DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicant's amendment and remarks filed on 07/13/2026 are acknowledged.
Claims 1-20 are pending.
3. Applicant’s election without traverse of the invention of Group IV (claims 1-13 and 16-19, drawn to an anti-BCMA antibody, and to a method for prevention or treatment of B-cell associated neoplastic diseases, the method comprising administering to a subject a cell therapy comprising engineered T cells comprising a chimeric antigen receptor which comprises an scFv form of the antibody) in the reply filed on 07/13/2026 is acknowledged.
Applicant further elected without traverse the following species:
(a) an anti-BCMA antibody comprising: a VH comprising: a VH-CDR1 of SEQ ID NO: 7, a VH-CDR2 of SEQ ID NO: 10 and a VH-CDR3 of SEQ ID NO: 14; and a VL comprising: a VL-CDR1 of SEQ ID NO: 17, a VL-CDR2 of SEQ ID NO: 20 and a VL-CDR3 of SEQ ID NO: 21; and
(b) a costimulatory domain of 4-1BB.
Claims 14-15 and 20 are withdrawn from further consideration by the Examiner under 37 C.F.R. § 1.142(b) as being drawn to nonelected inventions.
Claims 1-13 and 16-19 are presently under consideration.
4. 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.
5. Claims 1-13 and 16-19 are 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.
(i) Claims 1-4 are indefinite because, in the absence of conjunctions (such as “and” or “or”) in listing variable region or CDR sequences it is unclear whether the sequences must be present together or in the alternative.
(ii) Claim 9 is indefinite in the use of the term “preferably,” because it is unclear whether or not the preferred embodiments constitute claim limitations. Description of examples or preferences is properly set forth in the specification rather than the claims.
(iii) Claim 9 is indefinite as being in improper Markush format. The Office recommends the use of the phrase "selected from the group consisting of ..." with the use of the conjunction "and" rather than "or" in listing the species. See MPEP 803.02.
(iv) Claim 18 is indefinite in the recitation of “B-cell associated neoplastic diseases” because, in the absence of defined nature or degree of the requisite “association” it is unclear which diseases are within the scope of the claim. For example, insufficient B-cell mediated humoral immune response against tumor antigens plays a role in progression of certain cancers, and it is unclear whether such cancers are within the scope of the claim.
(v) Claim 19 is indefinite in the use of the phrase “such as” because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
(vi) Claims 2-13 and 16-19 are indefinite, because they encompass the indefinite limitations of the claim(s) on which they depend.
In view of the above, a person of ordinary skill in the art cannot unequivocally interpret the metes and bounds of the claims so as to understand how to avoid infringement. Applicant is reminded that any amendment must point to a basis in the specification so as not to add New Matter. See MPEP 714.02 and 2163.06.
6. The following is a quotation 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.
7. Claims 18-19 are rejected under 35 U.S.C. 112(a) because the specification, while being enabling for method for treatment of B-cell associated neoplastic diseases, does not reasonably provide enablement for method for prevention of B-cell associated neoplastic diseases. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims without undue experimentation.
Factors to be considered in determining whether undue experimentation is required to practice the claimed invention are summarized in In re Wands (858 F2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)). The factors most relevant to this rejection are the scope of the claim, the amount of direction or guidance provided, limited working examples, the unpredictability in the art and the amount of experimentation required to enable one of skill in the art to make and use the claimed invention.
In the medical context, preventing a disease involves identifying healthy human subjects susceptible the disease, applying the treatment, and, after a sufficiently long period of time has elapsed, ascertaining that the absence of the disease in the subjects is due to the treatment and not some other factors. Therefore, the burden of enabling a method of preventing a disease is much greater than that of enabling a method of treating a disease, due to the inherent difficulty of identifying healthy human subjects susceptible the disease, and especially the hurdle of proving that the administered treatment was the factor that resulted in prevention of the disease.
Instant specification discloses a working example indicating that engineered T cells comprising a chimeric antigen receptor of instant claims are capable of killing BCMA-expressing target cells (Example 6). Multiple clinical studies of anti-BCMA CAR-T cell therapies for multiple myeloma were ongoing at the time of the invention, as reviewed e.g. by Roex et al. (2020). In contrast, the specification does not provide any guidance, direction, or working examples of preventing cancer with anti-BCMA CAR-T cells, nor does there appear to have been any knowledge in the art to that effect (e.g. Seoung et al. 2025).
Accordingly, the entire scope of experimentation required to develop methods of preventing cancer by administering the recited therapy is left to those skilled in the art, the present claims and disclosure amounting to nothing more than an invitation to the skilled artisan to invent such methods. Given the resource-intensive nature of the required experimentation, the risks involved and the extremely low expectation of success, the skilled artisan would reasonably conclude that such experimentation would be unnecessarily, and improperly, extensive and undue.
8. 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.
9. Claims 1-13 and 16-19 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Brogdon et al. (US 20160046724).
Brogdon teaches anti-BCMA antibody “C13F12.1,” which comprises a VH of SEQ ID NO: 257 and a VL of SEQ ID NO: 261 (e.g. Table 16). Brogdon’s SEQ ID NO: 257 comprises instant SEQ ID NOS: 9, 13 and 16, and Brogdon’s SEQ ID NO: 261 comprises instant SEQ ID NOS: 19, 20 and 21 (see SCORE), thereby anticipating claims 1-3.
Brogdon’s VH of SEQ ID NO: 257 is 89.7% identical to instant SEQ ID NOS: 23 and 24, and Brogdon’s VL of SEQ ID NO: 261 is 91.4% identical to instant SEQ ID NO: 33 and 85.7 to 88.5% identical to instant SEQ ID NOS: 35 and 37-39 (see SCORE), thereby anticipating claims 4-5.
Brogdon further teaches that the amino acid sequence of anti-BCMA scFv “C13F12.1” is SEQ ID NO: 265 (e.g. Table 16), which is 88.5% identical to instant SEQ ID NO: 48, and 85.0 to 85.3% identical to instant SEQ ID NOS: 44, 45 and 53 (see SCORE), thereby anticipating claims 6-7.
Brogdon further teaches chimeric antigen receptor (CAR) targeting BCMA which comprises the C13F12.1 scFv (e.g. [0085]), a 4-1BB costimulatory domain (e.g. [0014]), and a CD3zeta intracellular signal transduction domain (e.g. [0016]), thereby anticipating claims 8-9.
Brogdon further teaches nucleic acids and vectors encoding the CAR, as well as host cells, compositions and kits comprising the nucleic acids (e.g. [0054], [0057], [0274], [0189]), thereby anticipating claims 10-13 and 16-17.
Brogdon further teaches methods of treating B cell leukemias and lymphomas (e.g. claims 51, 52 and 54), thereby anticipating claims 18-19.
10. Conclusion: no claim is allowed.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ILIA I OUSPENSKI whose telephone number is (571)272-2920. The examiner can normally be reached 9 AM - 5:30 PM.
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/ILIA I OUSPENSKI/ Primary Examiner, Art Unit 1644
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