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 .
Status of Claims
Claims 12-16 are canceled.
Claims 1-11, 17-24 are pending and are examined on the merits.
Information Disclosure Statement
The information disclosure statement filed August 8th, 2023 has been considered.
Priority
Provisional application 63/046,467 with filing date June 30th, 2020, and PCT with application number 18/003911 with filing date June 30th, 2021 are acknowledged. The effective filing date is June 30th, 2020.
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.
Claim 11 is 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, “relatively high” and “relatively low” on lines 4-24. The term “relatively high” is relative and indefinite. The specification is silent regarding a clear and precise definition of “relatively”. One skilled in the art would not recognize the metes and bounds of the limitation. For the purposes of speedy prosecution, the examiner interprets these terms as any level of degree.
Claim 11 recites, “high” and “low” on lines 4-24. The specification is silent regarding a clear and precise definition of “high” and “low”. One skilled in the art would not recognize the metes and bounds of the limitation. For the purposes of speedy prosecution, the examiner interprets these terms as any level of degree.
Claim 11 recites, “moderate” on line 21. The term “moderate” is relative and indefinite. The specification is silent regarding a clear and precise definition of “desired edit”. One skilled in the art would not recognize the metes and bounds of the limitation. For the purposes of speedy prosecution, the examiner interprets these terms as any level or degree.
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 1-11, 17-24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea of mental steps, mathematic concepts, organizing human activity, or a natural law without significantly more.
Step 2A, Prong 1
In accordance with MPEP § 2106, claims found to recite statutory subject matter (claim 1-23 are drawn to a method; claim 24 is drawn to a system) (Step 1: YES) are then analyzed to determine if the claims recite any concepts that equate to an abstract idea, law of nature or natural phenomenon (Step 2A, Prong 1). In the instant application, the claims recite the following limitations that equate to an abstract idea:
Claim 1 and 24 recites:
“…detecting activation and/or repression in the sample of one or more regulons selected from E2F1, TP63, and ZNF385A;…”, mental step, i.e. can be done with pen or paper
“…detecting an increase in somatic copy number…”, mental step
“…detecting expression in the sample of one or more genes selected from FOXM I, RXRA, MYC, E2F1, EZH2, FGFR3, STAT4, and NFATC2…”, mental step
“…detecting an immune score and/or a stromal score for the sample…”, mental step
“…detecting expression and/or repression of genes associated with CIS in the sample…”, mental step
“…detecting expression of one or more genes selected from E2F target genes, G2M checkpoints genes, inflammatory response genes, IL2/STAT5 signaling genes, IFNG response genes, INFA response genes, and MYC target genes…”, mental step
“…classifying the sample by one or more subtype classifiers selected from Lund, TCGA mRNA subtype classifier, consensusMIBC, and UROMOL class…”, mental step
Claims 2-10 recite “performing [a number between “two” and “all ten” (respectively from claim 2-10) ] of steps (a)-(j)”, mental step
Claim 11 recites: “…classifying the Stage TS1 bladder cancer into one of five (5) classes…”, mental step and:
“class 1 (which optionally may be referred to as "T1-LumGU"), is defined by one or more of the following criteria: (a) activation of the E2F1 regulon relative to class 2, class 3, class 4, and/or class 5; (b) a high increase in somatic copy number relative to class 2, class 4, and/or class 5; (c) relatively high expression of E2F 1 and EZH2 in comparison to class 2, class 3, class 4, and/or class 5; and relatively low expression of FGFR2 and MYC in comparison to class 2, class 3, class 4, and/or class 5; (d) high tumor purity; (e) a moderate immune score and/or a low stromal score; (h) presence of CIS, and/or increased or decreased expression of genes associated with CIS; (i) enriched expression of E2F target genes and/or G2M checkpoints genes relative to class 2, class 3, class 4, and/or class 5; and (j) a classification selected from Lund:GU, TCGA mRNA:Lum-papillary, consensus MIBC:LumU, and UROMOL class:2a, class 2 (which optionally may be referred to as "T1-Inflam"), is defined by one or more of the following criteria: (a) activation of the TP63/ZNF385A regulon relative to class 1, class 3, and/or class 5; (b) a low increase in somatic copy number relative to