DETAILED ACTION
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 .
Priority
The instant application is a 35 USC 371 National Stage filing of international application PCT/CN2021/078115, filed February 26, 2021.
Information Disclosure Statement
3. The information disclosure statement (IDS) submitted on July 12, 2023 was in compliance with the provisions of 37 CFR 1.97 and 37 CFR 1.98. The IDS document was considered. A signed copy of form 1449 is enclosed herewith.
Election/Restriction
4. Applicant's election with traverse of Group II in the reply filed on November 14, 2025 is acknowledged. The traversal is on the ground(s) that the prior art cited in the restriction requirement does not break unity of invention because the reference cited does not teach the invention; however, as evidenced by art rejections below, this is not the case as the prior art both anticipates and renders obvious the instant claimed compositions. As such, the claims lack unity of invention.
The requirement is still deemed proper and is therefore made FINAL.
Status of Claims
5. Claims 5-12 and 15-20 are pending in the instant application. Claims 5-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention and/or species. Claims 15-20 read on an elected invention and are under consideration herein.
Claim Rejections - 35 USC § 112
6. The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
7. Claim 16 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 16 is drawn to a composition comprising two enantiomers, the (R) and (S) enantiomers of the compound of formula (I), also known as compounds 3423 and 3424. While the enantiomers are present at a 1:1 ratio in the racemic mixture of formula (I), also known as compound 2870, the enantiomers are not inherently encompassed by formula (I) without an explicit limitation.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Examiner suggests rewriting claim 15 part 1) to include the racemic mixture and both enantiomers, if supported by the present specification.
Claim Rejections - 35 USC § 102
8. 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.
9. 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.
10. Claim(s) 16 is/are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by WO 2019062919.
WO 2019062919 teaches pharmaceutical compositions for treating acute lymphoblastic leukemia comprising compounds I and II, also known as, 3423 and 3424, (enantiomers of compound of instant formula (I) as taught in instant claim 16) further comprising a combination of additional anti-cancer drugs, as follows: purine nucleoside analogs comprising nelarabine, clofarabine, fludarabine cladribine, pentostatin, forodesine, 8-chloroadenosine, azathioprine, or a combination thereof.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
11. Claims 15, 17, and 20 are rejected under 35 U.S.C. 103(a) as being unpatentable over CN108290911 in view of WO 2019062919.
Determining the scope and contents of the prior art and ascertaining the differences between the prior art and the claims at issue
12. CN108290911 teaches pharmaceutical compositions comprising compound 2870, anticipating compound of formula I of the instant claims (see example 1, example 5-7, claims) as well as compounds 3423 and 3424, enantiomers of compound 2870, for treating a cancer wherein AKR1C3 reductase level is high, including liver cancer, HCC, non-small cell lung cancer, melanoma, prostate cancer, breast cancer, leukemia, esophageal cancer, renal cancer, gastric cancer, colon cancer, brain cancer, bladder cancer, cervical cancer, ovarian cancer, head and neck cancer, endometrial cancer, pancreatic cancer, sarcoma, and rectal cancer (claims 1-2, 9-12, [0013]). CN108290911 does not teach a composition comprising another anti-cancer drug. WO 2019062919 cures this deficiency.
13. WO 2019062919 teaches pharmaceutical compositions for treating acute lymphoblastic leukemia comprising compounds I and II, also known as, 3423 and 3424, (enantiomers of compound of instant formula (I) as taught in instant claim 16) further comprising a combination of additional purine nucleoside analogs comprising nelarabine, clofarabine, fludarabine (instant claim 17), cladribine, pentostatin (instant claim 17), forodesine, 8-chloroadenosine, azathioprine, or a combination thereof. Said compounds are prodrugs selectively activated by AKR1C3.
Resolving the level of ordinary skill in the pertinent art
14. With respect to this difference, MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.’" KSR, 550 U.S. at ___, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
15. Based on the teachings of the MPEP and KSR above, by employing the rationale in (A) (F), and (G) above, it would have been obvious for one of ordinary skill in the art to extrapolate using the suggestion of WO 2019062919 to use an anti-cancer drug in the pharmaceutical composition of enantiomers 3423 and 3424, one of ordinary skill would find it obvious to use an anti-cancer drug in the pharmaceutical composition of the racemic mixture 2870 in CN108290911 to combine and arrive at pharmaceutical compositions in the same field of endeavor, pharmaceutical compositions for treating cancer.
Thus, it would have been prima facie obvious at the time the invention was made for one of ordinary skill in the art to combine said references to arrive at the present invention, compositions for the treatment of cancer.
Claim Objections
16. Claims 18-19 are objected to for depending on a rejected base claim.
Conclusion
17. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Samantha Shterengarts whose telephone number is (571)270-5316. The examiner can normally be reached on Monday-Friday, 9-7pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan can be reached on 571-272-0699. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAMANTHA L SHTERENGARTS/Primary Examiner, Art Unit 1623
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