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 1-12 are pending and are currently under examination.
Information Disclosure Statement
The information disclosure statement filed on 10/24/2024 has been considered. A signed copy is enclosed.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 11 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as containing subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
It is apparent that the cell line with the designation N2-42F is required to practice the claimed invention. As such they it be readily available or obtainable by a repeatable method set forth in the specification, or otherwise readily available to the public. If it is not so obtainable or available, the requirements of 35 USC 112, first paragraph, may be satisfied by a deposit of the cell line.
It is not apparent if the cell line is readily available to the public. It is noted that Applicants have referred to a deposit of the cell line, but the specification lacks the required information regarding the address of the depository.
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, 7-10, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fernandez-Salas et al (PLOS One, 7:e49516, 1-13, 2012; IDS filed 10/24/2024).
The instant claims are drawn to methods of intoxicating a cell by contacting it with a neurotoxin in a medium comprising Gt1b, N2 or B27 supplements.
Fernandez-Salas et al disclose methods where various neuronal cells (including neuro-2a cells and SiMa cells) were grown in medium and contacted with botulinum toxin (see pages 10-11). The medium for neuro-2a cells contained EMEM with GlutaMAX, NEAA, N2 supplement, and B27 supplement (see page 10). The EMEM medium for SiMa cells also included GT1b (see page 2). EMEM is known to contain L-arginine and GlutaMAX contains L-alanyl-L-glutamine.
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) 1-10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Fernandez-Salas et al (PLOS One, 7:e49516, 1-13, 2012; IDS filed 10/24/2024).
The instant claims are drawn to methods of intoxicating a cell by contacting it with a neurotoxin in a medium comprising Gt1b, N2 or B27 supplements.
Fernandez-Salas et al disclose methods where various neuronal cells (including neuro-2a cells and SiMa cells) were grown in medium and contacted with botulinum toxin (see pages 10-11). The medium for neuro-2a cells contained EMEM with GlutaMAX, NEAA, N2 supplement, and B27 supplement (see page 10). The EMEM medium for SiMa cells also included GT1b (see page 2). EMEM is known to contain L-arginine and GlutaMAX contains L-alanyl-L-glutamine.
The disclosure of Fernandez-Salas differs from the instant invention in that they do not disclose that the GT1b was in the form of a trisodium salt.
It would have been obvious to use GT1b in the trisodium salt form because there are only a few forms commercially available and one of these is the trisodium salt. As a salt, when added to solution, the ions would disassociate, leaving the GT1b free of the accompanying ion. Therefore, the various salt forms are essentially interchangeable.
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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