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 .
Non-Final Rejection
The Status of Claims:
Claims 1-18 are pending.
Claims 1-18 are rejected.
DETAILED ACTION
1. Claims 1-18 are under consideration in this Office Action.
Priority
2. It is noted that this application is a 371 of PCT/US2021/064877 12/22/2021 , which has a priority of 63130246 12/23/2020.
Drawings
3. The drawings filed on 6/16/23 are accepted by the examiner.
IDS
4. The IDS filed on 6/13/24 & 10/08/24 are reviewed by the examiner.
Claim Rejections - 35 USC § 112
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 1-6, and 9-10, 13-18 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 pre-AIA the applicant regards as the invention.
In claims 1-6, and 9-10, 13-18, the phrases “cytochrome P450 enzyme inhibitor” and “a small molecule “ and “a stilbene or a variant thereof” can be vague and indefinite because the terms can be read on the reach-through claim. A functional definition of a chemical compound ("reach-through" claim) covers all compounds possessing the activity or effect specified in the claim. It would be an undue burden to isolate and characterize all potential compounds, without any effective pointer to their identity or to test every known compound and every conceivable and undiscovered future compound for this activity to see if it falls within the scope of the claims. In effect, the applicant is attempting to patent what has not yet been invented. Therefore, an appropriate correction is required.
Claims 9-11 are rejected under 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter that was not described in the specification in such a way to convey reasonably to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention. The issue concerning the meaning of phrases “ a small molecule”,” an antibody”, and ““variant thereof” are discussed above. Claims 9-10 do not contain a complete generic formula.
According to the MPEP §2163 I. A. “the issue of a lack of adequate written description may arise even for an original claim when an aspect of the claimed invention has not been described with sufficient particularity such that one skilled in the art would recognize that the applicant had possession of the claimed invention. The claimed invention as a whole may not be adequately described if the claims require an essential or critical feature which is not adequately described in the specification and which is not conventional in the art or known to one of ordinary skill in the art.” The MPEP states in §2163 II 3 ii) “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A), above), reduction to drawings (see i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.” Applicants have disclosed no species and have made no assertion that there is any correlation between the biological function of radical “ a small molecule”,” an antibody”, and ““variant thereof” and each of their corresponding structures.
The Court of Appeals for the Federal Circuit held in University of California v. Eli Lilly and Co. 43 USPQ2d 1398 at 1406. "[a] written description of an invention involving a chemical genus, like a description of a chemical species, "requires a precise definition, such as by structure, formula, [or] chemical name, of the claimed subject matter sufficient to distinguish it from other materials." In re Smythe, 480 F.2d 1376, 1383, Fiers, 984 F.2d at 1171, 25 USPQ2d at 1606; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284-85 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus. . . .")." Applicants' functional definitions in the claimed formula simply lack the precision required by the Court of Appeals for the Federal Circuit.
As discussed above the phrases “ a small molecule”,” an antibody”, and ““variant thereof” are not art recognized in the field of the cytochrome P450 enzyme inhibitor. According to the MPEP §2163.02 Standard for Determining Compliance With the Written Description Requirement,
“The courts have described the essential question to be addressed in a description requirement issue in a variety of ways. An objective standard for determining compliance with the written description requirement is, “does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed". In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). Under Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description requirement, an applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention, and that the invention, in that context, is whatever is now claimed. The test for sufficiency of support in a parent application is whether the disclosure of the application relied upon “reasonably conveys to the artisan that the inventor had possession at that time of the later claimed subject matter". Ralston Purina Co. v. Far-Mar-Co., Inc., 772 F.2d 1570, 1575, 227 USPQ 177, 179 (Fed. Cir. 1985) (quoting In re Kaslow, 707 F.2d 1366, 1375, 217 USPQ 1089, 1096 (Fed. Cir. 1983)).”
