DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Claim 14 is objected to because of apparent typographical errors in the terms ”rhabdomyo sarcoma” and “menangioma,” where it appears that ”rhabdomyosarcoma” and “meningioma” were intended. Appropriate corrections or clarification are required.
3. 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.
4. Claims 1-14 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
(i) Claims 1-14 are indefinite because of the following contradiction:
Claims 1 and 9-11 recite a CAR encoded by nucleic acid of SEQ ID NO:41 which comprises an scFv that binds to CD123. SEQ ID NO:41 encodes a polypeptide of 401 amino acids (aa), which matches aa 1-401 of SEQ ID NO: 32 (see SCORE). The specification discloses at p. 33 that “SEQ ID NO:32 shows a CD33 CAR-P2A-CD16 peptide” [069]. Therefore, SEQ ID NO:41 encodes a CAR comprising an scFv that binds to CD33 rather than to CD123, as recited.
(ii) Claims 1 and 9 are indefinite in the recitation of a “binding domain comprised therein,” because the boundaries of the binding domain within a polypeptide encoded by a nucleic acid having sequence SEQ ID NO: 41 are not defined.
(iii) Claim 13 is indefinite in the recitation of the abbreviation “N-803,” because it is unknown what the abbreviation stands for.
(iv) Claims 2-8 and 10-14 are further indefinite, because they encompass the indefinite limitations of the claim(s) on which they depend.
In view of the above, a person of ordinary skill in the art cannot unequivocally interpret the metes and bounds of the claims so as to understand how to avoid infringement. Applicant is reminded that any amendment must point to a basis in the specification so as not to add New Matter. See MPEP 714.02 and 2163.06.
5. The following is a quotation of 35 U.S.C. 112(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 12 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.
Claim 12 depends on claim 1 which is limited to NK-92 cell, whereas claim 12 encompasses any NK cell. Therefore, dependent claim 12 may be infringed without infringing the base claim, and as such, claim 12 fails to further limit, and fails to include all the limitations of the claim upon which it depends.
Applicant may cancel the claim, amend the claim to place it in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
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)(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 1-14 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Soon-Shiong et al. (US 20210038645; cited on IDS).
As pointed out in section 4(i) above, instant SEQ ID NO: 41 encodes a polypeptide of 401 amino acids (aa), which matches aa 1-401 of instant SEQ ID NO: 32 (see SCORE).
Instant SEQ ID NO: 32 is identical to SEQ ID NO: 28 taught by Soon-Shiong (see SCORE).
Soon-Shiong teaches a tricistronic expression cassette used to transfect recombinant NK-92 cells, which encodes CD33 CAR-P2A-CD16 of SEQ ID NO: 28 and erIL2 ([0031], [0137], Fig. 5A, 5B). Accordingly, transfected NK-92 cells comprise recombinantly expressed cytokine IL-2, recombinantly expressed CD16, and a CAR encoded by instant SEQ ID NO: 41. Since the CAR taught by Soon-Shiong is structurally identical to CAR recited in instant claims 1 and 9, the binding specificity of the CAR taught by Soon-Shiong is inherently the same as that of CAR recited in instant claims 1 and 9. Instant SEQ ID NO: 35 is identical to aa 424-677 of Soon-Shiong’s SEQ ID NO: 28 (see SCORE). Accordingly, the nucleic acids and transfected NK-92 cells taught by Soon-Shiong are within the scope of instant claims 1-2, 4-7 and 9-11, thereby anticipating these claims.
Claim 3 is anticipated, because Soon-Shiong exemplifies IL-15 as a recombinant cytokine expressed by NK-92 cells (e.g. [0066], [0115]).
Claim 8 is anticipated, because Soon-Shiong teaches that stable expression of the transgenes in NK-92 cells is achieved by incorporating the expression cassette into the genome (e.g. [0065], [0086], [0087]).
Claims 12-14 are anticipated, because Soon-Shiong teaches treating cancer such as acute myelogenous leukemia (AML) by administering the CAR-expressing NK-92 cells (e.g. the Abstract, [0010], [0021], [0131], [0146]).
9. 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 §§ 706.02(l)(1) - 706.02(l)(3) 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.
10. Claims 1-6 and 9-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 12403178.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the claims of US ‘178.
The latter recite a genetically modified NK cell expressing a CAR of SEQ ID NO: 16 (claims 1, 8, 17). SEQ ID NO: 16 is identical to a polypeptide encoded by instant SEQ ID NO: 41 (see SCORE). Since the CAR recited in US ‘178 is structurally identical to CAR recited in instant claims 1 and 9, the binding specificity of the CAR recited in US ‘178 is inherently the same as that of CAR recited in instant claims 1 and 9.
US ‘178 claims recite that the NK cells further comprise CD16 (claims 4, 17) and a cytokine such as IL-2 or IL-15 (claim 20). US ‘178 claims further recite a method for reducing the number of myeloid-derived suppressor cells (MDSC), tumor associated macrophages (TAM), or both, in a subject in need thereof, comprising: administering to the genetically modified NK cells to the subject (claims 12-16). It would be clear to a person of skill in the art that a subject in need of reducing tumor associated macrophages has a tumor.
Claim 4 is included in the rejection, because SEQ ID NO: 35 is the sequence of CD16, and as such is inherent in US ‘178 claims. Claim 13 is included, because a person of skill in the art would at once envisage the recited generic cancer treatment modalities. Claim 14 is included, because it lists most common cancer types.
11. Claims 1-6 and 9-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending application USSN 18/945002, published as US 20250073305.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the claims of USSN ‘002. The latter are directed to subject matter identical to that claimed in U.S. Patent No. 12403178 (described in section 10 above), of which USSN ‘002 is a continuation. Therefore, USSN ‘002 claims anticipate instant claims for the same reasons as articulated in section 10 above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
12. The following is noted regarding additional potential double patenting issues:
Instant application claims priority as a divisional to USSN 17341098 and 17056385, now US Patents No. 11643452 and 12435122, respectively. The claims of these patents are directed to NK cells expressing CARs which are different from the instantly recited CAR, and as such neither anticipate nor make obvious the presently claimed invention.
US Patent No. 11813292 issued from application 16/966868, which as published as 20210038645 described in section 8 above. The claims of US ‘392 recite NK-92 cells expressing the same CAR as recited in instant claims, but do not recite recombinantly expressed cytokine or CD16. Based on the present record, it appears that before the effective filing date of the claimed invention there was not sufficiently specific suggestion or motivation in the art to recombinantly express both a cytokine and CD16 in NK-92 cells expressing a CAR. Therefore, US ‘392 are deemed to neither anticipate not make obvious the presently claimed invention.
13. Conclusion: no claim is allowed.
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/ILIA I OUSPENSKI/ Primary Examiner, Art Unit 1644