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
Claims 1-89 are pending in the instant application.
Independent claim 38 has been amended.
Claims 1-37, 64, 66, 68, and 70-89 were previously withdrawn as being drawn to a nonelected invention.
Claims 44-45, 47-48, 51, 53-57, and 60-63 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/3/2025.
Claim status
Applicant previously elected without traverse of Group II, drawn to: (i) compounds having chemical structures of Formulas (I), (II), (Ill), (IV), (V), (VI); and (ii) methods of treating cancer with a pharmaceutical composition comprising a compound of Formula (I); and the species PA3 with the structure:
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which is present in claims 38-43, 65, 67, and 69, wherein the species PA3 with the structure:
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is free of prior art.
The Examiner previously elected the next species with a structure of:
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, but the claims have been amended to exclude this structure.
The next Examiner elected species for search purposes in the structure:
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.
Claims 38, 40-41, 46, 49-50, 52, 58-59, 65, 67, and 69 are under review for the next Examiner elected species.
Claim Rejections – 35 USC § 102
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 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.
Claims 38, 40-41, 46, 49-50, 52, and 58-59 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2020/132658 (Han A et al. IDS reference).
‘658 taught a compound with the structure
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compound D-5d (page 389, [0525]). ‘658 taught compounds useful for anti-cancer treatments, wherein the structure is Formula I
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, wherein compound D-5d is a species of Formula I, wherein R1 is a C1 alkyl, R2 is a C5 alkyl, Q is O, R3 is -C(O)-C1, R4 and R5 are C1 alkyl, R6 is OH, R8 is H, and R7 is -NR7aR7b wherein R7a H and R7b is a C2 alkyl optionally substituted with a =O and an NH2 (pages 1-3, [0005-0006]).
Response to Arguments
The Applicant has amended independent claim 38 to exclude the original Examiner elected species. An updated rejection on a second Examiner elected species is above.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 38, 40-41, 46, 49-50, 52, 58-59, 65, 67, and 69 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2020/132658 ( Han A et al. IDS reference).
‘658 taught the limitations of instant claims 38, 40-41, 46, 49-50, 52, and 58-59 for the reasons set forth above.
‘658 is described above. ‘658 further taught, regarding instant claim 65, a pharmaceutical composition of the compounds and a pharmaceutically acceptable carrier, diluent, and/or excipient, which included buffers for maintenance of proper composition pH and saline (page 212, [00227]). Regarding instant claims 67 and 69, ‘658 taught a method of treating cancer comprising administering to a patient having said cancer a therapeutically effective amount of a pharmaceutical composition comprising a compound of Formula I, wherein the cancer is breast cancer or colorectal cancer (pages 212-213, [0228-0229]). Regarding instant claims 67 and 69, ‘658 taught pharmaceutical compositions comprising compounds comprising Formula I were effective and cytotoxic to T47D breast cancer cells (pages 413-414, Table 9) or HCT-15 colorectal cancer (page 419, Table 12).
‘658 did not teach a single embodiment of using the compound
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in a pharmaceutical composition with an excipient to treat breast or colorectal cancer, but this would be obvious in view of ‘658.
Regarding instant claims 65, 67, and 69, it would have been obvious for a person having ordinary skill in the art to take the method of ‘658 of a method of treating cancer comprising administering to a patient having said cancer a therapeutically effective amount of a pharmaceutical composition comprising a compound of Formula I – and:
Administer the compound
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in view of ‘658;
Include a pharmaceutically acceptable excipient in the pharmaceutical composition in view of ‘658; and
Treat breast cancer or colorectal cancer in view of ‘658.
This is obvious because: 1) ‘658 taught a compound with the structure
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compound D-5d which is a species of Formula I and that compounds with the structure of Formula I are useful for anti-cancer treatments;
2) ‘658 taught pharmaceutical composition of the compounds and a pharmaceutically acceptable carrier, diluent, and/or excipient; and
3) ‘658 taught a method of treating cancer comprising administering to a patient having said cancer a therapeutically effective amount of a pharmaceutical composition comprising a compound of Formula I, wherein the cancer is breast cancer or colorectal cancer and pharmaceutical compositions comprising compounds comprising Formula I were effective and cytotoxic to T47D breast cancer cells or HCT-15 colorectal cancer.
There is a reasonable expectation of success because: 1-3) pharmaceutical compositions comprising compounds comprising Formula I were effective and cytotoxic to T47D breast cancer cells or HCT-15 colorectal cancer and an excipient would allow the compound to be effectively administered to the subject.
This would produce a method of treating breast or colorectal cancer comprising administering to a patient having said cancer a therapeutically effective amount of a pharmaceutical composition comprising a pharmaceutically acceptable excipient and
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(instant claims 65, 67, and 69).
Response to Arguments
The Applicant has amended independent claim 38 to exclude the original Examiner elected species. An updated rejection on a second Examiner elected species is above.
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 38, 40-41, 46, 49-50, 52, and 58-59 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 12,144,864.
‘864 taught a compound having the structure of Formula I in patented claims 21-27, wherein patented claim 21 taught a compound having the structure of Formula I
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, wherein R2 is C1-C10 alkyl; and Q1 is —O— in patented claim 21, wherein patented claim 25 taught a species of Formula I is
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, wherein patented claim 26 taught a species of Formula I is
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. ‘864 taught compounds attached to linkers and binding agents or an antibody in patented claims 1-20 and 28-33.
