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 5, 8, and 22-28 are pending.
Priority
Applicant’s claim for benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. This application is a national stage entry of and claims priority to Application Serial No. PCT/US2022/027072, filed 4/29/2022; and further claims priority to PRO application number 63/181,862, filed 04/29/2021.
Information Disclosure Statement
All references from IDS(s) received on 02/09/2024 have been considered unless marked with a strikethrough.
Election/Restrictions
Applicant’s election of Group I without traverse in the reply filed on 5/27/2026 is acknowledged. The claims that were in Group II have been cancelled.
Applicant’s election of compound E102 without traverse in the reply filed on 5/27/2026 is acknowledged.
PNG
media_image1.png
181
275
media_image1.png
Greyscale
Claims 5, 8, and 22-28 will be examined on their merits.
Anticipatory art was not found on the elected species, however the elected species is rejected using an obviousness-type rejection. See 103 analysis below.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 5, 8, and 22-28 are rejected under 35 U.S.C. 103 as being unpatentable over Benedini, F. et al. (WO2010012567A1; “Benedini”) in further view of Sturdivant, J. et al. (WO2018034702A1; “Sturdivant”) and Delong, M. et al. (WO2020047496A1; cited in IDS filed 2/9/2024; “Delong”).
This rejection applies to the elected specie.
Benedini teaches a compound with an overlapping genus structure with instant A (Claim 1). Benedini also teaches structural examples with the instant “A” (aka triamcinolone acetonide) of the elected specie conjugated through the same linker as the instant claims to another compound (Claim 10).
PNG
media_image2.png
174
356
media_image2.png
Greyscale
(Benedini, Claim 10)
Benedini teaches the core structure, one of which is triamcinolone acetonide, is known for treating ophthalmic diseases such as macular edema (Description, para. 2) and the compounds as useful in various eye conditions, such as macular degeneration (Description, para. 1).
Benedini fails to teach the corticosteroid conjugated to an isoquinoline compound.
Sturdivant teaches a structural example of instant “B” and its HCl salt (Compound 29).
PNG
media_image3.png
290
437
media_image3.png
Greyscale
(Sturdivant, Compound 29)
Sturdivant fails to teach the compounds conjugated to a corticosteroid, such as triamcinolone acetonide. However, Sturdivant teaches the compounds for use as therapeutic agents in a variety of eye diseases and conditions (Abstract), including but not limited to: glaucoma, allergy, cancers of the eye, neurodegenerative diseases of the eye, such as diabetic eye disease, macular degeneration (AMD), inflammation, and dry eye (para. 0041).
Along this line, Delong teaches structural examples with both “A” and “B” of the elected species conjugated together for use in treating eye diseases.
PNG
media_image4.png
671
661
media_image4.png
Greyscale
(Delong, Claim 34)
Delong fails to teach an example with the same linker as the instant application.
Therefore, it would be obvious to a person skilled in the art to modify a pharmaceutical compound known for treating eye diseases and has been modified with additional compounds for improved treatment of eye diseases, such as triamcinolone acetonide as taught by Benedini, and modify it with another known compound for treating eye diseases, such as the compounds taught by Sturdivant. A person would be motivated to do so because it has been done with a different linker, as taught by Delong. However, the combined teachings of Benedini and Sturdivant would result in a compound with the same linker as the elected species.
The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham.
Examples of rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Applying KSR example rationale (B), it would have been prima facie obvious to extract the pharmaceutical compound known for treating eye diseases and has been modified with additional compounds for improved treatment of eye diseases, such as triamcinolone acetonide, as taught by Benedini, and substitute the “R” or additional compound with another known compound for treating eye diseases, such as the compounds taught by Sturdivant. A person would be motivated to do so because it has been done with a different linker, as taught by Delong. However, the combined teachings of Benedini and Sturdivant would result in a compound with the same linker as the elected species.
Therefore, claims 5, 8, and 22-28 are taught by Benedini, Sturdivant, and Delong.
Conclusion
Claims 5, 8, and 22-28 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLA MARIA BAUER whose telephone number is (703)756-1269. The examiner can normally be reached Monday-Friday 7:30-5 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, Clint Brooks can be reached at (571) 270-7682. 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.
/N.M.B./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
Prosecution Insights