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 .
Application Priority
This application filed 09/22/2021 is a 371 of PCT/US20/23539 filed on 03/19/2020 has a PRO 62/822,126 filed on 03/22/2019.
DETAILED ACTION
The Office Action is in response to the Applicant's reply filed June 5, 2025 to the non-final rejection made on March 13, 2025.
Status of the Claims
Claims 21-27, 29-33, 35-39 are pending. Claims 38-39 are withdrawn from further consideration pursuant to 37 C.F.R. 1.142(b), as being drawn to non-elected subject matter. The claim corresponding to the elected subject matter is claims 21-27, 29-33, 35-37 and is herein acted on the merits.
Information Disclosure Statement
No new information disclosure statement(s) (IDS) filed.
Response to Arguments
Applicant’s arguments over the 35 U.S.C. 103(a) rejection of claims 21-23, 26-31, and 35-37 over Touitou et al. (USPN 8,911,751 B2) in view of Shahaf et al. (US Pre- Grant Publication No US 2016/0129205 A1) is persuasive in view of amendments made to the claims. The rejection is withdrawn.
Applicant’s arguments over the 35 U.S.C. 103(a) rejection of claims 24-25 and 32-33 over Touitou et al. (USPN 8,911,751 B2) in view of Shahaf et al. (US Pre- Grant Publication No US 2016/0129205 A1), as applied to claims 21-23, 26-31, and 35- 37 above, in view of Pipkin et al. (US Pre-Grant Publication No 2009/0312724 A1) is persuasive in view of amendments made to the claims. The rejection is withdrawn.
No arguments over the nonstatutory double patenting of Patent No. US11523986B2 were made. The rejection is maintained.
The following rejections are made:
Claim Objections
The numbering of claims is not in accordance with 37 CFR 1.126 which requires the original numbering of the claims to be preserved throughout the prosecution. When claims are canceled, the remaining claims must not be renumbered. When new claims are presented, they must be numbered consecutively beginning with the number next following the highest numbered claims previously presented (whether entered or not).
Misnumbered claim 29 should be renumbered 28.
Misnumbered claim 33 should be renumbered 34.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 21-23, 27, 30-31, and 36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li (US 20150342906 A1).
Li teaches an anti-sneeze formula was made of 25 mg diphenhydramine HCl in a 10 ml solvent of equal parts of water, glycerin, and propylene glycol. A mint extract was added as aroma.
Claims 21-26, 30-33, and 35, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fujimoto et al. (JP S6146451 B2).
Fujimoto et al. teaches Example 7 (wt%) comprises l-menthol 3.5%, d-camphor 3.0 , diphenhydramine 1.0, glycerin 2, propylene glycol 2, polyoxyethylene polyoxypropylene glycol ether 5%, ethanol 35, purified water 47.2, and Carbopol 940 1.3. Example 1 comprises Diphenhydramine 0.5g, d-Camphor 3.0, L-Menthol 3.5, Propylene glycol 10.0, Polyethylene glycol-1500 2.0, Polyoxyethylene (80) hydrogenated castor oil 5.0, "Carbopol 940" (Gutdrich Chemical Company, USA) 1.5, Ethanol 42.0, and Purified water 32.5
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
Claims 24-26, 32-33, and 35 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Li (US 20150342906 A1) , as applied to claims 21-23, 27, 30-31, and 36 above, in view of Fujimoto et al. (JP S6146451 B2),.
Li et al. is as discussed above.
Li et al. fails to specify polyethylene glycol in 0.5-50% by wt, and 50 mg/ml-150mg/ml of free base.
Fujimoto et al. teaches Example 7 (wt%) comprises l-menthol 3.5%, d-camphor 3.0 , diphenhydramine 1.0, glycerin 2, propylene glycol 2, polyoxyethylene polyoxypropylene glycol ether 5%, ethanol 35, purified water 47.2, and Carbopol 940 1.3. Example 1 comprises Diphenhydramine 0.5g, d-Camphor 3.0, L-Menthol 3.5, Propylene glycol 10.0, Polyethylene glycol-1500 2.0, Polyoxyethylene (80) hydrogenated castor oil 5.0, "Carbopol 940" (Gutdrich Chemical Company, USA) 1.5, Ethanol 42.0, and Purified water 32.5
Thus, it would have been obvious to a person of ordinary skill in the art, at the time of filing, to have modified the composition of Li, in order to have provided polyethylene glycol in amounts and a penetrating agent . The motivation to provided polyethylene glycol is because it is a suitable additive included for coating feel improvers or humectants as Fujimoto taught. Hence, a skilled artisan would have reasonable expectation of successfully achieving similar efficacy and results.
