present claims lack adequate written description. Thus, the specification does not provide an adequate written description of peptide fragment variants that bind VIP-R comprising SEQ ID NO: 3 and including any insertions, deletions, substitutions, or modifications that is required to practice the claimed invention.
Examiner Suggestion: Examiner suggests amending claims 1 and 3 to remove “or a fragment thereof”.
11. Claims 1, 3, 6, 9, 49-51, and 58-60 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a VIP-R antagonist of the sequence of SEQ ID NO: 3 and 6-16 and as a method to treat cancer, does not reasonably provide enablement for any fragments of SEQ ID NO: 3 or 6-16 as a VIP-R antagonist and as a method to treat cancer. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
The factors to be considered in determining whether undue experimentation is required are summarized In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988). The court in Wands states: "Enablement is not precluded by the necessity for some experimentation such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is 'undue,' not 'experimentation.' " (Wands, 8 USPQ2d 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. "Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations." (Wands, 8 USPQ2d 1404). The factors to be considered in determining whether undue experimentation is required include: (1) the quantity of experimentation necessary, (2) the amount or direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.
The claims are drawn to A vasoactive intestinal peptide receptor (VIP-R) antagonist comprising KPRRPYX1X2X3X4TX5LRKQX6AVX7X8KYLX9X10ILN (SEQ ID NO: 3) or a fragment thereof, wherein X1 is T or A; X2 is D, V, or S; X3 is N or D; X4 is Y or C; X is R or S; X6 is M or I; X7 is K or N; X8 is K; X9 is N or M; X10 is S, or L; and provided that the peptide is not KPRRPYTDNYTRLRKQMAVKKYLNSILN (SEQ ID NO: 1) or the combination wherein X1 is T, X2 is D, X3 is N; X4 is Y, X5 is R, X6 is M, X7 is K, X9 is N, and X10 is S.
Claim 3 is drawn to 11 specific peptides comprising derivatives of SEQ ID NO: 3 in the sequences of SEQ ID NOs: 6-16 or a fragment thereof.
Claims 49-51 and 58-60 are drawn to methods of using the VIP-R antagonist peptides to treat cancer or enhance an immune response to cancer.
The specification discloses 17 peptides sequences in Table 5 on pages 104-105 that are capable of binding VIP-Rs VAPC1 and VPAC2 including the sequences represented by SEQ ID NOs: 6-16.
The specification discloses examples of the various peptides correlated to SEQ ID NOs: 3 and 6-16 being used to extend survival in AML afflicted B6 mice (Figures 1 and 2).
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The specification also discloses examples of the VIP-R peptides correlated to SEQ ID NOs: 3 and 6-16 enhancing the immune response, for example in Figure 10 below, various VIP-R antagonists are shown activating CD4+ and CD8+ T cells over a control Scrambled peptide.
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The specification fails to demonstrate any working examples of fragments of the disclosed VIP-R antagonists that are capable of binding to VIP-Rs and treating cancer or enhancing an immune response.
Tang, et al. (International Journal of Oncology, 2014, 44:1023-1031) teaches that the VIP-R antagonist VIPhyb, which is represented in the present application by SEQ ID NO: 1, consists of a N-terminal Lys-Pro-Arg-Arg-Pro-Tyr (KPRRPY), which is included in all of the disclosed sequences, that is designed to increase membrane permeability and the 22 amino acids of the C-terminal of the VIP which is the portion of the VIP that recognizes the receptor binding site of VIP-Rs. (See Tang, pg. 1028 “8. Targeting VIP receptor for Cancer Molecular Therapy”, paragraph 1, also pg. 1024 column 1 “2. Structural and Functional Features of VIP/PACP and VIPRs” paragraph 1).
One cannot extrapolate the disclosure of the specification to the scope of the claims because the breadth of the claims allows for fragments of disclosed sequences to be used in antagonizing VIP-Rs and in methods of treatment for cancer and enhancing the immune response in cancer, the specification only demonstrates working examples of the disclosed sequences binding to VIP-R and being used to treat cancer and enhance the immune response but provides no working examples drawn to fragments of the sequences and the specification provides no guidance in what fragments of the peptide sequence are essential for functioning, and relevant art teaches that certain areas of the original peptide sequence, that are fully intact in the present claimed sequences, have functions not related to binding VIP-Rs.
Reasonable correlation must exist between the scope of the claims and scope of enablement set forth, and it cannot be reasonably predicted that fragments of SEQ ID NOs: 3 and 6-16 will predictably function as claimed.
Therefore, in view of the state of the art, the quantity of experimentation necessary, the breadth of the claims, lack of guidance in the specification, and the absence of working examples, it would require undue experimentation for one skilled in the art to practice the invention as broadly claimed.
Examiner Suggestion: Examiner suggests amending claims 1 and 3 to remove “or a fragment thereof”.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
12. Claims 1, 3, 6, 9, 49-51, and 58-60 are rejected under 35 U.S.C. 102(a)(2) and 102(a)(1) as being anticipated by Waller (WO2020/102694 A1 effectively filed 11/15/2018, as cited in IDS from 11/17/2023).
The applied reference has a common applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
As stated in the claim interpretation section above, the instant specification discloses that “fragments” of the instantly claimed peptides encompass sequences of the instant peptides comprising any mutations.
Waller discloses VIP receptor antagonist peptides SEQ ID NOs: 3-11 that comprise “fragments” of instant peptides SEQ ID NOs: 3 and 6-16 (see sequence alignments below) (See Waller, pg. 1, lines 15-25; pg. 2 lines 15-21, also claim 1).
Waller discloses:
KPRRPYX1X2NX3 T X4LRKQX5AVX6KYX7NX8ILN (SEQ ID NO:11)
wherein X1 is A or any amino acid; X2 is V or any amino acid; X3 is C or any amino acid; X4 is S or any amino acid; X5 is I or any amino acid; X6 is N or any amino acid; X7 is M or any amino acid; X8 is I or any amino acid; and provided that the peptide is not KPRRP YTDNYTRLRKQMAVKK YLN SILN (SEQ ID NO: 1) or the combination wherein X1 is T, X2 is D, X3 is Y, X4 is R, X5 is M, X6 is K, X7 is L, and X8 is S.
