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
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 invention after final rejection. Since this invention 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in 37 CFR 1.17(e) has been timely paid, the finality of the Final Rejection, mailed on February 25, 2026, has been withdrawn pursuant to 37 CFR 1.114. The inventor’s or joint inventor’s submission, filed on June 22, 2026, has been entered.
Claims 5-7, 11-15, 25-30 and 33-37 are pending in the instant invention. According to the In The Claims, filed June 22, 2026, claims 11 and 30 were amended, claims 1-4, 8-10, 16-24, 31 and 32 were cancelled and claims 33-37 were added.
Status of Priority
This invention is a 35 U.S.C. § 371 National Stage Filing of International Application No. PCT/JP2020/047370, filed December 18, 2020, which claims priority under 35 U.S.C. § 119(a-d) to JP 2019-229171, filed December 19, 2019.
Status of Restrictions / Election of Species
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The inventor’s or joint inventor’s affirmation of the following election, with traverse, in the reply filed on January 13, 2026, is acknowledged: a) Group II - claims 11, 12, 30 and 33-37; and b) substituted heteroaryl of the formula (I) - p. 47, compound (13).
Similarly, the inventor or joint inventor should further note that the requirement was made FINAL in the Non-Final Rejection, mailed on September 15, 2025.
Likewise, the inventor or joint inventor should further note that claim 11 is directed to an allowable method for treating chronic glomerulonephritis in a subject, wherein the method comprises administering to the subject in need thereof a therapeutically effective amount of (R)-1-(1-acryloylpiperidin-3-yl)-4-amino-N-(benzo[d]oxazol-2-yl)-1H-pyrazolo[3,4-d]pyrimidine-3-carboxamide. Pursuant to the procedures set forth in MPEP § 821.04(a), the restriction requirement as set forth in the Office action, mailed on April 1, 2025, has been reconsidered in view of the allowability of claims to the method for treating chronic glomerulonephritis in a subject, wherein the method comprises administering to the subject in need thereof a therapeutically effective amount of (R)-1-(1-acryloylpiperidin-3-yl)-4-amino-N-(benzo[d]oxazol-2-yl)-1H-pyrazolo[3,4-d]pyrimidine-3-carboxamide.
Next, the inventor or joint inventor should further note that (i) claims 5-7 and 13-15, directed to the invention of Group I, drawn to (a) a pharmaceutical composition comprising a substituted heteroaryl of the formula (I) and (b) substituted heteroaryls of the formula (I); and (ii) claims 25-29, directed to the invention of Group III, drawn to a method for inhibiting a decrease in renal function, comprising: administering… a substituted heteroaryl of the formula (I), respectively, which were previously withdrawn from consideration as a result of the restriction requirement as set forth in the Office action, mailed on April 1, 2025, do not require all the limitations of the allowable method for treating chronic glomerulonephritis in a subject, wherein the method comprises administering to the subject in need thereof a therapeutically effective amount of (R)-1-(1-acryloylpiperidin-3-yl)-4-amino-N-(benzo[d]oxazol-2-yl)-1H-pyrazolo[3,4-d]pyrimidine-3-carboxamide, and thus have NOT been rejoined.
Then, the inventor or joint inventor should further note that the restriction requirement as set forth in the Office action, mailed on April 1, 2025, is hereby maintained.
Moreover, the inventor or joint inventor should further note that claims 5-7, 13-15 and 25-29 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.
Furthermore, the inventor or joint inventor should also note that the sections of U.S.C. Title 35 that formed the basis of prior rejections formulated, as well as any references supporting said rejections, that are not included with this Office action, may be found in either the Non-Final Rejection, mailed on September 15, 2025, or the Final Rejection, mailed on February 25, 2026.
Also, the inventor or joint inventor should further note that any rejections and/or objections of record not explicitly addressed herein below, are hereby withdrawn, in light of the inventor’s or joint inventor’s arguments and/or the In The Claims, filed June 22, 2026.
Thus, a third Office action and prosecution on the merits of claims 11, 12, 30 and 33-37 is contained within.
New Claim Objections
Claim 11 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
A method for treating chronic glomerulonephritis in a subject, wherein the method comprises administering to the subject in need thereof a therapeutically effective amount of a compound having the following formula:
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or a pharmaceutically acceptable salt thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim 12 is objected to because of the following informalities: for clarity, the claim is dependent upon an objected base claim. Appropriate correction is required.
Claim 30 is objected to because of the following informalities: for clarity, the claim is dependent upon an objected base claim. Appropriate correction is required.
Claim 33 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 method for inhibiting the production of inflammatory cytokines by immunoglobulin G (IgG) in a subject, wherein the method comprises administering to the subject in need thereof a therapeutically effective amount of a compound having the following formula:
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or a pharmaceutically acceptable salt thereof;
wherein the inflammatory cytokines produced by IgG form a polymer immune complex; and
wherein the polymer immune complex is mediated by an immune complex-FCg receptor.
Appropriate correction is required. See MPEP § 2173.02.
Claim 35 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:
The method according to claim 30, wherein the pharmaceutically acceptable salt is a fumarate salt.
Appropriate correction is required. See MPEP § 2173.02.
Claim 36 is objected to because of the following informalities: for clarity, the claim is dependent upon an objected base claim. Appropriate correction is required.
Claim 37 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:
The method according to claim 36, wherein the pharmaceutically acceptable salt is a fumarate salt.
Appropriate correction is required. See MPEP § 2173.02.
New 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.
Claim 34 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 34 recites the limitation, The method of claim 33, wherein the chronic glomerulonephritis is immunoglobulin A (IgA) nephropathy or purpura nephritis, in lines 1-2 of the claim. There is insufficient antecedent basis, in claim 33, for this limitation, with respect to the method for inhibiting the production in a subject of inflammatory cytokines by IgG. According to claim 33, chronic glomerulonephritis is not recited, with respect to the method for inhibiting the production in a subject of inflammatory cytokines by IgG.
The examiner suggests cancelling the claim, 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
Prosecution Insights