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 .
Election/Restrictions
1. The Election filed February 23, 2026 in response to the Office Action of December 23, 2025 is acknowledged and has been entered. Applicant's election with traverse of Group 8, claims 1-6, 9-15, and 19-21 is acknowledged.
Applicant argues that while Applicant does not agree with the basis of the Restriction Requirement of December 23, 2025, Applicant traverses the Restriction Requirement at least because it has become erroneous in view of the current claim amendments. In particular, the Restriction Requirement's proposed Groups 1-7, 9-19, 21-31, and 33-36 are no longer applicable.
Moreover, Applicant respectfully submits that any search for elected Group 8 would also identify documents relating to Groups 20 and 32, such that a search and examination of all the current claims in an application (i.e., Groups 8, 20, and 32) can be made without serious burden. Accordingly, Applicant respectfully requests the Examiner to examine all pending claims on the merits. See MPEP § 803.
2. First, it is noted that burden of search is not the criteria for proper restriction for a National Stage application filed under 35 U.S.C. §371 under 37 C.F.R. 1.475, PCT article 17(3) (a), and 37 C.F.R 1.476 (c). Nevertheless, in view of Applicant’s amendments, the restriction requirement among Groups 8, 20, and 32, as set forth in the Office action mailed on December 23, 2025 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
3. Claims 1-21 are pending and under consideration
Priority
4. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
5. It is noted that the examiner has established a priority date of December 22, 2021 for claims 2-21 of the instant application because the priority of the instantly claimed invention is based on the prior filed application JP2020-212015 which is written Japanese. The prior filed application has not been translated and the Examiner is unable to determine the information in the document.
If Applicant disagrees with any rejection set forth in this action based on examiner's establishment of a priority date of December 22, 2021 for claims 2-21, then Applicant is invited to submit a proper translation of the priority document and to point to page and line where support can be found establishing an earlier priority date. If Applicant chooses to file a translation, then the translation must be filed together with a statement that the translation of the certified copy is accurate. See 35 U.S.C. 119 (b)(3), 37 C.F.R. 1.55(g)(3)(4), 37 C.F.R. 1.78(d)(7), and MPEP 1895.01.
The priority date of claim 1 is December 22, 2020 based on JP2020-212015.
Claim Rejections - 35 USC § 112
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.
6. Claims 3, 5, 6, 8, 12, 17, 18, 20 and 21 are 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.
Claims 3, 12, 17 and 20 are drawn in part to “malignant lymphoma (MALT lymphoma, DLBCL, mantle cell lymphoma, burkitt lymphoma, hodgkin lymphoma, adult T cell leukemia, peripheral T lymphoma, etc.)”. It is unclear whether the limitations in the parenthetical phrase are part of the claimed invention or simply examples of a malignant lymphoma. Additionally, it is unclear what tumor cells or tumors are included or excluded by “, etc.”.
Claims 8 is drawn in part to “the CD20 monoclonal antibody drug is at least one of rituximab, . . ., etc.” It is unclear what CD20 monoclonal antibody is included or excluded by “, etc.”.
Claims 5, 6, 18 and 21 are drawn in part to “CRAB, etc.”. The specification teaches at paragraph [0036] “CRAB (hypercalcemia, renal impairment, anemia, and bone lesions).” The specification teaches at paragraph [0116] “in this description, amyloidosis and hyperviscosity syndrome are added to CRAB and referred to as "CRAB, etc.". The specification teaches at paragraph [0125] “CRAB (kidney failure, amyloidosis, hyperviscosity syndrome, bone lesions (bone destruction).” Given the multiple definitions of CRAB, it is unclear what conditions (e.g., anemia or not or renal impairment vs kidney failure), are included or excluded from the limitation "CRAB, etc.". Thus the term is indefinite.
Claim Rejections - 35 USC § 102
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)(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.
7. Claim(s) 2-6 and 9-21 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 2024/0115589 A1 (Nishida et al. Apr. 11, 2024, effectively filed Feb. 15, 2021), “Nishida” .