Waller discloses VIP antagonists:
KPRRPYADNYTRLRKQMAVKKYLNSILN (SEQ ID NO: 3),
KPRRPYTVNYTRLRKQMAVKKYLNSILN (SEQ ID NO: 4),
KPRRPYTDNCTRLRKQMAVKKYLNSILN (SEQ ID NO: 5),
KPRRPYTDNYTSLRKQMAVKKYLNSILN (SEQ ID NO: 6),
KPRRPYTDNYTRLRKQIAVKKYLNSILN (SEQ ID NO: 7),
KPRRPYTDNYTRLRKQMAVNKYLNSILN (SEQ ID NO: 8),
KPRRPYTDNYTRLRKQMAVKKYMNSILN (SEQ ID NO: 9), and
KPRRPYTDNYTRLRKQMAVKKYLNLILN (SEQ ID NO: 10).
Regarding claim 6, Waller discloses the peptide can be in a pharmaceutical composition with a pharmaceutically acceptable carrier. (See Waller, pg. 3 lines 16-19).
Regarding claim 9, Waller discloses a nucleic acid encoding the peptide. (See Waller, pg. 3 line 24).
Regarding claims 49-51 and 58-60, Waller discloses that the peptide can be used for a method of treating cancer and of enhancing an immune response to cancer by administering one of the peptides disclosed, where the cancer comprises pancreatic cancer, colon cancer, leukemia, lung cancer, or melanoma, and where the method further comprises administering a therapeutically effective amount of an immune checkpoint inhibitor. (See Waller, pg. 27 lines- pg. 28 line 2).
SEQ ID NO: 6 is 93.2% identical to SEQ ID NO: 10 (Waller):
WO2020102694-A1.
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CC PD 22-MAY-2020.
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CC PF 15-NOV-2019; 2019WO-US061760.
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PR 15-NOV-2018; 2018US-0768060P.
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CC PA (UEMR ) UNIV EMORY.
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CC PI Waller EK, Li Y, Ravindranathan S, Li J;
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DR WPI; 2020-43927D/045.
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CC PT New peptide comprising specific amino acid sequence, useful for
CC PT augmenting T-cell activation to treat cancer e.g. liver cancer, lung
CC PT cancer, melanoma, mesothelioma, multiple myeloma and nasopharyngeal
CC PT cancer and viral infections.
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CC PS Claim 3; SEQ ID NO 10; 56pp; English.
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SQ Sequence 28 AA;
Query Match 93.2%; Score 137; Length 28;
Best Local Similarity 92.9%;
Matches 26; Conservative 0; Mismatches 2; Indels 0; Gaps 0;
Qy 1 KPRRPYADNYTRLRKQMAVNKYLNLILN 28
|||||| |||||||||||| ||||||||
Db 1 KPRRPYTDNYTRLRKQMAVKKYLNLILN 28
SEQ ID NO: 7 is 90.1% identical to SEQ ID NO: 4 (Waller):
WO2020102694-A1.
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CC PD 22-MAY-2020.
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CC PF 15-NOV-2019; 2019WO-US061760.
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PR 15-NOV-2018; 2018US-0768060P.
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CC PA (UEMR ) UNIV EMORY.
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CC PI Waller EK, Li Y, Ravindranathan S, Li J;
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DR WPI; 2020-43927D/045.
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CC PT New peptide comprising specific amino acid sequence, useful for
CC PT augmenting T-cell activation to treat cancer e.g. liver cancer, lung
CC PT cancer, melanoma, mesothelioma, multiple myeloma and nasopharyngeal
CC PT cancer and viral infections.
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CC PS Example; SEQ ID NO 4; 56pp; English.
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SQ Sequence 28 AA;
Query Match 90.1%; Score 128; Length 28;
Best Local Similarity 89.3%;
Matches 25; Conservative 1; Mismatches 2; Indels 0; Gaps 0;
Qy 1 KPRRPYAVNYTRLRKQIAVKKYLMSILN 28
|||||| |||||||||:|||||| ||||
Db 1 KPRRPYTVNYTRLRKQMAVKKYLNSILN 28
SEQ ID NO: 8 is 88.2% identical to SEQ ID NO: 4 (Waller):
WO2020102694-A1.
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CC PD 22-MAY-2020.
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CC PF 15-NOV-2019; 2019WO-US061760.
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PR 15-NOV-2018; 2018US-0768060P.
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CC PA (UEMR ) UNIV EMORY.
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CC PI Waller EK, Li Y, Ravindranathan S, Li J;
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DR WPI; 2020-43927D/045.
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CC PT New peptide comprising specific amino acid sequence, useful for
CC PT augmenting T-cell activation to treat cancer e.g. liver cancer, lung
CC PT cancer, melanoma, mesothelioma, multiple myeloma and nasopharyngeal
CC PT cancer and viral infections.
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CC PS Example; SEQ ID NO 4; 56pp; English.
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SQ Sequence 28 AA;
Query Match 88.2%; Score 127; Length 28;
Best Local Similarity 89.3%;
Matches 25; Conservative 0; Mismatches 3; Indels 0; Gaps 0;
Qy 1 KPRRPYAVNYTRLRKQMAVNKYLMSILN 28
|||||| |||||||||||| ||| ||||
Db 1 KPRRPYTVNYTRLRKQMAVKKYLNSILN 28
SEQ ID NO: 9 is 84.6% identical to SEQ ID NO: 5 (Waller):
WO2020102694-A1.
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CC PD 22-MAY-2020.
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CC PF 15-NOV-2019; 2019WO-US061760.
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PR 15-NOV-2018; 2018US-0768060P.
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CC PA (UEMR ) UNIV EMORY.
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CC PI Waller EK, Li Y, Ravindranathan S, Li J;
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DR WPI; 2020-43927D/045.
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CC PT New peptide comprising specific amino acid sequence, useful for
CC PT augmenting T-cell activation to treat cancer e.g. liver cancer, lung
CC PT cancer, melanoma, mesothelioma, multiple myeloma and nasopharyngeal
CC PT cancer and viral infections.
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CC PS Example; SEQ ID NO 5; 56pp; English.
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SQ Sequence 28 AA;
Query Match 84.6%; Score 129.5; Length 28;
Best Local Similarity 89.7%;
Matches 26; Conservative 1; Mismatches 1; Indels 1; Gaps 1;
Qy 1 KPRRPYADNCTRLRKQIAVNKKYLNSILN 29
|||||| |||||||||:|| |||||||||
Db 1 KPRRPYTDNCTRLRKQMAV-KKYLNSILN 28
SEQ ID NO: 10 is 85.2% identical to SEQ ID NO: 4 (Waller):
WO2020102694-A1.
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CC PD 22-MAY-2020.
