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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on October 16, 2023 is being considered by the examiner.
Drawings
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Specification
The substitute specification filed September 05, 2023 has not been entered because it does not conform to 37 CFR 1.125(b) and (c) because: a marked-up copy of the substitute specification has not been supplied (in addition to the clean copy).
Claim Rejections - 35 USC § 101
Claims 1-8 rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) “determining that the subject is at increased risk of having bladder cancer based on the elevated level of D-dimer in the urine sample; and performing an invasive testing for the bladder cancer on the subject”. This judicial exception is not integrated into a practical application because there is insufficient nexus between the determining step and the performing step. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim does not actually do anything based on the determining step.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-7, 9-13, are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Vogelstein et al. (“Vogelstein”) (Pub. No. US 2019/0256924 A1).
With respect to claim 1, Vogelstein teaches a method for identifying a subject for an invasive testing for bladder cancer, the method comprising: obtaining a first urine sample from the subject (paragraphs 1136-1137); assessing an elevated level of D-dimer in a urine sample obtained from the subject as compared to a predetermined threshold level (paragraph 0207); determining that the subject is at increased risk of having bladder cancer based on the elevated level of D-dimer in the urine sample (paragraph 0204); and performing an invasive testing for the bladder cancer on the subject (cystoscopy, paragraph 1137).
With respect to claim 2, the subject has had bladder cancer, and the assessing is for bladder cancer recurrence (paragraph 1137).
With respect to claim 3, the invasive testing for bladder cancer comprises one or more of cystoscopy, biopsy, and transurethral resection (cystoscopy, paragraph 1137; biopsy, paragraph 0021; transurethral resection, paragraph 1138).
With respect to claim 4, assessing an elevated level of one or more of MMP-1, Apolipoprotein A1/Apolipoprotein 1, Proteinase 3,and Apolipoprotein L1 in the urine sample obtained from the subject (Apolipoprotein 1, paragraph 0204) as compared to predetermined threshold levels (paragraph 0207) of MMP-1, Apolipoprotein A1/Apolipoprotein 1, Proteinase 3, or Apolipoprotein L1; and determining that the subject is at increased risk of having bladder cancer based on the elevated levels of the one or more of MMP-1, Apolipoprotein A2, Proteinase 3,and Apolipoprotein L1 in the urine sample (Apolipoprotein 1, paragraph 0204).
With respect to claim 5, assessing an elevated level of one or more of Apolipoprotein A1/Apolipoprotein 1 and IL-8 in the urine sample obtained from the subject as compared to predetermined threshold levels (paragraph 0207) of Apolipoprotein A1/Apolipoprotein 1 or IL-8 (Apolipoprotein 1, IL-8, paragraph 0204); and determining that the subject is at increased risk of having bladder cancer based on the elevated levels of the one or more of Apolipoprotein A1/Apolipoprotein 1 and IL-8 in the urine sample (Apolipoprotein 1, IL-8, paragraph 0204).
With respect to claim 6, conducting urine cytology (cytology, paragraph 0318) or assessing a level of nuclear matrix protein 22/NMP22 in the urine sample obtained from the subject determined to be at an increased risk of having bladder cancer (NMP22, paragraph 0295).
With respect to claim 7, the level of D-dimer in the urine sample is not normalized by a level of creatinine in the urine sample for the comparing with the predetermined threshold (paragraphs 0203-0204).
With respect to claim 9, a method for treating a subject for bladder cancer (paragraph 0206), the method comprising: (a) assessing an increased level of D-dimer in a urine (paragraph 0204) sample obtained from the subject as compared to a predetermined threshold level (paragraph 0207) through an enzyme-linked immunosorbent assay (ELISA) or a lateral flow assay (LFA) (ELISA, paragraph 0218); (b) in response to the level of D-dimer in the urine sample being above the predetermined threshold (paragraph 0207), identifying the subject as at increased risk of having bladder cancer (paragraph 0204); (c) performing an invasive testing for the bladder cancer on the subject (cystoscopy, paragraph 1137 and transurethral resection, paragraph 1138); (d) determining that the subject has the bladder cancer based on results of the invasive testing (paragraph 1137); (e) treating the subject for the bladder cancer by one or more of surgical resection, radiation, chemotherapy, and hormone therapy (transurethral resection, intravesical chemotherapy, adjuvant chemotherapy, neoadjuvant chemotherapy, radiation therapy, paragraph 0774).
With respect to claim 10, the subject has had bladder cancer, and is treated for bladder cancer recurrence (paragraph 1137).
With respect to claim 11, the invasive testing for bladder cancer comprises one or more of cystoscopy, biopsy, and transurethral resection (cystoscopy, paragraph 1137; biopsy, paragraph 0021; transurethral resection, paragraph 0221).
