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 .
Information Disclosure Statement
An information disclosure statement were filed 03/12/2024 and 07/30/2024.
Specification
The disclosure is objected to because of the following informalities: At page 24, between [0172] and [0173], applicant sets out “Description of the Drawings”. Applicant should amend this to “Brief Description of the Drawings”.
Appropriate correction is required.
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.
Claims 1, 3-5, 7-11 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO 95/16685 (Proctor & Gamble).
Proctor & Gamble disclose the use of the claimed compound for treatment of glaucoma (an eye condition) at page 23, lines 8-18. One of the symptoms of glaucoma is visual halos, visual starbursts, and visual glare. This section also sets out the amount of the claimed compound as being 0.01 ug/kg to 10.0 mg/kg. R’ on the compound can be a chloro- derivative according to claim 8. The claims are anticipated by Proctor and Gamble.
Claims 1, 3-5, 7-11 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US Patent No.5,478,858 (Cupps et al)
Cupps et al disclose the use of the claimed compound for treatment of glaucoma (an eye condition) at paragraph 79 and 84 and claim 20. Paragraph 79 also sets out the amount of the compound as between about 0.0001 to about 5.0%. One of the symptoms of glaucoma is visual halos, visual glare and visual starbursts. Claim 8 sets out a chloro-derivative compound. The claims are anticipated by Cupps et al.
Claim 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.
Claims 1, 2 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cupps et al in view of USPGPUB 20060233860A1 (Chang et al).
The teachings of Cupps are cited above. The claimed compound is used to treat glaucoma at the claimed concentration. Cupps fails to cite treatment of myopia and presbyopia. In a related disclosure, Chang et al cites treatment of both myopia and presbyopia using an alpha adrenergic receptor agonist at [0070. It would have been well within the skill of the ordinary practitioner to claim the instant method of treatment for both myopia and presbyopia given the teachings of Cupps et al, together with those of Chang et al with a reasonable expectation of therapeutic results in treating both myopia and presbyopia. The treatment of myopia and presbyopia would have been obvious to one of ordinary skill in the art at the time of filing given the teachings of Cupps et al in view of Chang et al.
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 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 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11,077,053(US’053). Although the claims at issue are not identical, they are not patentably distinct from each other because US’053 claims a method of treating an eye condition with the compound of Formula I in an amount of 0.01% (w/v) to 0.3%(w/v). Conditions or treatment are listed at claims 2-6, and include presbyopia, visual glare, visual starbursts, visual halos, and night myopia. A chloro- derivative is set out in claim 11. Those of ordinary skill would have expected similar therapeutic results in the same patient populations given the claims of US’053. The instant claims would have been obvious to one of ordinary skill in the art at the time of filing given the claims of US’053.
Conclusion
No claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CARLOS A AZPURU whose telephone number is (571)272-0588. The examiner can normally be reached 9 am- 3 pm, 4 pm-8pm.
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/CARLOS A AZPURU/Primary Examiner, Art Unit 1617 caz