Thus, each of the terms of the phrases “ a small molecule”,” an antibody”, and ““variant thereof” of ordinary skill in the art, who would use Applicants' compounds, would not know what each of the terms of “ a small molecule”,” an antibody”, and “variant thereof” is meant definitely for the cytochrome P450 enzyme inhibitor. Each of the terms of the phrases “ a small molecule”,” an antibody”, and “variant thereof” as the cytochrome P450 enzyme inhibitor would not have understood the inventor to be in possession of the claimed phrases “ a small molecule”,” an antibody”, and “variant thereof” at the time of filing.
This case was filed before Applicants had a clear idea of the structures of their desired compounds, how to make their compounds, and use those terms made from them. The specification provides broad areas of future research and speculation, inviting undue experimentation in learning how to use Applicants' invention. Applicants may well now be developing practical applications of their ***, but the question here is what application they possessed at the time of filing. Anything is possible but as the U.S. Patent and Trademark Office, Board of Patent Appeals and Interferences wrote in Bindra v. Kelly, 206 USPQ 570 “Probable utility does not establish practical utility. Practical utility can, in our view, be established only by actual testing therefore, or by establishing such facts as would be convincing that such utility could be "foretold with certainty.” Blicke v. Treves, supra, 112 USPQ at 475.”
Applicants are reminded of what the U.S. Court of Appeals Federal Circuit wrote in University of California v. Eli Lilly and Co. 43 USPQ2d 1398, "In claims involving chemical materials, generic formulae usually indicate with specificity what the generic claims encompass. One skilled in the art can distinguish such a formula from others and can identify many of the species that the claims encompass. Accordingly, such a formula is normally an adequate description of the claimed genus." "A definition by function, as we have previously indicated, does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is. See Fiers, 984 F.2d at 1169-71, 25 USPQ2d at 1605-06 (discussing Amgen). "It is only a definition of a useful result rather than a definition of what achieves that result." "The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.")".
Claim Rejections - 35 USC § 102
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.
(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.
Claim(s) 1, 6, 9, 13-15 and 18 are rejected under 35 U.S.C. 102(a)(2) as being clearly anticipated by Zhou et al (CN 105997872 A).
Zhou et al discloses an ophthalmic nanomicelle antifungal solution containing posaconazole as the cytochrome P450 inhibitor for eye drops as well as its use in the treatment of fungal keratitis, a pathology of the cornea [see pages 4-6, example 1-7; pages 10-11, claims 1-7]. These are identical with the claims.
Claim(s) 1, 6, 9, and 13-18 are rejected under 35 U.S.C. 102(a)(2) as being clearly anticipated by Zang et al (CN 101375848 A).
Zang et al describes an ophthalmic gel containing fluconazole, which is a known cytochrome P450 inhibitor, for use in the treatment of corneal ulcers(see page 2, a paragraph#0014) and [see page 3, example 1-3; pages 5-6, claims 1-7]. These are identical with the claims.
Claim(s) 1, 3-4, 6, 9,13-18 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Shetty et al (INVESTIGATIVE OPHTHALMOLOGY & VISUAL SCIENCE, vol. 56, 1 January 2015 (pages 738-750).
Shetty et al discloses the treatment of male and female subjects (see page 739 , the right col. , line 19) with ectasia/keratoconus with an eye drop formulation comprising cyclosporin A, a cytochrome P450 3A4 inhibitor (see page 738, abstract); Methods: Study Design and Endpoints; fig. 1-5]. These are identical with the claims.
