Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 3/3/26 has been entered.
Claims 1-18 are pending and are under examination
The indicated allowability of claims 1-18 is withdrawn in view of the newly discovered reference(s) to Hunt et al. US 8168206 10/19/2021 with priority to provisional application 60/725,126 10/6/2005.
Rejections based on the newly cited reference(s) follow.
The information disclosure statement filed 3/3/26 has been considered and initialed copies are enclosed.
Claim Rejections - 35 USC § 102
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 pre-AIA 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 –
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claim(s) 1-18 is/are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Hunt et al. US 8168206 10/19/2021 with priority to provisional application 60/725,126 10/6/2005.
Claim 1, 8-14: Hunt et al disclose a pharmaceutical composition (paragraphs 2, 64) comprising a liquid carrier (paragraph 40), wherein the liquid carrier comprises a botulinum toxin (see abstract, under background),
a non-ionic surfactant such as polysorbate 80, polysorbate 20, tween20, tween80 etc. (paragraph55),
*one or more non-reducing sugars selected from non-reducing disaccharides and a non-reducing trisaccharides including sucrose, trehalose, raffinose etc. (paragraph 46, 47, 48),
*a bulking agent such as polyols e.g. sorbitol, mannitol (see paragraph 49-51),
and
a physiologically compatible buffer (paragraph 64),
wherein the concentration of the bulking agent is in the range of 1% to 10% (see paragraph 49-51), and
wherein the concentration of the non-reducing sugar is in the range of 0.50 to 3.0% (w/v) (see paragraph 48) ,wherein the liquid carrier is formulated such that upon vacuum drying or lyophilization an amorphous solid is formed (see abstract, paragraph 1) .
Claim 2: Hunt et al disclose the botulinum toxin is a Type A toxin. See paragraph 26.
Claim 3: Hunt et al disclose the c the botulinum toxin is 150 kDa Type A toxin. See paragraph 26.
Claim 4, 6, 7, 8: Hunt et al discloses the composition comprises a viscosity-modifying agent such as a poloxamer e.g. poloxamer 188 (paragraphs 55 and 56).
Claim 4,5: Hunt et al disclose the composition further comprises a gelling agent such as a cellulose-based gelling agent e.g. hydroxyethyl cellulose etc. See paragraph 52, 53, .
Claim 6: Hunt et al disclose the composition further comprises a viscosity- modifying agent, wherein the viscosity-modifying agent is selected from one or more of polyethylene glycol. See paragraph 52.
Claim 15: Hunt et al disclose the physiologically compatible buffer is phosphate or histidine or citrate buffer. See paragraph 64.
Claim 16: Hunt et al disclose the concentration of the bulking agent is in the range of 1.5% to 7.5%. See paragraph 49-51.
Claim 17: Hunt et al disclose the concentration of the bulking agent is in the range of 2% to 6%. See paragraph 49-51.
Claim 18: Hunt et al disclose the composition according to claim 1, wherein the concentration of the bulking agent is in the range of 3% to 5%. See paragraph 49-51.
Status of Claims
Claim 1-18 are rejected.
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/OLUWATOSIN A OGUNBIYI/Primary Examiner, Art Unit 1645
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