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
Status of 17/917,853
Claims 15, 17-18, and 20-38 are currently pending.
Priority
Instant application 17/917,853, filed 10/7/2022, claims priority as follows:
PNG
media_image1.png
58
386
media_image1.png
Greyscale
The provisional application contains support for the claims, and thus, the instant claims are granted the effective filing date of 4/8/2020.
Information Disclosure Statement
All references from the IDS submitted on 9/2/2025 have been considered unless marked with a strikethrough.
Response to Applicants Arguments/Amendments
The amendment filed 1/20/2026 has been entered. Claims 15, 17, and 18 have been amended. Claim 38 has been added, but is not considered new matter and is added to Group II.
In the Non-Final dated 10/17/2025, the title was objected to because it was not descriptive. In response, Applicant has submitted a new title with the amendments to the specification. However, the submission does not overcome the objection because an application data sheet has already been submitted, so merely changing the title at the top of the specification is not sufficient. An updated application data sheet with the new title, which the Examiner notes is now sufficiently descriptive, must be submitted to overcome the objection. Thus, the objection is maintained.
In the Non-Final dated 10/17/2025, the abstract was objected to for insufficient length. In response, Applicant has submitted a new abstract, which overcomes the objection. Thus, the objection is withdrawn.
Claim 18 was rejected under 35 U.S.C. 112(d) in the Non-Final dated 10/17/2025. In response, Applicant amended the claim to omit the intended use language and recite pharmaceutically acceptable excipients, which overcomes the rejection. Thus, the rejection is withdrawn.
In the Non-Final dated 10/17/2025, claims 15, 17-18, and 20-25 were rejected under 35 U.S.C. 102(a)(2). In response, Applicant has amended independent claim 15 to recite, “which is an eye drop formulation solution”. Additionally, Applicant has amended claim 17 to omit where the composition is a powder for inhalation, and has replaced it with a listing of JAK inhibitors, and amended claim 18 to omit where the composition is for topical administration, and replaced it with a listing of pharmaceutically acceptable excipients. Though the amendments to claims 17 and 18 overcome the rejections of the claims of the Non-Final dated 10/17/2025 and obviate the need for the evidentiary references, the reference Aerie anticipates the content of the amended claims. Thus, the rejection is maintained and updated to reflect the amendments to the claims.
Claims 15, 17-18, and 20-25 were rejected under 35 U.S.C. 103 in the Non-Final dated 10/17/2025. In response, Applicant has amended claim 1 to recite “which is an eye drop formulation solution” and claims 17 and 18 to obviate the need for the evidentiary references, and argues Aerie does not teach or suggest all claim elements. However, Aerie does teach that the invention extends to compositions that include liquid formulations and delivery systems, and thus this argument is not considered persuasive.
Further, Applicant argues that the claimed combination is not obvious to try based on Aerie. This argument has been considered, but is also not persuasive because one of ordinary skill would be motivated to improve existing ocular disease and disorder treatments, Aerie lists a finite number of identifiable, predictable potential solutions, and one of ordinary skill could have pursued the solutions with a reasonable expectation of success.
Finally, Applicant argues Aerie does not qualify as prior art under 35 U.S.C. 103 because it is not analogous to the claimed subject matter. Applicant states that Aerie address the great need in the medical field for treatment for an intravitreal implant, which releases the composition in the eye over 3 months, whereas the instant claims are drawn to an eye drop formulation solution. The Examiner has considered the arguments, but they are not persuasive because the broadest goal of both Aerie and the instant disclosure is to treat ocular disorders, thus defining them as analogous art. Thus, the rejection is maintained and updated to reflect the amendments to the claims.
Election/Restriction
Applicant’s election of Group II, claims 15, 17, and 18, drawn to compositions comprising a compound of Formula 1 or a compound of Formula 5, without traverse, in the reply filed 9/2/2025 is acknowledged. The Examiner notes claims 20-37 have been added but are not considered new matter, and composition claims 20-25 are added to Group II herein. Applicant’s election of (S)-4-(3-amino-1-(isoquinolin-6-ylamino )-1-oxopropan-2-yl)benzyl 2,4-dimethylbenzoate:
PNG
media_image2.png
422
695
media_image2.png
Greyscale
in the reply filed 9/2/2025, without traverse, is also acknowledged.
Examination will begin with the elected species. In accordance with MPEP § 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non- elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be examined again. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during further examination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
The elected species was searched and prior art was identified in the Non-Final dated 10/17/2025. See the 102 and 103 rejections below. Because the prior art rejections are maintained, the scope of newly added claim 38 have not been searched. Additionally, the full scope of the claims has not yet been searched in accordance with Markush search practice. Claims 15, 17-18, and 20-25 read on the elected species. Claims 26-38 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species and/or group, there being no allowable generic or linking claim.
