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
1. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5/5/26 has been entered.
Applicant’s amendment and response filed 5/5/26 is acknowledged and has been entered.
2. Applicant is reminded of Applicant's election without traverse of Group I, drawn to a method of selecting universal donor NK cells for therapeutic administration comprising the recited method steps and to a method of preparing a population of universal donor NK cells for therapeutic administration comprising selecting the cells and exposing the cells to IL-21 (the protein) in vitro for a time sufficient to expand the NK cells, in Applicant’s said amendment and response filed 9/5/2024.
Claims 1-3, 5, 19-21, 25-31, 33-40 and 42-45 are presently being examined. Claims 1, 19, 28 and 37 are independent claims.
3. Applicant’s amendment filed 5/5/26 has overcome the prior rejection of record of claims 1-3, 5, 28-31 and 37-40 under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Applicant has amended the claims to recite an active method step of activating the NK cells by incubating the cells in vitro in the presence of IL-21.
4. 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.
5. Claims 26, 27, 35, 36, 44 and 45 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. Amer. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406; Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by "whatever characteristics sufficiently distinguish it"). "Compliance with the written description requirement is essentially a fact-based inquiry that will ‘necessarily vary depending on the nature of the invention claimed.' " Enzo Biochem, 323 F.3d at 963, 63 USPQ2d at 1612. An invention described solely in terms of a method of making and/or its function may lack written descriptive support where there is no described or art-recognized correlation between the disclosed function and the structure(s) responsible for the function. See MPEP 2163 I.A.
An applicant may also show that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics which provide evidence that applicant was in possession of the claimed invention, i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics. Enzo Biochem, 323 F.3d at 964, 63 USPQ2d at 1613 (quoting the Written Description Guidelines, 66 Fed. Reg. at 1106, n. 49, stating that "if the art has established a strong correlation between structure and function, one skilled in the art would be able to predict with a reasonable degree of confidence the structure of the claimed invention from a recitation of its function".). "Thus, the written description requirement may be satisfied through disclosure of function and minimal structure when there is a well-established correlation between structure and function." See MPEP 2163 II.3.
Applicant has broadly claimed a method for preparing a population of selected donor NK cells, a method for preparing and activating a collection of NK cells from a donor, or a method of cell preparation and activation [of NK cells], wherein any one of the FC21, PM21 or EX21 used in the claimed method further comprises NKG2D agonists, NKp46 agonists, NKp44 agonists, NKp30 agonists and CD16 agonists.
Each said agonist must possess the functional property of binding to the recited receptor (i.e., NKG2D, NKp46, NKp44, NKp30, CD16) and possessing agonist activity.
The specification does not disclose a representative number of species of such agonist that is used in the claimed method, nor sufficient relevant identifying characteristics in the form of structure or functional characteristics coupled with a known or disclosed correlation between structure and function. There is no evidence for a representative number of such agonists, nor a structure/function relationship.
The art defines agonist as “a molecule that can bind and activate a receptor to induce a biological response” with agonists including endogenous, exogenous, physiological, superagonist, full, partial, inverse, irreversible, selective, and co-agonist, with each type of agonist exhibiting different characteristics and mediating distinct biological activity (see evidentiary reference Biology Dictionary, 2022, pages 1-4).
The specification does not provide disclosure for what structures and/or sequences constitute an agonist for any of the said particular recited receptors.
Just for agonist antibodies alone, there are a large multitude of antibodies having different sequences, particularly in the CDRs that provide most of the contact with a cognate antigen, for antibodies that bind to a same antigen, a same epitope of an antigen, or an overlapping epitope of a same antigen, and then not all have agonist activity. Experimentation would have to be performed to discover such agonist antibodies. This example speaks to lack of a structure/function relationship and lack of a representative number of species of agonist antibodies. However, the agonists may potentially also be non-antibody molecules (e.g., proteins, small molecules), and equally there is no evidence for a representative number of species of such agonists or a structure/function relationship between structure and the two requisite functional properties of binding to their receptors and receptor agonism.
For the example of agonist antibodies, the art recognizes that the sequence of an antibody that binds to a same protein or other target antigen, a same epitope an antigen, or to overlapping epitopes of an antigen is broad and structurally diverse. The following evidentiary references are exemplary.
