DETAILED ACTION
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 .
Claim Interpretation
Content of Specification
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i)-(p).
The claimed invention is defined by the positively claimed elements, the structural elements listed on separate indented lines listed in the body of the claim after the transitional phrase, “comprising”.
For claims 1-9, the Examiner notes that the claims are directed to “An application of organic acids in urine” which is not a statutory category of invention. As such, the Examiner is unable to determine if the claims are directed to an apparatus or a process, and requests Applicant amend the claims to recite either a process or an apparatus. With respect to the prior art, the Examiner will address the claims as if they are directed to a process, and separately as a device. For the sake of 101 analysis, the Examiner will read the claims as directed to a process.
For claim 1, the Examiner notes that it is unclear what Applicant regards as a value as the term is not defined in the claims. Claim 1 recites obtaining multiple values of organic acids from liquid chromatography mass spectrometry, without providing any indication of what the values are, or what they represent. As such, the Examiner is unable to determine the metes and bounds of the term “value” as recited in the claim.
The Examiner notes that the application appears to comprise 10 claims, with claim 10 not being numbered. The Examiner requests Applicant amend the claims so that they are numbered properly. For the purposes of examination, the Examiner will consider the limitations after the “period” in claim 9, “The application of organic acids in urine for health management mentioned in Claim 1, further comprising a health management assessment unit, retrieving health-related promotion knowledge specific to the human body based on the indicators of the human body, in order to generate personalized health promotion recommendations.” , as claim 10 and will address these limitations as such.
For claims 3, 5, 7, and 9, the Examiner notes that the units are unclear as the Examiner is unable to determine what “µg/mg cr.” means. It appears that Applicant intends the units to be micrograms per milligrams creatinine; however, it is not readily apparent what the units are as presented in the claims. If Applicant does intend to recite micrograms per milligrams creatinine, it should be explicitly stated in the claims prior to using any abbreviations. The Examiner also notes that claims 3, 5, 7, and 9 should be amended to end with a single period, and not with two periods as currently presented.
For claim 6, the full name for IDO enzyme, KMO enzyme, and COMT enzyme should be explicitly stated prior to using abbreviations.
For claims 2-10, the Examiner contends that the phrase “mentioned in” should be changed to --according to-- or any other suitable phrase that references a prior claim.
For claim 2, the Examiner contends that “ethlmalonate” should be changed to --ethylmalonate--.
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 1-10 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
For claims 1-10, the phrase “An application of organic acids in urine for health management” is unclear as the Examiner is unable to determine if the claims are directed to a process or an apparatus. The Examiner requests Applicant amend the claims so that they are clearly directed to one of the statutory categories.
Claim 1 recites the limitation "the external testing" in lines 1 and 2. There is insufficient antecedent basis for this limitation in the claim.
For claim 1, “the urine” at line 5 is inconsistent with “urine specimens” at line 2, and “the urine specimens” at line 4. The Examiner requests Applicant amend the claims so the that language regarding urine specimens is consistent.
For claim 1, the phrase “urine organic acid” is inconsistent with “organic acids” recited earlier in the claim. The Examiner requests Applicant amend the claim so that language regarding the organic acids is consistent.
For claim 1, the term “value” is not defined by the claim, and therefore is indefinite as the Examiner is unable to determine the metes and bounds of “value.” Claim 1 recites utilizing liquid chromatography tandem mass spectrometry to obtain multiple values of organic acids, but does not provide an indication of what the values are or what they represent. Also, it is unclear what Applicant regards as an “ideal value” as the claim does not recite what makes a value ‘ideal’ compared to any other value measured for each organic acid.
Claim 1 recites the limitation "the ideal value range" in lines 6 and 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the reference value range" in line 8. There is insufficient antecedent basis for this limitation in the claim.
The term “healthy” in claim 1 is a relative term which renders the claim indefinite. The term “healthy” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The Examiner notes that what Applicant regards as healthy may not be considered as such by a user other than Applicant. As such, the term “healthy” is a relative term of degree.
