DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
2. Applicant’s election of Group I in the reply filed on March 10, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
3. Claims 3, 4 and 6-24 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter. Election was made without traverse in the reply filed on March 10, 2026.
Status of Claims
4. Claims 1-24 are pending. Claims 1, 2 and 5 are elected and under examination. Claim 1 is independent.
Information Disclosure Statement
5. The information disclosure statement (IDS) submitted on October 10, 2022 was in compliance with the provisions of 37 CFR 1.97 and 37 CFR 1.98. The IDS was considered. A signed copy of form 1449 is enclosed herewith.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
6. Claims 1, 2 and 5 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The claims refer to a crystalline form of the chemical Compound 1 which is characterized by powder X-ray diffraction pattern having one or more peaks selected from various peaks as listed. The limitation that one or more peaks must be selected from the various peaks as listed does not distinctly claim the crystalline form. For example, the specification provides a different crystalline form (see also claim 3 of the present application) with a different X-ray diffraction pattern. However, this different crystalline form contains the one or more peaks selected from various peaks as listed: eg. 8.09 of the different crystalline form corresponds to the peak at 8.00 + 0.2 degrees theta.
The claims refer to a crystalline form of the chemical Compound 1 which is characterized by powder X-ray diffraction pattern having peaks at 8.81 and 14.51 + 0.2 degrees theta. The two peak requirements does not distinctly claim the crystalline form. For example, see prior art rejection on Sections 8 and 14. The references of WO2019171222 and WO2012071336 describe crystalline forms of the claimed chemical compound that have an X-ray diffraction pattern that have the two peaks at 8.81 and 14.51 degrees theta.
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.
7. Claim(s) 1 and 5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO2019135253. The reference has a publication date of July 11, 2019 which antedates the present claims having an effective filing date of April 9, 2021 and priority claim to provisional application dated April 10, 2020.
The reference teaches polymorphic forms of venetoclax
PNG
media_image1.png
172
120
media_image1.png
Greyscale
and pharmaceutical compositions thereof, eg. abstract, page 10. The reference teaches crystalline form M23 which has PXRD pattern with peaks at 2 theta angles such as 17.57, which corresponds to the present claims of crystalline form characterized by a PXRD pattern with one or more peaks selected from, for example, 17.68 + 0.2 degrees 2 theta.
8. Claim(s) 1, 2 and 5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO2019171222. The reference has a publication date of September 12, 2019 which antedates the present claims having an effective filing date of April 9, 2021 and priority claim to provisional application dated April 10, 2020.
The reference teaches polymorphic forms of venetoclax
PNG
media_image1.png
172
120
media_image1.png
Greyscale
and pharmaceutical compositions thereof, eg. abstract, page 4. The reference teaches, for example, form A which has PXRD pattern with peaks at 2 theta angles such as 9.0 and 14.5, which corresponds to the present claims of crystalline form characterized by a PXRD pattern with one or more peaks selected from, for example, 8.82 and 14.51 + 0.2 degrees 2 theta.
9. Claim(s) 1 and 5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO2018157803. The reference has a publication date of July 9, 2018 which antedates the present claims having an effective filing date of April 9, 2021 and priority claim to provisional application dated April 10, 2020.
The reference teaches polymorphic forms of venetoclax
PNG
media_image1.png
172
120
media_image1.png
Greyscale
and pharmaceutical compositions thereof, eg. abstract. The reference teaches, for example, form CS1 which has PXRD pattern with peaks at 2 theta angles such as 19.0 which corresponds to the present claims of crystalline form characterized by a PXRD pattern with one or more peaks selected from, for example, 19.04 + 0.2 degrees 2 theta.
10. Claim(s) 1 and 5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO2018069941. The reference has a publication date of April 19, 2018 which antedates the present claims having an effective filing date of April 9, 2021 and priority claim to provisional application dated April 10, 2020.
The reference teaches polymorphic forms of venetoclax
PNG
media_image1.png
172
120
media_image1.png
Greyscale
and pharmaceutical compositions thereof, eg. abstract, claims. The reference teaches, for example, form M9 which has PXRD pattern with peaks at 2 theta angles such as 19.15 which corresponds to the present claims of crystalline form characterized by a PXRD pattern with one or more peaks selected from, for example, 19.04 + 0.2 degrees 2 theta.
11. Claim(s) 1 and 5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO2017212431. The reference has a publication date of December 14, 2017 which antedates the present claims having an effective filing date of April 9, 2021 and priority claim to provisional application dated April 10, 2020.