The claims of ‘864 did not teach a structure of:
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, but this is obvious in view of the claims of ‘864.
Regarding instant claims 38, 40-41, 46, 49-50, 52, and 58-59, it would have been obvious for a person having ordinary skill in the art to take the structures of patented claims 21 and 25-26 to produce a compound with the structure
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.
This is obvious because: 1a)
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is a species of Formula I; and 1b) patented claim 21 taught a compound having the structure of Formula I
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, wherein R2 is C1-C10 alkyl; and Q1 is —O— in patented claim 21, wherein species of Formula I include
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in patented claim 25 and
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in patented claim 26. Thus, only exchange of a C=C alkyne group for a C-C alkyl or exchange of NH2 for a NH-C(O)-CH2-NH2 would produce
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. Thus, the species is obvious.
There is a reasonable expectation of success because: 1a)
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is a species of Formula I as claimed; and 1b) patented claim 21 taught a compound having the structure of Formula I
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, wherein R2 is C1-C10 alkyl; and Q1 is —O— in patented claim 21, wherein species of Formula I include
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in patented claim 25 and
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in patented claim 26. Thus, only exchange of a C=C alkyne group for a C-C alkyl or exchange of NH2 for a NH-C(O)-CH2-NH2 would produce
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.
Response to Arguments
The Applicant has amended independent claim 38 to exclude the original Examiner elected species. An updated rejection on a second Examiner elected species is above.
Claims 38, 40-41, 46, 49-50, 52, 58-59, 65, 67, and 69 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 12,144,864 in view of WO 2020/132658 ( Han A et al. IDS reference).
The claims of ‘864 teach the claim limitations of instant claims 38, 40-41, 46, 49-50, 52, and 58-59 for the reasons set forth above.
‘864 is described above.
The claims of ‘658 did not teach
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in: 1) a pharmaceutical composition and a pharmaceutically acceptable excipient, carrier; or 2) a method for treating cancer in a subject comprising administering to the subject an effective treatment amount of a pharmaceutical composition, wherein the cancer is breast or colorectal cancer, but this is obvious in view of ‘658.
Regarding instant claim 65, ‘658 taught pharmaceutical composition of the compounds and a pharmaceutically acceptable carrier, diluent, and/or excipient, which included buffers for maintenance of proper composition pH and saline (page 212, [00227]). Regarding instant claims 67 and 69, ‘658 taught a method of treating cancer comprising administering to a patient having said cancer a therapeutically effective amount of a pharmaceutical composition comprising a compound of Formula I, wherein the cancer is breast cancer or colorectal cancer (pages 212-213, [0228-0229]). Regarding instant claims 67 and 69, ‘658 taught pharmaceutical compositions comprising compounds comprising Formula I were effective and cytotoxic to T47D breast cancer cells (pages 413-414, Table 9) or HCT-15 colorectal cancer (page 419, Table 12).
Regarding instant claims 65, 67, and 69, it would have been obvious for a person having ordinary skill in the art to take the method of ‘658 of a method of treating cancer comprising administering to a patient having said cancer a therapeutically effective amount of a pharmaceutical composition comprising a compound of Formula I – and:
Administer the compound
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above;
Include a pharmaceutically acceptable excipient in the pharmaceutical composition in view of ‘658; and
Treat breast cancer or colorectal cancer in view of ‘658.
This is obvious because: 1) ‘658 taught a compound with the structure
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compound D-5d which is a species of Formula I and that compounds with the structure of Formula I are useful for anti-cancer treatments;
2) ‘658 taught pharmaceutical composition of the compounds and a pharmaceutically acceptable carrier, diluent, and/or excipient; and
3) ‘658 taught a method of treating cancer comprising administering to a patient having said cancer a therapeutically effective amount of a pharmaceutical composition comprising a compound of Formula I, wherein the cancer is breast cancer or colorectal cancer and pharmaceutical compositions comprising compounds comprising Formula I were effective and cytotoxic to T47D breast cancer cells or HCT-15 colorectal cancer.
There is a reasonable expectation of success because: 1-3) pharmaceutical compositions comprising compounds comprising Formula I were effective and cytotoxic to T47D breast cancer cells or HCT-15 colorectal cancer and an excipient would allow the compound to be effectively administered to the subject
This would produce a method of treating breast or colorectal cancer comprising administering to a patient having said cancer a therapeutically effective amount of a pharmaceutical composition comprising a pharmaceutically acceptable excipient and
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(instant claims 65, 67, and 69).
Response to Arguments
The Applicant has amended independent claim 38 to exclude the original Examiner elected species. An updated rejection on a second Examiner elected species is above.
Conclusion
Claims 38, 40-41, 46, 49-50, 52, 58-59, 65, 67, and 69 are rejected.
Claims 39 and 42-43 are objected to for comprising unexamined species.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN J SKOKO III whose telephone number is (571)272-1107. The examiner can normally be reached M-F 8:30 - 5:00.
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, Julie Z Wu can be reached at (571)272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.J.S./Examiner, Art Unit 1643
/Karen A. Canella/Primary Examiner, Art Unit 1643
Prosecution Insights