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
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/06/2025 has been entered.
The Amendment filed 10/06/2025, amended claims 1 and 33.
Claims 1-51 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the examination is restricted to the elected species only, and claims not reading on the elected species are held withdrawn.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 10/06/2025 Amendment amended the definition of q and m from 0-1 to 1, and deleted “H” from the R1 Markush group. As such, the species searched and examined in the previous Office Action does not read on the amended claims; the search has been extended as detailed in the following prior art rejection.
Claims 3, 5-11, 13, 16-22, 25, 27-31 and 34-51 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and non-elected subject matter, there being no allowable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, 14-15, 23-24, 26, and 32-33 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.
35 U.S.C. § 102
Applicant’s amendments to claim 1 are sufficient to overcome this rejection, since claim 1 amended definition of q and m from 0-1 to 1, and deleted “H” from the R1 Markush group.
NEW REJECTIONS
Applicant’s amendment to independent claim 1, which modifies the definition of q and m from 0-1 to 1, and deletes “H” from the R1 Markush group, has resulted in the below new prior art rejections.
Specification
(New) The disclosure is objected to because of the following informalities:
-On pgs. 46-178 of the specification, the majority of the compounds are blurry and illegible. These compounds should be replaced with clear structures.
Appropriate correction is required.
Claim Objections
(New) Claims 1 and 33 is objected to because of the following informalities:
-In claim 1, to clarify the Markush group members in the definition of R1, “C1-6 alkyl and C3-6 cycloalkyl which are optionally substituted with 1, 2 or 3 independently selected R50 groups; or a 3-10 membered heterocycloalkyl having 1-3 ring atoms,” should be replaced with - -C1-6 alkyl optionally substituted with 1, 2 or 3 independently selected R50 groups; C3-6 cycloalkyl optionally substituted with 1, 2 or 3 independently selected R50 groups; or a 3-10 membered heterocycloalkyl having 1-3 ring atoms- -
-In claim 33, the majority of the compounds are blurry. These compounds should be replaced with clear structures.
Appropriate correction is required.
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.
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.
(New) Claims 1-2, 4, 12, 14-15, 23-24, 26, and 32 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, in the definition of R1, the phrase “which optionally comprises a –(C=O)- group or -S(=O)2- group in the ring,” renders the claim indefinite because it is not clear if the heterocycloalkyl ring comprises a substituent group of –(C=O)- group or -S(=O)2-, or if a carbon atom or a sulfur atom in the heterocycloalkyl group contain an =O group or (=O)2 group, respectively.
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.
(New) Claims 1-2, 4, 12, 14, 23, 26, and 32 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by WO 2005/026137 to Miller (published 2005, IDS of 10/06/2025).
Miller teaches modulators of ATP-Binding Cassette Transporters (title, abstract).
Miller teaches the following compounds:
1)
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, which meets the limitations of instant Formula (I) when:
W is –(L1)p-A2,
L1 is CH2,
p is 1,
A2 is a C6 aryl substituted with 1 R60 group, wherein R60 is the halogen Cl,
R1 is C3 alkyl substituted with 1 R50 group, wherein R50 is a 6-membered heterocycloalkyl having one nitrogen ring heteroatom, i.e., a piperidine ring,
A1 is ring system 1, and
RA is absent;
"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.
(New) Claims 1-2, 4, 12, 15, 23-24, 26, and 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN File Registry No. 2062351-25-9 (published 2017, PTO-892).
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which is E038 in instant claim 33, and meets the limitations of instant Formula (I) when:
W is –(L1)p-A2,
L1 is CH2,
p is 1,
A2 is a C6 aryl substituted with 1 R60 group, wherein R60 is the halogen F,
R1 is C5 cycloalkyl substituted with 1 R50 group, wherein R50 is a hydroxy
A1 is ring system 1, and
RA is absent.
"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 2062351-25-9 is available as prior art as of 01/31/2017, 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.
Response to Arguments
Since the Amendment to the claims necessitated the new grounds of rejection, the arguments filed 10/06/2025, directed toward the Kanao prior art reference, are not relevant to the above prior art rejections (see Remarks pgs. 32-34).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
(New) Claims 1-2, 4, 12, 14-15, 23-24, 26, 32-33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of copending Application No. 19/349,768 (claim set dated 10/03/2025, reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘768 claims a composition comprising a compound of instant Formula (I) (claim 1).
‘768 claims the compounds of instant claim 33 (claim 33 of ‘768).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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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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