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 .
DETAILED ACTION
Restriction/Election
1. Applicant’s election without traverse of Invention Group I (1, 3, 6, 9, 11, 17, 21, 26, 28, 31, 44, 47, 51-57, and 59) in the reply filed on 04/17/2026 is acknowledged. Applicant also elected the following species: (i) colorectal cancer as recited in claim 75; (ii) the first modification comprises the amino acid substitutions T366W and K409A, and the second modification comprises the amino acid substitutions T366S, L368G, Y407A, and F405K as recited in claim 44.
2. Claims 1, 3, 6, 9, 11, 17, 21, 26, 28, 31, 44, 47, 51-57, 59, 70-71, and 75 are pending. Claims 1, 3, 6, 9, 11, 17, 21, 26, 28, 31, 44, 47, 51-57, and 59 are currently under consideration. Claims 70-71, and 75 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Information Disclosure Statement
3. The information disclosure statement filed on 02/26/2026, 09/24/2024, and 12/27/2022 has been considered by the Examiner and an initialed copy of the form PTO-1449 is attached to this communication.
Drawings
4. The drawing filed on 12/27/2022 are accepted by the examiner.
Claim Rejections [Symbol font/0xBE]35 USC § 112 (d)
5. The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
6. Claim 59 is rejected under 35 U.S.C. 112 (d), as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Specifically, claim 59 recites “a cancer treatment composition, comprising the composition of claim 1”, which does not further limit the composition of claim 1 because cancer treatment indicates intended use but does not materially limit the composition of claim 1.
Claim Rejections[Symbol font/0xBE]35 USC § 102 (a)
7. 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.
8. Claims 1, 3, 6, 9, 11, 17, 21, 26, 28, 31, 44, 47, 51-54, and 59 are rejected under 35 U.S.C. 102 (a)(2) as being anticipated by CN111132998A (DINGFU BIOTARGET CO LTD, 08 May 2020).
CN111132998A discloses a composition for cancer treatment comprising an immunoconjugate and a cytotoxic agent, wherein said immunoconjugate comprises i) one or more interleukins, and ii) an Fc domain consisting of a first Fc subunit and a second Fc subunit, said first Fc subunit associates with said second Fc subunit to form a dimer; said one or more interleukins are fused to said Fc domain; said immunoconjugate comprises a first member and a second member different from said first member, wherein said first member comprises said first Fc subunit, and said second member comprises said one or more interleukins fused to said second Fc subunit, and said first Fc subunit associates with said second Fc subunit to form said heterodimer; said cytotoxic agent is capable of inducing immunogenic cell death and comprises oxaliplatin or 5-Fu; said interleukin is IL-10 and said one or more interleukins are fused to an amino-terminal amino acid of said Fc domain; two interleukins are fused to each other to form an interleukin dimer; said immunoconjugate further comprises a targeting moiety fused to said Fc domain, wherein said targeting moiety and is fused to an amino-terminal amino acid of said Fc domain and may be an anti-EGFR antibody, cetuximab; said Fc domain is an IgG Fc domain, said IgG is a human IgG1; said first Fc subunit comprises first modification, and said second Fc subunit comprises second modification, the first modification comprises the amino acid substitutions T366W and K409A, and the second modification comprises the amino acid substitutions T366S, L368G, Y407A, and F405K as recited in claim 44. CN111132998A discloses the use of an immunoconjugate in combination with a cytotoxic therapy in the preparation of a medicament for treating cancer in a subject in need thereof, wherein the cancer is a colorcetal cancer, a pancreas cancer, a melanoma etc. (see the description, pages 2-4; paragraphs [0006]-[0028], [0099]-[0107], [0126]-[0139] and [0152], Examples 1-3).
CN111132998A discloses the amino acid sequences of cetuximab and immunoconjugate thereof (see sequence list, SEQ ID NOs: 56-63, 37 and 39, which are identical to the SEQ ID NOs: 48-55, 37 and 39 in the present application, respectively). D1 also discloses the amino acid sequences of Fc subunit (see sequence list, SEQ ID NOs: 17 and 18, which are identical to SEQ ID NOs: 17 and 18 in the present application, respectively). CN111132998A discloses the amino acid sequences of IL10 and IL10-Fc (see sequence list, SEQ ID NOs: 80 and 50, which are identical to SEQ ID NOs: 56 and 42 in the present application, respectively).
Thus, the teachings of CN111132998A meet the limitations of claims 1, 3, 11, 17, 21, 26, 28, 31, 47, 51-54, and 59.
9. Claims 1, 3, 6, 9, 11, 17, 21, 26, 28, 31, 44, 47, 51-54, and 59 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by WO 2019/057181 A1 (28 March 2019) or US 11,883,503 B2. The rejection is set forth based upon the teachings of WO 2019/057181 A1.
