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/Restriction
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claims 1-4, drawn an immune cell comprising at least two exogenous cargos, wherein the exogenous cargo comprises a ribonucleoprotein (RNP), a nucleic acid, a protein, or any combination thereof.
Group II, claim(s) 5-7, drawn to an method of delivering at least two exogenous cargos across a plasma membrane of a non-adherent immune cell, comprising, providing a population of non-adherent cells; and contacting the population of cells with a volume of an isotonic aqueous solution, the aqueous solution including the exogenous cargo and an alcohol at greater than 0.2 percent (v/v) concentration.
This application contains claims directed to more than one species of the generic invention. These species are deemed to lack unity of invention because they are not so linked as to form a single general inventive concept under PCT Rule 13.1.
The species are as follows:
Species 1: Exogenous cargo. Applicant is required to elect one type exogenous cargo as described in claim 1, such as between an RNP, a nucleic acid, a protein, or a specific combination of the three.
Species 2: RNP type. Applicant is required to elect one RNA type between TRAC or CD7, as described in claim 2.
Applicant is required, in reply to this action, to elect a single species to which the claims shall be restricted if no generic claim is finally held to be allowable. The reply must also identify the claims readable on the elected species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered non-responsive unless accompanied by an election.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which are written in dependent form or otherwise require all the limitations of an allowed generic claim. Currently, all the claims are generic.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
The inventions of Group I and II lack unity with each other because even though the inventions of these groups require the technical feature of, an immune cell comprising at least two exogenous cargos, wherein the exogenous cargo comprises a ribonucleoprotein (RNP), a nucleic acid, a protein, or any combination thereof, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Chen (Chen, M., US-20180362975-A1).
Chen teaches gRNA molecules, CRISPR systems, cells, and methods useful for genome editing of immune cells including T cells further engineered to express a chimeric antigen receptor, and useful for treating diseases such as cancers [0004]. Chen teaches a gRNA nucleic acid molecule including a tracr and crRNA, wherein the crRNA includes a targeting domain that is complementary with a target sequence of an allogeneic T-cell target TRAC and B2M [0005]. Chen teaches the gRNA molecule within the CRISPR ribonucleoprotein (RNP) system where the RNP includes a Cas9 molecule and including the gRNA molecule, introduced into a cell, where an indel is formed at or near the target sequence complementary to the targeting domain of the gRNA molecule [0089]. Chen teaches lipids and/or polymers for containing the transfer of the cargo CRISPR systems (including the RNP and TRAC or B2M targeting gRNA), nucleic acids, or vectors, encoding CRISPR systems or components [1264], i.e. the immune T cell comprises at least two exogenous cargos comprising a RNP, nucleic acid and a protein.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN CHARLES MCKILLOP whose telephone number is (703)756-1089. The examiner can normally be reached Mon-Fri 8:30-5:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Dunston can be reached on 5712722916. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Application Status and Election
Claims 1-7 are pending. Applicant’s election of group I (claims 1-4) in the oral election on 1/28/26 with attorney Katherine Warburg (Reg# 75559) is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Applicant elects the species of RNP and TRAC. Claims 5-7 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.
Examination on the merits commences on claims 1-4.
Claim Rejections - 35 USC § 101
`35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 1, 3, and 4 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. The claims are drawn to an immune cell. However, the claims do not include elements, when considered separately and in combination, that are sufficient to amount to significantly more than the judicial exceptions as outlined below.
Subject Matter Eligibility Test for Products and Processes: Claim 1.
Step 1 - Is the Claim to a Process, Machine, Manufacture or Composition of Matter? YES
Claim 1 is directed to an immune cell comprising at least two exogenous cargos, wherein the exogenous cargo comprises a ribonucleoprotein (RNP).
Step 2A, Prong One - Does the Claim Recite an Abstract Idea, Law of Nature, or Natural Phenomenon? YES
Natural phenomena have been identified by the courts by way of example, including products of nature. Claim 1 describes an immune cell comprising at least two exogenous cargos, wherein the exogenous cargo comprises a ribonucleoprotein (RNP), which is a product of nature. For natural products, products that are not “markedly different” than their naturally occurring counterpart are judicial exceptions. See MPEP 2016.04((b). An immune cell comprising the phenomenon of taking up external RNA-protein complexes is a natural process used for intercellular communication, pathogen recognition, and immune regulation. As an example, Exosome Communication within immune cells, such as B cells, T cells, and dendritic cells, naturally produce and exchange extracellular vesicles (EVs) or exosomes. These vesicles carry cargo, including RNAs and RNA-binding proteins, from one cell to another (abstract; Wahlgren, Jessica. Intercellular communication via exosomes. 2014.).
