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 .
Application Status
Claims 68-92 are pending and examined on the merits herein.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter “Legal Framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS: Specific deficiency - The incorporation by reference paragraph required by 37 CFR 1.834(c)(1), 1.835(a)(2), or 1.835(b)(2) is missing, defective or incomplete.
Required response - Applicant must:
• Provide a substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph, consisting of:
• A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
• A copy of the amended specification without markings (clean version); and
• A statement that the substitute specification contains no new matter.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code on pages 25-65, 125, and 163-164. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The use of the term “G-Rex” (pages 20, 103-104, 138, and 146-147) which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 USC § 112(b)
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.
Claims 68, 82 and 85-88 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.
Regarding claim 68, in line 16 the claim recites “or other target antigen (marker)” expressed by a target cell”: the inclusion of the term “marker” in parentheses makes the claim indefinite as it is unclear if this is a required limitation of the claim.
Regarding claims 82 and 85, use of the term “similar to” in regards to chromosome sequence renders this limitation indefinite as it is unclear whether the sequence must be identical or if “similar to” allows for additional variation in the sequence identity.
Claims 86-88 depend from claim 85 but do not clarify the issue identified above and are therefore included in this rejection.
The term “substantially enriched” in claim 85 is a relative term which renders the claim indefinite. The term “substantially enriched” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The instant specification teaches preferably separating the cells bound by a CD16 antibody thereby obtaining the composition substantially enriched in human CD16+ and culturing thereafter (para 0122 and 0133), this still does not give the ordinary artisan a specific metric to determine what constitutes “substantially enriched.”
Claims 86-88 depend from claim 85 but do not clarify the issue identified above and are therefore included in this rejection.
Claim Rejections - 35 USC § 112(a)
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.
Claims 82 and 85-88 are rejected under 35 U.S.C. 112, first paragraph, as containing subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention
The claims in question recite a human natural killer cell with the deposit information at NPMD under NITE BP-03017. It is apparent that the recited natural killer cell is required to practice the claimed invention. However, it is not clear if the written description is sufficiently repeatable to avoid the need for a deposit. Further, it is unclear if the starting materials were readily available to the public at the time of invention.
Within the documents submitted with the 371 National Stage Application filed 14 July 2022, it is indicated that the deposited material was accepted under the Budapest Treaty on 2 September 2019. It is not clear is the deposit meets all of the criteria set forth in 37 CFR 1.801-1.809. The Applicant has not averred that all restrictions on the availability to the public of the materials so deposited will be irrevocably removed upon the granting of a patent. Moreover, while the deposits were referred to in the body of the specification and include deposit numbers and names of the depositories, the addresses of the depositories is not provided. Applicant or applicant’s representative may provide assurance of compliance with the requirements of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, in the following manner.
SUGGESTION FOR DEPOSIT OF BIOLOGICAL MATERIAL
A declaration by applicant, assignee, or applicant's agent identifying a deposit of biological material and averring the following may be sufficient to overcome an objection and rejection based on a lack of availability of biological material.
Identifies declarant.
States that a deposit of the material has been made in a depository affording permanence of the deposit and ready accessibility thereto by the public if a patent is granted. The depository is to be identified by name and address.
States that the deposited material has been accorded a specific (recited) accession number.
States that all restriction on the availability to the public of the material so deposited will be irrevocably removed upon the granting of a patent.
States that the material has been deposited under conditions that access to the material will be available during the pendency of the patent application to one determined by the Commissioner to be entitled thereto under 37 CFR 1.14 and 35 U.S.C § 122.
States that the deposited material will be maintained with all the care necessary to keep it viable and uncontaminated for a period of at least five years after the most recent request for the furnishing of a sample of the deposited microorganism, and in any case, for a period of at least thirty (30) years after the date of deposit for the enforceable life of the patent, whichever period is longer.
That he/she declares further that all statements made therein of his/her own knowledge are true and that all statements made on information and belief are believed to be true, and further that these statements were made with knowledge that willful false statements and the like so made are punishable by fine or imprisonment, or both, under section 1001 of Title 18 of the United States Code and that such willful false statements may jeopardize the validity of the instant patent application or any patent issuing thereon.
Alternatively, it may be averred that deposited material has been accepted for deposit under the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the purpose of Patent Procedure (e.g., see 961 OG 21, 1977) and that all restrictions on the availability to the public of the material so deposited will be irrevocably removed upon the granting of a patent.
Additionally, the deposit must be referred to in the body of the specification and be identified by deposit (accession) number, date of deposit, name and address of the depository and the complete taxonomic description.
