DETAILED ACTION
Response to Amendment
Election/Restrictions
Newly submitted claims 16 and 18 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Inventions I (claims 1-3, 5, 7-15) and Inventions II are directed to related products. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed have a materially different design in the type of material of the barrel and the preparation and also the dimensions of the syringe barrel. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 16-18 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 5, 9, 13-15, and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vogt (US 2019/0201630; hereafter Vogt).
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]).
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 claim 8, Vogt discloses wherein the botulinum toxin liquid preparation comprises botulinum toxin, an amino acid, a surfactant, and an isotonic agent (see par. [0118]).
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).
In regard to claim 17, Vogt discloses wherein the botulinum toxin liquid preparation comprises botulinum toxin, an amino acid, a surfactant, and an isotonic agent; or stabilizing protein and sugar (see par. [0118]-[0019]).
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) 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Vogt in view of Mudd et al. (US 2019/0308007; hereafter Mudd).
In regard to claims 2-3, Vogt fails to explicitly disclose 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 device of Vogt 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) 9-10 rejected under 35 U.S.C. 103 as being unpatentable over Vogt in view of Jarstad et al. (US 2019/0183988; hereafter Jarstad).
In regard to claims 9-10, Vogt is silent as to wherein the amino acid is methionine and wherein the surfactant is polysorbate 20, polysorbate 40, polysorbate 60, polysorbate 80, or poloxamer.
In a similar art, Jarstad discloses a preparation of stable liquid botulinum toxin that includes methionine and polysorbate 20 (see par. [0262]).
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 methionine and polysorbate 20 as disclosed by Jarstad because it amounts to selection of a known material based on its known suitability for the purpose.
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over Vogt in view of Jarstad et al. (US 2019/0183988; hereafter Jarstad).
In regard to claim 12, Vogt fails to disclose 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 device of Vogt 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 with respect to the claim(s) have been considered but are moot because the new ground of rejection does 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 THEODORE J STIGELL whose telephone number is (571)272-8759. The examiner can normally be reached M-F 9-5:30 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, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/Primary Examiner, Art Unit 3783