class 1; (c) relatively high expression of STAT4 and NFATC2 in comparison to class 1, class 3, class 4, and/or class 5; (d) low tumor purity relative to class 1, class 3, class 4, and/or class 5; (e) a high immune score and/or a high stromal score relative to class 1, class 3, class 4, and/or class 5; (f) detected immune cells; (g) detected inflammation; (h) presence of CIS, and/or increased or decreased expression of genes associated with CIS; (i) enrichment in expression of inflammatory response genes, IL2/STAT5 signaling genes, and IFNG response genes, and MYC target genes, and repression of expression of E2F target genes, G2M checkpoint genes, and MYC target genes relative to class 1, class 3, and/or class 5; and (j) a classification selected from Lund:(URO, some Basal/SCC-like, Mes-like), TCGA mRNA:Lum-papillary, consensusMIBC:LumP/Stroma-rich, and UROMOL class:2a/2b; class 3 (which optionally may be referred to as "T1-Myc"), is defined by one or more of the following criteria: (a) moderate activation of the E2F1 regulon relative to class 1, class 2, class 4, and/or class 5; (c) relatively high expression of FOXM1 and RXRA in comparison to class 1, class 2, class 4, or class 5, and a wide range of expression for MYC in comparison to class 1, class 2, and/or class 4; (d) high tumor purity; (e) a low immune score and/or a low stromal score; (h) presence of CIS, and/or increased or decreased expression of genes associated with CIS; and (j) a classification selected from Lund:URO, TCGA mRNA:Lum-papillary, consensusMIBC:LumP, and UROMOL class:2a; class 4 (which optionally may be referred to as "T1-TLum"), is defined by one or more of the following criteria: (a) activation of the ZNF385A (TP63) regulon relative to class 1, class 2, and/or class 5; (b) a low increase in somatic copy number relative to class 1, class 2, and/or class 5; (c) relatively low expression of E2F1, FOXM1, STAT4, and NFATC2 in comparison to class 1, class 2, class 3, and/or class 5; (d) high tumor purity; (e) a low immune score and/or a low stromal score; (h) presence of CIS, and/or increased or decreased expression of genes associated with CIS; (i) repression of expression E2F target genes and G2M checkpoint genes relative to class 1, class 3, and/or class 5; and (j) a classification selected from Lund:URO, TCGA mRNA:Lum-papillary, consensusMIBC:LumP, and UROMOL class:1/2a; class 5 (which optionally may be referred to as "T1-Early"), is defined by one or more of the following criteria: (a) moderate activation of the ZNF385A regulon relative to class 1, class 2, class 3, and/or class 4; (b) a low increase in somatic copy number relative to class 1; (c) relatively high expression of MYC in comparison to class 1, class 2, or class 4 (d) high tumor purity; (e) a low immune score and/or a low stromal score; (h) absence of CIS, and/or increased or decreased expression of genes associated with CIS in the sample; (i) enrichment in expression of MYC target genes; and repression of expression of IFNG genes and IFNA genes relative to class 1, class 2, and class 4; and (j) a classification selected from Lund:URO, TCGA mRNA:Lum-papillary, consensusMIBC:LumP, and UROMOL class:2a/3…”, which further limits claim 1.
Claim 17 recites: “wherein detecting expression comprises detecting mRNA of a gene in the sample”, mental step
Claim 18 recites, “administering therapy for bladder cancer to the subject after classifying the sample of Stage 1 bladder cancer”, mental step
Claim 19 recites: “the sample is classified as class 1 (which optionally may be referred to as "T1-LumGU"), and administering therapy to the subject comprises administering BCG therapy and/or EZH2-i therapy to the subject”, mental step
Claim 20 recites: “the sample is classified as class 2 (which optionally may be referred to as "T1-Inflam"), and administering therapy to the subject comprises administering BCG therapy to the subject.”, mental step
Claim 21 recites: “the sample is classified as class 3 (which optionally may be referred to as "T1-Myc"), and administering therapy to the subject comprises performing a cystectomy on the subject and/or administering Myc-I therapy to the subj ect.”, mental step
Claim 22 recites: “the sample is classified as class 4 (which optionally may be referred to as "T1-TLum"), and administering therapy to the subject comprises administering TURBT or BCG to the subject.”, mental step
Claim 23 recites: “the sample is classified as class 5 (which optionally may be referred to as "T1-Early"), and administering therapy to the subject comprises administering ad-stilidrin and/or MYC-i therapy to the subject.”, mental step
The claims recite an abstract idea of analyzing a biological sample (See MPEP 2106.07(a)).