The Specification (page 2) describes the exogenous cargo or "payload" as terms used to describe a compound, e.g., an RNP, or composition that is delivered via an aqueous solution across a cell plasma membrane and into the interior of a cell. The term, "exogenous" refers to cargo (or payload) coming from or deriving from outside the cell, e.g., an immune cell, as opposed to an endogenous agent that originated within the immune cell. Examples in the Specification include wherein the exogenous cargo comprises a T cell receptor alpha constant (TRAC) ribonucleoprotein (RNP) or a cluster of differentiation 7 (CD7) RNP, however, RNP TRAC is not a limitation within the independent claim 1.
Given, the claimed RNP cargo carrying immune cell is not markedly different than its naturally occurring counterpart this claim 1 limitation constitutes a judicial exception.
Step 2A, Prong Two - Does the Claim Recite an Additional Elements that Integrate the Judicial Exception into a Practical Application? NO
The Supreme Court has long distinguished between principles themselves, which are not patent eligible, and the integration of those principles into practical applications, which are patent eligible. The phrase "integration into a practical application" requires an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that it is more than a drafting effort designed to monopolize the exception. In this case, claim 1 is not limited to any particular engineered exogenous RNP such as disclosed in claim 2 (wherein the RNP comprises a T cell receptor alpha constant (TRAC)), therefore, claim 1 does not recite any additional elements that would integrate the natural product into a practical application.
Step 2B - Does the Claim Recite Additional Elements that Amount to Significantly More than the Judicial Exception? NO
The Supreme Court has identified a number of considerations for determining whether a claim with additional elements amounts to "significantly more" than the judicial exception(s) itself. The claim as a whole is evaluated as to whether it amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim (MPEP 2106.05). In this case no additional elements are recited in claim 1. Therefore, the claim does not amount to something significantly more than the judicial exception.
Subject Matter Eligibility Test for Products and Processes – Dependent claims
Note that Claim 2 is not rejected under §101. This claim is further limited to an immune cell comprising a cargo wherein the cargo is an RNP T-cell receptor alpha constant (TRAC). Examiner interprets a TRAC RNP as a human-engineered tool designed to disrupt the endogenous T-cell receptor (TCR) for cell therapy purposes. Therefore, claim 2 discloses more than mere natural phenomenon, which if incorporated into the independent claim 1 would be sufficient to overcome this §101 rejection.
Claim Objection
The claims are drawn to an RNP ribonucleoprotein which Examiner requests to be clarified such as a CRISPR-Cas9 RNP.
Claim Rejections - 35 USC § 112(a) – Written DescriptionThe 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 1-4 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.
MPEP 2163.II.A3.(a).(i) states, “whether the specification shows that applicant was in possession of the claimed invention is not a single, simple determination, but rather is a factual determination reached by considering a number of factors. Factors to be considered in determining whether there is sufficient evidence of possession include the level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention.”
For claims drawn to a genus, MPEP 2163.II.A3.(a).(ii) states, “written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species” where “representative number of species’ means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.”
The claims are drawn to an immune cell comprising at least two exogenous cargos, wherein the exogenous cargo comprises a ribonucleoprotein (RNP), a nucleic acid, a protein, or any combination thereof. These claims are not limited to any definition of “immune cell” provided in the disclosure. The specification has not adequately described the entire genus of these gene modulators for the following reasons.
Size and Breadth of Genus
The genus of “Immune cells” is extensive and diverse and can be split into innate (neutrophils, monocytes/macrophages, eosinophils, basophils, mast cells, NK cells, dendritic cells) and adaptive (B cells, T cells) types, each with distinct roles like fighting infections, clearing debris, and creating antibodies or memory for future threats.
