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 .
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.
Previously presented rejection of claims 1-15, 18-24, 26, 25, 30, 31 and method claims 16, 17, rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12070501 further in view of US 20150141448.is maintained.
Base claim 1 and claim 13 of 12070501
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Instant base claim 1 and claim 29
(Previously Presented) A topical ophthalmological composition comprising: a therapeutically effective amount of a muscarinic receptor antagonist as an active pharmaceutical ingredient; and a semifluorinated alkane, as a liquid vehicle.
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Perfluorobutyl hexane is an ophthalmological liquid, and is a type of semifluorinated alkane used in eye care. It is highly purified, water-free, and preservative-free, and acts as a barrier on the surface of the eye to prevent your natural tears from evaporating too quickly. Being an alkane, it is one of commonsense. it is a non-aqueous.
Applicants arguments are not persuasive.
Stating that the office action
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overlooks the correlation and rationale provided in the previous action.
As to the whether it is
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or
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, applicant is reminded of options as per MPEP 1204 Notice of Appeal [R-01.2024] or contacting Examiner’s supervisor or Director for improper or unreasonable office actions from the Examiner.
As to the rejection invoking the teachings of 20150141448 being
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20150141448 was invoked for the limitations MCT and semifluorinated alkanes in the non-aqueous ophthalmological formulations for treating myopia and atropine.
Applicant is encouraged to use word technique: How to use it:
Press Ctrl + F (or Cmd + F) to open the search bar.
Type the word you are looking for.
The app will highlight all instances of the word.
Press Enter or use the up/down arrows in the search box to jump between matches.
The limitations noted above occur at multiple locations in the disclosure of 20150141448 .
The difference, again, is the difference in concentrations of the active reagent. Note that Atropine is well-known as active agent in ophthalmological solution. See Yazdani, J Optom. 2018 Jul-Sep;11(3):135-143. It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. The differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Accordingly, the claims do not recite an unobvious distinction over the conflicting claims. Further, a reference is relevant not only for what it expressly teaches, but also for what it would have conveyed to one of ordinary skill in the art. See In re Opprecht, 12 USPQ2d 1235, 1236 (Fed. Cir. 1989); In re Bode, 193 USPQ 12 (CCPA 1976). In light of the foregoing discussion, the Examiner finds that the claimed subject matter as a whole would have been obvious to one of ordinary skill in the art at the time the invention was made, in view of the cited references and the knowledge generally available in the art
Previously presented rejection of claims 1-15, 18-24, 26, 25, 30, 31 and method claims 16, 17, rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No.12485177 further in view of US 20150141448. is maintained.
Base claim 1 and claim 13 of 12485177
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Instant base claim 1 and claim 29
(Previously Presented) A topical ophthalmological composition comprising: a therapeutically effective amount of a muscarinic receptor antagonist as an active pharmaceutical ingredient; and a semifluorinated alkane, as a liquid vehicle.
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Perfluorobutyl hexane is an ophthalmological liquid, and is a type of semifluorinated alkane used in eye care. It is highly purified, water-free, and preservative-free, and acts as a barrier on the surface of the eye to prevent your natural tears from evaporating too quickly. Being an alkane, it is one of commonsense. it is a non-aqueous.
20150141448 was invoked for the limitations MCT and semifluorinated alkanes in the non-aqueous ophthalmological formulations for treating myopia and atropine.
Applicant is encouraged to use word technique: How to use it:
Press Ctrl + F (or Cmd + F) to open the search bar.
Type the word you are looking for.
The app will highlight all instances of the word.
Press Enter or use the up/down arrows in the search box to jump between matches.
The limitations noted above occur in 20150141448 multiple locations.
With regards to Applicants argument that 20150141448 teaches ‘laundry list’ with respect to limitations:
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Instant claims, recites the phrase ‘muscarinic receptor antagonist’ for active ingredient and ‘semifluorinated alkane’ for the vehicle. These phrases are generic umbrella terms encompassing large number of possibilities. The working examples in this case is revealing: one option for each is found in the instant working examples.
