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 .
Status of the Claims
Claims 1-4, 18-20, 25, 28, 50, 52, 60, and 61-68 are currently pending and are the subject of this Office Action. This is the first Office Action on the merits of the claims.
IDS
The references cited on the information disclosure statement(s) were considered and have been made of record.
Notably, one or more of the disclosure statements filed to date lists the following documents: Search Reports, PCT Written Opinion.
The listing of the document(s) noted above is not considered to be an information disclosure statement (IDS) complying with 37 CFR 1.98. 37 CFR 1.98(a)(2) requires a legible copy of: (1) each foreign patent; (2) each publication or that portion which caused it to be listed; (3) for each cited pending U.S. application, the application specification including claims, and any drawing of the application, or that portion of the application which caused it to be listed including any claims directed to that portion, unless the cited pending U.S. application is stored in the Image File Wrapper (IFW) system; and (4) all other information, or that portion which caused it to be listed. In addition, each IDS must include a list of all patents, publications, applications, or other information submitted for consideration by the Office (see 37 CFR 1.98(a)(1) and (b)), and MPEP § 609.04(a), subsection I. states, "the list ... must be submitted on a separate paper." Therefore, the references cited in the document(s) noted above have not been considered.
Furthermore, the listing of references in the specification or claims is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Applicant is advised that the date of submission of any item of information or any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the IDS, including all "statement" requirements of 37 CFR 1.97(e). See MPEP § 609.05(a).
Note: If copies of the individual references cited on the document(s) noted above are also cited separately on the IDS (and these references have not been lined-through) they have been considered.
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 2-4, 18-20, 25, 28, 50, 52, 60, and 61-68 are rejected under 35 U.S.C. 112(b) as failing to set forth the subject matter which the inventor or a joint inventor regards as the invention.
Claims 2-4, 18-20, 25, 28, 50, 52, 60, and 61-68, recite more than two dosing cycles, while claim 1, from which they depend, recites only two dosing cycles. There is insufficient antecedent basis for this limitation in the claims.
Priority
The effective filing date of the claims is deemed the filing date of the provisional application (i.e., 63/354,491), namely June 22, 2022.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 18-20, 25, 28, 50, 52, 60, and 61-68 are rejected under 35 U.S.C. 103 as being unpatentable over Olszewski1 in view of Elliot2, and Brice3.
Regarding claim 1, Olszewski teaches a treatment method for patients with previously untreated follicular lymphoma (FL) comprising subcutaneously administering mosunetuzumab and orally administering lenalidomide as a first-line therapy (see Olszewski entire document, e.g., at p. 5). Olszewski further teaches: 8 dosing cycles, each lasting 21 days, wherein mosunetuzumab is administered using step-up dosing from 5 to 45 mg and wherein lenalidomide is administered starting at cycle 5 at 10 mg per day (see Olszewski, e.g., at p. 5-7; reads on claims 1, 2.a., 2.b., 2.d., 3.a., 3.b.4, 3.c., 3.d., 4.b., 4.c., 4.d., 18.a., 18.b., 18.c., 19.a., 19.b.); the FL is histologically confirmed as grade 1, 2, or 3a, but not 3b (see Olszewski, e.g., at p. 8-9; reads on claims 2.e., 20.a., 64.a.).
The prior art of Olszewski differs from the instantly claimed invention as follows: Olszewski does not expressly teach the particular number of dose cycles, days of administration, cycle length of 28 days Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria, use of corticosteroid, antihistamine, anti-pyretic, or prophylactic agents set forth in the claims.
Elliot discloses a bispecific antibody that targets both CD3 and CD20, and the use of the antibody in combination with a standard treatment regimen of rituximab and lenalidomide for the treatment of follicular lymphoma, such as relapsed and / or refractory follicular lymphoma (see Elliot, e.g., at paragraph 1 on page 1 and paragraph 4 on page 22), and describes a method for treating follicular lymphoma in a human subject, wherein a bispecific antibody that binds to human CD3 epsilon and human CD20 and an effective amount of rituximab and lenalidomide are administered to the subject (see Elliot, e.g., at Claims 1 and 49, paragraph 1 on page 73 to paragraph 1 on page 93, and Example 3), the bispecific antibody is subcutaneously administered (see Elliot, e.g., at Claim 29), and lenalidomide is orally administered (see Elliot, e.g., at Claim 31). In addition, the same document describes that cytokine release syndrome (CRS) can occur when a method utilizing an approach based on immune cells and bispecific antibodies that function by activation of immune effector cells by engaging CD3 or the like is used in a human subject, that corticosteroids are administered to a subject as a method for preventing CRS, and that dexamethasone is administered to a subject who develops grade 2, 3, or 4 CRS (see Elliot, e.g., at paragraph 5 on page 33 to paragraph 2 on page 34. Alternatively, it is also described that methylprednisolone is administered, and dexamethasone is administered to a subject presenting simultaneous ICANS (see Elliot, e.g., at paragraph 1 on page 38 to paragraph 1 on page 39); furthermore, it is described that human subjects are treated with pre-medication to reduce the response to injection, and as the pre-medication, antihistamines such as diphenhydramine are administered and antipyretics such as acetaminophen are administered (see Elliot, e.g., at paragraph 3 on page 34 to paragraph 2 on page 35); and it is also described that human subjects receive prophylactic treatment for tumor lysis syndrome (TLS) such as administration of rasburicase and allopurinol (see Elliot, e.g., at paragraph 3 on page 39; reads on claims 3.e., 20.c., 20.d., 25, 28, 50, 60-68). Elliot further discloses 12 cycles lasting 28 days, wherein lenalidomide is administered at a dose of 20 mg in cycle 2 to cycle 12 of the 28-day cycles, and wherein the bispecific antibody is administered on Days 1, 8, and 15 of the cycles (see Elliot, e.g., claim 24, 28; reads on claims 1.a., 4.a., 19).
