DETAILED ACTION
Response to Amendment
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 final rejection. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/3/2026 has been entered.
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.
Claim(s) 1, 5, 7, 9-11, and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Vogt (US 2019/0201630; hereafter Vogt) in view of Jung et al. (US 2015/0165003; hereafter Jung).
In regard to claim 1, Vogt discloses a syringe formulation pre-filled with botulinum toxin (see at least the Abstract), comprising: a syringe (10) comprising a syringe barrel (12), a plunger rod (16), and a plunger stopper (14); and a botulinum toxin liquid preparation filled in the syringe (see par. [0009], [0039]-[0044]), wherein a material of the syringe barrel is glass, COC or COP (see par. [0001], [0040] and [0043]), and wherein the botulinum toxin liquid preparation does not contain albumin (see par. [0123]), wherein Vogt discloses the possibility of including a botulinum toxin, an amino acid, a surfactant, and an isotonic agent (see par. [0119]).
Vogt does not expressly teach to include all of the botulinum toxin, an amino acid, a surfactant, and an isotonic agent as is recited in claim 1.
In a similar art, Jung describes an animal protein-free botulinum toxin composition for treating a patient in need of treatment for a disease, disorder, or condition, and describes that the animal protein-free botulinum toxin composition continues to act on the patient longer than the animal protein-containing botulinum toxin composition (see Abstract), that when polysorbate 20, methionine, and optionally isoleucine are used instead of animal-derived proteins such as albumin or gelatin, the liquid pharmaceutical composition eliminates the potential risk of serum-derived pathogens or microorganisms infecting the recipient, and thus is safe for ingestion by the body, and that the use of the stabilizer polysorbate 20, methionine, and optionally isoleucine can increase the stability of the botulinum toxin composition at around 25 degrees Celsius to about 37 degrees Celsius (see par. [0047]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Vogt with the features of Jung in order to reduce the risk of infection and increase the stability of the composition.
In regard to claim 5, Vogt discloses wherein a material of the plunger stopper is isoprene rubber (IS), butadiene rubber (BR), butyl rubber, halogenated butyl rubber, styrene- butadiene rubber, or a mixture thereof (see par. [0100]).
In regard to claim 7, Vogt discloses wherein the botulinum toxin liquid preparation does not contain any animal component (see par. [0123]).
In regard to claims 9-10, Jung teaches wherein the amino acid is methionine and wherein the surfactant is polysorbate 20, polysorbate 40, polysorbate 60, polysorbate 80, or poloxamer (see par. [0044]-[0047]).
In regard to claim 11, Vogt discloses wherein the botulinum toxin liquid preparation further contains a buffer to maintain a pH of 5.5 to 7.5 (see par. [0121]).
In regard to claim 13, Vogt discloses wherein, upon storage for 2, 4, or 6 months at 25 °C, which is an accelerated test condition, the botulinum toxin liquid preparation shows an LD5o titer recovery rate of 80 % to 125 % relative to an initial value (Vogt discloses the same syringe material and composition and therefore exhibits these features).
In regard to claim 14, Vogt discloses wherein, upon storage for 2, 4, or 6 months at 25 °C, which is an accelerated test condition, the botulinum toxin liquid preparation shows a protease activity recovery rate of 80 % to 125 % relative to an initial value (Vogt discloses the same syringe material and composition and therefore exhibits these features).
In regard to claim 15, Vogt discloses wherein, upon storage for 2, 4, or 6 months at 25 °C, which is an accelerated test condition, the botulinum toxin liquid preparation shows a pH change of ± 1.0 or less relative to an initial value (Vogt discloses the same syringe material and composition and therefore exhibits these features).
Claim(s) 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Vogt and Jung in view of Mudd et al. (US 2019/0308007; hereafter Mudd).
In regard to claims 2-3, the combination fails to teach a ratio of a length to an inner diameter of the syringe barrel is 10 to 22 and wherein the inner diameter of the syringe barrel is 3.5 mm to 6.5 mm, and the length of the syringe barrel is 60 mm to 100 mm.
In a similar art, Mudd discloses a syringe pre-filled with botulinum toxin (see Fig. 1, par. [0014], [0017], and [0078]), wherein the syringe includes a ratio of a length to an inner diameter of the syringe barrel is 10 to 22 (see par. [0065]). Mudd discloses wherein the inner diameter of the syringe barrel is 3.5 mm to 6.5 mm, and the length of the syringe barrel is 60 mm to 100 mm (see par. [0065]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination with the ratio of dimensions as disclosed by Mudd because Mudd shows that such dimensions are suitable for pre-filled syringes for botulinum toxin.
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over Vogt and Jung in view of Wu et al. (US 2020/0108129; hereafter Wu).
In regard to claim 12, the combination fails to teach wherein the buffer is citrate, histidine, HEPES, arginine, acetic acid, phosphoric acid, a salt thereof, or a mixture thereof.
In a similar art, Wu discloses a preparation of stable liquid botulinum toxin that includes histidine (see par. [0278]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination with the histidine as disclosed by Wu because it amounts to selection of a known material based on its known suitability for the purpose.
Response to Arguments
Applicant's arguments filed 6/3/2026 have been fully considered but they are not persuasive.
In response to the applicant’s argument that Vogt fails to disclose a botulinum toxin liquid preparation that does not contain albumin, the examiner respectfully disagrees. Vogt discloses at par. [0123] that the liquid botulinum toxin formulation may be free of animal-derived proteins such as human serum albumin.
The other arguments are moot because the rejection has been changed to include the new Jung reference.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THEODORE J STIGELL whose telephone number is (571)272-8759. The examiner can normally be reached M-F 9-5:30 EST.
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THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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