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CC PF 15-NOV-2019; 2019WO-US061760.
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PR 15-NOV-2018; 2018US-0768060P.
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CC PA (UEMR ) UNIV EMORY.
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CC PI Waller EK, Li Y, Ravindranathan S, Li J;
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DR WPI; 2020-43927D/045.
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CC PT New peptide comprising specific amino acid sequence, useful for
CC PT augmenting T-cell activation to treat cancer e.g. liver cancer, lung
CC PT cancer, melanoma, mesothelioma, multiple myeloma and nasopharyngeal
CC PT cancer and viral infections.
XX
CC PS Example; SEQ ID NO 4; 56pp; English.
XX
SQ Sequence 28 AA;
Query Match 85.2%; Score 121; Length 28;
Best Local Similarity 85.7%;
Matches 24; Conservative 1; Mismatches 3; Indels 0; Gaps 0;
Qy 1 KPRRPYTVNYTSLRKQIAVKKYLMLILN 28
||||||||||| ||||:|||||| |||
Db 1 KPRRPYTVNYTRLRKQMAVKKYLNSILN 28
SEQ ID NO: 11 is 86.5% identical to SEQ ID NO: 5 (Waller):
WO2020102694-A1.
XX
CC PD 22-MAY-2020.
XX
CC PF 15-NOV-2019; 2019WO-US061760.
XX
PR 15-NOV-2018; 2018US-0768060P.
XX
CC PA (UEMR ) UNIV EMORY.
XX
CC PI Waller EK, Li Y, Ravindranathan S, Li J;
XX
DR WPI; 2020-43927D/045.
XX
CC PT New peptide comprising specific amino acid sequence, useful for
CC PT augmenting T-cell activation to treat cancer e.g. liver cancer, lung
CC PT cancer, melanoma, mesothelioma, multiple myeloma and nasopharyngeal
CC PT cancer and viral infections.
XX
CC PS Example; SEQ ID NO 5; 56pp; English.
XX
SQ Sequence 28 AA;
Query Match 86.5%; Score 128; Length 28;
Best Local Similarity 85.7%;
Matches 24; Conservative 1; Mismatches 3; Indels 0; Gaps 0;
Qy 1 KPRRPYTDNCTSLRKQIAVNKYLNLILN 28
||||||||||| ||||:|| |||| |||
Db 1 KPRRPYTDNCTRLRKQMAVKKYLNSILN 28
SEQ ID NO: 12 is 82.8% identical to SEQ ID NO: 5 (Waller):
WO2020102694-A1.
XX
CC PD 22-MAY-2020.
XX
CC PF 15-NOV-2019; 2019WO-US061760.
XX
PR 15-NOV-2018; 2018US-0768060P.
XX
CC PA (UEMR ) UNIV EMORY.
XX
CC PI Waller EK, Li Y, Ravindranathan S, Li J;
XX
DR WPI; 2020-43927D/045.
XX
CC PT New peptide comprising specific amino acid sequence, useful for
CC PT augmenting T-cell activation to treat cancer e.g. liver cancer, lung
CC PT cancer, melanoma, mesothelioma, multiple myeloma and nasopharyngeal
CC PT cancer and viral infections.
XX
CC PS Example; SEQ ID NO 5; 56pp; English.
XX
SQ Sequence 28 AA;
Query Match 82.8%; Score 120; Length 28;
Best Local Similarity 82.1%;
Matches 23; Conservative 1; Mismatches 4; Indels 0; Gaps 0;
Qy 1 KPRRPYAVNCTSLRKQIAVNKYLNSILN 28
|||||| ||| ||||:|| ||||||||
Db 1 KPRRPYTDNCTRLRKQMAVKKYLNSILN 28
SEQ ID NO: 13 is 81.8% identical to SEQ ID NO: 5 (Waller):
WO2020102694-A1.
XX
CC PD 22-MAY-2020.
XX
CC PF 15-NOV-2019; 2019WO-US061760.
XX
PR 15-NOV-2018; 2018US-0768060P.
XX
CC PA (UEMR ) UNIV EMORY.
XX
CC PI Waller EK, Li Y, Ravindranathan S, Li J;
XX
DR WPI; 2020-43927D/045.
XX
CC PT New peptide comprising specific amino acid sequence, useful for
CC PT augmenting T-cell activation to treat cancer e.g. liver cancer, lung
CC PT cancer, melanoma, mesothelioma, multiple myeloma and nasopharyngeal
CC PT cancer and viral infections.
XX
CC PS Example; SEQ ID NO 5; 56pp; English.
XX
SQ Sequence 28 AA;
Query Match 81.8%; Score 117; Length 28;
Best Local Similarity 82.1%;
Matches 23; Conservative 1; Mismatches 4; Indels 0; Gaps 0;
Qy 1 KPRRPYAVNCTSLRKQIAVKKYLMSILN 28
|||||| ||| ||||:|||||| ||||
Db 1 KPRRPYTDNCTRLRKQMAVKKYLNSILN 28
SEQ ID NO: 14 is 77.9% identical to SEQ ID NO: 5 (Waller):
WO2020102694-A1.
XX
CC PD 22-MAY-2020.
XX
CC PF 15-NOV-2019; 2019WO-US061760.
XX
PR 15-NOV-2018; 2018US-0768060P.
XX
CC PA (UEMR ) UNIV EMORY.
XX
CC PI Waller EK, Li Y, Ravindranathan S, Li J;
XX
DR WPI; 2020-43927D/045.
XX
CC PT New peptide comprising specific amino acid sequence, useful for
CC PT augmenting T-cell activation to treat cancer e.g. liver cancer, lung
CC PT cancer, melanoma, mesothelioma, multiple myeloma and nasopharyngeal
CC PT cancer and viral infections.
XX
CC PS Example; SEQ ID NO 5; 56pp; English.
XX
SQ Sequence 28 AA;
Query Match 77.9%; Score 116; Length 28;
Best Local Similarity 82.1%;
Matches 23; Conservative 1; Mismatches 4; Indels 0; Gaps 0;
Qy 2 KPRRPYTVNCTSLRKQIAVKKYLMLILN 29
||||||| ||| ||||:|||||| |||
Db 1 KPRRPYTDNCTRLRKQMAVKKYLNSILN 28
SEQ ID NO: 15 is 92.4% identical to SEQ ID NO: 4 (Waller):
WO2020102694-A1.
XX
CC PD 22-MAY-2020.
XX
CC PF 15-NOV-2019; 2019WO-US061760.
