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 .
Response to Arguments
Applicant’s arguments, see Pages 3-5, filed 04/10/2026, with respect to the 103 rejection of claims 1-10, 12-16, 18-19, 21-24 and 26-29 under Fink et al. (WO 2019178129) and nonstatutory double patenting rejection over US Patent No. 11,352,356 and 12,441,724 have been fully considered and are persuasive. Therefore, the rejection of claims 1-10, 12-16, 18-19, 21-24 and 26-29 has been withdrawn.
Applicant’s argument (Pages 6-7) with respect to the nonstatutory double patenting rejection over application No. 18/550,306 and 18/550,486 is rendered moot. As applicant argues the nonstatutory double patenting applications be held in abeyance, the rejection of record is maintained.
Applicants’ argument (Page 8) with respect to the nonstatutory double patenting rejection over application No. 17/024,189 is fully considered but not persuasive. Applicant argues the formula of ‘189 does not teach or suggest the formula of claim 1 of claimed invention, in particular to the limitations of claimed L not corresponding to ‘189 limitation of (CR’R”)n. It is noted from ‘189 (CR’R”)n corresponds with claimed L of being CH2. Thus, the nonstatutory double patenting rejection over application No. 17/024,189 is maintained.
Applicants’ argument (Page 9) with respect to the nonstatutory double patenting rejection over US Patent No. 12,065,448 is fully considered but not persuasive. Applicant argues the formula of ‘448 does not teach or suggest the formula of claim 1 of claimed invention, in particular to the limitations of claimed L not corresponding to ‘448 limitation of CR’. It is noted from ‘448 CR’ corresponds with claimed L of being CH2. Thus, the nonstatutory double patenting rejection over US Patent No. 12,065,448 is maintained.
Applicants’ argument (Pages 10-12) with respect to the nonstatutory double patenting rejection over US Patent No. 11,787,796 and 12,221,441 are fully considered but not persuasive. Applicant argues the formula of ‘796 and ‘441 does not teach or suggest the formula of claim 1 of claimed invention, in particular to the limitations of claimed L not corresponding to ‘796 and ‘441 limitation of (R1R2)n. It is noted from ‘796 and ‘441 (R1R2)n corresponds with claimed L of being CH2. Thus, the nonstatutory double patenting rejection over US Patent 11,787,796 is maintained.
Applicant has canceled claims 11 and 26. Claims 1-10, 12-25 and 27-29 is pending. Claims 1-10, 12-25 and 27-29 is now evaluated on its merits.
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 1-7, 9-10, 12-16, 18-24 and 27-29 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 claim 1 and 7, the phrase " L is an optionally substituted C1-2 hydrocarbon chain, wherein 1 methylene unit is independently replaced with" renders the claim indefinite because it is unclear if applicant is intending a C1 hydrocarbon to be substituted or optionally substituted or the substitution is only when L is a C2 hydrocarbon chain and one methylene unit is replaced. Ultimately, the metes and bounds of the claim is unclear.
For prior art purposes examiner is interpreting the claim as optionally substituted C1-2 hydrocarbon chain wherein L can be CH2, which is represented in the above reasoning for the double patenting rejections being maintained.
Claims 2-6, 9-10, 12-16, 18-24 and 27-29 are equally rendered indefinite as being dependent from claim 1, thus bound to the above L limitation without further limiting.
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 1-6, 8-10, 12-16, 18, 20-22 and 27-29 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
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with the substitutions of claim 1 that over laps with claim 1 of claimed invention. Additionally taught are compounds
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as well as other compounds of claimed invention compounds I-62 through I-152.
Claims 1-6, 8-10, 12-16, 18, 20-22 and 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
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with the substitutions of claim 1 that over laps with claim 1 of claimed invention. Additionally taught are compounds
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as well as other compounds of claimed invention compounds I-62 through I-152.
Claims 1-6, 8-10, 12-16, 18-19 and 21-24 and 27-29 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
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with its limitations of claim 1 overlaps with the limitations of claim 1 of claimed invention.
Claims 1-6, 8-10, 12-16, 18-19, 21-24 and 27-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of US Patent No. 11370803. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-17 of US ‘803 teaches a treatment of kallikrein-mediated disease or disorder of hereditary angioedema or diabetic macular edema comprising administration of compound
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with its limitations of claim 1 over laps the limitations of claim 1 of claimed invention.
Claims 1-6, 9, 12-17, 20, 22 and 27-29 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 compound
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with its limitations of claim 1 overlaps the limitations 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 1-6, 9 and 12-25 and 27-29 are 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
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with its limitations of claim 1 over laps the limitations of claim 1 of claimed invention. Additionally taught are compounds of
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and
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This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at 571-270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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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
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