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 .
Detailed Action
Claims 60-74 and 87 are currently pending.
Election/Restriction
Applicant’s election without traverse of Group I (Claims 60-74 and 87, drawn to compositions comprising compounds of formula II) and the elected disease AMD in the reply filed on 10/16/2025 is acknowledged. All Claims 60-74 are being examined on the merits herein.
The requirement is deemed proper and is therefore made final.
The method of administering compounds of formula II to treat age-related macular dystrophy (AMD) was found to be free of the art. The scope of search and examination was expanded to the entire genus of diseases encompassed by Claims 72 and 74.
Drawings
The drawings filed on 9/14/2022 are objected to because BT2 in Figure 6A is depicted without the appropriate carboxamide group. Rather the C=O group is instead C=CH2:
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. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Title
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
Claim Objections
Claims 60 and 72-74 are objected to because of the following informalities:
Claims 60 and 72-73 read “neovascularisation", which should be amended to the standard American spelling “neovascularization”.
Claim 74 reads “claims 72” instead of “claim 72”.
Appropriate correction is required.
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.
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.
Claim 61 is 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.
Claim 61 does not further limit the scope of R3 or formula (II) in general. The description of R3 in Claims 60-61 are identical in scope.
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.
PROVISIONAL:
Claims 60-73 and 87 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 26-55 of copending Application No. 19120141 (hereinafter referred to as Khachigian).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a compounds of identical formulae (II) for the reduction of cell proliferation.
Both applications teach the same compounds used in different methods of treatment. Khachigian methods are directed to treating cancer, a disease characterized by cell proliferation, and are thus encompassed by the scope of the instant claims which recite “reducing…cell…proliferation”.
Since both applications teach these compounds of formula (II) to be deployed in the treatment of proliferative diseases, the examiner maintains that the aforementioned claims of the instant application are therefore substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Khachigian.
This is a provisional nonstatutory double patenting rejection.
Claims 60-74 and 87 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-12 of copending Application No. 19347608 (hereinafter referred to as Khachigian).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a compounds of identical formulae (II) for the reduction of vascularization and treatment of diseases including AMD.
Regarding the claims directed to compositions of matter, In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010). See MPEP 804 (II) (B) (1). Khachigian teaches the following utilities of the claimed compositions:
A method of reducing vascular permeability, neovascularization, angiogenesis, inflammation, cell migration and/or cell proliferation in a subject, comprising administering an effective amount of a compound of formula I or II (Page 3).
A method of treating or preventing a disease or condition mediated by AP-1, and/or FosB/ΔFosB and/or ERK1/2 and/or VCAM-1 and/or VEGF-A and/or IL-1β, in a subject, comprising administering to the subject an effective amount of a compound of formula I or II (Pages 5-6).
A method of treating or preventing a disease or condition selected from:
arthritis;
rheumatoid arthritis;
bone destruction;
age-related macular degeneration;
diabetic retinopathy;
macular edema;
vascular leakage;
vascular permeability;
retinal vascular permeability;
angiogenesis;
endothelial cell dysfunction;
atherosclerosis;
stroke;
myocardial infarction;
peripheral vascular disease;
stenosis;
restenosis;
inflammation;
cytokine storm;
pulmonary inflammation;
pulmonary fibrosis (Page 15).
Since both applications teach these compounds of formula (II) to be deployed in the same manner, it would be obvious to use the compositions of the copending claims for their disclosed utilities as claimed in the instant application. The examiner maintains that the aforementioned claims of the instant application are therefore substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Khachigian.
This is a provisional nonstatutory double patenting rejection.
Allowable Subject Matter
The closest prior art is found in the CAS Registry database. See for example compound RN 922055-50-3 (4/10/2025), which has been registered since 2007.
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However, no known use is disclosed for said chemical beyond its use for sale by Aurora Fine Chemicals. No therapeutic use is disclosed before the effective filing date of this instant application.
Conclusion
No claim is allowable.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Richard G. Peckham whose telephone number is (703)756-4621. The examiner can normally be reached 8:30am - 4:30pm EST.
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 on (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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/RICHARD GRANT PECKHAM/Examiner, Art Unit 1627
/Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627