Poosarla et al. (Biotechn. Bioeng., 2017, 114(6): 1331-1342) teach substantial diversity in designed mAbs (sharing less than 75% sequence similarity to all existing natural antibody sequences) that bind to the same 12-mer peptide, binding to different epitopes on the same peptide. Said reference further teaches “most B-cell epitopes…in nature consist of residues from different regions of the sequence and are discontinuous...de novo antibody designs against discontinuous epitopes present additional challenges...". (See entire reference.)
Khan and Salunke (J. Immunol, 2014, 192: 5398-5405) teach that two structurally diverse germline mAbs recognizing overlapping epitopes of the same short peptide do so in different topologies, the said antibodies possessing entirely different CDR sequences. Said reference teaches that unrelated mAbs structurally adjust to recognize an antigen, indicating that the primary B cell response is composed of BCRs having a high degree of structural adaptability. Said reference also teaches that the common epitope(s) also adopt distinct conformations when bound to different mAbs, with the higher degree of structural plasticity inherent to the mAbs. Said reference further teaches “It has been shown that both the framework region and the CDRs have a considerable amount of inherent conformational plasticity…Therefore, it is not surprising that distinct germline Abs recognize the same epitope by rearranging the CDR conformations. This may well have implications of Ag specificity beyond the naïve BCR repertoire, because Kaji et al….have shown in a recent report that the B cell memory can contain both germline-encoded and somatically mutated BCRs.” (See entire reference).
Lloyd et al. (Protein Engineering, Eng. Design & Selection, 2009, 22(3): 159-168) teach that a large majority of VH/VL germline gene segments are used in the antibody response to an antigen, even when the antibodies were selected by antigen binding. Said reference further teaches that in their studies, of the 841 unselected and 5,044 selected antibodies sequenced, all but one of the 49 functional VH gene segments was observed, and that there are on average about 120 different antibodies generated per antigen. Said reference also teaches that a wide variety of VH and VL pairings further increase diversity. (See entire reference.)
Edwards et al. (JMB, 2003, 334: 103-118) teach that over 1,000 different antibodies to a single protein can be generated, all with different sequences, and representative of almost the entire extensive heavy and light chain germline repertoire (42/49 functional heavy chain germlines and 33 of 70 V-lamda and V-kappa light chain germlines, and with extensive diversity in the HCDR3 region sequences (that are generated by VDJ germline segment recombination) as well.
Therefore, it appears that the instant specification does not adequately disclose the breadth of the said agonist used in the method recited in the instant claims. In light of this, a skilled artisan would reasonably conclude that Applicant was not in possession of the genus of all such agonists and hence not in possession of the claimed method at the time the instant application was filed.
6. 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.
7. Claims 25, 34-36 and 43-45 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.
a) Claim 25 is indefinite in the recitation of “IL-21 in solution mixed to be in co-contact with the NK cells” because it is not clear what is meant as the IL-21 present on FC21, PM21, and EX21 are not soluble IL-21, but rather the IL-21 is present on feeder cells, plasma membrane particles, or exosomes.
b) Claim 34 is indefinite in the recitation of “IL-21 in solution mixed to be in co-contact with the NK cells” because it is not clear what is meant as the IL-21 present on FC21, PM21, and EX21 are not soluble IL-21, but rather the IL-21 is present on feeder cells, plasma membrane particles, or exosomes.
c) Claim 43 is indefinite in the recitation of “IL-21 in solution mixed to be in co-contact with the NK cells” because it is not clear what is meant as the IL-21 present on FC21, PM21, and EX21 are not soluble IL-21, but rather the IL-21 is present on feeder cells, plasma membrane particles, or exosomes.
8. Applicant’s amendment filed 5/5/26 has overcome the prior rejection of record of claims 1, 2, 28, 30, 37 and 39 under 35 U.S.C. 102(a)(i) as being anticipated by Pittari et. al. (J. Immunol. 2013, 190: 4650-4660, IDS reference) or WO2015154012 A1 (IDS reference).
Applicant has amended the claims to recite that the NK cells are activated by incubating the NK cells in vitro in the presence of IL-21, a limitation that the reference does not teach. However, for completeness of the record, the art reference does teach a donor cell that inherently comprises a genotype of C1:C2, B24, 2DS1, 2DL3 and 3DL1, rebutting Applicant’s arguments re: the presence or absence of HLA-C2.
