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 the Applications, Amendments and/or Claims
This action is written in response to applicant's correspondence(s) submitted on 06/30/2025.
In the paper of 06/30/2025, Applicant amends claim 5 and cancels claims 18-19 and adds new claims 46- 47.
Accordingly, claims 5-6, 9-13, 15, 17, 20, 40-47 are under review and claims 1-4, 7-8, 14, 16, 18-19 and 21-39 are canceled.
Response to Arguments
Moot Rejection(s) and/or Withdrawn Rejection(s)
The rejection of claim 19 under 35 U.S.C. 103 as being unpatentable over Faruki et al. (WO2019/160914A1, filed 02/13/2019) is moot based on the cancellation of this claim.
The rejection of claims 5-6, 9-13, 15, 17, 20 and 40-43 under 35 U.S.C. 103 as being unpatentable over Faruki et al. (WO2019/160914A1, filed 02/13/2019) is withdrawn based on claim amendments.
While Faruki et al. (WO2019/160914A1) do not teach determining the FGFR3 genomic classifier value so as to subtype the bladder cancer for a subject as either FGFR3+, OR FGFR3-, the disclosure and claims omits disclosure of the classifier value that permit classification to either FGFR3+, OR FGFR3-, and thus the (new) rejection(s) presented below are necessitated.
Maintained Rejection(s)
The rejection of claims 5-6, 9-13, 15, 17-20 and 40-45 on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11,208,697 (published Dec 28, 2021, filed Jan 19, 2018) in view of Faruki et al. (WO2019/160914A1, filed 02/13/2019) is withdrawn based on claim amendments.
Claim Objections
Claims 18-19 are objected to because of the following informalities: These claims contain an impermissible concluding period. Please amend claims 18-19 as follows to obviate this objection.
18. (Canceled)[[.]]
19. (Canceled)[[.]]
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 5-6, 9-13, 15, 17, 20, 40-47 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 5 recites the limitation “determining the FGFR3 genomic classifier value of bladder cancer”. There is insufficient antecedent basis for “the FGFR3 genomic classifier value of bladder cancer” phrase in the noted limitation above as recited by claim 5. Claims 6, 9-13, 15, 17, 20, 40-47 are rejected as they depend from claim 5.
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 5-6, 9-13, 15, 17, 20 and 40-47 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.
Applicant’s amendment with respect to amended claims herein has been fully considered but is deemed to insert new matter into the claims since the specification as originally filed does not provide support for the limitation of “determining the FGFR3 genomic classifier value of bladder cancer”. Accordingly, it is unknown how to determine a FGFR3 genomic classifier value from the presence of at least two biomarkers recited by claim 5, or claim 44, 45 or 46; or how to determine a FGFR3 genomic classifier value from the expressional level amounts of at least two biomarkers recited by claim 5 or claim 44, 45 or 46.
Furthermore, the specification did not disclose any bladder cancer FGFR3 genomic classifier value(s) for signifying FGFR3(+), or the bladder cancer FGFR3 genomic classifier value for signifying FGFR3(-) bladder cancer.
The specification did not disclose administering surgery for FGFR3(+) bladder cancer, but no neoadjuvant chemotherapy in the manner as claimed by claims 5, 40 and 47.
The specification did not disclose administering neoadjuvant chemotherapy for FGFR3(-) bladder cancer and optionally, additional treatments including surgery as claimed by claim 20.
Consequently, there is nothing within the instant specification which would lead the artisan in the field to believe that Applicant was in possession of the invention as it is now claimed. See Vas-Cath Inc. v. Mahurkar, 19 USPQ 2d 1111, CAFC 1991, see also In re Winkhaus, 188 USPQ 129, CCPA 1975.
Claims 5-6, 9-13, 15, 17, 20 and 40-47 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 enablement requirement. Claims 5-6, 9-13, 15, 17, 20 and 40-47 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification fails to enable the full scope of the claims.
