Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Claim status
Claims 1-5 are pending
Claims 1-5 are under examination
Election/Restrictions
Applicant’s election of the following invention in the reply filed on 5/22/2026 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 § 818.03(a)).
The requirement is still deemed proper and is therefore made FINAL.
Group I, claims 1-5, drawn to an electroporation system.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/21/2023 and 5/22/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
However, Applicant is reminded that the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
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.
Claims 1-5 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Tandon et al. (WO 2019/183238, filed 3/20/2019, with priority to 62/645,275, filed 3/20/2018) .
The applied reference has a common inventor and applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
With respect to claims 1-5, Tandon teaches a system for automated, continuous flow transfer of cargo into cells, the system comprising,
[AltContent: textbox ([img-media_image1.png])]An electroporation assembly comprising multiple microfluidic channels disposed in parallel with trifurcated inlets and outlets, a first buffer exchanger for acoustically driving cells from a culture media into an electroporation media, an electrode layer, a second buffer exchanger for acoustically driving cells from the electroporation media into a cell culture media, and a pump system with controller (Detailed Description [0019-0027], Claims 1-7, and see Fig. 1 of priority document adjacent). Although Tandon does not explicitly recite an incubator for storing cells, since the device is for use with cells, an cell incubator would have been immediately apparent part of the system.
Accordingly, Tandon anticipates instant claims.
Claims 1-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zahn et al. (WO 2017/040995, filed 9/2/2016, published 3/09/2017, see IDS filed 11/21/2023)
Zahn teaches a system for an automated, continuous flow transfer of cargo into cells, the system comprising
An incubator for culturing cells [0069, 00104],
[AltContent: textbox ([img-media_image2.png])]An electroporation assembly comprising a layer supporting two microfluidic channels disposed in parallel (see Fig. 3F adjacent)
An upper first buffer exchanger (see inset from Fig. 3D adjacent),
An electrode layer (Fig. 3F),
A lower second buffer exchanger (Fig. 3D),
A precision pump controller [00104].
In regard to the first and second buffer exchangers “for driving cells” from one media to another, these represent the intended uses of the trifurcated microfluidic channels of Zahn. Note that the recited cells and buffers are not claimed as being part of the system, and based on applicant’s specification and the prior art, the trifurcated arrangement of inlets and outlets in the microfluidic device of Zahn would have been able to achieve a buffer exchange by simple diffusion of the streams coming in from each of the trifurcated inlets or going out each of the trifurcated outlets.
In regard to claim 2, as stated supra, Zahn teaches the system further comprises a pumping system for delivering cells to the first buffer exchanger of the microfluidic channel.
In regard to claim 3, as shown supra, each of the microfluidic channel has trifurcating inlets and trifurcating outlets.
In regard to claim 4, as shown supra, each member of the electroporation assembly comprises a left and right electrode layer.
In regard to claim 5, as stated supra, each microfluidic channel could been used to support a central stream and side sheath streams based on the trifurcating structure of the inlets, yet this is an intended use of the claimed device.
Accordingly, Zahn anticipates instant claims.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived 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(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Corso et al. (US 11,225,638, filed 4/04/2017, patented 1/18/2022, see IDS filed 11/21/2023), in view of Dzekunov et al. (US 7,141,425, patented 11/28/2006, see IDS filed 11/21/2023)
In regard to of claim 1, Corsco teaches a system comprising a microfluidic channel that allows for the automated, continuous flow transfer of cargo into cells by electroporation in a microfluidic channel, wherein the system comprises
an incubator (Example 1, col 12, 2nd para., see #600 of Fig. 5),
[AltContent: textbox ([img-media_image3.png])]an electroporation device comprising a chip layer (#100) supporting a microfluidic channel (col 13, 2nd para., Fig. 5, #604, see modified Fig. 2, adjacent),
a first buffer exchanger in the microfluidic channel (#107 of Fig. 2) for driving cells from a low conductance cell culture media to a high conductance electroporation media (col 14, 1st para.); importantly, Corsco teaches that although the low and high conductance streams flow in parallel in the channel, the device allows mixing slowly through diffusion to form the final electroporation medium of the central stream for the automated, continuous flow-transfer of the cargo (col 6, last para. col 8, 2nd para.),
a second buffer exchanger after the cells leave the device via outlet #108, that “drive” the cells by resuspension into a standard tissue culture media (col 8, 2nd para.) (Note that Applicant’s specification indicates that buffer exchange can performed by the resuspension of cells [0016] and places no limitations on manner by which cells are “driven”), and
a pump operating with a flow controller (see #601 of Fig. 5).