These recitations are similar to the concepts of collecting information, analyzing it and displaying certain results of the collection and analysis in Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQ2d 1739 (Fed. Cir. 2016)), organizing and manipulating information through mathematical correlations in Digitech Image Techs., LLC v Electronics for Imaging, Inc. (758 F.3d 1344, 111 U.S.P.Q.2d 1717 (Fed. Cir. 2014)) and comparing information regarding a sample or test to a control or target data in Univ. of Utah Research Found. v. Ambry Genetics Corp. (774 F.3d 755, 113 U.S.P.Q.2d 1241 (Fed. Cir. 2014)) and Association for Molecular Pathology v. USPTO (689 F.3d 1303, 103 U.S.P.Q.2d 1681 (Fed. Cir. 2012)) that the courts have identified as concepts that can be practically performed in the human mind or mathematical relationships. Therefore, these limitations fall under the “Mental process” and “Mathematical concepts” groupings of abstract ideas.
While claim 24 recites performing some aspects of the analysis using a “system”, there are no additional limitations that indicate that this model requires anything other than carrying out the recited mental process or mathematical concept in a generic computer environment. Merely reciting that a mental process is being performed in a generic computer environment does not preclude the steps from being performed practically in the human mind or with pen and paper as claimed. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then if falls within the “Mental processes” grouping of abstract ideas. As such, claim(s) 1-11, 17-24 recite(s) an abstract idea/law of nature/natural phenomenon (Step 2A, Prong 1: YES).
Step 2A, Prong 2
Claims found to recite a judicial exception under Step 2A, Prong 1 are then further analyzed to determine if the claims as a whole integrate the recited judicial exception into a practical application or not (Step 2A, Prong 2). This judicial exception is not integrated into a practical application because the claims do not recite an additional element that reflects an improvement to technology or applies or uses the recited judicial exception to affect a particular treatment for a condition. Rather, the instant claims recite additional elements that amount to mere instructions to implement the abstract idea in a generic computing environment or mere instructions to apply the recited judicial exception via a generic treatment. Specifically, the claims recite the following additional elements:
Claims 24 recites:
“…a computer processor …”
There are no limitations that indicate that the claimed analysis engine or the formats of the provided data require anything other than generic computing systems. As such, these limitations equate to mere instructions to implement the abstract idea on a generic computer that the courts have stated does not render an abstract idea eligible in Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983. As such, claims 1-11, 17-24 are directed to an abstract idea (Step 2A, Prong 2: NO).
Step 2B
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself (Step 2B). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims recite additional elements that equate to mere instructions to apply the recited exception in a generic way or in a generic computing environment.
The additional elements do not comprise an inventive concept when considered individually or as an ordered combination that transforms the claimed judicial exception into a patent-eligible application of the judicial exception. Therefore, the claims do not amount to significantly more than the judicial exception itself (Step 2B: No). As such, claims 1-11, 17-24 is/are not patent eligible.
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.
Claim(s) 1-11, 17-20, 22, and 24 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by David McConkey et al. (US20150292030A1) as evidenced by Ting Liu et al (Sig Transduct Target Ther 2, 17023 (2017).
Addresses to the limitations of the claims will be marked in italics.
Regarding claims 1 and 24, McConkey et al. discloses a method of diagnostic testing of primary tumors, circulating tumor cells, serum, and urine to detect high-risk bladder cancers, including statistical method to classify stage T1 bladder cancer from a subject, and comprising a computer processor configured for receiving input (Abstract, spec. para. 0061 (computer), 0164, clm. 26).
McConkey et al. further teaches an in vitro method of characterizing a bladder cancer comprising obtaining a sample from a bladder cancer patient and testing to determine the level of expression or activation of a plurality of genes wherein activation of TP63 is detected (clm. 26, re: clm. 1, 24… classifying a sample of Stage T1 bladder cancer from a subject, …performing one or more of the following detecting steps:(a) detecting activation and/or repression in the sample of one or more regulons selected from E2F1, TP63, and ZNF385A…).
