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 .
Specification
The amendment filed 10/2/2025 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: The addition of amino acid positions K118, K164, K289, K333 and K404 is new matter. None of these positions were recited in the originally filed claims/specification. Applicant states that the original positions (K261, K307, K432, and K547) correspond to the new matter positions K118, K164, K289, K333 and K404. However, applicant has not provided any evidence to demonstrate that the original amino acid positions correspond to the new matter positions. It is noted that the sequence listing (line <222> of SEQ ID NO: 4) states that the catalytic mutation is a Glu to Gln at position 304. Accordingly, the recitation of position E304Q is not new matter.
Applicant is required to cancel the new matter in the reply to this Office Action.
Withdrawn Rejections
The rejection of claims 4, 6, 15 and 17 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, has been withdrawn in view of applicant’s amendments to the claims to provide a reference sequence.
Claim Rejections - 35 USC § 112
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 4 and 15 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. This is a new matter rejection.
The addition of amino acid positions K118, K164, K289, K333 and K404 is new matter. None of these positions were recited in the originally filed claims/specification. Applicant states that the original positions (K261, K307, K432, and K547) correspond to the new matter positions K118, K164, K289, K333 and K404 of SEQ ID NO: 4. However, applicant has not provided any evidence to demonstrate that the original amino acid positions correspond to the new matter positions of SEQ ID NO: 4.
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 8-11 and 13-17 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 8 is directed to a method of detecting bacteria by contacting a sample with a phage tail-spike protein ΦAB6TSP and detecting a signal from the sample, where the phage tail spike protein ΦAB6TSP is fused to the signal indicator. It is not clear how bacteria are detected when the fusion protein is present. How is the signal generated? For example, if the ΦAB6TSP is fused to biotin and then added to a sample, it is not clear what signal is generated and how that signal is detected. This also affects dependent claims 9-11 and 16-17.
Claim 13 recites the limitation "The method of claim 1" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 1 is not a method claim.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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 and 2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lai et al. (PLoS ONE, 2016, 11(4): e0153361. https://doi.org/10.1371/journal.pone. 0153361).
The instant claims are directed to a fusion protein comprising a phage tail-spike protein ΦAB6TSP and a signal indicator.
Lai et al. teaches the expression and purification of ORF40 of ΦAB6. The expressed tail spike protein contained a His tag (see Materials and Methods: The resulting pET-orf40ϕAB6 plasmid was transformed into E. coli BL21 (DE3) cells. The recombinant His-tagged ORF40 protein was expressed under 0.1 mM IPTG induction at 20°C overnight then purified).
Allowable Subject Matter
Claims 3, 5 and 6 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nicole Kinsey White whose telephone number is (571)272-9943. The examiner can normally be reached M to Th 6:30 am to 6:00 pm.
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/NICOLE KINSEY WHITE/Primary Examiner, Art Unit 1672