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 7/9/26 are acknowledged. Any objection or rejection from the 4/9/26 office action that is not addressed below is withdrawn based on the amendments.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Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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Claim 8 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 § 102
This rejection is maintained from the previous office action.
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 7/9/26 have been fully considered but they are not persuasive with respect to the rejection set forth above.
Although applicants argue that the word “each” is a universal qualifier, MPEP 2111 states that claims are given the broadest reasonable interpretation consistent with the specification. The instant specification provides no special definition of the word “each”. The word “each” is used to describe variables that occur multiple times within a formula (see page 2 line 8 of the 5/16/24 specification and line 9 on page 1 of the 9/14/22 claims) while the word “each” is not used with other variables (such as R1) that only occur once in the formula. Based on applicants reasoning, it would appear that the phrase “each R2 is independently H or (C1-C6) alkyl” would then exclude any compounds with Hydrogen (such as water) from any composition. However, there is no reasonable basis for that interpretation. In the instant case, the word “each” is used previous to a component that is a plurality. Such language is not reasonably interpreted to exclude certain components.
In addition, when the instant claim language was added (11/19/25) applicants described the amendment as follows: “Examples of the present application disclose the preparation of compositions having a plurality of tetrapeptides currently recited in claim 1, which allows a person of ordinary skill in the art to recognize that the applicant is in possession of the claimed invention” (pages 8-9 connecting paragraph of 11/19/25 reply). The specification discloses mixture based libraries that contain at least 216,000 tetrapeptides (pages 20, 22 and 32).
Further confusing the argument/interpretation, applicants later state that “The composition may comprise a plurality of the same tetrapeptide” (page 9 2nd to last complete paragraph of 7/9/26 reply). Such argument appears to ignore the phrase ‘plurality of tetrapeptides’. It is unclear why one would interpret a plurality of tetrapeptides as a single tetrapeptide. MPEP 2111.01 III refers to the plain meaning that a term would have to a person of ordinary skill in the art. There is no explanation provided as to how a plurality would be reasonably interpreted as a single tetrapeptide. Although applicants can be their own lexicographer, any special meaning of a particular term must be sufficiently clear in the specification (MPEP 2111.01 IV A).
Although applicants argue that the facts of Amgen (i.e. Amgen Inc. v. Amneal Pharmaceuticals LLC, 945 F.3d 1368, 1379, 2020 USPQ2d 3197 (Fed. Cir. 2020)) are different, it is true that the facts of Amgen are different. Importantly, Amgen recognizes:
“In short, this case involves a claim that uses a “comprising” transition phrase and one of the following limitations requires a component that “consists of” items listed in a Markush group and that meets the limitation’s requirements for the component. Without more, such language is satisfied when an accused product contains a component that is from the Markush group and that meets the limitation’s requirements for the component. It does not forbid infringement of the claim if an additional component is present functionally similar to the component identified in the Markush group limitation, unless there is a further basis in the claim language or other intrinsic evidence for precluding the presence of such additional components. There is no such basis here.”
In the instant case, there is no intrinsic evidence (such as a special definition in the specification) for precluding the presence of additional components. Further, there is no basis in the claim language. Although the word “each” does appear in the instant claims, it is also used in the instant specification. However, one would not recognize its use in the specification as a universal qualifier. In addition, when the instant claim language was added (11/19/25) applicants described the amendment as follows: “Examples of the present application disclose the preparation of compositions having a plurality of tetrapeptides currently recited in claim 1, which allows a person of ordinary skill in the art to recognize that the applicant is in possession of the claimed invention” (pages 8-9 connecting paragraph of 11/19/25 reply). The specification discloses mixture based libraries that contain at least 216,000 tetrapeptides (pages 20, 22 and 32).
Although applicants argue about Apple v. Samsung, it is first noted that in the Apple case Markush type language was not used. In the Apple decision, the specification is referenced as part of the interpretation (page 16 last paragraph) as well as the prosecution history (page 17 first paragraph). As discussed in detail above, neither the specification or prosecution history support applicants interpretation in the instant case. Further, the Apple decision appears to also focus on the fact that after that word “each” is used the word “and” is used to introduce another limitation. The instant claims do not follow such pattern.
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.
Although applicants argue about selecting portions within a reference and combining them, Haslach has clearly described and delineated the peptides (although there are a large number of them): 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).
Applicants state that “The composition may comprise a plurality of the same tetrapeptide” (page 9 2nd to last complete paragraph). Such argument appears to ignore the phrase ‘plurality of tetrapeptides’. It is unclear why one would interpret a plurality of tetrapeptides as a single tetrapeptide.
Double Patenting
The rejection set forth below is maintained from the previous office action.
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 7/9/26 have been fully considered but they are not persuasive with respect to the rejection set forth above.
Although applicants refer to arguments about the claim interpretation explained above, such arguments are addressed above and not found persuasive.
Although applicants argue about arbitrary selections, 793 recites a specific finite number of peptides and provides further suggestions about modifications. MPEP 2141.03 I specifically recognizes that a person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.
Although applicants argue about a lack of motivation to modify, one would have been motivated 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.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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RONALD T. NIEBAUER
Primary Examiner
Art Unit 1658
/RONALD T NIEBAUER/Examiner, Art Unit 1658
Prosecution Insights