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
This Office Action is in response to Applicant’s Arguments and Amendment filed, 04/28/2026, wherein the Amendment amended claims 1 and 33, and cancelled claims 27-29 and 32.
Claims 1-26, 30-31, and 33-51 are pending.
Priority
This application claims the following priority:
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Election/Restrictions
Applicant elected Group I and the species E057
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as the compound of Formula I and elected chronic urticaria as the inflammatory disease, in the reply filed on 04/04/2025.
The elected species is allowable over the prior art. The examination of the Markush claim has been extended. If a Markush grouping as set forth in a claim is proper and election of species has been required, the examiner must continue to search the species of the claim unless the claim has been found to be unpatentable over prior art. MPEP 803.02.
As detailed in the following prior art 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the examination is restricted to the elected species only, and claims not reading on the elected species are held withdrawn.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.
The 04/28/2026 Amendment amended the definition of R1 to limit its scope to 3-10 membered heterocycloalkyls having 1-3 heteroatoms selected from N, O, and S, which is optionally substituted with 1, 2 or 3 R51 groups. As such, the species searched and examined in the previous Office Action do not read on the amended claims; the search has been extended as detailed in the following prior art rejection.
Claims 3, 5-11, 15, 17-18, 20-21, 24-25, 31 and 34-51 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and non-elected subject matter, there being no allowable generic or linking claim.
Claims 1-2, 4, 12-14, 16, 19, 22-23, 26, 30, and 33 are examined on the merits herein.
REJECTIONS WITHDRAWN
The status for each rejection and/or objection in the previous Office Action is set out below.
Specification Objections
Applicant’s amendment to the specification is sufficient to overcome the objection.
Claim Objections
Applicant’s amendments to claims 1 and 33 are sufficient to overcome the objections.
35 U.S.C. § 112(b)
Applicant’s amendment to claim 1 is sufficient to overcome this rejection.
35 U.S.C. § 102
Applicant’s amendment to claim 1 that limits the definition of R1 to limit its scope to 3-10 membered heterocycloalkyls having 1-3 heteroatoms selected from N, O, and S, which is optionally substituted with 1, 2 or 3 R51 groups, is sufficient to overcome these rejections.
Double Patenting
Copending Application No. 19/349,768 defines k as 1, while the instant claims recite k as 0. As such, the compounds of ‘769 and the instant application are distinct.
REJECTIONS-NEW
In view of Applicant’s amendments to the claims, the below rejections are new.
Substantial Duplicates
Applicant is advised that should claim 19 be found allowable, claim 22 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112(a)-New Matter
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2, 4, 12-14, 16, 19, 22-23, 26, and 30 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
This is a new matter rejection.
-In claim 1, in the definition of R51, the term “oxo” is added as a member of the Markush group. However, neither the original disclosure nor the original claims provide support for “oxo” as R51. While Applicant states that “No new matter has been added,” on pg. 39, Remarks, Applicant does not point to specific support for “oxo” as R51.
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 (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.
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 1-2, 4, 12, 14, 23, 26, 30, and 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN File Registry No. 1625921-90-5 (published 2014, PTO-892).
Regarding claims 1 and 33, STN teaches
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132
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which meets the limitation of instant formula (I) when:
W is –L1-A2, wherein L1 is -CH2-, p is 1, and A2 is a phenyl substituted with 1 R60, the halogen F,
A1 is ring system 1
R1 is a 5 membered heterocycloalkyl with one heteroatom, oxygen.
Regarding claim 2, A1 is ring system 1.
Regarding claims 4, 12, 14, and 23, A2 is a phenyl substituted with one R60 group, F, at the 2-position.
Regarding claim 26, p is 1 and L1 is CH2.
Regarding claim 30, R1 is tetrahydrofuran-3-yl.
"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.
Registry number 1625921-90-5 is available as prior art as of 09/25/2014, 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 1-2, 4, 12, 16, 23, and 26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Obushak (Heterocyclic Syntheses on the Basis of Arylation Products of Unsaturated Compounds: X. 3-Aryl-2-chloropropanals as Reagents for the Synthesis of 2-Amino-1,3-thiazole Derivatives, published 2004, PTO-892).
Regarding claim 1, Obushak teaches:
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102
321
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(pg. 387), which meets the limitation of instant formula (I) when:
W is –L1-A2, wherein L1is -CH2-, p is 1, and A2 is phenyl substituted with one R60, the halogen F,
A1 is ring system 1
R1 is a 5 membered heterocycloalkyl with one heteroatom, oxygen.
Regarding claim 2, A1 is ring system 1.
Regarding claims 4, 12, 16, and 23, A2 is phenyl substituted with one R60, the halogen, F at the 4 position.
Regarding claim 26, p is 1 and Li is CH2.
"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.
Claims 1-2, 4, 13, 19, 22, 23, and 26 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by WO2008/050600 to Kazunori (published 2008, PTO-892).
Regarding claim 1 Kazunori teaches:
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330
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(pg. 2), which meets the limitations of instant Formula (I) when:
W is (L1)p-A2, wherein L1 is-CH2-, p is 1, and A2 is phenyl substituted with two halogens
A1 is Ring system 1
R1 is a 5-membered heterocycloalkyl with one heteroatom, oxygen.
Regarding claim 2, A1 is ring system 1.
Regarding claims 4, 13, 19, 22, and 23, A2 is a phenyl substituted with 2 R60, the halogens Cl, at the 2 and 5 position.
Regarding claim 26, p is 1 and L1 is CH2.
"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.
Conclusion
No claims are allowed.
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 LAUREN WELLS whose telephone number is (571)272-7316. The examiner can normally be reached M-F 7:00-4:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James (Jim) Alstrum-Acevedo can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAUREN WELLS/Examiner, Art Unit 1622
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