Species disclosed in the Specification
Example 1 from the specification (pg 17) teaches efficient engineering of primary human T Cells for ex vivo cell therapy applications using the SOLUPORE® delivery method. The delivery system was used to both introduce functionality to T cells, using mRNA, and to delete functionality, using CRISPR-Cas9 protein-gRNA ribonucleoprotein (RNP) complexes.
Although the specification discloses potential embodiments of immune cells such as T cells, the specification fails to sufficiently describe representative species or how the various immune cells relate to the functional claimed method.
Species Disclosed in the Art
Regarding immune cells, Annunziato teaches the immune system has tailored its effector functions to optimally respond to distinct species of microbes (abstract, Figure 2; Annunziato, Francesco, Chiara Romagnani, and Sergio Romagnani. "The 3 major types of innate and adaptive cell-mediated effector immunity." Journal of Allergy and Clinical Immunology 135.3 (2015): 626-635.). The innate and adaptive immune systems converge into 3 major kinds of cell mediated effector immunity, categorized as type 1, type 2, and type 3. Type 1 immunity consists of T-bet1 IFN-g–producing group 1 ILCs (ILC1 and natural killer cells), CD81 cytotoxic T cells (TC1), and CD41 TH1 cells, which protect against intracellular microbes through activation of mononuclear phagocytes. Type 2 immunity consists of GATA-31 ILC2s, TC2 cells, and TH2 cells producing IL-4, IL-5, and IL-13, which induce mast cell, basophil, and eosinophil activation, as well as IgE antibody production. Type 3 immunity is mediated by retinoic acid–related orphan receptor ILC3s, TC17 cells, and TH17 cells producing IL-17, IL-22, or both, which activate mononuclear phagocytes but also recruit neutrophils and induce epithelial antimicrobial responses, thus protecting against extracellular bacteria and fungi (abstract).
As the prior art establishes, there is substantial variation within the genus of immune cells. Applicant fails to adequately describe a sufficient variety of species to reflect the variation within the genus. Furthermore, the description of a representative number of species from the specification is not representative of the entire genus. Given the lack of guidance in the art and specification regarding the various immune cells as influenced by the claimed method and the lack of predictability of undefined immune cells, the specification disclosure is not sufficient to show that the Applicant was in possession of all such at the time the invention was filed. However, given evidence in the art and specification examples regarding T-cell immune cells, Examiner interprets these as sufficiently predictable within Applicant’s written description.
Dependent claims
The dependent claims of claim 1 do not further limit the genus of immune cells so as to resolve the issues above, and therefore lack adequate written description for the reason outlined for claim 1.
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.
Claim(s) 1-4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen (Chen, M., US-20180362975-A1).
Regarding claim 1, Chen teaches gRNA molecules, CRISPR systems, cells, and methods useful for genome editing of immune cells including T cells further engineered to express a chimeric antigen receptor, and useful for treating diseases such as cancers [0004]. Chen teaches a gRNA nucleic acid molecule including a tracr and crRNA, wherein the crRNA includes a targeting domain that is complementary with a target sequence of an allogeneic T-cell target TRAC and B2M [0005]. Chen teaches the gRNA molecule within the CRISPR ribonucleoprotein (RNP) system where the RNP includes a Cas9 molecule and including the gRNA molecule, introduced into a cell, where an indel is formed at or near the target sequence complementary to the targeting domain of the gRNA molecule [0089]. Chen teaches lipids and/or polymers for containing the transfer of the cargo CRISPR systems (including the RNP and TRAC or B2M targeting gRNA), nucleic acids, or vectors, encoding CRISPR systems or components [1264], i.e. the immune T cell comprises at least two exogenous cargos comprising a RNP, nucleic acid and a protein.
Regarding claim 2, Examiner is interpreting, with guidance from the Specification (pg 18-22), the claimed T cell receptor alpha constant (TRAC) ribonucleoprotein (RNP) as a complex used in gene editing, specifically for CRISPR-Cas9 technologies aimed at engineering T cells wherein the complex consists of an RNP such as Cas9 protein bound to a guide RNA (gRNA) that is specifically designed to target the T cell receptor alpha constant (TRAC) gene. For example, from the Specification (pg 18) in Example 1, CRISPR-Cas9 RNP complexes using gRNA for targeting the TRAC and CD7 genes were delivered to T cells individually and sequentially, and described as TRAC RNP and CD7 RNP (Cas9 RNP -TRAC sgRNA; pg 22. FIG. 1D).
