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 .
Current Status of 17/762,779
This Office Action is responsive to the Applicant Remarks and amended claims of 03/16/2026. Claims 1-17 are pending. Claims 5-6,8-9,11,13-15 and 17 are withdrawn from consideration. Claims 2, 3, and 12 have been cancelled. Claims 1, 4, 7, 10, 16, and 18-20 have been examined on the merits.
Priority
The instant application is a national stage entry of PCT/EP2020/078252, filed 10/8/2020, which claims priority to European Patent Application No. 19202288.7, filed 10/9/2019.
Response to Applicant Remarks
112(b) Rejections
Applicants have amended claims 7, 10, 12, and 16. Claims 7, 10, and 16 have been amended to remove the phrase "optionally" and claim 12 has been amended to remove the word "product." These amendments render the previous rejection moot. The rejection of the above mentioned claims is withdrawn.
103 Rejections
Applicants allege that the compounds of the instant application exhibit unexpected characteristics that distinguish them from the compounds of Tosatti. The Applicants support their position through a comparison of their compounds I-002 and I021 to compound I-63 of Tosatti. The Applicants' compounds outperformed the reference's compound in both the concentration of the compound and the duration of activity (see Tables 1 and 2 of Remarks of 03/16/2026). These arguments have been fully considered and are found persuasive. The previous rejections are withdrawn.
Double Patenting
Applicants have amended the limitations of claim 3, which was not rejected in the Non-Final of 11/24/2025. The previous rejections over co-pending applications 17/997,884, 17/767,018, 17/628,519, 17/628,542, 17/771,732, and 17/800,489 are withdrawn as the compounds are distinct. The rejection over U.S. Patent No. 12,187,705 B2 is similarly withdrawn. However, the rejection over 11,528,907 B2 is maintained and discussed below.
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 4 and 18-20 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.
Claim 4 recites the limitation "
PNG
media_image1.png
155
518
media_image1.png
Greyscale
" beginning on line 5 of claim 4. There is insufficient antecedent basis for this limitation in the claim. Claim 4 depends from claim 1 and claim 1 recites that R2 is phenyl or pyridine. The wherein clause stating that the phenyl or pyridine of R2 could be optionally substituted has been struck through. Accordingly, the base claim now limits R2 to unsubstituted phenyl and pyridine only. Claim 4 recites substituted phenyl and pyridine substituents, which are no longer encompassed by the amended base claim. Therefore, these substituted moieties lack antecedent basis.
Claim 18 recites the limitation
PNG
media_image2.png
149
522
media_image2.png
Greyscale
. There is insufficient antecedent basis for this limitation in the claim.
There is insufficient antecedent basis for this limitation in the claim. Claim 18 depends from claim 1 and claim 1 recites that R2 is phenyl or pyridine. The wherein clause stating that the phenyl or pyridine of R2 could be optionally substituted has been struck through. Accordingly, the base claim now limits R2 to unsubstituted phenyl and pyridine only. Claim 18 recites substituted phenyl and pyridine substituents, which are no longer encompassed by the amended base claim. Therefore, these substituted moieties lack antecedent basis.
Claims 19 and 20 recite the following limitations:
PNG
media_image3.png
161
586
media_image3.png
Greyscale
. There is insufficient antecedent basis for this limitation in the claim. Claims 19 and 20 depend from claim 18, which depends from claim 1 and claim 1 recites that R4 is pyridine or pyrimidine. The wherein clause stating that the pyridine or pyrimidine of R4 could be optionally substituted has been struck through. Accordingly, the base claim now limits R4 to unsubstituted pyridine and pyrimidine only. Claims 19 and 20 recite substituted pyridine and pyrimidine substituents, which are no longer encompassed by the amended base claim. Therefore, these substituted moieties lack antecedent basis.
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.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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 4 and 18-20 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, 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. As discussed above, claim 1 limits R2 to unsubstituted phenyl and pyridine and R4 to unsubstituted pyridine and pyrimidine. The wherein clauses that R2 and R4 may be optionally substituted have been struck through, limiting R2 and R4 to the specified unsubstituted rings. Claims 4 and 18-20 expand the scope of the claims to include substituted phenyl, pyridine, and pyrimidine rings. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,528,907 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the scope of the claims of the ‘907 patent substantially overlap with the instant claims, such that it would be obvious for one of ordinary skill in the art to arrive at the instant invention. The ‘907 patent claims a compound of formula (I)
PNG
media_image4.png
161
265
media_image4.png
Greyscale
. The following substitutions overlap with those of the instant application: X is O; Q1 is N; Q2 is CR5; R5 is halogen; Y is a direct bond; R1 is H; R2 is either phenyl or pyridine; R3 is C1-3 alkyl; R4 is pyridine or pyrimidine. The only difference between the instant claims and those of the ‘907 patent is that the instant claims recite specific halogens. However, these specific halogens remain within the scope of the prior genus. Accordingly, the claims are not patentably distinct.
Conclusion
Claims 1, 4, and 18-20 are rejected.
Claims 7, 10, and 16 are objected to for depending from a rejected base claim.
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 CONNOR KENNEDY ENGLISH whose telephone number is (571)270-0813. The examiner can normally be reached Monday Friday, 8 a.m. 5 p.m. ET..
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, Andrew Kosar can be reached at (571)272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/C.K.E./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
Prosecution Insights