DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s amendment, filed 05/24/2024, has been entered.
Claims 1-39 have been canceled.
Claims 40-64 are pending and currently under examination as they read on a method of treating a condition comprising administering a cell that expresses a chimeric receptor comprising an extracellular domain that comprises a partial sequence of B-cell activating factor (BAFF).
Independent Claim
Claim 40. A method of treating a condition in a patient in need thereof, the method comprising administering to the patient a cell that expresses a chimeric receptor, wherein the chimeric receptor comprises, from N-to-C terminus:
(a) an extracellular domain that comprises: (i) a B-cell activating factor (BAFF) partial sequence consisting of an amino acid sequence with at least 90% sequence identity to SEQ ID NO: 3, and (ii) a hinge domain;
(b) a transmembrane domain;
(c) a CD28 intracellular domain; and
(d) an OX40 intracellular domain.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 40-43, 45-64 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding the instant claim limitations, the specification does not appear to provide an adequate written description for a genus of BAFF partial sequence consisting of an amino acid sequence with at least 90% sequence identity to SEQ ID NO: 3 because there is a lack of sufficient written description to support the genus of polypeptides encompassed by the limitation. The standard for Written Description is met by "showing that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics ... i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics." See Enzo Biochem., Inc. v. Gen-Probe Incorporated 323 F.3d 956 (Fed. Cir. 2002). The present claims are drawn to a genus of BAFF polypeptides consisting of 90% sequence identity with SEQ ID NO: 3. Furthermore, the claims require said genus to have the function of binding to BCMA, TACI and BAFF-R, a feature essential to the instant invention.
The fact that two polypeptides that are homologous in structure or share certain degrees of identity in sequence does not in and of itself required that the two sequences share any functional activity such as promoting quiescent state. In the absence of sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, the claimed invention is not described in such a way as to reasonably convey to one skilled in the relevant art that the inventors, at the time the application was filed, had possession of all the BAFF polypeptide variants to have the function of binding BCMA, TACI and BAFF-R.
A person of skill is well aware, at the time of the invention was made, that different molecules, even with sequence similarity, do not necessarily have the same function. For example, Attwood (Science 290: 471-473, 2000) teaches that “[i]t is presumptuous to make functional assignments merely on the basis of some degree of similarity between sequences. Similarly, Skolnick et al. (Trends in Biotech. 18: 34-39, 2000) teach that the skilled artisan is well aware that assigning functional activities for any particular protein or protein family based upon sequence homology is inaccurate, in part because of the multifunctional nature of proteins (e.g., "Abstract" and "Sequence-based approaches to function prediction", page 34). Even in situations where there is some confidence of a similar overall structure between two proteins, only experimental research can confirm the artisan's best guess as to the function of the structurally related protein (see in particular "Abstract" and Box 2).
The problem here is that there is insufficient written description to lead a person of skill in the art to know, regarding the polypeptide with the percent identity, which sequences are essential, which sequences are non-essential for the variants of BAFF polypeptide to be able to bind BCMA, TACI and BAFF-R, a required property of the claimed polypeptide.
Therefore, the disclosed species are not sufficiently representative of the genus encompassing all the variants of BAFF encompassed by the above-mentioned limitations because the disclosure fails to describe the common attributes or characteristics that identify all members of the genus, known and unknown at the time the invention was made.
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the written description inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116.) Consequently, Applicant was not in possession of the instant claimed invention. See University of California v. Eli Lilly and Co. 43 USPQ2d 1398.
Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. § 112 is severable from its enablement provision. (See page 1115.)
Claims 40-64 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The present claims are drawn to a method of treating a condition comprising administering a cell expressing a chimeric receptor comprising an extracellular domain comprising a BAFF. The breadth of the claims encompasses treating any conditions. However, the instant specification, as filed, does not provide sufficient enabling description for treating the full scope of the diseases encompassed by the claims because there does not appear to be sufficient in vitro or in vivo evidence to support administering the cells comprising chimeric receptor to prevent or ameliorate the symptoms of all the diseases encompassed by the claims.
Pharmaceutical therapies in the absence of in vivo clinical data are unpredictable for the following reasons; (1) the protein may be inactivated before producing an effect, i.e. such as proteolytic degradation, immunological inactivation or due to an inherently short half-life of the protein; (2) the protein may not reach the target area because, i.e. the protein may not be able to cross the mucosa or the protein may be adsorbed by fluids, cells and tissues where the protein has no effect; and (3) other functional properties, known or unknown, may make the protein unsuitable for in vivo therapeutic use, i.e. such as adverse side effects prohibitive to the use of such treatment. See page 1338, footnote 7 of Ex parte Aggarwal, 23 USPQ2d 1334 (PTO Bd. Pat App. & Inter. 1992).
The specification does not adequately teach how to effectively prevent or treat the breadth of diseases or reach an appropriate beneficial therapeutic endpoint in by administering the antibody. The specification does not teach how to extrapolate data obtained from various in vitro or in vivo observations as well as clinical experience with the cell expressing chimeric receptor to the development of effective methods of preventing or treating plethora of the diseases broadly encompassed by the claimed invention.
There is insufficient guidance and direction as well as objective evidence provided for treating the scope of diseases encompassed by the claimed method. In view of the lack of predictability of the art (e.g., treating a cancer) to which the invention pertains, undue experimentation would be required to practice the claimed method of treating any cancer with a reasonable expectation of success, absent a specific and detailed description in applicant's specification of how to effectively use the claimed agent and absent working examples providing evidence which is reasonably predictive that the claimed agent is effective for treating any cancer commensurate in scope with the claimed invention.
Reasonable correlation must exist between the scope of the claims and scope of the enablement set forth. In view on the quantity of experimentation necessary, the limited working examples, the nature of the invention, the state of the prior art, the unpredictability of the art and the breadth of the claims, it would take undue trials and errors to practice the claimed invention.
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 40-46, 48-64 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Ma et al. (US 2019/0135894 A1; cited in IDS; see entire document).
Ma et al. taught a method of treating a condition comprising administering a NK cell, NK T cell and cytotoxic T cell expressing a chimeric receptor comprising an extracellular domain that comprises BAFF, IgG1 hinge domain, CD28 transmembrane domain, and OX40, CD3 zeta or CD28 intracellular domain from N-to-C terminus and a linker, wherein the cell is autologous or allogeneic (see, e.g., paragraphs 0016, 0236, 0249, 0270, 0071, 0245, 0029, 0573, 0229, 0278 Fig 1A and 11A). Ma’s chimeric receptor would bind BCMA, TACI and BAFF-R because its extracellular domain comprises BAFF. Given that Ma’s chimeric receptor comprises the same domains as the claimed chimeric receptor of the present application, Ma inherently taught the amino acid sequences of the domains of the chimeric receptor as the amino acid sequences are inherent features of these domains disclosed by Ma. Furthermore, Ma taught the recited conditions such as multiple myeloma, B cell malignancies, follicular lymphoma and SLE (see, e.g., paragraphs 0358, 0448, 0450, 0481).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 40-64 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12,023,354 in view of Ma et al. (US 2019/0135894 A1.
The claims of the reference patent disclosed the same chimeric receptor as recited in the present claims and the immune cells expressing the chimeric receptor. Although the patent claims did not disclose a method of treating a condition, it would have been obvious to do so in view of the teachings by Ma et al. as discussed above (see 102 above). Therefore, the patent claims in view of Ma render obvious of the present claims.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHARON X WEN whose telephone number is (571)270-3064. The examiner can normally be reached Mon-Fri 8-5.
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/SHARON X WEN/Primary Examiner, Art Unit 1641
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