XX
PR 15-NOV-2018; 2018US-0768060P.
XX
CC PA (UEMR ) UNIV EMORY.
XX
CC PI Waller EK, Li Y, Ravindranathan S, Li J;
XX
DR WPI; 2020-43927D/045.
XX
CC PT New peptide comprising specific amino acid sequence, useful for
CC PT augmenting T-cell activation to treat cancer e.g. liver cancer, lung
CC PT cancer, melanoma, mesothelioma, multiple myeloma and nasopharyngeal
CC PT cancer and viral infections.
XX
CC PS Example; SEQ ID NO 4; 56pp; English.
XX
SQ Sequence 28 AA;
Query Match 92.4%; Score 134; Length 28;
Best Local Similarity 92.9%;
Matches 26; Conservative 1; Mismatches 1; Indels 0; Gaps 0;
Qy 1 KPRRPYTSDYTRLRKQMAVKKYLNSILN 28
||||||| :|||||||||||||||||||
Db 1 KPRRPYTVNYTRLRKQMAVKKYLNSILN 28
SEQ ID NO: 16 is 93.8% identical to SEQ ID NO: 10 (Waller):
WO2020102694-A1.
XX
CC PD 22-MAY-2020.
XX
CC PF 15-NOV-2019; 2019WO-US061760.
XX
PR 15-NOV-2018; 2018US-0768060P.
XX
CC PA (UEMR ) UNIV EMORY.
XX
CC PI Waller EK, Li Y, Ravindranathan S, Li J;
XX
DR WPI; 2020-43927D/045.
XX
CC PT New peptide comprising specific amino acid sequence, useful for
CC PT augmenting T-cell activation to treat cancer e.g. liver cancer, lung
CC PT cancer, melanoma, mesothelioma, multiple myeloma and nasopharyngeal
CC PT cancer and viral infections.
XX
CC PS Claim 3; SEQ ID NO 10; 56pp; English.
XX
SQ Sequence 28 AA;
Query Match 93.8%; Score 136; Length 28;
Best Local Similarity 92.9%;
Matches 26; Conservative 1; Mismatches 1; Indels 0; Gaps 0;
Qy 1 KPRRPYTSDYTRLRKQMAVKKYLNLILN 28
||||||| :|||||||||||||||||||
Db 1 KPRRPYTDNYTRLRKQMAVKKYLNLILN 28
13. Claims 1, 3, 6, 9, 49-51, and 58-60 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US Patent 12,098,180, Waller et al (Hereinafter Waller 2).
The applied reference has a common applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Waller 2 discloses a peptide comprising the amino acid sequence of SEQ ID NO: 10 (KPRRPYTDNYTRLRKQMAVKKYLNLILN). (See Claim 1). The US Patent discloses that this peptide inherently has VIP receptor antagonist function (See Summary, Examples, and Figures 1-3). Given the instant specification’s interpretation of “fragments” of the instantly claimed peptides, SEQ ID NO: 10 of the US Patent is a “fragment” of the instantly claimed peptide SEQ ID NOs: 3 and 6-16 having VIP receptor antagonist function.
Regarding claim 6, Waller 2 claims a pharmaceutical composition comprising the peptide and a pharmaceutically acceptable excipient. (See claim 3).
Regarding claim 9, Waller 2 discloses a nucleic acid encoding the amino acid sequence. (See column 3 lines 12-14).
Regarding claims 49-51 and 58-60, Waller 2 discloses that the peptide can be used to treat cancer and enhance immunity in cancer treatments, including pancreatic cancer, colon cancer, leukemia, lung cancer, and melanoma and in combination with an immune checkpoint inhibitor. (See Patent ‘180 pg. 18 column 20 lines 40-58; also pg. 19 column 21 lines 9-12).
SEQ ID NO: 6 is 93.2% identical to SEQ ID NO: 10 (Waller 2):
%
Result Query Filing
No. Score Match Length ID Date Dups Description
-------------------------------------------------------------------------------------------------------------
7 137 93.2 28 PCT-US22-29628-6 2022-05-17 1 VASOACTIVE INTESTINAL PEPTIDE (VIP) ANTAGONISTS
ALIGNMENT:
Query Match 93.2%; Score 137; Length 28;
Best Local Similarity 92.9%;
Matches 26; Conservative 0; Mismatches 2; Indels 0; Gaps 0;
Qy 1 KPRRPYTDNYTRLRKQMAVKKYLNLILN 28
|||||| |||||||||||| ||||||||
Db 1 KPRRPYADNYTRLRKQMAVNKYLNLILN 28
US-18-562-111-6
Filing date in PALM: N/A
Sequence 6, US/18562111
GENERAL INFORMATION
APPLICANT: Emory University
TITLE OF INVENTION: VASOACTIVE INTESTINAL PEPTIDE (VIP) ANTAGONISTS
FILE REFERENCE: 10029-089WO1
CURRENT APPLICATION NUMBER: US/18/562,111
CURRENT FILING DATE: 2023-11-17
PRIOR APPLICATION NUMBER: 63/189,507
PRIOR FILING DATE: 2021-05-07
NUMBER OF SEQ ID NOS: 22
SEQ ID NO 6
LENGTH: 28
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: Synthetic construct
SEQ ID NO: 7 is 78.2% identical to SEQ ID NO: 10 (Waller 2):
%
Result Query Filing
No. Score Match Length ID Date Dups Description
-------------------------------------------------------------------------------------------------------------
19 115 78.2 28 PCT-US22-29628-7 2022-05-17 1 VASOACTIVE INTESTINAL PEPTIDE (VIP) ANTAGONISTS
ALIGNMENT:
Query Match 78.2%; Score 115; Length 28;
Best Local Similarity 82.1%;
Matches 23; Conservative 1; Mismatches 4; Indels 0; Gaps 0;
Qy 1 KPRRPYTDNYTRLRKQMAVKKYLNLILN 28
|||||| ||||||||:|||||| |||
Db 1 KPRRPYAVNYTRLRKQIAVKKYLMSILN 28
US-18-562-111-7
Filing date in PALM: N/A
Sequence 7, US/18562111
GENERAL INFORMATION
APPLICANT: Emory University
TITLE OF INVENTION: VASOACTIVE INTESTINAL PEPTIDE (VIP) ANTAGONISTS
