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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/19/25 has been entered.
Election/Restrictions and Claim Status
Applicants’ amendments and arguments filed 11/19/25 are acknowledged. Any objection or rejection from the 5/21/25 office action that is not addressed below is withdrawn based on the amendments.
Previously, Group 1 and the species of COR1-25 were elected.
Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 12/12/23.
Claims to the elected species are rejected as set forth below. Claims 1, 7 and 9-10 are interpreted as reading on the elected species. Claim 8 does not encompass the elected species.
Claim 8 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/12/23.
Claims 2-6 have been canceled.
Claims 1, 7 and 9-10 are being examined.
Priority
The priority information is provided in the filing receipt dated 9/27/23.
Claim Interpretation
Instant claim 1 recites ‘composition comprising a plurality of tetrapeptides’ and then recites a wherein clause about tetrapeptides selected from a group consisting of.
MPEP 2111.03 recites: “In Amgen Inc. v. Amneal Pharmaceuticals LLC, 945 F.3d 1368, 1379, 2020 USPQ2d 3197 (Fed. Cir. 2020), in an infringement suit, the court interpreted a claim for a pharmaceutical composition having a "comprising" transition phrase and following limitations, including limitations requiring "at least one" binder and "at least one" disintegrant, each "consisting of" items listed in a Markush group. The court found that the Markush grouping recited particular binders or disintegrants, but while the components of the Markush grouping are closed as to the components therein, the claim transition "comprising" allowed for additional component(s) that were functionally similar to the members of the Markush grouping. Thus, the plain language of the claim requires "at least one" of the Markush members and does not further limit the claim to only binders and disintegrants listed in the Markush grouping.”
MPEP 2111.03 further recites: “Amgen Inc. v. Amneal Pharmaceuticals LLC, 945 F.3d 1368, 1378-79, 2020 USPQ2d 3179 (Fed. Cir. 2020) (the claim’s "comprising" transition phrase does not foreclose additional binders and disintegrants when an accused infringing product contains and meets the limitation’s requirements for one of the binders or disintegrants recited in the Markush groupings – there is no inconsistency with another binder or disintegrant outside of the Markush group also being part of the claimed formulation)”.
In the instant case, the transitional phrase ‘comprising’ in line 1 of claim 1 does not foreclose additional components (including peptides). Since claim 1 recites a plurality of tetrapeptides, at least 2 of the tetrapeptides from the recited group are required. In the instant case, the plain language of the claim requires "at least two" (a plurality) of the Markush members and does not further limit the claim to only those listed in the Markush grouping.
Claim Rejections - 35 USC § 112
This rejection is a new rejection necessitated by amendment.
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 1, 7 and 9-10 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.
A period appears after the 16th recited peptide in claim 1. It is unclear if the peptides after the period are intended to be within the group. It is unclear if claim 7 is a proper dependent claim. Claims 9-10 do not clarify the claim scope. Although unclear, claim 1 has been interpreted as including the peptides after the 16th recited peptide of claim 1.
Claim Rejections - 35 USC § 102
Claims were previously rejected under 102 based on the reference cited below.
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 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)(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.
Claim(s) 1, 7 and 9-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Haslach et al. (cite 30 of the 9 page IDS of 12/12/23; ‘Haslach’).
Haslach teach the use of a tetrapeptide library to discover molecules (abstract). Haslach teach that there are 240 acetylated tetrapeptide mixtures each made up of 216000 acetylated tetrapeptides (page 4624 ‘Experimental Section’). Haslach teach that each of the four positions are defined with a single amino acid (O) with the three remaining positions made up of one of 60 different amino acids (X) (page 4624 ‘Experimental Section’). Haslach teach that the library is N-acetylated and C-amidated (page 4624 ‘Experimental Section’). Thus, there are 60 sublibraries that comprise Ac-O-X-X-X-NH2, 60 sublibraries that comprise Ac-X-O-X-X-NH2, 60 sublibraries that comprise Ac-X-X-O-X-NH2, and 60 sublibraries that comprise Ac-X-X-X-O-NH2. Haslach teach that the 60 different amino acids include (pI)DPhe, Arg and 2-Nal (page 4624 ‘Experimental Section’). Haslach teach that the peptides were synthesized, extracted and resuspended and brought to a final concentration in a composition comprising water (page 4624 ‘Experimental Section’). Haslach teach a total of 12960000 tetrapeptides (page 4617 last paragraph).
