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 .
DETAILED ACTION
Claims 1-18 are pending. Claims 19 and 20 have been canceled. Note that, Applicant’s amendment and arguments filed July 9, 2026, have been entered.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 July 9, 2026, has been entered.
Objections/Rejections Withdrawn
The following objections/rejections as set forth in the Office action mailed 5/1/26 have been withdrawn:
None.
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 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.
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.
Claims 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over Xia et al (US2004/0063620).
With respect to independent, instant claim 1, Xia et al teach methods and/or compositions, which includes ophthalmic solutions, which may be in the form of drops and may include a cationic cellulosic polymer that exhibits prolonged duration in the eye. See para. 12. The pH of the solutions and/or compositions of the present invention may be maintained within the range of pH=5.0 to 8.0, preferably about pH=6.0 to 8.0, more preferably about pH=6.5 to 7.8, most preferably pH values of greater than or equal to 7; suitable buffers may be added, such as borate, citrate, bicarbonate, tris(hydroxymethyl)aminomethane (TRIS-Base) and various mixed phosphate buffers (which may include combinations of Na2HPO4 NaH PO4 and KH₂PO4) and mixtures thereof. Generally, buffers will be used in amounts ranging from about 0.05 percent by weight to 2.5 percent by weight, and preferably, from 0.1 percent by weight to 1.5 percent weight. See para. 49. The compositions generally include a primary antimicrobial agent. Antimicrobial agents suitable for use in the present invention include chemicals that derive their antimicrobial activity through a chemical or physiochemical interaction with the microbial organisms. These agents may be used alone or in combination. Known antimicrobial agents include known organic nitrogen-containing agents such as biguanides. The biguanides include the free bases or salts of alexidine, chlorhexidine, hexamethylene biguanides and their polymers, and/or combinations of the foregoing. The biguanide salts are typically gluconates, nitrates, acetates, phosphates, sulfates, halides and the like. A preferred biguanide is the hexamethylene biguanide commercially available from Zeneca, Wilmington, Del. under the trademark Cosmocil ™M CQ. Generally, the hexamethylene biguanide polymers, also referred to as polyaminopropyl biguanide (PAPB), have molecular weights of up to about 100,000. Yet another example of a known primary antimicrobial agent is various materials available as polyquaternium-1. The amount of the primary antimicrobial agent may vary depending on the specific agent employed. For the aforementioned organic nitrogen-containing agent, typically, such agents are present in concentrations ranging from about 0.00001 to about 0.5% weight percent, and more preferably, from about 0.00003% to about 0.05% weight percent. See paras. 42-44. Xia et al exemplify compositions containing 1% by weight of Poloxamine 1107 and 2% poloxamer F127, wherein these components are surfactants; 1% glycerin, etc. See para. 63. Demulcents such as hydroxyethyl cellulose, carboxymethylcellulose, etc., may be used in the composition in amounts from 0.01 to 5% by weight. See para. 54.
Xia et al do not teach, with sufficient specificity, a composition containing tris(hydroxymethyl)aminomethane, a polyquaternium polymer, and the other requisite components of the composition in the specific amounts as recited by independent, instant claim 1 and the respective dependent claims.
Nonetheless it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to formulate a composition containing tris(hydroxymethyl)aminomethane, a polyquaternium polymer, and the other requisite components of the composition in the specific amounts as recited by independent, instant claim 1 and the respective dependent claims, with a reasonable expectation of success and similar results with respect to other disclosed components, because the broad teachings of Xia et al suggest a composition containing tris(hydroxymethyl)aminomethane, a polyquaternium polymer, and the other requisite components of the composition in the specific amounts as recited by independent, instant claim 1 and the respective dependent claims.
Response to Arguments
With respect to the rejection of the instant claims under 35 USC 103 using Xia et al, Applicant states that Applicant's claimed arrangement recites a contact lens treating solution comprising one or more of anionic polysaccharides and Xia et al fails to teach or suggest at least the newly added feature of independent claim 1. In response, note that, Xia et al clearly teach that suitable demulcents include carboxymethylcellulose, wherein carboxymethylcellulose is clearly listed as a suitable anionic polysaccharide as recited by instant claim 16 and para. 77 of the instant specification. Thus, the Examiner asserts that the teachings of Xia et al are sufficient to render the claimed invention obvious under 35 USC 103.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Remaining references cited but not relied upon are considered to be cumulative to or less pertinent than those relied upon or discussed above.
Applicant is reminded that any evidence to be presented in accordance with 37 CFR 1.131 or 1.132 should be submitted before final rejection in order to be considered timely.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GREGORY R DEL COTTO whose telephone number is (571)272-1312. The examiner can normally be reached M-F, 8:30am-6:00pm, EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Angela Brown-Pettigrew can be reached at (571) 272-2817. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GREGORY R DELCOTTO/Primary Examiner, Art Unit 1761
/G.R.D/September 4, 2026
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