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 .
DETAILED ACTION
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/16/2025 has been entered.
Claim Status
Claims 17-27 are pending. Claims 21 and 23 have been amended. Claims 17-27 are being examined in this application.
Duplicate claims
Applicant is advised that should claims 17 and 20 be found allowable, claims 21 and 23 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 706.03(k).
Claim Objections
Claims 19-20 are objected to because of the following informalities: Claim 19 should be rewritten to recite “…having a VIPR2 antagonist activity and a conformational….”. With respect to claim 20, periods may not be used elsewhere in the claims except for abbreviations. See Fressola v. Manbeck, 36 USPQ2d 1211 (D.D.C. 1995); See also MPEP § 608.01(m). Claim 20 should be rewritten to recite “..represented by any one of SEQ ID NOs: 1 to 10….”. Appropriate correction is required.
Sequence Compliance
Applicant is advised that the application is not in compliance with 37 CFR §§ 1.821-1.825.
This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR § 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR §§ 1.821-1.825. Applicant must comply with the requirements of the sequence rules (37 CFR §§ 1.821-1.825) in order to completely respond to this office action.
Specifically, the amino acid sequence presented in Fig. 2 requires a sequence identifier. In order to satisfy the sequence rules requirements, Applicant needs to provide an amendment to the instant claims, specification and drawings to include reference to the appropriate sequence identifier “SEQ ID NO:” in parenthesis next to each of the sequences having 4 or more amino acids. Please confirm that all peptides having 4 or more than 4 amino acid residues have sequence identifiers and are included in the sequence listing.
In case of any new sequences not properly identified in the instant specification, Applicant is required to provide a substitute computer readable form (CRF) copy of a “Sequence Listing” which includes all of the sequences that are present in the instant application and encompassed by these rules, a new or substitute paper copy of that “Sequence Listing”, an amendment directing the entry of that paper copy into the specification, and a statement that the content of the paper and computer readable copies are the same and, where applicable, include no new matter, as required by 37 C.F.R. § 1.821(e) or 1.821(f) or 1.821(g) or 1.825(d). The instant specification will also need to be amended so that it complies with 37 C.F.R. § 1.821(d) which requires a reference to a particular sequence identifier (SEQ ID NO:) be made in the specification and claims wherever a reference is made to that sequence. For rules interpretation Applicant may call (571) 272-2533. See M.P.E.P. 2422.04.
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Claim Rejections - 35 USC § 112
The rejection of claim 23 under 35 USC 112(a) is withdrawn in view of the amendments to the claims.
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.
This is a new rejection.
Claim 25 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The MPEP states:
“There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.” These factors include, but are not limited to: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.”
(A) The breadth of the claims; and (B) The nature of the invention;
The claim is drawn to a method for treating or preventing central nervous system diseases involving VIPR2 activation, comprising administering a pharmaceutical or diagnostic reagent comprising a cyclic peptide of formula (17).
The instant specification teaches that central nervous system diseases involving VIPR2 activation include, but are not limited, mental disorders (schizophrenia, schizoaffective disorder, schizophreniform, delusional disorder, etc.), pediatric mental disorders (attention deficit disorder, attention-deficit/hyperactivity disorder, conduct disorder, autism, etc.), neurodegenerative disorders, neural stem cell disorders, neural precursor disorders, ischemic disorders, neurotraumatic disorders, affective disorders, psychomotor disorders, sleep disorders (hypersomnia, circadian rhythm sleep disorders, insomnia, abnormal sleep behavior, sleep deprivation, etc.) mental disorders such as anxiety (acute stress disorder, generalized anxiety disorder, social anxiety disorder, panic disorder, posttraumatic stress disorder, square fear, obsessive-compulsive disorder, etc.), false psychiatric disorders (acute hallucinatory mania, etc.), impulse control disorders (compulsive gambling, intermittent explosive disorder, etc.), mood disorders (bipolar I type I disorder, bipolar II disorder, mania, mixed affective states, etc.), major depression, chronic depression, seasonal depression, psychotic depression, seasonal depression, cognitive disorders (amnesia, geriatric dementia, HIV-related dementia, Alzheimer's disease, Alzheimer's disease, etc.) HIV-related dementia, Alzheimer's disease, Huntington's disease, dementia with Lewy bodies, vascular dementia, drug-related dementia, late onset dyskinesia, clonic muscle spasms, dystonia, delirium, Pick's disease, Creutzfeldt-Jakob disease, HIV disease, Gilles de la Tourette syndrome, epilepsy, muscle spasticity, mild cognitive impairment, etc.), mental lability (spasticity, Down syndrome, fragile X syndrome, etc.); premenstrual syndrome (PMS), premenstrual dysphoric mood disorder (PDD), postpartum depression, neuronal damage disorders (eye damage, retinopathy or macular degeneration of the eye, tinnitus, hearing Parkinson's disease, Parkinson's-like disorder, migraine, epilepsy, Alzheimer's disease, brain injury, stroke, cerebrovascular disease (cerebral atherosclerosis, cerebral amyloid angiopathy, hereditary cerebral hemorrhage, cerebral hypoxia-ischemia, etc.), drug addiction (drug addiction, alcoholism, amphetamine dependence, cocaine addiction, nicotine dependence, drug withdrawal syndrome, etc.), and eating disorders (anorexia, bulimia, distracted eating disorder, polyphagia, obesity, compulsive eating disorder, ice eating disorder, etc.). Additional diseases include, but are not limited to, inhibition of the growth of VIPR2-expressing cancers and use in the activation of immunity through inhibition of VIPR2 function, and the like (para [0086]).
