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 .
Notes
All the objections and rejections in the previous Office Action not reiterated herein have been withdrawn.
Claim Objections
Claims 21 and 25 are objected to because of the following informalities: In claim 8, the “ark risk” should read --- arc risk --. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a cooling module” in claims 1 and 23; “a pre-cooling assembly” in claim 14; “a capping mechanism” in claim 16.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-6, 14-18 and 20-25 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.
Claim 1 recites the limitations "an electroporation assembly electrically coupled to the electroporation chamber for generating and delivering an electrical pulse to the electroporation chamber, the electroporation assembly having a conductivity sensor configured to measure conductivity across the electroporation chamber" in lines 9-11. The electroporation assembly is structurally defined to comprise a conductivity sensor. The electroporation assembly is functionally defined as “generating and delivering an electrical pulse to the electroporation chamber” and to “measure conductivity across the electroporation chamber." Therefore, it is unclear how the electroporation assembly which is a conductivity sensor is configured to perform the function of “generating and delivering an electrical pulse to the electroporation chamber.” Claims 2-6, 14-18, 20-22 and 24 are included in this rejection by virtue of their dependency upon a rejected base claim.
Claim 23 recites the limitations "an electroporation assembly configured to electrically couple to the electroporation chamber when the electroporation cartridge is received by the electroporation compartment, wherein the electroporation assembly is configured to generate and deliver an electrical pulse to the electroporation chamber" in lines 6-9. The claim defines the electroporation assembly as a conductivity sensor. The electroporation assembly is functionally defined as “generating and delivering an electrical pulse to the electroporation chamber” and to “measure conductivity across the electroporation chamber." Therefore, it is unclear how the electroporation assembly which is a conductivity sensor is configured to perform the function of “generating and delivering an electrical pulse to the electroporation chamber.”
Claims 21 and 25 recite the limitation "ark risk," how Applicant’s disclosure does not define what constitutes “an ark risk.”
Appropriate correction is required.
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 1-4, 14-15 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Masquelier et al. (already of record, US 2019/0002814; hereinafter “Masquelier”) in view of Gascoyne et al. (WO 2013/096304-A1; hereinafter “Gascoyne”).
Regarding claim 1, Masquelier discloses an electroporation system comprising: a modular casing having electroporation system components (chassis of the electroporation system adapted to receive components of an electroporation system; see [0089], [0105]-[0106], [0112], [0172], [0241]), the electroporation system components comprising: an electroporation compartment having an electroporation cartridge comprising an electroporation chamber (chassis includes an upper chamber adapted to receive an electroporation module (e.g., cuvettes)having an electroporation chamber; [0086], [0099], [0089], [0187]-[0188]); a cooling module in thermal contact with the electroporation chamber and configured to regulate the temperature of the electroporation chamber (see [0107]); an electroporation assembly electrically coupled to the electroporation chamber for generating and delivering an electrical pulse to the electroporation chamber (an electrical pulse generator; [0187]); and a controller having a processor and a hardware storage device, the controller being communicatively coupled to the electroporation assembly (FIG. 9; electroporation system of Masquelier is automated; [0202], [0213]-[0214]). Masquelier does not explicitly disclose the electroporation assembly having a conductivity sensor configured to measure conductivity across the electroporation chamber. Gascoyne discloses a system comprising a chamber comprising electrodes ([0008], claim 1), a conductivity sensor configured to measure conductivity across the chamber ([0011], [0078], claims 17-19), and a controller coupled to the conductivity sensor and configured to adjust electrical signal generated by a signal generator to achieve desired electrical signal ([0078]; claims 17-19). In view of Gascoyne, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have employed the conductivity sensor of Gascoyne with the system of Masquelier in order to measure conductivity across the chamber as disclosed by Gascoyne ([0078]). One of ordinary skill in the art would have made said modification for the purpose of maintaining desired conductivity across the chamber as disclosed by Gascoyne (see [0078]; claims 17-19).
Regarding claim 2, modified Masquelier further discloses wherein the electroporation cartridge is a single use electroporation cartridge ([0173], [0182]).
