DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 12/10/2025 is acknowledged.
Claims 5-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/10/2025.
Claims 1-4 and 14-18 are under consideration in this office action.
Drawings
The drawings are objected to because Drawing 10 of 14 recites “G.7A” and “IG.7B”. These recitation appear to be corresponding to Figure 7A and 7B but the drawing do not state as such. 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.
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 1-4 and 14-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to product of nature without significantly more.
According to the 2019 Revised Patent Subject Matter Eligibility Guidelines (2019PEG), the claim is first analyzed (Step 1) to determine if it is directed to one of the acceptable statutory categories of invention (i.e. process, machine, manufacture, or composition of matter). Claims 1-4 and 14-18 are drawn to a process. Thus claims 1-4 and 14-18 meet the requirements for Step 1 of the analysis.
Second, the claim is assessed to determine if it is directed to a judicial exception under step 2A. Under 2019PEG, “directed to” is determined via a two-prong inquiry: (1) Does the claim recite a law of nature, a product of nature, a natural phenomenon, or an abstract idea; and (2) Does the claim recite additional element(s) that integrate the judicial exception into a practical application. The phrase, “integration of a practical application”, requires the presence of an additional claim element(s) or a combination thereof to apply, rely on or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception, such that the claim does not monopolize the judicial exception. (See MPEP § 2106.05 for examples of integration of practical application).
Regarding the first prong (1), claims 1-4 and 14-18 recites the following equation:
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According to PEG2019, mathematical equations fall under the mathematical concept groupings of abstract ideas. As such, all of the claims are directed to an abstract idea. As such, claim 1-4 and 14-18 meet the requirement of the first prong of Step 2A as being reciting a judicial exception.
Regarding the second prong (2), independent claim 1 recites the additional elements of (a) providing a device, (b) selecting parameters of the above equation, and (c) passing cells and a composition through the device while providing the selected parameters. As such, the steps of the method are generically claimed. While the parameters are selected, they are not actually required to be applied to the equation, the device, the cells, the composition, or active steps. The device is claimed as comprising (i) an entry zone with a first inlet and first outlet; (ii) first and second electrodes; and (ii) an active zone comprising a second inlet and a second outlet. The claimed device does not further specify any further aspects of the configuration of the device. Thus, the device is also generically claimed. Regarding the claimed composition, the structural and function limitations of the composition are not defined by the claims. As such, the composition is also generically claimed. The end-result of the method claimed is also generically claimed as introducing the composition into the cells. Thus, the additional elements are generally linking the use of the mathematical equation to a generic device. This amounts to generally linking the use of the judicial exception to a particular technology, technological environment or field of use, which has been deem as additional elements that are not indicative of integration into a practical application (see MPEP2106.05(h). As such, claim 1 does not meet the requirement of integration of the judication exception into a practical application and is a judicial exception not integrated into a practical application.
Independent claim 14 recites that same limitations as claim 1 accept it more narrowly defines the cells as human immune cells. Again, this solely appears to be an application of the judicial exception to a field of use with subgenus of cells. Such generic application is not indicative of integration into a practical application as cited for claim 1. As such, claim 14 does not meet the requirement of integration of the judication exception into a practical application.
Claims 2 and 16 further specify a rate at which the composition is introduced into the cells. It does not further specify any aspect of applying the equation to the method, the composition, or the device. This amounts to generally linking the use of the judicial exception to a particular technology, technological environment or field of use, which has been deem as limitations that are not indicative of integration into a practical application (see MPEP2106.05(h). As such, claims 2 and 16 do not meet the requirement of integration of the judication exception into a practical application.
Claims 3 and 17 generically specify the configuration of the entry zone and active zone of the device to have a particular function of increase in average velocity flow. These additional limitations do not further specify an actual application of the equation to the method, device, or composition in a meaning way. This amounts to generally linking the use of the judicial exception to a particular technology, technological environment or field of use, which has been deem as limitations that are not indicative of integration into a practical application (see MPEP2106.05(h). As such, claims 2 and 17 do not meet the requirement of integration of the judication exception into a practical application.
