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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. A copy of Japanese Application JP2020-219130 has been filed with a priority date of 28 December 2020.
Claim Rejections - 35 USC § 112
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 1-2 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 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. Claims 1-2 both recite “mitochondrial function/activity in a tissue or organ other than the kidney”, however, in the detailed description of the invention, as an example, it is disclosed that as a result of measuring the correlation between the accumulation of PET probes in rat organs and tissues and the BUN/CRE value using [18F]BCPP-BF, which is a PET probe already known to be used for detecting mitochondrial complex-I (MC-I), a significant correlation was found between the accumulation amount of PET probes, that is, MC-I activity, and the BUN/CRE value in the brain, heart, pancreas, liver, and brown adipose tissue (see [0027-0061]). However, it is not clear from the present invention that a similar correlation would be present in all other organs or tissues other than kidney. As no correlation exists in the kidney (see [0058]), it is presumed that there are other organs or tissues for which no correlation is found. Therefore, it cannot be said the contents disclosed in the detailed description of the invention can be extended or generalized to the scope of the invention of claims 1 and 2. In other words, the species of brain, heart, pancreas, liver, and brown adipose tissue does not adequately cover all other organs or tissues of a subject other than kidney (see MPEP 2163 3(a)ii) For each claim drawn to a genus).
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 1-4 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Claims 1 and 3:
Step 1: Claims 1 and 3 are directed toward a process and thus fall under one of the four statutory categories of invention (see MPEP 2106.03 Eligibility Step 1: The Four Categories of Statutory Subject Matter).
Step 2A Prong 1: Claim 1 recites “a step of estimating mitochondrial activity in a tissue or organ other than the kidney in the test subject using the calculated ration (BUN/CRE)” which under its broadest reasonable interpretation can be performed in the mind, falling under the mental processes grouping of abstract ideas, and thus recites a judicial exception (see MPEP 2106.04(a)(2) III. Mental Processes).
Step 2A Prong 2: This judicial exception is not integrated into a practical application because after the mitochondrial activity is estimated, nothing else is done (see 2106.04(d) Integration of a Judicial Exception Into A Practical Application). Furthermore, the additional step of “calculating a ratio (BUN/CRE) of blood urea nitrogen (BUN) concentration to blood creatinine (CRE) concentration in a test subject” is itself an abstract idea (see MPEP 2106.04(a)(2) I. Mathematical Concepts). Dependent claim 3 merely further defines the tissue or organ other than the kidney in the test subject used in the abstract idea.
Step 2B: The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because, while the method appears not to be well-understood, routine, or conventional in the art, the abstract idea itself cannot be enough to qualify as an inventive concept (see 2106.05 Eligibility Step 2B: Whether a claim amounts to Significantly More).
Claims 2 and 4:
Step 1: Claims 2 and 4 are directed toward a process and thus fall under one of the four statutory categories of invention (see MPEP 2106.03 Eligibility Step 1: The Four Categories of Statutory Subject Matter).
Step 2A Prong 1: Claim 2 recites “a step of calculating a ratio (BUN/CRE) of blood urea nitrogen (BUN) concentration to blood creatinine (CRE) concentration in a test subject” which falls under the mathematical concepts of abstract ideas, and thus recites a judicial exception (see MPEP 2106.04(a)(2) I. Mathematical Concepts).
Step 2A Prong 2: This judicial exception is not integrated into a practical application because after the ratio calculation, nothing else is done (see 2106.04(d) Integration of a Judicial Exception Into A Practical Application). Dependent claim 4 merely further defines the tissue or organ other than the kidney in the test subject used in the abstract idea.
Step 2B: The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because, while the method appears not to be well-understood, routine, or conventional in the art, the abstract idea itself cannot be enough to qualify as an inventive concept (see 2106.05 Eligibility Step 2B: Whether a claim amounts to Significantly More).
Therefore, claims 1-4 are not patent eligible.
Examiner’s Comment
The closest prior art to the instant application is “Effects of the blood urea nitrogen to creatinine ratio on haemorrhagic transformation in AIS patients with diabetes mellitus” to Deng Linghui et al. (herein Deng) as cited on the 11/01/24 IDS; “Blood Urea Nitrogen to Creatinine Ratio and Long-Term Mortality in Patients with Acute Heart Failure: A Prospective Cohort Study and Meta-Analysis” to Zhu Xu et al. (herein Zhu) as cited on the 11/01/24 IDS; and United States Patent Application US 2020/0003762 to Brown as cited on the 07/26/23 IDS.
Deng discloses the use of the BUN-to-Cr ratio (blood urea nitrogen to blood creatinine) (BUN/CRE) as a marker for disease severity in acute ischemic stroke (i.e., brain). Deng also reports the Bun-to-Cr ratio was previously used as a marker for heart failure and neurological deterioration (see abstract; pg. 1, col. 2, para bridging pg. 2; Table 4).
Zhu discloses the use of BUN/CRE ratio as a marker for severity of heart failure (i.e., heart) (see abstract; pg. 424, para 1; Fig. 4).
Brown discloses a method for predicting a mitochondrial dysfunction, comprising measuring reference biomarkers in a sample, and indicates that one of the reference biomarkers used is creatinine (see claims; [0109-0110]; Table 5).
However, neither Deng, Zhu, nor Brown teach nor fairly suggest a method of estimating mitochondrial activity or function of a tissue or organ other than the kidney using the BUN/CRE ratio as recited in instant, independent claims 1 or 2.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHRYN E LIMBAUGH whose telephone number is (571)272-0787. The examiner can normally be reached Monday-Thursday 7:00-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KATHRYN ELIZABETH LIMBAUGH/Primary Examiner, Art Unit 1797
Prosecution Insights