DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/6/26 has been entered.
Claims 28, 30, and 32 have been amended. Claims 1-27 and 43-60 have been canceled. Claims 28-42 are pending and under examination.
Withdrawn Rejections
The rejection of claims 28-44 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention, is withdrawn in light of Applicant’s amendment thereto. See paragraph 8, page 3 of the previous Office action.
The rejection of claims 29-42 and 44 under 35 U.S.C. 101 because the claimed invention is directed to judicial exception without significantly more, is withdrawn in light of Applicant’s amendment thereto. See paragraph 10, page 5 of the previous Office action.
New Rejections
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 28-42 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. This is a new matter rejection.
The instant claims recite a “non-transitory computer readable medium having stored thereon a computer program that, when executed by a computer system operably connected to an assay kit, causes the computer system to perform an operation of monitoring a kidney disease or a causative condition thereof…”. However, the specification does not describe “a computer readable medium having stored thereon a computer program that, when executed by a computer system operably connected to an assay kit, causes the computer system to perform an operation of monitoring a kidney disease or a causative condition thereof…” and therefore this limitation constitutes new matter.
The disclosure concerning the use of a computer is limited to the following statement:
“The specific methods/algorithms for using biomarker levels to make these determinations, as described herein, may optionally be implemented by software running on a computer that accepts the biomarker levels as input and returns a report with the determinations to the user. This software may run on a standalone computer or it may be integrated into the software/computing system of the analytical device used to measure the biomarker levels or, alternatively, into a laboratory information management system (LIMS) into which crude or processed analytical data is entered.” (See page 8 of the specification) However, this not interpreted as a computer-readable medium comprising a computer program that, when executed on a computer system operably connected to a computer system to perform an operation of monitoring a kidney disease or a causative condition thereon, as claimed.
Although the PTO has the initial burden of presenting evidence or reasons why persons skilled in the art would not recognize in the disclosure a description of the invention defined by the claims, when filing an amendment an applicant should show support in the original disclosure for new or amended claims. See MPEP 714.02 and 2163.06 (“Applicant should therefore specifically point out the support for any amendments made to the disclosure.”).
It is noted that Applicant did not point to support in the specification, by page and line number, for the limitation recited in the amended claims. Accordingly, the limitations in the claims constitute new matter.
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 28-42 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 28 recites “determining from said comparing step (b) that the patient has an altered level of at least two of said plurality of biomarkers relative to normal control levels and administering to the patient at least one of an oral insulin, an ACE inhibitor, and an angiotensin II receptor blocker”. The term “altered” is a relative term than renders the claim indefinite. The term altered” 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 “altered level of at least two of said plurality of biomarkers compared to a normal control” is used to make a treatment decision; however, there is no guidance regarding the change in the biomarkers levels that is required such that a treatment is administered to the patient. Thus, the claim scope is ambiguous and one of skill in the art would not be apprised of the metes and bounds of the claim. Dependent claims 29-42 do not cure the deficiencies of claim 28, and thus, are included in the rejection.
Claim Status
No claims are allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SANDRA CARTER whose telephone number is (571)272-2932. The examiner can normally be reached 8:00-5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa L. Ford can be reached at (571)272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SANDRA CARTER/Examiner, Art Unit 1674
/VANESSA L. FORD/Supervisory Patent Examiner, Art Unit 1674
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