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 .
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 1-3, 10-11, 13, 18-19, 21-22, 24, 26-27 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 claims require “a working electrode comprising one or more members of the cytochrome P450 group of enzymes” that is “configured to convert the propofol into a quinone/quinol redox pair with the oxidation of the quinol occurring after the reduction of the quinone”
First of all, as indicated in the specification – the cytochrome P450 superfamily comprises 18 superfamilies, 43 subfamilies, 57 genes and 59 pseudogenes in humans [pg.6, ll.16-17]. However, the specification repeatedly and primarily describes a sensor based on cytochrome P450 2B6 (CYP2B6) [pg. 6, ll.5-6; pg.16, ll.37-38; fig.2-3] with the particular sequencing requirement “configured to convert the propofol into a quinone/quinol redox pair with the oxidation of the quinol occurring after the reduction of the quinone” in the context of the CYP2B6 embodiment [pg. 15, ll.34-35; pg. 17, ll.1-5].
The specification mentions other CYP isoforms in passing (CYP2C9, CYP2A6, CYP2C8, CYP2C18, CYP2C19, CYP1A2 at pg.6, ll.18-20), stating that these “have been suggested” for propofol metabolism. However, no experimental data is provided showing that any CYP enzyme other than CYP2B6 produces the claimed quinone/quinol redox pair [oxidation of the quinol occurring after the reduction of the quinone] when incorporated into the claimed electrode structure. The specification even warns that “lack of specificity of CYP enzymes could potentially cause problems” and notes “2B6 is one of the less promiscuous enzymes,” [pg.6, ll.31-32] suggesting that different CYP isoforms may behave differently and unpredictably in the claimed sensor context.
As such, the claim scope extends far beyond CYP2B6 to encompass an entire enzyme superfamily, yet the specification provides possession evidence for only a single species. This is insufficient written description support for the claimed genus.
Allowable Subject Matter
Claim 8 is 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.
Response to Arguments
Applicant’s arguments submitted 5/28/26 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
THIS ACTION IS MADE FINAL. 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 Tse Chen whose telephone number is (571)272-3672. The examiner can normally be reached M-F 7-3 EST.
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/TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
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