DETAILED ACTION
Claims 1-117 were/stand cancelled. Claims 118-137 are pending.
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 .
Priority
This application is a CON of PCT/US2022/019020 (03/04/2022) which claims benefit of 63/157,332 (03/05/2021) as reflected in the filing receipt issued on February 15 2024.
Information Disclosure Statement
No IDS has been filed.
Drawings
The drawings are objected to because 37 C.F.R. 1.84 states “Character of lines, numbers, and letters. All drawings must be made by a process which will give them satisfactory reproduction characteristics. Every line, number, and letter must be durable, clean, black (except for color drawings), sufficiently dense and dark, and uniformly thick and well-defined.”
In the current case, the words in Figure 2, 4, 5, 6, 7A and 7B, 8A and 8B, 10A and 10B, 10C, 11B, 11C, 11D, 11E, 11F, 11G, 11H, 12A and 12B are illegible.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," 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 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) 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") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) 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 of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings.
Specifically Fig. 12A and 12B contain sequences but neither the drawings nor the brief description of the drawings identify the sequences.
Required response – Applicant must provide:
Replacement and annotated drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, 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.
Claim Objections
Claim 119 is objected to because of the following informalities: the acronym “NK” is not defined in the claims. When an acronym is used in a claim set, it should be defined the first time it appears in the claims. For the purposes of examination, the term “NK” is interpreted to mean natural killer. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 136 is 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.
Claim 136 recites “wherein the method comprises contacting the iPS cell with the synthetic RNA encoding one or more gene-editing proteins”. This claim depends from claim 118. Claim 118 already recites using a synthetic RNA encoding one or more gene-editing proteins to cause a disruption of a B2M gene in the iPS cell. Therefore, it is unclear how the scope of claim 136 is different from claim 118. While claim 118 uses the term “using” and claim 136 uses the term “contacting”, in reality these two do not appear to be of a different scope. Nothing in the specification clarifies how using and contacting are different (as there is no other way for the disruption of B2M to occur by the gene editing proteins unless the cell is contacted with the gene editing proteins).
Claim Rejections - 35 USC § 102
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.
(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.
Claim 137 is rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Valamehr et al. (USPGPUB No. 20190271005)
The instant application claims a composition comprising an isolated immune cell comprising a genetically engineered disruption in a beta-2-microglobulin (B2M) gene, wherein the immune cell is selected from a lymphoid cell or myeloid cell.
Valamehr et al. is directed to genomic engineering of pluripotent cells.
Example 15 is directed to iPSCs that were transfected with B2M-targeting gRNA pair in a plasmid expressing Cas9 nickase. Cells negative for B2M were sorted. As claimed the iPSC derived cell is a T cell (i.e. lymphoid cell) (claim 1;6). A therapeutic composition comprising the iPSC derived cell is claimed (claim 8).
Therefore, Valamehr et al. teaches a lymphoid cell (aka t-cell) which has been genetically engineered to cause a disruption in the B2M gene. The cells were isolated and in a therapeutic composition.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 118-128 and 132-137 are rejected under 35 U.S.C. 103 as being unpatentable over Valamehr et al. (USPGPUB No. 20210015859).
Applicant Claims
The instant application claims method of making an engineered immune cell, the method comprising:(a) providing a gene-edited induced pluripotent stem (iPS) cell, wherein the gene-edited iPS cell is generated by: (1) contacting a somatic cell with a ribonucleic acid (RNA) encoding one or more re- programming factors, which results in reprogramming of the somatic cell into an iPS cell, and (2) causing a disruption of a beta-2-microglobulin (B2M) gene in the iPS cell by using a synthetic RNA encoding one or more gene-editing proteins; and (b) differentiating the gene-edited iPS cell into an immune cell, wherein the immune cell is a lymphoid cell or myeloid cell.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Valamehr et al. is directed to immunotherapeutics using enhanced IPSC derived effector cells. Standard methodologies of cellular reprogramming in which exogenous pluripotency genes are introduced to a somatic cell, expressed and then either silenced or removed from the resulting pluripotent cells (0093). Induced pluripotent stem cells are cells which are produced from differentiated adult, neonatal or fetal cells that have been induced or changed i.e. reprogrammed into cells capable of differentiating into tissues of all three germ or dermal layers (paragraph 0089).
