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 .
DETAILED ACTION
Claims 1-8 are pending.
Election/Restrictions
Claim 8 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 2/5/2026.
Applicant's election with traverse of Group I, claims 1-7, and the species of 2-methylhippuric acid (starting material), aminoacylase having an amino acid sequence of SEQ ID NO: 1, and 2-methylbenzoic acid (main product) in the reply filed on 2/5/2026 is acknowledged. The traversal is on the ground(s) that the claims require the special technical feature of aminoacylase having an amino acid sequence of SEQ ID NO: 1 capable of hydrolyzing 2-methylhippuric acid for materials detection and that Girish does not teach that SEQ ID NO: 1 hydrolyzes 2-methylhippuric acid. This is not found persuasive because claim 8 is drawn to a kit comprising only the aminoacylase having an amino acid sequence of SEQ ID NO: 1. Claim 8 does not require any specific starting material. Thus, claims 1-8 only share the technical feature of SEQ ID NO: 1, which is taught by the prior art of Girish.
The requirement is still deemed proper and is therefore made FINAL.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. See [0038] and [0094]. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Information Disclosure Statement
The information disclosure statement filed 1/18/2024 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because NPL references 6-7 do not include the full date of publication, only the year. It has been placed in the application file, but the NPL reference 6-7 have not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
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.
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 1-7 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.
Claim 1 recites “A material detection method comprising detecting at least a presence of a starting material by measuring glycine formed as a by-product along with a main product through a chemical reaction involving the starting material and catalyzed by a hydrolase.” Claim 1 does not recite any active method step, thus the claim is indefinite. In addition, claim 1 has at least two different reasonable interpretations, further rendering the claim indefinite. In one interpretation, the method comprises measuring glycine and a main product. In a second interpretation, the method comprises measuring only glycine.
Claim 2 recites “wherein the measuring of the glycine is accomplished by measuring hydrogen peroxide formed from the glycine.” Claim 2 is indefinite because it is unclear how the hydrogen peroxide is formed from the glycine. Claim 2 depends from claim 1, which recites a single chemical reaction that converts hippuric acid an/d or methylhippuric acid to glycine and an unknown main product.
Claim 3 recites “wherein the hydrogen peroxide is formed by an enzymatic reaction catalyzed by glycine oxidase.” It is unclear when the glycine oxidase is introduced in the method. In one interpretation, the glycine oxidase is present in the chemical reaction during the hydrolysis of hippuric acid and/or methylhippuric acid to glycine. In a second interpretation, the method further comprises an additional step in which the glycine is contacted with glycine oxidase to produce hydrogen peroxide.
Claim 4 is indefinite because it is unclear when the aminoantipyrine, Trinder reagent, and peroxidase are added. The claim may reasonably be interpreted as adding the aminoantipyrine, Trinder reagent, and peroxidase together with the glycine oxidase to the glycine, or by first reacting glycine with glycine oxidase to form hydrogen peroxide and then adding aminoantipyrine, Trinder reagent, and peroxidase to the hydrogen peroxide to form the quinone pigment.
Claim 6 recites the limitation "the measuring of the hydrogen peroxide" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites “wherein an amount of the methylhippuric acid is obtained by subtracting an amount of the hippuric acid from the determined total amount of the hippuric acid and the methylhippuric acid.” It is unclear whether “an amount of the methylhippuric acid” and “an amount of the hippuric acid” are the amount of methylhippuric acid contained in the sample (recited in claim 6) and the amount of hippuric acid contained in the sample (recited in claim 6), respectively.
Claims 2-7 are rejected for depending from a rejected base claim and not rectifying the source of indefiniteness discussed above.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 6-7 are rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 6 recites “wherein a total amount of the hippuric acid and the methylhippuric acid contained in a sample that is an object of detection is determined by the measuring of the hydrogen peroxide.” Claim 6 fails to further limit the subject matter of claim 1 because claim 1 does not recite any sample.
Claim 7 depends from claim 6, which depends from claim 1, thus claim 7 likewise fails to further limit the subject matter of claim 1.
Applicant may cancel the claims, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims complies with the statutory requirements.
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 1-7 are rejected under 35 U.S.C. 112(a) 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites a genus of fragments of SEQ ID NO: 1 that retain aminoacylase activity (“an aminoacylase having an amino acid sequence of SEQ ID NO: 1”). Claim 1 also recites a genus of proteins having the amino acid sequence of SEQ ID NO: 1 in which one or more amino acids are deleted, replaced, or added and having activity for hydrolysis of the hippuric acid and the methylhippuric acid. The claim only recites methylhippuric acid and does not recite any particular isomers of methylhippuric acid (e.g. 2-methylhippuric acid). Thus, claim 1 is not limited to a protein having activity for hydrolysis of hippuric acid and 2-methylhippuric acid. Rather, claim 1 is limited to a protein having activity for hydrolysis of hippuric acid and any methylhippuric acid (e.g. 2-methylhippuric acid, 3-methylhippuric acid, or 4-methylhippuric acid).
