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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 27, 2026 has been entered.
Status of Application
Receipt of Applicant’s remarks and amended claims filed on January 27, 2026 is acknowledged.
Claims 1 and 3-23 are pending in this application.
Claims 1, 11, and 19 have been amended.
Claim 2 has been cancelled.
Claims 8, 12, 14-15, 17-18, and 21-23 remain withdrawn per the election requirement dated March 20,2023.
Therefore, claims 1, 3-7, 9-11, 13, 16, and 19-20 are under examination in this application.
Withdrawn Rejections
Claim Rejections - 35 USC § 103
The rejection of claims 1, 3-7, 9-11, 13, 16, and 19-20 under 35 U.S.C. 103 as being unpatentable over Jablonski et al. (US 2001/0049369) in view of Sela (US 2009/0035369) and further in view of Xia et al. (US 2005/0214382) has been withdrawn in view of Applicant’s amendment to recite the preservative cannot include zinc salts.
Newly Applied Rejections
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.
Claims 1, 3-7, 9-11,, 13, 16, and 19-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 has been amended to recite “an effective amount of one or more preservatives, wherein the one or more preservatives is not a zinc salt”. However, Applicant did not particularly point out where in the specification support for said amendment can be found. After a review of the specification, the Examiner was unable to locate support for said amendment. This is a new matter rejection.
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 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.
Claims 1, 3-7, 9-11, 13, 16, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Jablonski et al. (US 2001/0049369) in view of National Eye Institute (Antioxidant Vitamins and Zinc Reduce Risk if Vison Loss from Age-Related Macular Degeneration, NIH (October 12, 2001).
Jablonski discloses the use of brimonidine tartrate (an alpha-adrenergic receptor agonist) for prevention of photoreceptor cell degeneration and the associated Muller cell degeneration and retinal detachment (abstract).
The brimonidine was delivered topically to the eye (paragraph 0026), as ophthalmic solutions (paragraph 0027).
The pH of the solution is between 6 and 8 (paragraph 0029).
The composition can also include a preservative (paragraph 0029). It is noted that none the of disclosed preservatives are zinc salts.
Regarding claims 3-4, as noted above, brimonidine is disclosed.
Regarding claim 7, suitable wetting and clarifying agents include polysorbate and poloxamer (paragraph 0030).
Regarding claims 9-10, viscosity increasing agents, including hydroxymethylpropyl cellulose can be added (paragraph 0030).
Regarding claim 11, the composition can comprise antioxidants (paragraphs 0030).
Regarding claim 13, glycerin (glycerol) can be added (paragraph 0030).
Regarding claim 16, suitable buffers include sodium and potassium borates and sodium acetate (paragraph 0029).
Regarding claims 19-20, the brimonidine is present in the concentration of about 0.01-1% by weight (paragraph 0028). Applicant is reminded that where the general conditions of the claims are met, burden is shifted to applicant to provide a patentable distinction. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See In re Aller, 220 F.2d 454 105 USPQ 233,235 (CCPA 1955).
Furthermore, the claims differ from the reference by reciting various concentrations of the commonly added excipients of eye solutions. However, the preparation of ophthalmic compositions having various amounts of the excipients is within the level of skill of one having ordinary skill in the art at the time of the invention. It has also been held that the mere selection of proportions and ranges is not patentable absent a showing of criticality. See In re Russell, 439 F.2d 1228 169 USPQ 426(CCPA 1971).
Jablonski does not disclose about 0.1% to about 5% w/v of a zinc salt.
The National Eye Institute discloses Scientists found that people at high risk of developing advanced stages of Age-Related Macular Degeneration (AMD), a leading cause of vision loss, lowered their risk by about 25 percent when treated with a high-dose combination of vitamin C, vitamin E, beta-carotene, and zinc. In the same high risk group—which includes people with intermediate AMD, or advanced AMD in one eye but not the other eye—the nutrients reduced the risk of vision loss caused by advanced AMD by about 19 percent.
The nutrients evaluated by the AREDS researchers contained 500 milligrams of vitamin C; 400 international units of vitamin E; 15 milligrams of beta-carotene; 80 milligrams of zinc as zinc oxide; and two milligrams of copper as cupric oxide (Copper was added to the AREDS formulations containing zinc to prevent copper deficiency, which may be associated with high levels of zinc supplementation).
The instant claims differ from the references only in the specific percentage selected for the compositions. However, It would have been deemed prima Facie obvious to one having ordinary skill in the art at the time of the invention to optimize the percentage of the zinc oxide to prepare a composition for the topical treatment of eye diseases, including AMD because the determination of a specific percentage having the optimum therapeutic effect is well within the level of one having ordinary skill in the art, and the artisan would be motivated to determine optimum amounts to get the maximum effect of the active compounds. Therefore, the invention as Whole has been prima face obvious to one of ordinary skill in the art at the time the invention was made.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA S MERCIER whose telephone number is (571)272-9039. The examiner can normally be reached M-F 6:30 am to 4 pm EST.
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/MELISSA S MERCIER/Primary Examiner, Art Unit 1615
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