DETAILED ACTION
Notice of Pre-AIA or AIA Status
The inventor or joint inventor should note that the instant invention, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-15 are pending in the instant invention. According to the Amendments to the Claims, filed June 12, 2023, claims 9 and 11-15 were amended.
Status of Priority
This invention is a 35 U.S.C. § 371 National Stage Filing of International Application No. PCT/CN2022/082684, filed March 24, 2022, which claims priority under 35 U.S.C. § 119(a-d) to CN 202110357313.2, filed April 1, 2021.
Restrictions / Election of Species
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The inventor’s or joint inventor’s provisional election of the following, without traverse, in the reply filed on November 24, 2025, is acknowledged: a) Group I - claims 1-9; and b) substituted benzo[d][1,3]dioxole of formula (I) - p. 4, compound I-11, shown to the right below, and hereafter referred to as (R)-N-(7-(1-(1-acryloylpiperidin-3-yl)-4-amino-1H-pyrazolo[3,4-d]-pyrimidin-3-yl)benzo[d][1,3]dioxol-4-yl)-4-(tert-butyl)benzamide, where m = 0; n = 1; A = -NHC(O)-; R1 is shown to the left, wherein p = 0, Y1 = CR5, where R5 = -H, Y2 = CR5, where R5 = -H, Y3 = CR5, where R5 = -H, Y4 = CR5, where R5 = -H, and R4 = -C(CH3)3; R3 = -H; and X = N. Claims 1, 3-7 and 9 read on the elected species. Affirmation of
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this election must be made by the inventor or joint inventor in replying to this Office action.
Similarly, the inventor or joint inventor should further note that the requirement is still deemed proper and is therefore made FINAL.
Likewise, the inventor or joint inventor should further note that the elected species, shown to the right, was found to be free of the prior art. Thus, the examiner has expanded the forthcoming prosecution to include all claims relevant to the genus of Group I, for a first Office action and prosecution on the merits.
Moreover, the inventor or joint inventor should further note that claims 10-15 were withdrawn from further consideration, pursuant to 37 CFR 1.142(b), as being drawn to a nonelected or cancelled invention, there being no allowable generic or linking claim.
Thus, a first Office action and prosecution on the merits of claims 1-9 is contained within.
Specification Objection - Disclosure
The following guidelines illustrate the preferred layout for the specification of a utility application. These guidelines are suggested for the inventor’s or joint inventor’s use.
Arrangement of the Specification
As provided in 37 CFR 1.77(b), the specification of a utility invention should include the following sections in order. Each of the lettered items should appear in upper case, without underlining or bold type, as a section heading. If no text follows the section heading, the phrase Not Applicable should follow the section heading:
(a) TITLE OF THE INVENTION.
(b) CROSS-REFERENCE TO RELATED APPLICATIONS.
(c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR
DEVELOPMENT.
(d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT.
(e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A
COMPACT DISC.
(f) BACKGROUND OF THE INVENTION.
(1) Field of the Invention.
(2) Description of Related Art (including information disclosed under 37 CFR 1.97
and 1.98).
(g) BRIEF SUMMARY OF THE INVENTION.
(h) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S).
(i) DETAILED DESCRIPTION OF THE INVENTION.
(j) CLAIM OR CLAIMS (commencing on a separate sheet).
(k) ABSTRACT OF THE DISCLOSURE (commencing on a separate sheet).
(l) SEQUENCE LISTING (See MPEP § 2424 and 37 CFR 1.821-1.825).
The inventor or joint inventor is advised to format the specification according to 37 CFR 1.77(b) above and 37 CFR 1.77(c). Revisions should particularly include and/or address: a) section headings (b-i), where applicable; and b) bold-type, underline, and/or upper case formatting. Appropriate correction may be required.
Specification Objection - Title
The inventor or joint inventor is reminded of the proper content of the title of the invention.
The title of the invention should be brief, but technically accurate and descriptive and should contain fewer than 500 characters. See 37 CFR 1.72(a) and MPEP § 606.
The title of the invention is not technically accurate and descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. In the revised title, the examiner suggests additionally identifying a particular utility for the substituted benzo[d][1,3]-dioxoles of the formula (I).