In relation to claims 1 and 7, Haslach teach that there are 240 acetylated tetrapeptide mixtures each made up of 216000 acetylated tetrapeptides (page 4624 ‘Experimental Section’). Haslach teach that each of the four positions are defined with a single amino acid (O) with the three remaining positions made up of one of 60 different amino acids (X) (page 4624 ‘Experimental Section’). Haslach teach that library is N-acetylated and C-amidated (page 4624 ‘Experimental Section’). Thus, there are 60 sublibraries that comprise Ac-O-X-X-X-NH2. Haslach teach that the 60 different amino acids include (pI)DPhe, Arg and 2-Nal (page 4624 ‘Experimental Section’). When O is DPhe(pI), the sublibrary comprises Ac-DPhe(pI)-X-X-X-NH2 and specifically comprises Ac-DPhe(pI)-Arg-2-Nal-Arg-NH2 (the elected species and 16th compound of claim 1 and last compound of claim 7) and Ac-DPhe(pI)-Arg-DPhe(pI)-Arg-NH2 (the 14th compound of claim 1 and the 3rd to last compound of claim 7). Haslach teach that the peptides were synthesized, extracted and resuspended and brought to a final concentration in a composition comprising water (page 4624 ‘Experimental Section’). The claim interpretation is set forth above. Haslach teach that the TPI924 library was used (Table 4) which is the same library as used in the instant specification (page 20 line 20 and page 32 first paragraph).
In relation to claims 9-10, Haslach teach that the peptides were synthesized, extracted and resuspended and brought to a final concentration in a composition comprising water (page 4624 ‘Experimental Section’).
Response to Arguments – 102
Applicant's arguments filed 11/19/25 have been fully considered but they are not persuasive with respect to the rejection set forth above
Although applicants argue that the claims have been amended, the amended claims are addressed above.
Although applicants argue that Haslach does not teach a plurality of tetrapeptides selected from the tetrapeptides recited in claim 1, Haslach teach that there are 240 acetylated tetrapeptide mixtures each made up of 216000 acetylated tetrapeptides (page 4624 ‘Experimental Section’). Haslach teach that each of the four positions are defined with a single amino acid (O) with the three remaining positions made up of one of 60 different amino acids (X) (page 4624 ‘Experimental Section’). Haslach teach that library is N-acetylated and C-amidated (page 4624 ‘Experimental Section’). Thus, there are 60 sublibraries that comprise Ac-O-X-X-X-NH2. Haslach teach that the 60 different amino acids include (pI)DPhe, Arg and 2-Nal (page 4624 ‘Experimental Section’). When O is DPhe(pI), the sublibrary comprises Ac-DPhe(pI)-X-X-X-NH2 and specifically comprises Ac-DPhe(pI)-Arg-2-Nal-Arg-NH2 (the elected species and 16th compound of claim 1 and last compound of claim 7) and Ac-DPhe(pI)-Arg-DPhe(pI)-Arg-NH2 (the 14th compound of claim 1 and the 3rd to last compound of claim 7).
Instant claim 1 recites ‘composition comprising a plurality of tetrapeptides’ and then recites a wherein clause about tetrapeptides selected from a group consisting of.
MPEP 2111.03 recites: “In Amgen Inc. v. Amneal Pharmaceuticals LLC, 945 F.3d 1368, 1379, 2020 USPQ2d 3197 (Fed. Cir. 2020), in an infringement suit, the court interpreted a claim for a pharmaceutical composition having a "comprising" transition phrase and following limitations, including limitations requiring "at least one" binder and "at least one" disintegrant, each "consisting of" items listed in a Markush group. The court found that the Markush grouping recited particular binders or disintegrants, but while the components of the Markush grouping are closed as to the components therein, the claim transition "comprising" allowed for additional component(s) that were functionally similar to the members of the Markush grouping. Thus, the plain language of the claim requires "at least one" of the Markush members and does not further limit the claim to only binders and disintegrants listed in the Markush grouping.”
MPEP 2111.03 further recites: “Amgen Inc. v. Amneal Pharmaceuticals LLC, 945 F.3d 1368, 1378-79, 2020 USPQ2d 3179 (Fed. Cir. 2020) (the claim’s "comprising" transition phrase does not foreclose additional binders and disintegrants when an accused infringing product contains and meets the limitation’s requirements for one of the binders or disintegrants recited in the Markush groupings – there is no inconsistency with another binder or disintegrant outside of the Markush group also being part of the claimed formulation)”.
In the instant case, the transitional phrase ‘comprising’ in line 1 of claim 1 does not foreclose additional components (including peptides). Since claim 1 recites a plurality of tetrapeptides, at least 2 of the tetrapeptides from the recited group are required. In the instant case, the plain language of the claim requires "at least two" (a plurality) of the Markush members and does not further limit the claim to only those listed in the Markush grouping.
Double Patenting
Claims were previously rejected under double patenting based on the patent cited below.
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 1, 7 and 9-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10899793 (cited with IDS 12/12/23; ‘793’). Although the claims at issue are not identical, they are not patentably distinct from each other.
793 recites SEQ ID NO: 11 (claim 13, Ac-DNal(2’)-Arg-(pI)DPhe-Bip-NH2) and compositions thereof (claim 18).
793 does not recite a species in the claims such that the 4th amino acid is Arg as in instant claim 6.
