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 1-30 are presented for examination.
The amendments and remarks filed on 01/30/2026 have been received and entered.
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.
Claims 1, 8 and 29 are 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 1, 8 and 29 are indefinite in using improper Markush language.
The replacement of “Comprising” in line 3 of claim 1 with “selected from the group consisting of” will overcome the rejection.
The replacement of “comprises” in line 2 of claim 8 with “selected from the group consisting of” will overcome the rejection.
The replacement of “comprising” in line 2 of claim 29 with “selected from the group consisting of”will overcome the rejection.
The claims dependent on claims 1, 8 and 29 are also rejected, since they have all the limitations of the rejected claims.
Claim Rejections - 35 USC § 102
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4, 6, 7, 8 and 9 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Bratzler et al. (US 20190022105).
Regarding claims 1-4, Bratzler teaches a method of treating migraine in a subject in need thereof, the method comprising oral or mucosal membrane administration of a composition comprising latanoprost, isopropyl unoprostone, bimatoprost, travoprost, or tafluprost, or a pharmaceutically acceptable salt thereof, to the subject, in an amount effective to treat migraine; provided that the mucosal membrane is not an eye. See Claim 10. The nasal administration is taught in claim 15. The use of an adherence agent, such as cellulose and its derivatives is taught in Para [0031]. The use of carriers, such as propylene glycol is taught in Para [0030].
Regarding claim 6, Bratzler teaches that the composition can be in a viscous liquid. See Para [0021].
Regarding claim 7, Bratzler teaches the composition is in the form of solution, emulsion or suspension. See Para [0021].
Regarding claim 8, Bratzler teaches the use of components, such as, polyoxyethylene, carbomer, hydroxypropyl methylcellulose. See Para [0031].
Regarding claim 9, Bratzler teaches the use of drop for topical administration. See Para [0021].
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.
Claim(s) 1-11, and 19-26 and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bratzler et al. (US 20190022105) in view of Johnston et al. (WO 2014047722) and further in view of Hayreh et al. (Optic Disc Edema in Raised Intracranial Pressure).
Regarding claims 1-4, Bratzler teaches a method of treating migraine in a subject in need thereof, the method comprising oral or mucosal membrane administration of a composition comprising latanoprost, isopropyl unoprostone, bimatoprost, travoprost, or tafluprost, or a pharmaceutically acceptable salt thereof, to the subject, in an amount effective to treat migraine; provided that the mucosal membrane is not an eye. See Claim 10. The nasal administration is taught in claim 15. The use of an adherence agent, such as cellulose and its derivatives is taught in Para [0031]. The use of carriers, such as propylene glycol is taught in Para [0030]. Bratzler does not specifically teach "A nasal formulation", however, it teaches the administration to the nose as one route of administration. Therefore, it would have been obvious to a person skilled in the art to selected nasal as a route of administration in the absence of evidence to the contrary.
Regarding claim 5, Bratzler teaches the ophthalmic concentration for the claimed prostaglandins in Para [0044]-[0046]. Bratzler teaches that The dosage regimen can be determined by one of skill in the art and may vary according to factors such as the disease state, age, sex, and weight of the subject. Therefore, it would have been obvious to a person skilled in the art to determine the dosage used for nasal administration in the absence of evidence to the contrary.
Regarding claim 6, Bratzler teaches that the composition can be in a viscous liquid. See Para [0021].
Regarding claim 7, Bratzler teaches the composition is in the form of solution, emulsion or suspension. See Para [0021].
Regarding claim 8, Bratzler teaches the use of components, such as, polyoxyethylene, carbomer, hydroxypropyl methylcellulose. See Para [0031].
Regarding claim 9, Bratzler teaches the use of drop for topical administration. See Para [0021].
Regarding claim 10, Bratzler teaches the nasal spray as a mean of administering medications for treating migraine. Therefore, it would have been obvious to a person skilled in the art to employ the claimed prostaglandins in a nasal administration.
Regarding claim 11, Bratzler does not teach the higher viscosity of the nasal than an eye formulation. However, since Bratzler teaches the use of the claimed prostaglandins in a nasal formulation, the higher viscosity is the inherent property of the Bratzler's composition, which is administered by nasal administration.
Regarding claims 19 and 20, Bratzler teaches the composition of claim 1. To store a pharmaceutical composition in a container is the inherent property of being a pharmaceutical formulation, considering that such compositions have been stored routinely in a container. The intended use of a kit does not create a patentably distinct kit.
Regarding claims 23 and 24, Bratzler teaches the use of different prostaglandins in alternative and in combination. The alternative use reads on use of each of them separately.
Regarding claim 25, the transitional phrase “consisting essentially” reads on comprising in the absence of evidence that the addition of any ingredient would materially affect the nature of the claimed invention.
Regarding claim 26, Bratzler teaches that The dosage regimen can be determined by one of skill in the art and may vary according to factors such as the disease state, age, sex, and weight of the subject. Therefore, it would have been obvious to a person skilled in the art to determine the dosage used for nasal administration in the absence of evidence to the contrary.
Regarding claim 29, Bratzler teaches the use of components, such as, polyoxyethylene, carbomer, hydroxypropyl methylcellulose. See Para [0031].
Claims 12-18, 27, 28 and 30 are objected to as being dependent on a rejected claim.
Response to Arguments
Applicant’s arguments and remarks have been noted. Applicant in his remarks regarding the 112 (b)have been noted. However, the issues in claims 1, 8 and newly added 29 still exist.
Applicant’s arguments regarding anticipation rejection have been noted. Applicant in his remarks argues that “Bratzler fails to anticipate the pending claims. It is respectfully submitted that claim 1 and all dependent claims thereof require, 'A nasal formulation for at least one of increasing cerebrospinal fluid (CSF) outflow and reducing intracranial pressure (ICP) in a subject, the formulation comprising, at least one agent comprising latanoprost, latanoprost bunod, or a pharmaceutically acceptable salt thereof or a combination thereof.” It is the examiner’s position that a composition is separate than the method of use of such composition. Bratzler teaches the use of latanoprost in a pharmaceutical formulation, which can be applied to the nose in combination with the claimed polymers and diluents. Such teaching reads on the claimed composition regardless of the intended use of such composition. The obviousness rejection is maintained for the same reasons.
THIS ACTION IS MADE FINAL. 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 ZOHREH A FAY whose telephone number is (703)756-1800. The examiner can normally be reached Monday-Friday 9:30AM-6:00.
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/ZOHREH A FAY/Primary Examiner, Art Unit 1617
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