DETAILED ACTION
Status of the Application
Claims 1-2, 6-9, 12 are pending.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s amendment of claims 1-2, 6-7, 9, 12, and cancellation of claims 3-5, 10-11 as submitted in a communication filed on 5/18/2026 is acknowledged.
Applicant elected without traverse Group I, claims 1-6, drawn to a method for decolorizing a composition that comprises a pectate lyase, in a communication filed on 12/29/2025.
Claims 7-9, 12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/29/2025.
Claims 1-2 and 6 are at issue and are being examined herein.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2/24/2026 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 1 and 6 are objected to due to the recitation of “composition comprising pectate lyase”. To be grammatically correct, the term should be amended to recite “composition comprising the pectate lyase”. Appropriate correction is required.
Claim 6 is objected to due to the recitation of “90% or more of the enzymatic activity of pectate lyase”. To enhance clarity and to be consistent with commonly used claim language, the term should be amended to recite “90% or more of pectate lyase enzymatic activity”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b) or Second Paragraph (pre-AIA )
Claims 1-2 and 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 pre-AIA the applicant regards as the invention. New grounds of rejection are necessitated by amendment.
Claim 1 (claims 2 and 6 dependent thereon) is indefinite in the recitation of “the hydrogen peroxide is added to the composition comprising…lyase in an amount of 0.1M to 1 M” for the following reasons. As written, it is unclear if the concentration of 0.1 M to 1 M refers to the concentration of the hydrogen peroxide solution that is added to the composition comprising the pectate lyase, or if the concentration of 0.1 M to 1 M refers to the concentration of hydrogen peroxide in the composition comprising the pectate lyase. For examination purposes, no patentable weight will be given to the term. Correction is required.
When amending the claims, applicant is advised to carefully review all examined claims and make the necessary changes to ensure proper antecedent basis and dependency.
Claim Rejections - 35 USC § 112(a) or First Paragraph (pre-AIA )
Claims 1-2 and 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
This rejection has been discussed at length in the prior Office action. It is maintained for the reasons of record and those set forth below.
Applicant argues that Applicant has cancelled claims 3-5 and amended claim 1 to recite B. subtilis, thus rendering the instant rejection moot.
Applicant’s arguments have been fully considered but not deemed persuasive to overcome the instant rejection. The Examiner acknowledges the amendments made to the claims, including claim 1. However, the Examiner disagrees with Applicant’s contention that these amendments render the instant rejection moot.
While it is agreed that the claims now require the pectate lyase to be produced by culturing a B. subtilis, it is noted that the claims still require any pectate lyase having any structure because the B. subtilis can be a recombinant host cell that has been transformed to express any pectate lyase. The claims are not limited solely to an endogenous B. subtilis pectate lyase. While a few pectate lyases are known in the art, neither the specification nor the prior art disclose the structural features required in any pectate lyase or a structure/function correlation that would allow one of skill in the art to envision the structure of any pectate lyase. In addition, as previously indicated, it is unknown if any pectate lyase produced by a Bacillus subtilis cell, could be decolored with the defined range of concentrations of dicyandiamide and hydrogen peroxide recited in the claims without altering their enzymatic activity. Due to the fact that the specification only discloses a single species of the genus of pectate lyases to be decolored and a specific concentration range for dicyandiamide and hydrogen peroxide to avoid reducing enzymatic activity, and the lack of description of any additional species by any relevant, identifying characteristics or properties, one of skill in the art would not recognize from the disclosure that Applicant was in possession of the claimed invention.
Claims 1-2 and 6 remain rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of decolorizing a composition comprising a Bacillus subtilis pectate lyase, wherein said method comprises (a) culturing a B. subtilis cell in a medium to obtain a composition that comprises a B. subtilis pectate lyase, and (b) adding dicyandiamide and hydrogen peroxide to the composition such that the concentration of dicyandiamide in the composition is from 0.1 to 4% by weight of the composition, and the concentration of hydrogen peroxide in the composition is between 0.1 M and 1 M, does not reasonably provide enablement for a method of decolorizing a composition comprising any pectate lyase, wherein said method comprises (i) culturing any Bacillus cell in a medium to obtain a composition that comprises any pectate lyase, and (ii) adding any amount of dicyandiamide and hydrogen peroxide to the composition, wherein the enzymatic activity of said pectate lyase is not reduced compared to the composition before the addition of dicyandiamide and hydrogen peroxide. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
This rejection has been discussed at length in the prior Office action. It is maintained for the reasons of record and those set forth below.
Applicant argues that Applicant has cancelled claims 3-5 and amended claim 1 to recite B. subtilis, thus rendering the instant rejection moot.
Applicant’s arguments have been fully considered but not deemed persuasive to overcome the instant rejection. The Examiner acknowledges the amendments made to the claims, including claim 1. However, the Examiner disagrees with Applicant’s contention that these amendments render the instant rejection moot.
As indicated above, while it is agreed that the claims now require the pectate lyase to be produced by culturing a B. subtilis, the claims are not limited solely to an endogenous B. subtilis pectate lyase. The claims still require any pectate lyase having any structure because the B. subtilis can be a recombinant host cell that has been engineered to express any pectate lyase. The enablement provided is not commensurate in scope with the claims due to the extremely large number of pectate lyases of unknown structure encompassed by the claims, and the lack of knowledge regarding those pectate lyases that could be expressed in B. subtilis that can be decolored under the conditions recited without altering their pectate lyase activity. While a few pectate lyases are known in the art, neither the specification nor the prior art disclose the structural features required in any pectate lyase or a structure/function correlation that would allow one of skill in the art to envision the structure of any pectate lyase. While methods to isolate a protein and enzymatic assays were known in the art, it was not routine in the art to screen by a trial and error process any number of proteins to find those with pectate lyase activity. In addition, it was not routine in the art to test any number of pectate lyases produced in B. subtilis and find those that could be decolored under the conditions recited without altering pectate lyase activity. In the absence of a rational scheme to determine which proteins are more likely to have pectate lyase activity, and some knowledge or guidance suggesting which pectate lyases produced in B. subtilis are more likely to be decolored under the conditions recited without having an effect on pectate lyase activity, one of skill in the art would have to test a large number of proteins to find those with the desired pectate lyase activity, and determine which of those proteins with pectate lyase activity can be decolored with the recited method. This is not deemed routine experimentation. Therefore, one cannot reasonably conclude that the full scope of the claims is enabled by the teachings of the specification and/or the prior art.
Conclusion
No claim is in condition for allowance.
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 extension fee 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 date of this final action.
Applicant is advised that any Internet email communication by the Examiner has to be authorized by Applicant in written form. See MPEP § 502.03 (II). Without a written authorization by Applicant in place, the USPTO will not respond via Internet email to any Internet correspondence which contains information subject to the confidentiality requirement as set forth in 35 U.S.C. 122. Sample written authorization language can be found in MPEP § 502.03 (II). An Authorization for Internet Communications in a Patent Application or Request to Withdraw Authorization for Internet Communications form (SB/439) can be found at https://www.uspto.gov/patent/forms/ forms-patent-applications-filed-or-after-september-16-2012, which can be electronically filed.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to DELIA M RAMIREZ, Ph.D., whose telephone number is (571) 272-0938. The examiner can normally be reached on Monday-Friday from 8:30 AM to 5:00 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert B. Mondesi, can be reached at (408) 918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/DELIA M RAMIREZ/Primary Examiner, Art Unit 1652
DR
July 11, 2026
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