Taught is contacting non-pluripotent cells with one or more reprogramming factors to indicate reprogramming of the non-pluripotent cell. One or more constructs to allow targeted integration at a selected site one or more double stand breaks at a selected site using at least one endonuclease capable of selected site recognition then the cells are culture to allow endogens DNA repair to generate targeted in/dels at the selected site (paragraph 0010; 0228). Reprogram factors may be in the form of polynucleotides (paragraph 0229). Exemplified (example 3) is induced pluripotent cells which were engineered to knock out B2M gene. Taught is transfection with B2m-targeting gRNA pair with a plasmid expressing Cas9 nickase to knock out B2M. Derivative cells are obtained from iPSC differentiation. These derivative cells include NK cells, NKT cells, T cells (paragraph 0017; claim 30; 0071; 0117). Lymphocytes such as T cells and natural killer (NK) cells, are potent anti-tumor effectors that play an important role in innate and adaptive immunity (paragraph 0004). B2M knockout enables allogeneic cell therapies by eliminating the need for MEW (major histocompatibility complex) matching and avoid recognition and killing by host T cells (paragraph 0175).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
While Valamehr et al. suggest B2M knockout cells and differentiating iPSC cells into lymphoid cells and that reprogramming somatic cells into iPSC is a standard methodology, Valamehr et al. does not expressly exemplify the combination.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Regarding claim 118, Valamehr et al. teaches that the standard methods of cellular reprograming are those in which exogenous pluripotency genes are introduced into a somatic cell. Valamehr et al. teaches contacting non-pluripotent cells (aka somatic cells) with one or reprogramming factors wherein the reprogramming factors may be in the form of polynucleotides (i.e. RNA encoding; paragraph 0109; 0114). This results in reprogramming of the somatic cell into iPSC reading on step (a)(1) of instant claim 118. Regarding claim 135, the recitation “synthetic” does not structurally distinguish the reprogramming factors recited in Valamehr et al. compared to a non-synthetic version. Regarding step (a)(2) and claim 136, exemplified by Valamehr et al. is transfecting the iPSC with B2M-targeting gRNA paired with Cas9 (i.e. one or more gene-editing proteins). Regarding step (b) Valamehr et al. teaches differentiating the iPSC cell into T cells or NK cells (aka lymphoid cell).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to contact somatic cells with RNA encoding one or more reprogramming factors in order to form an iPS cell. One skilled in the art would have been motivated to perform this contacting step as Valamehr et al. teaches that this is a standard methodology in forming iPS cells. One skilled in the art would have been motivated to contact the iPS cell with a RNA encoding a sgRNA and Cas protein in order to cause knockout of B2M. One skilled in the art would have been motivated to knockout this gene as Valamehr et al. expressly exemplifies the knockout. Furthermore, removing B2M enables allogeneic cell therapies by eliminating the need for MEW (major histocompatibility complex) matching and avoid recognition and killing by host T cells as taught by Valamehr et al. One skilled in the art would have been motivated to differentiate the iPS cell into an immune cell such as a T cell or NK cell as Valamehr et al. expressly teaches this type of differentiation. Furthermore these cells are potent anti-tumor effectors that play an important role in innate and adaptive immunity as taught by Valamehr et al.
Regarding claims 119-120 and 122, derivative cells are obtained from iPSC differentiation. These derivative cells include NK cells, NKT cells, T cells (paragraph 0017; claim 30; 0071; 0117).
Regarding claim 121 and 126-127, Valamehr et al. teaches patient and donor sourced cells (paragraph 0004) and that the subject is a human patient (paragraph 0095). Since the NK cells are intended to be used as anti-tumor effectors, Valamehr et al. suggests human NK cells. Stromal cells include epithelial cells or fibroblasts (paragraph 0132).
