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 .
Claim Status
Claims 2-5 and 20-23 are cancelled. Claims 1, and 6-19 are pending and under examination.
Priority
This application is a national stage entry of PCT/JP2021/047886 filed on 12/23/2021, which claims priority from Japanese Patent applications JP2021-146903 filed on 9/9/2021 and JP2020-215231 filed on 12/24/2020.
Objections and Rejections Withdrawn
The objection over claims 13 and 14 are withdrawn per applicant’s amendment.
The rejection under USC 112(b) over claims 1, 18, and 19 and claims 2-17 is withdrawn per applicant’s amendment to provide for application to eyelid skin.
The rejection under USC 112(b) over claims 2, 18 and 19 is withdrawn per applicant’s amendment and cancellation of claim 2.
The rejection under USC 112(b) over claim 3 is withdrawn per applicant’s cancellation of claim 3.
The rejections under USC 112(b) over claim 13 is withdrawn per applicant’s argument that “an oil and fat” would be one member of the Markush group and not the end of the group. Additionally, applicant adds a Markush group that provides for a group of higher alcohols.
The rejection under USC 102(a)(1) over CN101036659A is withdrawn per applicant’s insertion of the limitation regarding viscosity into the claim.
The rejection under USC 102(a)(1) over WO2018079721A1 is withdrawn per applicant’s insertion of the limitation regarding viscosity into the claim.
The rejection under USC 102(a)(1) over Hayashi WO2005089803A2 is withdrawn per applicant’s insertion of the limitation regarding viscosity into the claim.
The rejection under non-statutory double patenting over 18/269452 is withdrawn per applicant’s amendment to incorporate the limitation of claim 5 into claim 1.
As these rejections are withdrawn, applicant’s arguments toward these rejections are now moot.
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.
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.
Maintained Rejection – Modified As Necessitated by Amendment
Claims 1, 6, 7, 9-17 are rejected under 35 U.S.C. 103 as being unpatentable over Hayashi WO2005089803A2 and Dow US6387383B1.
Applicant amended claims 1, 18 and 19 to include an intended use statement of “for treating allergic conjunctivitis” in addition of another intended use statement of “administered to a patient once daily” into claim 1. Applicant also imported the viscosity limitation of claim 5 into these claims. Applicant amended claim 13 to now have a Markush group of higher alcohols. It was found that Dow provides for stearyl alcohol.
Hayashi teaches 10 g of epinastine hydrochloride in 1 kg of total weight of cream or ointment (examples 6, 7 and 13 of Hayashi). 10g/lkg is 1% w/w of epinastine hydrochloride. Example 6 does not include parabens. The cream in example 6 is adjusted to pH of 5. Hayashi provides for emulsions, creams, gels or ointments as a composition forms (page 13 of Hayashi). Hayashi teaches epinastine or pharmaceutical salt thereof (page 5, lines 10-16). Hayashi teaches 0.1 mg/g to 800 mg/g of crude drug for topical use (page 9). This coverts to 0.01 wt% to 80 wt% of drug. Hayashi teaches from 1 to 50 mg per 1 g dose of in equivalent quantity to epinastine HCl for topical use (page 5). This converts to 0.1 to 5 wt% of epinastine hydrochloride. The cream in example 6 also has zinc undecylenate, glycyrrhetinic acid, medium chain fatty acid triglyceride (fat), propylene glycol, glyceryl monostearate (glycerin fatty acid ester with HLB about 4), polyoxyethylene cetyl ether, diisopropyl adipate (oil), and citric acid (aliphatic carboxylic acid) and adequate amount of antiseptics. Examples 7 and 13 provide for cetanol (cetyl alcohol) in the ointment. Hayashi notes preservatives and antiseptics as optional items, but also provides for surfactant as an item (paragraph 14). The ointment in example 7 has paraffin (a wax). Hayashi provides that dose adjustment of the epinastine and crude drug may reflect age, body weight, and manifesting symptoms (page 12). Hayashi provides for topically applied once or in divided doses (page 12). Hayashi teaches treatment of skin diseases (abstract).
Hayashi does not teach an example formulation with the amounts of epinastine or salt thereof in claims 9 and 10, but does allow for an overlapping range and a near value of 1% w/w by example. Hayashi does not teach a viscosity value of claim 5 for the composition.
