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 .
DETAILED ACTION
The preliminary amendment filed 05/29/2025, amended claims 3-5, 10-12, 19-20, 23-26, 29, 34-35 and 37, and cancelled claims 6-9, 13-18, 21-22, 27-28, 30-33, and 36.
Claims 1-5, 10-12, 19-20, 23-26, 29, 34-35, and 37-39 are pending and examined on the merits herein.
Priority
This application claims the following priority:
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Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
See, for example, pg. 319 of the instant specification.
Claim Objections
Claims 1-5 and 34 are objected to because of the following informalities:
-Claims 1-5 contains two periods, one at the end of the claim and one following the final member of the Markush group in the definition of R2. For example in claim 1, the period following “(i-47)” should be deleted.
Each claim must begin with a capital letter and end with a period. Periods may not be used elsewhere in the claims except for abbreviations. See MPEP 608.01(m).
-For proper Markush language, in claim 1, in the R5 definition, the term “and” between “C3-C10 cycloakenyl” and “3-10 membered heterocycloalkenyl,” should be delete, and the term “and” should be inserted following “3-10 membered heterocycloalkenyl,”.
-For proper Markush language, in claims 1-5, in the definition of R2, the term “and” should be inserted prior to the final member of the Markush group. For example, in claim 1, “and” should be inserted prior to “(i-47).”
-For proper Markush language, in claim 1, in the definition of RE1-RE4, the term “and” between “6-12 membered aryl” and “5-12 membered heteroaryl” should be deleted, and the term “and” should be inserted prior to “SREE.”
-Claim 34 recites “Table 2,” which is improper; incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. MPEP 2173.05(s)
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claims 1-5, 10-12, 19-20, 23-26, 29, 35, 37-39 are 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.
-In claim 1, on pgs. 4 and 7 of the claim set R9 is defined, wherein the definition on pg. 4 is distinct from the definition on pg. 7. It is not clear if the definition of R9 on pg. 4 is only referencing optional substituents of R3 and R3a, and if the definition of R9 on pg. 7 is only referencing optional substituents of RE1-RE4, or if R9 is defined by both the definitions on pg. 4 and pg. 9.
-In claims 1-5, in the definition of R5a, the recitation “O-3-10 membered heterocycloalkyl,” renders the claim indefinite because it is not clear if “O” is the hetero atom in the ring or if oxygen, O, is bonded to R5 and the 3-10 membered heterocycloalkyl of R5a.
In claims 1-5, R8 is also rendered indefinite for the recitation “O-3-10 membered heterocycloalkyl” since it is not clear if “O” is the hetero atom in the ring or if oxygen, O, is bonded to R4 and the 3-10 membered heterocycloalkyl of R8.
All other claims not specifically recited are rejected for depending from an indefinite claim and failing to cure the deficiency.
Claim Rejections - 35 USC § 102
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 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.
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, 10, 12, 24-26, 35, and 37-39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN104418860 to Ding (published 2015; Original, IDS of 05/13/2026; Translation, PTO-892).
Regarding claims 1, 10, and 24-26, Ding teaches:
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([0742]-[0744], Original Document; claim 5, Translation) which meets the limitations of instant formula (A-I) of claim 1, (IA) of claim 10, and IC of claim 25, when:
-n is 0
-X is O
-A is C6 aryl, phenyl
-R1 is the halo F and q is 1
-R2 is instant i-38, wherein L3 is a bond
-R4 is a 5 membered heterocycloalkyl substituted by R8, wherein R8 is C(O)alkyl,
-R5 is C6 aryl substituted by two R5a, wherein R5a is a C1alkoxy and a 6-membered heterocycloalkyl, i.e., piperazine, substituted with R5aa, wherein R5aa is a C1alkyl, and
-R6 is H.
"A generic claim cannot be allowed to an applicant if the prior art discloses a species falling within the claimed genus." The species in that case will anticipate the genus. See MPEP 2131.02.
Regarding claim 12, this claim is interpreted as if n is 1 or 2, then R3 and R3a are as recited in claim 12. Since n is 0 in the compound of Ding, this limitation is considered met.
Regarding claim 35, Ding teaches pharmaceutical composition comprising its compounds (claim 6, Translation).
Further regarding claims 35, and regarding claims 37-39, Ding teaches a method of treating non-small cell lung cancer by administering its compounds (claims 6-8, Translation). Ding specifically exemplifies a method of treating mice with non-small cell lung cancer by administering its compounds in a vehicle composition to the mice (Example 72, Translation).
Claims 1-2, 12, and 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS Registry No. 1428760-83-1 (published 2013, PTO-892).
Regarding claims 1-2, and 23 Reg. No. 1428760-83-1 teaches:
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which meets the limitations of instant formula (A-I) of claim 1, (IA) of claim 10, and IC of claim 25, when:
-n is 0
-X is a bond
-A is C6 aryl
-R1 is a C1 alkyl and q is 1
-R2 is instant i-45, wherein L3 is a bond
-R4 is a C1 alkyl,
-R5 is 6-membered heterocycloalkyl and
-R6 is H.
"A generic claim cannot be allowed to an applicant if the prior art discloses a species falling within the claimed genus." The species in that case will anticipate the genus. See MPEP 2131.02.
Regarding claim 12, this claim is interpreted as if n is 1 or 2, then R3 and R3a are as recited in claim 12. Since n is 0 in the compound of 1428760-83-1, this limitation is considered met.