FILE REFERENCE: 10029-089WO1
CURRENT APPLICATION NUMBER: US/18/562,111
CURRENT FILING DATE: 2023-11-17
PRIOR APPLICATION NUMBER: 63/189,507
PRIOR FILING DATE: 2021-05-07
NUMBER OF SEQ ID NOS: 22
SEQ ID NO 7
LENGTH: 28
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: Synthetic construct
SEQ ID NO: 8 is 77.6% identical to SEQ ID NO: 10 (Waller 2):
%
Result Query Filing
No. Score Match Length ID Date Dups Description
-------------------------------------------------------------------------------------------------------------
21 114 77.6 28 PCT-US22-29628-8 2022-05-17 1 VASOACTIVE INTESTINAL PEPTIDE (VIP) ANTAGONISTS
ALIGNMENT:
Query Match 77.6%; Score 114; Length 28;
Best Local Similarity 82.1%;
Matches 23; Conservative 0; Mismatches 5; Indels 0; Gaps 0;
Qy 1 KPRRPYTDNYTRLRKQMAVKKYLNLILN 28
|||||| ||||||||||| ||| |||
Db 1 KPRRPYAVNYTRLRKQMAVNKYLMSILN 28
US-18-562-111-8
Filing date in PALM: N/A
Sequence 8, US/18562111
GENERAL INFORMATION
APPLICANT: Emory University
TITLE OF INVENTION: VASOACTIVE INTESTINAL PEPTIDE (VIP) ANTAGONISTS
FILE REFERENCE: 10029-089WO1
CURRENT APPLICATION NUMBER: US/18/562,111
CURRENT FILING DATE: 2023-11-17
PRIOR APPLICATION NUMBER: 63/189,507
PRIOR FILING DATE: 2021-05-07
NUMBER OF SEQ ID NOS: 22
SEQ ID NO 8
LENGTH: 28
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: Synthetic construct
SEQ ID NO: 9 is 76.5% identical to SEQ ID NO: 10 (Waller 2):
%
Result Query Filing
No. Score Match Length ID Date Dups Description
-------------------------------------------------------------------------------------------------------------
22 112.5 76.5 29 PCT-US22-29628-9 2022-05-17 1 VASOACTIVE INTESTINAL PEPTIDE (VIP) ANTAGONISTS
ALIGNMENT:
Query Match 76.5%; Score 112.5; Length 29;
Best Local Similarity 82.8%;
Matches 24; Conservative 1; Mismatches 3; Indels 1; Gaps 1;
Qy 1 KPRRPYTDNYTRLRKQMAV-KKYLNLILN 28
|||||| || ||||||:|| ||||| |||
Db 1 KPRRPYADNCTRLRKQIAVNKKYLNSILN 29
US-18-562-111-9
Filing date in PALM: N/A
Sequence 9, US/18562111
GENERAL INFORMATION
APPLICANT: Emory University
TITLE OF INVENTION: VASOACTIVE INTESTINAL PEPTIDE (VIP) ANTAGONISTS
FILE REFERENCE: 10029-089WO1
CURRENT APPLICATION NUMBER: US/18/562,111
CURRENT FILING DATE: 2023-11-17
PRIOR APPLICATION NUMBER: 63/189,507
PRIOR FILING DATE: 2021-05-07
NUMBER OF SEQ ID NOS: 22
SEQ ID NO 9
LENGTH: 29
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: Synthetic construct
SEQ ID NO: 10 is 81.6% identical to SEQ ID NO: 10 (Waller 2):
%
Result Query Filing
No. Score Match Length ID Date Dups Description
-------------------------------------------------------------------------------------------------------------
18 120 81.6 28 PCT-US22-29628-10 2022-05-17 1 VASOACTIVE INTESTINAL PEPTIDE (VIP) ANTAGONISTS
ALIGNMENT:
Query Match 81.6%; Score 120; Length 28;
Best Local Similarity 85.7%;
Matches 24; Conservative 1; Mismatches 3; Indels 0; Gaps 0;
Qy 1 KPRRPYTDNYTRLRKQMAVKKYLNLILN 28
||||||| ||| ||||:|||||| ||||
Db 1 KPRRPYTVNYTSLRKQIAVKKYLMLILN 28
US-18-562-111-10
Filing date in PALM: N/A
Sequence 10, US/18562111
GENERAL INFORMATION
APPLICANT: Emory University
TITLE OF INVENTION: VASOACTIVE INTESTINAL PEPTIDE (VIP) ANTAGONISTS
FILE REFERENCE: 10029-089WO1
CURRENT APPLICATION NUMBER: US/18/562,111
CURRENT FILING DATE: 2023-11-17
PRIOR APPLICATION NUMBER: 63/189,507
PRIOR FILING DATE: 2021-05-07
NUMBER OF SEQ ID NOS: 22
SEQ ID NO 10
LENGTH: 28
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: Synthetic construct
SEQ ID NO: 11 is 83.7% identical to SEQ ID NO: 10 (Waller 2):
%
Result Query Filing
No. Score Match Length ID Date Dups Description
-------------------------------------------------------------------------------------------------------------
17 123 83.7 28 PCT-US22-29628-11 2022-05-17 1 VASOACTIVE INTESTINAL PEPTIDE (VIP) ANTAGONISTS
ALIGNMENT:
Query Match 83.7%; Score 123; Length 28;
Best Local Similarity 85.7%;
Matches 24; Conservative 1; Mismatches 3; Indels 0; Gaps 0;
Qy 1 KPRRPYTDNYTRLRKQMAVKKYLNLILN 28
||||||||| | ||||:|| ||||||||
Db 1 KPRRPYTDNCTSLRKQIAVNKYLNLILN 28
US-18-562-111-11
Filing date in PALM: N/A
Sequence 11, US/18562111
GENERAL INFORMATION
APPLICANT: Emory University
TITLE OF INVENTION: VASOACTIVE INTESTINAL PEPTIDE (VIP) ANTAGONISTS
FILE REFERENCE: 10029-089WO1
CURRENT APPLICATION NUMBER: US/18/562,111
CURRENT FILING DATE: 2023-11-17
PRIOR APPLICATION NUMBER: 63/189,507
PRIOR FILING DATE: 2021-05-07
NUMBER OF SEQ ID NOS: 22
SEQ ID NO 11
LENGTH: 28
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: Synthetic construct
SEQ ID NO: 14 is 75.5% identical to SEQ ID NO: 10 (Waller 2):
%
Result Query Filing
No. Score Match Length ID Date Dups Description
-------------------------------------------------------------------------------------------------------------
