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 .
Election/Restrictions
Applicant’s election of the invention of Group I, claims 1-13, 15, 20, and 21, and the species of SEQ ID NO: 18 and a neurotoxin translocation domain in the reply filed on 05/13/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim Status
The response of 05/13/2026 has been entered. Claims 1-13, 15, 20-21, 27, 30, 33, and 39 are pending in this US patent application. Claims 27, 30, 33, and 39 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/13/2026.
Claims 1-13, 15, and 20-21 are currently under examination and were examined on their merits.
Information Disclosure Statement
The information disclosure statement filed in this application on 07/22/2024 has been received and considered.
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 1-2, 4, 8-13, 15, and 20-21 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites a polypeptide with one or more amino acid substitutions “at one or more positions recited in Table 3.” Reference to a figure or table in a claim is permitted only in exceptional circumstances when there is no practical way to define the invention in words. In circumstances outside of those exceptional cases, reference to a table in a claim is indefinite. See MPEP § 2173.05(s).
Because claims 2, 4, 8-13, 15, and 20-21 depend from claim 1 but provide no further clarification of the indefinite language therein, these claims are also indefinite. Therefore, claims 1-2, 4, 8-13, 15, and 20-21 are rejected under 35 U.S.C. 112(b).
In the interest of compact prosecution, the Examiner has interpreted claim 1 to be identical to claim 3, which recites the sixteen amino acid positions in instant SEQ ID NO: 1 that are listed in Table 3 at which the polypeptide of claim 1 may have substitutions.
The following is a quotation of the first paragraph 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 the first paragraph of pre-AIA 35 U.S.C. 112:
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.
Claims 1-13, 15, and 20-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites a procaspase-1 cleaving polypeptide that is at least 70% identical to SEQ ID NO: 1 and comprises one or more substitutions at one or more of 16 different residues in SEQ ID NO: 1. The instant specification establishes that SEQ ID NO: 1 is a botulinum neurotoxin and has no procaspase-1 cleaving activity. The only variant of SEQ ID NO: 1 that Applicant demonstrates has any procaspase-1 cleaving activity is X(3015)8, a variant containing sixteen specific amino acid substitutions relative to SEQ ID NO: 1 that was identified through an extensive evolution process. Applicant has not disclosed the structural elements that are responsible for the function of procaspase-1 cleavage activity. As such, Applicant has not demonstrated that they have possession of any polypeptide that differs from SEQ ID NO: 1 by up to 30% and has any of sixteen different residues substituted with any other amino acid by their demonstration of one polypeptide that exhibits procaspase-1 cleavage activity and differs from SEQ ID NO: 1 only the present of sixteen specifically defined amino acid substitutions.
Therefore, claims 1-13, 15, and 20-21 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Erin M. Bowers, whose telephone number is (571)272-2897. The examiner can normally be reached Monday-Friday, 7:30-5:00.
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, Sharmila Landau, can be reached at (571)272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Erin M. Bowers/Primary Examiner, Art Unit 1653 07/21/2026
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