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
Election of Species and Status of the Claims
Applicant’s election of (S)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetrahydropyrazolo-[1,5-a]pyrimidine-3-carboxamide as the single specific BTK inhibitor, tacrolimus as the single specific immune-suppressant, and kidney and chronic active antibody-mediated rejection as the single antibody-mediated rejection in the response filed on January 6th 2026 is acknowledged. Claims 1-13 are pending. Claim 3 is withdrawn from further consideration as being directed towards nonelected species until a generic claim has been found allowable. Claims 1-2 and 4-13 are examined on their merits.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statements filed on November 26th 2025, November 26th 2024, and November 10th 2023 are in compliance with the provisions of 37 CFR 1.97 and has been considered in full. A signed copy of references cited from the IDS is included with this Office Action.
Duplicate Claims
Applicant is advised that should claim 8 be found allowable, claim 9 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 § 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.
Claims 1-2, 4-7, and 12-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lederman (WO2021001458A1 published on January 7th 2021).
Claims 1, 12, and 13 are directed towards a method for treating or preventing antibody-mediated rejection (AMR) in a subject having an organ transplant, comprising administration of applicant’s elected species of:
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a BTK inhibitor known in the art as Zanubrutinib.
Lederman teaches the treatment of transplant rejection in a subject (Lederman, pg. 171, claim 65), and that the transplant rejection is chronic humoral rejection (also known as chronic antibody-mediated rejection) (Lederman, pg. 171, claim 66) via administration of a composition that includes Zanubrutinib (Lederman, pg. 175, claim 95). Lederman thereby anticipates claims 1, 12, and 13.
Claim 2 requires that, in the method of claim 1, the subject has undergone an organ transplant and exhibits symptoms of AMR. Lederman teaches the treatment of AMR (humoral rejection) in a patient who has received an organ transplant (Lederman, pg. 171, claim 66), and that such a treatment comprises administration to patients who have exhibited symptoms of antibody-mediated rejection (Lederman, pg. 43, paragraph [0105]).
Claim 4 requires that, in the method of claim 1, the organ transplanted is the kidney. Lederman teaches treatment of rejection of a kidney transplant (Lederman, pg. 172, claim 69), anticipating claim 4.
Claims 5 and 6 require that, in the method of claim 1, the antibody-mediated rejection is chronic antibody-mediated rejection. Lederman teaches the treatment of chronic humoral rejection (also known as chronic antibody-mediated rejection) (Lederman, pg. 171, claim 66), anticipating claims 5 and 6.
Claim 7 is directed towards the method of claim 1, wherein the organ is a kidney and the symptoms of chronic antibody-mediated rejection comprise particular histological characteristics (note that the claim, as written, does not require that the patient receiving treatment exhibits said symptoms). Lederman teaches treatment of rejection of a kidney transplant (Lederman, pg. 172, claim 69) via administration of a composition that includes Zanubrutinib (Lederman, pg. 175, claim 95). Lederman thereby anticipates claim 7.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over Lederman (WO2021001458A1 published on January 7th 2021).
Claims 8-11 require that, in the method of claim 1, the BTK inhibitor is administered alongside an immune-suppressant, such as tacrolimus.
As stated in the above 102 rejection for claim 1, Lederman teaches the BTK inhibitor, Zanubrutinib, for the treatment of antibody-mediated rejection (Lederman, pg. 171, claim 66; pg. 175, claim 95). Lederman similarly teaches tacrolimus for the treatment of antibody-mediated rejection (Lederman, pg. 171, claim 66; pg. 175, claim 95). Lederman does not explicitly teach the combination of Zanubrutinib and tacrolimus. However, one of ordinary skill in the art would recognize that the two drugs, known in the art for the treatment of antibody-mediated rejection, could be used together for the same purpose. See MPEP 2144.06(I):
I. COMBINING EQUIVALENTS KNOWN FOR THE SAME PURPOSE
"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious); and In re Couvaras, 70 F.4th 1374, 1378-79, 2023 USPQ2d 697 (Fed. Cir. 2023) (That the two claimed types of active agents, GABA-a agonists and ARBs, were known to be useful for the same purpose—alleviating hypertension—alone can serve as a motivation to combine).
As one of ordinary skill in the art would have a reasonable expectation of success in treating antibody-mediated rejection with a combination of Zanubrutinib (applicant’s elected BTK inhibitor) and tacrolimus (applicant’s elected immunosuppressant), claims 8-11 are prima facie obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anthony Seitz whose telephone number is (703)756-4657. The examiner can normally be reached 7:30 AM ET - 5:00 PM ET M-F.
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/A.J.S./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629