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
This Office Action is in response to the Applicant’s reply received 5/19/26. Claims 1 and 6 are pending and considered on the merits.
Response to Applicant’s Arguments and Amendments
In the response submitted by the Applicant the following 35 U.S.C § 103 (a) rejections are withdrawn:
Claim(s) 1-5 were 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).
Claim(s) 6 was 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).
The Applicant’s amendments limiting the immobilized enzyme comprises cyclooxygenase necessitated the above withdrawals. All arguments drawn to these rejections are now considered moot.
Claim Interpretation
The phrase “generating fluorophore from the hydrogen ion and electron” is interpreted as:
–making a fluorophore from the hydrogen ion and electron— or
---the fluorophore is made from the hydrogen ion and electron---.
And “the fluorophore” is a chemical compound capable of fluorescence. This appears in agreement with 0062 of the Specification which state “The fluorophore 200 may be any suitable type of fluorescent chemical compound capable of re-emitting light upon excitation”. The assertion of a fluorophore as a molecule is also supported by 0068-0069 of the Specification where acetylcholine and a fluorescence substance (e.g. fluorescence molecule) are reacted with a series of immobilized enzymes to produce fluorescence at ~600 nm when excited at ~550 nm.
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 remain 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”. The Specification does not provide sufficient guidance to a fluorophore that meets these two components of
The fluorophore is generated from a hydrogen ion and an electron; and
The fluorophore 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.
Response to Arguments
The Applicant argues that one of ordinary skill can readily find a fluorophore suitable for the claimed biomarker without undue experimentation. This does not appear to overcome the rejection. Initially fluorophore has to be generated from both the hydrogen ion and electron in claim 1. This is a specific chemical reaction in which both reagents are not know to fluoresce must create a compound capable of fluorescence. This information is insufficient for one of ordinary skill to understand what fluorophore is suitable for this invention.
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 and 6 remain 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 an electron. Steps 1-3 operates on the products from the previous step. However the 4th step generates a fluorophore from a hydrogen ion and an 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 to generate the fluorescence.
Response to Arguments
The Applicant argues that one of ordinary skill can readily understand the claim invention by reviewing Figs. 14B and 14D. and [0068-0069]. However neither of these show “generating fluorophore from the hydrogen ion and electron”. Instead 0068-0069 use a fluorescence substrate to generate fluorescence emission. It appears that claim 1 is missing the fluorescence substrate or some clear direction on how a hydrogen ion and election can combine to generate a fluorophore.
New Rejection Necessitated by Amendment
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 1 and 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The factors to be considered in determining whether undue experimentation is required are summarized in In re Wands, 858 F.2d 731, 737, 8 USPQd 1400, 1404 (Fed. Cir. 1988). These factors include, but are not limited to:
The breadth of the claims; and (B) The nature of the invention;
Claim 1 is amended to “introducing an immobilized enzyme comprising cyclooxygenase to the acetylcholine to convert the acetylcholine to acetate and choline”. This is interpreted as cyclooxygenase is able to split acetylcholine into choline and acetate.
The state of the prior art; (D) The level of one of ordinary skill; and (E) The level of predictability in the art;
Cyclooxygenase (EC 1.14.99.1) oxidizes arachidonate to prostaglandin as supported by ExplorEnz (Reaction) and Attiq et al. (see Fig. 1) which is not the hydrolysis reaction required to convert acetylcholine to acetate and choline. The enzyme suitable to hydrolyze acetylcholine is acetylcholine esterase (EC 3.1.1.7,) which is a different class of enzyme that catalyzes a different reaction (see ExplorEnz: Acetylcholine esterase). There is no indication in the prior art that cyclooxygenase converts acetylcholine to acetate and choline.
(F) The amount of direction provided by the inventor; and (G) The existence of working examples;
The Specification does not show an immobilized enzyme comprising cyclooxygenase converts acetylcholine to acetate and choline. The working example [0068] uses a trio of immobilized enzymes including acetylcholine esterase, horseradish peroxidase, and choline oxidase, but not cyclooxygenase to accomplish their method.
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The Applicant would require significant experimentation, without the predictability of success to enable cyclooxygenase to convert acetylcholine to acetate and choline.
In the instant case several of these factors are missing and do not provide assurance that the disclosure is enable and that undue experimentation would be needed to make and use this invention.
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.
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
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