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 .
Withdrawn Rejections
The rejection of claims 4 and 15 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph has been withdrawn in view of applicant’s arguments.
The rejection of claims 1 and 2 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 https://doi.org/10.1371/journal.pone. 0153361) has been withdrawn in view of applicant’s amendments to the claims .
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 8-11, 13-15 and 17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method for detecting bacteria having Pse on the surface using signal indicators such as a chemiluminescent molecule, a fluorescent dye, a colored molecule or a radioactive isotope, does not reasonably provide enablement for a method for detecting bacteria having Pse on the surface using signal indicators such as, for example, apatite, protein A, protein G, an antibody (or fragments thereof), Ni2+ or a his tag. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
Claim 8 is directed to a method of detecting bacteria having pseudaminic acid (Pse) on a surface of the bacteria, comprising steps of:
contacting a sample suspected of containing the bacteria with a phage tail-spike protein ΦB6TSP;
separating the bacteria bound with the phage tail-spike protein ΦAB6TSP from the sample, wherein the phage tail-spike protein ΦAB6TSP is fused with a signal indicator; and
detecting a signal from the separated bacteria,
wherein the phage tail-spike protein ΦAB6TSP comprises a catalytic residue mutation.
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 apatite, protein A, protein G, an antibody (or fragments thereof), Ni2+ or a his tag and then added to a sample, it is not clear what signal is generated from the “signal indicator” and how that signal is detected.
As stated above, it is not clear how a “signal” is generated from, for example, apatite, protein A, protein G, an antibody (or fragments thereof), Ni2+ or a his tag. These components do not generate a signal on their own like a chemiluminescent molecule, a fluorescent dye, a colored molecule or a radioactive isotope. A chemiluminescent molecule, a fluorescent dye, a colored molecule or a radioactive isotope can each generate a detectable signal on their own. However, many of the other recited “signal indicators” (such as apatite, protein A, protein G, an antibody (or fragments thereof), Ni2+ or a his tag and others) cannot. Applicant has identified a few compounds, which produce a signal on their own, but essentially all of the work required to ultimately develop a signal detection system for other “signal indicators” (apatite, protein A, protein G, an antibody (or fragments thereof), Ni2+ or a his tag) has been left for others.
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, 13-15 and 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 having pseudaminic acid (Pse) on a surface of the bacteria, comprising steps of:
contacting a sample suspected of containing the bacteria with a phage tail-spike protein ΦB6TSP;
separating the bacteria bound with the phage tail-spike protein ΦAB6TSP from the sample, wherein the phage tail-spike protein ΦAB6TSP is fused with a signal indicator; and
detecting a signal from the separated bacteria,
wherein the phage tail-spike protein ΦAB6TSP comprises a catalytic residue mutation.
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 apatite, protein A, protein G, an antibody (or fragments thereof), Ni2+ or a his tag and then added to a sample, it is not clear what signal is generated from the “signal indicator” and how that signal is detected. This also affects dependent claims.
Response to Arguments
In the reply dated 4/16/2026, applicant argues that a person highly skilled in the art would understand that once a signal indicator such as biotin or a fluorescent dye is fused to the protein and localized to the target bacteria, the specific method of triggering and measuring the signal is well within the common general knowledge. Applicant’s arguments have been fully considered and not found persuasive.
As stated above, it is not clear how a “signal” is generated from, for example, apatite, protein A, protein G, an antibody (or fragments thereof), Ni2+ or a his tag. These components do not generate a signal on their own like a chemiluminescent molecule, a fluorescent dye, a colored molecule or a radioactive isotope. A chemiluminescent molecule, a fluorescent dye, a colored molecule or a radioactive isotope can each generate a detectable signal on their own. However, many of the other recited “signal indicators” (such as apatite, protein A, protein G, an antibody (or fragments thereof), Ni2+ or a his tag and others) cannot. Applicant has identified a few compounds, which produce a signal on their own, but essentially all of the work required to ultimately develop a signal detection system for other “signal indicators” (apatite, protein A, protein G, an antibody (or fragments thereof), Ni2+ or a his tag) has been left for others.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
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