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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The IDS filed on 12/21/23 and 6/10/25 have been fully considered except where references have been lined through
Response to Amendment
This action is written in response to applicant’s amendments received on 6/23/26.
The rejection of the claims under 35 USC 112(a) and (b) is overcome by amendment.
Amended claims 1-6 and 9-14 are under examination herein.
Claim Objections
Claim 11 is objected to because of the following informalities: the claim recites “…a mediator…” rather than “the mediator”. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Modified rejection necessitated by amendment. Claims 1-2, 6, 9, 11, 13, and 14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. The claim(s) recite a polypeptide, a DNA encoding the polypeptide, an enzyme preparation, and a method of allowing the laccase to act on a protein respectively. This judicial exception is not integrated into a practical application because there are no elements beyond the naturally occurring laccase and the natural DNA encoding for the laccase. The enzyme preparation and the method of allowing the laccase to act on a protein do not comprise any specific components/steps that are different from what is naturally occurring as other proteins would naturally occur with expression of the laccase by the microbe. Newly amended claim 1 now requires a mediator and/or an additive. As evidenced by DOPA, Catechin, caffeic acid, and claims 11 and 13 (appendix), these are all naturally occurring compounds (e.g., L-DOPA is a naturally occurring fungal laccase substrate; and the “additive” can include saline, which encompasses physiological salts that would naturally occur with the claimed enzyme) and therefore the new limitation of a mediator and/or additive is not sufficient to overcome the 101 rejection. Therefore, no additional elements are present that renders the claimed process markedly different from the natural product. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Step 1: This part of the eligibility analysis evaluates whether the claim falls within any
statutory category. MPEP 2106.03. The claims recite a polypeptide, a DNA encoding the polypeptide, an enzyme preparation, and allowing the laccase to act on a protein respectively. Thus, the claim is to a product, which is one of the statutory categories of invention. As discussed above, the method claim does not have any additional elements to render it different from the natural product alone.
(Step 1: YES).
Step 2A Prong One: This part of the eligibility analysis evaluates whether the claim
recites a judicial exception. As explained in MPEP 2106.04(II) and the October 2019
Update, a claim “recites” a judicial exception when the judicial exception is “set forth” or
“described” in the claim. No extra elements are present in claims 1-2, and 6. In addition, the limitation in claim 9 allowing the laccase to act on a protein does not provide any details on how to do this and therefore does not structurally limit the claims beyond the product of nature as other proteins would be co-expressed with the laccase in the microbe in its natural environment. Newly amended claim 1 now requires a mediator and/or an additive. As evidenced by DOPA, Catechin, caffeic acid, and claims 11 and 13 (appendix), these are all naturally occurring compounds and therefore the new limitation of a mediator and/or additive is not sufficient to overcome the 101 rejection. Accordingly, the claims recites a judicial exception (natural product, and a process recited at such a high level of generality as to be equivalent to the product). Accordingly, the claim recites a judicial exception, and the analysis must therefore proceed to Step 2A Prong
Two.
Step 2A Prong Two: This part of the eligibility analysis evaluates whether the claim as a
whole integrates the recited judicial exception into a practical application of the
exception. This evaluation is performed by (a) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (b) evaluating
those additional elements individually and in combination to determine whether the
claim as a whole integrates the exception into a practical application. 2019 PEG Section
III(A)(2), 84 Fed. Reg. at 54-55. The claimed product and method step does not require any additional elements that render the claimed product markedly different from the natural
counterpart. No extra elements are present in claims 1-2, and 6. The limitation of allowing the laccase to act on a protein does not provide any details on how to do this and therefore does not structurally limit the claims beyond the product of nature. Accordingly, the limitations laid out in claims 1-2, 6 and 9 do not integrate the recited judicial exception into a practical application and the claim is therefore directed to the judicial exception. Newly amended claim 1 now requires a mediator and/or an additive. As evidenced by DOPA, Catechin, caffeic acid, and claims 11 and 13 (appendix), these are all naturally occurring compounds and therefore the new limitation of a mediator and/or additive is not sufficient to overcome the 101 rejection. See MPEP 2106.05(h), discussing the administration step in Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 78
(2012) (Step 2A: YES).
Step 2B: This part of the eligibility analysis evaluates whether the claim as a whole
amounts to significantly more than the recited exception, i.e., whether any additional
element, or combination of additional elements, adds an inventive concept to the claim.
MPEP 2106.05. No extra elements are present in claims 1-2, and 6. As discussed with Step 2A prong 2, the addition of the intended step of allowing the laccase to act on a protein is at best the equivalent of merely adding the words “apply it” as the claimed process does not require any additional elements that are sufficient to amount to
significantly more than the judicial exception. Mere instructions to apply an exception cannot
provide an inventive concept (Step 2B: NO).
Claims 1-2, 6, 9, 11, 13, and 14 are not eligible.
Allowable Subject Matter
Claims 3-5 and 10-12 are 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 filed 6/23/26 have been fully considered but they are not persuasive. Applicant argues that the 101 rejection is overcome by the addition of an additive or mediator (p5). As discussed above, this limitation includes naturally occurring components and therefore is unable to overcome the 101 rejection. Recitation of specific non-natural mediators and/or additives could overcome the 101 rejection.
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 TREVOR L KANE whose telephone number is (571)272-0265. The examiner can normally be reached M-F 7:00 am-4:00pm.
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/TREVOR KANE/Examiner, Art Unit 1657
/ROBERT J YAMASAKI/Primary Examiner, Art Unit 1657
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