DETAILED ACTION
This Office action details a final action on the merits for the above referenced application No. Claims 1 and 7-13 are pending in this application.
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 .
Status of Claims
Claims 1, 7, and 10 are amended. Claims 2-6 are cancelled
Response to Amendment
The amendments filed on 1 Jun. 2026 have been entered.
Response to Arguments
Claim Rejections - 35 USC § 112
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 7-13 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 for the reasons cited in the Office action filed on 30 Jan. 2026.
Applicants Arguments
Applicants assert that with respect of (NADP-2H) and (NADH-2H) the claims properly recite these as optional deuterium sources as fully supported by the specification.
Applicant's arguments filed 1 Jun. 2026 have been fully considered but they are not persuasive. Nicotinamide adenine dinucleotide phosphate and reduced nicotinamide adenine dinucleotide each comprise more than 1 H and it is not clear if “(NADP-2H)” and “(NADH-2H)” are examples of mono-deuterated compounds, mere abbreviations or required limitations. The dependent claims fall therewith.
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 7, and 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Medintz et al. (US 2018/0171325 A1; published 21 Jan. 2018), in view of Ascue Avalos et al. (ChemBioChem; published 2019) and Rowbotham et al. (Nat. Comm.; published 2020) for the reasons cited in the Office action filed on 30 Jan. 2026.
Claim(s) 1, 8, and 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Medintz et al. (US 2018/0171325 A1; published 21 Jan. 2018), in view of Ascue Avalos et al. (ChemBioChem; published 2019) and Klumbys et al. (Creen Chem.; published 2018) for the reasons cited in the Office action filed on 30 Jan. 2026.
Applicants Arguments
Applicants’ asset that Applicant has presented a novel and nonobvious methodology to incorporate stable isotopes into small molecules using an efficient and effective technique. Medintz does disclose the use of stable isotopes and such incorporation is not trivial but requires extensive experimentation and use of specific deuterium sources and specific enzymes as recited in the pending claims. Just because the method in Medintz is known it does not automatically follow that it can be used in all cases. Due the KIE, it would not be apparently obvious that one would still get enhancement by QDs even in the case of doing catalysts on the types of bonds. Ascue Avalos discloses subject matter completely different than the quantum dot technique. There is no motivation within Ascue Avalos which would serve as proper motivation to combine with Medintz in a manner disclosed. Rowbotham teaches a completely different method than the present application. Klumbys presents a completely different technique than the present application, Medintz and Ascue Avalos and presents no discussion of the use of deuterium in nanoparticles or small molecules. It would be inconceivable to one having ordinary skill in the art to somehow combine three references to render the present claims obvious.
Applicant's arguments filed 1 Jun. 2026 have been fully considered but they are not persuasive. Medintz provides for nanoparticle-attached enzyme cascades for accelerated multistep biocatalysts for products synthesis where Medintz teaches that the enzyme cascades as being generic and the nanoparticle allows for up to 7 generic cascade enzymes enabling rate enhanced product synthesis. At Fig. 9A, Medintz describes the nanoparticle assisted reduction of pyruvate to lactate using NADH as a reductant and LDH as an oxoreductase cascade enzyme. Rowbotham provides a method that combines a clean reductant (H2) with a cheap source of 2H-atoms (2H2O) to generate and recycle [4-2H]-NADH which can be used with an array of reductases to allow for deuteration across a range of organic molecules under ambient conditions. Accordingly, a person of ordinary skill in the art would not have been dissuaded by the KIE from using [4-2H]-NADH with reductases enzymes to deuterate organic molecules. Ascue Avalos provides or a synthesis of (+)dihydrocarvide using PETNR, CHMO, NAD+, and NADPH wherein PETNR and NADPH are used for C=C reduction to (2R,5R)-dihydrocarvone and CHMO catalyzes the NADPH dependent Baeyer-Villiger oxidation of the (2R,5R)-dihydrocarvone. Klumbys provides for a synthesis of cinnamyl alcohol via an enzyme cascade using PAL, CAR, and ADS in conjunction with NADH, and NAPH. A recognized advantage is the strongest reason to combine. See also Dystar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick, 464 F.3d 1356, 1368, 80 USPQ2d 1641, 1651 (Fed. Cir. 2006) ("Indeed, we have repeatedly held that an implicit motivation to combine exists not only when a suggestion may be gleaned from the prior art as a whole, but when the ‘improvement’ is technology-independent and the combination of references results in a product or process that is more desirable, for example because it is stronger, cheaper, cleaner, faster, lighter, smaller, more durable, or more efficient. Because the desire to enhance commercial opportunities by improving a product or process is universal—and even common-sensical—we have held that there exists in these situations a motivation to combine prior art references even absent any hint of suggestion in the references themselves."
It would have been obvious to a person ordinary skill in the art before the effective filing date to modify the method of Medintz (method that incorporates hydrogen into a target molecule by providing a nanoparticle attached to a plurality of enzymes configured as an enzyme cascade such that the product of the first enzyme is the substrate of the second enzyme and so forth a hydrogen source that is a reduced nicotinamide adenine dinucleotide and wherein the enzyme cascade comprises a reductase enzyme to utilize the hydrogen source and allows that enzyme cascade to act on the hydrogen source and source substrate thereby transferring hydrogen from the hydrogen source into a product molecule) so that hydrogen source is a deuterium source such as NADP-2H and/or NADH-2H uses enzymes comprising PETNR and/or CAR as taught by Rowbotham, Ascue Avalos and Klumbys because that would have been expected to advantageously enable deuterated (+)dihydrocarvide or cinnamyl alcohol at enhanced rate due to the nanoparticle attached plurality of enzymes. The basic technique of using deuterium sources such as NADP-2H and/or NADH-2H together with nanoparticles attached to a plurality of enzyme comprising PETNR or CAR to produce deuterated (+)dihydrocarvide or deuterated cinnamyl alcohol yielded no more than a predictable outcome which one or ordinary skill in the art would have expected to achieve and is therefore obvious.
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 SEAN R DONOHUE whose telephone number is (571)270-7441. The examiner can normally be reached on Monday - Friday, 8:00 - 5:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached on (571)272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
/SEAN R. DONOHUE/
Examiner, Art Unit 1618
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