The following title is suggested: SUBSTITUTED BENZO[d][1,3]DIOXOLES AS BTK AND/OR JAK3 KINASE INHIBITORS.
Appropriate correction is required.
Specification Objection - Abstract
The inventor or joint inventor is reminded of the proper content of an abstract of the disclosure.
With regard particularly to chemical patents, for compounds or compositions, the general nature of the compound or composition should be given as well as the use thereof, e.g., The compounds are of the class of alkyl benzene sulfonyl ureas, useful as oral anti-diabetics. Exemplification of a species could be illustrative of members of the class. For processes, the reactions, reagents and process conditions should be stated, generally illustrated by a single example, unless variations are necessary. See MPEP § 608.01(b), Section B.
The abstract of the disclosure is objected to because it fails to exemplify any clear members or formulae illustrative of its class. Correction is required. See MPEP § 608.01(b).
The examiner suggests incorporating a clear structure of formula (I) into the abstract, to overcome this objection.
Claim Objections
Claim 1 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b), the existing recitation should be replaced with the following recitation:
A compound of formula (I):
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(I)
or a pharmaceutically acceptable salt or stereoisomer thereof,
wherein:
A represents -NHC(O)-, -NHC(O)CH2-, -NHS(O)2-, -O-, or -S-;
R1 represents:
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,
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,
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, or
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;
Y1 represents CR5 or N;
Y2 represents CR5 or N;
Y3 represents CR5 or N;
Y4 represents CR5 or N;
each R5 independently represents H, F, Cl, Br, I, CN, CH3, CF3, OH, OCH3, or OCF3;
Z represents -NR6-, -O-, or -S-;
R6 represents H, CH3, CH2CH3, or cyclopropyl;
each R4 independently represents H, F, Cl, Br, I, CN, NO2, C1-C6 alkyl, CF3, C(O)NH2, C(O)NHCH3, C(O)NHCH2CF3, NH2, NHC1-C6 alkyl, NHC(O)CH3, N(CH3)2, N(CH2CH3)2, OH, OC1-C6 alkyl, OCF3, OCH2CH2OCH3, pyrrolidin-1-yl, piperazin-1-yl, 4-methylpiperazin-1-yl, morpholin-4-yl, or phenyl;
X represents CH or N;
m represents 0 or 1;
n represents 0 or 1;
R2 represents H, Cl, Br, or CN; and
R3 represents H, C1-C6 alkyl, or C2-C6 heterocycloalkyl;
wherein the C2-C6 heterocycloalkyl is a saturated 4-, 5-, or 6-membered ring containing one, two, or three heteroatoms or heteroatomic groups independently selected from the group consisting of N, NH, O, and S; and
wherein the C1-C6 alkyl or C2-C6 heterocycloalkyl is substituted with one or more substituents independently selected from the group consisting of NH2, NHCH3, NHC(O)CH3, OH, and OCH3.
Appropriate correction is required. See MPEP § 2173.02.
Claim 2 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The compound according to claim 1, or a pharmaceutically acceptable salt or stereoisomer thereof, wherein:
A represents -NHC(O)-, or -NHS(O)2-;
m represents 1;
n represents 0;
R2 represents H; and
R3 represents H.
Appropriate correction is required. See MPEP § 2173.02.
Claim 3 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The compound according to claim 1, or a pharmaceutically acceptable salt or stereoisomer thereof, wherein:
A represents -NHC(O)-, or -NHS(O)2-;
m represents 0;
n represents 1;
R2 represents H; and
R3 represents H.
Appropriate correction is required. See MPEP § 2173.02.
Claim 4 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The compound according to claim 1, wherein the compound is of formula (II):
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(II)
or a pharmaceutically acceptable salt thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim 5 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b), the existing recitation should be replaced with the following recitation:
The compound according to claim 4, or a pharmaceutically acceptable salt thereof, wherein R1 represents:
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, or
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;
R8 represents H, Cl, or CH3; and
each R7 independently represents H, F, Cl, Br, CN, CH3, C(CH3)3, CF3, C(O)NH2, C(O)NHCH3, C(O)NHCH2CF3, NH2, NHC(O)CH3, N(CH3)2, N(CH2CH3)2, OH, OCH3, OCF3, pyrrolidin-1-yl, 4-methylpiperazin-1-yl, morpholin-4-yl, or phenyl.
