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 .
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.
Election/Restrictions
Examiner have withdrawn 102 and 103 rejections on record.
Examiner is making new 102 and 103 rejection. Therefore, election of species requirement is maintained.
Since examiner did not reject claims 9 and 17 in the previous offices actions this office action is made non-final.
Examiner found prior art on applicant elected species. Therefore, the Markush search will not be extended unnecessarily to additional species in this Office Action.
Applicants’ elected species reads on claims 3-4, 7, 9, 12-17, 20-22.
Claims 10-11 and 18-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed 06/16/2025.
Claims 3-4, 7, 9, 12-17, 20-22 are examined in this office action.
Current Status of 17/636,476
This office action is in response to the amended claims on 10/23/2025.
Claims 3-4, 9, 12 and 17 currently amended; claims and 7, 13-16 and 20-22 are previously presented; and claims 10-11 and 18-19 are withdrawn.
Claims 3-4, 7, 9, 12-17, 20-22 are examined in this office action.
Priority
The effective filing date is 08/19/2020 since the instant claims find support in PCT/CN2020/110061.
Response to Arguments
Examiner acknowledges the receipt of applicant’s claim amendment and remarks of 10/23/2025. Examiner have reviewed these remarks and amendments.
Regarding 102 rejections applicant
Amended independent claim 3 and by incorporating “Bcr-Abl tyrosine kinase or BTK” and the limitation of claims 8 and 9 into instant claim 3.
Amended independent claim 4 by incorporating Bcr-Abl tyrosine kinase or BTK the claim
This renders moot 102 rejections on file, therefore 102 rejection is withdrawn
Regarding 103 rejections applicant
Amended independent claim 3 and by incorporating “Bcr-Abl tyrosine kinase or BTK” and the limitation of claims 8 and 9 into instant claim 3.
Amended independent claim 4 by incorporating Bcr-Abl tyrosine kinase or BTK the claim.
Applicant further argues
Cameron investigates the metabolism of dasatinib and compound 5826 by CYP3A4, a cytochrome P450 enzyme, not a kinase, and certainly not either tyrosine kinase of the instant claims. Contrary to the Examiner's assertion on page 4 of the Office Action, Cameron does not suggest that "a fluorinated analog of dasatinib may have a stronger biological activity in inhibiting BCR-ABL tyrosine kinase in vitro." Instead, Cameron investigates the metabolism of dasatinib and a series of dasatinib analogs (including compound 5826) by CYP3A4, which is not a kinase, let alone a tyrosine kinase of the instant claims
Examiner’s response,
Examiner agrees Cameron does not teach compound of formula I as BCR-ABL tyrosine kinase inhibitor. Cameron teaches metabolism of compound of formula I by CYP3A4 enzyme.
This render’s moot the 103 rejection on file, thus 103 rejection is withdrawn.
Claim Rejections - 35 USC § 102 (new)
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.
Claim(s) 3-4, 9, 13 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Furga et.al. (Proc Natl Acad Sci U S A. 2007 Aug 14;104(33):13283-8)
Furga et. al discloses dasatinib
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, examiner is interpreting dasatinib as prodrug or active metabolites of compound of formula I,
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a highly potent inhibitor of ACR-ABL for targeting BTK tyrosine kinase(claims 9 and 17) for treating myelogenous leukemia (page 13284, abstract) anticipating claims 3-4, 9 and 17. Dasatanib (prodrug or active metabolites) of compound of formula I, inhibit BTK in vitro and in vivo (page 13284), thus anticipating claim 13.
Applicant can overcome this 102 rejection by striking “prodrug” and “active metabolites” from the claims.
Claim Rejections - 35 USC § 103(new)
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(s) 3-4, 7, 9, 12-17, 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over
Furga et.al. (Proc Natl Acad Sci U S A. 2007 Aug 14;104(33):13283-8
In view of
Brahmachari et. al. (Journal of Parkinson’s Disease 7 (2017) 589-601)
In further in view of
Rousselot et. al. (Leukemia Research 35 (2011) 777-782)
1. Determining the scope and contents of the prior art.
Furga teaches claims 3-4, 9, 13 and 17, see, above.