MAINTAINED OBJECTIONS AND REJECTIONS
Objection to the 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. See MPEP § 606.01. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 15, 17-18, and 20-25 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Aerie Pharmaceuticals, Inc. (WO 2020/181060, herein after “Aerie”). This rejection applies to the elected species. The Examiner notes the instant claims use the transitional phrase, “comprising”, which allows for additional components of the composition not recited in the instant claims.
The reference Aerie discloses a pharmaceutical composition comprising a polymer matrix and at least one therapeutic agent, wherein the therapeutic agents can be selected from a rho kinase, Janus kinase (JAK), vascular endothelial growth factor receptor kinase, or receptor tyrosine kinase inhibitor (page 56, claim 1). The elected species, (S)-4-(3-amino-1-(isoquinolin-6-ylamino)-1-oxopropan-2-yl)benzyl 2,4-dimethylbenzoate, is a rho kinase inhibitor disclosed by Aerie as netarsudil (page 56, claim 4), and a JAK inhibitor is disclosed as a therapeutic agent by Aerie (page 56, claim 3). Further, Aerie teaches that the invention extends to compositions that include liquid formulations and delivery systems, and includes solutions, suspensions, emulsions, and the like, such as other liquid-containing compositions used in ophthalmic therapies (page 32, para [0113]), of which eye drop formulation solutions are. Aerie also discloses the storage and stability of eye drop solutions of the instant invention (page 52, para [0186]).
With respect to claim 17, Aerie discloses axitinib as part of the pharmaceutical composition (page 57, claim 6), and with respect to claim 18, Aerie discloses that the compositions, include eye drop solutions, within containers may include mannitol (page 53, para [0188]), which is a sugar alcohol and is defined in the instant disclosure a tonicity agent.
With respect to claims 21-24 the elected species reads on Formula 1:
PNG
media_image3.png
143
408
media_image3.png
Greyscale
When R1 and R2 are hydrogen, A is - CH2CH(R10), R10 is an optionally substituted aryl, substituted with an ethyl ester linker and a 2,4-dimethylphenyl, and X1 and X2 are H.
With respect to claim 25, Aerie discloses the elected species and axitinib as specific elements of the pharmaceutical composition comprising at least one therapeutic agent of claim 1 (page 46, claim 4 and page 57, claim 6). However, given the small number of examples provided in the claim, a skilled artisan could at once envisage the combination. Thus, Aerie anticipates instant claims 15, 17-18, and 20-25.
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.
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 15, 17-18, and 20-25 are rejected under 35 U.S.C. 103 as being unpatentable over Aerie Pharmaceuticals, Inc. (WO 2020/181060, herein after “Aerie”). This rejection applies to the elected species. The Examiner notes the instant claims use the transitional phrase, “comprising”, which allows for additional components of the composition not recited in the instant claims.
Determining the scope and contents of the prior art
The reference Aerie teaches as disclosed above, and at least those teachings are incorporated herein.
Ascertaining the differences between the prior art and the claims at issue
Aerie fails to teach a working example of a composition comprising the elected species and axitinib.
Resolving the level of ordinary skill in the pertinent art
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of compositions comprising the elected species and axitinib. An artisan possess the technical knowledge necessary to make adjustments to the compositions to enhance their effectiveness. Said artisan has also reviewed the problems in the art as regards to use of said compositions comprising the elected species and axitinib and understands the solutions that are widely known in the art.
Considering objective evidence present in the application indicating obviousness or nonobviousness
Above, the Examiner took the position that a skilled artisan could at once envisage the combination given the small number of specific inhibitors found in the claim. In the alternative, applying KSR prong (A), it would have been prima facie obvious for one of ordinary skill to combine the elected species and axitinib because Aerie teaches a small number of specific inhibitors, and one of ordinary skill would expect the combination of drugs to with the same purpose to be successful in treating ocular diseases and disorders. The artisan would be motivated before the effective filing date of the claimed invention to test combinations of compounds taught for the same purposes to improve the overall activity of the compositions and would have readily predicted the success of the combination in light of the teachings of Aerie.
Conclusion
Claims 15, 17-18, and 20-25 are rejected. Claims 26-38 are withdrawn.
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 Kendall Heitmeier whose telephone number is (703)756-1555. The examiner can normally be reached Monday-Friday 8:30AM-5:00PM 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, Clinton 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.
/K.N.H./Examiner, Art Unit 1621 /CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621