Regarding claim 2, Chen teaches the cell includes three gRNA molecules as delivered, and the first gRNA molecule includes a targeting domain complementary with a target sequence of TRAC; the second gRNA molecule includes a targeting domain complementary with a target sequence of B2M; and the third gRNA molecule includes a targeting domain complementary with a target sequence of CIITA [0133]. Figure 17A teaches RNP gRNA TRAC electroporation of the immune cell.
Regarding claim 3, Chen teaches the cargo compositions (gRNA molecule or nucleic acid encoding the gRNA molecule, and the Cas9 molecule or nucleic acid encoding the Cas9 molecule), are formulated in more than one composition wherein the more than one composition are delivered to the immune cell simultaneously or sequentially [0132].
Regarding claim 4, Chen teaches inhibition or elimination of one or more allogeneic T cell targets, by the methods and compositions disclosed, to improve the efficacy, survival, function and/or viability of the allogeneic cell by reducing or eliminating undesirable immunogenicity [0480]. Figure 17 further teaches RNP gRNA TRAC electroporation and viability of the immune cell.
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 1 are rejected on the grounds of nonstatutory double patenting as being unpatentable over Claim 1 of patent No. US11827899B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because the co-pending claims anticipate the instant claims.
Regarding instant claim 1, reference claim 1 teaches an immune cell T cell delivered with the RNP cargo of a Cas9 protein/gRNA complex. 1. A method for delivering a gene editing composition across a plasma membrane of a cell, comprising:
providing a population of mesenchymal stem cells (MSCs), U2OS, Jurkat or T cells; and
contacting the population of cells with a volume of a hypotonic aqueous solution, the hypotonic aqueous solution comprising the gene editing composition, ethanol at a concentration of about 25% (v/v), about 32 mM sucrose, about 12 mM potassium chloride, about 12 mM ammonium acetate, about 5 mM 4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid (HEPES), and about 2.5 mM MgCl2,
wherein the volume is a function of: (i) exposed surface area of the population of cells; or (ii) a number of cells in the population of cells;
wherein the gene editing composition includes a Cas9 protein and a gRNA complex;
wherein contacting the population of cells with the volume of the hypotonic aqueous solution is performed by gas propelling the hypotonic aqueous solution to form a spray.
Claim 1 is rejected on the grounds of nonstatutory double patenting as being unpatentable over Claim 1, 18, 26, and 36 of patent No. US11981915B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because the co-pending claims anticipate the instant claims.
Regarding instant claim 1, the reference claims teaches an immune cell T delivered with RNP cargo.
Reference claims:1. A system comprising:
a housing configured to receive a plate comprising a well, wherein the plate comprises a population of cells;
a differential pressure applicator configured to apply a differential pressure to the well;
a delivery solution applicator configured to deliver atomized delivery solution to the well;
a reservoir fluidically coupled to the delivery solution applicator, the reservoir including a delivery solution that is vector-free, the delivery solution including an aqueous solution including a payload and an alcohol at greater than 5 percent (v/v) concentration, wherein the aqueous solution is isotonic wherein the population of cells is contacted with a volume of aqueous solution by gas propelling the aqueous solution to form a spray, wherein the payload comprises a gene editing composition;
a stop solution applicator configured to deliver a stop solution to the well; and
a culture medium applicator configured to deliver a culture medium to the well.
18. The system of claim 1, wherein the well contains a population of non-adherent cells.
26. The system of claim 18, wherein said non-adherent cell comprises an immune cell.
36. The system of claim 1, wherein the gene editing composition comprises one or more of (a) gene editing protein; (b) RNA molecule; and/or (c) ribonucleoprotein (RNP).
Conclusion
All claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN CHARLES MCKILLOP whose telephone number is (703)756-1089. The examiner can normally be reached Mon-Fri 8:30-5:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Jennifer Dunston can be reached on (571) 272-2916. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JOHN CHARLES MCKILLOP/Examiner, Art Unit 1637
/EKATERINA POLIAKOVA-GEORGANTAS/Primary Examiner, Art Unit 1637