Registry number 1428760-83-1 is available as prior art as of 04/19/2013, the date it was indexed into the CAPlus database. Since this date represents the date that the compound entered the CAPlus database on STN, this represents the date that each compound was made accessible to the public.
Per MPEP 2128, an electronic publication, including an online database or Internet publication (e.g., discussion group, forum, digital video, or social media post), is considered to be a "printed publication" within the meaning of 35 U.S.C. 102(a)(1) and pre-AIA 35 U.S.C. 102(a) and (b) provided the publication was accessible to persons concerned with the art to which the document relates. See In re Wyer, 655 F.2d 221, 227, 210 USPQ 790, 795 (CCPA 1981). . . Electronic publications on the internet or on an online database are considered to be publicly available as of the date the item was publicly posted.”
As such, the instantly claimed compound is anticipated.
Claims 1, 12, 19, and 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS Registry No. 402925-73-9 (published 2002, PTO-892).
Regarding claim 1, Reg. No. 402925-73-9 teaches:
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which meets the limitations of instant formula (A-I) of claim 1, when:
-n is 0
-X is a bond
-A is C6 aryl
-q is 0
-R2 is instant i-36, wherein L3 is a bond
-R4 is a C1 alkyl,
-R5 is 10-membered bicyclic ring, or R5 is a 6-membered cycloalkenyl substituted by R5a, wherein R5a is a 5-membered heterocycloalkyl, and
-R6 is H.
"A generic claim cannot be allowed to an applicant if the prior art discloses a species falling within the claimed genus." The species in that case will anticipate the genus. See MPEP 2131.02.
Regarding claim 12, this claim is interpreted as if n is 1 or 2, then R3 and R3a are as recited in claim 12. Since n is 0 in the compound of 402925-73-9, this limitation is considered met.
which meets the limitations of instant formula (A-I) of claim 1, (IA) of claim 10, and IC of claim 25, when:
-n is 0
-X is a bond
-A is C6 aryl
-R1 is a C1 alkyl and q is 1
-R2 is instant i-45, wherein L3 is a bond
-R4 is a C1 alkyl,
-R5 is 6-membered heterocycloalkyl and
-R6 is H.
"A generic claim cannot be allowed to an applicant if the prior art discloses a species falling within the claimed genus." The species in that case will anticipate the genus. See MPEP 2131.02.
Regarding claim 12, this claim is interpreted as if n is 1 or 2, then R3 and R3a are as recited in claim 12. Since n is 0 in the compound of Ding, this limitation is considered met.
Registry number 402925-73-9 is available as prior art as of 03/27/2002, the date it was indexed into the CAPlus database. Since this date represents the date that the compound entered the CAPlus database on STN, this represents the date that each compound was made accessible to the public.
Per MPEP 2128, an electronic publication, including an online database or Internet publication (e.g., discussion group, forum, digital video, or social media post), is considered to be a "printed publication" within the meaning of 35 U.S.C. 102(a)(1) and pre-AIA 35 U.S.C. 102(a) and (b) provided the publication was accessible to persons concerned with the art to which the document relates. See In re Wyer, 655 F.2d 221, 227, 210 USPQ 790, 795 (CCPA 1981). . . Electronic publications on the internet or on an online database are considered to be publicly available as of the date the item was publicly posted.”
As such, the instantly claimed compound is anticipated.
Claims 1, 12, 23-24, and 26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shen (Structure Based Design of 5-Methylpyrimidopyridone Derivatives as New Wild-Type Sparing Inhibitors of the Epidermal Growth Factor Receptor Triple Mutant (published 2019, IDS of 05/13/2026).
Regarding claims 1, 23-24 and 26, Shen teaches compound 8r:
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(pg. S21 and Abstract), which meets the limitations of instant A-I when:
-X is a bond;
-n is 0;
-A is a C6aryl;
-R1 is F and q is 1;
-R2 is instant i36, wherein L3 is a bond;
-R4 is 6 membered heterocycloalkyl, a piperidine, substituted with one R8, wherein R8 is C(O)-C2alkyl;
-R5 is a C6aryl, phenyl, substituted by two R5a’s, wherein R5a is a C1alkyl and a 6 membered heterocycloalkyl, a piperazine, substituted by one R5aa, wherein R5aa is a C1 alkyl;
-R6 is a C1 alkyl.
Compound 8r-B is taught has a selective fourth generation EGFR inhibitor (pgs. 7306-7307, Conclusion).
"A generic claim cannot be allowed to an applicant if the prior art discloses a species falling within the claimed genus." The species in that case will anticipate the genus. See MPEP 2131.02.
Regarding claim 12, this claim is interpreted as if n is 1 or 2, then R3 and R3a are as recited in claim 12. Since n is 0 in the compound of Shen, this limitation is considered met.
Allowable Subject Matter
Claim 34 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 3-5, 11, 20, 29, and 34 are free of the prior art. The closest prior art is discussed in the above rejections.
The prior art does not teach R2 as defined by claims 3-5 and 29. The prior art does not teach compound (IB) as recited in claim 11 or the compounds of Table 2 as recited in claim 34. And the prior art does not teach a compound of claim 1 wherein R5 is a cyclic compound bound to a C3-C6cycloalkyl in a spiro configuration as recited in claim 20.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN WELLS whose telephone number is (571)272-7316. The examiner can normally be reached M-F 7:00-4:30.
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/LAUREN WELLS/Examiner, Art Unit 1622
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