The specification discloses SEQ ID NO: 1 has activity for the hydrolysis of hippuric acid and all three isomers of methylhippuric acid (2-methylhippuric acid, 3-methylhippuric acid, and 4-methylhippuric acid) ([0077]). However, it is unclear why the amidohydrolase, unlike aminoacylase PH1043, has enzymatic activity for 2-methylhippuric acid despite the fact that the amino acid sequence of the amidohydrolase is homologous to that of aminoacylase PH1043 ([0077]). The specification also discloses the aminoacylase PH1043 ([0095]). No variants of SEQ ID NO: 1 are disclosed in which one or more amino acids are deleted, replaced, or added.
Nomura (JP 2019-187285A; cited on the IDS filed on 1/18/2024) teaches that aminoacylase (EC3.5.1.14) catalyzes the reaction of hippuric acid or methylhippuric acid into benzoic acid or methylbenzoic acid and glycine ([0030]). Nomura exemplifies hippurate hydrolase (EC3.5.1.32) as another enzyme which catalyzes this reaction ([0030]). Nomura does not teach any sequences of aminoacylase or hippurate hydrolase.
Imai et al. (“Functional Improvement of Hippurate Hydrolase,” Japan Society for Bioscience, Biotechnology and Agrochemistry, 2019; cited on the IDS filed 2/6/2024) teaches functional mutants of hippuric acid hydrolase (PDB ID: 1XMB) containing amino acid substitutions W164A and W164L with improved reactivity to methylhippurate (page 1, Results, paragraph 1).
Imai et al. (“Development of Method and Enzyme for Enzymatic Assay of Hippuric Acid,” The Society of Analytical Bio-Science, Vol.42, No.1, 2019; cited on the IDS filed on 1/18/2024) teaches protein engineering of an enzyme derived from Pyrococcus horikoshii in order to improve the reactivity to hippuric acid and methylhippuric acid at 37°C (page 1, Method and results, paragraph 1 and page 2, paragraph 2). However, although Imai reports introducing 10 types of mutations at 5 sites (page 2 paragraph 2), Imai does not teach the specific amino acid substitutions or types of mutations.
Girish et al. (ActaCryst., F69, 2013; cited on the IDS filed on 1/18/2024) teaches the amidohydrolase SACOL0085, which is identical to the instant SEQ ID NO: 1 (see the instant specification [0032]), but does not teach whether the enzyme has hydrolytic activity for hippuric acid or methylhippuric acid. Girish also does not teach any variants of SEQ ID NO: 1 that retain hydrolytic activity for hippuric acid or methylhippuric acid.
Given the lack of species of fragments of SEQ ID NO: 1 that retain aminoacylase activity and proteins having hydrolytic activity for hippuric acid or methylhippuric acid, as well as the lack of a structure-function correlation between the structure of the enzyme and its activity, the person of ordinary skill in the art would not have recognized that the inventors, at the time the application was filed, had possession of the claimed genera of fragments of SEQ ID NO: 1 that retain aminoacylase activity and proteins having activity for hydrolysis of hippuric acid and methylhippuric acid.
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.
Claims 1-7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to the judicial exception of an abstract idea without significantly more.
The rationale for this determination is explained below.
A flowchart has been established to determine subject matter eligibility under 35 U.S.C. 101. See MPEP 2106 part (III) and 2106.04 part (II)(A). The flowchart comprises answering: Step 1) Is the claim to a process, machine, manufacture or composition of matter? Step 2A Prong One) Does the claim recite an abstract idea, law of nature or natural phenomenon? Step 2A Prong Two) Does the claim recite additional elements that integrate the judicial exception into a practical application? Step 2B) Does the claim recite additional elements that amount to significantly more than the judicial exception? The claims are analyzed for eligibility in accordance with their broadest reasonable interpretation.
Claim 1 recites a material detection method comprising detecting at least a presence of a starting material by measuring glycine formed as a by-product along with a main product through a chemical reaction involving the starting material and catalyzed by a hydrolase, wherein the starting material comprises hippuric acid and/or methylhippuric acid, and the hydrolase is an aminoacylase having an amino acid sequence of SEQ ID NO; 1 or a protein having the amino acid sequence of SEQ ID NO: 1 in which one or more amino acids are deleted, replaced, or added and having activity for hydrolysis of the hippuric acid and the methylhippuric acid.
