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 .
Claims 1-5, 9-11, 13-16, 18, 19, 21, 23, 25-27 and 29 are currently pending in this Application.
Priority
CONTINUING DATA
This application is a 371 of PCT/US22/72287 05/12/2022
PCT/US22/72287 has PRO 63/187,472 05/12/2021
Information Disclosure Statement
Applicant’s Information Disclosure Statement, filed on November 09, 2023 has been considered. Please refer to Applicant’s copies of the 1449 submitted herewith.
Response to Restriction
Applicants’ election, without traverse, the invention of Group II, claims 9, 11, 13-16, 19, 21, 23, 25-27 and 29, drawn to a nanoemulsion comprising a delta-9-tetrahydrocannabinol amino acid ester or a derivative thereof, and the species
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where n is 2, in response filed March 25, 2026 is acknowledged. Therefore, the restriction requirement is considered proper and is maintained.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a petition under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
The scope of the invention of the elected subject matter is as follows:
In accordance with the MPEP, 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 and the claims drawn to the elected species are allowable, the search of the Markush-type claim will be extended (see MPEP 803.02). 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 reexamined. Id. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. Id. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final. Id.
The elected species, of claim 11 was found to be free of prior art and therefore, the scope of the examined subject matter was expanded to include the full scope of products of claim 9.
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 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 9, 13-16, 21, 23 and 25 are rejected, under 35 U.S.C. 102(a)(1) as being anticipated by (SWEENEY, C ET AL.). "Effect of surfactant concentration and sterilization process on intraocular pressure-lowering activity of 9 tetrahydrocannabinolvaline hemisuccinate (NB 1111) nanoemulsions." pages 2096-2107. Drug Delivery & Translational Research. Vol. 11, No. 5. 09 November 2020.
In regards to claim 9, Sweeney et al discloses a nanoemulsion comprising a delta-9-tetrahydrocannabinol amino acid ester or derivative thereof. (The current study was undertaken to develop an optimized THC-VHS-loaded nanoemulsion formulation (NE; THC-VHS-NE) that could improve the drug load and duration of activity; abstract), an ophthalmically suitable oil, an ophthalmically suitable surfactant, and water (THC-VHS-NE formulations were prepared as an oil phase and an aqueous phase, containing surfactant TWEEN-80, and mixed to form a coarse emulsion; page 4, first column, second and fifth paragraphs).
In regards to claim 13, Sweeney et al discloses the nanoemulsion of claim 9, and Sweeney further discloses wherein the nanoemulsion comprises from about 0.01 % w/v to about 2% w/v of the delta-9-tetrahydrocannabinol amino acid ester or derivative thereof (THC-Val-HS comprises 0.5%-2% w/v of nanoemulsion; page 4, second column, Table 1).
In regards to claim 14, Sweeney et al discloses the nanoemulsion of claim 9, and Sweeney further discloses wherein the ophthalmically suitable oil comprises castor oil, cottonseed oil, soybean oil, sesame oil, or any combination thereof (an accurately measured amount of castor oil, soybean oil, cottonseed, and sesame oil; page 4, first column, second paragraph).
In regards to claim 15, Sweeney et al discloses the nanoemulsion of claim 9, and Sweeney further discloses wherein the nanoemulsion comprises from about 1 % to about 10% w/v of the ophthalmically suitable oil (sesame oil comprises 5% w/v of nancemulsion; page 4, second column, Table 1).
In regards to claim 16, Sweeney et al discloses the nanoemulsion of claim 9, and Sweeney further discloses wherein the ophthalmically suitable surfactant comprises a nonionic surfactant (THC-VHS-NE formulations were stabilized by Tween-80, a nonionic surfactant; page 10, first column, third paragraph).
In regards to claim 21, Sweeney et al discloses the nanoemulsion of claim 9, and Sweeney further discloses comprising an ophthalmically suitable polyol (glycerin comprises 2.25% w/v of nanoemulsion; page 4, second column, Table 1).
In regards to claim 23, Sweeney discloses the nanoemulsion of claim 9, and Sweeney further discloses comprising an ophthalmically suitable ethoxylated tocopherol or tocotrienol (vitamin E tocopherol polyethylene glycol succinate comprises 0.002% w/v of nanoemulsion; page 4,second column, Table 1.
In regards to claim 25, Sweeney et al discloses the nanoemulsion of claim 23, and Sweeney further discloses wherein the nanoemulsion comprises from about 0.0001 % w/v to about 0.01 % w/v of the ophthalmically suitable ethoxylated tocopherol or tocotrienol (vitamin E tocopherol polyethylene glycol succinate comprises 0.002% w/v of nanoemulsion; page 4, second column, Table 1).
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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claim 9, 11, 13-16, 19, 21, 23, 25-27 and 29 are rejected under 35 U.S.C. 103(a) as being unpatentable over Sweeney et al in view of (TASKAR, PS ET AL.). "Delta-9-Tetrahydrocannabinol Derivative-Loaded Nanoformulation Lowers lntraocular Pressure in Normotensive Rabbits." pages 1-19. Translational Vision Science & Technology. Vol. 8, No. 5. 19 September 2019.