More specifically, the specification is enabling for a method that uses mRNA expression levels or long non-coding RNA (lncRNA) expression levels detected for two or more biomarkers of a sample obtained from a human subject with bladder cancer, the biomarker are selected from FGFR3, BCAS1, PDE10A, BMP5, SHH, TMPRSS4, RP11-706015.3, SNURF, SEMA6A, MECOM, PGAP1, FRY, PLCD3, ATP8B1, CAT, BHLHE41, PPDPF, TOX3, RNF128, TBX3, RP11-58K22.1, POF1B, SORL1, ADAM10, ADIRF, CTD-2340E1.2, AF038458.3, ACOX1, SEMA5A, AC019117.1, CHI3L1, GREM1, AEBP1, COL6A1, ZNF626, HMGCS2, AC017060.1, AC019117.2, UGT1A8, UGT1A3, UGT1A5, UGT1A1, UGT1A9, PHGR1, RP11-473M20.16, HPGD, ZNF737, BEX4, SLITRK6, CTD-2626G11.2, RP11- 488L18.10, AGR2, BTG2, SLC14A1, GPX2, DHRS2, RP11-172F10.1, SULF1, COL6A3,SFRP4, COL3A1, COL1A1, COL1A2, PTPN13, and AQP3.
The specification teaches providing many algorithms to transform/analyze the expression values of the two or more biomarkers as noted from above and disclose assignment bladder tumor sample into six consensus mRNA subtypes (Ba/Sq, LumNS, LumP, LumU, Stroma-rich and NE-like) corresponding to basal/squamous, luminal-infiltrated, luminal-papillary, luminal, and neuronal subtype (see Table 10 on page 63).
The specification omits disclosure of any FGFR3 genomic classifier value that is for signifying FGFR3-positive bladder cancer and/or FGFR3 genomic classifier value that is for signifying FGFR3-negative bladder cancer, but does disclose neoadjuvant cisplatin-based chemotherapy (NAC) is too aggressive for FGFR3-positive bladder cancer while radical cystectomy (RC) surgery yields favorable overall survival, and disclose treatment with neoadjuvant cisplatin-based chemotherapy (NAC) followed by pelvic lymph node dissection and/or radical cystectomy (RC) for FGFR3-negative bladder cancer yields favorable overall survival.
The specification does not enable any of the other aspects broadly encompassed by the claims. These other aspects include MIBC/bladder cancer sample of non-human subjects.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
Factors to be considered in determining whether a disclosure meets the enablement requirement of 35 USC 112, first paragraph, have been described by the court in In re Wands, 8 USPQ2d 1400 (CA FC 1988). These factors include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims. Each of these factors is discussed below.
Nature of the Invention
The claims are drawn to a method for analyzing two of more biomarkers from a human bladder tumor (MIBC) sample, the biomarkers are selected from PDE10A, FGFR3, BMP5, SHH, TMPRSS4, RP 11-706015.3, SNURF, SEMA6A, MECOM, PGAP1, FRY, PLCD3, ATP8B1, CAT, BHLHE41, PPDPF, TOX3, RNF128, TBX3, RP11-58K22.1, POF BCAS1, SORL1, ADAM10, ADIRF, CTD-2340E1.2, AF038458.3, ACOX1, SEMA5A, AC019117.1, CHI3L1, GREM1, AEBP1, COL6A1, ZNF626, HMGCS2, AC017060.1, AC019117.2, UGT1A8, UGT1A3, UGT1A5, UGT1A1, UGT1A9, PHGR1, RP11-473M20.16, HPGD, ZNF737, BEX4, SLITRK6, CTD-2626G11.2, RP11- 488L18.10, AGR2, BTG2, SLC14A1, GPX2, DHRS2, RP11-172F10.1, SULF1, COL6A3,SFRP4, COL3A1, COLlA1, COL1A2, PTPN13, and AQP3; and administering surgery without neoadjuvant chemotherapy to human subjects with FGFR3-positive tumor and/or administering neoadjuvant chemotherapy to human subjects with FGFR3-negative tumor.
The claimed invention is classified in the unpredictable arts of molecular biology and biochemistry.
Relative Skill of the Ordinary Artisan
The ordinary artisan typically holds a master’s or doctoral degree and has at least several years of post-graduate laboratory and/or clinical experience.
Breadth of the Claims
As noted above, Applicant has elected measuring expression levels of a plurality of genes/biomarkers as claimed in claims 5, 43, 44, 45 or 46. The claims are very broad with respect to the subjects and types of samples from non-human subjects.
State of the Prior Art & Unpredictability
The prior art discloses methods that comprise using expression levels to subtype bladder cancer. See, for example, Faruki et al. (WO2019/160914A1, filed 02/13/2019).
