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 .
The status of the claims stands as follows:
Pending claims: 1-14
Withdrawn claims: 13-14
Claims currently under consideration: 1-12
Currently rejected claims: 1-12
Allowed claims: None
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-12) in the reply filed on 01/15/2026 is acknowledged. The traversal is on the ground(s) that unity of invention exists between Groups I-III as there is a technical relationship that involves the same special technical feature and that this special technical feature, which taken as a whole, defines a contribution over the prior art. Applicant argued that a search of all the claims would not impose a serious burden on the Examiner. For these reasons, Applicant argued that the Examiner has not met the burden necessary in order to sustain the requirement for restriction.
This is not found persuasive because, although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). As such, any additional features recited in the present specification, but not recited in the present claims, are not considered to be part of the claimed invention and thus are not considered to define a contribution over the prior art. Furthermore, the Examiner identified the special technical feature of Groups I-III and demonstrated that Lo discloses the special technical feature as described in the Restriction Requirement filed 12/02/2025. Therefore, the Examiner has demonstrated that the special technical feature does not make a contribution over the prior art so that Groups I-III now lack unity of invention. Since Groups I-III now lack unity of invention, a search of all the claims would impose a serious burden on the Examiner.
The requirement is still deemed proper and is therefore made FINAL.
Claims 13-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups II-III, there being no allowable generic or linking claim.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Interpretation
Claim 9 is being interpreted as the enzyme-containing composition consisting of at least one of the recited enzymes. It is noted that under this interpretation, the enzyme-containing composition does not contain protease despite the enzyme-containing composition having protease activity.
In claim 12, the phrase “one to several amino acid residues” is being interpreted as “one to 20 amino acid residues”.
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.
Claims 1-12 are rejected under 35 U.S.C. 112(b) 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.
Claims 1, 2, 3, and 4 recite a ratio of a protease activity to a peroxidase activity. However, the claims do not recite a unit of measurement for the protease activity and peroxidase activity. Therefore, the claims are indefinite.
For the purpose of this examination, the unit of measurement for protease activity and peroxidase activity is U/ml.
Claims 5-12 are rejected by reason of dependency from claim 1.
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, 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.
Claims 1-5 and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Nishimura (WO2011126067A1; English translation relied on for translation).
Regarding claims 1, 2, 3, 4, and 5, Nishimura teaches an enzyme containing composition (corresponding to the second reagent (R2)) (page 5, lines 49-52), comprising a peroxidase and protease (page 6, lines 4-5; 17-18) as recited in present claim 4. Nishimura teaches that the activity of the protease in the composition may be 1,000-10,000 U/mL (page 7, lines 34-36); and that the activity of the peroxidase in the composition may be 0.01-4,000 U/mL (corresponding to 0.01 KU/L to 4 MU/L) (page 7, lines 58-59). This disclosed peroxidase activity encompasses the claimed peroxidase activity recited in present claim 5. These activities provide a ratio of protease activity to peroxidase activity which overlaps the ratio ranges recited in present claims 1, 2, 3, and 4.
In regard to the encompassing and overlapping ranges, it would have been obvious to one of ordinary skill in the art to select any portions of the disclosed ranges including the instantly claimed ranges from the ranges disclosed in the prior art references, particularly in view of the fact that; "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages" In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05.I.
Regarding claims 7 and 8, Nishimura teaches the invention as described above in claim 1, including the composition further comprises a stabilizing agent selected from salts and sugar alcohol (corresponding to glycerol) (page 10, lines 8-9, 16-17, 19-20) as recited in present claims 7 and 8.
Claims 1 and 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Debnath (Debnath et al., “Bromelain Plus Peroxidase From Pineapple Induces Apoptosis Via Mitochondrial Dependent Pathway In Lymphoma Cells”, 2018, International Journal of Pharmaceutical Sciences and Research, vol. 9, issue 11, pages 4610-4618).
