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/Restriction Requirement
Applicant’s election of Group I, claims 1-6, without traverse in the reply filed on 2/5/26 is acknowledged. Claims 7-11 are withdrawn as non-elected species.
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.
Claim 1-6 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.
The final step in claim 1 is “generating a fluorophore from the hydrogen ion and electron”. Claim 4 limits the hydrogen ion and electron are generated by a peroxidase. Claim 5 limits the fluorophore is excited to fluorescence. The Specification does not provide sufficient guidance to a fluorophore that meets these two components of
generated from a hydrogen ion and an electron; and
can be subsequently excited to fluorescence.
There are no specific examples of the fluorophores used in the Specification. The term is generically used in the examples. The practical applications refer to the fluorophore as the “fluorescence substrate” or simply “fluorophore” but not to a specific chemical compound by either name or structure. In particular, [0074-0075] refer to the excitation and emission wavelengths of the fluorescence substrate as well as the concentration, but only use generic terms to identify this substate. The Applicant provides no class or common structure of fluorophore that is suitable to meet requirements i)-ii). Because of this, there is insufficient written description since it is unclear what fluorophore or fluorescent substate would be suitable to execute the claimed method.
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 1-6 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 is drawn to a sequence of reactions to covert Acetylcholine to a hydrogen ion and electron. Steps 1-3 operates on the products from the previous step. However the 4th step generates a fluorophore from a hydrogen ion and a electron. It is unclear what, if anything, is added to achieve this final step since a hydrogen ion and electron, by themselves are not fluorophores, and they do not seem to combine with the prior ingredients to accomplish this step. It is unclear what are the reactants of the 4th step besides the hydrogen ion and electron that generate the fluorophore.
Claim 6 is also indefinite because it requires the fluorescence to be correlated to an inverse of a concentration of organo-phosphates. However none of the previous steps mention a concentration of organophosphates. Furthermore it is unclear at what step the organo-phosphates are included in the method.
Claim Interpretation
Considering the 35 USC 112(a) and 112(b) rejections and in the interest of compact prosecution the claims will read on any fluorescent substate that reacts and emits light with the reaction products of a peroxidase.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alfonta et al. (Anal. Chem, 2000) in view of Cranley et al. (US 7794994) in light of support by Berglund et al. (Nature, 2002).
Alfonta et al. teach a method for detecting acetylcholine using the following cascading enzyme system with acetycholine esterase (AChE), choline oxidase (ChO), and horseradish peroxidase (HRP) (Alfonta, pg. 928, col 2):
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These enzymes are linked together as a chain and immobilized on a gold electrode for electrochemcical measurments (Alfonta, pg. 929 Scheme 1).
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While the HRP reaction taught by Alfonta et al. does not expressly show “oxidizing the hydrogen peroxide to generate a hydrogen ion and electron”, this is the inherent property of the HRP oxidation as supported by Berglund et al. (see Fig 1 and 3c).
Alfonta et al. teaches their acetylcholine esterase sensor is electrochemical and does not generate a fluorophore. However this would be obvious in view of Cranley et al. who also teach electrodes with cascading enzymes systems to detect various compounds (Cranley Figs 1, 6, 9, 13, 15, 25) by amperometry. They also teach non-electrochemical means of detection including fluorescence-based detection(Cranley, col 21, lines 34-40). Specifically Cranley et al. teach using luminol-HRP system which produces a fluorophore that emits light at 425 nm when excited (e.g. reacted) by hydrogen peroxide (Cranley, 23, lines 45-60) through chemiluminescence.
It would be obvious for one of ordinary skill in the art to apply the HRP-luminol system. to Alfonta et al. since Cranley et al. teach this is a suitable alternative to electrochemical detection. One of ordinary skill would recognize this as simply substitution one means of detection compatible with HRP for another (MPEP 2141 V (B) and (D).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alfonta et al. (Anal. Chem, 2000) in view of Cranley et al. (US 7794994) as applied to claim 1-5 above, and further in view of Badawy et al. (Inter. J. Anal. Chem, 2014).
Alfonta et al. and Cranley et al. teach a method of converting acetylcholine to generate a fluorophore using cascading reactions of acetycholine esterase (AChE), choline oxidase (ChO), and horseradish peroxidase (HRP) to excite luminol. However they do not teach correlating the fluorescence to an inverse of the concentration of organo-phosphates. However this would be obvious in view of Badawy et al. who teach organo-phosphates are inhibitors to AChE (Badawy, Abstract). They teach that the % inhibition (the inverse of enzyme activity) can be plotted against the increase of organophosphate concentration (Badawy, Fig 4).
One of ordinary skill in the art would recognize that the enzyme activity of the assay by Alfonta et al. and Cranley et al. is based on fluorescence, therefore the % inhibition would be the inverse of that fluorescence measurement since the more organophosphate present, would mean less enzyme activity. Therefore it would be obvious for one of ordinary skill to correlate the fluorescent to an inverse correlation of the concentration of organophosphates.
In response to this office action the applicant should specifically point out the support for any amendments made to the disclosure, including the claims (MPEP 714.02 and 2163.06).
CONTACT INFORMATION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THANE E UNDERDAHL whose telephone number is (303) 297-4299. The examiner can normally be reached Monday through Thursday, M-F 8-5 MST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at (571) 272-3311.The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THANE UNDERDAHL/Primary Examiner, Art Unit 1699