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 the peptide SER140 (i.e. a dendrimer of 4 monomeric peptides SGRKSSKMQA (SEQ ID NO: 1) and coupled to a lysine backbone) in the reply filed on 7/16/2026 is acknowledged.
Status of the Claims
Claims 22-26 are pending in this application.
Claim 24 is withdrawn from consideration as being drawn to a non-elected species.
Claims 22-23 and 25-26 are presently under consideration as being drawn to the elected species.
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 22-26 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claims recite a use without any active, positive steps delimiting how this use is actually practiced (see MPEP 2173.05(q)).
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 22-26 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 22-26 recite a use without any active, positive steps delimiting how this use is actually practiced (see MPEP 2173.05(q)).
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.
Claims 22-23 and 25-26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Berezin et al. (WO 2012/122985).
With respect to claims 22-23, Berezin et al. teach a multimeric compound comprising two or more peptides consisting of SEQ ID NO: 1 (claims 1-2 and 30). It is noted that SEQ ID NO: 1 corresponds to instantly claimed SEQ ID NO: 1.
Furthermore, 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 in the treatment of diabetic nephropathy" does not appear to add any further structural differences that would distinguish the instant invention with regards to the invention of Berezin et al. Thus, Berezin et al. is deemed to anticipate these claims.
With respect to claim 25, Berezin et al. teach that the compound is a tetrameric dendrimer (claim 37).
With respect to claim 26, Berezin et al. teach that the tetrameric dendrimer is coupled to a lysine backbone (page 25, lines 32-35).
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 22-23 and 25-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 9359405. Although the claims at issue are not identical, they are not patentably distinct from each other because they relate to the same compound.
With respect to claims 22-23, ‘405 teaches a multimeric compound comprising two or more peptides, wherein each of said two or more peptides consists of 10 to 14 consecutive amino acid residues derived from IL-1 receptor antagonist protein (IL1RA), each peptide consisting of: the amino acid sequence of SEQ ID NO: 1 (claim 11). It is noted that SEQ ID NO: 1 corresponds to instantly claimed SEQ ID NO: 1.
Furthermore, 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 in the treatment of diabetic nephropathy" does not appear to add any further structural differences that would distinguish the instant invention with regards to the invention of ‘405. Thus, ‘405 is deemed to anticipate these claims.
With respect to claim 25, ‘405 teaches that the compound is a tetrameric dendrimer (claim 18).
With respect to claim 26, Berezin et al. teach that the tetrameric dendrimer is coupled to a lysine backbone (claim 20).
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.
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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
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