There is a great deal of unpredictability associated with the claimed methods.
More specifically, given the diversity of subjects and samples from all subjects encompassed by the claims, it is unpredictable as to whether the plurality of biomarkers obtained from any subject with bladder cancer will be present and/or show differential expression at the mRNA level or lncRNA level.
This is supported by the teachings in the prior art referenced above, especially Faruki et al. (WO2019/160914A1), who only reports on gene expression changes observed at the mRNA level in samples of a human subject with bladder cancer and a diverse treatment of different subtypes of bladder cancer as assigned using expression level values.
Quantity of Experimentation & Unpredictability
The ordinary artisan would have to conduct a very large quantity of unpredictable experimentation to enable the full scope of the claimed methods.
More specifically, the ordinary artisan would have to determine, for each different subject encompassed by the claims, whether the combination of genes is differentially expressed at the mRNA level or lncRNA level can be assigned to the subject as a FGFR3 positive bladder cancer, or as a FGFR3 negative bladder cancer, without any classifier value disclosed.
This experimentation would have to be conducted with only minimal guidance from the specification and prior art and would also be unpredictable given the breadth of the claims and the results obtained for one subject would not necessarily extend to any other subject encompassed by the claims.
To summarize, the instant claims are extremely broad in scope, particularly when considered relative to the disclosure in the specification and the teachings of the prior art. The prior art and Examples of the specification also indicates that several aspects of the invention are associated with unpredictability, in particular whether a particular gene is differentially expressed in response to bladder cancer subtype. Accordingly, claims are rejected for failing to comply with the enablement requirement of 35 U.S.C. 112(a).
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.
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.
Claims 5-6, 9-13, 15, 17, 19-20 and 40-43 are rejected under 35 U.S.C. 103 as being unpatentable over Faruki et al. (WO2019/160914A1, filed 02/13/2019).
Regarding claims 5 and 9, Faruki et al. teach muscle invasive bladder cancer (MIBC) as being characterized into one of 4 subtypes (Type I: luminal, Type II: luminal infiltrated, Type III: basal, and Type
IV: basal infiltrated/neuronal)) (pg 2, para [0007]).
Regarding claims 5, 43 and 9-11, Faruki et al. teach a method for determining a bladder cancer subtype of a bladder cancer sample obtained from a patient (see pg 2, para [0008]), the sample is urine, blood (para [0008], pg 4, para [0009]), biopsy from human/resection specimen (para [0061]).
The method of Faruki et al. comprises detecting an expression level of one or more classifier biomarkers in Table 1 (Table 1 on pg 18-20, para [0051] discloses: TOX3, TBX3, BCAS1, GREM1 and SFRP4), and/or detecting an expression level of one or more classifier biomarkers in Table 2 (Table on pg 20-23, para [0052]: discloses TOX3, TBX3, HMGCS2 and SFRP4).
Regarding claims 5 and 17, Faruki et al. teach methods for detecting the presence or expression levels (para [0079]-[0089]).
Faruki et al. teach that the detection of the expression level of the classifier biomarker specifically identifies a luminal, luminal infiltrated, basal or basal infiltrated/neuronal bladder cancer subtype (pg 2, para [0008]).
Faruki et al. teach the detected levels of expression of the at least one classifier biomarker of Table 1 or Table 2 are compared to the expression of the at least one classifier biomarker of Table 1 or Table 2 in at least one sample training set(s), wherein the at least one sample training set(s) comprises expression data of the at least one classifier biomarker of Table 1 or Table 2 from a reference bladder cancer luminal sample, expression data of the at least one classifier biomarker of Table 1 or Table 2 from a reference bladder cancer luminal infiltrated sample, expression data of the at least one classifier biomarker of Table 1 or Table 2 from a reference bladder cancer basal sample, expression data of the at least one classifier biomarker of Table 1 or Table 2 from a reference bladder cancer basal infiltrated/neuronal (para [0008]).
Regarding claims 5-6, 9 and 41, Faruki et al. teach administering neoadjuvant chemotherapy cisplatin to the MIBC (muscle invasive bladder cancer) subject with basal subtype based at least on the presence or levels of expression (pg 60, para [00152]).
Regarding claims 5 and 20, Faruki et al. teach administering immunotherapy to the MIBC (muscle invasive bladder cancer) subject with luminal infiltrated subtype based at least on the presence or levels of expression (pg 60, para [00152]).
