DETAILED ACTION
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 Claims
Claims 1, 143, 145-147, and 149 are pending. Claims 2-142, 144, 148, and 150-159 are cancelled.
Examiner previously required a restriction (dated September 19, 2025). In response, Applicant elected, without traverse, Group I which now encompasses claims 1, 143, 145, and 146. Accordingly, claims 147 and 149 remain withdrawn.
Status of Priority
The present application is a 35 U.S.C. § 371 national stage patent application of International patent application PCT/US2021/063761, filed on December 16, 2021. This application also claims priority to U.S. Provisional Application No. 63/126,505, filed on December 16, 2020.
Withdrawn Rejections
Applicant is notified that any outstanding rejection or objection that is not expressly maintained in this office action has been withdrawn or rendered moot in view of applicant's amendments and/or remarks.
Election/Restrictions
As a reminder, Applicant elected, without traverse, Group I which now corresponds to claims 1, 143, 145, and 146. Applicant also elected the following species without traverse:
PNG
media_image1.png
237
652
media_image1.png
Greyscale
and indicated that at least claims 1, 31, 51, 73, 96, 99, 102, 112, 133, 142, 145, and 146 encompass said species. The elected species was not found in the prior art and, thus, the search was expanded.
Claim Objections
Claim 1 is objected to for the following informalities:
In claim 1, the structure of B0700-541 is the same as B0700-540. However, according to the instant specification, B0700-541 should have the following structure instead:
PNG
media_image2.png
128
489
media_image2.png
Greyscale
(see pg. 350).
Appropriate correction is required.
Specification - Disclosure
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Note on 35 USC § 102 and § 103 Rejections
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.
----------------------------- Maintained Rejections -----------------------------
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 145, and 146 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by:
Butler et al. (Butler) (WO2020142557A1; International filing date: December 31, 2019; published July 9, 2020.)
Butler discloses the following compound:
PNG
media_image3.png
229
458
media_image3.png
Greyscale
(see pg. 206, Table 1, compound 1) which anticipates compound B0700-701 of instant claim 1.
Butler also discloses pharmaceutical compositions formulated for a route of administration which includes oral administration, parenteral administration, nasal administration, topical administration, and rectal administration (see Example 6 on pg. 225-226). These pharmaceutical compositions comprise of any compound of formula (I) through (XLIIIc) which includes instant compound B0700-701 (i.e., a compound of formula I and IVa [see claim 42 of Butler] as disclosed in Butler and discussed above). Thus, these pharmaceutical compositions disclosed by Butler read on instant claims 145 and 146.
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 1, 143, 145, and 146 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over:
claims 1-6, 8-14, and 23-26 of U.S. Patent No. 11,084,825 B2 (‘825B2),
claims 1-4, 6-9, 14-17 of U.S. Patent No. 12,251,385 B2 (‘385B2),
claims 1, 2, 4-6, 8-15, 17-21, 23, 25, 26, 35, 39, 41, 43, 46, 48, 56, 59-61, and 67-83 of U.S. Patent Application No. 19/489,148 (‘148),
claims 1-3, 10, 12, 13, 23, 25, 43, 44, 47, 55, 67, 70-73 of U.S. Patent Application No. 18/865,235 (‘235).
Although the claims at issue are not identical, they are not patentably distinct from each other because there is overlap between the instant claims and the claim sets from the patents and co-pending patent applications listed above as explained below:
Regarding ‘825B2:
Compound from instant claim 1:
Instant compound encompassed by the following claims disclosed in ‘825B2:
PNG
media_image4.png
279
745
media_image4.png
Greyscale
(B0700-701)
1-4, 6, and 9-14
PNG
media_image5.png
335
1025
media_image5.png
Greyscale
(B0700-614)
5 and 8
Claims 23 and 24 of ‘825B2 encompasses instant claims 145 and 146.
Claims 25 and 26 of ‘825B2 are directed to a method for inhibiting menin-MLL activity in a patient, comprising administering to the patient in need thereof a therapeutically effective amount of a pharmaceutical composition comprising a compound according to claim 1 of ‘825B2.
As stated above, instant compound B0700-701 is encompassed by claim 1 of ‘825B2.
Thus, instant claim 1 represents an obvious variation of the method claims of ‘825B2 (which also encompasses the isotopically-labelled derivatives of the disclosed compounds; see col. 75, lines 33-54 of ‘825B2) as instant claim 1 is directed to multiple compounds which includes at least one compound that is required to practice the claimed method of ‘825B2.
Regarding ‘385B2:
The claims of ‘385B2 are directed to a method for reducing HbA1c in a patient in need thereof, comprising administering to the patient a therapeutically effective amount of a compound according to Formula (I):
PNG
media_image6.png
153
449
media_image6.png
Greyscale
Thus, instant claim 1 represents an obvious variation of the method claims of ‘385B2 (which also encompasses the isotopically-labelled derivatives of the disclosed compounds; see col. 71, lines 38-55 of ‘385B2) as instant claim 1 is directed to multiple compounds which includes at least one compound that is required to practice the claimed method of ‘385B2 as shown in the table below:
Compound from instant claim 1:
Instant compound encompassed by the following claims disclosed in ‘385B2:
PNG
media_image5.png
335
1025
media_image5.png
Greyscale
(B0700-614)
1-3
PNG
media_image4.png
279
745
media_image4.png
Greyscale
(B0700-701)
6, 7, 9, 14
PNG
media_image7.png
297
754
media_image7.png
Greyscale
(B0700-549)
4
PNG
media_image8.png
282
1079
media_image8.png
Greyscale
(B0500-104)
8
Claims 15-17 do not explicitly list any compounds, but they can encompass compounds that include the ones listed in the table above.