(C) The state of the prior art;
Cleveland Clinic (downloaded from URL:<>) teaches that neurodegenerative diseases are not preventable ” (page 2; “Treatment”).
(D) The level of one of ordinary skill;
The skill of those skilled in the art is high.
(E) The level of predictability in the art;
Considering that Cleveland Clinic teaches that neurodegenerative diseases are not preventable, the unpredictability of preventing neurodegenerative diseases is very high.
Furthermore, given the different etiology of the enormous list of diseases claimed, the unpredictability of preventing or treating said diseases is very high.
(F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The specification does not provide any examples with respect to the use of the claimed pharmaceutical or diagnostic reagent comprising a cyclic peptide of formula (17) to prevent or treat any of the diseases claimed.
The MPEP (2164.02) states that " The specification need not contain an example if the invention is otherwise disclosed in such manner that one skilled in the art will be able to practice it without an undue amount of experimentation. In re Borkowski, 422 F.2d 904, 908, 164 USPQ 642, 645 (CCPA 1970).” The MPEP further states that
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“Lack of a working example, however, is a factor to be considered, especially in a case involving an unpredictable and undeveloped art.”
In the instant application, the specification does not provide any guidance to allow for the prevention or treatment of the diseases claimed.
Working examples are necessary since the art has indicated unpredictability of prevention or treatment of such diseases is very high.
Considering the state of the art as discussed above and the high unpredictability and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to use the invention as claimed.
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.
This is a new rejection.
Claim 24 is 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 24 recites the limitation "the prodrug" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 24 should be rewritten to recite “A prodrug ; or a pharmaceutically acceptable salt of the prodrug”.
Claim Rejections - 35 USC § 102
The rejection of claims 21 and 23 under 35 U.S.C. 102(a)(1) as being anticipated by Sakamoto et al. is withdrawn in view of the amendments to the claims.
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.
This is a new rejection.
Claim 19 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sakamoto et al. (Biochemical and Biophysical Research Communications 503 (2018) 1973-1979, previously cited).
Sakamoto et al. teach the cyclic peptide VIpep-3 (Ac-CPPYLPRRLCTLLLRS-OH) (abstract), which corresponds to the cyclic peptide of claim 19.
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.
This rejection has been modified.
Claims 17-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-4 and 6-8 of copending Application No. 18/841363 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they relate to the same cyclic peptide.
‘363 teaches a cyclic peptide of formula (1) (claim 1), which corresponds to the claimed cyclic peptide of instant claims 17-21 and 23.
With respect to claims 22 and 24, ‘363 teaches that an N-terminus amino group is acetylated (claim 1). Furthermore, since the teachings of ‘363 relate to a method of treating a subject comprising administering a cyclic peptide of formula (1), one of ordinary skill in the art would have at once envisaged administering a pharmaceutical reagent or a prodrug comprising said cyclic peptide.
With respect to claim 25, the only active step is the administration of the pharmaceutical or diagnostic reagent of the cyclic peptide, which, once administered, would inherently prevent the diseases claimed.
With respect to claim 26, ‘363 teaches that SEQ ID NOs: 1-10, are resistant to protease degradation (para [0074]).
With respect to claim 27, ‘363 teaches that the cyclic peptide is biotin-labeled, fluorescence-labeled, or luminescence-labeled (para [0036]). Please note that it is proper to turn to and rely on the disclosure of a patent application to ascertain what constitutes an obvious modification. This position is supported by the courts. See In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
In the response filed on 12/16/2025, Applicant requested the rejection to be held in abeyance until the claims are otherwise in condition for allowance.
For this reason, the rejection is maintained.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERGIO COFFA whose telephone number is (571)270-3022. The examiner can normally be reached M-F: 6AM-4PM.
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, MELISSA FISHER can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SERGIO COFFA Ph.D./
Primary Examiner
Art Unit 1658
/SERGIO COFFA/Primary Examiner, Art Unit 1658