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 .
Claim amendments filed 6/30/2026 are acknowledged. Claims 1-11 and 13-20 are pending.
Response to Arguments
Arguments filed 6/30/2026 have been considered.
As to the 112(a) rejection, the positive recitation that there can be (permissive) a phosphate buffer is not alone sufficient to support excluding the inclusion of all other buffers (“as the only buffer”). MPEP 2173.05(i) states that “While silence will not generally suffice to support a negative claim limitation, there may be circumstances in which it can be established that a skilled artisan would understand a negative limitation to necessarily be present in a disclosure." Novartis Pharms. Corp. v. Accord Healthcare, Inc., 38 F.4th 1013, 2022 USPQ2d 569 (Fed. Cir. 2022) (quoting Ariad Pharm. Inc. v. Eli Lilly & Co., 589 F.3d 1336, 1351, 94 USPQ2d 1161, 1172).”. It is not clear that the negative limitation must necessarily be present here. The discussion of the buffer is in passing and not in detail. There is not any mention of a benefit of just a phosphate buffer or discouragement of other buffers. The rejection is maintained.
As to the new use of the transitional phrase “consisting essentially of”, MPEP 2111.03 III. states “For the purposes of searching for and applying prior art under 35 U.S.C. 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, "consisting essentially of" will be construed as equivalent to "comprising."”. The present disclosure is permissive of multiple additives and components in the composition. The main goal of the present invention is to improve hydrophilicity and wettability of the lens and high standards of comfort and biocompatibility over extended wear times (para [0004]). The prior art teaches pH and osmolality that overlaps with the claimed invention, both of which relate to biocompatibility and comfort. Newman et al. also teaches providing a comfortable experience (para [0003], [0013]) and improved wettability (Newman et al. teaches at least the presence of a tonicity agent and a wetting agent (abstract and para [0029])). It is thus not clear that any potential additional components are changing the basic characteristics of the solution in Newman from that of the present application. As the present specification is not clear what the basic and novel characteristics are beyond that of the prior art, the claims are treated as equivalent to having the transitional phrase “comprising”.
As to the limitation that the lens is “unused”, Newman teaches the solution for use with new contact lenses (unworn; at least para [0003], [0033]).
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 1-11 and 13-20 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.
Independent claims recite that the only buffers present are one or more a phosphate buffers. This is a negative limitation that excludes all other buffers. The specification does not provide literal support. Further, it does not contemplate all other buffers and thus cannot exclude all other buffers. See MPEP 2173.05(i) for the requirements to provide proper support for a negative limitation.
Dependent claims are rejected for the same reason as the claims from which they depend.
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.
Claim(s) 1-11 and 13-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Newman et al. (US 2008/0307751) in view of Gallois-Bernos et al. (US 2013/0005805).
With regards to claim 1, Newman et al. teaches a packaging system for the storage of ophthalmic devices (contact lens) comprising a sealed container containing one or more unused ophthalmic devices immersed in an aqueous packaging solution (para [0033], [0034]; abstract). The packaging solution contains one or more osmoprotectants (recites multiple polyols may be present and includes sucrose which is an exemplary one in the present specification for the osmoprotectant; instant para [0045]; Newman para [0028]-[0029]), a non ionic surfactant (para [0029]), and one or more polyol demulcents (glycerol; para [0029]). The osmolality and pH are taught to be within or overlapping the claimed ranges (abstract and para [0029], [0030]). The package is terminally sterilized with heat sterilization (para [0033]).
Newman et al. teaches that the solution can have sodium chloride, potassium chloride, and phosphate buffers (abstract; para [0030]). The buffer can also be a borate buffer (para [0030]). Phosphate or borate can be the only added buffering agents (para [0030]).
Newman teaches a non ionic surfactant but does not specify that it is a poloxamer. Gallois-Bernos et al. teaches that poloxamers such as Pluronic 127 are particularly suitable for lens packaging solutions (para [0087], [0090], [0091]). A person having ordinary skill in the art at the time the invention was effectively filed would have found it obvious to have selected a poloxamer such as Pluronic 127 as the non-ionic surfactant as it is a non-ionic surfactant taught to be particularly useful in lens packaging solutions. That it is a comfort agent is an intended use of the poloxamer. Pluronic 127 is a poloxamer of the later recited formula in claim 4 and is thus taken to be capable of functioning as a comfort agent.
With regards to claim 2, the device is a contact lens (abstract).
With regards to claim 3, Newman et al. does not teach the use of erythritol. Gallois-Bernos et al. teaches that erythritol is useful as an osmoprotectant that protects against hypertonicity (para [0036]). A person having ordinary skill in the art would have found it obvious to have used erythritol as an osmoprotectant/tonicity agent in order to protect against hypertonicity.
With regards to claim 4, Pluronic 127 is a poloxamer with the claimed copolymer formula.
With regards to claim 5, Pluronic 127 has an HLB of 22.
With regards to claim 6, the one or more polyol demulcents can be glycerol (para [0029]).