Brahmachari et. al, discloses Parkinson’s disease (applicant’s elected species of disease) can be treated with therapeutics by targeting tyrosine kinase (page 589 abstract) partially teaching claim 3-4, 8, 12, 20, and 22.
Rousselot et. al teaches use of Daunorubicin (applicant elected species of therapeutics) in combination imatinib (tyrosine kinase inhibitor) increase survival of patient with chronic myelogenous leukemia (CML) (page 781). Rousselot further teaches dasanitib (prodrug or active metabolites) of compound of formula I can be used with daunorubicin for treatment of CML(page 781) thus partially teaching claims 7,14-16 and 21.
2. Ascertaining the differences between the prior art and the claims at issue.
Furga et. al does not teach treatment of Parkinson’s disease with dasatinib, prodrug or active metabolites of compound of formula 1 in combination with daunorubicin.
Brahmachari et. al does not teach treatment of Parkinson’s disease with dasatinib, prodrug or active metabolites of compound of formula 1 in combination with daunorubicin.
Rousselot et. al does not teach treatment of Parkinson’s disease with dasatinib, prodrug or active metabolites of compound of formula 1 in combination with daunorubicin.
3. Resolving the level of ordinary skill in the pertinent art.
The level of ordinary skill is an artisan who have sufficient background in disease associated with tyrosine kinase and looking into developing therapeutics for disease associated with tyrosine kinase.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
A person skilled in the art would be motivated to use dasatinib, prodrug or active metabolites of the compound of formula I (Furga et.al. page 13284, abstract) (a known tyrosine kinase inhibitor) to treat Parkinson’s Disease, since Parkinson’s disease can be treated by inhibiting tyrosine kinase (Brahmachari et. al page 589 abstract). It is expected dasatinib, prodrug or active metabolites of the compound of formula I (Furga et.al. page 13284, abstract) can be used to treat Parkinson’s disease from the combined teaching Furga et. al. and Brahmachari et. al, thus teaching all the element of claims 3-4, 12-13, 20 and 22.
Similarly, person skilled in the art would be motivated to combine daunorubicin with compound of dasatinib(prodrug or active metabolites of compound of formula I) since daunorubicin is known in the art to be combined with tyrosine inhibitor for treatment of disease associated with tyrosine kinase (Rousselot et. al page 781). It would be expected daunorubicin in combination dasatinib (prodrug or of compound of formula I) would treat Parkinson’s disease more effectively than compound of dasatinib , because both dasatinib and daunorubicin are used to treat Parkinson’s disease on their own, thus teaching all the elements of claims 3-4, 7-8, 12-17, and 20-22.
Therefore, it is prima facie obvious to combine the teaching of Furga et. al. with the teaching of Brahmachari et. al and the teaching Rousselot et. al to develop a treatment for Parkinson’s disease associated with tyrosine kinase inhibition.
Applicant can overcome this 103 rejection by striking “prodrug” and “active metabolites” from the claims.
Conclusion
Claims 3-4, 7, 12-17, and 20-22 are rejected.
Applicant can overcome 102 and 103 rejections by striking “prodrug” and “active metabolites” from the claims.
Examiner did not find prior art on method of treating diseases associated with Bcr-Abl tyrosine kinase or BTK tyrosine kinase with compound of formula I. Cameron et. al. (Drug Metabolism and Disposition Volume 37, Issue 6, June 2009, Pages 1242-1250) discloses compound 5826 same as formula I (see p. 1242, abstract, p. 1244, table 2, & p. 1250, the left column, paragraph 2) and the metabolism of compound of formula I by CYP3A4 enzyme. Cameron does not teach compound of formula 1 to inhibit Bcr-Abl tyrosine kinase or BTK tyrosine kinase. A person skilled in the could not envision using compound of formula I for inhibiting Bcr-Abl tyrosine kinase or BTK tyrosine kinase, therefore Cameron is a close art not a prior art.
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/R.I./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625