Regarding claim 3, modified Masquelier further discloses wherein the electroporation cartridge is a flow- through electroporation cartridge ([0012], [0086], [0088], [0172]-[0173], [0241]).
Regarding claim 4, modified Masquelier further discloses a graphical user interface having functionality to receive input from a user to control operation of the electroporation system (FIGS. 2C-2D and 11; [0037], [0224], [0320]).
Regarding claim 14, modified Masquelier further discloses a pre-cooling assembly and configured for cooling sample prior to being introduced into the electroporation chamber (temperature control unit; see [0106], [0138]).
Regarding claim 15, modified Masquelier further discloses at least one flow sensor (flow sensor 712; [0154]).
Regarding claim 23, Masquelier disclose an electroporation system comprising: an electroporation compartment configured to receive an electroporation cartridge having an electroporation chamber (chassis includes an upper chamber adapted to receive an electroporation module (e.g., cuvettes)having an electroporation chamber; [0086], [0099], [0089], [0187]-[0188]); a cooling module configured to be in thermal contact with the electroporation chamber when the electroporation cartridge is received by the electroporation compartment, and wherein the cooling module is configured to regulate the temperature of the electroporation chamber (see [0107]); an electroporation assembly configured to electrically couple to the electroporation chamber when the electroporation cartridge is received by the electroporation compartment, wherein the electroporation assembly is configured to generate and deliver an electrical pulse to the electroporation chamber (an electrical pulse generator; [0187]); and a controller having a processor and a hardware storage device, the controller being
communicatively coupled to the electroporation assembly (FIG. 9; electroporation system of Masquelier is automated; [0202], [0213]-[0214]). Masquelier does not explicitly disclose wherein the electroporation assembly comprises a conductivity sensor configured to measuring conductivity across the electroporation chamber. Gascoyne discloses a system comprising a chamber comprising electrodes ([0008], claim 1), a conductivity sensor configured to measure conductivity across the chamber ([0011], [0078], claims 17-19), and a controller coupled to the conductivity sensor and configured to adjust electrical signal generated by a signal generator to achieve desired electrical signal ([0078]; claims 17-19). In view of Gascoyne, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have employed the conductivity sensor of Gascoyne with the system of Masquelier in order to measure conductivity across the chamber as disclosed by Gascoyne ([0078]). One of ordinary skill in the art would have made said modification for the purpose of maintaining desired conductivity across the chamber as disclosed by Gascoyne (see [0078]; claims 17-19).
Claims 1 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Chen (already of record, US 2017/0335269) in view of Dai (WO 2019/076353-A1; with English machine translation) and Gascoyne et al. (WO 2013/096304-A1; hereinafter “Gascoyne”).
Regarding claim 1, Chen discloses an electroporation system comprising:electroporation system comprising: a modular casing having electroporation system components, the electroporation system components comprising: an electroporation compartment having an electroporation cartridge comprising an electroporation chamber (as shown in FIG. 11, electroporation cartridge having electroporation chamber (tube 1) is received within a compartment of a modular casing). Chen does not explicitly disclose a cooling module in thermal contact with the electroporation chamber and configured to regulate the temperature of the electroporation chamber. Dai discloses an electroporation device comprising an electroporation chamber, one or more electrodes coupled to the electroporation chamber, and thermal regulating system for regulating temperature of the electroporation chamber (see [0069]). In view of Dai, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have employed the thermal regulating system of Dai with the system of Chen to arrive at the claimed invention with a reasonable expectation of success. One of ordinary skill in the art would have made said modification for the purpose of regulating the temperature of the electroporation chamber as disclosed by Dai ([0069]). Chen does not explicitly disclose an electroporation assembly electrically coupled to the electroporation chamber for generating and delivering an electrical pulse to the electroporation chamber, the electroporation assembly having a conductivity sensor configured to measure conductivity across the electroporation chamber; and a controller having a processor and a hardware storage device, the controller being communicatively coupled to the electroporation assembly. Gascoyne discloses a system comprising a chamber comprising electrodes ([0008], claim 1), a conductivity sensor configured to measure conductivity across the chamber ([0011], [0078], claims 17-19), and a controller coupled to the conductivity sensor and configured to adjust electrical signal generated by a signal generator to achieve desired electrical signal ([0078]; claims 17-19). In view of Gascoyne, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have employed the conductivity sensor and controller of Gascoyne with the system of Chen in order to measure conductivity across the chamber as disclosed by Gascoyne ([0078]). One of ordinary skill in the art would have made said modification for the purpose of maintaining desired conductivity across the chamber as disclosed by Gascoyne (see [0078]; claims 17-19).