WO 2019/057181 A1 teaches a composition for cancer treatment comprising an immunoconjugate and a cytotoxic agent, wherein said immunoconjugate comprises 1) one or more interleukins, and 2) an Fc domain consisting of a first Fc subunit and a second Fe subunit, said first Fc subunit associates with said second Fc subunit to form a dimer; said one or more interleukins are fused to said Fc domain; wherein said two interleukins are fused to each other to form an interleukin dimer (page 2); said immunoconjugate further comprises a targeting moiety fused to said Fc domain, wherein said targeting moiety and is fused to an amino-terminal amino acid of said Fc domain and may be an anti-EGFR antibody, cetuximab; said Fc domain is an IgG Fc domain, said IgG is a human IgG1 (page 1); said first Fc subunit comprises first modification, and said second Fc subunit comprises second modification, the first modification comprises the amino acid substitutions T366W and K409A, and the second modification comprises the amino acid substitutions T366S, L368G, Y407A, and F405K as recited in claim 44 (page 3). WO 2019/057181 A1 discloses cytotoxic agent, 5-fluorouracil (5-Fu), and oxaliplatin (page 5, paragraphs {0023} and [0027]). Thus, the teachings of WO 2019/057181 A1 meet the limitations of claims 1, 3, 6, 9, 11, 17, 21, 26, 28, 31, 44, 47, 51-54, and 59.
Claim Rejections under 35 USC § 103(a)
10. The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
11. Claims 55-57 are rejected under 35 U.S.C. 103(a) as being unpatentable over either CN111132998A (DINGFU BIOTARGET CO LTD, 08 May 2020) or WO 2019/057181 A1 (28 March 2019) as applied to claims 1, 3, 6, 9, 11, 17, 21, 26, 28, 31, 44, 47, 51-54, and 59 above.
CN111132998 A and WO 2019/057181 A1 disclose a composition for cancer treatment comprising an immunoconjugate and a cytotoxic agent, as applied to claims 1, 3, 6, 9, 11, 17, 21, 26, 28, 31, 44, 47, 51-54, and 59 above.
Neither CN111132998 A nor WO 2019/057181 A1 teaches the chemotherapeutic agent, folinic acid, tetrahydrofolate, calcium leucovorin, or FOLFOX regimen recited in claims 55-57.
However, the therapeutic agents for cancer treatment are well known in the art. It would have been obvious to one having ordinary skill in the art at the time the invention was made to make a composition for cancer treatment comprising an immunoconjugate and a cytotoxic agent, such as folinic acid, tetrahydrofolate, a calcium leucovorin, or FOLFOX regimen with a reasonable expectation of success. One would have been motivated to do so because folinic acid, tetrahydrofolate, calcium leucovorin, or FOLFOX regimen are well known in the field and it is conventional to apply a cytotoxic agent, such as folinic acid, tetrahydrofolate, a calcium leucovorin, or FOLFOX regimen for chemotherapy.
Claim Rejections[Symbol font/0xBE] Nonstatutory Obviousness-Type Double Patenting
12. Basis for nonstatutory 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. See 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);and, 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/ guidance/eTD-info-I.jsp.
13. Claims 1, 3, 6, 9, 11, 17, 21, 26, 28, 31, 44, 47, 51-57, and 59 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-4 of US Patent No. 11,883,503 B2. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
Claims 1-4 of US Patent No. 11,883,503 B2 are drawn to a composition comprising an immunoconjugate and a cytotoxic agent, wherein said immunoconjugate comprises a first member and a second member different from said first member, wherein said first member comprises said a first Fc subunit, and said second member comprises said two or more interleukins fused to said a second Fc subunit, and said first Fc subunit associates with said second Fc subunit to form a heterodimer; said two interleukins are fused to an amino-terminal amino acid of said second Fc subunit; wherein said two interleukins are two copies of IL 10; wherein the amino acid sequence of a light chain comprised in the first member is SEQ ID NO: 37, and the amino acid sequence of a heavy chain comprised in the first member is SEQ ID NO: 39; wherein said cytotoxic agent comprises a radiation agent that emits X-ray radiation and/or electron beam radiation, said cytotoxic therapy comprises at least one dose of a radiation therapy at a dosage of 10Gy, or, wherein said cytotoxic agent is capable of inducing immunogenic cell death comprising oxaliplatin.
On the other hand, claims 1, 3, 6, 9, 11, 17, 21, 26, 28, 31, 44, 47, 51-57, and 59 of the instant application are drawn to a composition comprising an immunoconjugate and a chemotherapeutic agent, wherein: said immunoconjugate comprises 1) one or more interleukins, and 2) an Fc domain consisting of a first Fc subunit and a second Fe subunit, said first Fc subunit associates with said second Fc subunit to form a dimer; said one or more interleukins are fused to said Fc domain; and wherein said chemotherapeutic agent comprises a fluorouracil and/or an oxaliplatin.
Claims 1-4 of US Patent No. 11,883,503 B2 and and claims 1, 3, 6, 9, 11, 17, 21, 26, 28, 31, 44, 47, 51-57, and 59 of the instant application vary in scope and are obvious over each other.
Conclusion
14. No claims are allowed.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ruixiang Li whose telephone number is (571) 272-0875. The examiner can normally be reached on Monday through Friday from 8:30 am to 5:00 pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Vanessa Ford, can be reached on (571) 272-0857. The fax number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/RUIXIANG LI/Primary Examiner, Art Unit 1674
May 16, 2026
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