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 .
Claim Rejections - 35 USC § 101/112
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-16 are rejected under 35 U.S.C. 101 because the claimed invention is not supported by either a specific and substantial asserted utility or a well-established utility.
The claims 1-16 recite “the step of using an anterior segment ocular drug depot system”. However, the specification and claims do not describe how the product is to be used. Because the claimed invention merely recites a use without any active, positive steps, the artisan is unable to determine how this use is actually practiced.
Claims 1-16 also rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. Specifically, because the claimed invention is not supported by either a specific and substantial asserted utility or a well-established utility for the reasons set forth above, one skilled in the art clearly would not know how to use the claimed invention.
Claim Rejections - 35 USC § 112--Indefiniteness
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The claims 1-16 recite “the step of using an anterior segment ocular drug depot system”. It is not clear how the microemulsion is being used in the claimed method. Ophthalmic uses include topical application to the eye, intravitreal injections, ingestion, and parenteral injections, i.e. IV, IM, SubQ. Given the variability in uses for treating the eye, the artisan would not reasonably appreciate the metes and bounds of the claimed method.
Claim Rejections - 35 USC § 102/103
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.
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.
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(s) 1-16 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Solfato et al., (US 10,980,745, cited in IDS).
Solfato et al. teaches “oil-in-water microemulsions for formulating pharmaceutically active compounds” (Abstract).
“The emulsions, which can be formulated for administration via a variety of routes and for a variety of uses, are particularly advantageous for ophthalmic applications” (col. 1, lines 50-53).
“The emulsions herein not only have enhanced stability, but also confer enhanced bioavailability of poorly water-soluble drugs in a liquid dosage form” (col. 1, lines 59-61).
The microemulsion is composed of “an oil component in an amount of 0.4-4.0% weight/volume (w/v) of the composition; a surfactant or a mixture of surfactant(s) and co-surfactants(s) in an amount of 5.71-40.15% (w/v), inclusive of the composition; an aqueous component that is in an amount between 55.85%-93.89% (w/v), inclusive, of the composition; and optionally a pharmaceutically active compound” (col. 4, lines 22-29).
The prior art teaches as specific embodiment for ophthalmic administration comprising:
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(col. 30, lines 35-45). Here, the oil phase (1.41%), surfactant mixture (15.56%), and aqueous phase (75.27%), fall within the claimed range.
Since the microemulsion is for ophthalmic use, the prior art anticipates the step of using of the microemulsion as anterior segment ocular drug depot system.
The prior art also teaches:
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(col. 40, lines 25-35). This embodiment is capable of treating corneal neovascularization, as per claims 15-16 insofar as sorafenib (active; clm. 8-10) is a multikinase inhibitor which blocks VEGF receptors to block angiogenesis (see also Technological Background below).
Concerning claims 2, the oil-in-water microemulsion of the prior art is taught to “contain dispersed particles of a size <30 nm” (col. 1, lines 18-20), and provide “the weight/volume ratio between the surfactants/co-surfactants in the lipid phase and the surfactants/co-surfactants in the aqueous phase, is from 2 to 10, such as 2.2, to 9.8 or 2.4 to 8.6” (col. 2, lines 21-24) and “the weight/volume ratio between the oily (oil) component of the lipid phase and the surfactants/co-surfactants in the aqueous phase is from 0.2 to 1.0, such as 0.22 to 0.98 or 0.24 to 0.96” (Id. lines 25-28).
The prior art teaches “a narrow size distribution; generally the size distribution of particles in the resulting microemulsion is 15 nm±10 nm” (col. 3, lines 61-65), as per claim 3; a “polydispersity index (PDI)” of “0.02 to 0.380” (col. 4, lines 32-35), as per claim 4; an “HLB” of “at least 10, such as 10-16, or 12-14” (col. 5, lines 20-24), as per claim 5; “natural oil or synthetic oil” (col. 22, lines 1-3), as per claim 6, e.g. ”vegetable oil” (Id. line 4), as per claim 7; reduction of “TNF-alpha” (col. 43, lines 50-54), as per claim 11; antioxidants such as “nordihydroguaiaretic acid” (col. 7, lines 46-48), as per claim 12; “NSAIDS” (col. 25, lines 42-45), as per claim 13; actives from “0.01 to 50 mg/ml” (col. 25, lines 46-48), as per claim 14.
The prior art is anticipatory insofar as it teaches a microemulsion comprising an oil component, a surfactant component, and an aqueous component as claimed for use in treating the eye. Solfato et al. teaches, “The microemulsions can be formulated for topical administration to the eye or for injection or any suitable route” (col. 26, lines 25-26). Topical administration to the eye would have inherently included the anterior segment of the eye. The composition is capable of performing the intended use insofar as it is an oil-in-water microemulsion comprising actives, such as sorafenib, suitable for treating corneal neovascularization (see Technological Background below).
Assuming, for the sake of argument, that the prior art is not specific enough to give rise to anticipation, it would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to use the microemulsion comprising sorafenib, for example, to treat corneal neovascularization based on its function as multikinase inhibitor for blocking angiogenesis.
Technological Background
1) The prior art made of record and considered pertinent to applicant's disclosure Kang et al., (WO 2021/125800). Kang et al. is pertinent for teaching a compound and method for treating angiogenic diseases (Abstract). Angiogenic diseases include “neovascular ocular disease”, e.g. “corneal neovascular disease” (p. 10, lines 4-7). The compositions “may also be provided as a solution for topical administration, for example, eye drops” (p. 55, lines 23-25], and teaches the use of actives such as “sorafenib” (p. 2, lines 4-5).
2) The prior art made of record and considered pertinent to applicant's disclosure Yang et al., (US 2020/0031783). Cleland et al. is pertinent for teaching “microemulsions” for ocular delivery of active compounds (p. 1, para. [0004]), where active compounds include “sorafenib” (p. 3, para. [0025]), and ocular diseases include “corneal neovascularization” (p. 154, para. [0852]) and administration includes topical delivery for treating anterior ocular diseases (p. 1, [0005]).
3) The prior art made of record and considered pertinent to applicant's disclosure Fangueiro et al., (Current Pharmaceutical Design, 2016). Fangueiro et al. is pertinent for teaching new strategies for targeting anterior and posterior segments of the eye including “microemulsions” (Abstract). “The use of microemulsions for ocular administration is very interesting since these systems are relatively stable, can be easily sterilized, and have a high loading capacity of drugs. Also, microemulsions provide adequate fluidity and viscosity increasing ocular retention while retaining the therapeutic efficiency” (p. 1139, left column, 3rd paragraph).
Conclusion
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to WALTER E WEBB whose telephone number is (571)270-3287 and fax number is (571) 270-4287. The examiner can normally be reached from Mon-Fri 7-3:30.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Walter E. Webb
/WALTER E WEBB/Primary Examiner, Art Unit 1612
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