With regards to claim 7-9, Newman et al. teaches 0.1-5% total concentration of the tonicity agents in the solution (total of things such as glycerol, sucrose, erythritol). Newman is silent to the amount of the non-ionic surfactant. Gallois-Bernos et al. teaches using the nonionic surfactant at concentrations of 0.25-5%; Tween/polysorbate 80 in Table 4 and claim 20). A person having ordinary skill in the art would have found it obvious to have used amounts of the claimed components within the claimed ranges motivated by an expectation of successfully providing the glycerol, erythritol, and nonionic surfactant in a lens packaging solution. Further, a person having ordinary skill in the art would have found it obvious to have optimized the concentrations in order to get the desired osmoprotection, tonicity, and/or surfactant action.
With regards to claim 10, Newman et al. does not teach the use of a poloxamine but as set forth above teaches the use of a non ionic surfactant. Gallois-Bernos et al. teaches that a combination of poloxamine and poloxamer can be used as a surfactant in lens packaging solutions (para [0090]). A person having ordinary skill in the art would have found it obvious to have provided a combination of poloxamer and poloxamine as the non-ionic surfactant motivated by an expectation of successfully providing a non-ionic surfactant for use in the lens packaging solution.
With regards to claim 11, Newman et al. teaches that the solution can have sodium chloride and/or potassium chloride (abstract; para [0030]).
With regards to claims 13-15, Newman et al. does not teach the use of a disinfecting agent or germicide in the heat sterilized sealed package (para [0033], see whole document).
With regards to claim 16, Newman et al. teaches a method of preparing a package comprising a storable, sterile ophthalmic device, the method comprising: (a) providing an ophthalmic device (contact lens); (b) immersing the ophthalmic device in an aqueous packaging solution (solution and lens are placed in the blister container); (c) packaging the aqueous packaging solution and the ophthalmic device in a manner preventing contamination of the ophthalmic device by microorganisms (sealed); and (d) sterilizing the packaged solution and ophthalmic device (heat sterilized in an autoclave) (para [0033]).
As to the solution, The packaging solution contains one or more osmoprotectants (recites multiple polyols may be present and includes sucrose which is an exemplary one in the present specification for the osmoprotectant; instant para [0045]; Newman para [0028]-[0029]), a non ionic surfactant (para [0029]), and one or more polyol demulcents (glycerol; para [0029]). The osmolality and pH are taught to be within or overlapping the claimed ranges (abstract and para [0029], [0030]). The package is terminally sterilized with heat sterilization (para [0033]).
Newman et al. teaches that the solution can have sodium chloride, potassium chloride, and phosphate buffers (abstract; para [0030]). The buffer can also be a borate buffer (para [0030]). Phosphate or borate can be the only added buffering agents (para [0030]).
Newman teaches a non ionic surfactant but does not specify that it is a poloxamer. Gallois-Bernos et al. teaches that poloxamers such as Pluronic 127 are particularly suitable for lens packaging solutions (para [0087], [0090], [0091]). A person having ordinary skill in the art at the time the invention was effectively filed would have found it obvious to have selected a poloxamer such as Pluronic 127 as the non-ionic surfactant as it is a non-ionic surfactant taught to be particularly useful in lens packaging solutions. That it is a comfort agent is an intended use of the poloxamer. Pluronic 127 is a poloxamer of the later recited formula in claim 4 and is thus taken to be capable of functioning as a comfort agent.
With regards to claim 17, the device is a contact lens (abstract).
With regards to claim 18, Pluronic 127 is a poloxamer with the claimed copolymer formula.
With regards to claim 19, Newman et al. teaches 0.1-5% total concentration of the tonicity agents in the solution (total of things such as glycerol, sucrose, erythritol). Newman is silent to the amount of the non-ionic surfactant. Gallois-Bernos et al. teaches using the nonionic surfactant at concentrations of 0.25-5%; Tween/polysorbate 80 in Table 4 and claim 20). A person having ordinary skill in the art would have found it obvious to have used amounts of the claimed components within the claimed ranges motivated by an expectation of successfully providing the glycerol, sucrose, and nonionic surfactant in a lens packaging solution. Further, a person having ordinary skill in the art would have found it obvious to have optimized the concentrations in order to get the desired osmoprotection, tonicity, and/or surfactant action.
With regards to claim 20, Newman et al. does not teach the use of a poloxamine but as set forth above teaches the use of a non ionic surfactant. Gallois-Bernos et al. teaches that a combination of poloxamine and poloxamer can be used as a surfactant in lens packaging solutions (para [0090]). A person having ordinary skill in the art would have found it obvious to have provided a combination of poloxamer and poloxamine as the non-ionic surfactant motivated by an expectation of successfully providing a non-ionic surfactant for use in the lens packaging solution. Newman et al. teaches that the solution can have sodium chloride and potassium chloride (abstract; para [0030]).
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 DONALD R SPAMER whose telephone number is (571)272-3197. The examiner can normally be reached Monday to Friday from 9-5.
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/DONALD R SPAMER/Primary Examiner, Art Unit 1799
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