The term “sub-healthy” in claim 1 is a relative term which renders the claim indefinite. The term “sub-healthy” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The Examiner notes that what Applicant regards as sub-healthy may not be considered as such by a user other than Applicant. As such, the term “sub-healthy” is a relative term of degree.
For claims 3, 5, 7, and 9, the units “µg/mg cr.” is unclear as the claims do not recite what “mg cr.” represents. The Examiner believes that Applicant intends the units to be micrograms per milligrams creatinine; however, it is not readily apparent what the units are as presented in the claims. If Applicant does intend to recite micrograms per milligrams creatinine, it should be explicitly stated in the claims prior to using any abbreviations.
Claim 10 recites the limitation "the indicators of the human body" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
For claim 10, it is unclear if the claims is directed to an apparatus, or a process. Claim 10 recites “The application of organic acids in urine for health management” comprising a health management assessment unit, which is a structural limitation. If the entire claim is intended to be directed to an apparatus, the limitations of “retrieving health related promotion knowledge” would be indefinite as a claim directed to an apparatus cannot comprise process limitations. Also, the phrase “promotion knowledge” is indefinite as it is unclear what Applicant regards as ‘knowledge’ and how the claimed knowledge promotes anything related to a subject’s health.
For claim 10, it is unclear what makes up the claimed health management assessment unit as neither the claims, nor the specification defines a structural element that makes up the assessment unit.
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 1-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claim(s) recite(s) an abstract idea in that they require making a determination of a subjects health status based on values of organic acids measured in a urine sample. Determining a subject’s health status as recited in the claim is a mental process that only requires analyzing the values of the measured organic acids, and making a decision on a subject’s health status based on the values. Analyzing the values of measured organic acids, and making a determination of a subject’s health status can be performed in a person’s mind, and therefore is a mental process (MPEP 2106.04(a)(2)). Similarly, categorizing the organic acid values as first, second, third, and fourth indicators is also a mental process in that one can arbitrarily categorize the values in their mind, and designate the categories as first, second, third, and fourth indicators. This judicial exception is not integrated into a practical application because nothing occurs after making a determination of the subject’s health status. Because there are no additional steps after making the determination, the judicial exception is not integrated into a practical application. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the step of using liquid chromatography tandem mass spectrometry to analyze urine specimens for organic acids is well known in the art. Here, the Examiner points to reference to Du (US 2006/0160237) who teaches a method of screening urine for organic acids wherein liquid chromatography tandem mass spectrometry is utilized to detect organic acids in a urine sample (paragraphs 0005, 0030). As such, the Examiner contends that utilizing liquid chromatography tandem mass spectrometry to analyze urinary organic acids is well known, conventional, and routine activity in the art. Therefore, based on the limitations of the instant claims, the Examiner contends that the claims are directed to ineligible subject matter under 35 U.S.C. 101.
Claim Rejections - 35 USC § 102
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(s) 1-9 and the limitations designated as “claim 10”is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Du (US 2006/0160237).
For claim 1, Du teaches a device comprising a liquid chromatography tandem mass spectrometer (paragraphs 0027, 0030). The Examiner notes that liquid chromatography tandem mass spectrometer is the only structural element recited in claims 1-9 as claims 2-9 merely recite metabolites measured by the device and their concentrations. The Examiner notes that the metabolites analyzed by the device represents the material worked upon by the device (MPEP 2115), and are not structural elements of the device.
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.
Claim(s) 1-3 and the limitations designated as “claim 10” is/are rejected under 35 U.S.C. 103 as being unpatentable over Du (US 2006/0160237) in view of Bouatra et al., (PLOS One, Vol. 8, Issue 9, September 2013).
Regarding claim 1, Du teaches a method for screening urine for organic acids comprising measuring organic acids in a urine sample with liquid chromatography tandem mass spectrometry (paragraphs 0005, 0027, 0030) and comparing the measured levels or organic acids with a normal level of organic acids wherein the comparison indicates the presence or status of a metabolic disorder (paragraph 0009). Du teaches various organic acids that meet the limitations of the first, second, and fourth indicators (Table 1), but do not teach the indicators recited as the third indicators.
