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 .
Application and Claims Status
In the amendment as filed on 04/24/2026, applicants have amended claims 16, 17, 20, 21, 23, 25, 26, 30, 31 and 34; cancelled claims 19 and 35; and added no new claims. Therefore, claims 16-18, and 20-34 are currently pending.
Priority
Regarding Applicant’s Remarks (page 22, under Priority), Examiner is not aware of any previous Office Action revoking the Applicant’s claim to foreign priority. Applicant’s submission of certified copies of English translations of the three priority applications is, however, acknowledged.
Claim Objections
Claim 1 is objected to because of the following informalities: in the limitations of ring A and B, there is an additional comma between “N, and O”, which should be removed to read “N and O”. The limitation of Ra’ should be in the singular form to read “Ra’ is” (emphasis added). Appropriate correction is required.
Claim 2 is objected to because of the following informality: The limitation of Ra’ should be in the singular form to read “Ra’ is” (emphasis added). Appropriate correction is required.
Claim 28 is objected to because of the following informality: in the listing of species, on page 16, two of the species are separated by an “or” and the second species of set is followed by a semi-colon. Applicant is advised to remove the “or” and amend the semi-colon to a comma instead. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The rejection of claim 28 under AIA 35 U.S.C. 112(b) is withdrawn based on Applicant arguments.
The rejection of claims 16-18, and 20-34 under AIA 35 U.S.C. 112(a) are withdrawn based on Applicant amendments. Note: in the Office Action filed 1/28/2026, Examiner mistakenly rejected claims 33-34 over 112(b) issues, when it in fact was claims 34-35 over 112(b) issues.
Claim Rejections - 35 USC § 112(a)
The rejection of claim 16-34-35 under AIA 35 U.S.C. 112(a) is withdrawn based on Applicant amendments.
Claim Rejections - 35 USC § 112(d)
(Necessitated by Claim Amendment)
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.
Claim 17 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 17, which depends on claim 16, recites the limitation of Rb, which is “selected from the group consisting of…substituted with one or more hydroxy or halogen” (emphasis added). However, claim 16 does not include the additional halogen substitution. Therefore, claim 17 broadens the scope of the claim from which it depends.
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.
Claim Rejections - 35 USC § 103
The rejection of claims 16-23, 25, and 29-31 under AIA 35 U.S.C. 103(a) as being unpatentable over CAS 1111018-07-5 in view of Silverman and Patani et al. is withdrawn based on the amendments.
35 USC § 103 Rejections
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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) 16-17, 22, 25-27, 29, and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (WO 2017/186148 A1, published November 2, 2017)(hereinafter, ‘Li’).
Li teaches (page 68) the following species, Example 043 with connection of the 6,5-heteroaryl to the rest of the compound, shown encircled below.
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Li also teaches the method of preparing compounds of reference application, their use in inhibiting enzymatic activities of BCR-ABL in the treatment of chronic myeloid leukemia (CML) (page 1-2), and a pharmaceutical composition thereof.
Li teaches that R3 is selected from a substituted or unsubstituted 5-10 membered heteroaryl group, where the R3 point of attachment to the core scaffold is alternatively usable (page 5).
It can be seen that the species taught by Li is a positional isomer of compounds of instant claims where the connection to the 5,6-heteroaryl is shifted. These compounds are positional isomers and considered equivalent. The MPEP 2144.09 states “Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. Adjacent homologues are generally so structurally similar that "without more" such structural similarity could give rise to prima facie obviousness. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). MPEP 2144.08(II)(A)(4)(c).
It is well known in the art that compounds having the same radical at different positions on the nucleus are position isomers. Their properties are often so nearly alike as to present difficulties in identification or separation. Ex parte Mowry (POBA 1950) 91 USPQ 219. A novel, useful compound which is isomeric with a compound of the prior art is unpatentable unless it possesses some unobvious or unexpected beneficial property not possessed by the prior art compound. In re Norris (CCPA 1950) 179 F2d 970, 84 USPQ 458; In re Finley (CCPA 1949) 174 F2d 130 and 135, 81 USPQ 383 and 387.
A compound need not be an adjacent homolog or position isomer of a prior art compound in order to be susceptible to a rejection based on structural obviousness; the name used to designate the structural relationship between compounds is not controlling, it is the closeness of that relationship. In re Payne et al. (CCPA 1979) 606 F2d 303, 203 USPQ 245. When chemical compounds have “very close” structural similarities…without more, a prima face case of obviousness may be made. In re Grabiak (CAFC 1985) 769 F2d 729, 226 USPQ 870. Analogs differing only in the position of a single moiety are well known to be prime facie obvious in the law, as cited above, and require no secondary teaching.
Here, the prior art teaches a highly similar structural isomer of the instantly claimed invention, wherein such isomers have the same utility as the instantly claimed compounds. The reference specification teaches the treatment of diseases mediated by inhibition of BCR-ABL for the treatment of CML, their preparation, and pharmaceutical compositions. Therefore, the close structural similarity between the compounds of Li and compounds of instant claims render the instant claims obvious because one of ordinary skill in the art would readily appreciate that isomers of such compounds could be utilized for the treatment of diseases mediated by inhibition of BCR-ABL, as taught by the prior art.
One of ordinary skill would have a reasonable expectation of success in synthesizing a positional isomer of the compound taught by Pfeifer since it is well known in the art that positional isomers have similar chemical properties. It would be expected that altering a known compound by creating a positional isomer would result in a compound with the same chemical properties and utility as the known compound.
Conclusion
Claims 18, 20-21, 23-24, 28, and 30-33 are allowed.
Claims 16-17, 22, 25-27, 29 and 34 are rejected.
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 LUKE ALAN BORALSKY whose telephone number is (571)272-9746. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 am.
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/L.A.B./Examiner, Art Unit 1624
/SUSANNA MOORE/Primary Examiner, Art Unit 1624
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