Claim 4 specifies additional elements of the end result (i.e. unaltered cell surface markers of the cells). This does not further specifies any type of application of the equation to the method. Thus the additional elements of claim 4 amounts to generally linking the use of the judicial exception to a particular technology, technological environment or field of use, which has been deem as limitation that are not indicative of integration into a practical application (see MPEP2106.05(h). As such, claim 4 does not meet the requirement of integration of the judication exception into a practical application.
Claim 15 recites a wherein clause that specifies the intended means in which the immune cells are obtained. This does not further specifies any type of application of the equation to the method. Thus the additional elements of claim 15 amount to generally linking the use of the judicial exception to a particular technology, technological environment or field of use, which has been deem as limitations that are not indicative of integration into a practical application (see MPEP2106.05(h). As such, claim 15 does not meet the requirement of integration of the judication exception into a practical application.
Claim 18 specifies additional elements of the end result (i.e. unaltered cell characteristics). This does not further specify any type of application of the equation to the method as claimed. Thus the additional elements of claim 18 amounts to generally linking the use of the judicial exception to a particular technology, technological environment or field of use, which has been deem as limitations that are not indicative of integration into a practical application (see MPEP2106.05(h). As such, claim 18 does not meet the requirement of integration of the judication exception into a practical application.
Thus overall, claims 1-4 and 14-18 do not meet the requirement of integrating the judicial exception into a practical application as required in prong 2 of Step 2A. Thus claim 1-4 and 14-18 do recite a judicial exception that maybe possible ineligible subject matter at Step 2A of the PEG2019.
Third (Step 2B), if a judicial exception is present in the claim, it is further assessed to determine if the claim recites any additional elements or steps that are sufficient to ensure that the claim as a whole amounts to significantly more than the judicial exception (i.e. an inventive concept).
As previously discussed in step 2A of the analysis above, none of the claims actually apply the equation to the method, device, cells, and the composition. While the term “apply it” is not recited in the claims, the generic nature of the claims are simply appending well-understood conventional activity of both flow dynamics and electroporation, cell characterization, and leukapheresis previously known in industry at a high level of generality to the method claims and do not apply any type of inventive concept to the recited equation. As such, it appears to be that the equation is merely a recited generically applied equation. Thus additional limitations are not indicative of an inventive concept or “significantly more” than the abstract idea equation (see MPEP 2106.05(d)). As such, claims 1-4 and 14-18 do not meet the requirements of Step 2B of the analysis.
In conclusion, claims 1-4 and 14-18 are patent ineligible subject matter because the claims would be considered a judicial exception with no integration into a practical application as required by step 2A of the analysis and further do not recite elements that amount to significantly more than the judicial exception as required by step 2B of the PEG2019.
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.
Claims 1-4 and 14-18 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.
Claims 1 and 14 are indefinite because the selecting the parameters of step (b) and the providing the selected combination of parameters in step (c) do not appear to use the recited equation in step be in any way. As such, it is not apparent how the recited equation relates to the method of the claims. For purposes of determining applicable art, step (b) is being interpreted only requiring selection of the claimed parameters expressly or inherently, regardless of the equation, and providing the parameters via the passing the plurality of cells and the composition in any way that results in introducing the composition into the cells.
Claims 2-13 and 15-18 are dependent on claims 1 and 14 respectively and therefore also comprise the above indefinite subject matter.
Claim 18 recites, “the plurality of mammalian cells”. However, base claim 14 more narrowly recites, “plurality of human immune cells”. As such, the scope of the plurality of cells in claim 18 is not apparent because it is not apparent if the claims are limited to human immune cells or more broadly can be mammalian cells.
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.
(1) Claims 1-4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 32 and 58 of copending Application No. 16/306115. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant and copending claims overlapping non-mutually exclusive subject matter.