With respect to claim 12, assessing an elevated level of one or more of MMP-1, Apolipoprotein A1/Apolipoprotein 1, Proteinase 3, and Apolipoprotein L1 in the urine sample obtained from the subject (Apolipoprotein 1, paragraph 0204) as compared to predetermined threshold levels (paragraph 0207) of MMP-1, Apolipoprotein A1/Apolipoprotein 1, Proteinase 3, or Apolipoprotein L1; and determining that the subject is at increased risk of having bladder cancer based on the elevated levels of the one or more of MMP-1, Apolipoprotein A1/Apolipoprotein 1, Proteinase 3, and Apolipoprotein L1 in the urine sample (Apolipoprotein 1, paragraph 0204).
With respect to claim 13, assessing an elevated level of one or more of Apolipoprotein A1/Apolipoprotein 1 and IL-8 in the urine sample obtained from the subject as compared to predetermined threshold levels (paragraph 0207) of Apolipoprotein A1/Apolipoprotein 1 or IL-8 (Apolipoprotein 1, IL-8, paragraph 0204); and determining that the subject is at increased risk of having bladder cancer based on the elevated levels of the one or more of Apolipoprotein A1/Apolipoprotein 1 and IL-8 in the urine sample (Apolipoprotein 1, IL-8, paragraph 0204).
Claims 14-18, are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kang et al. (“Kang”) (Pub. No. US 2019/0011465 A1).
With respect to claim 14, Kang teaches an assay system for assessing a level of D-dimer (abstract) in a urine sample (paragraphs 0109-0110), for use in risk stratification for bladder cancer (paragraph 0043).
Regarding the limitation "for use in risk stratification of bladder cancer", this limitation is directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Kang and the apparatus of Kang is capable of being used to assess risk of cancer. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Kang (see MPEP §2114).
With respect to claim 15, the assay system is an enzyme-linked immunosorbent assay system (ELISA) (paragraph 0123).
With respect to claim 16, comprising a lateral flow test strip (paragraphs 0148-153).
With respect to claim 17, a capture reagent and a detection reagent that each bind to D-dimer (second immunochemical component, capture reagent paragraph 0171); a signal development element that can bind to the detection reagent (paragraph 0171); a washing buffer (paragraph 0123); a blocking buffer (paragraph 0125); a calibration curve to relate a signal to the level of D-dimer; and/or an instruction for use (calibration of standard curve, paragraphs 0158-0166).
With respect to claim 18, the assay system is a vertical flow assay (paragraph 0170).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 8, is rejected under 35 U.S.C. 103 as being unpatentable over Vogelstein et al. (“Vogelstein”) (Pub. No. US 2019/0256924 A1) in view of Ruddock et al. (“Ruddock”) (Pub. No. US 2012/0135886 A1).
With respect to claim 8, Vogelstein teaches a level of D-dimer in the urine sample with a level of creatinine in the urine sample for comparing the predetermined threshold (paragraph 203).
Vogelstein does not teach that the level of D-dimer in the urine sample is normalized.
Ruddock teaches a level of D-dimer in the urine sample is normalized with a level of creatinine in the urine sample (paragraphs 0043-0045; table 1).
It would have been obvious to one having ordinary skill in the art before the effective
filing date of the claimed invention to normalize the level of D-dimer in the urine sample because the hydration status of the patient and thus the urine sample may affect the detection of a biomarker (paragraph 0043).
Claims 19-20, are rejected under 35 U.S.C. 103 as being unpatentable over in view of Kang et al. (“Kang”) (Pub. No. US 2019/0011465 A1) in view of Vogelstein et al. (“Vogelstein”) (Pub. No. US 2019/0256924 A1).
With respect to claim 19, Kang teaches the assay system of claim 14. See supra.
Kang does not teach assessing levels of one or more of MMP-1, Apolipoprotein A1, Proteinase 3, and Apolipoprotein L1 in the urine sample.
Vogelstein teaches assessing levels of one or more of MMP-1, Apolipoprotein A1, Proteinase 3, and Apolipoprotein L1 in the urine sample, for use in risk stratification for bladder cancer (paragraph 0204).
It would have been obvious to one having ordinary skill in the art before the effective
filing date of the claimed invention to use the assay of Kang to assess the levels of other biological markers because it was taught that the device and method is also applicable to other immunological analysis, simple detection and quantification of biological markers of interest (paragraph 0010).
With respect to claim 20, Kang teaches the assay system of claim 14. See supra.
Kang does not teach assessing the biomarkers Apolipoprotein A1 and IL-8.
Vogelstein teaches assessing levels of one or more of Apolipoprotein A1/Apolipoprotein 1 and IL-8 in a urine sample, for use in risk stratification for bladder cancer (paragraph 0295).
It would have been obvious to one having ordinary skill in the art before the effective
filing date of the claimed invention to use the assay of Kang to assess the levels of other biological markers because it was taught that the device and method is also applicable to other immunological analysis, simple detection and quantification of biological markers of interest (paragraph 0010).
Conclusion
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/B.K.S./Examiner, Art Unit 1796
/ELIZABETH A ROBINSON/Supervisory Patent Examiner, Art Unit 1796