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 1-15 are pending in the application. Preliminary amendment filed 19 April 2024.
Priority
This application is a 371 of PCT/TR2021/051681 filed 12/31/2021. This application claims foreign priority to TURKIYE 2021/016287 filed 10/19/2021, under 35 U.S.C. 119(a)-(d). The certified copy of the priority document has been filed in the instant application.
Claim Objections
Claims 2-3 are objected to because of the following informalities: Claim 2 recites b-alanine. This should be corrected to recite b-alanine. It appears that there should be a comma after the term ‘hydroxytyrosol’ at line 5 in claim 3, and a comma after the term palmitate at line 7 in claim 4. Appropriate correction is required. Applicant is requested to check all the claims and insert a comma where necessary.
Claim Rejections - 35 USC § 112
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.
Claim 13 is rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for a method of treatment of presbyopia, dry eye disease or computer vision syndrome via administration of the ophthalmic formulation of claim 1 to a subject in need thereof, does not reasonably provide enablement for the method of preventing as claim 13. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
A conclusion of lack of enablement means that, based on the evidence regarding each of the factors below, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation.
(A) The breadth of the claims
(B) The level of one of ordinary skill
(C) The amount of direction provided by the inventor
(D) The existence of working examples
(E) The level of predictability in the art
(F) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Nature of the Invention
Claim 13 drawn to a method of preventing presbyopia, dry eye disease or computer vision syndrome via administration of the ophthalmic formulation of claim 1 to a subject in need thereof.
The breadth of the claims
In the instant case prevention means keeping the said diseases/conditions from happening in a subject. Prevention as recited involves administration of the instant formulation to a healthy subject, and subsequent exposure to conditions that would cause presbyopia, dry eye disease or computer vision syndrome, wherein the said formulation prevents said presbyopia, dry eye disease or computer vision syndrome from manifesting itself in said subject.
The amount of direction provided by the inventor
The background section of the specification teaches the recited diseases/conditions and what causes them, and some references to the treatment of the diseases. There are no references to preventive measures.
The existence of working examples
There are no examples set forth in the instant specification which show treatment or prevention.
The level of Predictability in the Art
It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. In re Fisher, 427.2d 833, 166 USPQ (CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary to satisfy the statute.
“Preventing” as recited in the instant claims is the complete and total blocking of presbyopia, dry eye disease or computer vision syndrome for an indefinite period of time. Prevention is seen to include the administration of the said composition to a healthy subject, and subsequent exposure to conditions that would cause presbyopia, dry eye disease or computer vision syndrome, wherein the said composition prevents said exposure from manifesting itself in said subject so exposed. Any therapy which merely reduces the number or severity of presbyopia, dry eye disease or computer vision syndrome, or which is effective for a period shorter than the subject’s remaining lifespan, is considered to be ineffective at preventing presbyopia, dry eye disease or computer vision syndrome. In general, preventing presbyopia, dry eye disease or computer vision syndrome according to the definition of prevention given above is not possible as any so-called preventive effects of a drug therapy are expected to cease when the drug is cleared from the patient’s system. More generally, prevention in the sense being used herein is not a recognized clinical outcome in the art, as no treatment is perfectly effective. One of ordinary skill in the art will not have a reasonable expectation of prevention of presbyopia, dry eye disease or computer vision syndrome.
Regarding presbyopia Davies et al (Ophthalmic and Physiological Optics, 2016, 36, 1-4) teaches that eye’s subjective amplitude of accommodation declines with age. Despite significant effort and approaches to restore ocular accommodation to the ageing eye failed to achieve the desired goal (page 1, left col; and right col. last para).
Colligris et al (Saudi Journal of Ophthalmology 2014, 28, 19-30) teaches that multiple causes can lead to dry eye (Introduction). Dry eye is treated with different agents (pages 20-28). Additional research is needed on understanding the immunomodulatory and inflammatory mechanisms of the conjunctiva (page 29-Concluding Remarks).
Akinbinu et al (Medical Practice and Review, 2014, 5(3), 20-30) teaches that a better understanding of the pathophysiology underlying CVS is necessary to empower practioners to accurately diagnose and treat CVS (Abstract). CVS is a growing health problem which is not clearly understood (page 27-Conclusion).
The teachings of Davies, Colligris and Akinbinu tells one of ordinary skill in the art that even treatment of presbyopia, dry eye disease or computer vision syndrome is difficult, let alone prevention.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure
In view of the information set forth, the instant disclosure is not seen to be sufficient to represent the method of prevention of presbyopia, dry eye disease or computer vision syndrome via administration of the instant composition.
Thus, the specification fails to provide sufficient support for preventing presbyopia, dry eye disease or computer vision syndrome.
Therefore, in view of the Wands factor and In re Fisher (CCPA 1970) discussed above, there is no assurance of success in preventing presbyopia, dry eye disease or computer vision syndrome as recited in claim 13.
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 2-3 and 5 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 2 recites the broad recitation betaine, and the claim also recites glycine betaine, b-alanine betaine which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. This also applies to claim 3 for the broad recitations ‘polyphenols’ and ‘carotene’ and the narrower recitations ‘quercetin and resveratrol’ and ‘beta carotene’.
Claim 5 recites the notation PCA. Para 0034 mentions the notation PCA but does not teach what it stands for. The notation should be expanded in the claim and amended in the specification. Claim 5, at lines 6-7, recites ‘selenium,’ followed by lactate, citrate and borate. Does applicant intend the lactate, citrate and borate salt of selenium? The recitation of lactate, citrate and borate, each followed by a comma, indicates that any metal lactate, citrate or borate is intended. This raises broad and narrow issues since citrate and lactate salts of calcium and magnesium are also recited in the claim.
