DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions and Claim Status
Applicants amendments and arguments filed 5/27/25 are acknowledged. Any objection or rejection from the 2/27/25 office action that is not addressed below is withdrawn based on the amendments.
Previously, Group 2 and the species of SEQ ID NO:18 and ALS were elected.
Claims 1-5 and 12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/10/24.
The claim to the elected species is rejected as set forth below. Any relevant art that was uncovered during the search for the elected species is cited herein in order to advance prosecution.
Claims 7-11 have been canceled.
Claims 6 is being examined.
Priority
The priority information is provided in the filing receipt dated 3/5/24.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 4/23/25 and 3/6/25 have been considered by the examiner.
Claim Rejections - 35 USC § 103
The rejection below is a new rejection necessitated by amendment (specifically claim 6 has been amended to remove ‘being no longer than ten amino acids’ and recites ‘consists of’ in relation to the amino acid sequences, thus narrowing the scope of peptides).
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ovadia et al. (US 2016/0033529; ‘Ovadia’; first cited 2/27/25) in view of Herkel et al. (WO 2006/021954 as cited with IDS 3/3/24; ‘Herkel’).
Ovadia teach the use of SEQ ID NO:1 (LPPLPYP) for treating neurodegenerative disease specifically ALS (abstract and sections 0003 and 0036). Ovadia teach in examples 2-3 the administration of SEQ ID NO:1 (LPPLPYP) to mice with ALS (sections 0190-0191 and 0202) and teach a significant increase in survival (section 0195) and delay in progression of disease symptoms (sections 0201-0202). Ovadia teach advantages of using the peptide (section 0029). Ovadia teach that ALS is characterized by apoptosis (section 0190). Ovadia teach anti-apoptotic effects of the peptide (section 0092).
Ovadia does not specifically recite one of the amino acid sequences recited in instant claim 6.
Herkel teach peptides for treating degenerative disease (abstract and claim 45) specifically amyloid lateral sclerosis (pages 20-21 connecting paragraph). Herkel teach a peptide identified as stressin-1 (SEQ ID NO:1) of sequence LPPLPYP (page 7 line 1). Herkel teach beneficial properties of SEQ ID NO:1 (examples 2-8). Herkel teach peptides with anti-apoptotic activity (claim 1). Herkel teach a fragment of SEQ ID NO:1 (claim 12). Herkel teach that the peptide comprises from 5 to 25 amino acids (claim 2) with 5 to 20 amino acids being preferred (page 17 lines 15-16). Herkel expressly refers to peptides having a deletion of a residue (page 18 first complete paragraph). Herkel teach that methods of synthesis are known (page 17 first complete paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of Ovadia because Herkel teach the same LPPLPYP peptide and also teach for treating amyloid lateral sclerosis. Since Herkel specifically teach that the peptide comprises from 5 to 25 amino acids (claim 2) with 5 to 20 amino acids being preferred (page 17 lines 15-16) and Herkel expressly refer to peptides having a deletion of a residue (page 18 first paragraph) one would have been motivated to delete a residue from either terminal end of SEQ ID NO:1 resulting in LPPLPY for example. Since both references teach for amyloid lateral sclerosis one would have been motivated to administer to such subjects. One would have had a reasonable expectation of success since Herkel teach that methods of synthesis are known (page 17 first complete paragraph).
In relation to the subject of claim 6, Ovadia teach for treating ALS (abstract and sections 0003 and 0036). Ovadia teach in examples 2-3 the administration of a peptide to mice with ALS (sections 0190-0191 and 0202).
In relation to the peptide of claim 6, LPPLPY as discussed above is instant SEQ ID NO:7.
Double Patenting
Claims were previously rejected under double patenting. Since the claims have been amended the rejections are updated to correspond to the instant claim.
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.
Claim 6 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 10-12 and 15-20 of copending Application No. 17/105,557 (‘557’) in view of Ovadia et al. (US 2016/0033529; ‘Ovadia’; first cited 2/27/25) in view of Herkel et al. (WO 2006/021954 as cited with IDS 3/3/24; ‘Herkel’)
This is a provisional nonstatutory double patenting rejection.
557 recites treating a subject with ALS by administering SEQ ID NO:1 (LPPLPYP) (claim 1).
557 does not specifically recite one of the amino acid sequences recited in instant claim 6.
