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 with traverse of Group I (claims 1-9) in the reply filed on 04/12/2026 is acknowledged.
The traversal is on the ground(s) that the claims require expression of IL-15Rα and the Xu reference is completely silent on IL-15Rα and thus fails to teach or suggest this feature.
This is not found persuasive because not all the claims require IL-15Rα. The claims have been restricted under Lack of Unity practice PCT Rule 13.1. For example, claims 1-2, 5-6, 7-21 do not necessarily require IL-15Rα and thus IL-15Rα is not a common technical feature that links all the claims as is required for unity of invention.
In addition, Applicant argues that the subject matter of all claims is sufficiently related that a thorough search for the subject matter of any one Group of claims would encompass a search for the subject matter of the remaining claims and thus there would be no serious burden to examine all the claims. Applicant points to MPEP 803 with regard to the teaching on lack of burden.
This is not found persuasive because burden is not a consideration in a lack of unity restriction.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-21 are currently pending.
Claims 10-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 04/12/2026.
Claims 1-9 have been examined on their merits.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1-2, 5, 7-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xu et al (machine translation for CN-103484429-A published 2014) as evidenced by Sentman et al (WO 2017/190100).
Regarding claims 1 and 7, Xu disclose feeder cells in which NCR3LG1 (=B7H6) is expressed and a composition for proliferating natural killer cells comprising the same (abstract, claims 1-7 and pages 3-4 paragraphs 22-24).
The term “B7H6” refers to natural killer cell cytotoxicity receptor 3 ligand 1, a specific ligand for the NK cell activating receptor NKp30 (as disclosed in Applicant’s Specification page 8 para 56) and is also known as “NCR3LG1” as evidenced by Sentman (page 19 para 85).
Regarding claims 2 and 8, Xu disclose feeder cells that express NCR3LG1 (=B7H6) and IL-15 (abstract, claims 1-7 and pages 3-4 paragraphs 22-24).
Regarding claims 5 and 9, Xu disclose feeder cells are K562 cells that express NCR3LG1 (=B7H6) and IL-15 (abstract, claims 1-7 and pages 3-4 paragraphs 22-24).
Therefore, the teaching of Xu et al anticipates Applicant’s invention as claimed.
.
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.
Claim(s) 2-4 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Xu et al (machine translation for CN-103484429-A published 2014) as evidenced by Sentman et al (WO 2017/190100) in view of Wickham et al (KR 20200140279- machine translation).
Regarding claims 2-4 and 8, Xu disclose K562 feeder cells in which NCR3LG1 (=B7H6) and IL-15 are expressed and a composition for proliferating natural killer cells comprising the same (abstract, claims 1-7 and pages 3-4 paragraphs 22-24).
The term “B7H6” refers to natural killer cell cytotoxicity receptor 3 ligand 1, a specific ligand for the NK cell activating receptor NKp30 (as disclosed in Applicant’s Specification page 8 para 56) and is also known as “NCR3LG1” as evidenced by Sentman (page 19 para 85).
Xu do not disclose wherein the feeder cells also express CD137L or IL15Rα.
Wickham disclose red blood cells that have been constructed to contain exogenous stimulating peptides on the cell surface that are sufficient to stimulate immune killer cells, specifically natural killer cells (NK) (abstract, page 4 lines 1-8, pages 6-7). The manufactured red blood cells comprise exogenous stimulating polypeptides such as IL-15, IL-15Rα, and 4-1BBL wherein 4-1BBL is also known as CD137L (pages 7-9, page 13, page 49). These manufactured cells activate and stimulate NK cells to expand (page 23).
One of ordinary skill in the art would have been motivated to modify the feeder cells of Xu to express CD137L (4-1BBL) and IL15Rα in addition to NCR3LG1 (B7H6) and IL-15 because Wickham teach and suggest that CD137L (4-1BBL) and IL15Rα also activate and stimulate NK cells to expand. One of ordinary skill in the art would have had a reasonable expectation of success because both Xu and Wickham are directed to making and using cells manufactured to express exogenous peptides for the purpose of stimulating natural killer cells to expand.
Therefore, the combined teachings of Xu et al and Wickham et al render obvious Applicant’s invention as claimed.
Claim(s) 2-6 and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Xu et al (machine translation for CN-103484429-A published 2014) as evidenced by Sentman et al (WO 2017/190100) in view of Liu et al (WO 2015/154012) and Fey et al (US 2009/0220501).