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Nishida teaches a pharmaceutical composition for inhibiting cytokine storms or inhibiting TNF-alpha and IL-6 production, a processed food containing, or an agent containing M14:
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. See ¶¶ 0016-0018 and claims 1-5.
It is noted that the intended uses of M14 in claims 2-6, 9-20 and 21 are not given weight for comparison of the claims with the prior art because a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art
Additionally, it is noted that, regarding the labels of claims 17, 18, 20 and 21, patentable weight is not given to printed matter absent a new and unobvious functional relationship between the printed matter and the product. See MPEP 2111.05 and 2112.01 (III) In re Lowry, 32 F.3d 1579, 1583-84, 32 USPQ2d 1031, 1035 (Fed. Cir. 1994); In re Ngai, 367 F.3d 1336, 70 USPQ2d 1862 (Fed. Cir. 2004).
8. Claim(s) 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over US 2024/0115589 A1 (Nishida et al. Apr. 11, 2024, effectively filed Feb. 15, 2021), “Nishida” as applied to claims 2-6 and 9-21 above, and further in view of US 2020/0246179 A1 (Peyman, GA Aug. 6, 2020), “Peyman”.
Nishida teaches as set forth above, but does not teach using a CD20 antibody like rituximab.
Peyman teaches using the anti-CD20 antibody rituximab to kill B lymphocytes and prevent a cytokine storm. See ¶ [0394].
It would have been prima facie obvious at the time the invention was filed given that the level of skill in the art was high to combine the teachings of Nishida and Peyman and add the anti-CD20 antibody rituximab to the M14 compositions of Nishida because Nishida teaches the pharmaceutical composition is for inhibiting cytokine storms and Peyman teaches using rituximab to kill B lymphocytes and prevent a cytokine storm. Thus, one would have been motivated to combine M14 and rituximab in the compositions of Nishida to enhance the anti-cytokine storm response.
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.
9. Claims 1-6 and 9-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of co-pending Application No. 18/276,114 (reference application, published as US 2024/0115589 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the co-pending claims are drawn to a pharmaceutical composition for inhibiting cytokine storms or inhibiting TNF-alpha and IL-6 production, a processed food, or an agent containing M14:
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. See ¶¶ 0016-0018 and claims 1-5.
It is noted that the intended uses of M14 in claims 2-6, 9-20 and 21 are not given weight for comparison of the claims with the prior art because a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art
Additionally, it is noted that, regarding the labels of claims 17, 18, 20 and 21, patentable weight is not given to printed matter absent a new and unobvious functional relationship between the printed matter and the product. See MPEP 2111.05 and 2112.01 (III) In re Lowry, 32 F.3d 1579, 1583-84, 32 USPQ2d 1031, 1035 (Fed. Cir. 1994); In re Ngai, 367 F.3d 1336, 70 USPQ2d 1862 (Fed. Cir. 2004).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
10. Claims 7 and 8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of co-pending Application No. 18/276,114 (reference application, published as US 2024/0115589 A1), as applied to claims 1-6 and 9-21 above in further view of US 2020/0246179 A1 (Peyman, GA Aug. 6, 2020), “Peyman”.
The ‘114 claims teach as set forth above, but does not teach using a CD20 antibody like rituximab.
Peyman teaches using the anti-CD20 antibody rituximab to kill B lymphocytes and prevent a cytokine storm. See ¶ [0394].
It would have been prima facie obvious at the time the invention was filed given that the level of skill in the art was high to combine the teachings of the ‘114 claims and Peyman and add the anti-CD20 antibody rituximab to the M14 compositions the ‘114 claims because Nishida teaches the pharmaceutical composition is for inhibiting cytokine storms and Peyman teaches using rituximab to kill B lymphocytes and prevent a cytokine storm. Thus, one would have been motivated to combine M14 and rituximab in the compositions the ‘114 claims to enhance the anti-cytokine storm response.
This is a provisional nonstatutory double patenting rejection.
Conclusion
10. No claims allowed.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER J REDDIG whose telephone number is (571)272-9031. The examiner can normally be reached M-F 8:30-5:30 Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Greg Emch can be reached at 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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/PETER J REDDIG/Primary Examiner, Art Unit 1646