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
Applicant’s amendment filed March 4, 2024 was received and entered.
Claims 8-11, 13-18, 20-33, and 42-50 have been canceled.
Claims 19 and 34-39 have been amended.
Claims 1-7, 12, 19, and 34-41 are pending and under consideration.
Priority
This application is a 371 of PCT/US2022/016218 filed February 11, 2022, which claims priority to U.S. Provisional Application No. 63/148,567 filed February 11, 2021.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. However, Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of previous application 63/148,567 fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Claims 1-7 are drawn to the amino acid sequences (SEQ ID NOs) for the CDR regions of the instantly claimed anti-ROR1 antibodies.
Prior application 63/148,567 has proper support for instant claim 41. However, prior application 63/148,567 does not recite any amino acid sequences for the anti-ROR1 antibody CDR regions. The first occurrence the SEQ ID NOs as recited is in PCT/US2022/016218. Therefore, claims 1-7, 12, 19, and 34-40 of the instant application are not entitled to the benefit of the prior application date of February 11, 2021.
Should Applicant disagree with the examiner’s factual determination as to the disclosure of the various sequences, Applicant may point out the particular places within applications 63/148,567 which discloses the sequences.
Accordingly, PCT/US2022/016218 with the filing date of February 11, 2022 will be used for the purpose of applying art for claims 1-7, 12, 19, and 34-40. And 63/148,567 with the filing date of February 11, 2021 will be used for the purpose of applying art for claim 41.
Claim Objections
Claims 34 and 36-41 are objected to for the following informalities:
Claims 34 and 40 - the following terms in the claims should read as Burkitt’s lymphoma, acute myeloid leukemia (AML), and B-cell acute lymphoblastic leukemia (B-ALL).
Claims 36-39 - recite “an anti-ROR1 antibody of claim 1”, however, should read “the anti-ROR1 antibody of claim 1”.
Claim 41 part (iii) - “ROR 1” should read “ROR1”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claim 41 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 41 is drawn to a method of identifying an anti-ROR1 antibody comprising contacting said antibody with an ROR1 polypeptide not comprising a threonine corresponding to position 346 of SEQ ID NO: 30, wherein the antibodies that do not bind to the ROR1 polypeptide with a substitution at position 346 of SEQ ID NO: 30 are anti-ROR1 antibodies.
The instant specification discloses that the antibodies were screened by substituting the threonine at position 346 of human ROR1 with serine, corresponding to position 346 of mouse ROR1. It is unclear whether any amino acid substitution would produce the same result (i.e., not binding to SEQ ID NO: 30) as contacting said antibody with a second ROR1 polypeptide that corresponds to the mouse ROR1 polypeptide (SEQ ID NO: 31).
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 34 and 40 are rejected under 35 U.S.C. 112(a) because the specification, while being enabling for an anti-ROR1 antibody binding to a B cell leukemia cell, a mantle cell lymphoma (MCL) cell, a Burkitt's lymphoma cell, a chronic lymphocytic leukemia (CLL) cell, an acute myeloid leukemia (AML) cell, a B-cell acute lymphoblastic leukemia (B-ALL) cell, a (T-ALL) cell, a renal cancer cell, a colon cancer cell, a breast cancer cell, an ovarian cancer cell, a lung cancer cell, a skin cancer cell, a pancreatic cancer cell, a testicular cancer cell, a bladder cancer cell, a uterine cancer cell, a prostate cancer cell, or an adrenal cancer cell; and administering the recited antibody for the treatment of B cell leukemia, mantle cell lymphoma (MCL), Burkitt's lymphoma, chronic lymphocytic leukemia (CLL), acute myeloid leukemia (AML), B-cell acute lymphoblastic leukemia (B-ALL), T-cell acute lymphoblastic leukemia (T-ALL), renal cancer, colon cancer, breast cancer, ovarian cancer, lung cancer, skin cancer, pancreatic cancer, or adrenal cancer, does not reasonable provide enablement for:
A method of binding any lymphoma cell or treating any lymphoma with the recited anti-ROR1 antibody.
The specification disclosure is insufficient to enable one skilled in the art to practice the invention as claimed without an undue amount of experimentation. Undue experimentation must be considered in light of factors including: the breadth of the claims, the nature of the invention, the state of the prior art, the level of one of ordinary skill in the art, the level of predictability of the art, the amount of direction provided by the inventor, the existence of working examples, and the quantity of experimentation needed to make or use the invention, in re Wands, 858 F.2d at 737, 8 USPQ2d at 1404 (Fed. Cir. 1988).
“The amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art.” In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). The “amount of guidance or direction” refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast, if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling (MPEP 2164.03). The MPEP further states that physiological activity can be considered inherently unpredictable.