Claims 9, 13-16, 21, 23 and 25 are anticipated by Sweeney et al as discussed supra.
In regards to claim 19, Sweeney discloses the nanoemulsion of claim 9, but Sweeney does not disclose further comprising an ophthalmically suitable polymer. Taskar discloses nanoemulsion comprising an ophthalmically suitable polymer (the emulsion is stabilized by the block copolymer Pluronic-F68; page 4, second column, fourth paragraph). It would have been obvious to a person of ordinary skill in the art, at the time of invention, to have combined the nanoemulsion of delta-9-tetrahydrocannabinol, as previously disclosed by Sweeney, with the polymer Pluronic-F68, as previously disclosed by Taskar, to provide the benefit of a novel delta-9-tetrahydrocannabinol nanoemulsion with the stabilizing structure of the polyacrylic Pluronic-F68 for superior emulsion stability.
In regards to claim 26, Sweeney discloses a nanoemulsion comprising from about 0.01% w/v to about 2% w/v of a delta-9- tetrahydrocannabinol amino acid ester or derivative thereof (THC-Val-HS comprises 0.5%-2% w/v of nanoemulsion; page 4, second column, Table 1), from about 1 % to about 10% w/v of an ophthalmically suitable oil (sesame oil comprises 5% w/v of nanoemulsion; page 4, second column, Table 1), from about 0.51% w/v to about 6% w/v of an ophthalmically suitable surfactant (Tween-80 comprises 0.75-4% w/v of nanoemulsion; page 4, second column, Table 1), from about % to about 5% w/v of an ophthalmically suitable polyol (glycerin comprises 2.25% w/v of nanoemulsion; page 4, second column, Table 1), from about 0.0001 % w/v to about 0.01 % w/v of an ophthalmically suitable ethoxylated tocopherol or tocotrienol (vitamin E tocopherol polyethylene glycol succinate comprises 0.002% w/v of nanoemulsion; page 4, second column, Table 1), and water (water is used as QS (quantity sufficient) of nanoemulsion; page 4, second column, Table 1). Sweeney does not disclose from about 0.1 % w/v to about 2% w/v of an ophthalmically suitable polymer. Taskar discloses from about 0.1 % w/v to about 2% w/v of an ophthalmically suitable polymer (the emulsion is stabilized by the block copolymer Pluronic-F68; page 4, second column, fourth paragraph). It would have been obvious to a person of ordinary skill in the art, at the time of invention, to have combined the nanoemulsion of delta-9-tetrahydrocannabinol, as previously disclosed by Sweeney, with the polymer Pluronic-F68, as previously disclosed by Taskar, to provide the benefit of a novel delta-9-tetrahydrocannabinol nanoemulsion with the stabilizing structure of the polyacrylic Pluronic-F68 for superior emulsion stability.
In regards to claim 29 is rejected under 35 U.S.C. 103(a) as being obvious over Sweeney and Taskar in further view of the publication entitled "Anti-fibrotic activity of a rho-kinase inhibitor restores outflow function and intraocular pressure homeostasis" by Li, G. et al. Sweeney and Taskar, in combination, disclose the nanoemulsion of claim 27, but Sweeney does not wherein the nanoemulsion comprises from about 0.005% w/v to about 0.05% w/v of the Rho kinase inhibitor. Li discloses wherein the nanoemulsion comprises from about 0.005% w/v to about 0.05% w/v of the Rho kinase inhibitor (in the prevention study, mice were treated unilaterally with 0.04% netarsudil; page 15, second paragraph). It would have been obvious to a person of ordinary skill in the art, at the time of invention, to have combined a nanoemulsion containing active ingredient delta-9-tetrahydrocannabinol, as previously disclosed by Sweeney, with the anti-IOP and anti-glaucoma properties of rho-kinase inhibitor netarsudil, as previously disclosed by Li, to provide the benefit of a nanoemulsion with a known active ingredient in an approved glaucoma treatment with the novel delta-9-tetrahydrocannabinol for superior reduction in intraocular pressure.
A reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings. (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976). In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). Granting a patent on the discovery of an unknown but inherent function "would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art." 596 F.2d at 1022, 201 USPQ at 661.); In re Baxter Travenol Labs., 952 F.2d 388, 21 USPQ2d 1281 (Fed. Cir. 1991). See MPEP 2145, Section II. "The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Accordingly, claims 9, 11, 13-16, 19, 21, 23, 25-27 and 29 are rendered obvious in view of the references above. Applicant may wish to consider providing evidence of unexpected results to overcome the obviousness rejection.
Claim Objections
Claim 11 is objected to for depending on a rejected base claim.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAMAL A SAEED whose telephone number is (571) 272-0705.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam C Milligan can be reached at (571)270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Kamal A Saeed/
Primary Examiner, Art Unit 1626
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