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 Rejections - 35 USC § 112
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 25-26 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.
Regarding claims 25-26, the phrase "compounds I-1 through I-56, I-58, I-62 through I-152, I-154 through I-161, I-157, I-59 through I-61, I-53" renders the claim indefinite because it is unclear what are the structural limitations of the above compounds as “I-57….” are not known chemical names in the art and are not chemical formulas. As to the extent of the above compounds being of the same compounds found in applicants’ specifications, it is improper to import limitations from the specifications into the claims without properly showing the structure of the compounds in the claims.
For prior art purposes examiner in interpreting the compounds of “I-57…” to be of the same compounds with its structural limitations as in applicants’ specification.
Claim Rejections - 35 USC § 103
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.
Claims 1-10, 12-16, 18-19, 21-24 and 26-29 are rejected under 35 U.S.C. 103 as being unpatentable over Fink et al. (WO 2019178129 A1).
Regarding claims 1-10, 12-16, 18-19, 21-24 and 26-29, Fink teaches a method of treating a plasma kallikrein-mediated disease or disorder of hereditary angioedema or diabetic macular edema (relevant to claims 27-29) comprising administering to a patient in need thereof a compound of Formula (I)
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or a pharmaceutically acceptable salt thereof. Wherein
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(relevant to claims 1-10, 12-16) (para. 0038) and in some embodiments the compound is
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,
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,
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, .
Therefore it would have been obvious to someone of ordinary skill in the art at the time of filling to have developed formula (II), (III), (V), (VI), (VII), (VIII) and I-57
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of claimed invention to treat kallikrein-mediated disease or disorder of hereditary angioedema or diabetic macular edema. One would have been motivated to do so from the teachings of Fink of the above compounds and general formula (I) with its embodiments to treat kallikrein-mediated disease or disorder of hereditary angioedema or diabetic macular edema wherein CyA is 5- to 6- membered heteroarylene having 1-4 heteroatoms selected from oxygen, nitrogen, or sulfur which includes
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. There is a reasonable expectation of treating kallikrein-mediated disease or disorder of hereditary angioedema or diabetic macular edema comprising administering formula (II), (III), (V), (VI), (VII), (VIII) and I-57
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of claimed invention from the teaching of Fink.
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 1-9 and 12-29 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 and 15-34 of copending Application No. 18/550,306 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because copending ‘306 teaches a treatment of kallikrein-mediated disease or disorder of hereditary angioedema or diabetic macular edema comprising administration of compounds that over laps the embodiments of claim 1 of claimed invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-9, 12-17, 20, 22 and 26-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of copending Application No. 18/550,486 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-30 of copending ‘486 teaches a treatment of kallikrein-mediated disease or disorder of hereditary angioedema or diabetic macular edema comprising administration of compounds that over laps the embodiments of claim 1 of claimed invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-10, 12-16, 18-19 and 21-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of copending Application No. 17/024,189 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-17 of copending ‘189 teaches a treatment of kallikrein-mediated disease or disorder of hereditary angioedema or diabetic macular edema comprising administration of compounds that over laps the embodiments of claim 1 of claimed invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-10, 12-16, 18-19 and 21-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 18-36 of U.S. Patent No. 12065448. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 18-36 of U.S ‘448 teaches a treatment of kallikrein-mediated disease or disorder of hereditary angioedema or diabetic macular edema comprising administration of compounds that over laps the embodiments of claim 1 of claimed invention.
Claims 1-10, 12-16, 18-19, 21-24 and 26-29 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20, 22-37 and 39-50 of U.S. Patent No. 11352356. Although the claims at issue are not identical, they are not patentably distinct from each other because U.S ‘356 teaches a treatment of kallikrein-mediated disease or disorder of hereditary angioedema or diabetic macular edema comprising administration of compounds that over laps the embodiments of claim 1 of claimed invention and compound
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.
Claims 1-10, 12-16, 18-19, 21-24 and 26-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 and 21-33 of U.S. Patent No. 12441724. Although the claims at issue are not identical, they are not patentably distinct from each other because U.S ‘724 teaches a treatment of kallikrein-mediated disease or disorder of hereditary angioedema or diabetic macular edema comprising administration of compounds that over laps the embodiments of claim 1 of claimed invention and compound
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.
Claims 1-10, 12-16, 20-22 and 25-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5, 7, 9-12, 16, 20-22, 32, 36-37, 39 and 42-43 of U.S. Patent No. 11787796. Although the claims at issue are not identical, they are not patentably distinct from each other because U.S ‘796 teaches a pharmaceutical composition comprising compounds that over laps with claim 1 of claimed invention and compounds
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as well as other compounds of claimed invention compounds I-62 through I-152.
Claims 1-10, 12-16, 20-22 and 25-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5-7, 9-10, 13, 15-16, 20-22, 27, 32, 35-37 and 41 of U.S. Patent No. 12221441. Although the claims at issue are not identical, they are not patentably distinct from each other because U.S ‘441 teaches a pharmaceutical composition for the treatment of kallikrein-mediated disease or disorder of hereditary angioedema or diabetic macular edema comprising compounds that over laps with claim 1 of claimed invention and compounds
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as well as other compounds of claimed invention compounds I-62 through I-152.
Allowable Subject Matter
Claim 11 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MIKHAIL O'DONNEL ROBINSON whose telephone number is (571)270-0777. The examiner can normally be reached Monday-Friday 7:30am-5:30pm.
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MIKHAIL O'DONNEL. ROBINSON
Examiner
Art Unit 1627
/MIKHAIL O'DONNEL ROBINSON/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627