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 .
Status of the Claims
The amendment filed 09/02/2025 has been entered. Claims 1-20 and 22 are pending and under consideration.
Examiner’s note
In view of the telephone interview conducted on 03/03/2026, the finality of the previous office action mailed 12/10/2025 is hereby withdrawn. A corrected final office action is being issued herewith to fix the addressed issue during the interview.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/09/2025 was filed after the mailing date of the non-final office action on 06/02/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
In response to applicant’s argument with respect 35 USC 102 and 103 rejections have been considered and are at least partially persuasive, but are moot in light of new rejection/interpretation.
In response to applicant’s argument with respect 35 USC 103 rejections have been considered but they are not persuasive. For instance, with regard claim rejections 12-15, Applicant traverse the obviousness rejection on the grounds that Aberg is directed to use of a specialized solution comprising adrenergic beta-receptor agonists composition, not use of a general multipurpose cleaning, rinsing, disinfecting and storage solution for use with contact lenses as taught by Yamazaki. Examiner respectfully disagrees. As stated in the non-final rejection, one of skill in the art, one of skill in the art would be motivated to utilize the composition of Aberg as a multipurpose cleaning solution as taught by Yamazaki, for the purpose of reducing a feeling of dryness in a user during wear of soft contact lenses. Specifically, soaking the lenses in the multipurpose cleaning solution comprising the composition of Aberg enables prolonged administration of the composition from the lenses during wearing, which benefits the relief of dry eye symptoms.
Specification
The disclosure is objected to because it contains, see page 27, an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
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 3 is 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.
Claims 3 recites “about” which renders the claim indefinite. The use of word “about” when indicating a value, duration, numerical range, location, shape, or comparative sizing or proximity is considered indefinite as the specification or arguments previously presented fails to provide some standard for measuring that degree; and there is no standard that is recognized in the art for measuring the meaning of the term of said degree. Terms of Degree: When a term of degree is used in the claim, the examiner should determine whether the specification provides some standard for measuring that degree. If the specification does not provide some standard for measuring that degree, a determination must be made as to whether one of ordinary skill in the art could nevertheless ascertain the scope of the claim (e.g., a standard that is recognized in the art for measuring the meaning of the term of degree). The claim is not indefinite if the specification provides examples or teachings that can be used to measure a degree even without a precise numerical measurement (e.g., a figure that provides a standard for measuring the meaning of the term of degree). During prosecution, an applicant may also overcome an indefiniteness rejection by submitting a declaration under 37 CFR 1.132 showing examples that meet the claim limitation and examples that do not. <Federal Register / Vol. 76, No. 27 / February 9, 2011 / Notices, (Page 7165: Col 3, Par. 0003)>.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of copending Application No. 17/991083 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application claim 4 recites features in the claims 1-8, including administering a composition to the eyes, lacrimal gland(s) and/or meibomian glands comprises a combination of demulcents including a hyaluronic acid compound and a polyethylene glycol compound.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
Claims 1-12 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Aberg et al (US 20110294897 A1)
Regarding claim 1, Aberg teaches substantially teaches applicant’s claimed invention, and specifically discloses a device with every structural limitation of applicant’s claimed invention (except for the limitations shown in italics and grayed-out) including:
a method of treating, preventing, relieving or reducing the symptoms associated with tear film deficiency and/or tear film instability in one or both eyes of a subject in need thereof, comprising the step of administering a composition comprising a combination of demulcents including a hyaluronic acid compound and a polyethylene glycol compound (abstract, [0002] and [0132] administrating composition comprises hyaluronic acid) to the eye(s), lacrimal gland(s) and/or the meibomian gland(s) of the subject, which treatment, prevention, relief or reduction is observed within 1 day or more, 10 days or more, 20 days or more, or 30 days or more, after such administration ([0030]-[0031] treatment observed after the administration. Furthermore, the phrase regarding the observation window (1 to 30+ days) is a non-limiting functional limitation. It describes the expected clinical result of the preceding administration step rather than an actual step, and therefore does not impart patentable weight to the claim).
Aberg does not expressly teach the composition comprising a polyethylene glycol compound, though Aberg teaches humectants including polyethylene glycol could be used in all formulations mentioned herein ([0090]).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Aberg to incorporate the teachings of Aberg and provides the composition as claimed for the purpose of increasing water-holding capacity of ocular tissues and providing desired viscosity for topical administration as taught by Aberg ([0090, 0100 and 0116]).