The reference teaches polymorphic forms of venetoclax
PNG
media_image1.png
172
120
media_image1.png
Greyscale
and pharmaceutical compositions thereof, eg. abstract, claims. The reference teaches, for example, form B2 which has PXRD pattern with peaks at 2 theta angles such as 19.37 which corresponds to the present claims of crystalline form characterized by a PXRD pattern with one or more peaks selected from, for example, 19.51 + 0.2 degrees 2 theta.
12. Claim(s) 1 and 5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO2017156398. The reference has a publication date of September 14, 2017 which antedates the present claims having an effective filing date of April 9, 2021 and priority claim to provisional application dated April 10, 2020.
The reference teaches polymorphic forms of venetoclax
PNG
media_image1.png
172
120
media_image1.png
Greyscale
and pharmaceutical compositions thereof, eg. abstract, claims. The reference teaches, for example, form 1 which has PXRD pattern with peaks at 2 theta angles such as 19.2 which corresponds to the present claims of crystalline form characterized by a PXRD pattern with one or more peaks selected from, for example, 19.04 + 0.2 degrees 2 theta.
13. Claim(s) 1 and 5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO2017063572. The reference has a publication date of April 20, 2017 which antedates the present claims having an effective filing date of April 9, 2021 and priority claim to provisional application dated April 10, 2020.
The reference teaches polymorphic forms of venetoclax
PNG
media_image1.png
172
120
media_image1.png
Greyscale
and pharmaceutical compositions thereof, eg. abstract. The reference teaches, for example, form B which has PXRD pattern with peaks at 2 theta angles such as 20.6 which corresponds to the present claims of crystalline form characterized by a PXRD pattern with one or more peaks selected from, for example, 20.61 + 0.2 degrees 2 theta.
14. Claim(s) 1, 2 and 5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO2012071336. The reference has a publication date of May 31, 2012 which antedates the present claims having an effective filing date of April 9, 2021 and priority claim to provisional application dated April 10, 2020.
The reference teaches polymorphic forms of venetoclax
PNG
media_image1.png
172
120
media_image1.png
Greyscale
and pharmaceutical compositions thereof, eg. abstract. The reference teaches, for example, form A which has PXRD pattern with peaks at 2 theta angles such as 9.0 and 14.5 which corresponds to the present claims of crystalline form characterized by a PXRD pattern with one or more peaks selected from, for example, 8.81 and 14.51 + 0.2 degrees 2 theta.
15. Claim(s) 1 and 5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by EP 3333167. The reference has a publication date of June 13, 2018 which antedates the present claims having an effective filing date of April 9, 2021 and priority claim to provisional application dated April 10, 2020.
The reference teaches polymorphic forms of venetoclax
PNG
media_image1.png
172
120
media_image1.png
Greyscale
and pharmaceutical compositions thereof, eg. abstract. The reference teaches, for example, form S which has PXRD pattern with peaks at 2 theta angles such as 14.3 which corresponds to the present claims of crystalline form characterized by a PXRD pattern with one or more peaks selected from, for example, 14.51 + 0.2 degrees 2 theta.
16. Claim(s) 1 and 5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CZ2017762. The reference has a publication date of November 28, 2017 which antedates the present claims having an effective filing date of April 9, 2021 and priority claim to provisional application dated April 10, 2020.
The reference teaches polymorphic forms of venetoclax
PNG
media_image1.png
172
120
media_image1.png
Greyscale
and pharmaceutical compositions thereof, eg. abstract. The reference teaches, for example, form JR which has PXRD pattern with peaks at 2 theta angles such as 8.7 which corresponds to the present claims of crystalline form characterized by a PXRD pattern with one or more peaks selected from, for example, 8.81 + 0.2 degrees 2 theta.
17. Claim(s) 1 and 5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CZ201769. The reference has a publication date of June 2, 2017 which antedates the present claims having an effective filing date of April 9, 2021 and priority claim to provisional application dated April 10, 2020.
The reference teaches polymorphic forms of venetoclax
PNG
media_image1.png
172
120
media_image1.png
Greyscale
and pharmaceutical compositions thereof, eg. abstract. The reference teaches, for example, form which has PXRD pattern with peaks at 2 theta angles such as 20.5 which corresponds to the present claims of crystalline form characterized by a PXRD pattern with one or more peaks selected from, for example, 20.61 + 0.2 degrees 2 theta.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUN JAE YOO whose telephone number is (571)272-9074. The examiner can normally be reached Mon-Fri 8-5.
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.
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.
/SUN JAE YOO/Primary Examiner, Art Unit 1621
