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. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/16/26 has been entered.
3. Claims 79, 84-86, 98-100, 102-112, 114-116, 118, 122, 125-126, 156, 160-164, 166-170, 173 and 175-178 are pending upon entry of amendment filed on 1/16/26.
Claims 125-126 and 160-164 stand withdrawn from further consideration by the examiner, 37 CFR 1.142 (b) as being drawn to a nonelected invention.
Claim 79, 84-86, 98-100, 102-112, 114-116, 118, 122, 156, 166-170, 173 and 175-178 are under consideration in the instant application.
4. IN light of Applicant’s amendment to the claims filed on 1/16/26, the rejection under 35 U.S.C. 103 (see sections 6-8 of the office action mailed on 10/17/25) has been withdrawn.
The currently amended claims recite a composition for stimulating Tcells expressing a chimeric antigen receptor (CAR) for BCMA at concentration about 0.5ug/ml to about 500ug/ml.
5. The following rejections remain.
6. 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.
7. Claims Claim 79, 84-86, 98-100, 102-112, 114-116, 118, 122, 156, 166-170, 173 and 175-178 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. Specifically, there is insufficient written description to demonstrate that Applicant was in possession of the claimed genus of the BCMA at least 95% sequence identity to SEQ ID NO:1.
The guidelines of the Examination of Patent Applications Under the 35 U.S.C. 112, §1 “Written Description” Requirement make clear that if a claimed genus does not show actual reduction to practice for a representative number of species, then the Requirement may be alternatively met by reduction to drawings, or by disclosure of properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the Applicant was in possession of the genus (Federal Register, Vol. 66, No. 4, pages 1099-1111, Friday January 5, 2001, see specially page 1106 column 3).
The instant claims are drawn to surface modified particles comprising a huge genus of structurally distinct at least 95% SEQ ID NO:1. This would encompass any BCMA of at least 95% sequence identity (that share similar structure of the BCMA) but has not define any function in any part of cellular domain of B cell maturation antigen. Thus, claims would encompass structurally unrelated and functionally unrelated. There is no art recognized correlation between structure and function of such classes of the BCMA exhibiting the claimed specific functions. The instant specification does not disclose a correlation between structure of the BCMA that attributes the various functions based on the sequence variations. Further, the disclosed species are not sufficiently representative of the huge genus encompassed by the present claims. Thus, one of skilled in the art would conclude that the specification fails to provide adequate written description to demonstrate that Applicant was in possession of the claimed genus of the claimed pharmaceutical compositions. See Eli Lilly, 119 F, 3d 1559, 43, USPQ2d, 1398. Applicant is advised to limit BCMA to SEQ ID NO:1.
Applicant’s response filed on 1/16/25 has been considered but they were not persuasive.
Applicant has asserted that there is known correlation between structure and function for extracellular domain of BCMA and Examples 1-5 of the instant application describe extracellular domain of BCMA. In addition, Applicant has asserted that the claimed SEQ ID NO:1 and [647] of the specification sufficiently describe extracellular domain of BCMA.
Unlike Applicant’s assertion, the working examples 1-5 described the SEQ ID NO:1 but the claimed invention encompasses any BCMA comprises at least 95% of the sequence identity. No examples disclose the sequence identity greater than 95% and the specification fail to disclose any BCMA less than 100% identity. The correlation between structure and function for BCMA less than 100% identity does not exist. The rejection is maintained.
8. The following new ground of rejection is necessitated by Applicants’ amendment filed on 1/16/26.
9. 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.
10. Claims 79, 84-86, 98-100, 102-112, 114-116, 118, 122, 156, 166-170, 173 and 175-178 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 pre-AIA the applicant regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). Note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), as to where broad language is followed by "such as" and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Note also, for example, the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949). In the present instance, claim 79 recites the broad recitation of concentration between 0.5ug/ml and 500ug/ml or between about 0.5ug/ml and about 500ug/ml which is the broader statement of the range/limitation.
11. No claims are allowable.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YUNSOO KIM whose telephone number is (571)272-3176. The examiner can normally be reached on Mon-Fri 8:30-5. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached on 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Yunsoo Kim
Patent Examiner
Technology Center 1600
February 2, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641