Regarding Claim 2, Aberg teaches a method of increasing lacrimal secretion in a subject in one or both eyes of need thereof, comprising the step of administering a composition comprising a combination of demulcents including a hyaluronic acid compound and a polyethylene glycol compound (abstract, [0002] and [0132] administrating composition comprises hyaluronic acid) to the eye(s) and/or lacrimal gland(s) of the subject, which increase can be observed within 1 day or more, 10 days or more, 20 days or more, or 30 days or more, after such administration ([0030]-[0031] treatment observed after the administration. Furthermore, the phrase regarding the observation window (1 to 30+ days) is a non-limiting functional limitation. It describes the expected clinical result of the preceding administration step rather than an actual step, and therefore does not impart patentable weight to the claim.).
Aberg does not expressly teach the composition comprising a polyethylene glycol compound, though Aberg teaches humectants including polyethylene glycol could be used in all formulations mentioned herein ([0090]).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Aberg to incorporate the teachings of Aberg and provides the composition as claimed for the purpose of increasing water-holding capacity of ocular tissues and providing desired viscosity for topical administration as taught by Aberg ([0090, 0100 and 0116]).
Regarding Claim 3, Aberg teaches a method of increasing meibomian gland secretion in one or both eyes of a subject in need thereof, comprising the step of administering a composition comprising a combination of demulcents including a hyaluronic acid compound and a polyethylene glycol compound (abstract, [0002] and [0132] administrating composition comprises hyaluronic acid) to the eye(s) and/or the meibomian gland(s) of the subject, which increase can be observed within 1 day or more, about 10 days or more, 20 days or more, or 30 days or more, after such administration ([0030]-[0031] treatment observed after the administration. Furthermore, the phrase regarding the observation window (1 to 30+ days) is a non-limiting functional limitation. It describes the expected clinical result of the preceding administration step rather than an actual step, and therefore does not impart patentable weight to the claim.).
Aberg does not expressly teach the composition comprising a polyethylene glycol compound, though Aberg teaches humectants including polyethylene glycol could be used in all formulations mentioned herein ([0090]).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Aberg to incorporate the teachings of Aberg and provides the composition as claimed for the purpose of increasing water-holding capacity of ocular tissues and providing desired viscosity for topical administration as taught by Aberg ([0090, 0100 and 0116]).
Regarding Claim 4, Aberg teaches a method of increasing tear film break up time in one or both eyes of a subject in need thereof, comprising the step of administrating a composition comprising a combination of demulcents including a hyaluronic acid compound and a polyethylene glycol compound (abstract, [0002] and [0132] administrating composition comprises hyaluronic acid) to the eye(s), lacrimal gland(s) and/or the meibomian gland(s) of the subject, which increase can be observed within (or after) 1 day or more, 10 days or more, 20 days or more, or 30 days or more, after such administration ([0030]-[0031] treatment observed after the administration. Furthermore, the phrase regarding the observation window (1 to 30+ days) is a non-limiting functional limitation. It describes the expected clinical result of the preceding administration step rather than an actual step, and therefore does not impart patentable weight to the claim.).
Aberg does not expressly teach the composition comprising a polyethylene glycol compound, though Aberg teaches humectants including polyethylene glycol could be used in all formulations mentioned herein ([0090]).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Aberg to incorporate the teachings of Aberg and provides the composition as claimed for the purpose of increasing water-holding capacity of ocular tissues and providing desired viscosity for topical administration as taught by Aberg ([0090, 0100 and 0116]).
Regarding Claim 5, Aberg teaches a method of treating, reducing, relieving or preventing low, decreased or decreasing tear film break up times in one or both eyes of a subject in need thereof due to meibomian gland dysfunction, comprising the step of administering a composition comprising a combination of demulcents including a hyaluronic acid compound and a polyethylene glycol compound (abstract, [0002] and [0132] administrating composition comprises hyaluronic acid) eye(s), lacrimal gland(s) and/or the meibomian gland(s) of the subject, which treatment, prevention, relief or reduction can be observed within 1 day or more, 10 days or more, 20 days or more, or 30 days or more, after such administration ([0030]-[0031] treatment observed after the administration. Furthermore, the phrase regarding the observation window (1 to 30+ days) is a non-limiting functional limitation. It describes the expected clinical result of the preceding administration step rather than an actual step, and therefore does not impart patentable weight to the claim.).
