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 .
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 9 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 9 recites the limitation "output ports" in line 3. There is insufficient antecedent basis for this limitation in the claim. It is unclear if the output ports are the same ports as the outlet ports or if they are different ports than the outlet ports. For examination purposes, they are being treated as the outlet ports.
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.
Claims 1-7, 10-12, 14-16, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rubinsky et al. (WO0107585A1).
Regarding Claim 1, Rubinsky discloses the following:
A device used for the electroporation of biological cells (page 9, lines 8-9)(an electroporation assembly)
Two electrodes (27 and 31 in Fig. 2, below and page 22, line 35 – page 23, line 2)(at least two electrically conductive layer components)
A lower silicon layer 22, and an upper silicon layer 25, together defining a channel layer disposed between the two electrically conductive layer components (page 22, lines 27-29). The channel layer and two electrode layers being components of the device means they are attached together to build the device and therefore are capable of being removed as well.
The two electrically conductive layer components and the channel layer define a plurality of electroporation flow paths in an assembled state (Fig. 2, below)
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Regarding Claim 2, Rubinsky teaches all of the limitations of Claim 1 (see above). Rubinsky further teaches an acrylic (an insulating material) base 21 (support layer) which interfaces with one of the at least two electrically conductive layer components (Fig. 2, above).
Regarding Claim 3, Rubinsky teaches all of the limitations of Claim 2 (see above). The support layer seals against electrode 31 (one of the at least two conductive layer components)(Fig. 2, above). Further, the support layer configured to seal against one of the at least two conductive layers is an intended use of the device. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim (see MPEP 2114). The support layer is capable of sealing to the electrode and therefore meets the claim.
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Regarding Claim 4, Rubinsky teaches all of the limitations of Claim 2 (see above). Rubinsky further teaches the at least one support layer component is an inlet support layer component which defines a plurality of input ports (Fig. 2, below). The input ports configured to receive a cell sample fluid from a manual pipette, an automated liquid dispenser, or an automated liquid handling system is an intended use of the device. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim (see MPEP 2114). The input ports would be capable of receiving a cell sample fluid by manual pipette and therefore meet the claim.
Regarding Claim 5, Rubinsky teaches all of the limitations of Claim 2 (see above). Rubinsky further teaches the at least one support layer component is an inlet support layer component which defines a plurality of input ports (Fig. 2, above). The input ports configured to connect with one or more cell sample reservoirs such that cell sample fluid entering the assembly from the one or more cell sample reservoirs is sealed is an intended use of the device. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim (see MPEP 2114). The input ports would be capable of connecting with one or more cell sample reservoirs such that cell sample fluid entering the assembly from the one or more cell sample reservoirs would be sealed and therefore meet the claim.
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Regarding Claim 6, Rubinsky teaches all of the limitations of Claim 2 (see above). Rubinsky further teaches the at least one support layer component is an outlet support layer component defining a plurality of outlet ports (Fig. 2, below).
Regarding Claim 7, Rubinsky teaches all of the limitations of Claim 6 (see above). The outlet support layer component configured to connect with the one or more collection reservoirs such that cell sample fluid exiting the assembly into the one or more collection reservoirs is sealed is an intended use of the device. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim (see MPEP 2114). The outlet support layer component would be capable of connecting with the one or more collection reservoirs such that cell sample fluid exiting the assembly into the one or more collection reservoirs is sealed and therefore meets the claim.
Regarding Claim 10, Rubinsky teaches all of the limitations of Claim 1 (see above). Rubinsky further teaches the different structural components to include the two electrodes 27 and 31 (page 22, line 26 – page 23, line 2). Being components of the device means they would, in some way, be removable from the device.
Regarding Claim 11, Rubinsky teaches all of the limitations of Claim 1 (see above). Rubinsky further teaches the electrodes 27 and 31 to be layers of n+ poly-silicon (page 22, line 35 – page 23, line 2). A layer made of the same material across the layer would make the layer uniformly conductive.
Regarding Claim 12, Rubinsky teaches all of the limitations of Claim 1 (see above). Rubinsky further teaches each electrode if joined by electric leads to a circuit board with controls the voltage applied (page 23, lines 2-3) and the device comprises a means for varying the electrical current between the electrodes (page 15, lines 11-12)(at least one of the at least two electrically conductive layer components comprises selectively activatable electrodes capable of producing electric fields that vary in strength for the electroporation flow paths).
Regarding Claim 14, Rubinsky teaches all of the limitations of Claim 1 (see above). Rubinsky further teaches the lower layer 22 and upper layer 24 (making the channel layer component) to be made of silicon (page 22, lines 27-29), an electrically insulating material.
Regarding Claim 15, Rubinsky teaches all of the limitations of Claim 1 (see above). Rubinsky further teaches the different structural components to include the lower layer 22 and upper layer 24 (channel layer component) (page 22, lines 26-29). Being components of the device means they would, in some way, be removable from the device.
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Regarding Claim 16, Rubinsky teaches all of the limitations of Claim 1 (see above). Rubinsky further teaches the channel layer component to define a constriction region of each of the plurality of flow paths, a geometry of at least a subset of the constriction regions comprising a uniform cross-sectional area (see Fig. 2, below).
Regarding Claim 18, Rubinsky teaches all of the limitations of Claim 1 (see above). Rubinsky further teaches a lower silicon layer 22 and an upper silicon layer 25 (combined they are the channel layer) which define the flow paths (page 22, lines 27-29)(the channel layer comprises at least two channel layer components defining a portion of the plurality of electroporation flow paths).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 8, 9, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Rubinsky et al. (WO0107585A1) in view of Shkolnikov et al. (WO2019059936A1).
