DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1, 3-6, 8, 9, 11-18 are pending in the instant application.
Applicant's election with traverse of Invention I in the reply filed on 06/02/2026 is acknowledged. The arguments filed have been considered but are not found persuasive.
The combination of the references of Popiel et al. ("Detoxification of sulfur mustard by enzyme-catalyzed oxidation using chloroperoxidase" Enzyme and Microbial Technology, Vol. 53, No. 5, 05 July 2013; IDS filed 03/25/2024) in view of WO2008036061 (03/27/2008; IDS filed 03/25/2024), Park et al. ("Deactivation mechanisms of chloroperoxidase during biotransformations", BIOTECHNOLOGY AND BIOENGINEERING, JOHN WILEY, HOBOKEN, USA, vol. 93, no. 6, 19 January 2006; IDS filed 12/15/2025) as stated below in the rejection of the claims under 35 U.S.C. 103 teach and render obvious the claimed invention. Thus, the same or corresponding technical feature was known in the prior art and therefore cannot make a contribution over the prior art. Since the inventions lack the same or corresponding special technical feature, then Inventions 1-3 are not so linked as to form a single general inventive concept under PCT Rule 13.1.
Claims 6, 8, 14-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention. The requirement is still deemed proper and is therefore made FINAL.
Claims 1, 3-5, 9, 11-13 are under consideration in this Office Action.
Claim Rejections - 35 USC § 112(b) or 35 U.S.C. 112 (pre-AIA ) 2nd Paragraph
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, 4, 11 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 recites the phrase “characterized by one or more of the following items” which renders the claim vague and indefinite because it is unclear if the claim is limited to the subject matter recited after “characterized by”. For examination purposes the claim will not be limited to the subject matter recited after “characterized by one or more of the following items”.
Claim 4 recites the phrase “characterized by one or more of the following items” which renders the claim vague and indefinite because it is unclear if the claim is limited to the subject matter recited after “characterized by”. For examination purposes the claim will not be limited to the subject matter recited after “characterized by one or more of the following items”.
Claim 11 recites the phrase “characterized by one or more of the following items” which renders the claim vague and indefinite because it is unclear if the claim is limited to the subject matter recited after “characterized by”. For examination purposes the claim will not be limited to the subject matter recited after “characterized by one or more of the following items”.
Claim Rejections - 35 USC § 112
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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, 3-5, 9, 11-13 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.
The claims are drawn to a broad and widely varying genus of decontamination compositions, which comprises a genus of chloroperoxidases, hydrogen peroxide, a halide ion, a buffer solution and a cosolvent where the chloroperoxidases are of any amino acid sequence and structure and are from any biological source. According to MPEP 2163:
“For each claim drawn to a genus: 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 (see i)(A), above), reduction to drawings (see i)(B), above), 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 the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
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. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014)…”
According to MPEP 2163.02:
“The courts have described the essential question to be addressed in a description requirement issue in a variety of ways. An objective standard for determining compliance with the written description requirement is, "does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed." In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). Under Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description requirement, an applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention, and that the invention, in that context, is whatever is now claimed. The test for sufficiency of support in a parent application is whether the disclosure of the application relied upon "reasonably conveys to the artisan that the inventor had possession at that time of the later claimed subject matter." Ralston Purina Co. v. Far-Mar-Co., Inc., 772 F.2d 1570, 1575, 227 USPQ 177, 179 (Fed. Cir. 1985) (quoting In re Kaslow, 707 F.2d 1366, 1375, 217 USPQ 1089, 1096 (Fed. Cir. 1983)).”
The reference of Chica et al. (Curr Opin Biotechnol. 2005 Aug;16(4):378-84; PTO 892) teaches that the complexity of the structure/function relationship in enzymes has proven to be the factor limiting the general application of rational enzyme modification and design, where rational enzyme modification and design requires in-depth understanding of structure/function relationships. The reference of Singh et al. (Curr Protein Pept Sci. 2017, 18, 1-11; PTO 892) reviews protein engineering methods including directed evolution, rational design, semi-rational design, and de-novo design; and states that despite the availability of a growing database of protein structures and highly sophisticated computational algorithms, protein engineering is still limited by the incomplete understanding of protein functions, folding, flexibility, and conformational changes (see entire publication especially Figs.1 and 3, and page 7, left column, lines 8-17). The reference teachings only provide guidance for searching and screening for the claimed chloroperoxidase.
The specification as originally filed does not disclose a representative number of species encompassed by the claimed genus by actual reduction to practice. The specification as originally filed does not provide a correlation between function and structure to enable one of ordinary skill in the art to predict which amino acid sequences and structures correlate with chloroperoxidase activity.