Aberg does not expressly teach the composition comprising a polyethylene glycol compound, though Aberg teaches humectants including polyethylene glycol could be used in all formulations mentioned herein ([0090]).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Aberg to incorporate the teachings of Aberg and provides the composition as claimed for the purpose of increasing water-holding capacity of ocular tissues and providing desired viscosity for topical administration as taught by Aberg ([0090, 0100 and 0116]).
Regarding Claim 6, Aberg teaches a method of treating, reducing, relieving or preventing evaporative dry eye due to reduced or the inhibition or blockage of meibomian gland secretions in one or both eyes of a subject in need thereof, comprising the step of administering a composition comprising a combination of demulcents including a hyaluronic acid compound and a polyethylene glycol compound (abstract, [0002] and [0132] administrating composition comprises hyaluronic acid) to the eye(s), lacrimal gland(s) and/or the meibomian gland(s) of the subject, which treatment, prevention, relief or reduction can be observed within 1 day or more, 10 days or more, 20 days or more, or 30 days or more, after such administration ([0030]-[0031] treatment observed after the administration. Furthermore, the phrase regarding the observation window (1 to 30+ days) is a non-limiting functional limitation. It describes the expected clinical result of the preceding administration step rather than an actual step, and therefore does not impart patentable weight to the claim.).
Aberg does not expressly teach the composition comprising a polyethylene glycol compound, though Aberg teaches humectants including polyethylene glycol could be used in all formulations mentioned herein ([0090]).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Aberg to incorporate the teachings of Aberg and provides the composition as claimed for the purpose of increasing water-holding capacity of ocular tissues and providing desired viscosity for topical administration as taught by Aberg ([0090, 0100 and 0116]).
Regarding Claim 7, Aberg teaches method of preventing, reducing, relieving and/or treating meibomian gland and/or lachrymal gland dysfunction in one or both eyes of a subject in need thereof, comprising the step of administering a composition comprising a combination of demulcents including a hyaluronic acid compound and a polyethylene glycol compound (abstract, [0002] and [0132] administrating composition comprises hyaluronic acid) to the eye(s), the meibomian gland(s) and/or lachrymal glands of the subject, which treatment, prevention or reduction can be observed within 1 day or more, 10 days or more, 20 days or more, or 30 days or more, after such administration ([0030]-[0031] treatment observed after the administration. Furthermore, the phrase regarding the observation window (1 to 30+ days) is a non-limiting functional limitation. It describes the expected clinical result of the preceding administration step rather than an actual step, and therefore does not impart patentable weight to the claim.).
Aberg does not expressly teach the composition comprising a polyethylene glycol compound, though Aberg teaches humectants including polyethylene glycol could be used in all formulations mentioned herein ([0090]).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Aberg to incorporate the teachings of Aberg and provides the composition as claimed for the purpose of increasing water-holding capacity of ocular tissues and providing desired viscosity for topical administration as taught by Aberg ([0090, 0100 and 0116]).
Regarding Claim 8, Aberg teaches method of preventing, reducing, relieving and/or treating evaporative dry eye symptoms due to meibomian gland disfunction, lacrimal gland dysfunction and/or tear film instability in one or both eyes of a subject in need thereof, comprising the step of administering a composition comprising a combination of demulcents including a hyaluronic acid compound and a polyethylene glycol compound (abstract, [0002] and [0132] administrating composition comprises hyaluronic acid) to the eye(s), the meibomian gland(s) and/or lachrymal glands of the subject, which treatment, prevention or reduction can be observed within 10 days or more, 20 days or more, or 30 days or more, after such administration ([0030]-[0031] treatment observed after the administration. Furthermore, the phrase regarding the observation window (1 to 30+ days) is a non-limiting functional limitation. It describes the expected clinical result of the preceding administration step rather than an actual step, and therefore does not impart patentable weight to the claim.).