Regarding claim 16, modified Chen further discloses a capping mechanism configured to engage with the electroporation cartridge, wherein the electroporation cartridge comprises a first electrode and a second electrode, each disposed at opposite ends of the electroporation chamber (FIG. 2: electrodes 2 and 3), wherein at least one of the first electrode or second electrode is engageable with the capping mechanism and is moveable between a capped position for electroporation and an uncapped position for venting as a result of actuation of the capping mechanism (see FIG. 2: stopple (4) coupled to the second electrode 3; [0104]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Masquelier”) in view of Gascoyne as applied to claim 1 above, and further in view of Schlaubitz et al. (US 2019/0070611; hereinafter “Schlaubitz”).
Regarding claim 5, modified Masquelier discloses the electroporation system according to claim 1. Modified Masquelier discloses the claimed cooling module but does not explicitly disclose wherein the cooling module comprises a ceramic block. Schlaubitz discloses a system including a cooling module comprising ceramic plate ([0006], [0027]). In view of Schlaubitz, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the cooling module of modified Masquelier with the cooling module of Schlaubitz to arrive at the claimed invention. One of ordinary skill in the art would have made said modification because said modification would have been the simple substitution of art recognized for the same intended purpose of regulating temperature of a system (see also MPEP 2144.07). Further, one of ordinary skill in the art would have made said modification because Schlaubitz discloses that the thermal regulating device can be formed from a variety of materials including ceramic ([0027]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Masquelier”) in view of Gascoyne as applied to claim 1 above, and further in view of Mickelsen et al. (US 2017/0065330; hereinafter “Mickelsen”).
Regarding claim 6, modified Masquelier discloses the electroporation system according to claim 1. Modified Masquelier discloses the claimed cooling module but does not explicitly disclose wherein the cooling module is cooled via thermoelectric cooling. Mickelsen discloses an electroporation system including a cooling module comprising thermoelectric cooling unit ([0019], [0062]). In view of Mickelsen, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the cooling module of modified Masquelier with the cooling module of Mickelsen to arrive at the claimed invention. One of ordinary skill in the art would have made said modification because said modification would have been the simple substitution of art recognized for the same intended purpose of regulating temperature of the electroporation system (see also MPEP 2144.07).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Chen in view of Dai and Gascoyne as applied to claim 1 above, and further in view of Hogan et al. (already of record, US 2018/0051243; hereinafter “Hogan”).
Regarding claim 17, modified Chen discloses the electroporation system according to claim 1. Modified Chen does not explicitly disclose a safety door configured to mechanically open an electroporation circuit to prevent voltage discharge to the electroporation chamber while the safety door is open. Hogan discloses an electroporation system comprising a safety door configured to mechanically open an electroporation circuit to prevent voltage discharge to the system ([0092]). In view of Hogan, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the housing of modified Chen with the housing of Hogan to arrive at the claimed invention. One of ordinary skill in the art would have made said modification for the purpose of preventing electrical shock to the user as disclosed by Hogan ([0092]).
Allowable Subject Matter
Claims 18, 20-22 and 24-26 are 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.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-20 have been considered but are moot in view of the new ground of rejection.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 LIBAN M HASSAN whose telephone number is (571)270-7636. The examiner can normally be reached on 8:30 AM - 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached on 5712721374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LIBAN M HASSAN/Primary Examiner, Art Unit 1799
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