Regarding instant claim 1, copending claim 32 is a method of transfecting mammalian cells (i.e. a method of introducing a composition into mammalian cells as claimed in the instant claim) comprising the use of a fluid transport structure in which a mammalian cell suspensions flow through (i.e. providing a device). The claim does expressly state that it has an entry zone comprising a first inlet and a second outlet. However, for the mammalian cell suspension flow through the fluid transport structure of the claim, inherently it must have an entry zone having a first inlet and a first outlet, otherwise flow could not occur. As such, the claimed fluid transport structure that allows for flow therethrough inherently comprises the claimed entry zone of the instant claim. Copending claim 32 also specifies that the fluid transport structure comprises conductive elements configured to produce an electric field in the flow path, wherein the conductive elements are hollow cylindrical electrodes arranged axially at either end of the flow path. Therefore, the fluid transport structure also comprises a first and second electrodes and an active zone comprising second inlet and a second outlet. As such, the copending claim provides a species of providing a device as claimed in instant claim 1. Copending claim 32 discloses flowing a mammalian suspension through a flow path device within a fluid transport structure, and applying a voltage to generate an electric flow path, wherein the electric field is sufficient to transfect the mammalian cells as the cells travel through the flow path. Thus copending claim 32 discloses passing a plurality of mammalian celled suspending in a fluid liquid through the active zone thereby introducing (i.e. transfecting) the composition into the plurality of mammalian cells as recited in the instant claims.
Copending claim 32 does not teach selecting the combination of electrical field, average flow velocity, a hydraulic diameter in the active zone, a liquid conductivity and liquid density. Copending claim 32 does not disclose the recited equation and overall step (b). However, the claims solely requires selecting these parameters and does not actually require any type of application of the claimed equation. As such, since the copending claims discloses that liquid suspension of cells is “flowing” through the fluid transport structure and a voltage to generate an electrical field is being applied. Inherently and expressly all of the above parameters are being selected as claimed. Thus copending claim 32 discloses a species of instant claim 1.
Copending claim 58 also discloses a species of instant claim 1 for reasons discussed above.
Regarding instant claim 2, copending claims 32 and 58 do not teach the recited rate of cell flow through the active zone. However, determining the rate of cell flow that is optimal for introducing/transfecting is routine optimization at the time of the copending application and instant application. As such, instant claim 2 is an obvious variant of copending claims 32 and 58.
Regarding instant claim 3, copending claims 32 and 58 teach that the flow path comprises a minimum diameter of 50 microns. This disclosure teaches a species of wherein the entry zone and active zone are configured to provide an increase in average flow velocity as claimed.
Regarding instant claim 4, it recites a wherein clause that is not an active step in the claimed method and generically claims “without altering a desire cell surface marker”. The breadth of “a desired cell surface marker” encompasses any cell surface marker and implies as long some characteristic of the cells surface is the same the limitation is met. An artisan of ordinary skill would reasonably expect that at least one characteristic of the cells surface in the copending claims 32 and 58 would stay the same. As such, copending claims 32 and 58 teach an obvious variant of instant claim 4.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
(2) Claims 1 and 14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6 and 20 of copending Application No. 16/666,302. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant and copending claims overlapping non-mutually exclusive subject matter.
Regarding instant claim 1, copending claim 6 discloses a method of introducing a composition into a plurality of cells suspended in a flowing liquid, the method comprising: (a) providing a device comprising: (i) a first electrode comprising a first outlet, a first inlet, and a first lumen comprising a minimum cross-sectional dimension; (ii) a second electrode comprising a second outlet, a second inlet, and a second lumen comprising a minimum cross-sectional dimension; and (iii) an electroporation zone disposed between the first outlet and the second inlet, wherein the electroporation zone has a length of between 0.5 mm and 50 mm and comprises a minimum cross-sectional dimension between 0.1 mm and 50 mm, and wherein the electroporation zone has a substantially uniform cross-sectional area; wherein the ratio of the minimum cross-sectional dimension of each of the first and second lumen to the minimum cross-sectional dimension of the electroporation zone is between 1:10 and 10:1, and wherein the first outlet, the electroporation zone, and the second inlet are in fluidic communication; (b) applying an electrical potential difference between the first and second electrodes, thereby producing an electric field in the electroporation zone; and (c) passing the plurality of cells and the composition in the flowing liquid through the electroporation zone, thereby enhancing permeability of the plurality of cells and introducing the composition into the plurality of cells. As such, copending claim 6 discloses a species of instant claim 1.
