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 .
DETAILED ACTION
Restriction/Election
1. Applicant’s election without traverse of Group II (claims 2-4, 6, 10, 14, 18, 24, 28-29, 41-48, and 50-53) in the reply filed on 10/09/2025 is acknowledged. In response to Applicant’s species election requirement, Applicant elected without traverse the following species:
(a) cell that overexpress the receptor and/or ganglioside express more the receptor of ganglioside (instant claim 4);
(b) the cell that has been engineered to express or overexpress an enzyme of the ganglioside synthesis pathway (instant claim 14);
(c) the cell that overexpress the receptor and/or ganglioside express more the receptor of ganglioside (instant claim 41); and
(d) the cell that has been genetically engineered to express or overexpress an enzyme of the ganglioside synthesis pathway (instant claim 44).
2. Claims 1, 49, and 54 are canceled. Claims 2-4, 6, 10, 14, 18, 24, 28-29, 41-48, and 50-53 are pending. Claims 2-4, 14, 24, 28-29, 41, 44, and 46-48 are currently under consideration. Claims 6, 10, 18, 42-43, 45, and 50-53 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species.
Information Disclosure Statement
3. The information disclosure statement filed on 11/21/2024, 05/20/2024, 01/05/2024, and 12/03/2021 has been considered by the Examiner and an initialed copy of the form PTO-1449 is attached to this communication.
Drawings
4. The drawing filed on 12/03/2021 are accepted by the examiner.
Claim Rejections[Symbol font/0xBE]35 USC § 112 (b)
5. The following is a quotation of the second paragraph of 35 U.S.C. 112:
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.
6. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claims 2-3 recite “a receptor and/or ganglioside having binding affinity for the clostridial neurotoxin” in lines 4-5 (claim 2) or in lines 5-6 (claim 3). The claims recite “a receptor”, which is the broad recitation, and the claims also recite “ganglioside having binding affinity for the clostridial neurotoxin”, which is the narrower statement of the range/limitation (ganglioside is capable of acting as a receptor). The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Likewise, claims 4 and 41 are rejected on the same basis. Claims 14, 24, 28-29, 44, and 46-48 are rejected as being dependent either claim 2 or claim 3.
7. Claims 2-4, 14, 24, 28-29, 41, 44, and 46-48 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
(i). Claims 2-3 are rejected under 35 U.S.C. 112(b), as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: determining the cleavage of the indicator protein; and characterizing the activity of a clostridial neurotoxin formulation. Claims 4, 14, 24, 28-29, 41, 44, and 46-48 are rejected as being dependent either claim 2 or claim 3.
(ii). Claims 2-3 recites “therapeutic and/or cosmetic use”, and claim 3 recites “a control clostridial neurotoxin formulation”. However, it is unclear what the limitations refer to.
(iii). Claims 4 and 41 recite “… as compared with that expressed by a natural target of the clostridial neurotoxin”. It is unclear what the metes and bounds of the limitation are.
Claim Rejections[Symbol font/0xBE]35 USC § 102 (a)(1)
8. 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.
9. Claims 2-4, 24, 28, 41, and 46-47 are rejected under 35 U.S.C. 102 (a)(2) as being anticipated by WO 2009/035476 A1 (International Publication Date: 19 March 2009).
WO2009/035476 A1 teaches a method of detecting the activity of a clostridial neurotoxin (Figure 9), comprising contacting the clostridial neurotoxin (botulinum neurotoxin or BoNT) with a cell that expresses/overexpresses a clostridial neurotoxin receptor and a cleavable reporter fusion protein comprising a SNARE domain and C- and N-terminal fluorophores that can be used as FRET-partners (see, Figure 9; paragraphs [0040], [00125]-[00126], and [00130]. It is noted that the “wherein clause” recited in claims 2-3 does not represent an active step; it merely indicates the interpretation of the results. It does not limit the claims. Thus, the teachings of WO2009/035476 A1 meet the limitations of claims 2-4, 24, 28, 41, and 46-47.
Claim Rejections under 35 USC § 103(a)
10. The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
11. Claims 14, 29, 44, and 48 are rejected under 35 U.S.C. 103(a) as being unpatentable over WO 2009/035476 A1 as applied to claims 2-4, 24, 28, 41, and 46-47 above and in view of WO 2006107921 A2 (International Publication Date: 12 October 2006).
WO 2009/035476 A1 teaches a method of detecting the activity of a clostridial neurotoxin as applied to claims 2-4, 24, 28, 41, and 46-47 above.
WO 2009/035476 A1 does not teach (i) a cell that has been genetically engineered to express or overexpress an enzyme of the ganglioside synthesis pathway; (ii) the C-terminal label/the N-terminal label comprising the amino acid sequence of mScarlet, and N-terminal/C-terminal label comprising the amino acid sequence of NeonGreen.
WO 2006107921 teaches a cell that has been engineered to express one or more exogenous nucleic acid molecules encoding one or more clostridial toxin receptors. The selection of the clostridial toxin receptor depends on which clostridial toxin is to be assayed (see, e.g., paragraph [0221]). WO 2006107921 also teaches the use of Monster Green as fluorophore, which is NeonGreen (see, e.g., claims 39 and 41).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to make a cell that has been genetically engineered to express or overexpress an enzyme of the ganglioside synthesis pathway and a cell comprising an indicate protein that comprises the C-terminal label/the N-terminal label comprising the amino acid sequence of mScarlet, and N-terminal/C-terminal label comprising the amino acid sequence of NeonGreen with a reasonable expectation of success. One would have been motivated to do so because gangliosides are known to act as receptors in the art, whereas fluorophores, such as mScarlet,and NeonGreen, are routinely used in the field for detection method by one of skills in the art.
Claim Objections
12. Claims 2-4 are objected to because they use the language “and/or”.
Conclusion
13. No claims are allowed.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ruixiang Li whose telephone number is (571) 272-0875. The examiner can normally be reached on Monday through Friday from 8:30 am to 5:00 pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Vanessa Ford, can be reached on (571) 272-0857. The fax number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/RUIXIANG LI/Primary Examiner, Art Unit 1674
March 26, 2026
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