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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 15 September 2026 has been entered.
Status
Applicant’s response dated 15 September 2026 to the previous Office action dated 17 June 2026 is acknowledged. Pursuant to amendments therein, claims 1-22 are pending in the application.
The rejection under 35 U.S.C. 102 made in the previous Office action is withdrawn in view of applicant’s claim amendments.
A new rejection under 35 U.S.C. 103 is made herein in view of applicant’s claim amendments.
Election/Restrictions
Claims 1-13 and 16-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 19 August 2025.
Claims 14-15 are under current consideration.
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.
Claim(s) 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Horn ‘006 (US 8,933,006 B1; issued 13 January 2015; of record).
Horn ‘006 discloses a contact lens cleaning composition comprising 0.10% w/v poloxamer 188, 0.20% w/v poloxamer 407, 5.00% w/v polyoxyl 40 stearate, 0.25-1.5% w/v polyoxyl 35 castor oil, and sodium chloride (claim 1), wherein the amount of polyoxyl 35 castor oil can be from 0.1-2.5% w/v (column 3 lines 49-50) and the amount of polyoxyl 40 stearate can be 1% w/v (Table 1 composition 5) wherein the composition is instilled as drops to contact lens wearers complaining of dry, uncomfortable lenses after 16 hours of continuous contact lens use which provided long-lasting relief upon instillation with improved comfort (column 5 lines 5-14) wherein the method of the invention is directed to a method of cleaning a contact lens while the contact lens remains on the eye (column 1 lines 5-14).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow the suggestions of Horn ‘006 as discussed above and to instill a composition as drops to contact lens wearers complaining of dry, uncomfortable lenses after 16 hours of continuous contact lens use to provide long-lasting relief upon instillation with improved comfort and to clean a contact lens with a composition while the contact lens remains on the eye (i.e., a method of enhancing contact lens comfort and a method of enhancing contact lens wear time comprising administering a composition to a subject in need thereof), wherein the composition comprises 0.1% w/v poloxamer 188, 0.2% w/v poloxamer 407, 1-5% w/v polyoxyl 40 stearate, 0.1-2.5% w/v polyoxyl 35 castor oil, and sodium chloride, with a reasonable expectation of success.
Such a composition comprises 0.1% w/v poloxamer 188, 0.2% w/v poloxamer 407, and 0.1-2.5% w/v polyoxyl 35 castor oil, which are three nonionic surfactants selected from poloxamers and polyoxyl castor oils at a total concentration of 0.4-2.8% w/v, which overlaps the claimed range of about 3-5.9% w/v, given that “about” is defined by applicant as ±10% (instant specification paragraph [000100]) thus resulting in a claimed range of 2.7-6.49% w/v, and a prima facie case of obviousness exists where prior art and claimed ranges overlap per MPEP 2144.05(I).
Response to Arguments
Applicant's arguments filed 15 September 2026 have been fully considered but they are not persuasive.
Applicant argues that the claims are limited to two or more NIS at a total concentration from about 3-5.9% w/v NIS that do not include polyoxyl 40 stearate (remarks page 6). In response, the claims do not exclude polyoxyl 40 stearate in that the claims are open-ended by using the transitional term “comprises” and thus the composition can comprise NIS other than ones in the claimed list.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL B. PALLAY whose telephone number is (571)270-3473. The examiner can normally be reached Monday through Friday from 8:30 AM to 5:00 PM Eastern Time.
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, Sue Liu can be reached at (571)272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL B. PALLAY/Primary Examiner, Art Unit 1617
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