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 .
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.
Election/Restrictions
Applicant’s election of species with traverse in the reply filed on 06/22/2026 is acknowledged. The traversal is on the ground(s) that generic claims are not too broad as to place undue burden on the Patent Office. This is not found persuasive because the species are structurally different as stated in page 6 of the office action of 3/19/2026.
The requirement is still deemed proper and is therefore made FINAL
Applicants elected compliant species of compound of formula I
PNG
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160
420
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Greyscale
where X is arginine and R is methyl.
Examiner found prior art for applicants elected species where X is arginine. Therefore Markush search is not extended further as Markush search practices.
Elected species read on claims 9-17.
Current Status of 18/574,162
This Office Action is in response to the amended claims of 06/22/2026.
Claims 9-17 are currently amended and examined in this office action
Information Disclosure Statement
The information disclosure statements (IDS) were submitted on 04/19/2024. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Priority
Effected filing date is 06/23/2022.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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.
Claim 9-17 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.
Claim 9 recites the limitation of the phrase “including…” . The examiner does not know if the phrase “including” further limits the embodiments in the claim or list the different embodiments of the claims. Moreover, the reader does not know if the limitations following “including” are merely exemplary or are required limitations of the claim. As drafted, the term “including” renders the metes and bounds of claim 9undefined hence rendering claim 9 indefinite. Please delete all occurrences of “including” and either delete: 1) the broad limitations immediately preceding “including” or 2) the limitations immediately following “including”.
Similarly, claims 10-17 are also rejected as indefinite because they refer back to claim 9 but do not remedy the bases for the rejection of claim 9.
Applicant can overcome indefinite rejection by deleting the phrase “including” from claim 9.
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.
Claim(s) 9-11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ulmann et,al. (CN112334136A).
Ulmann et.al. discloses a preparation comprising at least one folate compound including 6S-5-methylterahydrofolic acid or levofolinic acid for treating epithelial tissue irritations and disorders, preferably skin irritations and skin disorders. Skin irritation or skin disorder is an inflammatory skin disorder, wherein the epithelial tissue disorder is dry eyes syndrome (page 3, paragraph 4), and the preparation comprises at least one folate compound salt, including arginine (page 3 ) (applicant elected species), calcium ion, sodium ion, an organic amine, and glucosamine (page 3), thus anticipating claims 9-10. Since prior art of Ulmann et.al. is silent about type of dry eyes, therefore examiner interpret dry eyes to include evaporative dry eyes, anticipating claims 11
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 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) 9-17 are rejected under 35 U.S.C. 103 as being unpatentable over
Ulmann et.al. (CN112334136A).
In view of
Downie et.al. (CN-111788224-A).
1. Determining the scope and contents of the prior art.
Ullman, M. discloses claims 9-11.
Downie et.al. discloses that symptoms reported by patients experiencing symptomatic lens wear (e.g., eye irritation, burning, stinging and pain) are highly similar to the symptomatology associated with dry eye disease, which is recognized to involve an inflammatory overlay, and some clinical data lend support to the presence of a low grade, sub-clinical anterior eye inflammatory response during contact lens wear, teaching claim 15. Downie L further states the symptoms of dry eyes changes the expression inflammation biomarker proinflammatory cytokines and increases protease activity such as metalloproteins MMP-2 and TNF-α(page1) partially teaching claims 14 and 16.
2. Ascertaining the differences between the prior art and the claims at issue.
Although Ulmann teaches a method of treating dry eye with arginine salt of 6S-5-methylterahydrofolic acid or levofolinic acid, Ulmann does not teach treating discomfort due to dry eyes with arginine salt of 6S-5-methylterahydrofolic acid or levofolinic acid .
Although Donnie teaches, symptoms of contacts less discomfort is similar to dry eye symptoms and inflammation caused by dry eyes increases proinflammatory cytokines and increases protease activity such as metalloproteins MMP-2 and TNF-α. Donnie does not teach treating discomfort due to dry eyes with arginine salt of 6S-5-methylterahydrofolic acid or levofolinic acid.
3. Resolving the level of ordinary skill in the pertinent art.
A person skilled in art is an artisan who is an expert in treating ocular diseases.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
A person skilled in the art would be motivated to use arginine salt of 6S-5-methylterahydrofolic acid or levofolinic acid for treating any dry eye caused by contact less discomfort with arginine salt of 6S-5-methylterahydrofolic acid or levofolinic (Ulmann page 3) since the symptoms of contact lens disorders comfort is same as dry eyes (Downie et.al. page 1). Therefore, it would be expected that arginine salt of 6S-5-methylterahydrofolic acid or levofolinic (Ulmann page 3) would also treat inflammation caused by contact less discomfort. Furthermore, since proinflammatory cytokines, due to inflammation as a result of eye dry disease, increases protease activity such as metalloproteins MMP-2 and TNF-α expressed in trigeminal ganglion of eyes (Downie et.al. . page 1), it would be expected inhibition inflammation would also decrease expression of metalloproteins MMP-2 and TNF-α, thus inhibiting neuritis and neuralgia, thus teaching claims 14 and 16. Therefore it would be prima facie to obvious to combine the teaching of Ulmann et,al. and Downie et.al. to develop a method of treating dry eyes diseases or contact lens discomfort with arginine salt of 6S-5-methylterahydrofolic acid or levofolinic acid, teaching claims 9 and 14-6.
Regarding claims 12 and 13, it is expected any type of delivery of drug to the eye would be formulated in the form of eye drop, therefore it would be obvious for person skilled in the art to deliver compound of formula I with arginine thus teaching claims 12-13.
Regarding claim 17, formulation of eye drops with 6S-5-methylterahydrofolic acid or levofolinic acid would require auxiliary material for the formulation to achieve appropriate viscosity, therefore it would be obvious for a person skilled in the art use auxiliary material to formulate 6S-5-methylterahydrofolic acid or levofolinic acid into eye drop, thus teaching claim 17.
Conclusion
No Claims are allowable as written.
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/R.I./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
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