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 .
Status of the claims
Claims 17-24 are pending and under consideration.
Claim Objections
Claim 17 is objected to because of the following informalities:
“A peptide consisting of an amino acid sequence of …” in line 1 should be amended to “A peptide consisting of the amino acid sequence of …”.
A colon should be added in line 3 after “…the group consisting of..”.
“(a) a non-natural amino acid added to an N-terminus of the peptide, a C-terminus of the peptide, or both” should be amended to “(a) a non-natural amino acid added to the N-terminus of the peptide, the C-terminus of the peptide, or both”.
Appropriate correction is required.
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 17-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11,779,630 in view of Tugyi et al. (PNAS USA 2005 Jan 3;102(2):413-418). Although the claims at issue are not identical, they are not patentably distinct from each other because the USPN claims a peptide identical to instantly claimed SEQ ID NO: 57 (claim 1). The USPN also claims a fusion of the peptide with an epitope tag or half-life extender and wherein the peptide is administered orally, topical or parenteral.
The USPN does not claim the peptide is modified by a non-natural amino acid added the N or C-terminus. However, the teachings of Tugyi et al. cure this deficiency.
Tugyi et al. teach the addition of D-amino acids at the N and C-terminus improves stability (Abstract).
It would have been obvious to a person of ordinary skill in the art to modify the peptide of the USPN by addition of non-natural amino acids at the N and/or C-terminus in order to improve stability of the peptide. There is a reasonable expectation of success given this is a well-known method of improving peptide enzymatic stability.
Furthermore, the MPEP 804 states: “Further, those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized “that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim,” but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent or application which provides support for the claim.” In the instant case, the specification of the USPN states: “In certain embodiments, the SERPIN peptides disclosed herein can be further modified to extend the shelf life and/or bioavailability using one or more non-natural peptide bonds or amino acids or by attaching to the peptide functional groups such as polyethylene glycol (PEG)…. in certain embodiments, the SERPIN peptides are modified by adding two, three, or four amino acid residues at both ends.”. Therefore, the specification of the USPN defines adding a non-natural amino acid at the N and/or C-terminus as an obvious variation.
Claims 17-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,020,462 in view of Tugyi et al. (PNAS USA 2005 Jan 3;102(2):413-418). Although the claims at issue are not identical, they are not patentably distinct from each other because the USPN claims a peptide identical to instantly claimed SEQ ID NO: 57 (claim 1). The USPN also claims a fusion of the peptide with an epitope tag, half-life extender, D-configuration, N-terminus acetylation, C-terminus amidation and PEGylation and wherein the peptide is administered orally and subcutaneously.
The USPN does not claim the peptide is modified by a non-natural amino acid added the N or C-terminus. However, the teachings of Tugyi et al. cure this deficiency.
Tugyi et al. teach the addition of D-amino acids at the N and C-terminus improves stability (Abstract).
It would have been obvious to a person of ordinary skill in the art to modify the peptide of the copending application by addition of non-natural amino acids at the N and/or C-terminus in order to improve stability of the peptide. There is a reasonable expectation of success given this is a well-known method of improving peptide enzymatic stability.
Furthermore, the MPEP 804 states: “Further, those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized “that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim,” but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent or application which provides support for the claim.” In the instant case, the specification of the USPN states: “The peptide can be modified to extend the shelf life and/or bioavailability using one or more non-natural peptide bonds or amino acids or by attaching to the peptide functional groups such as, e.g., polyethylene glycol (PEG)..”. Therefore, the specification of the USPN defines adding a non-natural amino acid at the N and/or C-terminus as an obvious variation.
Claims 17-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-12, 18,22-23, 26,61-62, 93-94 and 129 of the copending application 18/726,945 in view of Tugyi et al. (PNAS USA 2005 Jan 3;102(2):413-418). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending application claims a peptide identical to instantly claimed SEQ ID NO: 57 (claim 1). SEQ ID NO: 35 of the copending application is identical to instantly claimed SEQ ID NO: 57. The copending application claims the peptide is a fusion peptide with an epitope tag or a half-life extender.
The copending application does not claim the peptide is modified by a non-natural amino acid added the N or C-terminus. However, the teachings of Tugyi et al. cure this deficiency.
Tugyi et al. teach the addition of D-amino acids at the N and C-terminus improves stability (Abstract).
It would have been obvious to a person of ordinary skill in the art to modify the peptide of the copending application by addition of non-natural amino acids at the N and/or C-terminus in order to improve stability of the peptide. There is a reasonable expectation of success given this is a well-known method of improving peptide enzymatic stability.