Claim 6 recites “wherein a total amount of the hippuric acid and the methylhippuric acid contained in a sample that is an object of detection is determined by the measuring of the hydrogen peroxide.”
Claim 7 recites wherein an amount of the methylhippuric acid is obtained by subtracting an amount of the hippuric acid from the determined total amount of the hippuric acid and the methylhippuric acid.
Claims 1-7 are drawn to a process, which is one of the four statutory categories of invention (Step 1: Yes). Claim 1 recites the judicial exception of an abstract idea, which is detecting at least a presence of a starting material by measuring glycine formed as a by-product (Step 2A Prong One: Yes). Claim 6 recites the abstract idea of “determining a total amount of hippuric acid and methylhippuric acid by measuring hydrogen peroxide,” which requires converting the measured hydrogen peroxide into a total amount of hippuric acid and methylhippuric acid. Claim 7 explicitly recites the judicial exception of a mathematical concept: ”subtracting an amount of the hippuric acid from the determined total amount of the hippuric acid and the methylhippuric acid.”
Although the measuring steps themselves are not abstract ideas, the claims require the mental conversion of the presence or the amount of the by-product glycine into the presence or amount of the hippuric acid or methylhippuric acid in the starting material. The claims do not integrate the judicial exception into a practical application (Step 2A Prong Two: No) because the result of performing the claimed method is purely the information gathered (the presence of hippuric acid or methylhippuric acid) and this information is not used in any way. The claims do not recite additional elements that amount to significantly more than the judicial exception of an abstract idea. Each of the additional claim elements is well-understood, routine, and conventional (Step 2B: No). For example, Nomura (JP 2019-187285A; cited on the IDS filed on 1/18/2024) teaches a method of detecting hippuric acid or methylhippuric acid by generating a glycine by-product and benzoic acid or methylbenzoic acid by chemical reaction of hippuric acid or methylhippuric acid (Nomura claims 1 and 5). Nomura teaches that the catalytic reaction of converting hippuric acid or methylhippuric acid into benzoic acid or methylbenzoic acid is carried out with the enzyme aminoacylase (Nomura claims 3-4). Nomura teaches oxidizing the glycine by-product by the catalytic action of glycine oxidase (Nomura claim 1). Nomura teaches detecting the presence of glycine (main product) or starting material (hippuric acid or methylhippuric acid) by measuring hydrogen peroxide (page 3, Overview, Solution). Nomura teaches reacting the hydrogen peroxide, a Trinder reagent, and 4-aminoantipyrine in the presence of an oxidizing enzyme to generate a quinone dye, resulting in a colored sample ([0022]). Nomura teaches measuring the degree of color development using an absorbance device in order to quantify the amount of hydrogen peroxide in the sample and thus the amount of glycine present before the enzyme reaction ([0022]]). The oxidizing enzyme is peroxidase ([0021]). Furthermore, enzymes capable of hydrolyzing hippuric acid and methylhippuric acid are also well-understood, routine, and conventional: Imai et al. (“Functional Improvement of Hippurate Hydrolase,” Japan Society for Bioscience, Biotechnology and Agrochemistry, 2019; cited on the IDS filed 2/6/2024) teaches functional mutants of hippuric acid hydrolase (PDB ID: 1XMB) containing amino acid substitutions W164A and W164L with improved reactivity to methylhippurate (page 1, Results, paragraph 1).
Therefore, none of the claims are eligible under 35 U.S.C. 101.
Claim Rejections - 35 USC § 103
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 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 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Nomura et al. (JP 2019-187285A; cited on the IDS filed on 1/18/2024) in view of Imai et al. (“Functional Improvement of Hippurate Hydrolase,” Japan Society for Bioscience, Biotechnology and Agrochemistry, 2019; cited on the IDS filed 2/6/2024) as evidenced by PDB 1XMB (2001, website).
“Methylhippuric acid” is given its broadest reasonable interpretation as any isomer of methylhippuric acid, including 2-methylhippuric acid, 3-methylhippuric acid, or 4-methylhippuric acid.
Nomura teaches a method of detecting hippuric acid or methylhippuric acid by generating a glycine by-product and benzoic acid or methylbenzoic acid by chemical reaction of hippuric acid or methylhippuric acid (Nomura claims 1 and 5). Nomura teaches that the catalytic reaction of converting hippuric acid or methylhippuric acid into benzoic acid or methylbenzoic acid is carried out with the enzyme aminoacylase (Nomura claims 3-4). Nomura teaches oxidizing the glycine by-product by the catalytic action of glycine oxidase (Nomura claim 1).
