DETAILED ACTION
Status of the Application
Claims 1-12 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 election without traverse of Group I, claims 1-6, drawn to a method for decolorizing a composition that comprises a pectate lyase, as submitted in a communication filed on 12/29/2025 is acknowledged.
Claims 7-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 1-6 are at issue and are being examined herein.
Priority
Acknowledgment is made of a claim for foreign priority under 35 U.S.C. 119(a)-(d) to REPUBLIC OF KOREA 10-2023-0000841 filed on 01/03/2023. Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 1/2/2024 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.
Drawings
The drawings submitted on 1/2/2024 have been reviewed and are accepted by the Examiner for examination purposes.
Claim Objections
Claim 1 is objected to due to the recitation of “culturing a microorganisms”. To be grammatically correct, the term should be amended to recite “culturing a microorganism”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b) or Second Paragraph (pre-AIA )
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 3-6 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.
Claim 3 is indefinite in the recitation of “wherein the dicyandiamide is comprised in an amount of…” for the following reasons. As written, it is unclear as to where is the dicyandiamide comprised at the recited amount. If the intended concentration is in the composition that comprises pectate lyase, the claim should be amended to recite, for example, “wherein the dicyandiamide is added to the composition comprising pectate lyase in an amount of…”. For examination purposes, it will be assumed that claim 3 is a duplicate of claim 1. Correction is required.
Claim 4 is indefinite in the recitation of “..wherein the dicyandiamide is comprised in an amount of…..and the hydrogen peroxide is comprised in an amount of 0.1 M to 1 M” for the following reasons. As written, it is unclear as to where are the dicyandiamide and hydrogen peroxide comprised at the recited concentration/amount. If the intended concentration/amount is in the composition that comprises pectate lyase, the claim should be amended to recite, for example, “wherein the dicyandiamide is added to the composition comprising pectate lyase in an amount of… and the hydrogen peroxide is added to the composition comprising pectate lyase such that the hydrogen peroxide concentration in the composition is between 0.1 M to 1 M”. For examination purposes, it will be assumed that claim 4 is a duplicate of claim 1. Correction is required.
Claim 5 is indefinite in the recitation of “…composition …has increased stability of pectate lyase after the decolorizing step, as compared to a composition not comprising dicyandiamide and hydrogen peroxide” for the following reasons. It is unclear as to what is the meaning of the term “stability of pectate lyase” in the absence of the pectate lyase’s property that has the recited increased stability. Does the stability refer to enzymatic activity? Does the term refer to thermal stability? In addition, the term “as compared to a composition not comprising dicyandiamide and hydrogen peroxide” implies that the basis for comparison is a genus of compositions because there is more than one composition that lacks dicyandiamide and hydrogen peroxide. If the basis for comparison is variable, the determination as to what is included or excluded from the scope of the claim is impossible. For example, the stability of the pectate lyase can be higher if compared with composition A that lacks dicyandiamide and hydrogen peroxide but lower if compared with composition B that lacks dicyandiamide and hydrogen peroxide. The same composition can be included and excluded from the scope of the claim depending on what is used for comparison. For examination purposes, claim 5 will be considered a duplicate of claim 1. Correction is required.
Claim 6 is indefinite in the recitation of “…composition…maintains 90% or more of the activity of pectate lyase as compared to the composition before the…step” for the following reasons. The term “activity of pectate lyase” is unclear in the absence of the activity intended. A protein can have more than one activity, such as enzymatic activity, binding activity, antibody eliciting activity, etc. If the intended activity is enzymatic activity, the claim should be amended accordingly. 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 )
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 1-6 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 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.
As stated in MPEP 2111.01, during examination, the claims must be interpreted as broadly as their terms reasonably allow. Claims 1-6 are directed in part to a method which requires decoloring a genus of pectate lyases having any structure by adding any amount of dicyandiamide and hydrogen peroxide to a composition comprising said pectate lyases, wherein said decoloring does not decrease the enzymatic activity of the pectate lyases when compared to the enzymatic activity of the pectate lyases prior to the addition of dicyandiamide and hydrogen peroxide. It should be noted that as written, the pectate lyases are not limited to endogenous Bacillus pectate lyases since the microorganisms of the genus Bacillus recited in the claims can be engineered to produce any recombinant pectate lyase. See Claim Rejections - 35 USC § 112(b) or Second Paragraph (pre-AIA ), for claim interpretation.
