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 .
Claims 1, 4-7, 9-16, 24 and 25 are presented for examination.
The amendments and remarks filed on 08/19/2025 have been received and entered.
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.
Claim(s) 1, 4-7, 9-16, 24 and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yamaguchi et al. (US 20150366879) in view of JP 2016179960 and further in View of Inagaki et al. (US 20170348344) and Miyake et al. (US 20160022468), Castillo et al. (US 20050158387) and Khopade et al. (20100137432).
Yamaguchi teaches an emulsion composition comprising difluprednate, which has immediate effectiveness of the preservative efficacy, can be prepared by adding antimicrobial metal. See Para [0007]. Yamaguchi teaches that the metal salt is silver, which can be silver nitrate. Yamaguchi teaches wherein the silver salt or silver complex has a silver ion concentration of not less than 0.00005 (w/v) % and not more than 0.6 (w/v) %. See Para [0035] and [0036]. The use of atonicity agent is taught in para [0038]. Yamaguchi teaches that The composition is preferably used for topical administration to the eye, nose, ear or skin, and further as an ophthalmic composition such as an eye drop and the like, a nasal drop, an ear drop or a lotion. See para [0051]. Yamaguchi makes clear that a silver salt, such as silver nitrate at the claimed concentration has been added to an ophthalmic formulation in combination with an active ingredient as a preservative. Yamaguchi differs from the claimed invention in the use of the claimed containers and the active ingredients of claims 14-15.
JP (960) teaches an ophthalmic compositions for the improvement of eye strain and/or blurry vision to be contained in a multi-dose container. The ophthalmic composition comprises rebamipide, a rebamipide salt or a rebamipide derivative , wherein the ophthalmic composition is preferably eye drops to be contained in a multi-dose container. See the abstract. JP (960) teaches that the container for storing the ophthalmic composition according to the present embodiment is made of resin, the container may be formed from only a single resin, or may be formed by combining a plurality of synthetic resins... When combining a plurality of synthetic resins, the above-mentioned synthetic resins (PET, PEN, PP, PAR, PBT, PC and PE) may be combined. In addition to the above-mentioned synthetic resins, a synthetic resin container is usually formed. You may combine the synthetic resin used. Such synthetic resins include polyester resins (polyethylene terephthalate resin, polyethylene naphthalate
resin, polybutylene terephthalate, etc.), olefin resins (polyethylene, polypropylene, etc.), polyacrylate resins, polyphenylene ether resins, polycarbonate resins, polysulfone resins. See the entire document. JP(960) makes clear that the claimed containers for storing ophthalmic formulations as old and well known.
Inagaki teaches an aqueous ophthalmic solution comprising diquafosol or a salt thereof at a concentration of 0.1% to 10% (w/v) and a chlorhexidine at a concentration of 0.0001% to 0.1% (w/v). see the abstract. Inagaki teaches that the ophthalmic solution can also be used when wearing a soft contact lens as an ophthalmic solution for a soft contact lens. Examples of soft contact lenses include contact lenses having hydroxyethyl methacrylate for the main component thereof and silicone hydrogel contact lenses. See Para [0059]. Inagaki makes clear that diquafosol in combination with a preservative has been used in an ophthalmic formulation and can be used when wearing a contact lens.
Miyake et al. teach the use of sirolimus in an ophthalmic formulation for the treatment of ophthalmic disorders. See claims 4 and 5. The use the composition by instillation is taught in claim 8. The composition being in the form of an eye drop is taught in claim 10. The use of a preservative is taught in Para [0090]. Miyake makes clear that sirolimus has been previously used in combination with a preservative in an ophthalmic formulation.
Castillo et al. teach a to topical formulations used for treating allergic and inflammatory diseases. More particularly, the present invention relates to formulations of olopatadine and their use for treating and/or preventing allergic or inflammatory disorders of the eye and nose. See Para [0003]. The use of tonicity agents is taught in Para [0020] and [0021]. Castillo teaches that The compositions of the present invention are preferably packaged in opaque plastic containers. A preferred container for an ophthalmic product is a low-density polyethylene container that has been sterilized using ethylene oxide instead of gamma-irradiation. A preferred container for a nasal product is a high-density polyethylene container equipped with a nasal spray pump. See Para [0024]. The use of sodium chloride as a tonicity adjusting agent is taught in claim 17.
Khopade et al. teach a to pharmaceutical composition suitable for ophthalmic use comprising prostaglandin derivatives. See Para [0001]. The use of a tonicity agent is taught in Para [0058]. Khopade teaches that a pharmaceutical composition suitable for ophthalmic use comprising latanoprost that shows no sorption to the low density polyethylene containers (LDPE). See Paras [0013] and [0081].