Nomura teaches that aminoacylase (EC3.5.1.14) catalyzes the reaction of hippuric acid or methylhippuric acid into benzoic acid or methylbenzoic acid and glycine ([0030]). Nomura exemplifies hippurate hydrolase (EC3.5.1.32) as another enzyme which catalyzes this reaction ([0030]).
Nomura does not teach that the aminoacylase is a protein having the amino acid sequence of SEQ ID NO: 1 in which one or more amino acids are deleted, replaced, or added and having activity for hydrolysis of the hippuric acid and the methylhippuric acid.
Imai teaches functional mutants of hippuric acid hydrolase (PDB ID: 1XMB) containing amino acid substitutions W164A and W164L with improved reactivity to methylhippurate (page 1, Results, paragraph 1). PDB 1XMB is 23.4% identical to the instant SEQ ID NO: 1 (OA Appendix A), thus the enzyme contains more than one amino acid substitution relative to SEQ ID NO: 1 but retains activity for hippuric acid and methylhippuric acid.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to apply the hippuric acid hydrolase with amino acid substitutions W164A or W164L to the method of Nomura in order to improve the enzymatic conversion of hippuric acid and methylhippuric acid to glycine. The person of ordinary skill in the art would have had a reasonable expectation of success in applying the hippuric acid hydrolase of Imai to the method of Nomura.
Regarding claim 2, Nomura teaches detecting the presence of glycine (main product) or starting material (hippuric acid or methylhippuric acid) by measuring hydrogen peroxide (page 3, Overview, Solution).
Regarding claim 3, Nomura teaches that the hydrogen peroxide is produced from glycine by the enzyme glycine oxidase ([0009] and Nomura claim 1).
Regarding claim 4, Nomura teaches reacting the hydrogen peroxide, a Trinder reagent, and 4-aminoantipyrine in the presence of an oxidizing enzyme to generate a quinone dye, resulting in a colored sample ([0022]). Nomura teaches measuring the degree of color development using an absorbance device in order to quantify the amount of hydrogen peroxide in the sample and thus the amount of glycine present before the enzymatic reaction ([0022]]). The oxidizing enzyme is peroxidase ([0021]).
Regarding claim 5¸ Nomura teaches that the main product is benzoic acid or methylbenzoic acid (Nomura claim 5).
Regarding claim 6, Nomura teaches that 1 mol of hydrogen peroxide is generated by oxidation of 1 mol of glycine, thus the amount of oxidized glycine can be quantified by quantifying the amount of hydrogen peroxide produced (lines 2-5 on page 8). Nomura teaches that an equimolar amount of glycine is produced from hippuric or methylhippuric acid ([0040] and Fig. 1). Nomura teaches that hippuric acid and methylhippuric acid are used as indicators of exposure to toluene or xylene, respectively ([0031]).
Nomura does not explicitly teach determining the total amount of hippuric acid and methylhipppuric acid.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to determine the total amount of hippuric acid and methylhippuric acid based on the measured amount of hydrogen peroxide produced from glycine. The person of ordinary skill in the art would have been motivated by the teachings of Nomura, who suggests that hippuric acid and methylhippuric acid are indicators of toluene and xylene exposure. The person of ordinary skill in the art would have had a reasonable expectation of success because Nomura teaches that an equimolar amount of glycine is produced from hippuric and or methylhippuric acid ([0040] and Fig. 1) and that 1 mol of hydrogen peroxide is generated by oxidation of 1 mol of glycine ((lines 2-5 on page 8).
Regarding claim 7, Nomura does not teach obtaining an amount of the methylhippuric acid by subtracting an amount of the hippuric acid from the determined total amount of the hippuric acid and the methylhippuric acid.
However, Nomura teaches that an equimolar amount of glycine is produced from hippuric or methylhippuric acid ([0040] and Fig. 1). Nomura teaches that hippuric acid and methylhippuric acid are used as indicators of exposure to toluene or xylene, respectively ([0031]). Nomura also teaches other detection methods, including mass spectrometry ([0002]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to subtract the amount of hippuric acid from the total amount of hippuric acid and methylhippuric acid in order to obtain the amount of methylhippuric acid. The person of ordinary skill in the art would have been motivated to distinguish the exposure to xylene from the exposure to toluene. The person of ordinary skill in the art would have had a reasonable expectation of success in determining the amount of methylhippuric acid by subtracting the amount of hippuric acid (for example, measured by mass spectrometry) from the total amount of hippuric acid and methylhippuric acid.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CANDICE LEE SWIFT whose telephone number is (571)272-0177. The examiner can normally be reached M-F 8:00 AM-4:30 PM (Eastern).
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/CANDICE LEE SWIFT/Examiner, Art Unit 1657
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