McConkey et al. further teaches molecular pathway analyses to identify candidate biological mechanisms leading to the emergence of the 3 bladder cancer subsets, in which “cellular growth and proliferation” were significantly enriched in all three subsets, which reads on detecting an increase in somatic copy number (Spec, para. 0119, Table 1B, re: clm. 1, 24 … (b) detecting an increase in somatic copy number…)
McConkey et al. further teaches detected expression of FOXM1 (clm. 25, re: clm. 1, 24 … c) detecting expression in the sample of one or more genes selected from FOXM I, RXRA, MYC, E2F1, EZH2, FGFR3, STAT4, and NFATC2…)
McConkey et al. further teaches classification of urothelial tumors using whole genome mRNA expression analysis. McConkey et al. classifies each tumor based on detected gene expression within a sample in addition to component analysis, which reads on detecting purity of a sample (Spec, para. 0117, “Patients in cluster 1 had more tumors with squamous or sarcomatoid components and advanced disease at presentation (Table 4A).”, re: clm. 1, 24 … (d) detecting tumor purity for the sample…)
McConkey et al. further teaches a measurement of the proliferation of immune cells in a tumor sample and includes a bias-corrected Z score (Table 1A, re: clm. 1, 24 … e) detecting an immune score and/or a stromal score for the sample… detecting immune cells in the sample…)
McConkey et al. further teaches measuring NFkB, a transcription factor involved in the regulation of the immune and inflammatory response as evidenced by Ting Liu et al. (clm. 1, 24 Table 2, re: clm. 1, … (f) detecting immune cells in the sample; (g) detecting inflammation in the sample…).
McConkey et al. further teaches detecting carcinoma in situ (CIS) via measurement of Gata3 expression (clm. 1) , a CIS-specific gene signature as evidenced by Junghye Lee et al. (“However, PSI besides in situ prostatic duct involvement was diagnosed because scattered infiltrating tumor cells with positive GATA3 and pancytokeratin positivity with lack of HMWCK stain within the inflammatory infiltrates and subsequently pT4a was re-assigned in this case.”, re: clm. 1, 24 … (h) detecting carcinoma in situ (CIS) in the sample, and/or detecting expression and/or repression of genes associated with CIS in the sample …)
McConkey et al. further teaches characterization of gene expression patterns associated with active tumor suppressors (p53, CDKN2A (p16) and RB) and suppressed E2F pathway genes (Table 2) in a sample (Spec, para. 0123, re: clm. 1,24 … (i) detecting expression of one or more genes selected from E2F target genes, G2M checkpoints genes, inflammatory response genes, IL2/STAT5 signaling genes, IFNG response genes, INFA response genes, and MYC target genes…)
McConkey et al. further teaches using quantitative real-time RT-PCR to measure miR-205 levels in RNA isolated from a cohort of primary bladder cancers and confirmed that high miR-205 was associated with short disease-specific and overall survival. McConkey et al. states on para. 0055 of the specification: “Analysis of the publicly-available TCGA RNA sequencing data confirmed that miR-200c is expressed almost exclusively by luminal cancers and that the other four members of the miR-200 family are as well.”, which reads on using a TCGA mRNA subtype classifier during sample classification (re: clm. 1, 24 … optionally performing the following classifying step: () classifying the sample by one or more subtype classifiers selected from Lund, TCGA mRNA subtype classifier, consensusMIBC, and UROMOL class; thereby classifying the Stage T I bladder cancer.). As McConkey et al. teaches a method for classifying a sample of Stage T1 bladder cancer from a subject, McConkey et al. anticipates claims 1 and 24.
Regarding claims 2-10, McConkey et al. discloses steps (a)-(j) referenced in claim 1 as previously described in regard to claim 1 (re: clms. 2-10, … performing … of steps (a)-(j)). McConkey et al. anticipates claims 2-10.
