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 .
DETAILED ACTION
The office acknowledges Applicants filing of the claim amendments on 7/31/2023. Claims 3, 8, 10-12, 16-20 have been amended. Claims 1-20 are pending and are examined based on the merits herein.
Application Priority
This application filed 07/31/2023 is a Continuation in Part of 18068403, filed 12/19/2022, now U.S. 12201600.
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed on 12/16/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS is being considered by the Examiner.
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.
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.
Claim(s) 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over
Zhang (IDS: WO 2012/064766 A2) in view of Buyuktimkin et al. (IDS: WO 2011/028629 A1), Wickenhauser et al. (US 8,263,047 B2, IDS), and Riopelle et al. (IDS: J. American Academy of Dermatology, 1994, Vol. 30, Issue 5, Part 1, pp 757-767).
Zhang teaches a method of reducing pain associated with herpes zoster in the acute or eruptive phase comprising topically and locally administering a composition comprising at least 0.1 mg tetracaine/cm2 (See, the abstract, and claims 129-130). The tetracaine employed therein may be tetracaine base or salt of tetracaine, such as tetracaine hydrochloride ([0038]). In some embodiment, the amount of tetracaine in each cm2 is 0.15mg, 0.3 mg, I mg, 2mg, or 3mg ([0048]).
Zhang et al. do not teach expressly a composition comprising from about 2% to about 10% of tetracaine base or its pharmaceutically acceptable salt, and other pharmaceutically acceptable excipients.
However, Buyuktimkin et al. teach a topical composition for alleviating pain especially associated with acute herpes zoster, the composition comprising an anesthetic active ingredient, which may be tetracaine, lidocaine, prilocaine, etc. (abstract, [0066]). The amount of anesthetic active agent in the composition is in the range of 0.1% to about 20% by weight, such as 0.1, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10% by weight ([0068])
Wickenhauser et al. teach the tetracaine topical composition as topical mucosal anesthetic composition which comprises about 3 wt % to 10 wt % tetracaine in a vehicle. The vehicle includes a water soluble mucoadhesive or a combination of mucoadhesives such as a high molecular weight poly(ethylene oxide) homopolymer and a cellulose polymer. The vehicle may additionally include a penetration enhancer such as propylene glycol. The tetracaine is ground into a powder and is suspended in a plasticized hydrocarbon gel which completes the vehicle. See, the abstract. The tetracaine used in the example is in base form (col. 2, lines 12-24). In one embodiment, the poly(ethylene oxide) polymer has molecular weight of 4,000,000. When the poly (ethylene oxide) homopolymer is present in an amount of about 5 wt % and the sodium carboxymethylcellulose is present in an amount of about 4 wt %, it may be preferred that the propylene glycol be present in an amount of about 10 wt %, and wherein tetracaine is 6% by weight (col. 2, line 57 to col. 3, line 36, and example in col. 4). Wickenhauser et al. further teach that the anesthetic composition has superior properties in that it tends to stay on the application site for effective absorption of the tetracaine, which effect occurs in about three to five minutes after application. There may be a synergistic effect between the delivery vehicle and the tetracaine as the anesthetic effect (i.e., efficacy and potency of the tetracaine) is greater than was expected (col. 3, line 65 to col. 4, line 5).
Riopelle et al. teach that treatment of the pain of acute herpes zoster with topical percutaneous local anesthesia (TPLA) offer a valid strategy of providing regional analgesia in affected patients. See, page 757. The treatment is largely effective, particularly, in reduction of pain (p 760). The times and duration of the treatment various from 1-3 to over 14 days and application time from 1 time to greater than 7 times (page 762, Fig. 4).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed the invention, to arrive at the tetracaine topical percutaneous local anesthetic composition, such as those disclosed by Buyuktimkin, Wickenhauser et al., and treat acute herpes zoster or herpes zoster in general, including the patient in the eruptive phase. A person of ordinary skill in the art would have been motivated to treat acute herpes zoster or herpes zoster (e.g. eruptive phase) with tetracaine topical percutaneous local anesthetic composition with a reasonable expectation of success that the treatment would result in reducing the pain associated with herpes zoster in eruptive phase because (i) treatment of acute herpes zoster, or herpes zoster in eruptive phase, with topical percutaneous local anesthesia, tetracaine composition in particular, has been known in the art and (ii) the topical tetracaine anesthetic composition herein employed has been particularly known for its superiority in application and effective delivery of tetracaine. As to the particular concentration of tetracaine in the composition, Buyuktimkin teach alleviating pain associated with acute herpes zoster with anesthetic, e.g. tetracaine and the amount ranging from 0.1% to about 20% by weight. Wickenhauser et al. teach about 3 wt % to 10 wt % tetracaine in a vehicle. Thus one skilled in the art would have found it obvious to apply for e.g. 2-10 wt% tetracaine base topical composition in patients with herpes zoster. As to the limitation of ‘deactivating varicella zoster virus’ in a herpes zoster patient, it is noted that topical administration of the same active agent, herein tetracaine composition (e.g. 2-10 wt%) would result in the same effect of deactivating varicella zoster virus. Thus claims 1, 2, 4-7, 10-11, 17-18 are addressed.