Regarding claims 1, 5, and 6, Debnath teaches an enzyme-containing composition (corresponding to crude extract) comprising a protease (corresponding to bromelain) and peroxidase (page 4613, 2nd column, paragraph under “Total Protein, Bromelain Activity, and Peroxidase Activity of Crude Extract”). Debnath teaches that the activity of the protease is 63.56 ± 1.8 CDU/ml and that the activity of the peroxidase is 68 ± 2.64 U/ml (page 4613, 2nd column, paragraph under “Total Protein, Bromelain Activity, and Peroxidase Activity of Crude Extract”). This protease activity is considered to fall within the range recited in present claim 6. This peroxidase activity falls within the range recited in present claim 5. Therefore, the protease activity and peroxidase activity are considered to provide a ratio of protease activity to peroxidase activity which falls within the range recited in present claim 1.
Claims 1 and 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over Shows (US 2021/0198618) in view of UniProt (Accession No. A0A6H0CXF6, Database UniProt [online], 2020; IDS citation) as evidenced by ABSS (comparison between amino acid sequence of SEQ ID NO:1 and amino acid sequence of A0A6H0CXF6).
Regarding claims 1, 9, 10, 11, and 12, Shows teaches an enzyme-containing composition (corresponding to peroxidase composition) [0002], [0219], wherein the enzyme in the composition may be catalase-peroxidase from the actinomycete Streptomyces [0206]-[0207] as recited in present claims 1, 9, 10, and 11. Shows does not teach that the composition has a ratio of a protease activity to a peroxidase activity of 10 or less as recited in present claim 1; or that the catalase-peroxidase is one of (a) and (b) as recited in present claim 12.
However, UniProt teaches a catalase-peroxidase from the actinomycete Streptomyces (page 1, line beginning “OS” to 2nd line beginning “OC”). This catalase-peroxidase has an amino acid sequence that is 98.5% similar to SEQ ID NO:1 and has several deleted and substituted amino acids when compared to SEQ ID NO:1. Therefore, the catalase-peroxidase of UniProt is (b) as recited in present claim 12.
It would have been obvious for a person of ordinary skill in the art to have modified the catalase-peroxidase in the composition of Shows to be the catalase-peroxidase taught by UniProt. Since Shows discloses that the enzyme in the composition may be catalase-peroxidase from the actinomycete Streptomyces [0206]-[0207], but does not disclose such an enzyme, a skilled practitioner would have been motivated to consult an additional reference such as UniProt in order to find a suitable enzyme, thereby rendering present claim 12 obvious. “The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) (Claims to a printing ink comprising a solvent having the vapor pressure characteristics of butyl carbitol so that the ink would not dry at room temperature but would dry quickly upon heating were held invalid over a reference teaching a printing ink made with a different solvent that was nonvolatile at room temperature but highly volatile when heated in view of an article which taught the desired boiling point and vapor pressure characteristics of a solvent for printing inks and a catalog teaching the boiling point and vapor pressure characteristics of butyl carbitol. "Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle." 325 U.S. at 335, 65 USPQ at 301.).” MPEP 2144.07.
In regard to the composition having a ratio of a protease activity to a peroxidase activity of 10 or less as recited in present claim 1, the combination of prior art teaches a composition comprising the enzyme as recited in dependent claims 9, 10, 11, and 12. Since the prior art teaches a composition comprising the same enzyme as claimed and instantly disclosed, the composition of the prior art would necessarily have the claimed ratio of protease activity to peroxidase activity. Regarding product claims, when the ingredient recited in the reference is substantially identical to that of the claims, claimed properties are presumed to be present in the product of the prior art. “The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s function, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. IRECO Inc., 190 F .3d 1342, 1347, 51 USPQ2d 1943. 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function, or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). MPEP §2112.I. Therefore, the claimed ratio recited in present claim 1 is rendered obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kelly Kershaw whose telephone number is (571)272-2847. The examiner can normally be reached Monday - Thursday 9:00 am - 4:00 pm.
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/KELLY P KERSHAW/Examiner, Art Unit 1791