Furthermore, the MPEP 804 states: “Further, those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized “that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim,” but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent or application which provides support for the claim.” In the instant case, the specification of the copending application states [PGPUB0066]: “the SERPIN peptides disclosed herein can be further modified to extend the shelf life and/or bioavailability using one or more non-natural peptide bonds or amino acids or by attaching to the peptide functional groups such as polyethylene glycol (PEG). In certain embodiments, the SERPIN peptides disclosed herein are modified by adding one or more amino acid residues such as arginine at either or both ends. In certain embodiments, the SERPIN peptides are modified by adding two, three, or four amino acid residues at both ends. In some embodiments, the SERPIN peptides are modified by adding two amino acid residues at both ends. In some embodiments, the SERPIN peptides are modified by adding three amino acid residues at both ends. In some embodiments, the SERPIN peptides are modified by adding four amino acid residues at both ends..”. Therefore, the specification of the copending application discloses that adding a non-natural amino acid at the N and/or C-terminus as an obvious variation.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 17-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, 10-10, 22-23, 26-27, 61, 72-76, 93,104,109-110 and 129 of the copending application 18/148,942 in view of Tugyi et al. (PNAS USA 2005 Jan 3;102(2):413-418). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending application claims a peptide identical to instantly claimed SEQ ID NO: 57 (claim 1). SEQ ID NO: 35 of the copending application is identical to instantly claimed SEQ ID NO: 57.
The copending application does not claim the peptide is modified by a non-natural amino acid added the N or C-terminus. However, the teachings of Tugyi et al. cure this deficiency.
Tugyi et al. teach the addition of D-amino acids at the N and C-terminus improves stability (Abstract).
It would have been obvious to a person of ordinary skill in the art to modify the peptide of the USPN by addition of non-natural amino acids at the N and/or C-terminus in order to improve stability of the peptide. There is a reasonable expectation of success given this is a well-known method of improving peptide enzymatic stability.
Furthermore, the MPEP 804 states: “Further, those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized “that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim,” but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent or application which provides support for the claim.” In the instant case, the specification of the copending application states [PGPUB0067]: “the SERPIN peptides disclosed herein can be further modified to extend the shelf life and/or bioavailability using one or more non-natural peptide bonds or amino acids or by attaching to the peptide functional groups such as polyethylene glycol (PEG). In certain embodiments, the SERPIN peptides disclosed herein are modified by adding one or more amino acid residues such as arginine at either or both ends. In certain embodiments, the SERPIN peptides are modified by adding two, three, or four amino acid residues at both ends. In some embodiments, the SERPIN peptides are modified by adding two amino acid residues at both ends. In some embodiments, the SERPIN peptides are modified by adding three amino acid residues at both ends. In some embodiments, the SERPIN peptides are modified by adding four amino acid residues at both ends..”. Therefore, the specification of the copending application discloses that adding a non-natural amino acid at the N and/or C-terminus as an obvious variation.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 17-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of the copending application 19/764,446 in view of Tugyi et al. (PNAS USA 2005 Jan 3;102(2):413-418). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending application claims a peptide identical to instantly claimed SEQ ID NO: 57 (claim 1). SEQ ID NO: 35 of the copending application is identical to instantly claimed SEQ ID NO: 57. The copending application claims a fusion comprising an epitope tag or half-life extender.
The copending application does not claim the peptide is modified by a non-natural amino acid added the N or C-terminus. However, the teachings of Tugyi et al. cure this deficiency.
Tugyi et al. teach the addition of D-amino acids at the N and C-terminus improves stability (Abstract).
It would have been obvious to a person of ordinary skill in the art to modify the peptide of the USPN by addition of non-natural amino acids at the N and/or C-terminus in order to improve stability of the peptide. There is a reasonable expectation of success given this is a well-known method of improving peptide enzymatic stability.
Furthermore, the MPEP 804 states: “Further, those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized “that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim,” but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent or application which provides support for the claim.” In the instant case, the specification of the copending application states [0072]: “the SERPIN peptides disclosed herein can be further modified to extend the shelf life and/or bioavailability using one or more non-natural peptide bonds or amino acids or by attaching to the peptide functional groups such as polyethylene glycol (PEG). In certain embodiments, the SERPIN peptides are modified by adding two, three, or four amino acid residues at both ends. In some embodiments, the SERPIN peptides are modified by adding two amino acid residues at both ends...”. Therefore, the specification of the copending application discloses that adding a non-natural amino acid at the N and/or C-terminus as an obvious variation.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
There was no prior art found that teaches or suggests a peptide consisting of SEQ ID NO: 57, wherein the peptide is modified by one of a-d. The closest prior art is Gelber et al. (WO2011/126882), however the art differs from instantly claimed SEQ ID NO: 57 by the addition of 5 amino acids at the N-terminus and is missing the C-terminal lysine. There is no teaching or suggestion in Gelber et al. that would lead to one of ordinary skill in the art to modify the peptide by removing the 5 N-terminal amino acids and adding a lysine residue at the C-terminus. SEQ ID NO: 57 is free of the art.
Conclusion
No claims are allowed.
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/TARA L MARTINEZ/ Primary Examiner, Art Unit 1654
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