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 1-34 are pending. Claims 1-34 are rejected.
Election/Restrictions
Applicant's election of the elected species
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without traverse in the reply filed on 08/03/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-10, 14-16, 18-23, 25-27 and 29-34 read on Applicant’s species election of the compound I-449. Examination of the elected invention was conducted in accordance with the MPEP 803.02.
The elected species is allowable in view of the prior art; therefore, examination of the Markush-type claim has been extended to the full scope of claims 1-34.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
Priority
This application is a 35 U.S.C. 371 National Stage Filing of International Application No. PCT/US2022/020482 filed 03/16/2022, which claims priority under 35 U.S.C. 119(a-d) to PRO 63/162,468 filed 03/17/2021. Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Information Disclosure Statement
The information disclosure statements (IDS) dated 01/07/2026 and 08/03/2026 (3) have been considered.
The information disclosure statement filed 08/03/2026 beginning with US Patent 6,906,075 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because NPL documents for entries 1, 2, 14, 43 and 44 have not been included. Additionally, the information disclosure statement filed 08/03/2026 beginning with US Patent Application 20240228488 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because foreign patent documents for entries 1-3 have not been included. They have been placed in the application file, but the information in the documents referenced above has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Claim Rejections - 35 USC § 112(b)
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.
Claims 6, 15, 18, 19 and 21 are rejected under 35 U.S.C. 112(b) being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 6 recites Formulas (V-a), (V-b), and (V-c) which include the variable “Ro”, however neither the claim itself nor parent claim 1 defines said variable. Therefore, there is insufficient antecedent basis for this limitation in the claim. Applicant may overcome the rejection by, for instance, amending the claims to define “Ro” in claim 6 as defined in claim 7.
Regarding claims 15, 18, 19 and 21, the phrases "for example", “such as”, and “in particular” render the claims indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Applicant may overcome the rejection, for instance, by amending the claims to delete the phrases and the examples that immediately follow.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 8 and 24 are rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 8 recites formulas (VI-a), (VI-b) and (VI-c) which depends from claim 7 with formulas (V-a-1), (V-b-1) and (V-c-1). However, the formulas of the parent claim include stereochemistry at the cyclopropyl group whereas the formulas of the dependent claim do not. Therefore, claim 8 does not properly limit parent claim 7. Applicant may overcome the rejection by amending the formulas of claim 8 such that they properly depend from claim 7.
Claims 8 and 24 define R6 as Lc-Rc wherein Lc is a covalent bond and Rc is C1-6 aliphatic or CyC but parent claim 1 defines R6 exclusively as CyC. Therefore, dependent claims 8 and 24 do not properly limit parent claim 1. Applicant may overcome the rejection by, for instance, amending the dependent claims such that the R6 group is only defined as CyC in accordance with parent claim 1.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
(1 of 2) Claims 1-34 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-20, 23 and 28 of copending Application No. 18/550,504 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because copending application ‘504 recites compounds and compositions that overlap with the embodiments of claim 1 of the presently claimed invention.
Of note are compounds of Formula (III-c) in claim 23,
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, which have definitions for CyA, CyB, LC, RC and L that overlap substantially with those groups of the pending claims.
Regarding instant claim 32 drawn to a pharmaceutical composition of a compound of claim 1, copending claim 28 is drawn to the same.
Regarding instant claims 33 and 34 and with respect to the fact that the claims of the copending claims are drawn to compounds and compositions while the instant claims are drawn to methods of treating a kallikrein-mediated disease or disorder of hereditary angioedema or diabetic macular edema comprising administration of compounds of Formula (I), Applicant is directed to Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co. 95 USPQ2d 1797, Geneva Pharmaceuticals, Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373 [68 USPQ2d 1865] (Fed. Cir. 2003), and Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353 [86 USPQ2d 1001] (Fed. Cir. 2008) for analogous situations. The copending application discloses the instantly claimed utilities in, for instance page 1, para. [0001]-[0002] and Examples 109 and 110 beginning on page 252.
Thus, the claims are obvious in view of the claims of the copending application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
(2 of 2) Claims 1-10, 14, 16, 19-33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 24-26 of copending Application No. 19/113,778 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claim 24 recites compound (IXb),
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, which is identical to one stereoisomer of the elected species I-449 of claim 31,
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, and reads on Formula (I) of claim 1 wherein:
CyA is pyrimidine (see also instant claims 5 and 16);
CyB is pyrimidine substituted with methyl (see also instant claim 19-21);
Rx, Rx', Ry, Ry' are each H (see also instant claims 22-23);
R8 is H
L' is a bond (see also instant claims 2-4);
L is NH C2 alkyl (see also instant claims 6-10, 14);
R3, R5, R7 are each H (see also instant claims 24-25, 27, 30);
R4 is 5 membered heterocycle subs with two oxo groups and a C1 alkyl (see also instant claim 26); and
R6 is cyclopropyl (see also instant claims 28-29).
Regarding instant claim 32 drawn to a pharmaceutical composition of a compound of claim 1, copending claim 25 is drawn to the same.
Regarding instant claim 33 and with respect to the fact that the claims of the copending claims are drawn to compounds and compositions while the instant claims are drawn to methods of treating a kallikrein-mediated disease or disorder comprising administration of compounds of Formula (I), Applicant is directed to Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co. 95 USPQ2d 1797, Geneva Pharmaceuticals, Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373 [68 USPQ2d 1865] (Fed. Cir. 2003), and Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353 [86 USPQ2d 1001] (Fed. Cir. 2008) for analogous situations. The patent discloses the instantly claimed utilities in, for instance, page 1, first paragraph and intended use claim 26.
Thus, the claims are obvious in view of the claims of the copending application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jalisa H. Ferguson whose telephone number is (703)756-1489. The examiner can normally be reached Monday - Friday 9:00am - 5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached on (571) 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.H.F./Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626
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