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 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.
Claim(s) 1-4 and 6-7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by IL22583A (submitted by applicants with IDS on 9/29/24).
On page 3, Example 2, art discloses a method where pilocarpine reacted with benzoic acid to produce pilocarpine benzoate. Pilocarpine benzoate anticipated the claimed compound when R1-R5 are H and R is COOH. The disclosed method of preparation anticipates the method of claim 6. On page 5, claim 7, art discloses therapeutic preparation containing pilocarpine benzoate, which anticipates claim 7.
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.
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) 5, 8-10 and 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over IL22583A.
Scope of prior art
Art teaches that salts of pilocarpine are used for treatment of glaucoma. Art also teaches the conventional salts such as HCl or nitrate have a drawback due to their acidity (page 2, 2ng paragraph). Art teaches pilocarpine benzoate as a solution to the low pH drawback of conventional salts (page 3, paragraph 3).
Ascertaining the difference
With regards to claim 5, claimed compounds JQ-3 and JQ-6 have a methyl substituent on the benzene ring. Benzoate has a hydrogen atom in that position.
With regards to claim 8, art teaches pharmaceutical composition comprising Pilocarpine benzoate (page 5, claim 7), but does not recite the concertation of Pilocarpine benzoate in the composition.
With regards to claims 9-10 and 12-13 art teaches that pilocarpine salt can be used for treatment of glaucoma, but does not exemplify such treatment with pilocarpine benzoate.
Obviousness
Claim 5:
A person of ordinary skill in the art would have found it obvious to prepare a methylated derivative of pilocarpine benzoate. Substitution of a hydrogen atom for a methyl group on the benzoate ion be expected to result in a compound that has similar pharmacological properties as the parent compound because benzoate is there to serve as a counter ion and is not taught to be a pharmacologically active portion of the salt. Additionally, it is well established that the substitution of methyl for hydrogen on a known compound is not a patentable modification absent unexpected or unobvious results. In re Lincoln, 126 U.S. P.Q. 477, 51 U.S.P.Q. 40 (C.C.P.A. 1942); In re Druey, 319 F.2d 237, 138 U.S.P.Q. 39 (C.C.P.A. 1963); In re Lohr, 317 F.2d 388, 137 U.S.P.Q. 548 (C.C.P.A. 1963): In re Hoehsema, 399 F.2d 269, 158 US.P.Q. 598 (C.C.P.A. 1968); In re Wood, 582 F.2d 638, 199 U.S.P.Q. 137 (C.C.P.A. 1978); In re Hoke, 560 F.2d 436, 195 U.S.P.Q. 148 (C.C.P.A. 1977); Ex parte Fauque, 121 U.S.P.Q. 425 (P.O.B.A. 1954); Ex parte Henkel. 130 U.S.P.Q. 474. (P.O.B.A. 1960).
Regarding claim 8:
A person of ordinary skill in the art, prior to filing of the current application, would have found it obvious to determine through routine experimentation the optimal concertation of pilocarpine benzoate. Determining the optimal effective and safe amount of a pharmaceutical agent to include in a formulation is within the scope of routine optimization.
Regarding claims 9-10 and 12-13:
A person of ordinary skill in the art, prior to the earliest effective filing date of the current application, would have found it obvious to treat glaucoma by administering to a subject in need a composition comprising pilocarpine benzoate. Art teaches pilocarpine as having utility in treatment of glaucoma and discloses the benzoate salt as an improvement over conventional HCl and nitrate salts.
Claim(s) 11 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over IL22583A as applied to claims 9 and 10 above, and further in view of Kandula et al (WO 2019150341).
Ascertaining the difference
IL22583A teaches treatment of glaucoma by administration of pilocarpine salt, but does not recite presbyopia.
Secondary reference
Kandula teaches composition comprising a pilocarpine salt (page 50, claim 16) and it’s utility in treatment of glaucoma and presbyopia (page 50, claim 20).
Obviousness
A person of ordinary skill in the art prior to the earliest effective filing date of the current application, would have found it obvious to utilize pilocarpine benzoate of IL22583A in treatment of conditions for which administration of pilocarpine salt is indicated. Kandula teaches that presbyopia is a ocular condition that can be treated by administration of a composition comprising pilocarpine HCl. Since IL22583A teaches that the benzoate salt is preferable to chloride salt due to reduced acidity of the formulation, a skilled artisan would have found it obvious to substitute the benzoate salt for HCl salt of pilocarpine in treatment of presbyopia.
Conclusion
Claims 1-14 are pending
Claims 1-14 are rejected
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YEVGENY VALENROD whose telephone number is (571)272-9049. The examiner can normally be reached Mon-Fri 9am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached at 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/YEVGENY VALENROD/Primary Examiner, Art Unit 1628
Prosecution Insights