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.
Claims 68-83, 85-87, and 89-92 are rejected under 35 U.S.C. 103 as being unpatentable over Eamon (US 2019/0321402 A1; IDS entered July 14, 2022) and O’Dwyer (US 2018/0161371 A1; IDS entered July 14, 2022) as evidenced by DSMZ_KHYG-1 (DSMZ no: ACC 725; PTO-892), ATCC (ATCC CRL-2407 Product Sheet; PTO-892) and NIH (Human Genomic Variation, 2023; PTO-892).
Regarding claims 68, 72, and 85, Eamon teaches a natural killer transiently expressing an Fc receptor from an extra-chromosomal nucleic acid (claim 1), wherein the Fc receptor is CD16 (claim 3) shown to be CD16 positive in Figure 3C and D, wherein the NK cell is of the KHYG-1 cell line (claim 6). Eamon further teaches that NK cells are cytotoxic lymphocytes, that are generally found to express the markers CD16 and CD56 and not CD3, wherein CD16 functions as an Fc receptor and mediates antibody dependent cell-mediated cytotoxicity (ADCC) (para 0006). The cells are derived from the KHYG-1 cell line therefore the cells are not derived from NK-92 (ATCC CRL-2407) or NK3.3 cell lines.
Regarding claim 69, Eamon teaches the modified NK cells lines used in the examples have been rendered incapable of division as a result of irradiation (para 0059).
Regarding claim 73, as evidenced by DSMZ, KHYG-1 cells are natural killer cell leukemia cells derived from the peripheral blood of a 45 year old woman with strong cytotoxic activity in 1997 (origin).
Regarding claims 75-76, Eamon teaches that several permanent NK cell lines have been established and the most notable is NK-92 which is derived from a patient with non-Hodgkin’s lymphoma (para 0010). A cell line that is “permanent” is capable of being cultured for multiple months.
Regarding claims 70 and 74, as evidenced by ATCC, NK-92 (CRL-2407) cells are derived from a 50 year old white male.
Regarding claims 82 and 85, as evidenced by NIH, on average a person’s genome sequence is ~99.6% identical to a reference human genome sequence; that person’s set of genomic variants accounts for the ~0.4% difference (page 1), therefore any human cell line would meet the limitation of 90 or 95% genomic sequence identity to the deposited NK cell line.
Regarding claim 83, Eamon teaches that NK cells generally express the marker CD16, but KHYG-1 cells have low expression of CD16 (para 006), therefore generation of the cells by sorting for CD16 rather than transfection would comprise natural expression of CD16.
Regarding claim 84, Eamon teaches resuspension of 1x10^6 cells in 200ul of buffer (para 185-187) which results in a composition of more than 5x10^5 cells and 5% of the total composition (as seen in Figure 3D).
Eamon does not teach that the NK cells express a chimeric antigen receptor (CAR) or the specific components of the CAR.
Regarding claim 68, 71, 77, and 89-91, O’Dwyer teaches a method of treating a CD38-expressing cancer by administering to a patient a natural killer (NK) cell expressing a chimeric antigen receptor (CAR) for CD38 (claim 1).
Regarding claim 78, O’Dwyer teaches that CAR transfected NK cells mock transfected as TRAIL control express CD107a (figure 14), therefore all of CAR NK cells are also CD107a+.
Regarding claims 79-80 and 86-87, O’Dwyer teaches co-stimulatory domains 41BB-CD3zeta in the CD38-CAR (para 0182).
Regarding claim 81, O’Dwyer teaches that the CAR comprises a defined polypeptide sequence expressed from an exogenous polynucleotide that has been introduced into the immune effector and that the cell targeting domain of the CAR is a single chain variable fragment (scFv) (figure 1a & b; para 0047).
Regarding claim 92, O’Dwyer teaches that CD38 is overexpressed in many solid tumors (para 0068) and in certain embodiments the cancer to be treated is a solid tissue tumor (para 0092).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to add a CAR and use the composition to treat cancer as taught by O’Dwyer to the NK cell composition comprising CD16+CD3-CD56+ NK cells with cytotoxic capability generated from KHYG-1 or NK-92 as taught by Eamon. This would result in a cytotoxic CD16+CD56+CD3- NK cell composition derived from NK-92 or KHYG-1 cells, further comprising a CD38-41BB-CD3zeta CAR to be used in the treatment of cancer. The ordinary artisan would have been motivated to do so because O’Dwyer teaches a method of treating a CD38-expressing cancer by administering to a patient a NK cell expressing a CD38-CAR. Further the ordinary artisan would recognize that the NK cells could be developed from multiple sources including cell lines such as NK-92, KHYG-1 or primary sources such as PBMC or umbilical cord blood. The ordinary artisan had a reasonable expectation of success to add a CAR to provide more targeted cancer immunotherapy into the CD16+ CD3-CD56+ NK cells to use as treatment for cancer.