Aberg does not expressly teach the composition comprising a polyethylene glycol compound, though Aberg teaches humectants including polyethylene glycol could be used in all formulations mentioned herein ([0090]).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Aberg to incorporate the teachings of Aberg and provides the composition as claimed for the purpose of increasing water-holding capacity of ocular tissues and providing desired viscosity for topical administration as taught by Aberg ([0090, 0100 and 0116]).
Regarding Claim 9, Aberg teaches the method of claim 1.
Aberg further teaches wherein the step of administering comprises the step of administering an eye drop to the eyes in need thereof ([0133] and [0168] the composition is intended for topical administration to the eye).
Regarding Claim 10, Aberg teaches the method of claim 9.
Aberg further teaches wherein the eye drop is administered at least once per day, at least twice per day, at least 3 times per day, 3 times per day, at least four times per day, at least five per day, at least six times per day, or as needed to the eye in need thereof ([0135] one to two topical administrations daily).
Regarding Claim 11, Aberg teaches the method of claim 9.
Aberg further teaches wherein the eye drop is administered every 12 hours, every 8 hours, every 6 hours every 4 hours, or as needed ( [0135] the frequency of administration can be six administrations daily (every 4 hours)).
Regarding Claim 12, Aberg teaches the method of claim 1.
Aberg further teaches wherein the composition comprises a multipurpose cleaning, rinsing, disinfecting and storage composition, rewetting composition, or in-the-eye cleaning composition ([0094] the formula comprises a water. Administrating water to the ocular surface inherently performs the function of rewetting or cleaning the eye of foreign matter, and therefore, under the broadest reasonable interpretation, the term “rewetting composition” or “eye cleaning composition” is construed to include water), and step of administering comprises administering a drop of the composition to the eyes in need thereof ([0089] and [0168] single eye drop administered).
Regarding Claim 17, Aberg teaches the method of claim 1.
Aberg further teaches wherein the treatment, prevention, relief or reduction produces an increase in non-invasive tear film break-up time of at least 10%, 15% or 20% compared to the eye without any treatment with the compositions of the present invention (Examiner’s note: the claim recites a non-limiting functional limitation. The claim describes the expected clinical result of the preceding administration step rather than an actual step, and therefore the limitation does not impart patentable weight to the claim. Because Aberg involves the same method of claim 1, for example, administrating composition comprising hyaluronic acid and polyethylene glycol, it necessarily and inherently produces the claimed result herein).
Regarding Claim 18, Aberg teaches the method of claim 1.
Aberg further teaches wherein the treatment, prevention, relief or reduction produces an increase in NITBUT of up to about 1 seconds, at least 1 second, 2 seconds, at least 2 seconds compared to the eye without any treatment with the compositions (Examiner’s note: the claim recites a non-limiting functional limitation. The claim describes the expected clinical result of the preceding administration step rather than an actual step, and therefore the limitation does not impart patentable weight to the claim. Because Aberg involves the same method of claim 1, for example, administrating composition comprising hyaluronic acid and polyethylene glycol, it necessarily and inherently produces the claimed result herein).
Regarding Claim 19, Aberg teaches the method of claim 1.
Aberg further teaches wherein the treatment, prevention, relief or reduction produces an increase in NITBUT of at least 10% or more, at least 15% or more, at least 20% compared to an untreated eye after one day, about 10 days, about 20 days, or about 30 days of administration of the composition (Examiner’s note: the claim recites a non-limiting functional limitation. The claim describes the expected clinical result of the preceding administration step rather than an actual step, and therefore the limitation does not impart patentable weight to the claim. Because Aberg involves the same method of claim 1, for example, administrating composition comprising hyaluronic acid and polyethylene glycol, it necessarily and inherently produces the claimed result herein).
Regarding Claim 20, Aberg teaches the method of claim 1.
Aberg further teaches wherein the treatment, prevention, relief or reduction produces an increase in NITBUT which treatment, prevention or reduction is observed within (or after) 2 days, 3 days, 4 days, 5 days, 6 day, 7 days, 8 days, 9 days, 15 days, 25 days of starting administration of the composition (Examiner’s note: the claim recites a non-limiting functional limitation. The claim describes the expected clinical result of the preceding administration step rather than an actual step, and therefore the limitation does not impart patentable weight to the claim. Because Aberg involves the same method of claim 1, for example, administrating composition comprising hyaluronic acid and polyethylene glycol, it necessarily and inherently produces the claimed result herein17-20).