As to claim 3, wherein the patient exhibits lesions associated with herpes zoster when initially administered the composition, it is noted that from the teachings of the prior art it is obvious that tetracaine composition is useful and administered to any and all herpes zoster patients. Hence a person skilled in the art would have found it obvious to administer topically the tetracaine base composition (2 wt%) to subjects with lesions associated with herpes zoster to provide therapeutic effects.
As to claims 8-9, pain is associated with herpes zoster subjects and is treated with tetracaine in the acute or eruptive phase (Zhang).
As to claims 12-16, a person skilled in the art would have found it obvious from Wickenhauser to formulate a composition tetracaine base composition comprising a non-aqueous vehicle, e.g. plasticized hydrocarbon gel or poly(ethylene oxide) polymer (molecular weight of 4,000,000) in an amount of about 5 wt % and the sodium carboxymethylcellulose in an amount of about 4 wt % with tetracaine is 6% by weight. It is noted that claim 12 has been interpreted that the carrier further comprises non-aqueous vehicle.
As to claim 19, it is within the skill of an artisan (e.g. physician) to administer or provide instructions to the patient to apply up to three times per day depending on the herpes zoster condition to be treated. Further the time and duration of the application of the anesthetic composition, note, "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 Adler, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1055). In instant case, the optimization of those result affecting parameters, such as the effective amount/concentration of therapeutic agents and the frequency and duration of administration through a routine experimentation would have been within the purview of ordinary skill in the art. As to claim 20, the composition formulated from the prior art contains tetracaine base as the sole active ingredient.
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of US 12201600 (‘600).
The instant claims are directed to a method of deactivating varicella zoster virus in a patient in need thereof, where the patient suffers from herpes zoster, comprising topically administering to the patient a composition comprising from about 2 wt.% to about 10 wt. % of tetracaine base or a pharmaceutically acceptable salt thereof, based on the 100% total weight of the composition. The dependent claims wherein the composition comprises a carrier comprising a non-aqueous vehicle, specific vehicles, amount etc. Also dependent claims are limited to specific amount of tetracaine base, administration regimen and tetracaine base the sole active ingredient in the composition.
600’ reference claims are to a method of reducing the number of blisters in a patient having herpes zoster in the active eruptive phase comprising topically administering to the patient a composition comprising (i) from about 2 wt % to about 10 wt. % of tetracaine base or a pharmaceutically acceptable salt thereof, based on the 100% total weight of the composition, wherein an effective amount of the composition is administered to reduce the number of blisters in said patient having herpes zoster in the active eruptive phase, wherein the administering is performed each day for one to seven contiguous days and wherein tetracaine base is the sole active ingredient in the composition; the composition comprises a carrier comprising a non-aqueous vehicle, and the non-aqueous vehicle comprises a high molecular weight poly(ethylene oxide) homopolymer, a cellulose polymer, propylene glycol and a plasticized hydrocarbon gel, wherein the administering is performed each day for one to seven contiguous days, and wherein tetracaine base is the sole active ingredient in the composition. The dependent claims wherein the composition comprises a carrier comprising a non-aqueous vehicle, specific vehicles, amount etc. Also dependent claims are limited to specific amount of tetracaine base, administration regimen and tetracaine base the sole active ingredient in the composition.
The instantly claimed method would have been obvious over the reference claims because they teach a method of reducing the number of blisters in a patient having herpes zoster in the active eruptive phase comprising topically administering to the patient a composition comprising (i) from about 2 wt % to about 10 wt. % of tetracaine base or a pharmaceutically acceptable salt thereof. Administration of the same composition comprising the same sole active agent, herein tetracaine (2-10 wt%) would result in deactivating varicella zoster virus in a herpes zoster patient in the active eruptive phase. In other words, the recited functions or benefits would have been reasonably expected upon administration of the same composition (comprising the same active agent 2-10 wt%) to herpes zoster patients. Thus claims 1-7, 20 are addressed. As to claims 8-9, the reference claims teach treating lesions. As to claims 10-11, 17-18, they are addressed by the reference claims teaching of about 2 wt % to about 10 wt. % of tetracaine base composition administration. Claims 12-16 are addressed by reference claims 3, 11-14. Claim 19 is addressed by reference claims 14-15.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to UMAMAHESWARI RAMACHANDRAN whose telephone number is (571)272-9926. The examiner can normally be reached M-F- 8:30-5:00 PM (PST).
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, Kortney Klinkel can be reached at 5712705239. 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.
/Umamaheswari Ramachandran/Primary Examiner, Art Unit 1627