Regarding ‘148:
Compound from instant claim 1:
Instant compound encompassed by the following claims disclosed in ‘148:
PNG
media_image9.png
286
792
media_image9.png
Greyscale
(B0700-513)
1, 35, 41, 46
PNG
media_image10.png
344
1075
media_image10.png
Greyscale
(B0700-304)
2, 5, 8-13, 26, 56
PNG
media_image11.png
293
1051
media_image11.png
Greyscale
(B0700-341)
4, 6, 15, 17-19, 23, 25
PNG
media_image12.png
417
1056
media_image12.png
Greyscale
(B0700-608)
14
PNG
media_image13.png
316
1041
media_image13.png
Greyscale
(B0700-619)
20, 21, 39
PNG
media_image14.png
308
1051
media_image14.png
Greyscale
(B0700-343)
48
PNG
media_image15.png
285
1073
media_image15.png
Greyscale
(B0500-105)
43, 59
PNG
media_image7.png
297
754
media_image7.png
Greyscale
(B0700-549)
60
PNG
media_image16.png
280
760
media_image16.png
Greyscale
(B0700-555)
61
Claims 67 and 68 of ‘148 encompass instant claims 145 and 146.
Claims 69-83 of ‘148 are directed to claims that require compounds that encompass the ones listed in the table above.
Thus, instant claim 1 represent an obvious variation of the claims of ‘148 (which also encompasses the isotopically-labelled derivatives of the disclosed compounds; see para. 00604 of ‘148) as instant claim 1 is directed to multiple compounds which includes at least one compound that is required to practice the claims of ‘148.
Regarding ‘235:
The claims of ‘235 are directed to claims that require a menin inhibitor.
According to claim 25 of ‘235, the menin inhibitor can be a compound according to Formula (I):
PNG
media_image6.png
153
449
media_image6.png
Greyscale
Thus, instant claim 1 represents an obvious variation of the claims of ‘235 (which also encompasses the isotopically-labelled derivatives of the disclosed compounds; see para. 00356 of ‘235) as instant claim 1 is directed to multiple compounds which includes at least one compound that is required to practice the claims of ‘235 as shown in the table below:
Compound from instant claim 1:
Instant compound encompassed by the following claims disclosed in ‘235:
PNG
media_image4.png
279
745
media_image4.png
Greyscale
(B0700-701)
1-3, 10, 12, 13, 23, 25, 43, 44, 47, 55, 67, and 70-73
Claims 1-3, 10, 12, 13, 23, 43, 44, 47, 55, 67, and 70-73 do not explicitly list any compounds that are menin inhibitors, but they can encompass compounds that include the ones listed in the table above.
----------------------------- Added Rejections -----------------------------
Claim Rejections - 35 USC § 103
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.
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.
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.
Claim 143 is rejected under 35 U.S.C. 103 as being unpatentable over:
Butler et al. (Butler) (WO2020142557A1; International filing date: December 31, 2019; published July 9, 2020.)
Butler discloses the following compound:
PNG
media_image3.png
229
458
media_image3.png
Greyscale
(see pg. 206, Table 1, compound 1) which has the same structure as compound B0700-701 of instant claim 1.
Butler also states:
“Examples of isotopes that can be incorporated into the present compounds include isotopes of hydrogen, carbon, nitrogen, oxygen, fluorine and chlorine, such as 2H, 3H, 13C, 14C, 15N, 18O, 17O, 35S, 18F, 36Cl, respectively… Further, substitution with isotopes such as deuterium, i.e., 2H, can afford certain therapeutic advantages resulting from greater metabolic stability, for example increased in vivo half-life or reduced dosage requirements” (Butler, para. 00355).
Therefore, one of ordinary skill in the art would have found it prima facie obvious before the effective filing date of the claimed invention to take compound 1 of Butler (shown above; also encompassed by instant claim 1) and subsequently substitute at least one H of the compound with deuterium. One of ordinary skill in the art would have been motivated to make this modification because Butler explicitly teaches that deuterium substitution can improve metabolic stability of the compound and could reduce dosage requirements of the compound. A POSITA would also have been motivated to specifically modify compound 1 of Butler because Butler shows how compound 1 was able to reach max inhibition at lower concentrations compared to the MI-503 reference compound across all cell lines tested (see Butler, Table 5 and para. 00665).
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 1, 145, and 146 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over:
claims 1-23 of U.S. Patent Application No. 18/879,030 (‘030).
Although the claims at issue are not identical, they are not patentably distinct from each other because there is overlap between the instant claims and the claim set from the co-pending patent application listed above as explained below:
Regarding ‘030:
The claims of ‘030 are directed to claims that require a menin-MLL inhibitor.
According to claim 18 of ‘030, the menin-MLL inhibitor can be a compound according to Formula (I):
PNG
media_image6.png
153
449
media_image6.png
Greyscale
Thus, instant claim 1 represents an obvious variation of the claims of ‘030 as instant claim 1 is directed to multiple compounds which includes at least one compound that is required to practice the claims of ‘030 as shown in the table below:
Compound from instant claim 1:
Instant compound encompassed by the following claims disclosed in ‘030:
PNG
media_image4.png
279
745
media_image4.png
Greyscale
(B0700-701; this is the same as compound 1 of claim 19 in ‘030)
1-23
Claims 1-17 and 20-23 do not explicitly list any compounds that are menin-MLL inhibitors, but they can encompass compounds that include the ones listed in the table above.
Conclusion
No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTEN ROMERO whose telephone number is (571)272-6478. The examiner can normally be reached M-F 9:30 AM - 6:00 PM ET.
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, JEFFREY H. MURRAY can be reached at (571) 272-9023. 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.
/KRISTEN W ROMERO/Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
Prosecution Insights