24 111 75.5 29 PCT-US22-29628-14 2022-05-17 1 VASOACTIVE INTESTINAL PEPTIDE (VIP) ANTAGONISTS
ALIGNMENT:
Query Match 75.5%; Score 111; Length 29;
Best Local Similarity 82.1%;
Matches 23; Conservative 1; Mismatches 4; Indels 0; Gaps 0;
Qy 1 KPRRPYTDNYTRLRKQMAVKKYLNLILN 28
||||||| | | ||||:|||||| ||||
Db 2 KPRRPYTVNCTSLRKQIAVKKYLMLILN 29
US-18-562-111-14
Filing date in PALM: N/A
Sequence 14, US/18562111
GENERAL INFORMATION
APPLICANT: Emory University
TITLE OF INVENTION: VASOACTIVE INTESTINAL PEPTIDE (VIP) ANTAGONISTS
FILE REFERENCE: 10029-089WO1
CURRENT APPLICATION NUMBER: US/18/562,111
CURRENT FILING DATE: 2023-11-17
PRIOR APPLICATION NUMBER: 63/189,507
PRIOR FILING DATE: 2021-05-07
NUMBER OF SEQ ID NOS: 22
SEQ ID NO 14
LENGTH: 29
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: Synthetic construct
SEQ ID NO: 15 is 88.4% identical to SEQ ID NO: 10 (Waller 2):
%
Result Query Filing
No. Score Match Length ID Date Dups Description
-------------------------------------------------------------------------------------------------------------
16 130 88.4 28 PCT-US22-29628-15 2022-05-17 1 VASOACTIVE INTESTINAL PEPTIDE (VIP) ANTAGONISTS
ALIGNMENT:
Query Match 88.4%; Score 130; Length 28;
Best Local Similarity 89.3%;
Matches 25; Conservative 1; Mismatches 2; Indels 0; Gaps 0;
Qy 1 KPRRPYTDNYTRLRKQMAVKKYLNLILN 28
||||||| :||||||||||||||| |||
Db 1 KPRRPYTSDYTRLRKQMAVKKYLNSILN 28
US-18-562-111-15
Filing date in PALM: N/A
Sequence 15, US/18562111
GENERAL INFORMATION
APPLICANT: Emory University
TITLE OF INVENTION: VASOACTIVE INTESTINAL PEPTIDE (VIP) ANTAGONISTS
FILE REFERENCE: 10029-089WO1
CURRENT APPLICATION NUMBER: US/18/562,111
CURRENT FILING DATE: 2023-11-17
PRIOR APPLICATION NUMBER: 63/189,507
PRIOR FILING DATE: 2021-05-07
NUMBER OF SEQ ID NOS: 22
SEQ ID NO 15
LENGTH: 28
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: Synthetic construct
SEQ ID NO: 16 is 92.5% identical to SEQ ID NO: 10 (Waller 2):
%
Result Query Filing
No. Score Match Length ID Date Dups Description
-------------------------------------------------------------------------------------------------------------
9 136 92.5 28 PCT-US22-29628-16 2022-05-17 2 VASOACTIVE INTESTINAL PEPTIDE (VIP) ANTAGONISTS
ALIGNMENT:
Query Match 92.5%; Score 136; Length 28;
Best Local Similarity 92.9%;
Matches 26; Conservative 1; Mismatches 1; Indels 0; Gaps 0;
Qy 1 KPRRPYTDNYTRLRKQMAVKKYLNLILN 28
||||||| :|||||||||||||||||||
Db 1 KPRRPYTSDYTRLRKQMAVKKYLNLILN 28
US-18-562-111-16
Filing date in PALM: N/A
Sequence 16, US/18562111
GENERAL INFORMATION
APPLICANT: Emory University
TITLE OF INVENTION: VASOACTIVE INTESTINAL PEPTIDE (VIP) ANTAGONISTS
FILE REFERENCE: 10029-089WO1
CURRENT APPLICATION NUMBER: US/18/562,111
CURRENT FILING DATE: 2023-11-17
PRIOR APPLICATION NUMBER: 63/189,507
PRIOR FILING DATE: 2021-05-07
NUMBER OF SEQ ID NOS: 22
SEQ ID NO 16
LENGTH: 28
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: Synthetic construct
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.
14. Claims 1, 3, 6, and 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3 of U.S. Patent No. 12098180 B2 (Hereinafter Patent ‘180).
Patent ‘180 claims a peptide comprising the amino acid sequence of SEQ ID NO: 10 (KPRRPYTDNYTRLRKQMAVKKYLNLILN). The US Patent discloses that this peptide inherently has VIP receptor antagonist function (see summary, Examples, and Figures 1-3). Given the instant specification’s interpretation of “fragments” of the instantly claimed peptides, SEQ ID NO:10 of the US Patent is a “fragment” of the instantly claimed peptide SEQ ID NOs: 3 and 6-16 having VIP receptor antagonist function.
Patent ‘180 claims a pharmaceutical composition comprising the peptide and a pharmaceutically acceptable excipient which corresponds to instant claim 6.
Patent ‘180 does not claim a nucleic acid encoding the amino acid sequence, however, given the finite nucleic acid degenerate code for encoding amino acid sequences, the nucleic acid sequences encoding the claimed peptide sequences are obvious for instant claim 9.
It would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date to use the claimed product of Patent ‘180 for the claimed product of the present application. It would be obvious because Patent ‘180 discloses an amino acid sequence that is the same as the present application and a person of ordinary skill in the art would know the nucleic acid sequence for the peptide based on the claimed amino acid structure. Therefore, it would be obvious for a person of ordinary skill in the art prior to the effective filing date to use the peptide of Patent ‘180 for the present claimed invention with a reasonable expectation of success.