Regarding claims 122-125 Valamehr et al. teaches that the iPSC can be differentiated to a specific cell type including any hematopoietic lineage (paragraph 0117). Hematopoietic stem and progenitor cells include macrophages (paragraph 0101). T cells include gamma delta T cells (γδ T cells) (paragraph 0102). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to differentiate the iPSC into any desired hematopoietic cell type. Since Valamehr et al. suggests all the claimed cell types can be obtained from iPSC there is a reasonable expectation of success.
Regarding claims 128 and 132-133, firstly, the comparison in the claim to cells without disruption of the B2M gene. Since Valamehr et al. teaches the same disruption in the B2M gene, the method taught in Valamehr et al. would be expected to provide an increase in proliferation rate of differentiating cells, downregulation of MHC class 1 expression and/or activity; reduced or eliminated NK-cell fratricide. "A 'whereby' clause that merely states the result of the limitations in the claim adds nothing to the patentability or substance of the claim." Texas Instruments, Inc. v. International Trade Comm., 988 F.2d 1165, 1172 (Fed. Cir. 1993). See also Minton v. National Assoc. of Securities Dealers, Inc., 336 F.3d 1373, 1381 (Fed. Cir. 2003) ("A whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited."). Note MPEP 2111.04.
In this case, claims 128 and 132-133, use the term "wherein", rather than "whereby", but it is concluded that the terms should be treated the same…the wherein clause does not inform the artisan of how the “contacting”, “disruption" and “differentiating” steps are performed; rather, the wherein clause merely characterizes the results of those steps. Therefore, we determine that the "wherein" clause is not entitled to weight in construing the claim. Nonetheless, Valamehr et al. teaches feeder cells can be used to enhance proliferation capacity (paragraph 0132); Figure 3 shows that the iPSC-derived NK cells represent greater proliferation (paragraph 0298) suggesting claim 128. Valamehr et al. teaches that the iPSC-derived cells comprises one or more inducible suicide gene integrated at one or more desired integration sites comprising beta-2 microglobulin (B2M). In some embodiments, the genome-engineered iPSC-derived cells comprising one or more suicide genes further comprise one or more in/del comprised in one or more endogenous genes associated with immune response regulation and mediation, including, but not limited to, check point genes, endogenous T cell receptor genes, and MHC class I suppressor genes (paragraph 0249) suggesting claim 132. Fig. 5 shows that HLA-G expression rescues B2M null iPSCs from killing by NK cells (paragraph 0039) suggesting claim 133.
Regarding claim 134, as claimed by Valamehr et al. induced or expression of HLA-G, HLA-E, is optional (see claim 2; 0176; 0181). Thus optional knocking in of HLA-G would result in an immune that does not include an engineered alteration in HLA-G. The claim is interpreted as only requiring that one is not genetically altered not that all of them are required to not be altered.
Regarding claim 137, Valamehr et al. teaches NK (aka lymphoid) cells with a B2M gene disruption as set forth above. Valamehr et al. teaches a composition for therapeutic use which includes any of the derivative cells (paragraph 0027).
Claims 129-130 are rejected under 35 U.S.C. 103 as being unpatentable over Valamehr et al. (USPGPUB No. 20210015859) as applied to claims 118-128 and 132-137 above in view of Andre et al. (USPGPUB No. 20200046767).
Applicant Claims
The instant application claims wherein the method further comprises enriching for CD34+ cells. The instant application claims wherein the differentiating comprises differentiating the immune cell into CD5+/CD7+ common lymphoid progenitors.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
The teachings of Valamehr et al. are set forth above. It is taught that iPSC derived non-pluripotent cells include CD34 cells (paragraph 0007). T lymphocyte/T cells are taught. It is taught that the T cell can be any T cell (paragraph 0102).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
Valamehr et al. does not expressly teach enriching CD34 cells or CD5+/CD7+ common lymphoid progenitors. However, this deficiency is cured by Andre et al.