Claim 88 is rejected under 35 U.S.C. 103 as being unpatentable over Eamon (US 2019/0321402 A1; IDS entered July 14, 2022) and O’Dwyer (US 2018/0161371 A1; IDS entered July 14, 2022) as evidenced by DSMZ_KHYG-1 (DSMZ no: ACC 725; PTO-892), ATCC (ATCC CRL-2407 Product Sheet; PTO-892) and NIH (Human Genomic Variation, 2023; PTO-892) as applied to claims 68-87, and 89-92 above, and further in view of Seong (KR20160066837A; English translation downloaded from Espacenet attached as NPL).
The teachings of Eamon and O’Dwyer as applied to claims 68-87 and 89-92 are detailed above.
Eamon and O’Dwyer to not teach a certain concentration or percentage of cells in the composition or culturing the NK cells in a container with human platelet lysate and IL-2 for multiple days.
Regarding claim 88, Seong teaches a method of culturing natural killer cells in medium containing platelet lysate (claim 1) wherein the platelet lysate comprises 0.1-5% (w/v) (claim 7) and the medium additionally comprises a cytokine (claim 40 consisting of IL-2 (claim 6) at 500 U/ml (para 0057). Seong further teaches that CD3-CD56+ cells are used as raw material for in vitro expansion of NK cells (para 0005). Seong further teaches that there is no difference in the proliferation rate, cytotoxicity , and phenotype of the plasma versus platelet lysate cultured NK cells that can further the mass production thereof (para 0074). Seong further teaches that CellGro™ medium is currently mainly used to culture high purity NK cells but it is very expensive and therefore not suitable for commercial production (para 0006).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to culture the cells as taught by Seong to the method of treatment with a CD38-CAR expressing CD16+CD56+CD3- NK cell composition as taught by Eamon and O’Dwyer. The ordinary artisan would have been motivated to do so because Seong teaches that the use of platelet lysate in combination with IL-2 versus the standard CellGro™ medium, produces stable NK population with no change in proliferation rate, cytotoxicity, and phenotype but less cost. The ordinary artisan has a reasonable expectation of success to use media comprising platelet lysate and IL-2 for in vitro expansion of the CAR CD16+CD3-CD56+ NK cells to be used for cancer therapy.
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. 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 § 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 68-76, 81-85, and 88-91 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 83-84, 86-87, 89, 91-92, 103, 112-113, 116, 118, 120-121, 124, 129, 132-133, 141-142, 145-146, 149-154, 156-162, and 164-165 of copending Application No. 17/423,044 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claims 68, 70-73, 77, and 90-91, the copending claims teach a human natural killer cell which has the following characteristics: i) derived from the human natural killer cell which is deposited at NPMD having the deposit number NITE BP-03017; and ii) expressing a CD16 receptor (withdrawn claim 83), wherein the cell further comprises at least an exogenous targeting unit complexed to the cell (withdrawn claims 89, 118, and 152), wherein the exogenous targeting unit comprises a targeting moiety that exhibits specific binding to a biological marker on a target cell (withdrawn claims 92 and 121) wherein the exogenous targeting unit comprises a targeting moiety comprises an antigen-binding unit, and the antigen-binding unit binds to a cancer antigen (withdrawn claims 103, 124, 129, 132-133, and 153-154), wherein the cell is capable of mediating an antibody-dependent cell cytotoxicity (ADCC) response, and the cell is a male cell (withdrawn claims 91, 120, 156 and 159).
Regarding claim 69, the copending claims teach the cell is non-tumorigenic in an immune compromised mouse and after being irradiated with y-ray, the cell is non-tumorigenic in an allogeneic subject. (withdrawn claims 86-87 and 116).
Regarding claim 76, the copending claims teach wherein the cell further has the following characteristic: iii) retaining its capability to proliferate after subculture for at least 3 months (withdrawn claims 84, 113, and 149)(claim 165).
Regarding claim 84, the copending claims teach a composition substantially enriched in human CD16+ natural killer cells, wherein the number of the human CD 16+ natural killer cells in the composition is at least 5 x 105 and the human CD 16+ natural killer cells are in an amount equal to or more than 5% by number, based on the total number of the cells in the composition as 100% (withdrawn claims 112, 145 and 161)(claim 164).