Regarding claim 20, Faruki et al. teach immunotherapy may be additionally provided to the MIBC (muscle invasive bladder cancer) subject with basal subtype based at least on the presence or levels of expression (pg 60, para [00152]).
Regarding claims 5 and 40, Faruki et al. teach administering FGFR3 inhibitor to the MIBC (muscle invasive bladder cancer) subject with luminal subtype based at least on the presence or levels of expression (pg 60, para [00152]).
Regarding claim 19, Faruki et al. teach sample where FGFR3 is a tumor driver (para [0026], [00203]).
Regarding claim 42, Faruki et al. teach FGFR3 is a suitable biomarker for subtyping bladder cancer (pg 6, para [0011] and pg 24, para [0054]).
Omitted from Faruki et al. (claim 5)
Faruki et al. do not teach determining a FGFR3 genomic classifier value of bladder cancer based at least on the presence or levels of expression of a plurality of genes as recited by claim 5, or the FGFR3 genomic classifier value of bladder cancer that signifies FGFR3-positive bladder cancer, or the FGFR3 genomic classifier value of bladder cancer that signifies FGFR3-negative bladder cancer.
Faruki et al. do not teach treatment with surgery without neoadjuvant chemotherapy for FGFR3-positive bladder cancer or i.e. treatment of bladder cancer subject with luminal subtype with surgery without neoadjuvant chemotherapy.
It would have been prima facie obvious to an ordinary skilled artisan, before the effective filing date of the instant invention to apply the teachings of Faruki et al. of analyzing expression data and/or detecting and/or measuring the expression levels of two or more classifier biomarkers (specifically, FGFR3, TOX3, TBX3, BCAS1, GREM1, SFRP4 and HMGCS2) which Faruki et al. disclose are known to be suitable for subtyping bladder cancer (e.g. MIBC) into Type I: luminal, Type II: luminal infiltrated, Type III: basal, and Type IV: basal infiltrated/neuronal)).
It also would have been obvious to the ordinary skilled artisan following subtyping a patient with bladder cancer using the expression data to select the therapy taught by Faruki et al. to be useful per subtype, i.e. select administer cisplatin-based neoadjuvant therapy to bladder cancer patient with basal subtype, or luminal infiltrated subtype (FGFR3- bladder cancer), and administer FGFR3 inhibitor to bladder cancer patient with luminal subtype (FGFR3+ bladder cancer).
In view of the teachings from the cited reference(s) above, the instant claims 5-6, 9-13, 15, 17, 19-20 and 40-43 are prima facie obvious.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 5-6, 9-13, 15, 17-20 and 40-45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No.11,208,697 (published Dec 28, 2021, filed Jan 19, 2018) in view of Faruki et al. (WO2019/160914A1, filed 02/13/2019).
Although the claims at issue are not identical, they are not patentably distinct from each other.
Both the instant methods and the methods of the claims of U.S. Patent No.11,208,697 are directed to methods for treating a subject with bladder cancer. The claims of U.S. Patent No.11,208,697 notes muscle-invasive bladder cancer (MIBC), specifically.
Both methods comprise: a step of obtaining an expression level of a plurality of genes in a biosample (e.g. biopsy, urine, bladder, bladder tumor sample, transurethral resection (TUR) specimen), obtained from a subject with bladder cancer, and determining the subtype of bladder cancer of the subject, prior to administering the treatment.
For the methods of U.S. Patent No.11,208,697, the four bladder cancer subtypes (for a subject with MIBC) are:
(a) basal subtype (treatment is neoadjuvant chemotherapy (i.e. cisplatin));
distinguishable from:
(b) luminal-infiltrated subtype (anti-cancer treatment other than neoadjuvant chemotherapy);
(c) luminal non-infiltrated subtype (anti-cancer treatment other than neoadjuvant chemotherapy);
(d) claudin-low subtype (anti-cancer treatment other than neoadjuvant chemotherapy).
The anti-cancer treatment other than neoadjuvant chemotherapy consists of surgery, radiation therapy, immunotherapy, biological therapy, hormonal therapy, and photodynamic therapy.