It would have been obvious toa person skilled in the art to use silver salt in an ophthalmic formulation and use muti-dose container, motivated by the JP (960), which teaches the use of the claimed containers in an ophthalmic field as old and well known. The use of the claimed active ingredients, such as, diquafosol, rebamipide and sirolimus in an ophthalmic formulation is taught by JP (960), Miyake, Inagaki. The use of an ophthalmic composition to the soft contact wearing composition is taught by Inagaki et. al. The use of the claimed tonicity agents and low density polyethylene containers in ophthalmic formulations is taught by Castillo et al. and Khopade et al. To fill any ophthalmic formulations in a low density polyethylene container would have been obvious to a person skilled in the art in the absence of evidence to the contrary.
The combination of relied upon references makes clear that silver nitrate at the claimed concentration in combination with an ophthalmic active ingredient has been previously used in an ophthalmic formulation. The references also make clear that the claimed active ingredients have been previously used in ophthalmic formulations. To substitute one ophthalmic active ingredient for another and use it in combination with silver salt would have been obvious to a person skilled in the art in the absence of evidence to the contrary. The use of the claimed containers in the ophthalmic field is taught by Castillo et al. and Khopade et al. The use of sodium chloride as a tonicity agent as claimed in claim 25 is taught by Castillo et al.
Response to arguments
Applicant’s arguments and remarks have been noted. Applicant in his remarks argues that “Amended claim 1 recites: “An ophthalmic aqueous composition comprising a silver salt and an ionic tonicity agent, the ophthalmic aqueous composition being filled in a container made of low density polyethylene.”
In Test 6 of the specification, the adsorption of silver ions onto various resins was examined. The residual rate of silver ions onto a container made of “low density polyethylene” (LDPE), according to amended claim 1, was 89%. On the other hand, the residual rate of silver ions onto a container made of polypropylene (PP) was 0%. These results show that silver ions strongly adsorb onto a container made of polypropylene (PP), but did not strongly adsorb onto a container made of LDPE. See paras. [0152]-[0157] on pp. 31-32 of the specification.
Further, in Test 7, the adsorption of silver ions onto a resin in a diquafosol sodium- containing aqueous solution was examined. When sodium chloride (an ionic tonicity agent) was added onto a container made of LDPE (Formulation 7-1), the residual rate of silver ions was 102%. On the other hand, when sodium chloride was not added onto the container made of LDPE (Formulation 7-2), the residual rate of silver ions was only 9%. These results show that silver ions do not absorb onto a resin container made of LDPE when an ionic tonicity agent (sodium chloride) was added. Accordingly, adsorption of a silver ion onto a resin container made of LDPE can be remarkably suppressed by adding an ionic tonicity agent such as sodium chloride. See paras. [0158]-[0165] of the specification” It is the examiner’s position that the prior art specifically Castillo and Khopade teach the use of ophthalmic formulations in combination with a tonicity adjusting agent being stored in low density polyethylene container. Khopade further teaches that the prostaglandin compounds did not adsorb to the low density polyethylene containers. Applicant has selected well known ophthalmic formulations and is storing them in low density polyethylene containers, which is taught by the prior art to be preferable in storing ophthalmic formulations. To compare low density polyethylene containers with other containers and showing no or small adsorption of the drug to such containers is the expected property of using LDPE containers, as it is taught by Khopade et al. Applicant further, argues each reference individually and concludes that such reference does not teach all the elements of the claimed composition. It is the examiner’s position that the rejection is an obvious rejection and not anticipation. Yamaguchi teaches the use of the claimed compounds in combination with tonicity adjusting agents. The use of LDPE containers for storing ophthalmic formulations is taught by Castillo and Khopade. Furthermore, the suppression of the adsorption of silver ions onto the container is the inherent property of Yamaguchi, which teaches the use of a silver ion in combination with a tonicity adjusting agent. Therefore, it would have been obvious to store the composition of Yamaguchi in in LDPE container, motivated by Castillo and Khopade, which both teach the use of LDPE containers in ophthalmic formulations as preferable. Additionally, to store a well- known ophthalmic composition in a specific container does not create a patentably distinct composition. The stability and lower adsorption to a container of an ophthalmic formulation reads on a method of increasing the stability of the ophthalmic formulation by using LDPE containers and not the composition itself.
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.
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/ZOHREH A FAY/Primary Examiner, Art Unit 1617