In University of California v. Eli Lilly & Co., 43 USPQ2d 1938, the Court of Appeals for the Federal Circuit has held that “A written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula, [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials”. As indicated in MPEP § 2163, the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show that Applicant was in possession of the claimed genus. In addition, MPEP § 2163 states that a representative number of species means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
The claims require decoloring a genus of pectate lyases having any structure present in a culture medium composition without altering their enzymatic activity by using any amount of dicyandiamide and hydrogen peroxide. While the specification in the instant application discloses a decoloring method of B. subtilis pectate lyases by using a defined range of concentrations for dicyandiamide (0.1 to 4% by weight of the composition) and hydrogen peroxide (0.1 M to 1 M) without reducing enzymatic activity, the specification is silent as to (a) which are the concentrations of dicyandiamide and hydrogen peroxide required to decolor any pectate lyase without reducing its enzymatic activity, and (b) whether any pectate lyase produced by a Bacillus cell, including any endogenous Bacillus pectate lyase, could be decolored with the defined range of concentrations of dicyandiamide and hydrogen peroxide provided in Tables 3-5 without altering their enzymatic activity. While the argument can be made that the results provided in the specification as to decoloring using dicyandiamide and hydrogen peroxide could be applicable to compositions comprising other pectate lyases, it is unknown as to whether any amount of dicyandiamide and hydrogen peroxide could be used with any pectate lyase without reducing or eliminating its 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 1-6 are 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.
Factors to be considered in determining whether undue experimentation is required are summarized in In re Wands (858 F.2d 731, 737, 8 USPQ2nd 1400 (Fed. Cir. 1988)) as follows: 1) quantity of experimentation necessary, 2) the amount of direction or guidance presented, 3) the presence and absence of working examples, 4) the nature of the invention, 5) the state of prior art, 6) the relative skill of those in the art, 7) the predictability or unpredictability of the art, and 8) the breadth of the claims. The factors which have led the Examiner to conclude that the specification fails to teach how to make and/or use the claimed invention without undue experimentation, are addressed in detail below.
The breadth of the claims. Claims 1-6 broadly encompass 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 (b) 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. See Claim Rejections - 35 USC § 112(b) or Second Paragraph (pre-AIA ), for claim interpretation.
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 information regarding the amounts of dicyandiamide and hydrogen peroxide that would be required in a decoloring method where the enzymatic activity of any pectate lyase is not reduced. In the instant case, the specification enables 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.
The amount of direction or guidance presented and the existence of working examples. The specification discloses a decoloring method of B. subtilis pectate lyases by using a defined range of concentrations for dicyandiamide (0.1 to 4% by weight of the composition) and hydrogen peroxide (0.1 M to 1 M) without reducing enzymatic activity. However, the specification is silent as to (a) which are the concentrations of dicyandiamide and hydrogen peroxide required to decolor any pectate lyase without reducing its enzymatic activity, and (b) whether any pectate lyase produced by a Bacillus cell, including endogenous Bacillus pectate lyases, could be decolored with the defined range of concentrations of dicyandiamide and hydrogen peroxide provided in Tables 3-5 without altering their enzymatic activity.
The state of prior art, the relative skill of those in the art, and the predictability or unpredictability of the art. As stated by the specification, the prior art is silent with regard to the effect of decoloration agents on enzymatic activity. Neither the specification nor the prior art provide a correlation between pectate lyase activity and dicyandiamide and hydrogen peroxide concentrations. Moreover, the art does not provide any teaching or guidance suggesting that the effect on enzymatic activity observed with the dicyandiamide and hydrogen peroxide concentrations used in Tables 3-5 with the B. subtilis pectate lyase is likely to be observed with any pectate lyase, as encompassed by the claims.
The quantity of experimentation required to practice the claimed invention based on the teachings of the specification. While methods of generating a recombinant protein in Bacillus cells and enzymatic assays were known in the art, it was not routine in the art to screen by a trial and error process for an essentially infinite number of concentration combinations of dicyandiamide and hydrogen peroxide to determine which combination of concentrations result in decoloration without altering the enzymatic activity of any pectate lyase produced in a Bacillus cell. In the absence of some knowledge suggesting that the concentration ranges provided in the specification could be applied to any composition that comprises any pectate lyase produced in any Bacillus cell, without reducing enzymatic activity, one of skill in the art would have to test a large number of combinations to find those with the desired results.
Therefore, taking into consideration the extremely broad scope of the claim, the lack of guidance, the amount of information provided, the lack of knowledge about a correlation between enzymatic activity and concentration of dicyandiamide and hydrogen peroxide, one of ordinary skill in the art would have to go through the burden of undue experimentation in order to practice the claimed invention. Thus, Applicant has not provided sufficient guidance to enable one of ordinary skill in the art to make and use the invention in a manner reasonably correlated with the scope of the claims.
Conclusion
No claim is in condition for allowance.
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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
February 11, 2026