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
Claim Status
The amendment on August 7, 2023 is acknowledged. Claims 8-10 are canceled. Claims 1-7 have been amended. Claims 1-7 are subjected to examination.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. However, certified English copies have not been filed and therefore the examiner cannot determine if it discloses the now-claimed invention. For the purposes of applying prior art, the effective filing date is December 9, 2022, the date that PCT/CN2022/137907 was filed.
Information Disclosure Statement
Accordingly, the information disclosure statement (IDS) submitted on August 7, 2023 is being considered by the examiner.
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.
Claims 2-3 and 5-6 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. Claims 2-6 are generally narrative and indefinite, failing to conform with the current U.S. practice.
Claims 2 and 5-6 recite the term “tool drug”, which is indefinite because there is no designation for what this term stands for. Therefore, the boundary of claims 2 and 5-6 is unclear.
Claim 3 recites the term “T-drug”, which is unclear. The term “T-drug” is recited in the specification as a synonym for “tencetrinp” (see page 2; paragraph [0008]). However, it remains unclear because “tencetrip” is a tradename (Tecentriq), which is indefinite.
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 1-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wernig et al. (WO2021101966A1; hereafter PTO-892).
As to claims 1-2, Wernig teaches “The present invention provides compositions and methods useful for reducing fibrosis, by administering an effective dose of (i) an immune checkpoint blocking agent; and (ii) an IL-6 blocking agent. In some embodiments the immune checkpoint blocking agent is selected from: an agent that blocks the CD47/SIRPoc pathway; and an agent that blocks the PD-1/PD-L1 pathway. Blocking agents of interest include antibodies and variant proteins derived from an antibody that retains the complementarity determining regions of the antibody, e.g. an scFv, chimeric antigen receptor, FAb fragment, and the like. In certain embodiments a blocking agent is a soluble receptor, a dominant negative ligand, etc. Agents can inhibit a pathway by binding to and blocking either or both components of a pathway, for example a PD-1/PD-L1 blocking agent can bind to PD-1 or to PD-L1; a CD47/SIRPa blocking agent can bind to CD47 or to SIRPa, and an IL-6 blocking agent can bind to IL-6, or the IL-6 receptor, IL-6R [001]. “A method of prevention or treatment of fibrosis in a mammalian patient, the method comprising: administering a dose of (i) an immune checkpoint blocking agent; and (ii) an IL-6 blocking agent to the mammalian patient effective to reduce fibrosis” (claim 1).
Wernig also teaches “Exemplary forms of fibrosis include, but are not limited to, tumor fibrosis, cardiac fibrosis, liver fibrosis, kidney and bladder fibrosis, lung fibrosis, dermal scarring and keloids, wound healing and adhesions, post-irradiation fibrosis, fibrosis related to chronic graft v host disease (GvHD), systemic sclerosis, and Alzheimer's disease. In still further embodiments, cardiac fibrosis is associated with hypertension, hypertensive heart disease (HHD), myocardial infarction (Ml), cardiac scarring related to ischemia congestive heart failure, cardiomyopathy, post-myocardial infarction defects in heart function, atherosclerosis, and restenosis…” [0066].
As to claim 3-4, Wernig teaches “Antibodies in clinical trials against PD-1 include, for example, Pembrolizumab (Keytruda), Nivolumab (Opdivo), Cemiplimab (Libtayo), Spartalizumab (PDR001); Camrelizumab (SHR1210); Sintilimab (IBI308); Tislelizumab (BGB-A317); Toripalimab (JS 001); AMP-224, by GlaxoSmithKline; and AMP-514, by GlaxoSmithKline. Antibodies in clinical trials against PD-L1 include, for example, Atezolizumab (Tecentriq); Avelumab (Bavencio); and Durvalumab (Imfinzi)” [00100].
Wernig also teaches, “As used herein, the terms “treatment,” “treating,” and the like, refer to administering an agent, or carrying out a procedure for the purposes of obtaining an effect. The effect may be prophylactic in terms of completely or partially preventing a disease or symptom thereof and/or may be therapeutic in terms of effecting a partial or complete cure for a disease and/or symptoms of the disease. “Treatment,” as used herein, covers any treatment of fibrosis in a mammal, particularly in a human, and includes: (a) preventing the development of fibrosis; (b) inhibiting ongoing fibrosis, i.e., arresting its development; and (c) relieving fibrosis, i.e., causing regression of fibrosis” [00102].
As to claim 5-7, Wernig teaches “The terms "pharmaceutically acceptable", "physiologically tolerable" and grammatical variations thereof, as they refer to compositions, carriers, diluents and reagents, are used interchangeably and represent that the materials are capable of administration to or upon a human without the production of undesirable physiological effects to a degree that would prohibit administration of the composition” [00109]. “According to the present invention, compositions can be administered by parenteral, topical, intravenous, oral, subcutaneous, intraarterial, intracranial, intraperitoneal, intranasal, aerosol, or intramuscular means. The most typical route of administration is intravenous although other routes can be equally effective” [00122]. “Antibodies and/or polypeptides can be administered in the form of a depot injection or implant preparation which can be formulated in such a manner as to permit a sustained release of the active ingredient. An exemplary composition comprises polypeptide at 1 mg/ml, formulated in aqueous buffer consisting of 10 mM Tris, 210 mM sucrose, 51 mM L-arginine, 0.01% polysorbate 20, adjusted to pH 7.4 with HCI or NaOH” [00123].
Conclusion
No claim is allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PRICILA HAUK TEODORO whose telephone number is (571) 272-2784. The examiner can normally be reached M-F 6:15AM-3:15PM.
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/PRICILA NMN HAUK TEODORO/Examiner, Art Unit 1645
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1644