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Aberg et al (US 20110294897 A1) in view of Yamazaki et al (US 20190142990 A1).
Regarding claim 13, Aberg teaches the method of claim 1.
Aberg does not teach wherein the step of administering comprises administering a contact lens that has been soaked in the composition prior to administration.
In the same field of endeavor, namely a liquid preparation for contact lens comprising hydrolyzed hyaluronic acid derivative, Yamazaki teaches wherein the step of administering comprises administering a contact lens that has been soaked in the composition prior to administration ([0071] soft contact lens is immersed in a PBS solution)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Aberg to incorporate the teachings of Yamazaki and provide administering a contact lens that has been soaked in the composition prior to administration for the purpose of reducing a feeling dryness in a user during wear of soft contact lenses, as taught by Yamazaki ([0012]-[0013]). For example, adding the cleaning agent to the claimed composition would allow the lenses to absorbs the composition during cleaning, and provide prolonged release of it while worn by the user.
Regarding Claim 14, Aberg, as modified by Yamazaki, teaches the method of claim 13.
The combination does not teach wherein the contact lens is a hydrogel contact lens or a silicone hydrogel contact lens.
In the same field of endeavor, namely a liquid preparation for contact lens comprising hydrolyzed hyaluronic acid derivative, Yamazaki teaches wherein the contact lens is a hydrogel contact lens or a silicone hydrogel contact lens ([0003] Silicone hydrogel contact lenses are contact lenses developed as soft contact lenses having high oxygen permeability.).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Aberg, as modified by Yamazaki, to incorporate the teachings of Yamazaki and provide the contact lens as claimed for the purpose of providing comfortable lenses having by providing higher oxygen permeability, as taught by Yamazaki ([0003]).
Claims 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Aberg et al (US 20110294897 A1) in view of Yamazaki et al (US 20190142990 A1), and in further view of Edens et al (US 20160175457 A1).
Regarding Claim 15, Aberg, as modified by Yamazaki, teaches the method of claim 14.
The combination does not expressly teach where the contact lens is a daily disposable contact lens.
In the same field of endeavor, namely an ocular device, Edens teaches where the contact lens is a daily disposable contact lens ([0035] disposable contact lens).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Aberg, as modified by Yamazaki, to incorporate the teachings of Edens and provide the disposable contact lens for the purpose of reducing risk of infection lens-related irritation and discomfort by being replaced with new lenses, as taught by Edens ([0002]).
Regarding Claim 16, Aberg, as modified by Yamazaki, teaches the method of claims 14.
The combination further teaches wherein the contact lens is soaked in the composition ([0071])
The combination does not teach where the contact lens is reusable contact lens and the contact lens is soaked in the composition.
In the same field of endeavor, namely an ocular device, Edens teaches where the contact lens is reusable contact lens ([0038] traditional (reusable) lenses).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Aberg, as modified by Yamazaki and Edens, to incorporate the teachings of Edens and provide reusable contact lens for the purpose of lowering long-term costs.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Aberg et al (US 20110294897 A1) in view of Li et al (US 20200030394 A1)
Regarding Claim 22, Aberg teaches the method of claim 1.
Aberg does not teach wherein the composition consists essentially of Sodium Hyaluronate, Sodium Chloride, Potassium Chloride, Boric Acid, Sodium Borate, Polyethylene Glycol 400, Sodium Chlorite, and Purified Water.
In the same field of endeavor, namely compositions and method for treating the eye, Li teaches wherein the composition consists essentially of Sodium Hyaluronate, Sodium Chloride, Potassium Chloride, Boric Acid, Sodium Borate, Polyethylene Glycol 400, Sodium Chlorite, and Purified Water (see table 1, formulations comprising sodium hyaluronate, Polyethylene Glycol 400, boric acid, sodium borate, sodium chloride, potassium chloride, sodium chlorite, and purified water).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Aberg, to incorporate the teachings of Li and provide the composition as claimed to induce, promote and/or improve production/release/delivery/excretion of hyaluronic acid from and/or in the cornea, as taught by Li ([0002]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SETH HAN whose telephone number is (571)272-2545. The examiner can normally be reached M-F 0900-1700.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/S.H./ Examiner, Art Unit 3781
/PHILIP R WIEST/ Primary Examiner, Art Unit 3781