Regarding claim 14, copending claim 20 teaches human immune cells. Thus copending claim 20 is an obvious species of claim 14.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
(3) Claims 1 and 14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 26 and 56 of copending Application No. 17/624,535. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant and copending claims overlapping non-mutually exclusive subject matter.
Regarding instant claim 1, copending claim 26 teaches a method of electro-mechanical delivery of a composition into a plurality of cells suspended in a flowing liquid, the method comprising: (a) providing a device comprising: (i) a first electrode comprising a first outlet, a first inlet, and a first lumen comprising a minimum cross-sectional dimension; (ii) a second electrode comprising a second outlet, a second inlet, and a second lumen comprising a minimum cross-sectional dimension; and (iii) an electroporation zone disposed between the first outlet and the second inlet, wherein the electroporation zone comprises a minimum cross-sectional dimension greater than about 100 μm, wherein the electroporation zone has a substantially uniform cross sectional area; and wherein the first outlet, the electroporation zone, and the second inlet are in fluidic communication; (b) applying an electrical potential difference between the first and second electrodes, thereby producing an electric field in the electroporation zone; and (c) passing the plurality of cells and the composition through the electroporation zone, thereby enhancing permeability of the plurality of cells and introducing the composition into the plurality of cells. Thus copending claim 26 teaches an obvious species of instant claim 1.
Regarding claim 14, copending claim 56 teaches human immune cells. Thus copending claim 20 is an obvious species of claim 14.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
(1) Claim(s) 1-4 and 14-18 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Bernate (US 2019/0100774 A1 pub date:4/4/2019 and effectively filed 4/2017).
The claimed are being interpreted as discussed above in the 112(b) rejection.
Regarding claim 1, Bernate discloses a method of electroporating cells (i.e. a method of introducing a composition into a plurality of cells) comprising: providing a flow-through electroporation (FTEP) device, wherein the flow-through electroporation device comprises an inlet and at least an inlet channel for receiving a fluid comprising electrocompetent cells and exogenous material (i.e. composition to be introduced as claimed) into the FTEP device; an outlet and an outlet channel for removing a fluid comprising transformed cells and exogenous material from the FTEP device (i.e a device comprising an entry zone comprising a first inlet and first outlet) ; a flow channel intersecting and positioned between the inlet channel and the outlet channel (i.e. the device also comprising an active zone comprising a second inlet and second outlet), wherein the flow channel decreases in width to a dimension no smaller than at least 2x diameter of the cells being electroporated between the first inlet channel and a center of the flow channel and the outlet channel and the center of the flow channel; and two electrodes positioned between the intersection of the flow channel with the inlet channel and the intersection of the flow channel with the outlet channel (i.e. the device also comprising a first and second electrodes and step a providing the claimed device); wherein the electrodes are in fluid and electrical communication with fluid in the flow channel but not directly in the path of the cells traveling through the flow channel; flowing the cells comprising the electrocompetent cells and exogenous material into the inlet and the inlet channel; flowing the cells through the flow channel and past the two electrodes; providing electrical pulses to the cells in the fluid as the cells flow through the flow channel past the electrodes producing electroporated cells; and removing the electroporated cells from the outlet channel and outlet (i.e. step (b) selecting the claimed combination of electroporation/flow parameters and (c) passing the plurality of cells and the composition through the active zone while providing the combination of electroporation/flow parameters claimed thereby introducing the composition into the plurality of cells). See page 21, claim 1.