Dow teaches a composition for treating a skin disorder that has a viscosity less than 15000 cP (15 Pa.s) (abstract). Dow teaches the low viscosity has the advantage of being administered more accurately (abstract and summary of invention). Dow teaches cetyl alcohol or stearyl alcohol as oil phase components (top of column 6 and example X).
One of ordinary skill in the art before the time of filing would have used the overlapping ranges of Hayashi to provide other effective formulations of epinastine hydrochloride and made suitable adjustments based on the patients and symptoms to be treated as well as to provide divided doses when applicable with a reasonable expectation of success in making effective formulations for treatment with epinastine. One of ordinary skill in the art before the time of filing would have seen such viscosities as acceptable values for a topical pharmaceutical product by the teachings of Dow in making topical products of Hayashi to obtain a low viscosity with the advantage of more accurate administration. Therefore, there was a reasonable expectation of success in combining the teachings of Hayashi and Dow to obtain pharmaceutical composition of epinastine with viscosities taught by Dow that are seen as advantageous in topical administration to skin. Dow also provides the use of stearyl alcohol as a oil phase component for topical formulations.
New Rejection – As Necessitated by Applicant’s Amendment (The limitation of claim 5 being imported into claim 1)
Claim(s) 8, 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Hayashi WO2005089803A2, Dow US6387383B1 and Kellner US3536816A.
Hayashi and Dow teach the claims as discussed above.
Although Hayashi and Dow teach creams which are emulsions, it does not particularly say water-in-oil emulsion.
Kellner teaches a stable nonionic water-in-oil emulsion useful as a vehicle for cosmetic and pharmaceutical compositions (Disclosure, column 1). Kellner teaches gels, creams, ointments and the like (Disclosure, column 1 and bottom of column 5). Kellner teaches glyceryl partial esters of fatty acids (column 2). Kellner teaches suitable for skin and eyes (bottom of column 1). Kellner teaches its compositions also do not develop a disagreeable odor (column 1 to column 2). Kellner provides for adjustment of viscosity (column 5, lines 16-18).
One of ordinary skill in the art before the time of filing would have utilized water-in-oil emulsions of Kellner to make the creams of Hayashi and Dow as Kellner recognizes its water-in-oil emulsions are used to make creams and other pharmaceutical products that are stable and do not produce odors. Therefore there was a reasonable expectation of success in combining the teachings of the references to include epinastine or its salts into a water-in-oil cream composition as taught by Kellner while using amounts of epinastine taught by Hayashi and Dow to provide a more stable and less odorous product.
Response to Applicant’s Arguments Regarding the Rejection under USC 103 over Hayashi and Dow
Applicant argues that Hayashi does not teach the use for treating allergic conjunctivitis. In this product claim, the treatment of allergic conjunctivitis is toward the intended use of the composition/product, however, a product is considered for the ingredients and structure that the claim provides. If the prior art teaches and motivates a composition of applicant’s claims then it can have such a use among other uses. See MPEP 2111.02 II regarding intended use in the preamble. If this claim were “A method of treating allergic conjunctivitis comprising administering to eyelid skin of a subject in need thereof….”, then such a use would have patentable weight. Applicant’s amendment to “administered to a patient once daily” is also toward the intended use of “application” of the composition rather than providing a structural or compositional limitation to the claimed composition.
Applicant argues that Dow also does not teach administering to eyelid skin, and thus, would not motivate one to do so. Again, the claims are to a composition and not to a method of treatment. Limitations that applicant argues for the intended use of application to the eyelid skin for treatment of allergic conjunctivitis are toward the intended use of the composition (see MPEP 2111.02 II). Dow provides a motivation to adjust the formulation of Hayashi to viscosities of applicant’s claims, and thus, the teachings of Hayashi and Dow will produce a composition of applicant’s claims with the ingredients and structure that the composition claims provide with a reasonable expectation of success.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
As importing the limitation of claim 5 into claims 1, 18 and 19 changed the scope of dependent claims 8, 18 and 19, the rejection over Hayashi and Kellner was modified to also include Dow which teaches the viscosity. As the rejection under USC 103 over Hayashi and Dow is maintained, this rejection with Kellner teaches amended claims 18 and 19.
Conclusion
No claims are allowed.
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 MARK V STEVENS whose telephone number is (571)270-7080. The examiner can normally be reached M-F 9:00 am to 6:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached on (571)272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARK V STEVENS/Primary Examiner, Art Unit 1613