Claim(s) 1 , 2, 6 , 9, 12-18 are rejected under 35 U.S.C. 102(a)(2) as clearly anticipated by ZUGUO et al (CN 111991391 A)
ZUGUO et al discloses a method for treating or preventing non-infectious ocular surface inflammation, which comprises: administering to a subject in need thereof ophthalmic formulations comprising berberine, its stereoisomers, and its pharmaceutically acceptable The accepted salt, its pharmaceutically acceptable hydrate, or its pharmaceutically acceptable solvate in the followings:
the pharmaceutical composition is an ophthalmic liquid preparation (for example, eye drops, eye washes, intraocular injection solutions), wherein the berberine, its stereoisomers, and the content of the pharmaceutically acceptable salt, its pharmaceutically acceptable hydrate or its pharmaceutically acceptable solvate is 0.05-0.5 w/v%. (see page 4, a paragraph#0024)
1.The use of berberine, its stereoisomers, its pharmaceutically acceptable salts, its pharmaceutically acceptable hydrates or its pharmaceutically acceptable solvates in the preparation of medicines, wherein the medicines are used It is used to treat or prevent non-infectious ocular surface inflammation, inhibit non-infectious ocular surface inflammation, promote ocular surface tissue repair, increase the number of conjunctiva! goblet cells, promote tear secretion and/or maintain tear film stability.
10.The use of any one of claims 1-9, wherein the non-infectious ocular surface inflammation includes dry eye, meibomian gland dysfunction, blepharitis, blepharitis, corneal chemical injury, syndrome, Stevens-Johnson synthesis Signs, allergic conjunctivitis, giant papillary conjunctivitis, vernal conjunctivitis, atopic keratoconjunctivitis, pterygium, Mooren corneal ulcer, scleritis, superficial scleritis, pigmentary inflammation, by light (including fluorescent screen, Blue light, etc.) caused by eye discomfort or ocular surface damage. (see pages 27 & 30 , claims 1 and 10).
These are identical with the claims.
Claim(s) 1-4,6, 9-10, and 13-18 are rejected under 35 U.S.C. 102(a)(2) as clearly anticipated by Burke et al (US 2007/0026034).
Burke discloses a method for inhibiting or treating a disease or pathology of the cornea in a subject (Compositions. systems, kits, and methods of administering rapamycin analogs with paclitaxel, Title; uses include the treatment and prophylaxis of ... various eye diseases ... including ... conical cornea, dystrophia epithelialis corneae as in claims 2-4. (see page 7, a paragraph#0081); invention is directed to methods of treatment, by placing or administering to a subject any of the described systems or compositions that include ... paclitaxel or salts, prodrugs, or derivatives thereof, (see page 4, a paragraph#0045), the method comprising administering to the subject a therapeutically effective dose of cytochrome P450 enzyme inhibitor (the invention is directed to pharmaceutical compositions that include paclitaxel or salts, derivatives thereof .... wherein the composition is formulated for local delivery to a subject who can be humans as in claims 16-17 (see page 3, a paragraph# 0043); a therapeutically of one of the compounds may be employed in pure form or .... may be administered as a composition including the compound of interest in combination with one or more pharmaceutically acceptable excipients as in claim 18 , (see page 10 , a paragraph#0096)and topical administration includes administration to the skin or mucosa, including surfaces of the lung and eye as in claim 15(see page 11, a paragraph#0116). These are identical with the claims.
Claim(s) 1, 6-9, 13-18 are rejected under 35 U.S.C. 102(a)(2) as clearly anticipated by Yang et al (US 2020/0255859).
Yang et al discloses a method for inhibiting or treating a disease or pathology of the cornea(see page 7, a paragraph#0072) in a subject being a human(see page 4, a paragraph#0039); the disease is corneal dystrophy(see page 9, a paragraph#0092) the method comprising administering to the subject a therapeutically effective dose of cytochrome P450 enzyme inhibitor (the target gene comprises a mutated or defective ... CYP1B1 and CYP4F2 (see page 4 , a paragraph#0040); a composition includes ... a CRISPR guide RNA targeting a nucleic acid sequence ... of or within 100 bps to a target gene, (see page 10, a paragraph#0098); methods comprise administering or delivering an effective amount... of said vectors to the subject's eye, (see page 29, a paragraph# 0343) by any suitable means such as eye drops (see page 41, a paragraph#0449); pharmaceutical compositions include carriers, diluents, or excipients suitable for administration by various routes(see page 20, a paragraph#0228). These are identical with the claims.
Conclusion
Claims 1-18 are rejected.
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/TAYLOR V OH/Primary Examiner, Art Unit 1625 10/10/2025