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 01/15/26 is acknowledged.
2. Claims 12,13,16-29 are pending.
Claims 12,13,16-29 read on a method of treating an advanced solid cancer, comprising administering a pharmaceutical composition comprising BT8009 are under consideration in the instant application.
3. The previous rejection of record of claims under 35 U.S.C. 112, first paragraph mailed on 10/16/25 is hereby withdrawn in view of Applicants amendments , arguments and submitted additional date filed on 01/15/26
The following new ground of rejection is necessitated by the amendment filed on 01/15/26.
4. 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.
5. Claims 12,13,16-29 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application 20220135614 or US Patent Application 20250002536 or US Patent Application 20250066421 each in view of US Patent Application 20250163155 and newly cited US Patent Application 20200339643 and US Patent Application 20240376147.
US Patent Application ‘614 teaches a method of treating solid cancer comprising administering to the patient an effective amount of pharmaceutical composition comprising bicycle toxin. ( see entire document, paragraphs 0009, 0133, 0135 in particular).
US Patent Application ‘536 teaches a method of treating solid cancer comprising administering to the patient an effective amount of pharmaceutical composition comprising BT8009. ( see entire document, paragraphs 0962, 0970 , 1069, in particular)
US Patent Application ‘421 teaches a method of treating solid cancer comprising administering to the patient an effective amount of pharmaceutical composition comprising BT8009. ( see entire document, paragraphs 0034, 0894, 0913, 0940, paragraphs in particular)
US Patent Application 20220135614 , US Patent Application 20250002536 and US Patent Application 20250066421 do not explicitly teach using a pharmaceutical buffer comprising histidine, sucrose and Polysorbate 20 or Nivolumab for treating solid tumor.
US Patent’ 614 teaches a method for treating solid malignant tumors comprising administering Nivolumab in combination with other therapeutic compounds ( see entire document, paragraphs 0008, 0010, 0058, 0063, 0065
Newly cited US Patent Application’ 147 teaches a pharmaceutical buffer for toxin conjugate to be administering to a patient wherein said buffer comprises histidine, sucrose and Polysorbate 20. ( see entire document, paragraph 0340)
Newly cited US Patent Application ‘ 643 teaches a pharmaceutical buffer for toxin conjugate to be administering to a patient wherein said buffer comprises histidine, sucrose and Polysorbate 20. ( see entire document, paragraphs 0148 , 0187)
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 administer Nivolumab in a method taught by US Patent Application 20220135614 , US Patent Application 20250002536 and US Patent Application 20250066421 with a reasonable expectation of success because the prior art suggests that each of said compounds can be used for treating solid tumor malignancy.
“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. . . [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205USPQ 1069, 1072 (CCPA 1980) (see MPEP 2144.06).
Thus it would have been to one of ordinary skill in the art before the effective filing date of the claimed invention to use a pharmaceutical buffer taught by US Patent Application 20200339643 and US Patent Application 20240376147 in a method of treating solid cancer taught by US Patent Application 20220135614 or US Patent Application 20250002536 or US Patent Application 20250066421 with a reasonable expectation of success because the prior art suggests that pharmaceutical buffer comprising comprises histidine, sucrose and Polysorbate 20 can be used for administering toxin conjugates to the patient.
Claims 12, 22-28 are included because it would be conventional and within the skill of the art to : (i) identify the optimal dose and schedule administering BT8009 toxin (ii) determine an optimal amounts of histidine, sucrose and Polysorbate 20 to be present in pharmaceutical buffer. 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.
It is well settled that "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980). See also Merck & Co. v. Biocraft Labs. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1847-48 (Fed. Cir. 1989) (determination of suitable dosage amounts in diuretic compositions considered a matter of routine experimentation and therefore obvious).
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.
6. No claim is allowed.
7. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609(B)(2)(i). 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 event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
8. 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 571/273-8300
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/MICHAIL A BELYAVSKYI/Primary Examiner, Art Unit 1644