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 .
Election/Restrictions
Applicants’ election without traverse of Claim 8-11 and 20-22 in the reply filed on 05/29/2026 is acknowledged.
Claims 1-7 and 12-19 withdrawn from further consideration pursuant to 37 CFR 1.142(b), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/29/2026.
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 11 and 22 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.
Claim 11 recites the limitation "the non- human mammal". There is no mention of "the non- human mammal" in claim 8 which claim 11 is dependent upon. There is insufficient antecedent basis for this limitation in the claim. For examining purposes, the “the non-human mammal” is interpreted as “the subject”’.
Claim 22 recites the limitation "the blood FGF23 concentration". There is no mention of "the blood FGF23 concentration" in claim 8 or 20 which claim 22 is dependent upon. There is insufficient antecedent basis for this limitation in the claim. For examining purposes, the “the blood FGF23 concentration” mentioned in claim 22 in being interpreted as being depended on claim 9.
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 8 and 9 rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Claim 8 recites the steps for inhibiting a progression of chronic kidney disease. Claim 9 adds another step. Thus, the claim is to a method, which is one the statutory categories of invention. Claim 9-11 and 20-22 also are dependent on Claim 8.
Step 2A Prong One: Claim 8 recite a judicial exception and identify the abstract idea/law
of nature/natural phenomenon. Claim 8 recites “calculating” an estimated primary urine phosphorus concentration of a subject using a formula and “comparing” it with a normal subject. The "mathematical concepts" abstract idea grouping is defined as mathematical relationships, mathematical formulas or equations, and mathematical calculations (see MPEP 2106(a)(2)(I)). The "mental processes" abstract idea grouping is defined as concepts performed in the human mind, and examples of mental processes include observations, evaluations, judgments, and opinions (See MPEP 2106(a)(2)(III)). Calculating an estimated primary urine phosphorus concentration of a subject using a formula can be done with pen and paper and comparing it with a normal subject is a mental evaluation. Thus, both the calculating and comparing steps would fall under the abstract idea groups of mathematical concepts and mental processes. In addition, claim 9 recite a judicial exception and identify the abstract idea/law of nature/natural phenomenon. Claim 9 recites “comparing” the blood fibroblast growth factor-23 (FGF23) concentration of a subject with a normal subject. This comparison step would fall under the abstract category of a mental evaluation. (Step 2A -Prong 1: Yes)
Step 2A Prong Two: The judicial exception is not integrated into a practical application
because the claims do not impose any meaningful limits on practicing the abstract idea. Claim 8
describes the equation for estimating the primary urine phosphorus concentration as well as comparing it and then carrying out treatment based on the comparison. Claim 9 comparing the blood FGF23 concentration and then carrying out treatment based on the comparison. Both claims recite the additional element of carrying out treatment based on the comparison. However, that additional element of carrying out treatment is recited in a high level of generality. Accordingly, this additional element does not integrate the abstract idea into
a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea. (Step 2A -Prong 2: No)
Step 2B: Claims 8 and 9 have the additional step of carrying out treatment after the comparation step is completed. However, the step of carrying out treatment is not significantly more and is well known in the art as taught in the prior art below. Claims 8 and 9 are ineligible. Claims 10-11 and 20-22 do not appear to have ‘significantly’ more. Claim 10 recites a treatment which is highly general. Claims 11 and 20 recite sources for the sample. Claims 22 and 22 recite reference standards used for comparation of samples. Claims 10-11 and 20-22 do not add any additional elements that are significantly more than the abstract ideas, and they are well understood routine and conventional as referenced in the prior art below. Since it is claimed at a high level of generality, there are no meaningful limitation claimed, such as a particular or unconventional machine or transformation of a particular article. (Step 2B: No)
Thus, claims 8 and 9 are ineligible. Claims 10-11 and 20-22 are dependent on Claim 8, and are also rejected.
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 (i.e., changing from AIA to pre-AIA ) 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.
Claims 8-11 and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Biourge et al (US 20200163363 A1).