Bouatra et al., teach analysis of the human urine metabolome wherein a tryptophan metabolism indicator, kynurenine metabolism indicator, and a catecholamine metabolism indicator are included in the urine metabolome (Table 3). The Examiner is reading this combination as combining prior art elements according to known methods to yield predictable results which would have been obvious to one of ordinary skill in the art. Reference to Bouatra et al., teach a database of urinary metabolites comprising the normal and disease associated concentrations ranges of urinary metabolites (Introduction, page 2 right column first full paragraph, Results and Discussion, page 3 left column first full paragraph). As such, one of ordinary skill in the art would have found it obvious to analyze the urinary metabolites taught by Bouatra et al., as a means of determining the normal and disease associated concentrations of the specific metabolites. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Du to analyze the urinary metabolites taught by Bouatra et al., as combining prior art elements according to known methods to yield predictable results requires only routine skill in the art.
Regarding claim 2 Du does not teach a fatty acid metabolism indicator, carbohydrate metabolism indicator, and a mitochondrial energy generation indicator comprising the values recited in the claims.
Bouatra et al., teach analysis of the human urine metabolome wherein adipate, suberate, ethylmalonate, pyruvate, lactate, beta-hydroxybutyric acid citrate, cis-aconitate, isocitrate, alpha-ketoglutaric acid, succinate, fumarate, malate, and hydroxymethylglutaric acid (Table 3). Reference to Bouatra et al., teach a database of urinary metabolites comprising the normal and disease associated concentrations ranges of urinary metabolites (Introduction, page 2 right column first full paragraph, Results and Discussion, page 3 left column first full paragraph). As such, one of ordinary skill in the art would have found it obvious to analyze the urinary metabolites taught by Bouatra et al., as a means of determining the normal and disease associated concentrations of the specific metabolites. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Du to analyze the urinary metabolites taught by Bouatra et al., as combining prior art elements according to known methods to yield predictable results requires only routine skill in the art.
Regarding claim 3, Du in view of Bouatra et al., do not teach the normal and disease state metabolite concentrations recited in the claim. The Examiner is reading these limitations as optimization which would have been obvious to one of ordinary skill in the art. The MPEP states that differences in concentration will not support the patentability of subject matter encompassed by the prior art absent evidence indicating the concentrations to be critical. Additionally, the MPEP states that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimal ranges by routine experimentation (MPEP 2144.05 II A). The Examiner contends that the combination of Du in view of Bouatra et al., teach the general conditions of the claim, thus one of ordinary skill in the art would have found it obvious to determine the optimal concentrations by which one can determine a disease state by routine experimentation. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Du in view of Bouatra et al., to determine the concentration of urinary metabolites as recited in the claim, as optimization requires only routine skill in the art.
Regarding claim 10, Du does not teach a health management assessment unit.
Bouatra et al., teach analysis of the human urine metabolome wherein a database comprising detectable urinary metabolites, their concentrations, and disease associations (Introduction, page 2 right column first full paragraph). The Examiner notes that the database provides health related promotion information in that it provides concentrations of urinary metabolites and their disease associations, which can be utilized for health related recommendations. The Examiner also notes that the claim is being read in light of the rejection under 35 U.S.C. 112(b) in which the health management assessment unit is unclear. Bouatra et al., teach that it is advantageous to provide a database for the human urine metabolome as a means of facilitating future research into urine chemistry and urine metabolomics (Introduction, page 2 right column first full paragraph).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Du to include a database of detectable urinary metabolites in order to facilitate research into urine chemistry and urine metabolomics as taught by Bouatra et al.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The Examiner makes note of reference to Martinez-Moral et al., (Analytical and Bioanalytical Chemistry, 2022, 414:2103-2116). Martinez-Moral et al., teach analysis of 19 urinary biomarkers of oxidative stress, nitrative stress, metabolic disorders, and inflammation using liquid chromatography-tandem mass spectrometry wherein deoxyguanosine and reactive oxygen species are included in the analyzed biomarkers (figure 1, Table 1).
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/DWAN A GERIDO/ Examiner, Art Unit 1797 /LYLE ALEXANDER/ Supervisory Patent Examiner, Art Unit 1797