The instant claims are directed to a method of treatment of various cancers comprising administering to a subject an anti-ROR1 antibody that specifically binds ROR1 expressed on the surface of many cancer cells. The state of the art is such that several anti-ROR1 antibodies and anti-ROR1 ADCs have been identified as an effective therapeutic for the treatment of many cancers including ALL, AML, breast, bladder, gastric, and multiple myeloma [see Peng (2021), Table 1]. However, the instant claims broadly encompass treating any lymphoma by binding of the anti-ROR1 antibody to any lymphoma cell. The state of the art is such that ROR1 has been identified as a marker for specific B-cell neoplasm subsets, not all lymphomas. For example, as taught by Silva et al. (2024), that although tumor samples from mantle cell lymphoma, triple negative breast cancer, and diffuse large B-cell lymphoma tested positive for ROR1 expression, all acute myeloid leukemia (n=52) and most T-cell non-Hodgkin lymphoma (n=31/32) tested samples were negative for ROR1 via IHC [Abstract].
Thus, given the unpredictability of the art and the breadth of the claims, the instant specification must provide a sufficient an enabling disclosure commensurate in scope with the instant claims. The specification provides guidance for using an anti-ROR1 antibody for treating several cancers associated with ROR1 overexpression. The specification does not provide any guidance or examples for an anti-ROR1 antibody binding all subsets of lymphoma cells or treating all lymphomas, as broadly encompassed by the instant claims. Thus, given the unpredictability of the art and the lack of guidance provided by the instant specification, it would require undue experimentation to practice the method as broadly claimed.
Allowable Subject Matter
The following is an examiner’s statement of reasons for allowance:
Claims 1-7 are drawn to an anti-ROR1 antibody comprising a heavy chain variable domain and a light chain variable domain, wherein said heavy chain variable domain comprises:
CDR H1 of SEQ ID NO:36, CDR H2 of SEQ ID NO:38, CDR H3 of SEQ ID NO:40, CDR L1 of SEQ ID NO:43, CDR L2 of SEQ ID NO:45, and CDR L3 of SEQ ID NO:47; or
CDR H1 of SEQ ID NO:64, CDR H2 of SEQ ID NO:66, CDR H3 of SEQ ID NO:68, CDR L1 of SEQ ID NO:71, CDR L2 of SEQ ID NO:73, and CDR L3 of SEQ ID NO:7; or
CDR H1 of SEQ ID NO:78, CDR H2 of SEQ ID NO:80, CDR H3 of SEQ ID NO:82, CDR L1 of SEQ ID NO:85, CDR L2 of SEQ ID NO:87, and CDR L3 of SEQ ID NO:89; or
CDR H1 of SEQ ID NO:92, CDR H2 of SEQ ID NO:94, CDR H3 of SEQ ID NO:96, CDR L1 of SEQ ID NO:99, CDR L2 of SEQ ID NO:101, and CDR L3 of SEQ ID NO:103; or
CDR H1 of SEQ ID NO:106, CDR H2 of SEQ ID NO:108, CDR H3 of SEQ ID NO:110, CDR L1 of SEQ ID NO: 113, CDR L2 of SEQ ID NO: 115, and CDR L3 of SEQ ID NO: 117; or
CDR H1 of SEQ ID NO:50, CDR H2 of SEQ ID NO:52, CDR H3 of SEQ ID NO:54, CDR L1 of SEQ ID NO:57, CDR L2 of SEQ ID NO:59, and CDR L3 of SEQ ID NO:61; or
CDR H1 of SEQ ID NO: 120, CDR H2 of SEQ ID NO: 122, CDR H3 of SEQ ID NO: 124, CDR L1 of SEQ ID NO:127, CDR L2 of SEQ ID NO:129, and CDR L3 of SEQ ID NO:131.
Claim 12 further defines the anti-ROR1 antibody with the CDR sequences recited in embodiment 1) as having a heavy chain variable domain amino acid sequence of SEQ ID NO:2 and a light chain variable domain amino acid sequence of SEQ ID NO:4.
The amino acid sequences for all 7 claimed anti-ROR1 antibody CDR regions are free of prior art. The closest prior art to the claimed amino acid sequences, U.S. Patent No. 11,312,787, is directed towards an anti-ROR1 scFv, however, does not teach or suggest the amino acid sequences of the CDR regions of the presently claimed anti-ROR1 antibodies.
Conclusion
Claims 1-7, 12, 19, and 35 are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAUREEN DRISCOLL whose telephone number is (571) 270-0730. The examiner can normally be reached Monday through Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached on (571) 270-3503. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/MAUREEN VARINA DRISCOLL/ Examiner, Art Unit 1644
/SAMIRA J JEAN-LOUIS/ Supervisory Patent Examiner, Art Unit 1642