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.
Claim(s) 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Bhushan et al (US 2006/0166879A1) in view of Feinbaum et al (2017/0007637A1) and further in view of Kaufman (WO 2010/135731 A1; cited in IDS filed 4/29/2024) and Garner et al (Invest Ophthalmol Vis Sci, 2016, 57, 2851-2863).
Bushan et al’s invention is drawn to a composition and its use in a method of treating several age-related ocular disorders like presbyopia, and dry eye syndrome (paras 0003, 0046; method of claim 13). The composition can comprise hyaluronic acid or the salt sodium hyaluronate (para 0074; component recited in claim 1). The composition can have potassium bicarbonate (para 0070; electrolyte as in claims 1 and 6). The formulation can be prepared in the form of nanospheres and liposomes (para 0074; as in claim 8). The composition can contain L-carnosine and vincamine because of their antioxidant properties in about 0.2wt% to 5wt% and 0.01wt% to about 0.2wt% respectively (paras 0067-0068; antioxidant as in claim 1 and its percentage range). Since an antioxidant is suggested as a component, including the use of L-carnosine, the use of N-acetylcarnosine and the other antioxidants as components as in claim 3 is rendered obvious. Ophthalmologically active agents that can be included are carbachol, diclofenac, pilocarpine, physostigmine, tetrahydrozoline and naphazoline as salts (para 0073; cholinergic, ocular decongestants and non-steroidal anti-inflammatory drug as in claim 1 and the limitations of claims 9-12). The ophthalmic formulation can be administered as an ointment or gel (para 0031). This renders obvious the limitation of claim 14.
Bhushan et al does not teach some of the components and their percentages as in claim 1, and does not teach the limitations of claims 2-5, and 7.
Feinbuam’s invention is drawn to ophthalmic formulations for treating presbyopia (para 0001; method of claim 14). The formulation has sodium hyaluronate from 0.1% to 0.9%, diclofenac sodium 0.006% to 0.012% and pilocarpine hydrochloride from 0.2 to 0.4% (para 0007 and claims 4-5 of Feinbaum; part of the limitations of claim 1).
Kaufman’s invention is also drawn to treatment of presbyopia (paras 0001, 0014; method of claim 14). Kaufman teaches a composition for this purpose which contains physostigmine, neostigmine, pridostigmine, demecarium and rivastigmine (para 0010; as in claim 19). Other components that can be present are carbachol, naphazoline, tetrahydrozoline (para 0012, 0020; as in claims 9 and 12). The formulation can contain mannitol, sorbitol, electrolytes like sodium chloride, magnesium sulfate, calcium chloride, potassium chloride, vitamins (para 0024; osmoprotectant, mineral salt and electrolyte as in claim 1 and limitation of claims 1 and 4-6). The formulation contains 0.0001% to 2% of each of the components (para 0026; percentages recited in claim 1). Buffering ingredients that can be present are sodium borate, sodium acetate, gluconate buffers, and phosphate buffer (para 0041, 0043; as in claim 1). The formulation can contain phospholipids and can be in the form of micellar droplets (paras 0046, 0052, phospholipids as in claim 1 and micelles as in claim 8). The suggestion to use phospholipids renders obvious the use of the components recited in claim 7.
Garner et al teaches that lipoic acid treatment led to an increase in lens elasticity due to disulfides and most likely accommodation would be restored to the presbyope (Abstract; page 2852, left col, first, second and third full paras; right col., second full para; Discussion; lipoic acid as component as in claim 3). This is another suggestion to include an antioxidant in the composition.
Regarding claim 15, Bhushan teaches water was filtered through a 0.2 micrometer filter and components of the composition were added to the water and mixing the components and the mixture is poured into bottles (Examples 1 and 3 at paras 0083 and 0093)
Kaufman also teaches making the ophthalmic solutions in water and adjusting pH to about 7.3 (Example 1 at para 0058). In view of these teachings of Bhushan and Kaufman one of ordinary skill in the art can use a buffer solution, filter it through a 0.2-micron filter, adjust the pH between 6.8-7.6, mix the components well and fill the mixture into vials and bottles under sterile conditions with packaging and labelling as in claim 15. Degassing as in claim 15 will also be obvious to the artisan. The method of producing using the steps as in claim 15 would be obvious and can be adapted to produce the claimed formulation by one of ordinary skill in the field of pharmacy.
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary 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."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings, formulation comprising the claimed components are known in the art for making the same and using it for treating presbyopia and dry eye disease.
Thus, the claimed invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention over the combined teachings of the prior art. Product improvement is the motivation. One of ordinary skill in the art would make the claimed composition and use it in the claimed method of treatment in order to look for a formulation that has enhanced beneficial effects in the treatment of presbyopia and dry eye disease. It would be obvious to the artisan to use it for treating the related computer vision syndrome as in claim 13. The artisan can adjust the percentages of the components using the amounts disclosed in the prior art as a starting point.
It is well established that merely selecting proportions and ranges and modifying the process conditions such as temperature, reaction time and concentration is not a patentable modification absent a showing of criticality (In re Aller, 220 F.2d, 454, 105 U.S.P.Q 233 C.C.P.A, 1995 and In re Becket, 33 U.S.P.Q 33, C.C.P.A, 1937 and In re Russell, 439 F. 2d 1228, 169 U.S.P.Q. 426, C.C.P.A 1971).
In view of the teachings of the prior art the artisan would also use all the other components recited in claims 2-11 to look for alternative compositions for treating presbyopia, dry eye disease and computer vision syndrome.
Conclusion
Pending claims 1-15 are rejected
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/GANAPATHY KRISHNAN/ Primary Examiner, Art Unit 1693
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