Appropriate correction is required. See MPEP § 2173.02.
Claim 6 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The compound according to claim 5, or a pharmaceutically acceptable salt thereof, wherein:
R8 represents Cl; and
each R7 independently represents H, Cl, CH3, C(CH3)3, CF3, C(O)NHCH2CF3, N(CH3)2, N(CH2CH3)2, or OCH3.
Appropriate correction is required. See MPEP § 2173.02.
Claim 7 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
A compound selected from the group consisting of:
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I-1,
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I-2,
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I-3,
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I-4,
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I-5,
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I-6,
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I-7,
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I-8,
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I-9,
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I-10,
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I-11,
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I-12,
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I-13,
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I-14,
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I-15,
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I-16,
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I-17,
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I-18,
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I-19,
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I-33, and
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I-34,
or a pharmaceutically acceptable salt thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim 8 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The compound according to claim 1, or a pharmaceutically acceptable salt or stereoisomer thereof, wherein the pharmaceutically acceptable salt is an acid addition salt selected from the group consisting of an acetic acid addition salt, a benzenesulfonic acid addition salt, a carbonic acid addition salt, a citric acid addition salt, a ferulic acid addition salt, a hydrobromic acid addition salt, a hydrochloric acid addition salt, a lactic acid addition salt, a maleic acid addition salt, a methanesulfonic acid addition salt, an oxalic acid addition salt, a phosphoric acid addition salt, a pyruvic acid addition salt, a succinic acid addition salt, a sulfuric acid addition salt, a tartaric acid addition salt, and a p-toluenesulfonic acid addition salt.
Appropriate correction is required. See MPEP § 2173.02.
Claim 9 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
A pharmaceutical composition comprising a pharmaceutically acceptable carrier and a compound according to claim 1, or a pharmaceutically acceptable salt or stereoisomer thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim Rejections - 35 U.S.C. § 112(b)
The following is a quotation of the second paragraph of 35 U.S.C. § 112:
(b) CONCLUSION. The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or joint inventor regards as the invention.
Claims 5 and 6 are rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that claim 5 recites the limitation, The compound… according to claim 4, wherein R1 represents… 1,2,3,4-tetrahydronaphthalen-5-yl-R7, in lines 1-4 of the claim. There is insufficient antecedent basis, in claim 4, for this limitation, with respect to the substituted benzo[d][1,3]dioxoles of the formula (II). According to claim 1, R1 is not recited as 1,2,3,4-tetrahydronaphthalen-5-yl, with respect to the substituted benzo[d][1,3]-dioxoles of the formula (I).
Moreover, the inventor or joint inventor should further note that [C]laims which depend from indefinite claims are also indefinite. {See Ex parte Cordova, 10 USPQ 2d 1949, 1952 (PTO Bd. App. 1989)}.
The examiner suggests amending the claims, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim 7 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that claim 5 recites the limitation, The compound… according to claim 1, wherein the compound is… I-8, I-20, I-27, I-33, and I-34, in lines 1-4 of the claim. There is insufficient antecedent basis, in claim 1, for this limitation, with respect to the substituted benzo[d][1,3]dioxoles of the formula (I). According to claim 1, the aforementioned species are not recited as substituted benzo[d][1,3]dioxoles of the formula (I), particularly with regard to the following: I-8 (R5), I-20 (R1), I-27 (R3), I-33 (R5), and I-34 (R5), respectively.
The examiner suggests amending the claim, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Allowable Subject Matter
No claims are allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOUGLAS M. WILLIS, whose telephone number is 571-270-5757. The examiner may normally be reached on Monday thru Thursday from 8:00-6:00 EST. The examiner is also available on alternate Fridays.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mr. Jeffrey Murray, may be reached on 571-272-9023. The fax phone number for the organization where this invention or proceeding is assigned is 571-273-8300.
Information regarding the status of an invention may be obtained from Patent Center. For more information about Patent Center, see https://www.uspto.gov/patents/apply/patent-center. Should you have questions on access to Patent Center, contact the Patent Electronic Business Center (PEBC) at 866-217-9197 (toll-free) or ebc@uspto.gov.
/DOUGLAS M WILLIS/
Primary Examiner, Art Unit 1624