DETAILED ACTION
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 .
Claims 1-121 and 128-148 have been cancelled. Claims 158-161 have been newly added.
Applicant's arguments filed 6/24/2026 have been fully considered but they are not fully persuasive.
The provisional rejection of claims 122-125, 128-131, and 139-154 on the ground of nonstatutory double patenting as being unpatentable over claims 102-123 of copending Application No. 19/016,060 (4/30/2025 claim set, common applicant Genentech; common inventor Cooper) is withdrawn in view of the claim amendments. The instant application is senior to the co-pending application.
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 122-127 and 149-161 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.
Claim 122 has been amended to recite wherein the first dosing cycle comprises a first dose (C1D1), a second dose (C1D2), and a third dose (C1D3) of cevostamab “wherein the C1D1 is between about 0.3 mg to about 1.2 mg, the C1D2 is between about 3.2 mg to about 10 mg, and the C1D3 is between about 90 mg to about 160 mg, wherein the C1D1, the C1D2, and the C1D3 are administered on Days 1, 8, and 15, respectively, of the first dosing cycle.”
Applicant states that claim 122 has been amended to recite the dosing features of Arms B and D of Study GO39775 and points for basis in pending claims 123-125 and in the specification, e.g., at page 41, lines 11-16; at page 131, Table 12; and at page 170, lines 3-5. This is not agreed with. It is noted that claims 123-125 are not original claims and were added by amendment on 8/9/2023. These claims do not disclose the dosage ranges now recited in claim 122 for each of C1D1, C1D2 and C1D3. At least for example, claim 123, part (a), of the 8/9/2023 claim set recites the C1D1 is between about 0.1 mg to about 1.5 mg; the C1D2 is between about 3.2 mg to about 10 mg; and the C1D3 is between about 80 mg to about 300 mg. While the C1D2 range matches what is now in claim 122, the ranges for C1D1 and C1D3 do not provide support for the ranges for C1D1 and C1D3 in claim 122. Page 170, lines 3-5, and Table 12 provide specific dosages and not ranges. No basis is seen for the C2D1 range of between about 90 mg and about 160 mg in claim 123, part (b). No basis is seen for the C2D1 dosage of about 90 mg in claim 124, part (i). No basis is seen for the about 90 mg to about 160 mg ranges in parts (a) and (b) of claim 127.
In addition, applicant has not pointed to support for the ranges in claim 122 in combination with the limitations of the dependent claims. At least for example, claim 125 includes the embodiment of claim 122 with the limitations of claim 123, in combination with the limitations of claim 124, part (d) (alone), in combination with claim 125 part (d) (alone). Applicant’s response does not explain support for all embodiments of the methods in the dependent claims with respect to the ranges in claims 122-123. Applicant is again reminded that the dependent claims have a multiplicity of alternative choices within the claims themselves and within the chain of dependent claims. The alternatives may be unrelated to each other (e.g. length of first dosing cycle, type of multiple myeloma, particular dosage). Basis must be provided for each embodiment encompassed by all of the alternative choices in the dependent claims. It is suggested that applicant simplify their claims.
Claims 158-161 are not original claims. They were added by amendment on 6/24/2026.
Claim 158 depends upon claim 122. Claim 122 is directed to treating an individual subject. The limitations of claim 158 are with respect to a population of subjects. No basis is seen for this claim. Table 12 shows an objective response rate (ORR) of 33.3% for 10 of 30 subjects where different subjects had particular dosages. Note that six of the subjects had dosages 1.2/3.6/60 (i.e. not within the limitations of current claim 122). The claimed ORR is not disclosed in the context of a single subject or the ranges recited in claim 122. No basis is seen for this claim.
Basis for claims 159 is stated to be at page 158, lines 24-29. This is not agreed with. These results are not disclosed in the context of the ranges recited in claim 122.
Basis for claims 160 and 161 is stated to be at page 98, line 34, to page 99, line 2; and at page 102, lines 30-31. This is not agreed with. These results are not disclosed in the context of the ranges recited in claim 122.
The claims constitute new matter.
Claims 122-127 and 149-161 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for methods of treatment as discussed below, does not reasonably provide enablement for all methods encompassed by the claims. 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.
Independent claim 122 is directed to a method of treating multiple myeloma wherein the recited dosing regimen decreases the rate of disease progression of multiple myeloma (MM) in the subject.
While the examples of the specification disclose slowing progression of MM (included in the definition of treatment at page 37, lines 25-26), this is not synonymous with decreasing the rate of disease progression for MM. A rate of disease progression is considered to be a change in some activity or property of the disease per unit time. The specification does not disclose any rates of disease progression for any aspect of MM and does not show that administration of the claimed antibodies decreases that rate for any aspect of MM. Note that a response rate (e.g. objective response rate, ORR, or progression-free survival (PFS) rate) is also not synonymous with the concept of decreasing the rate of disease progression of multiple myeloma (MM). In fact, the goal would be a higher ORR or higher PFS. See instant claim 158.
Note that the therapeutic limitations of new claims 159-161 do not speak to rates either.
The scope of the claims is not enabled.
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 125-127 and 152-157 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.
Claim 124 has alternative parts (a)-(d) (i.e. “and/or”). Claims 125-127 and 155-157 ultimately depend upon claim 124 and also have alternative parts (i.e. “and/or” and “or”). Claims 125-127 and 155-157 are confusing in the multiplicity of alternative choices in each claim, particularly as the alternatives may be unrelated to each other (e.g. length of first dosing cycle, type of multiple myeloma, particular dosage) within the claim and within the chain of dependent claims. The claims are confusing with respect to the metes and bounds of the methods being claimed.
Claims 152-153, recite “to manage the CRS event.” It is unclear what “managing” requires. There is no specific definition in the specification. In particular with respect to claim 152, it is unclear how long the cevostamab treatment of claim 122 would be suspended while managing the CRS event. The claim does not make clear if the cevostamab treatment is permanently suspended or under what conditions it is resumed. The metes and bounds of these claims cannot be determined. Applicant’s arguments are not persuasive. The examples pointed to on page 10 of the 6/24/2026 response are not limitations of the claims. At least for example, the claims do not require identifying symptoms or assigning a CRS grade, particularly as outlined in Table 5A. The claims do not require any actions set forth in Table 2.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIANNE P ALLEN whose telephone number is (571)272-0712. The examiner can normally be reached 7:00-3:30 EST Monday-Friday.
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/Marianne P Allen/Primary Examiner, Art Unit 1647
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