Hence, the specification does not provide sufficient written description to inform one of ordinary skill in the art that applicants were in possession at the time the application was filed of the claimed genus of decontamination compositions, which comprises a genus of chloroperoxidases, hydrogen peroxide, a halide ion, a buffer solution and a cosolvent where the chloroperoxidases are of any amino acid sequence and structure and are from any biological source.
Claim Rejections - 35 USC § 102
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 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Popiel et al. ("Detoxification of sulfur mustard by enzyme-catalyzed oxidation using chloroperoxidase" Enzyme and Microbial Technology, Vol. 53, No. 5, 05 July 2013; IDS filed 03/25/2024).
Popiel et al. teach detoxification of sulfur mustard by enzyme-catalyzed oxidation using chloroperoxidase (EC 1.11.1.10, CPO) where the CPO) is an enzyme for catalyzing peroxide oxidation of various organic compounds in the presence of halide ions. Popiel et al. teach compositions comprising CPO, hydrogen peroxide, sodium chloride, Britton-Robinson buffer solution, and tert-butyl alcohol cosolvent. See entire publication and abstract especially 2. Equipment, reagents and research methods section, 3. Results and discussion section, and pages 296-299. Thus, the teachings anticipate the claimed invention.
Claim Rejections - 35 USC § 103
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 of this title, 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.
Claims 1, 3-5, 9, 11-13 are rejected under 35 U.S.C. 103 as being unpatentable
over Popiel et al. ("Detoxification of sulfur mustard by enzyme-catalyzed oxidation using chloroperoxidase" Enzyme and Microbial Technology, Vol. 53, No. 5, 05 July 2013; IDS filed 03/25/2024) in view of WO2008036061 (03/27/2008; IDS filed 03/25/2024), Park et al. ("Deactivation mechanisms of chloroperoxidase during biotransformations", BIOTECHNOLOGY AND BIOENGINEERING, JOHN WILEY, HOBOKEN, USA, vol. 93, no. 6, 19 January 2006; IDS filed 12/15/2025).
Popiel et al. teach detoxification of sulfur mustard by enzyme-catalyzed oxidation using chloroperoxidase (EC 1.11.1.10, CPO) where the CPO) is an enzyme for catalyzing peroxide oxidation of various organic compounds in the presence of halide ions. Popiel et al. teach compositions comprising CPO, hydrogen peroxide, sodium chloride, Britton-Robinson buffer solution, and tert-butyl alcohol cosolvent. See entire publication and abstract especially 2. Equipment, reagents and research methods section, 3. Results and discussion section, and pages 296-299. The teachings of the reference differ from the claims in that the reference does not teach the specific amounts of the components.
WO2008036061 teaches decontamination compositions of chemical poisons which comprise a chloroperoxidase, in particular fumago peroxidase is disclosed; the enzymatic activity comprises a halogenation reaction to form a hypohalite from hydrogen peroxide and chloride, bromide or iodide (see Example 3, claims 81, 84-86, 118); among the chemical poisons nerve agents including sarin and mustard gas (see page 156); the enzyme can be formulated in preparation and equipments for application (see pag. 164); the CPO is formulated in buffer solution (see page 199-200, investigation into large scale decontamination of Tetriso; enzyme based active decontamination). See entire publication and claims especially claims 76-81, 84-86, 118.
Park et al. teach compositions comprising chloroperoxidase (CPO) from Caldariomyces fumago which are suitable for decontamination. Park et al. teach compositions comprising CPO and t-butyl alcohol as well as phosphate buffer (Fig. 3) where tert-butyl alcohol and phosphate buffer (pH 4.1) reduce inactivation mechanisms of CPO Caldariomyces fumago. See entire publication and abstract especially MATERIALS AND METHODS section, RESULTS section, and pages 1190-1193.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify and/or combine the reference teachings to make the claimed invention by modifying the comprising CPO, hydrogen peroxide, sodium chloride Britton-Robinson buffer solution, and tert-butyl alcohol cosolvent taught by Popiel et al. to have any and all of the recited concentration amounts of the stated components as taught by WO2008036061 and Park et al. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do this in order to obtain a decontamination composition comprising chloroperoxidase that can be used for decontamination of chemical poisons including agents including sarin and mustard gas. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to formulate a decontamination preparation comprising the said composition as taught by WO2008036061. It would have been obvious to adjust the amounts chloroperoxidase in the composition recited in the claims as routine optimization and/or as desired. One of ordinary skill in the art at the time the invention was made would have a reasonable expectation of success because making compositions comprising chloroperoxidase for decontamination are known in the art as shown by the reference teachings. Hence, the claimed invention as a whole is prima facie obvious.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Christian L Fronda whose telephone number is (571)272 0929. The examiner can normally be reached Monday-Thursday and alternate Fridays between 9:00AM-5:00PM.
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/CHRISTIAN L FRONDA/Primary Examiner, Art Unit 1652
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