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
Applicant’s election without traverse of Group III (claims 1 and 4) in the reply filed on 2/10/2026 is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
Status of Application, Amendments, And/Or Claims
Claims 1 and 4-7 are pending.
Because claims 2-3 are cancelled, previously numbered Group 3 is renumbered as Group 1 and Group 4 is renumbered as Group 2.
Claims 5-7 are withdrawn for being drawn to a non-elected invention (i.e., Group 2).
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
The instant application is a 371 of PCT/KR2021/015290 filed on 10/29/2021.
Information Disclosure Statement
The Information Disclosure Statements (IDSs) filed on 4/24/2023 and 2/5/2026 have been considered.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Tamada et al.(IDS, US 2019/0099446) in view of Shomer et al. (IDS, WO 2020/027832).
The instantly claimed invention is broadly drawn to an immune cell transformed with a nucleic acid molecule encoding IL-7 or a functional portion thereof; and a nucleic acid molecule encoding CCL19 or a functional portion thereof, wherein the immune cell is a natural killer cell; and a method of treating cancer using the same.
Tamada et al. teach a transformed immune cell with a nucleic acid vector comprising a molecule encoding interleukin-7 (IL-7) and chemokine ligand 19 (CCL19) in a T cell for treating cancer (see Fig. 1, abstract and paragraph [0008]). They do not teach that the immune cell is a NK cell.
Shomer et al. teach a transformed immune cell with a nucleic acid vector comprising a molecule encoding C-C chemokine receptor type 7 (CCR-7) and chemokine ligand 19 (CCL19) for treating cancer (see abstract). They teach that immune cell is a NK cell (abstract, Background, Brief summary).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to use a NK cell as an immune cell as taught by Shomer et al to transfect with a nucleic acid molecule comprising a nucleic acid encoding IL-7 and CCL19 as taught by Tamada et al. Additionally, one would have been motivated to do so because Shomer et al teach use of a NK cell to transfect CCL19 and other chemokines for treating cancer in a subject. Further, one would have a reasonable expectation of success in using a NK as taught by Shomer et al for treating cancer. Therefore, the instantly claimed invention would have been obvious over the combined teachings of the prior art.
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.
Claim 4 is 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 a method of treating a cancer comprising administering an immune cell of claim1 to a subject in need thereof, does not reasonably provide enablement for a method of preventing any cancer or infectious diseases comprising administering an immune cell of claim 1 to a subject in need thereof. 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/or use the invention commensurate in scope with these claims.
In In re Wands, 8USPQ2d, 1400 (CAFC 1988) page 1404, the factors to be considered in determining whether a disclosure would require undue experimentation include: (1) Nature of the invention, (2) the state of the prior art, (3) the predictability or lack thereof in the art, (4) the amount of direction or guidance present, (5) the presence or absence of working examples, (6) the breath of the claims, (7) the quantity of experimentation needed, (8) relative skill of those in the art.
The instant disclosure fails to meet the enablement requirement for the following reasons:
The instant claims are broadly drawn to a method of preventing any cancer comprising administering an immune cell of claim1 to a subject in need thereof.
The state of the prior art and the predictability or lack thereof in the art:
With regards to the preventing any cancer comprising administering an immune cell of claim 1 to a subject in need thereof, the specification does not disclose sufficient guidance or objective evidence that such cell would predictably prevent any cancer from occurring in a subject need thereof.
Tamada et al. teach a transformed immune cell with a nucleic acid vector comprising a molecule encoding interleukin-7 (IL-7) and chemokine ligand 19 (CCL19) in a T cell for treating cancer (see Fig. 1, abstract and paragraph [0008]). Adachi et al. (IDS, Nature Biotech. 2018) teach that the expression of IL-7 and CCL19 in CAR-T cells improves immune cell infiltration and CAR-T cell survival in the tumor and complete regression of pre-established tumor (see the title, pg. 348, Figure 2). Duan et al. (IDS, Frontiers in Immunol 20121) teach that CAR-T cells secreting IL-7 and CCL19 has been used for treating refractor/Recurrent multiple myeloma. Pang et al. (IDS, J. Hematol Oncol. 2021) teach using IL-7 and CCL19 secreting CAR-T cell therapy for tumors with positive glypican-3 or mesothelin. However, Neither the art nor the specification teaches preventing cancer by administering an immune cell comprising a nucleic acid molecule of claim 1 to a subject in need thereof. Therefore, it is unpredictable and would require a large amount of experimentation to prevent cancer by administering an immune cell of claim 1 to a subject need thereof.
The amount of direction and guidance present and the presence or absence of working examples: Given the teachings found in the art, detailed teachings are required to be present in the disclosure in order to enable the skilled artisan to practice the invention as claimed. These teachings are absent.
The specification of pages 11-16 disclose transfecting NK-92 cells with a nucleic acid encoding IL-7 and a nucleic acid encoding CCL19 that express IL-7 and CCL19 result in lysing HepG2 liver cancer cell line. The specification does not teach administering an immune cell of claim 1 that can prevent happening of any cancer in a subject in need thereof. The art or the specification is devoid of any example where the administration of an immune cell comprising with a nucleic acid encoding IL-7 and a nucleic acid encoding CCL19 that express IL-7 and CCL19 that can prevent any cancer in a subject in need thereof. Therefore, it is unpredictable how one of the skill in the art can practice the instantly claimed invention.
The breadth of the claims and the quantity of experimentation needed: Due to the large quantity of experimentation necessary to prevent any cancer comprising administering an immune cell (NK cell) comprising a nucleic acid molecule encoding IL-7 and a nucleic acid molecule encoding CCL19 that express IL-7 and CCL19 to a subject in need thereof, the lack of direction/guidance presented in the specification regarding the same, the state of the prior art which establishes the unpredictability about preventing cancer, undue experimentation would be required of the skilled artisan to make and/or use the claimed invention in its full scope.
Conclusion
No claim is allowed.
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/GYAN CHANDRA/Primary Examiner, Art Unit 1674