DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Preliminary Amendments
1) Acknowledgment is made of Applicants’ preliminary amendments filed 08/13/25, 08/08/23 and 02/16/23.
Election
2) Acknowledgment is made of Applicants’ election filed 08/13/25 in response to the restriction and the species election requirement mailed 05/14/25. Applicants have elected, without traverse, invention I, and the SEQ ID NO: 1 BoNT/A-LC species or a fragment thereof with the S156G mutation therein, the PEG functional moiety species, and the BoNT/A-HC further element species.
Status of Claims
3) Claims 3-15, 19-21, 23, 25-27, 29-82, 86, 88, 89, 91-93, 95-97, 100-102, 106-108, 112, 114 and 115 have been canceled via the preliminary amendment filed 02/16/23.
Claims 1, 2, 16-18, 22, 24, 28, 83-85, 87, 90, 94, 98, 99, 103-105, 109-111, 113, 116 and 117 have been amended via the preliminary amendment filed 02/16/23.
Claims 104, 105, 109-111, 113, 116 and 117 have been canceled via the preliminary amendment filed 08/13/25.
Claims 1, 2, 16-18, 22, 24, 28, 83-85, 87, 90, 94, 98, 99 and 103 are pending.
Claims 18, 24, 83, 84, 94 and 98 are withdrawn from consideration as being directed to a non-elected invention or species. See 37 C.F.R 1.142(b) and M.P.E.P § 821.03.
Claims 1, 2, 16, 17, 22, 28, 85, 87, 90, 99 and 103 are examined on the merits.
Sequence Listing
4) Acknowledgment is made of Applicant’s substitute Sequence Listing which has been entered on 08/08/23.
Drawings
5) Acknowledgment is made of Applicants’ drawings filed 07/19/22.
Information Disclosure Statement
6) Acknowledgment is made of Applicants’ information disclosure statement filed 12/07/22. The information referred to therein has been considered and a signed copy of the same is attached to this Office Action.
Priority
7) The instant AIA application, filed 07/19/2022, is the national stage 371 application of PCT/US21/14145 filed 01/20/2021, which claims priority to 62/963,774 filed 01/21/2020.
Rejection(s) under 35 U.S.C § 112(b) or (Pre-AIA ), Second Paragraph
8) 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.
9) Claims 1, 2, 22, 28, 85, 87, 90, 99 and 103 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 inventor or a joint inventor, or for the pre-AIA the Applicant regards as the invention.
(a) Claim 1 is vague and indefinite in the recitation: “reduces immunogenicity”, because it is unclear what degree of immunogenicity is encompassed in this limitation. The term ‘reduced’ is a relative term which renders the claim indefinite. Reduces immunogenicity compared to what is not clear. The specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably appraised of the scope of the invention.
(b) The dependent claim 2 is indefinite for lacking sufficient antecedence in the limitation “fragment thereof”. See lines 1 and 2. For sufficient antecedence, it is suggested that Applicants replace said limitation with the limitation --the fragment thereof--.
(c) The dependent claim 103 is indefinite for lacking sufficient antecedence in the limitation “fragment thereof”. See line 2. For sufficient antecedence, it is suggested that Applicants replace said limitation with the limitation --the fragment thereof--.
(d) The dependent claims 22, 28, 85, 87, 90 and 99 are indefinite for lacking sufficient antecedence in the limitation “fragment thereof”. See line 1. For sufficient antecedence, it is suggested that Applicants replace said limitation with the limitation --the fragment thereof--.
(e) Claim 85 is ambiguous and indefinite in the limitation “about .... %” because it is a relative term. The term “about .... %” is not specifically defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the claim. What precise % is encompassed within the term “about. ... %” is unclear.
(f) Claim 87 is ambiguous and indefinite in the limitation ‘about’ because it is a relative term. The term “about .... oC” is not specifically defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the claim. What precise oC is encompassed within the term “about .... oC” is unclear.
(g) Claims 2, 83, 85, 87, 90, 99 and 103, which depend directly or indirectly from claim 1, are also rejected as being indefinite because of the indefiniteness identified above in the base claim.
Notice Re Prior Art Available under Both Pre-AIA and AIA
In the event the determination of the status of the application as subject to AIA 35 U.S.C § 102 and § 103 (or as subject to pre-AIA 35 U.S.C § 102 and § 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection would be the same under either status.
Claim(s) Interpretation
10) In the art rejection(s) below, the limitations “optional” and “optionally” in instant claims are interpreted as encompassing elements and/or characteristics that are optional and are not required to be present. The claim limitation “a fragment ......” of a recited element is interpreted as encompassing said element’s fragment of no specific length or size.
Rejection(s) under 35 U.S.C § 102
11) 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.
12) Claims 1, 2, 16, 17, 22, 28, 85, 87, 90, 99 and 103 are rejected under 35 U.S.C § 102(a) as being anticipated by WO 2015177312 A1.
WO 2015177312 A1 disclosed the GPGA peptide sequence, SEQ ID NO: 111, which qualifies as a fragment or a peptide consisting of amino acid residues 154-157 of Applicants’ SEQ ID NO: 1 having therein the G amino acid substitution mutation at position 156. Said sequence linked to a peptide molecule and a composition comprising the same with a pharmaceutically acceptable carrier are taught. See the paragraph and the sentence bridging pages 15 and 16; and pages 16 and 47. Since the prior art the GPGA peptide sequence as disclosed meets the structure of a fragment of the instantly recited SEQ ID NO: 1, it is expected to possess all the same characteristics, activities and functions as those of Applicants’ fragment of SEQ ID NO: 1, i.e., reduced immunogenicity, about … percent activity relative to a fragment of a wildtype botulinum toxin light chain, and thermostability absent evidence to the contrary. All the characteristics, activities and properties of the prior art sequence are its intrinsic characteristics and properties inseparable therefrom. Two structurally identical products cannot have mutually exclusive functional properties. Note that “Products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the activities and characteristics Applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Claims 1, 2, 16, 17, 22, 28, 85, 87, 90, 99 and 103 are anticipated by WO 2015177312 A1.
Claim(s) Objection(s)
13) Claims 1, 16, 17, 85, 87 and 99 are objected to for the following reasons:
(a) Claim 1 is objected to for lacking the preceding article --a-- before each of the limitations “fragment”. See lines 1 and 4.
(b) Claim 87 is objected to for lacking the preceding article --a-- before each of the limitations “fragment”. See lines 3, 5 and 6.
(c) Claim 99 is objected to for lacking the preceding article --a-- before each of the limitations “fragment”. See lines 2 and 4.
(d) Claims 16 and 17 are objected to for lacking the preceding article --a-- before the limitation “fragment”. See line 2.
(e) Claim 85 is objected to for lacking the preceding article before each of the limitations “fragment”. See lines 3 and 5.
Conclusion
14) No claims are allowed.
Correspondence
15) Any inquiry concerning this communication or earlier communications from the Examiner should be directed to S. Devi, Ph.D., whose telephone number is (571) 272-0854. A message may be left on the Examiner’s voice mail system. The Examiner is on a flexible work schedule, however she can normally be reached Monday to Friday from 7.00 a.m. to 4.00 p.m. (EST). If attempts to reach the Examiner by telephone are unsuccessful, the Acting Supervisor of AU 1645, Vanessa Ford can be reached at (571) 272-0857. The fax phone number for the organization where this application or proceeding is assigned (571) 273-8300.
16) Information regarding the status of an application may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center or Private PAIR to authorized users only. Should you have questions about access to Patent Center or the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). 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.
/S. DEVI/
S. Devi, Ph.D.Primary Examiner
Art Unit 1645
November, 2025
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