Brice teaches the Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria.
Obviousness Analysis:
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have arrived at the presently claimed invention in view of the prior art because it amounts to no more than: combining the prior art elements of the cited references according to known methods to yield predictable results (e.g., incorporating the disclosures of Elliot and Brice into the known method of Olszewski, as the dose regimens, CRS prevention/treatment, and GELF criteria are known in the art for existing treatment methods for FL that use anti-CD20/CD3 bispecific antibodies ) (see MPEP 2143(I)(A),(G)).
Furthermore, doses, dosage regimens, as well as monitoring and adjusting for effective therapeutic regimens are result effective variables5, and are well known by medical practitioners, and thus can be easily developed by those skilled in the art through routine optimization (see MPEP § 2144.05(II)).
Additionally, there would be a reasonable expectation of success because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)). Thus, a skilled artisan could predictably and reasonably produce the methods and compositions of the present invention, as the prior art references cited above provides support and motivation for doing so, as discussed above.
Accordingly, claims 1-4, 18-20, 25, 28, 50, 52, 60, and 61-68 are rejected.
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.
Copending Application No.: 19/249,597 (US20260109777)
Claims 1-4, 18-20, 25, 28, 50, 52, 60, and 61-68 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 16, 26-27, 37-40, 42-45, 52, 59, 113, 116, 119, 124, 127-129, 189, 201, 202, 214, 222 of copending Application No. 19/249,597 (reference application) in view of Elliot (supra).
MPEP § 804(II)(B)(2)-(3) identifies that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)). The following rejection is based upon an obviousness analysis.
Obviousness analysis: Regarding instant claims 1-4, 18-20, 25, 28, 50, 52, 60, and 61-68, the reference application claims essentially the same method of treating a subject having a previously untreated follicular lymphoma (FL), the method comprising administering to the subject mosunetuzumab and lenalidomide according to the same dosing regimen as claimed (see reference claims 1-2, 16, 26-27, 37-40, 42-45, 52, 59, 113, 116, 119, 124, 127-129, 189, 201, 202, 214, 222), and is known in the prior art, as set forth above. Furthermore, although the reference claims do not recite the particular CRS prevention/treatment strategies, this deficiency is remedied by the prior art teachings/disclosures set forth in reference, Elliot, as discussed above.
Accordingly, the present claims are directed to obvious variants of the reference claims because it is well-within the ordinary skill in the art to combining the prior art elements of the cited references according to known methods to yield predictable results, as the dose regimens and CRS prevention/treatment are known in the art for existing treatment methods for FL that use anti-CD20/CD3 bispecific antibodies. See, e.g., MPEP § 804(II)(B)(3)(C)-(D); see also MPEP § 2143(A), (G)).
Lastly, doses and dosage regimens and monitoring and adjusting for effective therapeutic regimens are result effective variables, and are well known by medical practitioners, and thus can be easily developed by those skilled in the art through routine optimization. Accordingly, the present claims are directed to obvious variants of the reference claims.
Conclusion
Claims 1-4, 18-20, 25, 28, 50, 52, 60, and 61-68 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEA S O'BRIEN whose telephone number is (703)756-4793. The examiner can normally be reached Monday - Thursday 9:00 AM to 6:00 PM PT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gregory Emch can be reached on (571) 272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LEA S O'BRIEN/Examiner, Art Unit 1646
/MARK HALVORSON/Primary Examiner, Art Unit 1646
1 Olszewski: "Record History: BrUOG 401: A Phase 2 Study of Mosunetuzumab with Lenalidomide Augmentation as First-line Therapy for Follicular and Marginal Zone Lymphoma," ClinicalTrials.gov, Last Update Posted March 11, 2021, Retrieved on May 27, 2026 from <https://clinicaltrials.gov/study/NCT04792502?tab=history&a=1#version-content-panel> (14 pages)
2 WO2022053655A1, published March 17, 2022; cited on the IDS
3 Brice et al. Comparison in low-tumor-burden follicular lymphomas between an initial no-treatment policy, prednimustine, or interferon alfa: a randomized study from the Groupe d'Etude des Lymphomes Folliculaires. Groupe d'Etude des Lymphomes de l'Adulte.. J Clin Oncol 15, 1110-7(1997).
DOI:10.1200/JCO.1997.15.3.1110
4 Wherein 21 days reads on “about 28 days” as recited in instant claim 3.b.
5 It is well settled that "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980). See also Merck & Co. v. Biocraft Labs. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1847-48 (Fed. Cir. 1989) (determination of suitable dosage amounts in diuretic compositions considered a matter of routine experimentation and therefore obvious). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
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