DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/05/2026 has been entered.
Status of Application
The response filed 01/05/2026 has been received, entered and carefully considered. The response affects the instant application accordingly:
Claims 1 have been amended.
Claims 2, 5 are cancelled.
A terminal disclaimer for U.S. Pat. 12024504 has been submitted on 01/05/2026 and has been disapproved on 01/05/2026.
Applicant had previously elected Group I without traverse with the species election of the genera ocular neovascularization and the specific disease species election of diabetic retinopathy within the genera.
Claims 1, 3-4, 6-13 are pending.
Claims 1, 3 are present for examination at this time.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Current Grounds of Rejection
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 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Bates et al. (WO 2017/064512).
Rejection:
Bates et al. teaches compounds that are SRPK 1 specific inhibitors of formula I and more specifically formula Ia
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that is useful for ocular neovascularization conditions including those with pro-angiogenic VEGF isoforms like diabetic retinopathy by topical administration (abstract, Page 1 line 5-7, Page 3 line 29-Page 4, Page 5 line 20-25, Page 6 line 1-5, Page 12 line 24-36, Page 13 line 14-15, Page 14 line 5-9). The compounds can reduce/inhibit pro-angiogenic VEGF mediated conditions and be formulated in pharmaceutical topical compositions (page 3 line 33-35, Page 5 line 20-25, Page 38 line 11-28, claim 16 and 18) including eyedrops (Page 26 line 8-11, Page 27 line 14-24). Bates teaches wherein W,X, Y, Z is a 5 member aromatic heterocycle including
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(claim 6) where R4 is hydrogen (claim 7) and where R4 is a methyl (claim 8). Bates et al. exemplifies the formula with compound 14
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(R4 is hydrogen) The teaching of
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with R4 with hydrogen and methyl is demonstrated with compounds 9-10 which are similar to compound 14 (Page 42, see full document specifically areas cited).
Bates et al. does not expressly exemplify the elected compound
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for the treatment of diabetic retinopathy but does expressly teach treating diabetic retinopathy with the compound of the formula and exemplifies the formula with compound 14
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where R4 is hydrogen and expressly teaches and claims for R4 to be hydrogen or methyl on
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and demonstrated with compounds 9-10 which that are similar to compound 14 (compound 14 has the tetrahydropyran substituent on the furan) wherein it would be prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to exemplify the compound 14 with the methyl at R4 for treating diabetic retinopathy with a reasonable expectation of success as expressly taught by Bates et al. absent evidence of criticality for the claimed compound.
Response to Arguments:
Applicant's arguments are centered on the assertion that the compound of claim 1 was found allowable over Bates in the parent application based on the declaration of Andrew Baxter that demonstrated the compound has enhanced permeability into the eye by topical administration with high level of SRPK1 inhibitor activity compared to SPHINX31 and Compound R as the results were statistically significant compound to Compound R of Bates, that the compounds were tested using the same formulation under identical conditions, and that one of skill in the art would not be led to administer Compound R topical to ocular neovascularization caused by pro-angiogenic VEGF isoforms and effectively treat ocular neovascularization caused by proangiogenic VEGF isoforms when topically applied especially at the rear of the eye and as a results topical administration of Compound 1 teaches away from the use of Compound R.
This is fully considered but not persuasive.
The assertion that the parent application that A the compound of claim 1 was found allowable over Bates based on the declaration of Andrew Baxter that demonstrated the compound has unexpected results for enhanced permeability into the eye by topical administration with high level of SRPK1 inhibitor activity compared to SPHINX31 and Compound R as the results were statistically significant compound to Compound R of Bates, is not persuasive as each case is examined on its own merits and the breath of the claims are different and it is noted that an affidavit or declaration, such as those submitted under 37 CFR 1.130, 1.181 and 1.132; filed during the prosecution of previous applications do not automatically become a part of this application. Where if it is desired to rely on an earlier filed affidavit or declaration, the applicant should make the remarks of record in this application and include a copy of the original affidavit or declaration filed in the prior application.
As addressed previously, the assertion of unexpected results in the 132 declaration submitted on 6/10/2025 cannot be assessed as the image in item 5 of the declaration is not readable. The figure is fuzzy and the legend for the graphic to see the meaning of the brackets and what is the numerical standards for statistical significance to the topical administration of the compounds for permeability is not legible and cannot be read despite increasing the image. Wherein it cannot be properly assessed and therein not persuasive. Applicant has not filed clean copies of a declaration with a response to consider the assertion of unexpected results and the claims would need to be commensurate in scope with the showing and any 112 issues.
With regards to the assertion that the compounds were tested using the same formulation under identical conditions, that may be the case but Applicant has not demonstrated where that is disclosed as the permeability testing is with a eyedrop formulation and the angiogenesis assay had the Compound R and Compound 1 in different formulations with different components that would give different permeability profiles wherein it is not clear that the eye drop formulation in the permeability testing is the same formulation for all the compounds as asserted, if Applicant can provide support to clarify that the same formulation was used for the different compounds in the permeability testing that would distinguish it to be different that what was used in the angiogenesis assay.
With regards to the assertion that one of skill in the art would not be led to administer Compound R topically for effective treatment of ocular neovascularization caused by pro-angiogenic VEGF isoforms especially at the rear of the eye and as a results topical administration of Compound 1 teaches away from the use of Compound R, this is not persuasive as the prior art of Bates has the explicit teaching for these compounds to be useful for treating ocular neovascularization conditions including those with pro-angiogenic VEGF isoforms like diabetic retinopathy by topical administration and exemplifies compound 14
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where R4 is hydrogen and explicitly teaches and claims for R4 to by hydrogen or methyl on
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which is an explicit teaching - not a teach away as asserted – and was demonstrated with compounds 9-10 which are similar to compound 14 wherein the teaching for addition of the methyl is explicit and claimed and its exemplification for compound 14 is prima facie obvious with a reasonable expectation of success absent evidence of criticality for the claimed compound. It has been held that compounds that are structurally similar and/or homologous to prior art compounds are prima facie obvious, absent a showing of unexpected results. Note that any showing of unexpected results must be commensurate in scope with the claims.
.Accordingly, the rejection stands.
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 and 3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 12024504.
As the instant application is a continuation of 17/817136 it does not receive 121 safe harbor and subject to the double patenting rejection below.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are directed to the same instant claimed compound and a composition comprising it including topical administration forms. While the patented claims do not teach the specific utility of its use in treating ocular neovascularization conditions like diabetic retinopathy recited in the instant claims, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to arrive at this utility because the patent disclosure teaches this utility (e.g. Col. 1 line 18-23, Col. 5 line 11-15, Col. 26 line 8-18); wherein there are certain instances when the disclosure of the earlier patent may be used in the obviousness type double patenting analysis. The specification can be used as a dictionary to learn the meaning of a term in the patent claim and portions of the specification which provide support for the patent claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the patent; as the patented compounds must have a utility.
As the patent discloses the utility for treating diabetic retinopathy for these compounds in the known modalities and composition comprising them, the nonstatutory obviousness double patenting exists between the patent and the instant claims.
Response to Arguments:
Applicant's arguments center on the assertion that a terminal disclaimer was been filed and requests to withdraw the rejection. This is fully considered but not persuasives as the terminal disclaimer is not approved.
Accordingly, the rejection stands.
Conclusion
Claims 1 and 3 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GIGI GEORGIANA HUANG whose telephone number is (571)272-9073. The examiner can normally be reached Monday-Thursday 9:00-5:00pm.
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/GIGI G HUANG/Primary Examiner, Art Unit 1613
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