SEQ ID NO: 6 is 93.2% identical to SEQ ID NO: 10 (Patent ‘180):
%
Result Query Filing
No. Score Match Length ID Date Dups Description
-------------------------------------------------------------------------------------------------------------
7 137 93.2 28 PCT-US22-29628-6 2022-05-17 1 VASOACTIVE INTESTINAL PEPTIDE (VIP) ANTAGONISTS
ALIGNMENT:
Query Match 93.2%; Score 137; Length 28;
Best Local Similarity 92.9%;
Matches 26; Conservative 0; Mismatches 2; Indels 0; Gaps 0;
Qy 1 KPRRPYTDNYTRLRKQMAVKKYLNLILN 28
|||||| |||||||||||| ||||||||
Db 1 KPRRPYADNYTRLRKQMAVNKYLNLILN 28
US-18-562-111-6
Filing date in PALM: N/A
Sequence 6, US/18562111
GENERAL INFORMATION
APPLICANT: Emory University
TITLE OF INVENTION: VASOACTIVE INTESTINAL PEPTIDE (VIP) ANTAGONISTS
FILE REFERENCE: 10029-089WO1
CURRENT APPLICATION NUMBER: US/18/562,111
CURRENT FILING DATE: 2023-11-17
PRIOR APPLICATION NUMBER: 63/189,507
PRIOR FILING DATE: 2021-05-07
NUMBER OF SEQ ID NOS: 22
SEQ ID NO 6
LENGTH: 28
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: Synthetic construct
SEQ ID NO: 7 is 78.2% identical to SEQ ID NO: 10 (Patent ‘180):
%
Result Query Filing
No. Score Match Length ID Date Dups Description
-------------------------------------------------------------------------------------------------------------
19 115 78.2 28 PCT-US22-29628-7 2022-05-17 1 VASOACTIVE INTESTINAL PEPTIDE (VIP) ANTAGONISTS
ALIGNMENT:
Query Match 78.2%; Score 115; Length 28;
Best Local Similarity 82.1%;
Matches 23; Conservative 1; Mismatches 4; Indels 0; Gaps 0;
Qy 1 KPRRPYTDNYTRLRKQMAVKKYLNLILN 28
|||||| ||||||||:|||||| |||
Db 1 KPRRPYAVNYTRLRKQIAVKKYLMSILN 28
US-18-562-111-7
Filing date in PALM: N/A
Sequence 7, US/18562111
GENERAL INFORMATION
APPLICANT: Emory University
TITLE OF INVENTION: VASOACTIVE INTESTINAL PEPTIDE (VIP) ANTAGONISTS
FILE REFERENCE: 10029-089WO1
CURRENT APPLICATION NUMBER: US/18/562,111
CURRENT FILING DATE: 2023-11-17
PRIOR APPLICATION NUMBER: 63/189,507
PRIOR FILING DATE: 2021-05-07
NUMBER OF SEQ ID NOS: 22
SEQ ID NO 7
LENGTH: 28
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: Synthetic construct
SEQ ID NO: 8 is 77.6% identical to SEQ ID NO: 10 (Patent ‘180):
%
Result Query Filing
No. Score Match Length ID Date Dups Description
-------------------------------------------------------------------------------------------------------------
21 114 77.6 28 PCT-US22-29628-8 2022-05-17 1 VASOACTIVE INTESTINAL PEPTIDE (VIP) ANTAGONISTS
ALIGNMENT:
Query Match 77.6%; Score 114; Length 28;
Best Local Similarity 82.1%;
Matches 23; Conservative 0; Mismatches 5; Indels 0; Gaps 0;
Qy 1 KPRRPYTDNYTRLRKQMAVKKYLNLILN 28
|||||| ||||||||||| ||| |||
Db 1 KPRRPYAVNYTRLRKQMAVNKYLMSILN 28
US-18-562-111-8
Filing date in PALM: N/A
Sequence 8, US/18562111
GENERAL INFORMATION
APPLICANT: Emory University
TITLE OF INVENTION: VASOACTIVE INTESTINAL PEPTIDE (VIP) ANTAGONISTS
FILE REFERENCE: 10029-089WO1
CURRENT APPLICATION NUMBER: US/18/562,111
CURRENT FILING DATE: 2023-11-17
PRIOR APPLICATION NUMBER: 63/189,507
PRIOR FILING DATE: 2021-05-07
NUMBER OF SEQ ID NOS: 22
SEQ ID NO 8
LENGTH: 28
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: Synthetic construct
SEQ ID NO: 9 is 76.5% identical to SEQ ID NO: 10 (Patent ‘180):
%
Result Query Filing
No. Score Match Length ID Date Dups Description
-------------------------------------------------------------------------------------------------------------
22 112.5 76.5 29 PCT-US22-29628-9 2022-05-17 1 VASOACTIVE INTESTINAL PEPTIDE (VIP) ANTAGONISTS
ALIGNMENT:
Query Match 76.5%; Score 112.5; Length 29;
Best Local Similarity 82.8%;
Matches 24; Conservative 1; Mismatches 3; Indels 1; Gaps 1;
Qy 1 KPRRPYTDNYTRLRKQMAV-KKYLNLILN 28
|||||| || ||||||:|| ||||| |||
Db 1 KPRRPYADNCTRLRKQIAVNKKYLNSILN 29
US-18-562-111-9
Filing date in PALM: N/A
Sequence 9, US/18562111
GENERAL INFORMATION
APPLICANT: Emory University
TITLE OF INVENTION: VASOACTIVE INTESTINAL PEPTIDE (VIP) ANTAGONISTS
FILE REFERENCE: 10029-089WO1
CURRENT APPLICATION NUMBER: US/18/562,111
CURRENT FILING DATE: 2023-11-17
PRIOR APPLICATION NUMBER: 63/189,507
PRIOR FILING DATE: 2021-05-07
NUMBER OF SEQ ID NOS: 22
SEQ ID NO 9
LENGTH: 29
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: Synthetic construct
SEQ ID NO: 10 is 81.6% identical to SEQ ID NO: 10 (Patent ‘180):
%
Result Query Filing
No. Score Match Length ID Date Dups Description
-------------------------------------------------------------------------------------------------------------
18 120 81.6 28 PCT-US22-29628-10 2022-05-17 1 VASOACTIVE INTESTINAL PEPTIDE (VIP) ANTAGONISTS
ALIGNMENT:
Query Match 81.6%; Score 120; Length 28;
Best Local Similarity 85.7%;
Matches 24; Conservative 1; Mismatches 3; Indels 0; Gaps 0;
Qy 1 KPRRPYTDNYTRLRKQMAVKKYLNLILN 28
||||||| ||| ||||:|||||| ||||
Db 1 KPRRPYTVNYTSLRKQIAVKKYLMLILN 28
US-18-562-111-10
Filing date in PALM: N/A
Sequence 10, US/18562111
GENERAL INFORMATION
APPLICANT: Emory University
TITLE OF INVENTION: VASOACTIVE INTESTINAL PEPTIDE (VIP) ANTAGONISTS
FILE REFERENCE: 10029-089WO1