The difference, again, is the difference in concentrations of the active reagent. Note that Atropine is well-known as active agent in ophthalmological solution. See Yazdani, J Optom. 2018 Jul-Sep;11(3):135-143. It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. The differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Accordingly, the claims do not recite an unobvious distinction over the conflicting claims. Further, a reference is relevant not only for what it expressly teaches, but also for what it would have conveyed to one of ordinary skill in the art. See In re Opprecht, 12 USPQ2d 1235, 1236 (Fed. Cir. 1989); In re Bode, 193 USPQ 12 (CCPA 1976). In light of the foregoing discussion, the Examiner finds that the claimed subject matter as a whole would have been obvious to one of ordinary skill in the art at the time the invention was made, in view of the cited references and the knowledge generally available in the art
Claim 1-15, 18-24, 26, 25, 30, 31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 25-41 of copending Application No.19441283 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the active and inactive ingredient as well as the treated diseases are the same in conflicting claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lallemand, Cyclosporine A delivery to the eye: A comprehensive review of academic and industrial efforts, European Journal of Pharmaceutics and Biopharmaceutics, Volume 117, August 2017, Pages 14-28.
Feldman, Understanding ‘Evergreening’ : Making Minor Modifications Of Existing Medications To Extend Protections, Health Affairs June 2022 41:6, 801-804
Dwivedi, Evergreening: A deceptive device in patent rights, Technology in Society 32 (2010) 324–330.
Yazdani, J Optom. 2018 Jul-Sep;11(3):135-143
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.
Previously presented rejection of claim(s) 1-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Leo WO2020074697 and Carlson WO2020160493 (2020-08-06) and Gunther US 20200268682 is maintained.
Applicant arguments focuses on the diseases being treated with the language opiates in the Leo and Gunther references. Further Carlson teaches only the disease. The citations do not teach the effective amount.
Response:
Applicants arguments are not persuasive.
Underlying the rejection is the critical limitations of ‘atropine’ active agent and the use of ‘semifluorinated alkane’ as vehicle in compositions.
Gunther, for example is invoked for the teachings with respect to ophthalmic compositions comprising semifluorinated alkanes for keratoconjunctivitis sicca. The disease is irrelevant in the claimed composition (of base claim1 ); keratoconjunctivitis is a occular disease (same as in myopia of claim 17)
Atropine and analogs in ophthalmic compositions is the focus of Carlson, see claim 24 numbered page 79, third line from bottom.
The basis of the rejection is prior art use of the combination of atropine plus semifluorinated alkane. The cited prior art references teach these.
The rejection is not under Claim Rejections - 35 USC § 102. Obviousness can be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. A reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings. (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976).
With respect to effective amount: See previous action. It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. The differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Accordingly, the claims do not recite an unobvious distinction over the prior art. Further, a reference is relevant not only for what it expressly teaches, but also for what it would have conveyed to one of ordinary skill in the art. See In re Opprecht, 12 USPQ2d 1235, 1236 (Fed. Cir. 1989); In re Bode, 193 USPQ 12 (CCPA 1976). In light of the foregoing discussion, the Examiner finds that the claimed subject matter as a whole would have been obvious to one of ordinary skill in the art at the time the invention was made, in view of the cited references and the knowledge generally available in the art. Accordingly, the claims are rejected under 35 U.S.C. § 103.
Suggestion:
Amending base claim to
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would be consistent with disclosure and good a starting point for favorable action.
MPEP 1204 Notice of Appeal [R-01.2024].
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. WO2020160493 and US20160000941; Office action 05/25/2023 in file wrapper of US Application No. 17976660; office action 01/30/2025 in file wrapper of US Application No.18768656
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 NIZAL S CHANDRAKUMAR whose telephone number is (571)272-6202. The examiner can normally be reached M-F 8-5 EST.
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, Andrew Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NIZAL S CHANDRAKUMAR/Primary Examiner, Art Unit 1625
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