9. Applicant’s amendment filed 5/5/26 has overcome the prior rejection of record of claims 1-3, 5, 28-31 and 37-40 under 35 U.S.C. 103 as being unpatentable over Cooley et al. (Blood, 2009, 113(3): 726-732, of record) in view of WO2018169793 A1 (of record), McQueen et al. (IDS reference), and Handgretinger et al. (Blood, 2016, 127(26): 3341-3349, IDS reference).
Applicant has amended the claims to recite that the NK cells are activated by incubating the NK cells in vitro in the presence of IL-21, a limitation that the references do not teach.
Also, for completeness of the record even if this were not the case, Cooley does not teach selecting donor cells having all of C1, C2 and Bw4 genotypes, but rather teaches that the KIR genes segregate independently of HLA; nor do the secondary reference teach the presence of both HLA-C1 and HLA-C2 on donor cells also expressing Bw4. Additionally, although the secondary reference McQueen et al. teaches that all genes of the group A haplotype are represented in the group B haplotypes, evidentiary reference Hernandez et al. (Nature.com/scientific reports, 2018, 8:6014: 1-9) presently provided by the Examiner teaches lack of a 3DL1 KIR in the KIR B/B homozygous genotype. Consideration of these elements would be sufficient to withdraw the prior rejection of record.
Applicant’s argument ---the said argument being that while Cooley teaches the consideration of absence or presence of KIR B haplotypes in the selection of an HSC donor from among the HLA-matched HSC donors specifically identified for a given recipient, Cooley does not contemplate the use of specified activation KIRs as a criterion of selecting NK cell donors that would be suitable for multiple recipients--- is not persuasive. Applicant is arguing a non-recited limitation in arguing that the said primary art reference does not teach donors that would be suitable for multiple recipients. Also, Cooley teaches the protective effect of B/x donors was similar in recipients having different combinations of HLA-C and HLA-B epitopes that bind to KIRs, i.e., the protective effect was similar in any recipient with any HLA-C and HLA-B (paragraph preceding the Discussion section). Also, Applicant’s argument regarding haplotype assignment in Cooley involving at least one of KIR2DL5, 2DS1, 2DS2, 2DS3, 2DS5, or 3DS1 is not persuasive, as Cooley teaches one of these KIRs is indicative of the presence of the other KIRs in the B/x haplotype.
10. Applicant’s amendment filed 5/5/26 has overcome the prior rejection of record of claims 19-21, 25-27, 32-36 and 41-45 under 35 U.S.C. 103 as being unpatentable over Cooley et. al. (Blood, 2009, 113(3): 726-732, of record) in view of WO2018169793 A1 (of record), McQueen et al. (IDS reference), and Handgretinger et. al. (Blood, 2016, 127(26): 3341-3349, IDS reference), as applied to claims 1-3, 5, 28-31 and 37-40 above, and further in view of WO2014037422 A1 (of record) and WO2016197108 A1 (IDS reference).
This rejection is overcome for the same reasons cited above at item #7, and the additional two cited references do not provide the requisite limitations.
11. 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.
12. 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.
13. Claims 1-3, 28-30, 33-39 and 42-45 are rejected under 35 U.S.C. 103 as being unpatentable over Pittari et al. (J. Immunol. 2013, 190: 4650-4660, IDS reference) or WO2015154012 A1 (IDS reference), either one in view of WO2014037422 A1 (of record) and WO2016197108 A1 (IDS reference).
Independent claim 1 recites:
1. (Currently Amended) A method of preparing and activating a collection of NK cells, the method comprising:
selecting candidate NK cells from a donor, the candidate NK cells having (i) an HLA genotype carrying C1, C2, and Bw4 alleles and (ii) a KIR genotype or phenotype possessing inhibitory KIRs comprising 2DL1, 2DL2 or 2DL3, and 3DL1, as selected donor NK cells, and
preparing a collection of NK cells from the selected donor NK cells selected from said donor, and activating the collection of NK cells by incubating the collection of NK cells in vitro in the presence of IL-21.
Independent claim 28 recites:
28. (Currently Amended) A method of preparing and activating a collection of NK cells from a donor, the method comprising:
a) selecting from one or more donors a selected donor having (i) an HLA
genotype carrying C1, C2, and Bw4 alleles and (ii) a KIR genotype or phenotype possessing inhibitory KIRs comprising 2DL1, 2DL2 or 2DL3, and 3DL1; and
b) preparing a collection of NK cells from an ex vivo batch of NK cells of said
selected donor, and
c) activating the collection of NK cells by incubating the collection of NK cells in vitro in the
presence of IL-21.