Regarding claim 2, Bernate discloses the FTEP devices can provide a cell transformation rate of 103 to 1012 per minute, 104 to 1010 per minute, or 105 to 109 per minute (page 3, [0026]). Thus Bernate discloses a flux of at least 105 cells minute per active zone claimed.
Regarding claim 3, Bernate discloses decreasing the flow channel with between 10 micron to 5mm, 50 micron to 2mm (see page 21 claims 3 and 4). Such decrease in width of the flow channel increases average flow velocity.
Regarding claim 4, Bernate does not disclose wherein the composition is introduced into the plurality of cells without altering a desired cell surface marker. These limitations further describes the end product cell population. A desired cell surface marker is any type of marker on or indicative of the surface of the cell. It can be a physical marker or function marker of integrity. As such, the desired cell surface marker is very broad and can include the indirect measure of cell surface intactness, such as transformation survival rate. Bernate discloses the transformation survival rate is at least 90-99% (see page 20, [0162].
In conclusion, the prior art of Bernate anticipates the claims because it expressly or inherently discloses all of the limitations of the claims.
(2) Claim(s) 1-4 and 14-18 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Tandon (US11,859,162 patent date:1/2/2024; effectively filed 8/31/2018.
The claimed are being interpreted as discussed above in the 112(b) rejection.
Regarding claim 1, Tandon discloses a method of introducing a payload into a cell (i.e. a method of introducing a composition into a plurality of cells). In figure 4C, Tandon discloses a device with an entry zone comprising a cell entry port and cell exit port (i.e a first inlet and a first outlet); electroporation electrodes (i.e. first and second electrodes); and an active zone comprising a electroporation buffer inlet and outlet (i.e a second inlet and second outlet). As such, Tandon expressly discloses the providing a devices as claimed in step a. Tandon discloses driving cells from a cell culture medium flowing in a side stream of a sheath flow configuration, to an electroporation medium flowing through a central stream of the sheath flow configuration; applying an electric field to cells in the electroporation medium; and transferring or allowing the transfer of the payload into the cells (claim 1). These limitations encompass passing the plurality of cells and the composition through the active zone while providing the selected combination of parameters, thereby introducing the composition into the plurality of cells. Tandon does not expressly disclose the claimed equation in step b and selecting of the claimed combination of parameters per se. However, the parameters of electrophoresis, fluid flow rates, fluid conductivity, density, and viscosity. Given that the method combines mechanical fluid flow of cells in suspension combined with electroporation of the cells, these parameters are inherently selected to make the transfection of the cell occur in the device of Tandon. Tandon discloses examples of cells used in the instant method are primary T cells, NK cell, more particularly primary human T cells (i.e. mammalian cells; see col 6, last paragraph and col 8 paragraph 3) As such, Tandon expressly or inherently discloses all of the limitations of the claims.
Regarding claim 14, this claims recites essentially the same limitations except it specifies that the cells are immune cells. As discussed above, Tandon discloses primary T cell, NK cells, more particularly primary human T cells.
Regarding claim 2 and 16, Tandon discloses the throughput is at least 4 million cells per minute (see col 22, claim 8), meeting the limitations of at least 105 cell per minute.
Regarding claims 3 and 17, Tandon teaches the entry zone and electroporation zone have a configuration that increases average flow velocity thought the electroporation zone (see figure 4C).
Regarding claims 4 and 18, Tandon teaches that the transfected cells, particularly T cells at least 80-95% viability which is a marker of cell surface intactness and demonstrating that the T cell character is not altered (see figures 14B and 15; col 20, lines 24-26).
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCIA STEPHENS NOBLE whose telephone number is (571)272-5545. The examiner can normally be reached M-F 9-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Paras can be reached at 571-272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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MARCIA S. NOBLE
Primary Examiner
Art Unit 1632
/MARCIA S NOBLE/ Primary Examiner, Art Unit 1632