Regarding claim 8, Biourge teaches a method for inhibiting a progression of chronic kidney disease in subject (para 0004), comprising the following steps: measuring a blood creatinine concentration, a urine creatinine concentration, and a urine phosphorus concentration in the subject (para 0056 and 0004); comparing the estimated primary urine phosphorus concentration obtained in the calculation step with a primary urine phosphorus concentration in a normal subject (pg 15, Table 2); and carrying out a treatment intervention against the progression of chronic kidney disease based on comparison results of the phosphorus concentration comparison step (para 0004).
Biourge does not teach calculating an estimated primary urine phosphorus concentration based on the following Formula (II): ePTFp =(Up/Ucr) x Scr x 3.33 (II) wherein ePTFp represents the estimated primary urine phosphorus concentration, Up represents the urine phosphorus concentration, Ucr represents the urine creatinine concentration, and Scr represents the blood creatinine concentration.
Although the formula for calculating an estimated primary urine phosphorus concentration is not taught by Biourge, Biourge teaches a method measuring a blood creatinine concentration, a urine creatinine concentration, and a urine phosphorus concentration in the subject (para 0056 and 0004). The values measured as taught by Biourge can be formulated in an equation to estimate the primary urine phosphorus concentration because it is known that phosphorus retention happened early in chronic kidney disease and further leading to the progression of kidney diseases (para 0004). Thus, it would be obvious to one of ordinary skill in the art before the effective filing date to use the measure values of phosphorus and creatinine in urine and blood to determine the primary urine phosphorus concentration for the benefit of detecting chronic kidney disease and progression (para 0004).
Regarding claim 9, Biourge teaches measuring a concentration of a marker substance that is blood fibroblast growth factor-23 (FGF23) in the subject (para 0004), then comparing the blood FGF23 concentration in the subject with a blood FGF23 concentration in the normal subject (pg 15, Table 2), and further comprises carrying out a treatment intervention against the progression of chronic kidney disease based on the comparison results of the marker substance concentration comparison (para 0004).
Regarding claim 10, Biourge teaches the treatment intervention is carried out by dietary therapy (para 0097).
Regarding claim 11, Biourge teach the subject being a cat (0079).
Regarding claim 20, Biourge teach the subject being a human (para 0007).
Regarding claim 21, Biourge teaches the primary urine phosphate concentration reference values being 2.79-6.81 mg/dL (pg 15, Table 2).
The instant invention teaches the primary urine phosphorus concentration in the normal human subject is 2.3 mg/dL. Although the instant inventions discloses a concentration that is not in the range recited by the prior art, the standard reference value for the urine phosphorus concentration depends on the type of subject. The prior art reference interval were derived from cats as the normal subjects (para 0153). A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close (See MPEP 2144.05(I)). Thus, it would be obvious to one of ordinary skill in the art to modify the teaching of Biourge with the normal subject being a human with a reference primary urine phosphorus concentration of 2.3 mg/dL for the benefit of studying various subjects including human (para 0007).
Regarding claim 22, Biourge teaches the blood FGF23 concentration reference in a cat being 56-700 pg/mL (pg 15, Table 2).
The instant invention teaches the blood FGF23 concentration in the normal human subject is 53 pg/mL. Although the instant inventions discloses a concentration that is not the range recited by the prior art, the standard reference value for the blood FGF23 concentration depends on the type of subject. The prior art reference interval were derived from cats as the normal subjects (para 0153). A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close (See MPEP 2144.05(I)). Thus, it would be obvious to one of ordinary skill in the art to modify the teaching of Biourge with the normal subject being a human with a reference blood FGF23 concentration of 53 pg/mL for the benefit of studying various subjects including human (para 0007).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HENA BERA whose telephone number is (571)272-9964. The examiner can normally be reached Mon-Fri 8:00-5:00pm EST.
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/H.R.B./ Examiner, Art Unit 1798
/CHARLES CAPOZZI/ Supervisory Patent Examiner, Art Unit 1798
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