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
This application is a 371 of PCT/KR2022/004702 (04/01/2022)
And claims foreign priority to KOREA, REPUBLIC OF 10-2021-0042821 (04/01/2021)
and KOREA, REPUBLIC OF 10-2022-0039968 (03/30/2022).
Election/Restrictions
Applicant's election without traverse of the following species 250 in the reply filed on 6/8/26 is acknowledged. Applicant also elected the following species:
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N-(6-((5-bromo-2-((2-methoxy-5-methyl-4-(4-(4-methylpiperazin-1-yl)piperidin-1-yl)phenyl)amino)pyrimidin-4-yl)amino)-2,3-dihydrobenzofuran-5-yl)-N- methylmethanesulfonamide,
Corresponding to claim 1’s Formula 10 when:
A is (4-methylpiperazin-1-yl)piperidin-1-yl
B is 2,3-dihydrobenzofuran (subs by -NR8R9, R8 is S(O)2-CH3, R9 is CH3),
X1-3 are CH, R1 is Br, R5 is methoxy, R6 is methyl.
determined to read on claims 1-18.
As detailed in the following rejections, the generic claim encompassing the elected species was not found patentable. Therefore, the provisional election of species is given effect, the examination is restricted to the elected species only, and claims not reading on the elected species are held withdrawn. MPEP 803.02; Ex parte Ohsaka, 2 USPQ2d 1460, 1461 (Bd. Pat. App. lnt. 1987).
Should applicant, in response to this rejection of the Markush-type claim, overcome the rejection through amendment, the amended Markush-type claim will be reexamined to the extent necessary to determine patentability of the Markush-type claim. See MPEP 803.02.
Claim Interpretation
Claims 13 and 16-18 are to compositions having a “wherein” clause with an intended use step that raises a question as to the limiting effect of the clause.
Claim 13 – “is applied to a patient”
Claim 16-18 – “is administered to”
As per MPEP 2111.04, Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. In claims 13 and 16-18, the wherein clause does not limit the claim to a particular structure because the language describes a step to be performed with the existing product. Thus, the language does not limit the claim.
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.
Claims 1-18 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
Claim 1 has formulae 10, 11, and 12:
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which share “R” variables, however, the claim uses subscript numbers associated with the “R” groups while the formulae use both sub- and super-script. One of skill in the art would find the mixed notation confusing both because the use in the art is superscript (to avoid confusion with a repeating group like CH3) and because of the mixed use in the formulae (unclear whether they are intended to be different variables or not).
In addition, at least Formula 11 has illegible text on the 5-member ring, as does Formula 12 in the variable groups. Claims 7-8 also have illegible structures.
Thus, claim 1 and those that depend therefrom are indefinite.
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.
Claims 13 and 16-18 are rejected under 35 U.S.C. 112(d) 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. As detailed in the claim interpretation section above, the language of the claims does not further limit the product of claim 11. 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 § 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 1-7, 10-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee et al. (KR20180135781, published 2018-12-21, cited in 2024-05-14 IDS - citations to English equivalent US20200179384).
Lee taches pharmaceutical compositions for the “treatment of cancer with EGFR mutation or cancer with FLT3 or a mutation thereof” (Abstract) including comprising the following compound 10 ([0376] Table 3):
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Corresponding to claim 1’s Formula 10 when:
A is (4-methylpiperazin-1-yl)piperidin-1-yl
B is phenyl (subs by -NR8R9, R8 is S(O)2-CH3, R9 is CH3),
X1-3 are CH, R1 is Cl, R5 is methoxy, R6 is hydrogen.
Lee teaches compositions (claims 13-19) and comprising pharmaceutically acceptable salt ([0106]).
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT H HAVLIN whose telephone number is (571)272-9066. The examiner can normally be reached 9am - 6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at (571) 270-5293. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT H HAVLIN/Primary Patent Examiner, Art Unit 1626
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