DETAILED ACTION
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 .
Claims 1-7 are pending and are currently under examination.
Information Disclosure Statement
The information disclosure statements filed on 1/22/2024, 5/9/2024, 4/3/2025, 9/11/2025, and 12/1/2025 have been considered. Signed copies are enclosed.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(B) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4-7 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claims 4-5 are rendered indefinite by the recitation of the trademark TOYOPEARL, HYPERCEL, POROS, and ESHMUNO. If a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of the 35 U.S.C. 112, second paragraph. Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product.
Claim 6 is rendered indefinite by the phrase “culturing botulinum toxin in a culture medium”. It is not clear what is meant by this phrase. One cannot “culture” a toxin in order to grow it the way one does a cell. Applicant may intend to mean that the strain is cultured in the culture medium, but this is not what the claim reads.
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.
Claim(s) 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al (KR 10/2020/0121245; IDS filed 1/22/2024; English language equivalent: US Patent Application Publication 2022/0186201; IDS filed 1/22/2024; Note: references will be to the US PgPub) in view of Zhang et al (J. Pharmaceutical and Biomed. Analysis, 128:73-88, 2016; IDS filed 12/1/2025).
The instant claims are drawn to methods of purifying botulinum toxin comprising purifying a prepared culture solution using mixed-mode anion exchange resin followed by mixed-mode cation exchange resin.
Kim et al disclose methods of purifying botulinum toxin by culturing a solution to obtain botulinum toxin, then subjecting it to anion exchange chromatography followed by cation exchange chromatography (see abstract). The toxin can be from C. botulinum type A (see paragraph 0035).
Kim et al differs from the instant invention in that the chromatograph resins are not mixed mode resins and the specific resins listed in claims 4-5 are not disclosed.
Zhang et al disclose the use of mixed mode chromatography, which is an effective way to clean up complex sample matrices for purification (see abstract).
It would have been obvious to use mixed mode resins in the method of Kim et al because mixed mode chromatography has been shown to be an effective way to clean up complex sample matrices. With regard to the specific resins named in claims 4-5, the instant specification states that it is obvious to use any resin that has similar properties (see page 7).
One would have had a reasonable expectation of success because mixed mode chromatography is widely used in the art and, according to Kim et al, has been used in the purification of botulinum toxin (see paragraph 008).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brian J Gangle whose telephone number is (571)272-1181. The examiner can normally be reached M-F, 9-6:30.
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/BRIAN GANGLE/ Primary Examiner, Art Unit 1645
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