DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant's election with traverse of Group II, claims 15-27 in the reply filed 1/12/2026 is acknowledged. The traversal is on the ground(s) that Applicants argue that the WO ‘699 does not disclose treatment of elevated intraocular pressure in patients suffering from open angle glaucoma or ocular hypertension with once daily brimonidine. This is not found persuasive because Group I is directed to the composition and does not require the treatment method. WO ‘699 applies to the composition but also teaches the particle size distribution.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Group, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 1/12/2026.
INFORMATION DISCLOSURE STATEMENT
2. Information Disclosure Statements filed 6/29/2023, and 6/11/2024 are acknowledged.
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Claim Rejections- 35 USC § 102
3. 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)(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 22 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by Shah et al. (US 2022/0105102).
Shah et al. (US 2022/0105102) (hereinafter Shah et al.) disclose treatment of elevated intraocular pressure with brimonidine compositions (brimonidine tartrate) for treatment of open-angle glaucoma that are administered once daily to the eye (eye drops) (abstract, paras 0313, 0321, 0328-0332, 0334, 0340, 0510-0511, 0524, 0529, Table 3). With regards to the limitation “wherein after administration the patient achieved greater than 20 % intraocular pressure reduction from baseline which was sustained for at least 12 weeks”, the Examiner respectfully submits that since the same composition is taught the structural property would necessarily follow.
Claim Rejections- 35 USC § 103
4. 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.
Claims 15-21 and 23-27 rejected under 35 U.S.C. 103 as being unpatentable over Shah et al. (US 2022/0105102) in view of Khopade et al. (WO 2017/017699).
Shah et al. (US 2022/0105102) (hereinafter Shah et al.) disclose treatment of elevated intraocular pressure with brimonidine compositions (brimonidine tartrate) for treatment of open-angle glaucoma that are administered once daily to the eye (eye drops) (abstract, paras 0313, 0321, 0328-0332, 0334, 0340, 0510-0511, 0524, 0529, Table 3). With regards to the limitation “wherein after administration the patient achieved greater than 20 % intraocular pressure reduction from baseline which was sustained for at least 12 weeks”, the Examiner respectfully submits that since the same composition is taught the structural property would necessarily follow.
Shah et al. does not disclose brimonidine loaded nano-resin particles with a particle size distribution wherein the D90 value is between 80 to 900 nm and the D50 value is between 50-700 nm. Shah et al. discloses the concentration from about 0.5 % wt/v.
Khopade et al. WO 2017/017699- as cited on the IDS filed 6/29/2023 disclose an aqueous ophthalmic composition comprising nanoparticles of brimonidine tartrate and resin and excipients that are HPMC, PVP, Carbopol 974P, benzalkonium chloride, EDTA, N- laurolylsarcosine sodium, mannitol, tromethamine at pH 7.4. The particles have a particle size distribution such that D90 is 606 nm, D50 value is 240 nm. The formulation is for treatment of glaucoma (example 3). Khopade et al. disclose that purified nanoresins that find applicability as drug carriers where drugs can be absorbed onto the surface. Absent any evidence of criticality, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have the brimonidine tartrate of Shah et al. have the particle size distribution of Khopade et al. for the purpose of achieve pure nanoresins where drugs can be absorbed on the surface.
DOUBLE PATENTING
5. 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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined 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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 15-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 7, 9, 10-19 of U.S. Patent No. 11951106. Although the claims at issue are not identical, they are not patentably distinct from each other because both are drawn to methods of treating glaucoma in a patient the differences being the instant application recites reducing open angle glaucoma. Shah et al. (US 2022/0105102) (hereinafter Shah et al.) disclose treatment of elevated intraocular pressure with brimonidine compositions (brimonidine tartrate) for treatment of open-angle glaucoma ( a type of glaucoma) that are administered once daily to the eye (eye drops) (abstract, paras 0313, 0321, 0328-0332, 0334, 0340, 0510-0511, 0524, 0529, Table 3).
Claims 15-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 9, 11-14, 16-17, 21-22 of U.S. Patent No. 11931359. Although the claims at issue are not identical, they are not patentably distinct from each other because both are drawn to methods of treating glaucoma in a patient the differences being the instant application recites reducing open angle glaucoma. Shah et al. (US 2022/0105102) (hereinafter Shah et al.) disclose treatment of elevated intraocular pressure with brimonidine compositions (brimonidine tartrate) for treatment of open-angle glaucoma ( a type of glaucoma) that are administered once daily to the eye (eye drops) (abstract, paras 0313, 0321, 0328-0332, 0334, 0340, 0510-0511, 0524, 0529, Table 3).
Claims 15-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-14 of U.S. Patent No 12409175. Although the claims at issue are not identical, they are not patentably distinct from each other because both are drawn to methods of treating glaucoma in a patient the differences being the instant application recites reducing open angle glaucoma. Shah et al. (US 2022/0105102) (hereinafter Shah et al.) disclose treatment of elevated intraocular pressure with brimonidine compositions (brimonidine tartrate) for treatment of open-angle glaucoma ( a type of glaucoma) that are administered once daily to the eye (eye drops) (abstract, paras 0313, 0321, 0328-0332, 0334, 0340, 0510-0511, 0524, 0529, Table 3).
CORRESPONDENCE
6. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danah Al-awadi whose telephone number is (571) 270-7668. The examiner can normally be reached on 9:00 am - 6:00 pm; M-F (EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DANAH AL-AWADI/Primary Examiner, Art Unit 1615
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