Ovadia teach the use of SEQ ID NO:1 (LPPLPYP) for treating neurodegenerative disease specifically ALS (abstract and sections 0003 and 0036). Ovadia teach in examples 2-3 the administration of SEQ ID NO:1 (LPPLPYP) to mice with ALS (sections 0190-0191 and 0202) and teach a significant increase in survival (section 0195) and delay in progression of disease symptoms (sections 0201-0202). Ovadia teach advantages of using the peptide (section 0029). Ovadia teach that ALS is characterized by apoptosis (section 0190). Ovadia teach anti-apoptotic effects of the peptide (section 0092).
Herkel teach peptides for treating degenerative disease (abstract and claim 45) specifically amyloid lateral sclerosis (pages 20-21 connecting paragraph). Herkel teach a peptide identified as stressin-1 (SEQ ID NO:1) of sequence LPPLPYP (page 7 line 1). Herkel teach beneficial properties of SEQ ID NO:1 (examples 2-8). Herkel teach peptides with anti-apoptotic activity (claim 1). Herkel teach a fragment of SEQ ID NO:1 (claim 12). Herkel teach that the peptide comprises from 5 to 25 amino acids (claim 2) with 5 to 20 amino acids being preferred (page 17 lines 15-16). Herkel expressly refers to peptides having a deletion of a residue (page 18 first complete paragraph). Herkel teach that methods of synthesis are known (page 17 first complete paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 557 because Ovadia and Herkel teach the same LPPLPYP peptide and also teach for treating amyloid lateral sclerosis. Since Herkel specifically teach that the peptide comprises from 5 to 25 amino acids (claim 2) with 5 to 20 amino acids being preferred (page 17 lines 15-16) and Herkel expressly refer to peptides having a deletion of a residue (page 18 first paragraph) one would have been motivated to delete a residue from either terminal end of SEQ ID NO:1 resulting in LPPLPY for example. Since both references teach for amyloid lateral sclerosis one would have been motivated to administer to such subjects. One would have had a reasonable expectation of success since Herkel teach that methods of synthesis are known (page 17 first complete paragraph).
In relation to the subject of claim 6, 557 recites a subject with ALS (claim 1). Ovadia teach for treating ALS (abstract and sections 0003 and 0036). Ovadia teach in examples 2-3 the administration of a peptide to mice with ALS (sections 0190-0191 and 0202).
In relation to the peptide of claim 6, LPPLPY as discussed above is instant SEQ ID NO:7.
Claim 6 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of copending Application No. 17/792,787 (787) in view of Ovadia et al. (US 2016/0033529; ‘Ovadia’; first cited 2/27/25) in view of Herkel et al. (WO 2006/021954 as cited with IDS 3/3/24; ‘Herkel’).
This is a provisional nonstatutory double patenting rejection.
787 recites methods of treating a disease associated with apoptosis by administering a peptide (claim 12). 787 recites the peptide of SEQ ID NO: 2 (LPPLPYAib) (claim 5).
787 does not recite ALS in the claims.
Ovadia teach the use of SEQ ID NO:1 (LPPLPYP) for treating neurodegenerative disease specifically ALS (abstract and sections 0003 and 0036). Ovadia teach in examples 2-3 the administration of SEQ ID NO:1 (LPPLPYP) to mice with ALS (sections 0190-0191 and 0202) and teach a significant increase in survival (section 0195) and delay in progression of disease symptoms (sections 0201-0202). Ovadia teach advantages of using the peptide (section 0029). Ovadia teach that ALS is characterized by apoptosis (section 0190). Ovadia teach anti-apoptotic effects of the peptide (section 0092).
Herkel teach peptides for treating degenerative disease (abstract and claim 45) specifically amyloid lateral sclerosis (pages 20-21 connecting paragraph). Herkel teach a peptide identified as stressin-1 (SEQ ID NO:1) of sequence LPPLPYP (page 7 line 1). Herkel teach beneficial properties of SEQ ID NO:1 (examples 2-8). Herkel teach peptides with anti-apoptotic activity (claim 1). Herkel teach a fragment of SEQ ID NO:1 (claim 12). Herkel teach that the peptide comprises from 5 to 25 amino acids (claim 2) with 5 to 20 amino acids being preferred (page 17 lines 15-16). Herkel expressly refers to peptides having a deletion of a residue (page 18 first complete paragraph). Herkel teach that methods of synthesis are known (page 17 first complete paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 787 because Ovadia and Herkel teach similar peptides and teach for treating amyloid lateral sclerosis. Since Herkel specifically teach that the peptide comprises from 5 to 25 amino acids (claim 2) with 5 to 20 amino acids being preferred (page 17 lines 15-16) and Herkel expressly refer to peptides having a deletion of a residue (page 18 first paragraph) one would have been motivated to delete a residue from either terminal end of SEQ ID NO:1 resulting in LPPLPY for example. Further, 787 recognizes that X1 or X7 can be absent (claim 1). Since both references teach for amyloid lateral sclerosis one would have been motivated to administer to such subjects. One would have had a reasonable expectation of success since Herkel teach that methods of synthesis are known (page 17 first complete paragraph).
