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
In light of the claim amendment filed on 03/17/2025, the previous rejections in the Non-final Rejected dated 12/20/2024 are withdrawn. The amendment, however, necessitates the following new rejections.
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 1 is rejected under 35 U.S.C. 103 as being unpatentable over Lowe et al. (J Am Acad Dermatol. 2002, Vol. 47, No. 6, pp. 834-840) in view of Singh et al. (Toxicon 1996, Vol. 34, No. 2, pp. 267-275) and Aoki (US20040126397A1).
Regarding claim 1, Lowe teaches intramuscularly injecting 6, 12, or 18 units (“therapeutically effective amount”) of BTX-A (botulinum toxin A) into the orbicularis oculi muscle of humans for the treatment of crow’s feet (Title and Abstract). Lowe teaches that few and mild adverse events were seen (Abstract Results), so the injection is a non-lethal amount. Lowe’s treatment comprises a first and second treatment 16 months apart (Abstract Methods). 16 weeks corresponds to a point in time when the efficacy has already declined (Figure 4b). Lowe’s patients are 46-49 years old (Table 2).
Lowe’s BTX-A is BOTOX (page 835, left column, Study Medication), which contains the neurotoxic component of botulinum toxin in complex with other proteins, so Lowe does not teach that the neurotoxic component is devoid of other protein components of the toxin complex.
Singh teaches that the neurotoxin complex has a greater immunogenicity than the neurotoxic component (Abstract).
Aoki teaches the preparation and administration of a botulinum A neurotoxin component substantially free (“devoid”) of other proteins ([0012] and Aoki claims 1-2). Aoki defines “substantially free” as less than 10% complex proteins ([0032]), which is a range that encompasses 0%. Aoki administers the neurotoxin component to treat strabismus, which is an eye muscle condition.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Lowe by replacing the botulinum toxin complex with Aoki’s neurotoxic component substantially free of other proteins in order to decrease the immunogenicity of the composition and consequently any adverse effects experienced by the patient in immunogenic reaction to the botulinum toxin A composition. The person of ordinary skill in the art would have had a reasonable expectation of success in replacing BTX-A with Aoki’s composition comprising only the neurotoxin component of botulinum toxin A (devoid of any other protein component of the Clostridium botulinum toxin complex), given that Aoki also administers the toxin into facial muscles near the eye. It would have been further obvious to decrease the time interval between the first and second botulinum injections in order to maintain the improvement in crow’s eye condition.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Lowe et al. (J Am Acad Dermatol. 2002, Vol. 47, No. 6, pp. 834-840) in view of Singh et al. (Toxicon 1996, Vol. 34, No. 2, pp. 267-275) and Aoki (US20040126397A1) as applied to claim 1 above, and further in view of Carruthers et al. (US6358917).
Regarding claim 3, Lowe, Singh and Aoki do not teach that the muscle injected is the orbicularis oris muscle (circular muscle located around the mouth) or the depressor anguli oris.
Carruthers teaches injecting botulinum toxin into the depressor anguli oris and/or orbicularis oris muscle to treat age-related wrinkles (Abstract, column 1, lines 11-16 and column 4 lines 9-10).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to add additional injection sites, the orbicularis oris and/or depressor anguli oris, as suggested by Carruthers in order to further improve the aesthetics of the aging patient. The person of ordinary skill in the art would have had a reasonable expectation of success in adding an additional injection to the orbicularis oris and/or depressor anguli oris muscles.
Response to Arguments
Applicant’s arguments with respect to claims 1-5 under 35 U.S.C. §102 and under 35 U.S.C. §103 have been considered but are moot because the new grounds of rejection do not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 LOUISE W HUMPHREY whose telephone number is (571)272-5543. The examiner can normally be reached M-F 8am-4pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Louise W Humphrey can be reached at 571-272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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LOUISE HUMPHREY
Supervisory Patent Examiner
Art Unit 1657