Independent claim 37 recites:
37. (Currently Amended) A method of cell preparation and activation, the method comprising preparing a collection of NK cells from an ex vivo batch of NK cells of a selected donor, wherein the selected donor is selected from one or more donors having (i) an HLA genotype carrying C1, C2, and Bw4 alleles and (ii) a KIR genotype or phenotype
possessing inhibitory KIRs comprising 2DL1, 2DL2 or 2DL3, and 3DL1, and activating the collection of NK cells by incubating the collection of NK cells in vitro in the presence of IL-21.
Claim interpretation: The limitation “collection of NK cells” is not defined in the instant specification; therefore, the said limitation is being interpreted as including a collection of identical cells that make up an NK clone population, i.e., a group of NK cells that are genetically identical and share the exact same characteristics, created by taking a single predecessor NK cell and allowing it to divide and multiply in a lab setting. The limitations “an HLA genotype carrying C1, C2, and Bw4 alleles” and “a KIR genotype…possessing inhibitory KIRs comprising 2DL1, 2DL2 or 2DL3, and 3DL1” that is recited in each said base claim is being interpreted as the HLA genotype having been assessed for at least HLA-C1 group, HLA-C2 group, and Bw4 group alleles and the KIR genotype having been assessed for at least KIR 2DL1, 2DL2 or 2DL3, and 3DL1, while the dependent claims that recite obtaining a KIR genotype and/or obtaining an HLA genotype of the candidate NK cells is being interpreted as being further limiting as the KIRs and HLAs recited in the said base claims are not the only KIRs and HLAs that may be present in the respective genotypes. Please note that although all NK cells of an individual have the same HLA and KIR genotype (i.e., with regard to the latter, the same genetic blueprint in terms of the same set of possible KIR genes in their genomic DNA), they do not express all of these KIRs at the same time, leading to a mosaic pattern (for example, one NK might express one combination of KIRs while another NK cell from the same individual may express a different combination of KIRs). Note therefore that in the instant claims wherein the KIR genotype and phenotype are recited in the alternative, the selected NK cells may not have a KIR expression (i.e., a phenotype) that matches the genotype (although in total bulk NK cells from peripheral blood, the collective phenotype across all NK cells would be expected to have phenotype matching the genotype, while individual NK cells in the population would not necessarily have the matching phenotype). The instant base claims recite the open transitional phrase “comprising” (“the method comprising”), opening the claims to encompass other method steps and/or ingredients. The instant specification does not disclose a limiting definition for the limitation “candidate NK cells”. Thus, the said limitation is being interpreted broadly as any NK cells from a donor, wherein the donor/the bulk NK cells has/have the recited HLA and KIR genotypes. There is no requirement in the instant claims that the collection of NK cells must possess the recited KIR phenotype, as the KIR genotype is recited in the alternative to the KIR phenotype.
Pittari et al. teach obtaining NK cells from seven individuals, five healthy donors and two transplant (HCT) recipients), wherein HLA class I genotyping and KIR genotyping was performed on genomic DNA (NK cell donor section and Table 1). HCT donor NK cells from subject UDN007 were positive for HLA C1:C2 and Bw4 and positive for KIR 2DL1, 2DL3, and 3DL1 as well as 2DS1 and 3DS1 (Table I). Pittari et al. teach that NK cells from this donor were detected in the PMBC of the transplanted patient and that the said NK cells proliferated. Pittari et al. also teach donor NK cells from C1:C2 and Bw4 positive individuals, positive for KIR 2DL1, 2DL2/DL3, 3DL1, and also positive for 2DS1, 2DS2, and 3DS1 (UDN 004 and UDN005, Table 1). Pittari et al. further teach protection from relapse of AML following HCT from 2DS1 (NK cell) donors with the HLA-C genotypes C1:C1 and C1:C2, but that the HLA-C2 homozygous donors have significantly reduced frequency of 2DS1 clones (second paragraph on page 11). Pittari et al. teach propagating NK clones with IL-15 (NK cloning section). (See entire reference).