In relation to the subject of claim 6, Ovadia teach for treating ALS (abstract and sections 0003 and 0036). Ovadia teach in examples 2-3 the administration of a peptide to mice with ALS (sections 0190-0191 and 0202).
In relation to the peptide of claim 6, LPPLPY as discussed above is instant SEQ ID NO:7.
Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 11,852,634 (‘634’; first cited 2/27/25) in view of Ovadia et al. (US 2016/0033529; ‘Ovadia’; first cited 2/27/25) in view of Herkel et al. (WO 2006/021954 as cited with IDS 3/3/24; ‘Herkel’).
634 recites treating a subject with ALS by administering SEQ ID NO:1 (LPPLPYP) (claim 1).
634 does not specifically recite one of the amino acid sequences recited in instant claim 6.
Ovadia teach the use of SEQ ID NO:1 (LPPLPYP) for treating neurodegenerative disease specifically ALS (abstract and sections 0003 and 0036). Ovadia teach in examples 2-3 the administration of SEQ ID NO:1 (LPPLPYP) to mice with ALS (sections 0190-0191 and 0202) and teach a significant increase in survival (section 0195) and delay in progression of disease symptoms (sections 0201-0202). Ovadia teach advantages of using the peptide (section 0029). Ovadia teach that ALS is characterized by apoptosis (section 0190). Ovadia teach anti-apoptotic effects of the peptide (section 0092).
Herkel teach peptides for treating degenerative disease (abstract and claim 45) specifically amyloid lateral sclerosis (pages 20-21 connecting paragraph). Herkel teach a peptide identified as stressin-1 (SEQ ID NO:1) of sequence LPPLPYP (page 7 line 1). Herkel teach beneficial properties of SEQ ID NO:1 (examples 2-8). Herkel teach peptides with anti-apoptotic activity (claim 1). Herkel teach a fragment of SEQ ID NO:1 (claim 12). Herkel teach that the peptide comprises from 5 to 25 amino acids (claim 2) with 5 to 20 amino acids being preferred (page 17 lines 15-16). Herkel expressly refers to peptides having a deletion of a residue (page 18 first complete paragraph). Herkel teach that methods of synthesis are known (page 17 first complete paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 634 because Ovadia and Herkel teach the same LPPLPYP peptide and also teach for treating amyloid lateral sclerosis. Since Herkel specifically teach that the peptide comprises from 5 to 25 amino acids (claim 2) with 5 to 20 amino acids being preferred (page 17 lines 15-16) and Herkel expressly refer to peptides having a deletion of a residue (page 18 first paragraph) one would have been motivated to delete a residue from either terminal end of SEQ ID NO:1 resulting in LPPLPY for example. Since both references teach for amyloid lateral sclerosis one would have been motivated to administer to such subjects. One would have had a reasonable expectation of success since Herkel teach that methods of synthesis are known (page 17 first complete paragraph).
In relation to the subject of claim 6, 634 recites a subject with ALS (claim 1). Ovadia teach for treating ALS (abstract and sections 0003 and 0036). Ovadia teach in examples 2-3 the administration of a peptide to mice with ALS (sections 0190-0191 and 0202).
In relation to the peptide of claim 6, LPPLPY as discussed above is instant SEQ ID NO:7.
Response to Arguments – Double Patenting
Applicant's arguments filed 5/27/25 have been fully considered but they are not persuasive with respect to the rejection set forth above.
Although applicants request deferring addressing issues until certain conditions are met, the request is denied and no such conditions have been met.
Conclusion
Applicant's amendment necessitated any new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RONALD T NIEBAUER whose telephone number is (571)270-3059. The examiner can normally be reached M - F 6:30 - 2:30 EST.
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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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RONALD T. NIEBAUER
Primary Examiner
Art Unit 1658
/RONALD T NIEBAUER/Examiner, Art Unit 1658
Prosecution Insights