Regarding claims 83, 81-82 and 85, the copending claims teach a method of obtaining a composition substantially enriched in human CD16+ natural killer cells; the method comprising: (a) obtaining a population of human peripheral blood natural killer cells having the deposit number ATCC CRL-2407; (b) contacting the population of human peripheral blood natural killer cells with an antibody specific for a CD16 receptor; and (c) separating cells that are specifically bound by the antibody thereby obtaining the composition substantially enriched in human CD16+ natural killer cells; wherein the human CD16+ natural killer cell is: (A) deposited at NPMD having the deposit number NITE BP-03017; or (B) derived from the human natural killer cell which is deposited at NPMD having the deposit number NITE BP-03017 and having the following characteristics expressing a CD16 receptor (withdrawn claims 141 and 150), wherein the cell further comprising a synthetic, genetically modified and/or deliberately delivered polynucleotide encoding a target binding single-chain variable fragment (scFv) against an antigen (withdrawn claim 158)(claim 164).
Regarding claims 74-75 and 88, the copending claims teach wherein the step (c) comprises substeps: (cl) separating cells that are specifically bound by the antibody (c2) in a container, contacting the cells that are specifically bound by the antibody with a culture medium comprising human platelet lysate and IL-2; and (c3) culturing the cells for multiple days thereby obtaining the composition substantially enriched in human CD 16+ natural killer cells (withdrawn claim 142) and (x) in a container, contacting the human CD16+ natural killer cells obtained or derived from a population of NK-92 cells with a culture medium comprising 0.5-10 vol¾ human platelet lysate and 100-3000 IU/mL IL 2 500-3000 IU/mL IL-2; and (y) culturing the cells for multiple days, thereby producing the human CD16+ natural killer cells having sustained CD16 expression after at least a 1544-fold cell expansion (withdrawn claim 146).
Regarding claim 89, the copending claims teach a method of treating cancer, autoimmune disease, neuronal disease, human immunodeficiency virus (HIV) infection, hematopoietic cell-related diseases, metabolic syndrome, pathogenic disease, viral infection, or bacterial infection, comprising administering a composition comprising an effective amount of the human natural killer cell to a subject in need thereof, wherein the human natural killer cell is: deposited at NPMD having the deposit number NITE BP-03017 (withdrawn claims 151, 157, 160, and 162).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 68-78, 82, and 89-92 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1, 4, 6, 10, 20-22, and 35-39 of copending Application No. 18/717,216 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claims 68, 71, 77, and 90, the copending claims teach a method of treating a disease comprising administering an effective amount of effector cells to a subject with the disease: the effector cells comprise a surface and a population of targeting units complexed to the surface of the effector cells (claim 1), wherein the effector cells are cytotoxic cells (claim 4), wherein the effector cells are CD16+ cells (claim 6), wherein the specific interaction with a biological marker selected from a cancer antigen (claim 22), wherein the cytotoxic cell is a natural killer cell (claim 35).
Regarding claim 69, the copending claims teach wherein the effector cell is non-tumorigenic in an immune compromised mouse (claim 36).
Regarding claim 70, the copending claims teach wherein the effector cells are capable of mediating ADCC response (claim 10).
Regarding claim 72-75, the copending claims teach the cytotoxic cell and the NK cell line NK3.3 are derived from different subjects, the cytotoxic cell is derived from a subject with cancer, the cytotoxic cell is derived from a Caucasian male or the cytotoxic cell and NK cell having the deposit number ATCC CRL-2407 are derived from the same subject (claim 38).
Regarding claim 78, the copending claims teach ,wherein the effector cells further express CD2, CD45, CD4, CD25, NKp30, NKG2D, NKp44, NKp46, CD27, OX40, CD107a, NKG2A, PD-1, TIGIT, SlRPa, or CD158, or any combination thereof (claim 39).
Regarding claims 76 and 82, the copending claims teach wherein the NK cell has a deposit number NITE BP-03017, a CD16 receptor, can be cultured for at least 3 months (claim 37).
Regarding claim 89 and 91-92, the copending claims teach wherein the disease is selected from hyperproliferative disease (claim 20) consisting of solid or liquid tumors (claim 21).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMBER K FAUST whose telephone number is (703)756-1661. The examiner can normally be reached Monday - Thursday 9:00am-6:00pm EST.
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/AMBER K FAUST/Examiner, Art Unit 1643
/JULIE WU/Supervisory Patent Examiner, Art Unit 1643