Thus Pittari et al. inherently teach that there is a step of selecting candidate NK cells from a donor, the donor and their NK cells having an HLA genotype carrying C1, C2, and Bw4 alleles and a KIR genotype possessing inhibitory KIRs comprising 2DL1, 2DL2 or 2DL3, and 3DL1 (donors UDN 004, 005 and 007) by virtue of selecting a donor and isolating their bulk NK cells initially followed by preparing a collection of NK cells from the selected NK cells (by virtue of single cell deposition and generating a batch of identical cells from an NK clone). (This is so regardless of other donors being selected who do not possess the recited genotype since the instant claims recite the open transitional phrase “comprising” as is enunciated above in the claim interpretation of this rejection.) Donors UDN 004 and 005 also have NK cells possessing a KIR genotype comprising at least three activating KIRs comprising 3DS1 and 3DS1. The collection of NK cells that is prepared is the NK clone preparation (i.e., it is an NK cell collection of identical cells) that is prepared from an ex vivo batch of NK cells (that were isolated from the donor having the recited genotype). The claims recite that the selected candidate NK cells from the donor have the recited KIR genotype or phenotype, a recitation of genotype or phenotype in the alternative; thus, selecting a donor/NK cells having the recited genotype meets the claim limitation.
WO2015154012 A1 also provides the same said teachings (see entire reference, especially Table I for donor “UDN 007”, UDN 004, and 005, [0047]).
Pittari et. al. or WO2015154012 A1 do not teach wherein the NK cells are exposed to either soluble IL-21 or IL21 on feeder cells, nor to 41BBL, either soluble of on feeder cells.
WO2014037422 A1 teaches an in vitro method for expanding NK cells of a given KIR specificity comprising selecting donor cells of a given KIR specificity and contacting them with IL-21, either soluble or as an engineered membrane bound form expressed on feeder cells and/or another cytokine such as IL-12, IL-15, IL-7, including wherein the donor cells are heterozygous with respect to HLA-C1/C2. WO2014037422 A1 teaches administering these cells to a patient having AML. WO2014037422 A1 further teaches that anti-CD92 and/or anti-NKG2A antibodies may also be used to expand the NK cells (see entire reference, especially claims, paragraph spanning pages 17-18).
WO2016197108 A1 teaches a method of treating a disease such as leukemia in a subject by administering NK cells (e.g., abstract, claims). WO2016197108 A1 teaches that artificial antigen presenting cells or aAPCs (a type of feeder cell, e.g., [0053]) are useful in preparing therapeutic compositions and cell therapy products ([0066]), including wherein the aAPCs may comprise at least one exogenous assisting molecule such as costimulatory molecules such as for example 41BBL and IL-21 and adhesion molecules ([0067]).
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to have contacted the NK cells (i.e., the collection of NK cells identical to the original clone NK cell) taught by the primary art reference with IL-21 in vitro, either in soluble form or in the form of an engineered cell-surface expressed form as taught by WO2014037422 A1, or with the aAPCs comprising 41BBL and/or IL-21 taught by WO2016197108 A1.
One of ordinary skill in the art would have been motivated to do this, and with a reasonable expectation of success in doing so in order to expand the donor NK cells to sufficient numbers for administration, particularly in light of the teaching of WO2014037422 A1 that the donor cells can be contacted with IL-21 alone or in combination with IL-15 and the teaching of WO2016197108 A1 that NK cells for therapeutic administration can be prepared using aAPCs comprising 41BBL and IL-21.
Applicant’s arguments in the amendment and response filed 5/5/26 on pages 16-17 have been fully considered but are not persuasive.
Contrary to Applicant’s assertion that the primary art reference does not teach each and every element of the claims and teaches away from the claimed subject matter (but does not explain the latter assertion), the primary art reference does teach a donor that has a genotype of C1:C2, Bw4, 2DS1, 2DL3 and 3DL1 (plus or minus 2DS2 as well). This also rebuts Applicant’s argument that the secondary art references do not teach or suggest NK cells having the recited genotype carrying all of the recited alleles. The primary art reference does teach donors/NK cells that have the recited genotype. The instant claims require that the NK cells or the donor have the recited genotype. As is enunciated in the instant rejection in the claim interpretation section, the donor and the NK cells of that donor have the same genotype. The art references meet the claim limitations.
14. Claims 5, 31 and 40 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
15. Claims 19-21 are allowed.
16. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIANNE DIBRINO whose telephone number is (571)272-0842. The examiner can normally be reached on M, T, Th, F.
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/Marianne DiBrino/
Marianne DiBrino, Ph.D.
Patent Examiner
Group 1640
Technology Center 1600
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641
Prosecution Insights