The instant methods assign the following bladder cancer subtype and treatments:
(a) luminal-papillary subtype (treatment is FGFR3 inhibitor);
distinguishable from:
(b) basal/squamous subtype (treatment is neoadjuvant chemotherapy, cisplatin);
(b) luminal-infiltrated subtype (treatment is neoadjuvant chemotherapy, cisplatin);
(c) luminal subtype (treatment is neoadjuvant chemotherapy, cisplatin);
(d) neuronal subtype (treatment is neoadjuvant chemotherapy, cisplatin).
The basal/squamous, luminal, luminal-infiltrated, or neuronal subtypes may be further treated with one or more treatments selected from: surgery, radiation therapy, immunotherapy, biological therapy, hormonal therapy, and photodynamic therapy.
To subtype bladder cancer, both methods detect the presence of, and analyze the expression levels of two or more of the following genes:
TOX3, RNF128, ACOX1, SEMA5A, HMGCS2, UGT1A8, UGT1A3, UGT1A5, UGT1A1, UGT1A9, BEX4, SLITRK6, BTG2, SLC14A1, SULF1, COL1A2 and PTPN13.
The limitations of the instant claim 6 is recited in claim 2 of the ‘697 patent.
The limitations of the instant claim 9 is recited in claim 1 of the ‘697 patent.
The limitations of the instant claim 10 is recited in claim 3 of the ‘697 patent.
The limitations of the instant claim 11 is recited in claim 4 of the ‘697 patent.
The limitations of the instant claim 12 is recited in claim 5 of the ‘697 patent.
The limitations of the instant claim 13 is recited in claim 6 of the ‘697 patent.
The limitations of the instant claim 15 is recited in claim 8 of the ‘697 patent.
The limitations of the instant claim 17 is recited in claim 10 of the ‘697 patent.
The limitations of the instant claim 20 is recited in claim 11 of the ‘697 patent.
The limitations of the instant claim 40 is recited in claim 1 of the ‘697 patent.
The limitations of the instant claim 41 is recited in claim 1 of the ‘697 patent.
The limitations of the instant claim 42 is recited in claim 1 of the ‘697 patent.
The limitations of the instant claim 43 is recited in claim 11 of the ‘697 patent.
The limitations of the instant claim 44 is recited in claim 11 of the ‘697 patent.
The limitations of the instant claim 45 is recited in claim 11 of the ‘697 patent.
Faruki et al. (WO2019/160914A1, filed 02/13/2019) teach subtyping MIBC bladder cancer into Type I: luminal, Type II: luminal infiltrated, Type III: basal, and Type IV: basal infiltrated/neuronal using expression data or measured expression levels of two or more classifier genes selected from FGFR3, TOX3, TBX3, BCAS1, GREM1, SFRP4 and HMGCS2) and administering a cisplatin-based neoadjuvant therapy to bladder cancer patient with basal subtype and/or a FGFR3 inhibitor to bladder cancer patient with luminal subtype.
The ordinary skilled artisan before the effective filing date of the instant invention would have been readily apprised to apply the claims of U.S. Patent No.11,208,697 by selecting and administering a cisplatin or neoadjuvant chemotherapy treatment to a subject with a bladder cancer having the basal subtype, after analyzing the expression levels for two or more genes selected from TOX3, RNF128, ACOX1, SEMA5A, HMGCS2, UGT1A8, UGT1A3, UGT1A5, UGT1A1, UGT1A9, BEX4, SLITRK6, BTG2, SLC14A1, SULF1, COL1A2 and PTPN13.
It also would have been obvious to the ordinary skilled artisan following subtyping bladder cancer using the expression data from a patient sample to further select a suitable therapy to be administered. Both Faruki et al., and the claims of U.S. Patent No.11,208,697 disclose administering a cisplatin-based neoadjuvant therapy to bladder cancer patient with basal subtype, or luminal infiltrated subtype, while Faruki et al. teach administering a FGFR3 inhibitor to the bladder cancer patient with luminal subtype.
Conclusion
No claims are currently allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLAYINKA A OYEYEMI whose telephone number is (571)270-5956. The examiner can normally be reached Monday -Thursday: 9:00 am - 5:00 pm, EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, GARY Benzion can be reached at 571-272-0782. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
OLAYINKA A. OYEYEMI
Examiner
Art Unit 1681
/OLAYINKA A OYEYEMI/Examiner, Art Unit 1681
/GARY BENZION/Supervisory Patent Examiner, Art Unit 1681