Regarding claim 11, “high”, “low”, “relatively” and “moderate” are interpreted as any degree (such as, “any degree of expression…” or “any degree of activation”)
Regarding claim 11, McConkey et al. discloses classifying stage T1 bladder cancer from samples (Spec, para. 0054) into a class containing:
activation of the ZNF385A (TP63) regulon (clm. 11, Table 2, re: clm 11, …classifying the Stage TS1 bladder cancer into one of five (5) classes as follows: … class 4 (which optionally may be referred to as “T1-TLum”), is defined by one or more of the following criteria: (a) activation of the ZNF385A (TP63) regulon relative to class 1, class 2, and/or class 5…), and
measurements of “Cellular growth and proliferation” on table 1B in which a decrease is measured, which reads on a low increase in somatic copy number (re: clm. 11, …a low increase in somatic copy number relative to class 1, class 2, and/or class 5…)
As McConkey et al. teaches classification of T1 bladder cancer into a class containing one or more of the above criteria, McConkey et al. anticipates claim 11.
Regarding claim 17, McConkey et al. discloses detecting mRNA of a gene in a sample (Spec, para 0117, re: clm. 17, …wherein detecting expression comprises detecting mRNA of a gene in the sample.) in anticipation of claim 17.
Regarding claim 18, McConkey et al. discloses administering therapy after characterizing bladder cancer (Spec, para. 0010, clm. 36, re: clm. 18, …administering therapy for bladder cancer to the subject after classifying the sample of Stage 1 bladder cancer.) McConkey et al. anticipates claim 18.
Regarding claims 19-22, “high”, “low”, “relatively” and “moderate” are interpreted as any degree (such as, “any degree of expression…” or “any degree of activation”)
Regarding claim 19, McConkey et al. discloses classifying stage T1 bladder cancer from samples (Spec, para. 0054) into a class containing E2F pathway genes, a component of class 1 as disclosed in the instant claim (spec, para. 0123, Table 2, re: clm. 19 …the sample is classified as class 1…), and additionally discloses BCG therapy as a potential therapy to be administered to a patient (Spec, para. 0086, re: clm. 19, … administering therapy to the subject comprises administering BCG therapy and/or EZH2-i therapy to the subject….). As McConkey et al. discloses classification and therapy administration in this manner, McConkey et al. anticipates claim 19.
Regarding claim 20, McConkey et al. discloses classifying stage T1 bladder cancer from samples (Spec, para. 0054) into a class containing measured NFkB, a transcription factor involved in the regulation of the immune and inflammatory response (as evidenced by Ting Liu et al.), a component of class 2 as disclosed in the instant claim (clm. 1, Table 2, re: clm. 20 …the sample is classified as class 2…), and additionally discloses BCG therapy as a potential therapy to be administered to a patient (Spec, para. 0086, re: clm. 20, … administering therapy to the subject comprises administering BCG therapy ….). As McConkey et al. discloses classification and therapy administration in this manner, McConkey et al. anticipates claim 20.
Regarding claim 22, McConkey et al. discloses classifying stage T1 bladder cancer from samples (Spec, para. 0054) into a class discloses classifying stage T1 bladder cancer from samples (Spec, para. 0054) into a class containing: activation of the ZNF385A (TP63) regulon (clm. 11, Table 2), a component of class 4 as disclosed in the instant claim , and additionally discloses BCG therapy as a potential therapy to be administered to a patient (Spec, para. 0086, re: clm. 22, … and administering therapy to the subject comprises administering TURBT or BCG to the subject...). As McConkey et al. discloses classification and therapy administration in this manner, McConkey et al. anticipates claim 22.
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.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over McConkey et al. as evidenced by Liu et al. as applied to claims 1-11, 17-20, 22, and 24 above, in view of Witjes et al. (European Urology Volume 71, Issue 3, March 2017, Pages 462-475).
McConkey et al. as evidenced by Liu et al. are applied to claims 1-11, 17-20, 22, and 24 above.
Regarding claim 21, McConkey et al. discloses classifying stage T1 bladder cancer from samples (Spec, para. 0054) into a class containing testing to determine the level of expression or activation of a plurality of genes wherein activation of TP63 is detected (clm. 26), a component of class 3 as disclosed in the instant claim (re: clm. 21 …the sample is classified as class 3…).
McConkey et al. does not teach performing a cystectomy and/or administering Myc-I therapy (re: clm. 21, … administering therapy to the subject comprises performing a cystectomy on the subject and/or administering Myc-I therapy to the subject …).