Claims 27 and 36 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Fujimoto et al. (JP S6146451 B2), as applied to claims 21-26, 29-33, 35, and 37 above, in view of Li (US 20150342906 A1).
Fujimoto et al. is as discussed above.
Fujimoto et al. fails to specify diphenhydramine HCl.
However, Li teaches an anti-sneeze formula was made of 25 mg diphenhydramine HCl in a 10 ml solvent of equal parts of water, glycerin, and propylene glycol. A mint extract was added as aroma. Diphenhydramine HCl is a first generation antihistamine with strong anticholinergic function used on topically on the skin and orally.
Thus, it would have been obvious to a person of ordinary skill in the art, at the time of filing, to have modified the composition of Fujimoto, in order to have provided Diphenhydramine HCl. The motivation to provided Diphenhydramine HCl is because Li taught Diphenhydramine HCl provides antihistamine with strong anticholinergic function. Hence, a skilled artisan would have reasonable expectation of successfully achieving similar efficacy and results.
Claims 29 and 37 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Li (US 20150342906 A1) , as applied to claims 21-23, 27, 30-31, and 36 further in view of JP 4863589 B2.
Li et al. is as discussed above.
Li et al. fails to specify a penetration enhancer.
JP 4863589 B2 et al. teaches aqueous formulations comprising Antihistamine component or antiallergic component: for example diphenhydramine HCL, and sugars such as oligosaccharides, eg lactulose, raffinose, pullulan etc. and can be safely used in preparations for application for outer skin or internal use such as nasal drops.
Thus, it would have been obvious to a person of ordinary skill in the art, at the time of filing, to have modified the composition of Li, in order to have provided sugars. The motivation to provide oligosaccharides is because it is a suitable sugar in in preparations for application for outer skin or internal use as JP 4863589 B2 taught. Hence, a skilled artisan would have reasonable expectation of successfully achieving similar efficacy and results.
Claims 29 and 37 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Fujimoto et al. (JP S6146451 B2), as applied to claims 21-26, 29-33, 35, and 37 above, further in view of JP 4863589 B2.
Fujimoto et al. is as discussed above.
Fujimoto et al. fails to specify a penetration enhancer.
JP 4863589 B2 et al. teaches aqueous formulations comprising Antihistamine component or antiallergic component: for example diphenhydramine HCL, and sugars such as oligosaccharides, eg lactulose, raffinose, pullulan etc. and can be safely used in preparations for application for outer skin or internal use such as nasal drops.
Thus, it would have been obvious to a person of ordinary skill in the art, at the time of filing, to have modified the composition of Fujimoto, in order to have provided sugars. The motivation to provide oligosaccharides is because it is a suitable sugar in in preparations for application for outer skin or internal use as JP 4863589 B2 taught. Hence, a skilled artisan would have reasonable expectation of successfully achieving similar efficacy and results.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/forms/. The 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 21-37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of Patent No. US11523986B2. Although the claims at issue are not identical, they are not patentably distinct from each other because they both teach diphenhydramine to a patient in need thereof, the method comprising the steps of: providing a pharmaceutical composition comprising diphenhydramine hydrochloride or diphenhydramine citrate as the sole active ingredient, at least one penetration enhancer, and an aqueous vehicle, wherein said at least one penetration enhancer is present in an amount ranging from 0.5-2.0% by weight of the composition, and wherein said at least one penetration enhancer is selected from the group consisting of chitosan oligosaccharide, sodium lauryl sulfate, sodium caprate, and combinations thereof; and wherein the pharmaceutical composition does not include liposomes, propellant, or cyclodextrin; wherein the dynamic viscosity of the composition, measured at 23° C., is between 5 and 100 cP; intranasally administering the pharmaceutical composition to the patient, wherein intranasal administration provides a Cmax value of diphenhydramine that is at least 20 ng/mL and a Tmax value of diphenhydramine that is less than or equal to five minutes following administration.
Conclusion
No claims allowed.
The arguments are not persuasive and the rejection is made FINAL.
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 extension fee 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 LAYLA SOROUSH whose telephone number is (571)272-5008. The examiner can normally be reached on Monday thru Friday; 8:30 AM to 5:00 PM EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, James Henry Alstrum-Acevedo, can be reached on (571)272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAYLA SOROUSH/ Primary Examiner, Art Unit 1622