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 .
DETAILED ACTION
1Applicant’s amendment filed on 01/28/26 is acknowledged.
Claims 1,3, 5, 9, 11, 16, 17,19, 22,24, 26,30, 35,36, 39,40, 42,43,44, 48,54, 58,63,66,67,77, 88,99-103 are pending.
Claims 1,3, 5, 9, 11, 16, 17,19, 22,24, 26,30, 35,36, 39,40, 42,43,44, 48,54, 58,63,66,67,77, 88,99-103 read on a method of treating cancer in a human comprising administering to the subject an effective amount of antibody drug conjugate.
2. 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.
3. 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.
4. Claims 1,3, 5, 9, 11, 16, 17,19, 22,24, 26,30, 35,36, 39,40, 42,43,44, 48,54, 58,63,66,67,77, 88, 99 and 100 stand rejected under 35 U.S.C. 103 as being unpatentable over US Patent 8637642 for the same reasons set forth in the previous Office Action, mailed on 10/29/25.
Applicant’s arguments filed on 01/28/26 have been fully considered but have not been found convincing.
Applicant asserts that the claims have been amended to recite a specific type of patient to be treated with ADC. US Patent Application does not teaches or suggest said specific type of patients.
Contrary to Applicants assertion it is the Examiner’s position that it would be conventional and within the skill of the art to : (i) identify and select specific type of patients to be treated with ADC.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).
It is noted that Applicant provided no evidences or declaration of why it would not be obvious and within skill of one in the art to identify a specific type of patient to be treated with ADC bases on the teaching of US Patent ‘642.
As has been stated previously, US Patent ‘642 teaches a method of treating cancer in a human comprising administering to the subject an effective amount of antibody drug conjugate wherein antibody of said conjugate binds to 191P4D12 ( Nectin-4) and conjugated to MMAE. US Patent ‘642 teaches that the subject has bladder cancer. US Patent ‘642 teaches that administering of said antibody drug conjugate can be used in combination with additional art recognized cancer treatment. US Patent ‘642 further teaches that antibody conjugated to MMAE via a linker ( see entire document, Abstract and Paragraphs 9, 17, 35, 65, 75, 76, 137, 443 in particular). US Patent ‘642 teaches that said antibody comprising CDRs heavy chain variable domain of SEQ ID N: 4, that is 100% identical to the instantly claimed SEQ ID N:22 and CDRs light chain variable domain of SEQ ID N: 6, that is 100% identical to the instantly claimed SEQ ID N:23 ( see sequence alignment , Attached).
It is noted that US Patent ‘642 teaches does not explicitly teaches that the subject having bladder cancer received an immune checkpoint inhibitor (CPI) therapy or is a platinum-naïve subject or is ineligible to receive cisplatin treatment. However it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to identify the subject that would benefit from administering antibody drug conjugate. 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.
Claims 40,42,43,44,48, 54, 66,77, 88, are included because it would be conventional and within the skill of the art to : (i) identify an optimal linker to be used or (ii) determine an effective amount of units of MMAE per antibody; or (iii) determine the optimum duration , means of administration and optimal concentrations of antibody-drug conjugate. 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).
As dosing and modes of administration are known to the ordinary artisan, it would have been obvious to optimize both the dosing regimens and mode of administration to meet the needs of the patient at the time the invention was made.
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.
5. 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.
10. The claims 1,3, 5, 9, 11, 16, 17,19, 22,24, 26,30, 35,36, 39,40, 42,43,44, 48,54, 58,63,66,67,77, 88, 99-103 are provisionally rejected on the grounds of nonstatutory double patenting of the claims of copending Applications No: US 20230330251; US 20230025600 A1; US 20230001005 A1; US 20230364254 ; US 20230270871 ; US 20230025600 ; US 20200283540 A1; US 20250135020 A1; US 20250064956 A1
Although the claims at issue are not identical, they are not patentably distinct from each other because claims of copending Applications No: US 20230330251; US 20230025600 A1; US 20230001005 A1; US 20230364254 ; US 20230270871 ; US 20230025600 ; US 20200283540 A1; US 20250135020 A1; US 20250064956 A1 each recited a method of treatingcancer in a human comprisng administering to the subject an effective amount of antibody grug conjugate wherein antibody binds to 191P4D12 conjugated to one or more MMAE.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
It is noted that Applicant requested to held said rejection in abeyance until the claims are found to be allowable.
6. Claims 1,3, 5, 9, 11, 16, 17,19, 22,24, 26,30, 35,36, 39,40, 42,43,44, 48,54, 58,63,66,67,77, 88, 99-103 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-31 of US Patent 12257340 ; claims 1-5 of US Patent 9962454; claims 1-38 of US Patent 10894090; claims 1-32 of US Patent 11559582.; claims 1-11 of US Patent 863,7642.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims 1-31 of US Patent 12257340 ; claims 1-5 of US 9962454 B2; claims 1-38 of US 10894090; claims 1-32 of US 11559582 each are drawn to antibody-drug conjugate comprising antibody that binds to 191P4D12 that are used in the presently claimed methods, and wherein the presently claims methods are disclosed in the specification of US Patent 12257340 ; US 9962454 B2; US 10894090; US 11559582 and claims 1-11 of US Patent 863,7642.
This rejection is necessitated by the decision of the Court of Appeals for the Federal Circuit in Pfizer Inc. v Teva pharmaceuticals USA Inc., 86 USPQ2d 1001, at page 1008 (March 2008), which indicates that there is no patentable distinction between claims to a product and a method of using that product disclosed in the specification of the application and that the preclusion of such a double patenting rejection under 35 USC 121 does not apply where the present application is other than a divisional application of the patent application containing such patentably indistinct claims.
It is noted that Applicant requested to held said rejection in abeyance until the claims are found to be allowable.
The following new ground of rejection is necessitated by the amendment filed on 01/29/25.
7. 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.
8. Claims 1, 101-103 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent 8637642 in view of US Patent Application 20220249621.
The teaching of US Patent’642 has been discussed supra.
US Patent’ 642 does not explicitly teach administering an immune checkpoint inhibitor.
US Patent Application’621 teaches a method of treating bladder cancer in a patient comprising administering to said patient PD1 inhibitor ( see entire document, paragraphs 0008, 0013, 0026, 0032 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 use PD-1 inhibitor in the method of treating bladder cancer taught by US Patent’642 with a reasonable expectation of success because the prior art suggests that each of recited compounds can be used for treating bladder cancer.
“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).
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.
9. No claim is allowed.
10. 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.
11. 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