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 .
RESPONSE TO APPLICANT’S AMENDMENT
1. Applicants amendment filed on 07/24/06 is acknowledged.
Claims 1,3, 5, 7-8,13,14,19,20, 23,24,26 -30, 32, 66, 99 are pending.
Claims 1,3, 5, 7-8,13,14,19,20, 23,24,26 -30, 32, 66, 99 read on a method of treating bladder cancer comprising administering to the subject immune checkpoint blockage (ICB ) therapy are under consideration in the instant application.
2. 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.
3. Claims 1,3, 5, 7-8,13,14,19,20, 23,24,26 -30, 32, 66, 99 stand rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application 20230119171, US Patent Application 20210207198 in view of US Patent Application 20220152176, US Patent Application 20210087635 and US Patent Application 20250101435 for the same reasons set forth in the previous Office Action mailed on 04/24/26.
Applicant arguments filed on 07/24/26 have been fully considered but have not been found convincing.
Applicant asserts that none of the prior art references teaches or suggests the use of CXCL13 as a predictable biomarker for ICB response to bladder cancer.
Contrary to Applicant’s assertion it is the Examiner’s position that the instant claimed do to recite said feature., i.e. the use of CXCL13 as a predictable biomarker for ICB response to bladder cancer.
As has been stated previously, prior of setting art rejection it is noted that during patent examination, the pending claims must be "given the broadest reasonable interpretation consistent with the specification." See MPEP 2100.
It is the Examiner’s position that when claim 1 is given its broadest reasonable interpretation it read on a method of treating bladder cancer in a subject by administering ICB to the subject, wherein bladder cancer is determined by the increase level of expression of biomarker CXCL13 not as a predictable biomarker for ICB response (emphases added).
In other words the expression of CXCL13 is used to determine if a patient have a bladder cancer not as a predictable biomarker for patient’s response to cancer treatment.
As has been stated previously, US Patent Application’ 171 teaches a method of treating bladder cancer, including urothelial cancer, comprising administering to the subject immune checkpoint blockade (ICB) therapy. US Patent Application’ 171 teaches that said immune checkpoint blockade comprises anti-PD-1 antibody. US Patent Application’ 171 teaches that said anti-PD-1 antibody comprises nivolumab or pidilizumab. US Patent Application’ 171 teaches that determining the level of increasing expression of specific biomarker as an indicative of the presence of bladder cancer ( see entire document, Abstract and 0005, 0028,0042, 0044, 0054, 0111, 0112 in particular)
US Patent Application’ 198 teaches a method of treating bladder cancer, including urothelial cancer, comprising administering to the subject immune checkpoint blockade (ICB) therapy. US Patent Application’ 198 teaches that said immune checkpoint blockade comprises anti-PD-1 antibody. US Patent Application’ 171 teaches that said anti-PD-1 antibody comprises nivolumab or pidilizumab. US Patent Application’ 198 teaches that determining the level of increasing expression of specific biomarker as an indicative of the presence of bladder cancer ( see entire document, Abstract and paragraphs 0016, 0020, 0047, 0049, 0016, 0101in particular).
US Patent Application’ 171 and US Patent Application’ 198 do not explicitly teach measuring CXCL13 and /or ARID1A as a biomarkers of bladder cancer.
US Patent Application’ 176 teaches that measuring the level of expression of CXCL13 can be used as a biomarker for bladder cancer in a patient ( see entire document, paragraphs 0032, 0112, 0212,0380.
US Patent Application’ 635 teaches that measuring the level of expression of CXCL13 can be used as a biomarker for bladder cancer in a patient ( see entire document, paragraphs 0065, 0070, 0124, 0244, 0261
US Patent Application’ 435 teaches that measuring the decrease in the level of expression of ARID1A or measuring ARID1A mutant can be used as a biomarker for progression of bladder cancer in a patient ( see entire document, paragraphs 0044, 0064 in particular).
All the claimed elements were known in the prior art and one skill in the art could have combine the elements as claimed by known methods with no change in their respective function and the combination would have yield predictable results to one of ordinary skill in the art at the time of the invention ( see KSR International Co v Teleflex Inc., 550U.S.-, 82 USPQ2d 1385, 2007).
Thus it would have been to one of ordinary skill in the art before the effective filing date of the claimed invention to measure the level of expression of CXCL13 and ARID1A as an biomarker for bladder cancer in a method of treating bladder cancer taught by US Patent Application’ 171 and US Patent Application’ 198 with a reasonable expectation of success because the prior art suggests that measuring the increase level of expression of CXCL13 and decrease expression of ARID1A can be used as a marker for bladder cancer in a subject.
Claims 13 and 14 are included because it would be conventional and within the skill of the art to (i) determine an optimal means of measuring the expression of CXCL13 and ARID1A. Further, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 220 F2d 454,456,105 USPQ 233; 235 (CCPA 1955). see MPEP § 2144.05 part II A.
From the teachings of the references, it was apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
4. No claim is allowed.
5. THIS ACTION IS MADE FINAL even though it is a first action in this case. See MPEP § 706.07(b). 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 extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no, however, event will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
6. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michail Belyavskyi whose telephone number is 571/ 272-0840 The examiner can normally be reached Monday through Friday from 9:00 AM to 5:30 PM. A message may be left on the examiner's voice mail service. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Gregory Emch can be reached on 571/ 272-8149 .
The fax number for the organization where this application or proceeding is assigned is 703-872-9306.
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/MICHAIL A BELYAVSKYI/Primary Examiner, Art Unit 1644
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