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
Election/Restrictions
Applicant’s election without traverse of SEQ ID NO: 4, wherein the peptide does not further comprise an aminoacidic sequence, the pharmaceutical composition does not further comprise a therapeutic agent, and RASopathies caused by germline mutations in PTPN11 in the reply filed on 9/30/2025 is acknowledged.
Applicants elected species (i.e. SEQ ID NO: 4) was deemed to be free of the prior art. In accordance with Markush Practice, the search was extended to the Markush group/independent claim, and a reference was discovered that rendered it obvious. As a result, claims 1, 5, 11-12 and 18 have been examined and claims 2-4, 6-10, 14-17 and 19-21 are withdrawn from consideration. While applicant’s elected species may read on one or more withdrawn claims, they have not been fully examined for patentability, and thus a determination of allowability cannot be made with respect to these claims at this time. This is proper, as MPEP 803.02 states that, in these circumstances, the prior art search, however, will not be extended unnecessarily to cover all nonelected species (MPEP 803.02).
Status of the Claims
Claims 1-12 and 14-21 are pending in this application.
Claims 2-4, 6-10, 14-17 and 19-21 are withdrawn from consideration as being drawn to a non-elected species.
Claims 1, 5, 11-12 and 18 are presently under consideration as being drawn to the elected species.
Claim Objections
Claim 11 is objected to because of the following informalities: Claim 11 should be rewritten to recite “A pharmaceutical composition comprising the peptide according to claim 1….”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 5 and 12 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 5 is drawn to the peptide according to claim 1, wherein Z is a non-natural analogue of phosphotyrosine. Claim 1 already defines Z as a non-natural analogue of phosphotyrosine. Therefore, claim 5, fails to further limit the subject matter of claim 1. Claim 12 is drawn to an intended use of the peptide of claim 1. Thus, claim 12 fails to further limit the subject matter of claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1, 5, 11-12 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Mishra et al. (Journal of Cellular Biochemistry; 84:840-846, 2002) in view of Chen et al. (Biochem Biophys Res Commun. 1995 Nov 22;216(3):976-84).
With respect to claims 1, 5 and 18, Mishra et al. teach the peptide RPEDTLTpYADLDM (Table 1, last peptide).
Mishra et al. do not teach substituting the pY with a non-natural analogue of phosphotyrosine.
Chen et al. teach that phosphonodifluoromethyl phenylalanine (F2Pmp) is a non-hydrolyzable phosphotyrosine mimetic (summary).
Chen et al. also teach that “[S]ince amino acids flanking the phosphotyrosyl residue (pTyr) contribute to high affinity substrate binding (5), one current approach toward the design of potent and selective PTPase inhibitors relies on the incorporation of a nonhydrolyzable analog of pTyr into specific, optimal phosphopeptide
It would have been obvious to one of ordinary skill in the art to substitute the templates (page 977, 2nd para).pY of Mishra et al. with the non-natural analogue of phosphotyrosine phosphonodifluoromethyl phenylalanine because Chen et al. teach that one current approach toward the design of potent and selective PTPase inhibitors relies on the incorporation of a nonhydrolyzable analog of pTyr into specific, optimal phosphopeptide templates.
The skilled artisan would have reasonably expected the resulting peptide (i.e. RPEDTLT-F2Pmp-ADLDM) to be non-hydrolysable, thus having a prolonged effect.
With respect to claim 11, one of ordinary skill in the art concerned with phosphatase inhibitors, would have been motivated, with a reasonable expectation of success, to make a pharmaceutical composition comprising the peptide and a pharmaceutical acceptable carrier, excipient and/or diluent.
With respect to claim 12, it is noted that “[d]uring examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim” (MPEP 2111.02). In the instant case, the limitation “for use as a medicament” does not appear to add any further structural differences that would distinguish the instant invention with regards to the invention obvious over Mishra et al. and Chen et al.
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.
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.
/SERGIO COFFA Ph.D./
Primary Examiner
Art Unit 1658
/SERGIO COFFA/Primary Examiner, Art Unit 1658