However, in regard to the electroporation device comprising multiple microfluidic channels disposed on a chip in parallel, Corsco et al. are silent with respect to an assembly comprising multiple microfluidic channels. Nevertheless, Corsco cites the prior patent of Dzekunov et al. (US 7,141,425).
Dzekunov teaches methods for introducing a payload into cells by electroporation, the method comprising an assembly of microfluidic channels in parallel on a single chip (col 38, 3rd para., col 40, 1st para., col 42, 3rd para., see Fig. 16).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to prepare the device for the electroporation of cells comprising a microfluidic channel as taught by Corsco and combine multiple microfluidic channels into an assembly on a chip as taught by Dzekunov with a reasonable expectation of success. The ordinary skilled artisan would have been motivated to do so as taught by Dzekunov because multiple microfluidic channels increases throughput (col 40, 1st para., col 42, 3rd para.). Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to duplicate microfluidic channels because the courts have held that a mere duplication of the essential working parts of a device involves only routine skill in the art. MPEP 2144.04VI(B) summarizes that although a prior art reference does not disclose a plurality of elements, the court held that “mere duplication of parts has no patentable significance unless a new and unexpected result is produced”, In reHarza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960), see also St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
In regard to claim 2, as stated supra, Corso teaches the system further comprises a pumping system for delivering cells to the first buffer exchanger of the microfluidic channel (see also col 11, 4th para.).
In regard to claim 3, as shown supra, each of the microfluidic channel has trifurcating inlets (#103, #104, & #105) and an outlet (#108). Note that although Corso’s device comprises a microfluidic channel with a single outlet, using a secondary outlet (e.g., for overflow) was well known in the art (see col 38, 3rd para. of Dzekunov).
In regard to claim 4, as shown supra, each member of the electroporation assembly comprises an upper and lower electrode layer (#101 & #102).
In regard to claim 5, as shown supra, each microfluidic channel is configured to support a central stream with the cells in a low conductance buffer, and side sheath streams with high conductance buffer as a laminar flow (see also col 2, last para.).
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-5 are rejected on the grounds of nonstatutory double patenting over claims 1-13 of U.S. Patent No. 12,686,843 (Tandon et al., Patented 7/21/2026).
The subject matter claimed in the instant application is disclosed in the referenced patent as follows: the system comprising a microfluidic channel with trifurcated inlets, a first buffer exchanger for acoustically driving target particles from a target fluid into buffer fluid, an electroporation device, at least one outlet channel, a separation device that separates enriched target particles, and a pump system with controller makes obvious the system of instant application. It is clear that all the elements of the cited patent claims are to be found in instant claims. The differences between the cited patent claims and the instant claims lies in the fact that the instant application requires multiple microfluidic channels in parallel, and an incubator.
However, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to have claimed an incubator in the system because this would have been necessary for storing cells. Furthermore, it would have been obvious to claim two parallel microfluidic channels because the courts have held that a mere duplication of the essential working parts of a device involves only routine skill in the art. MPEP 2144.04VI(B) summarizes that although a prior art reference does not disclose a plurality of elements, the court held that “mere duplication of parts has no patentable significance unless a new and unexpected result is produced”, In reHarza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960), see also St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Since the instant application claims are obvious over cited patent claims, said claims are not patentably distinct.
Claims 1-5 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1-4, 6-9 and 22 of copending Application No. 19/224,207. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented
The subject matter claimed in the instant application is disclosed in the referenced application as follows: the system comprising a microfluidic channel with trifurcated inlets, an acoustic actuator driving target particles from a first cell buffer fluid into second electroporation fluid, and then out of the second fluid back into the first fluid, an electroporation device, makes obvious the system of instant application. It is clear that all the elements of the cited application claims are to be found in instant claims. The differences between the cited application claims and the instant claims lies in the fact that the instant application requires multiple microfluidic channels in parallel, a pump controller, and an incubator.
However, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to have claimed an incubator in the system because this would have been necessary for storing cells, and a pump controller would have been obvious in order to establish the sheath flow as claimed in cited application. Furthermore, it would have been obvious to claim two parallel microfluidic channels not only because it is claimed as a separate embodiment in cited application (i.e., co-pending claim 22) but also because the courts have held that a mere duplication of the essential working parts of a device involves only routine skill in the art. MPEP 2144.04VI(B) summarizes that although a prior art reference does not disclose a plurality of elements, the court held that “mere duplication of parts has no patentable significance unless a new and unexpected result is produced”, In reHarza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960), see also St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Since the instant application claims are obvious over cited application claims, said claims are not patentably distinct.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARTHUR S LEONARD whose telephone number is (571)270-3073. The examiner can normally be reached on Mon-Fri 9am-5pm.
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/ARTHUR S LEONARD/ Examiner, Art Unit 1631
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