Regarding Claim 8, Rubinsky teaches all of the limitations of Claim 6 (see above). Rubinsky does not teach each of the plurality of outlet ports to comprise a nozzle.
Shkolnikov teaches an electroporation system including a well plate, a dispenser, and multiples electrodes (Abstract). Shkolnikov further teaches a well positioning system with a well plate 24 and dispenser 30 (multiple layers) which are positioned relative to each other to control dispensing of cells (para 32). Shkolnikov further teaches the dispenser to have nozzles.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the outlet ports of the outlet support layer Rubinsky with a nozzle as taught by Shkolnikov. One would have been motivated to make this modification to be able to precisely position the layer to dispense the fluid into the collection reservoirs (para 32).
Regarding Claim 9, Rubinsky teaches all of the limitations of Claim 6 (see above). Rubinsky does not teach one of the at least two conductive layer components comprise nozzles disposed at terminating ends of the electroporation flow path, where the outlet ports are configured to receive the nozzles.
Shkolnikov teaches a well positioning system with a well plate 24 and dispenser 30 (multiple layers) which are positioned relative to each other to control dispensing of cells (para 32). Shkolnikov further teaches the dispenser to have nozzles.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the conductive layer components of Rubinsky with nozzles as taught by Shkolnikov. One would have been motivated to make this modification to be able to precisely position the layer to dispense the fluid to the outlet ports (para 32).
Regarding Claim 13, Rubinsky teaches all of the limitations of Claim 1 (see above). Rubinsky does not teach one of the at least two conductive layer components comprise nozzles disposed at a terminating end of each of the plurality of parallel electroporation flow paths.
Shkolnikov teaches a well positioning system with a well plate 24 and dispenser 30 (multiple layers) which are positioned relative to each other to control dispensing of cells (para 32). Shkolnikov further teaches the dispenser to have nozzles.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the conductive layer components of Rubinsky with nozzles as taught by Shkolnikov. One would have been motivated to make this modification to be able to precisely position the layer to dispense the fluid to a cell collection unit (para 32).
Further, the nozzles configured to direct a flow of a cell sample fluid travelling through the flow paths into corresponding receptacles of a cell collection unit is an intended use of the device. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim (see MPEP 2114). The nozzles would be capable of direct the flow into receptacles of a cell collection unit and therefore meets the claim.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Rubinsky et al. (WO0107585A1).
Rubinsky teaches all of the limitations of Claim 1 (see above). Rubinsky further teaches the channel layer component to define a constriction region of each of the plurality of flow paths (see Fig. 2, below).
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Rubinsky does not explicitly teach the geometry of at least a subset of the constriction regions to comprise a varying cross-sectional area providing for a converging channel, a diverging channel, are a converging and diverging channel.
The change of shape has been deemed a matter of choice and obvious to one of ordinary skill in the art (see MPEP 2144.04(IV)(B)). As such, it would have been obvious to vary the cross-sectional areas of the constriction regions.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Rubinsky et al. (WO0107585A1) in view of Culling (US5539362).
Rubinsky teaches all of the limitations of Claim 1 (see above). Rubinsky does net explicitly teach at least one of the conductive layer components to comprise a sealing structure configured to engage with a complimentary sealing structure of the channel layer component.
Culling teaches a dielectric board means of connection to another board to be the use of mounting pegs, where each mounting peg fits into associated mounting hole (col 4, lines 48-52). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Rubinsky with the peg and hole arrangement used for coupling as taught by Culling. Note, Applicant’s specification, para 38, states a sealing structure to be protrusions (pegs) and the complimentary sealing structures to be recesses (holes).
One would have been motivated to make this modification as it would allow for better alignment between the substrates (col 4, line 53).
Allowable Subject Matter
Claim 21 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Rubinsky teaches all of the limitations of Claim 1 (see above). Rubinsky does not teach each component of the two electrically conductive layer components and the channel layer component define a plurality of channels therethrough. Neither Shkolnikov nor Culling teach these limitations and examiner’s search provided no other prior art that anticipates the limitations of Claim 21 or would have been obvious to combine with Rubinsky to arrive at the claimed invention.
Response to Arguments
Applicant's arguments filed 09/04/2025 have been fully considered but they are not persuasive.
Regarding Applicant’s arguments on page 7 that Rubinsky’s device must be treated as a single electroporation flow path, Applicant agrees previously on page 7 that Rubinsky teaches multiple flow path separated by layer 24. An electroporation flow path is merely a flow path which is being exposed to an electric field. Given both flow paths taught by Rubinsky are exposed to an electric field by the two electrodes, Rubinsky’s device meets the claim.
In response to applicant's argument that Culling is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Culling relates to the coupling of layers together which is pertinent to the problem in which the Applicant’s invention is concerned.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., preventing leakage or cross contamination between or amount the plurality of electroporation flow paths) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
The amendments to correct the 112(b) rejections from the 06/04/2025 Office Action have been accepted and some of the 112(b) rejections have been withdrawn, however, the 112(b) rejection of Claim 9 has not been corrected and remains.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN E LEPAGE whose telephone number is (571)270-3971. The examiner can normally be reached 8:30-5:30 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Robinson can be reached at 571-272-7129. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.E.L./Examiner, Art Unit 1796
/ELIZABETH A ROBINSON/Supervisory Patent Examiner, Art Unit 1796