Regarding claims 2-4 and 8, Xu disclose K562 feeder cells in which NCR3LG1 (=B7H6) and IL-15 are expressed and a composition for proliferating natural killer cells comprising the same (abstract, claims 1-7 and pages 3-4 paragraphs 22-24).
The term “B7H6” refers to natural killer cell cytotoxicity receptor 3 ligand 1, a specific ligand for the NK cell activating receptor NKp30 (as disclosed in Applicant’s Specification page 8 para 56) and is also known as “NCR3LG1” as evidenced by Sentman (page 19 para 85).
Xu do not disclose wherein the feeder cells also express CD137L or IL15Rα.
Liu disclose methods of producing natural killer (NK) cell populations using feeder cells that are genetically engineered to trans-present IL-15 involving co-expressing Il-15 and IL-15 receptor α subunit (IL-15Rα) that are capable of stimulating the expansion of NK cells in vitro (abstract, page 20 para 55, page 37 para 134-135, page 44 para 163). Additional NK stimulating factors in addition to IL-15 trans-presentation include 4-1BBL (also known as CD137L), which have been shown to enhance NK proliferation in in vitro cultures (page 56 para 198).
One of ordinary skill in the art would have been motivated to modify the feeder cells of Xu to express CD137L (4-1BBL) and IL15Rα in addition to NCR3LG1 (B7H6) and IL-15 because Liu teach and suggest that CD137L (4-1BBL), IL-15 and IL15Rα also activate and stimulate NK cells to expand. One of ordinary skill in the art would have had a reasonable expectation of success because both Xu and Liu are directed to making and using cells manufactured to express exogenous peptides for the purpose of stimulating natural killer cells to expand.
Regarding claims 5-6 and 9, Xu disclose K562 feeder cells in which NCR3LG1 (=B7H6) and IL-15 are expressed and a composition for proliferating natural killer cells comprising the same (abstract, claims 1-7 and pages 3-4 paragraphs 22-24).
The term “B7H6” refers to natural killer cell cytotoxicity receptor 3 ligand 1, a specific ligand for the NK cell activating receptor NKp30 (as disclosed in Applicant’s Specification page 8 para 56) and is also known as “NCR3LG1” as evidenced by Sentman (page 19 para 85).
Xu do not disclose wherein the feeder cells are ARH77.
Liu disclose the use of one or more feeder cells in their method, such as K562 (page 20 para 56), and that additional feeder cells can also be used with non-limiting examples including EBV-B lymphoblastoid cells (EBV-BLCL) (page 20 para 56-57, page 56 para 199).
Fey disclose that ARH77 is an EBV-transformed B-lymphoblastoid cell line from the American Type Culture Collection, ATCC (page 7 para 83).
One of ordinary skill in the art would have been motivated to use ARH77 as the feeder cells in Xu, either in addition to K562 or as an alternative to K562, because Liu teach and suggest that additional feeder cell types can be modified and used to stimulate NK cells for expansion. Liu specifically suggest EBV-B lymphoblastoid cells (EBV-BLCL) can be used as a feeder cell type for this purpose and Fey indicate that ARH77 is a cell line that is an EBV-transformed B-lymphoblastoid cell. One of ordinary skill in the art would have had a reasonable expectation of success because both Xu and Liu are directed to making and using cells manufactured to express exogenous peptides for the purpose of stimulating natural killer cells to expand.
Therefore, the combined teachings of Xu et al, Liu et al and Fey et al render obvious Applicant’s invention as claimed.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Weiner et al., “Method for Cultivating HCV in Eukaryotic Cell”, JP 2004049235, published 2004-02-19, machine translation pp. 1-22.
Weiner disclose that related human leukocyte cell lines include K562 and ARH77 (page 15 para 69).
Duck et al., “Method of NK cell Activity Assay Using Cancer Cell Line Stably Expressing Luciferase”, KR 20130083267, published 2013-07-22, pp.
Duck disclose that related cell lines are K562 and ARH77 (abstract, page 10, claim 2).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA J SCHUBERG whose telephone number is (571)272-3347. The examiner can normally be reached 8:30-5:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James (Doug) Schultz can be reached at 571-272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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LAURA J. SCHUBERG
Primary Examiner
Art Unit 1631
/LAURA SCHUBERG/ Primary Examiner, Art Unit 1631
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