Witjes et al. teaches cystectomy (section 10.1. “Radical cystectomy”, re: clm. 21, … administering therapy to the subject comprises performing a cystectomy on the subject and/or administering Myc-I therapy to the subject …)
In KSR Int 'l v. Teleflex, the Supreme Court, in rejecting the rigid application of the teaching, suggestion, and motivation test by the Federal Circuit, indicated that “The principles underlying [earlier] cases are instructive when the question is whether a patent claiming the combination of elements of prior art is obvious. When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.” KSR Int'l v. Teleflex lnc., 127 S. Ct. 1727, 1740 (2007).
Applying the KSR standard of obviousness to McConkey et al. and Witjes et al., the examiner
concludes that the combination of the method of classifying and administering therapy for stage T1 bladder cancer from samples according to McConkey et al. with the cystectomy as taught by Witjes et al. represents a finding that there was some teaching, suggestion, or motivation, either in the references themselves or in the knowledge generally available to one of ordinary skill in the art, to modify the reference or to combine reference teachings.
One of ordinary skill in the art of oncology would be motivated to combine the method of classifying stage T1 bladder cancer according to McConkey et al. with the cystectomy as taught by Witjes et al. because the combination would lead to a stronger therapy administration method.
There would have been a reasonable expectation of success because the methods of both arts
are in the same field. In support of this motivation, McConkey et al. displays familiarity with the technique, disclosing several examinations of cystectomy-derived data (Table 3), and discusses the efficacy of the procedure on Spec, para. 0054. Therefore, claim 21 of the applicant’s invention would have been prima facie obvious to one of skill in the art at the time of filing of the application, absent evidence to the contrary.
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over McConkey et al. as evidenced by Liu et al. as applied to claims 1-11, 17-20, 22, and 24 above, in view of McKeown et al. (Cold Spring Harb Perspect Med. 2014 Oct 1;4(10):a014266.)
McConkey et al. as evidenced by Liu et al. is applied to claims 1-11, 17-20, 22, and 24 above.
Regarding claim 23, as previously stated, McConkey et al. discloses detecting carcinoma in situ (CIS) via measurement of Gata3 expression (clm. 1), a CIS-specific gene signature as evidenced by Junghye Lee et al., a component of class 5 as disclosed in the instant claim (re: clm. 23 …the sample is classified as class 5…).
McConkey et al. does not teach administering ad-stilidrin and/or MYC-i therapy to the subject. (re: clm. 23, …and administering therapy to the subject comprises administering ad-stilidrin and/or MYC-i therapy to the subject.…).
McKeown et al. teaches therapeutic strategies to inhibit MYC (title, abstract, “INHIBITION OF MYC-DEPENDENT TRANSCRIPTIONAL SIGNALING”, re: clm. 23, … and administering therapy to the subject comprises administering ad-stilidrin and/or MYC-i therapy to the subject …)
Applying the KSR standard of obviousness to McConkey et al. and McKeown et al., the examiner
concludes that the combination of the method of classifying and administering therapy for stage T1 bladder cancer from samples according to McConkey et al. with the MYC-I therapy as taught by McKeown et al. represents a finding that there was some teaching, suggestion, or motivation, either in the references themselves or in the knowledge generally available to one of ordinary skill in the art, to modify the reference or to combine reference teachings.
One of ordinary skill in the art of oncology would be motivated to combine the method of classifying stage T1 bladder cancer according to McConkey et al. with the MYC-I therapy as taught by McKeown et al. because the combination would lead to a stronger therapy administration method.
There would have been a reasonable expectation of success because the methods of both arts
are in the same field. In support of this motivation, McConkey et al. displays familiarity with the MYC expression in bladder cancer samples, disclosing several examinations of such on Spec, para. 0013, claim 22, and Table D. Therefore, claim 23 of the applicant’s invention would have been prima facie obvious to one of skill in the art at the time of filing of the application, absent evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN T STUBBS whose telephone number is (571)272-0340. The examiner can normally be reached M-F 8-5 EST.
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/J.T.S./ Examiner, Art Unit 1686
/LARRY D RIGGS II/Supervisory Patent Examiner, Art Unit 1686
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