793 does recite compounds of a specific formula (claim 1) and recites specific sequences including SEQ ID NO: 11 (claim 13). Further, 793 recites that Z can be L-Arg or D-Lys (claim 10).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 793 based on the specific teachings and suggestions of 793. 793 does recite compounds of a specific formula (claim 1) and recites specific sequences including SEQ ID NO: 11 (claim 13, Ac-DNal(2’)-Arg-(pI)DPhe-Bip-NH2). Further, 793 recites that Z can be L-Arg or D-Lys (claim 10). Since 793 suggests that Z can be L-Arg or D-Lys (claim 10) one would have been motivated to substitute L-Arg and D-Lys at the Z position (4th amino acid) in SEQ ID NO:11 to result in Ac-DNal(2’)-Arg-(pI)DPhe-Arg-NH2 and Ac-DNal(2’)-Arg-(pI)DPhe-D-Lys-NH2. Since 793 recites compositions (claim 18) and uses of the peptides (claims 19-20) one would have been motivated to make such peptides in a composition. One would have had a reasonable expectation of success because 793 recites a wide range of compounds (claim 13) and known residues at a particular location (claim 10).
In relation to the compound of claims 1 and 7, as discussed above the compounds Ac-DNal(2’)-Arg-(pI)DPhe-Arg-NH2 and Ac-DNal(2’)-Arg-(pI)DPhe-D-Lys-NH2 are suggested. Such compounds are the 5th-6th compounds of claims 1 and 7. Since 793 recites compositions thereof (claim 18) one would have been motivated to make a composition of such compounds.
In relation to claims 9-10, 793 recites compositions thereof (claim 18).
Response to Arguments – double patenting
Applicant's arguments filed 11/19/25 have been fully considered but they are not persuasive with respect to the rejection set forth above.
Although applicants argue that the claims have been amended, the amended claims are addressed above.
Although applicants argue that 793 does not teach a plurality of tetrapeptides selected from the tetrapeptides recited in claim 1, as discussed above the compounds Ac-DNal(2’)-Arg-(pI)DPhe-Arg-NH2 and Ac-DNal(2’)-Arg-(pI)DPhe-D-Lys-NH2 are suggested. Such compounds are the 5th-6th compounds of claims 1 and 7.
Instant claim 1 recites ‘composition comprising a plurality of tetrapeptides’ and then recites a wherein clause about tetrapeptides selected from a group consisting of.
MPEP 2111.03 recites: “In Amgen Inc. v. Amneal Pharmaceuticals LLC, 945 F.3d 1368, 1379, 2020 USPQ2d 3197 (Fed. Cir. 2020), in an infringement suit, the court interpreted a claim for a pharmaceutical composition having a "comprising" transition phrase and following limitations, including limitations requiring "at least one" binder and "at least one" disintegrant, each "consisting of" items listed in a Markush group. The court found that the Markush grouping recited particular binders or disintegrants, but while the components of the Markush grouping are closed as to the components therein, the claim transition "comprising" allowed for additional component(s) that were functionally similar to the members of the Markush grouping. Thus, the plain language of the claim requires "at least one" of the Markush members and does not further limit the claim to only binders and disintegrants listed in the Markush grouping.”
MPEP 2111.03 further recites: “Amgen Inc. v. Amneal Pharmaceuticals LLC, 945 F.3d 1368, 1378-79, 2020 USPQ2d 3179 (Fed. Cir. 2020) (the claim’s "comprising" transition phrase does not foreclose additional binders and disintegrants when an accused infringing product contains and meets the limitation’s requirements for one of the binders or disintegrants recited in the Markush groupings – there is no inconsistency with another binder or disintegrant outside of the Markush group also being part of the claimed formulation)”.
In the instant case, the transitional phrase ‘comprising’ in line 1 of claim 1 does not foreclose additional components (including peptides). Since claim 1 recites a plurality of tetrapeptides, at least 2 of the tetrapeptides from the recited group are required. In the instant case, the plain language of the claim requires "at least two" (a plurality) of the Markush members and does not further limit the claim to only those listed in the Markush grouping.
Although applicants argue about potency of compounds, it is noted that the features upon which applicant relies (i.e., potency) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). MPEP 716.02(b) recognizes that the burden is on the applicant to establish that results are unexpected and significant. Applicants refer to 15 potent mMC4R tetrapeptides. However, claim 1 includes many more than 15 tetrapeptides. MPEP 716.02(e) refers to a comparison to the closest prior art. MPEP 716.02(d) recognizes that unexpected results are to be commensurate in scope with the claimed invention. In the instant case, the applicants have not established that results are unexpected and significant or established that there is a comparison to the prior art or shown any unexpected results is commensurate in scope with the claimed invention.
Conclusion
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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RONALD T. NIEBAUER
Primary Examiner
Art Unit 1658
/RONALD T NIEBAUER/Examiner, Art Unit 1658