Andre et al. is directed to a method for generating t cells progenitors. Currently, in allograft situations with partial HLA incompatibility, the injections, to previously conditioned recipients, of increasing doses of sorted CD34+ HSPC allows donor transplantation with effective prevention of graft-versus-host disease (GVH) (paragraph 0034). It is important to accelerate the generation of T lymphocytes by the administration of precursors already engaged in the T lymphocyte differentiation pathway (T cell progenitors) (paragraph 0007). These T cell precursors are obtained from CD34+ HSPC differentiation and have in particular the CD7+ marker, which is a marker of differentiation in the T-cell pathway (paragraph 0008). Andre et al. teaches that samples were directly enriched for CD34+ cells (paragraph 0186). Figure 9 shows the percentage and total number of CD5+CD7+ cultured starting with CD34+ (paragraph 0185).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Valamehr et al. and Andre et al. and enrich the cells with CD34+ to allow differentiation to CD5+CD7+ T cells. One skilled in the art would have a reasonable expectation of success as Valamehr et al. teaches that iSPC can be CD34+ cells and any type of T cell and Andre et al. teaches that the CD34+ differentiate into CD5+CD7+ cells.
Claim 131 is rejected under 35 U.S.C. 103 as being unpatentable over Valamehr et al. (USPGPUB No. 20210015859) as applied to claims 118-128 and 132-137 above in view of Watkins et al. (USPGPUB No. 20200079867).
Applicant Claims
The instant application claims wherein the method yields CD56dim CD 16+ NK cells.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
The teachings of Valamehr et al. are set forth above. Valamehr et al. teaches iPSC derived cells which are NK cells. Lymphocytes such as T cells and natural killer (NK) cells, are potent anti-tumor effectors that play an important role in innate and adaptive immunity (paragraph 0004).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
Valamehr et al. does not expressly teach the NK cells are CD56dim CD 16+ NK cells. However, this deficiency is cured by Watkins et al.
Watkins et al. is directed to compositions and method for enhancing the killing of target cells by NK cells. In humans, NK cells are composed of two distinct populations: CD56dim/CD16pos and CD56bright/CD16neg. In healthy individuals, the CD16neg population represents 5-15% of the total NK cell population. However, in some cancer patients the proportion of CD16neg NK cells is greatly increased (e.g., up to 50%) (paragraph 0092). The tumor micro-environment has been shown to affect the phenotype of CD56dim/CD16pos NK cells by either inducing shedding of CD16A from the surface of the cells (activity mediated by ADAM17 enzyme) or TGFβ can promote conversion from CD16Apos to CD16neg NK cells (paragraph 0093).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Valamehr et al. and Watkins et al. and utilize NK cells that are CD56dim/CD16pos. One skilled in the art would have been motivated to utilize these cell types as there are one of two distinct types of NK cells in humans as taught by Watkins et al. Since Valamehr et al. suggests use as anti-tumor effectors and there is an increase in CD16neg NK cells is increased as taught by Watkins et al., one skilled in the art would have been motivated to utilize NK cells that are CD56dim/CD16pos when treating cancer.
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.
Claim 137 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 79 of copending Application No. 18861162. Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The instant application claims composition comprising an isolated immune cell comprising a genetically engineered disruption in a beta-2-microglobulin (B2M) gene, wherein the immune cell is selected from a lymphoid cell or myeloid cell.
Regarding claim 137, copending ‘162 claims an engineered cell comprising a disruption in a B2M gene, wherein the engineered cell expresses a fusion protein comprising a fragment of a B2M polypeptide and a HLA-E polypeptide (claim 79).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ABIGAIL VANHORN whose telephone number is (571)270-3502. The examiner can normally be reached M-Th 6 am-4 pm EST.
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/ABIGAIL VANHORN/Primary Examiner, Art Unit 1636