CURRENT APPLICATION NUMBER: US/18/562,111
CURRENT FILING DATE: 2023-11-17
PRIOR APPLICATION NUMBER: 63/189,507
PRIOR FILING DATE: 2021-05-07
NUMBER OF SEQ ID NOS: 22
SEQ ID NO 10
LENGTH: 28
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: Synthetic construct
SEQ ID NO: 11 is 83.7% identical to SEQ ID NO: 10 (Patent ‘180):
%
Result Query Filing
No. Score Match Length ID Date Dups Description
-------------------------------------------------------------------------------------------------------------
17 123 83.7 28 PCT-US22-29628-11 2022-05-17 1 VASOACTIVE INTESTINAL PEPTIDE (VIP) ANTAGONISTS
ALIGNMENT:
Query Match 83.7%; Score 123; Length 28;
Best Local Similarity 85.7%;
Matches 24; Conservative 1; Mismatches 3; Indels 0; Gaps 0;
Qy 1 KPRRPYTDNYTRLRKQMAVKKYLNLILN 28
||||||||| | ||||:|| ||||||||
Db 1 KPRRPYTDNCTSLRKQIAVNKYLNLILN 28
US-18-562-111-11
Filing date in PALM: N/A
Sequence 11, US/18562111
GENERAL INFORMATION
APPLICANT: Emory University
TITLE OF INVENTION: VASOACTIVE INTESTINAL PEPTIDE (VIP) ANTAGONISTS
FILE REFERENCE: 10029-089WO1
CURRENT APPLICATION NUMBER: US/18/562,111
CURRENT FILING DATE: 2023-11-17
PRIOR APPLICATION NUMBER: 63/189,507
PRIOR FILING DATE: 2021-05-07
NUMBER OF SEQ ID NOS: 22
SEQ ID NO 11
LENGTH: 28
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: Synthetic construct
SEQ ID NO: 14 is 75.5% identical to SEQ ID NO: 10 (Patent ‘180):
%
Result Query Filing
No. Score Match Length ID Date Dups Description
-------------------------------------------------------------------------------------------------------------
24 111 75.5 29 PCT-US22-29628-14 2022-05-17 1 VASOACTIVE INTESTINAL PEPTIDE (VIP) ANTAGONISTS
ALIGNMENT:
Query Match 75.5%; Score 111; Length 29;
Best Local Similarity 82.1%;
Matches 23; Conservative 1; Mismatches 4; Indels 0; Gaps 0;
Qy 1 KPRRPYTDNYTRLRKQMAVKKYLNLILN 28
||||||| | | ||||:|||||| ||||
Db 2 KPRRPYTVNCTSLRKQIAVKKYLMLILN 29
US-18-562-111-14
Filing date in PALM: N/A
Sequence 14, US/18562111
GENERAL INFORMATION
APPLICANT: Emory University
TITLE OF INVENTION: VASOACTIVE INTESTINAL PEPTIDE (VIP) ANTAGONISTS
FILE REFERENCE: 10029-089WO1
CURRENT APPLICATION NUMBER: US/18/562,111
CURRENT FILING DATE: 2023-11-17
PRIOR APPLICATION NUMBER: 63/189,507
PRIOR FILING DATE: 2021-05-07
NUMBER OF SEQ ID NOS: 22
SEQ ID NO 14
LENGTH: 29
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: Synthetic construct
SEQ ID NO: 15 is 88.4% identical to SEQ ID NO: 10 (Patent ‘180):
%
Result Query Filing
No. Score Match Length ID Date Dups Description
-------------------------------------------------------------------------------------------------------------
16 130 88.4 28 PCT-US22-29628-15 2022-05-17 1 VASOACTIVE INTESTINAL PEPTIDE (VIP) ANTAGONISTS
ALIGNMENT:
Query Match 88.4%; Score 130; Length 28;
Best Local Similarity 89.3%;
Matches 25; Conservative 1; Mismatches 2; Indels 0; Gaps 0;
Qy 1 KPRRPYTDNYTRLRKQMAVKKYLNLILN 28
||||||| :||||||||||||||| |||
Db 1 KPRRPYTSDYTRLRKQMAVKKYLNSILN 28
US-18-562-111-15
Filing date in PALM: N/A
Sequence 15, US/18562111
GENERAL INFORMATION
APPLICANT: Emory University
TITLE OF INVENTION: VASOACTIVE INTESTINAL PEPTIDE (VIP) ANTAGONISTS
FILE REFERENCE: 10029-089WO1
CURRENT APPLICATION NUMBER: US/18/562,111
CURRENT FILING DATE: 2023-11-17
PRIOR APPLICATION NUMBER: 63/189,507
PRIOR FILING DATE: 2021-05-07
NUMBER OF SEQ ID NOS: 22
SEQ ID NO 15
LENGTH: 28
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: Synthetic construct
SEQ ID NO: 16 is 92.5% identical to SEQ ID NO: 10 (Patent ‘180):
%
Result Query Filing
No. Score Match Length ID Date Dups Description
-------------------------------------------------------------------------------------------------------------
9 136 92.5 28 PCT-US22-29628-16 2022-05-17 2 VASOACTIVE INTESTINAL PEPTIDE (VIP) ANTAGONISTS
ALIGNMENT:
Query Match 92.5%; Score 136; Length 28;
Best Local Similarity 92.9%;
Matches 26; Conservative 1; Mismatches 1; Indels 0; Gaps 0;
Qy 1 KPRRPYTDNYTRLRKQMAVKKYLNLILN 28
||||||| :|||||||||||||||||||
Db 1 KPRRPYTSDYTRLRKQMAVKKYLNLILN 28
US-18-562-111-16
Filing date in PALM: N/A
Sequence 16, US/18562111
GENERAL INFORMATION
APPLICANT: Emory University
TITLE OF INVENTION: VASOACTIVE INTESTINAL PEPTIDE (VIP) ANTAGONISTS
FILE REFERENCE: 10029-089WO1
CURRENT APPLICATION NUMBER: US/18/562,111
CURRENT FILING DATE: 2023-11-17
PRIOR APPLICATION NUMBER: 63/189,507
PRIOR FILING DATE: 2021-05-07
NUMBER OF SEQ ID NOS: 22
SEQ ID NO 16
LENGTH: 28
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: Synthetic construct
Conclusion
15. Claims 1, 3, 6, 9, 49-51, and 58-60 are rejected.
16. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LINDSAY DUNN whose telephone number is (571)272-5825. The examiner can normally be reached Monday-Friday 8-4:30.
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, Samira Jean-Louis can be reached at 571-270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LINDSAY DUNN/Examiner, Art Unit 1642
/Laura B Goddard/Primary Examiner, Art Unit 1642
Prosecution Insights