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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 13 April 2026 has been entered.
Claims 1, 3, 4, 6, 7, 10-12 and 14-24 are currently pending and are considered here.
Any rejection not reiterated herein has been withdrawn.
Response to Arguments
Applicant's arguments filed 13 April 2026 have been fully considered but they are not persuasive. Applicant cites several studies regarding the urinary proteome of cancer subjects that do not show any active PKCα in the samples and argues that there would therefore not have been a reasonable expectation of success in detecting active PKCα in urine. This is not persuasive because each of the articles cited by Applicant uses an untargeted mass spectrometry (MS)-based approach to detect a wide range of proteins, whereas the cited prior art teaches detection using active PKCα-specific/targeted detection reagents (antibodies and substrate peptides). Thus, the cited articles are not sufficient to establish a lack of a reasonable expectation of success in detecting active PKCα using the method of Metzker and/or Katayama, but rather only that active PKCα is not routinely detected using a different MS approach. Moreover, any evidence regarding expectation of success or secondary considerations is inapplicable to overcome the anticipation rejections below (MPEP 2131.04). Evidence that one of ordinary skill would not expect to detect active PKCα in urine via the methodology used by the cited art might be persuasive to overcome the pending 103 rejections.
Claim Objections
Applicant is advised that i) should claim 1 be found allowable, claim 3 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof; ii) if claim 7 should be found allowable, claim 10 will be objected to as being a substantial duplicate thereof; and iii) if claim 4 should be found allowable, claim 12 will be objected to as being a substantial duplicate thereof.
When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112(d)
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.
Claims 3 and 10 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. Claims 3 and 10 recite that the cancer includes urothelial carcinoma, but claims 1 and 7 from which they depend have been amended to recite said limitation. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
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.
Claim 1, 3, 4, 6, 7, 10, 11-12 and 14-23 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative (in the case of claims 4, 11, 12, 14, 15), under 35 U.S.C. 103 as obvious over US20120329854 to Metzger et al. (cited in IDS of 22 Aug. 2022), as evidenced by Lenis et al., Jama 324.19 (2020): 1980-1991.
Regarding claims 1 and 3, Metzger teaches a method of detecting, prognosticating and/or grading cancer comprising detecting active PKCα in a sample from a subject ([0012]-[0014]; [0050]-[0053]; [0075]-[0080]; [0088]-[0095]). The sample can be a body fluid of the subject, and "Preferably, the body fluid is blood, plasma, urine, saliva, serum, semen, prostate fluid or seminal fluid" ([0120]-[0121]; [0198]; [0214]; [0226]). The subject can be suspected of suffering from cancer (i.e. be at risk of having cancer) or have cancer, e.g. wherein the cancer is graded and/or wherein detection is in a control subject known to have cancer ([0075]-[0079]; [0113]-[0116]). The cancer can be bladder cancer ([0050]; [0191]; [0209]; [0215]; [0227]). Lenis evidences that "[b]ladder cancer accounts for approximately 90% to 95% of urothelial carcinoma" (i.e. bladder cancer is a species of urothelial carcinoma) (Lenis, under Pathophysiology and Molecular Biology). The teaching of bladder cancer anticipates the recitation of urothelial carcinoma (see MPEP 2131.02, I. - teaching of a species within a genus anticipates the genus).
Regarding claims 4, 11 and 12, wherein the cancer includes carcinoma in situ, Metzger teaches that the method can be carried out for a wide range of cancers ([0050]; [0062]-[0064]; [0191]). Thus, it would have been prima facie obvious to carry out the method of Metzger for any type of cancer, including any urothelial/bladder cancer such as carcinoma in situ.
Regarding claims 6, 7 and 19, wherein the detecting is via reacting an antibody with active PKCα, Metzger teaches that the detecting can use an antibody against the active form of PKCα ([0095]; [0107]-[0108]).
Regarding claims 6, 7 and 20, wherein the detecting is via reacting a substrate peptide with active PKCα, Metzger teaches that the detecting can involve measuring kinase activity, e.g. by measuring phosphorylation of a labeled synthetic kinase substrate ([0093]-[0094]).
Regarding claim 7, wherein "a state of the cancer is evaluated with an obtained detection result used as an index", the instant specification states that an example of using the detection result as an index is comparison of the result with a reference value, such as a value representative of a healthy subject or a known cancer patient (Published Spec. US20230030314, [0070]). Metzger teaches comparing the detection result with a control/reference value that can be derived from known cancer patient(s) or healthy subject(s) ([0113]-[0120]). Moreover, the recitation that “the obtained detection result is used as an index” can be construed to include any use of the results for diagnostic purposes. Claim 7 does not require any particular use of the result, such as comparison to a reference value or the like.
Regarding claims 14 and 15, Metzker teaches that the diagnostic method can be carried out using urine from a subject, and it would have been obvious to further carry out a step of collecting such urine from the subject to carry out the testing.
Regarding claims 16-18, Metzker teaches that the detection can be carried out with a sample from a subject known to have cancer, e.g. wherein the cancer is graded and/or wherein detection is in a control subject diagnosed with cancer ([0075]-[0079]; [0113]-[0116]).
Regarding claims 21-23, Metzker teaches that the detection can comprise contacting with an antibody that binds active PKCα in the subject's sample (see above re claims 6, 7 and 19), and further teaches that the subject can be a human, mouse or rat ([0052]-[0053]).
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.
Claims 6, 7, 20 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Metzger, as applied to claims 1, 3, 4, 6, 7, 10, 11-12, 14-18 and 19-23, in view of JP2007236388 to Katayama et al. (previously cited; citations are to English translation).
Claims 6, 7, 20 and 24 (potentially) differ from Metzger, as applied to claims 1, 3, 4, 6, 7, 10, 11-12, 14-18 and 19-23, in that: the detecting comprises reacting a substrate peptide for detecting active PKCα with the PKCα (claims 6, 7, 20); and the substrate peptide is specific for active PKCα (claim 24).
Katayama teaches a method for detecting active protein kinase Cα (PKCα) in a subject, comprising detecting active PKCα in a biological sample from the subject, which can be a urine sample, by contacting the sample with a substrate peptide that is specifically phosphorylated by active PKCα and detecting the phosphorylated peptide (p. 3, ¶1-5 under Description; p. 5, embodiments (29)-(32); p. 7, under (4)). Katayama further teaches a method of diagnosing a disease associated with PKCα activity wherein the disease can be cancer (p. 7, under (4)).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to use the method of Metzger to measure active PKCα activity in urine for diagnosis of urothelial carcinoma wherein the detection is via contacting the active PKCα with a substrate peptide specific for active PKCα as taught by Katayama because it would have been obvious to combine prior art elements according to known methods to yield predictable results. Carrying out the method of Metzger using a substrate peptide of Katayama would have led to predictable results with a reasonable expectation of success because Metzger teaches that the detection can be via measuring phosphorylation with a synthetic peptide substrate and Katayama teaches measuring active PKCα in urine using such a peptide substrate for a substantially similar diagnostic purpose as in Metzger.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT J YAMASAKI whose telephone number is (571)270-5467. The examiner can normally be reached M-F 930-6 PST.
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/ROBERT J YAMASAKI/Primary Examiner, Art Unit 1657
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