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 .
Claim 1 is pending.
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 AlA. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/e T D-info-l.jsp.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7 of U.S. Patent No. 10,806,804 (“the ‘804 patent”). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims involve compounds encompassed by the Formula of independent claim 1 of the ‘804 patent. The claims differ in that those of the ‘804 patent include (1) various carbocyanine dyes including cypates and (2) various peptides including cypate-cyclo(Cys-Gly-Arg-Asp-Ser-Pro-Cys)-Tyr-OH which is set forth in the instant invention. Meanwhile, the instant claims require a divalent metal ion and a pharmaceutical acceptable carrier. Thus, the skilled artisan would recognize that the patented invention encompasses the instant invention. Hence, the inventions disclose overlapping subject matter.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11,413,359 (“the ‘359 patent”). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims involve compounds encompassed by the Formula of independent claim 1 of the ‘359 patent. The claims differ in that those of the ‘359 patent may include a pharmaceutical composition that includes albumin, whereas the instant claims require a divalent metal ion and a pharmaceutical acceptable carrier. Thus, the skilled artisan would recognize that the patented invention encompasses the instant invention. Hence, the inventions disclose overlapping subject matter.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 10,652,527. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to compounds/compositions comprising cypate-cyclo(Cys- Gly-Arg-Asp-Ser-Pro-Cys)-Lys-OH. In addition, both inventions would administer effective doses of the compositions in pharmaceutically acceptable carriers/salts. Hence, the inventions disclose overlapping subject matter.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 12,121,596. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to compounds/compositions comprising cypate-cyclo(Cys- Gly-Arg-Asp-Ser-Pro-Cys)-Lys-OH or cypate-Cyclo(Gys-Gly-Arg-Asp-Ser-Pro-Cys)-Tyr-OH. In addition, both inventions would administered effective doses of the compositions in pharmaceutically acceptable carriers/salts. Hence, the inventions disclose overlapping subject matter.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,712,482. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to compounds/compositions comprising cypate-cyclo(Cys- Gly-Arg-Asp-Ser-Pro-Cys)-Lys-OH or cypate-Cyclo(Gys-Gly-Arg-Asp-Ser-Pro-Cys)-Tyr-OH with the difference between the claims being that the’482 patent is lyophilized and has albumin. However, in this regard, it is prima facie obviousness to select a known material based on its suitability for its intended use. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
COMMENTS/NOTES
It should be noted that no prior art is cited against the instant invention. In particular, the claims are distinguished over the prior art of record because the prior art neither anticipates nor renders obvious compounds of claim 1. The closest art is Applicant’s own work which is cited in the double patenting rejections above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT S CABRAL whose telephone number is (571)270-3769. The examiner can normally be reached M-F 8 am - 5 pm.
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/ROBERT S CABRAL/Primary Examiner, Art Unit 1614
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