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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/17/2025 has been entered.
Election/Restrictions
Newly submitted claim 1 directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT rule 13.1.
Group I, claims 1-10 and 12, drawn to a first electroporation device including a holding portion.
Group II, claim 11, drawn to a method for producing cells with an introduced foreign substance including an electroporation device including a holding portion.
Group III, claim 13, drawn to a second electroporation device including a holding portion.
The groups of inventions listed above do not relate to a single general inventive concept under PCT rule 13.1 because, under PCT rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I-III lack unity of invention because even though the inventions of these groups require the technical feature of a holding portion, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Lamotte et al. (US 2017/0362564 A1) (already of record). Lamotte et al. discloses an electroporation method (abstract “lysing biological species… voltage pulse between the two electrodes”) in a system including a holding portion (para. 0024 “vessel with the solution containing the biological species”).
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 13 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Response to Arguments
Applicant’s arguments, see pp. 8, filed 12/17/2025, with respect to independent claim 1 have been fully considered and are persuasive.
Applicant argues on p. 8 that Mizuno et al.’s container (2) and electrodes (5a, 5b) are electrically connected with metal clips (7a, 7b) in parallel and not in series as required by claim 1 of the instant application, and the Examiner agrees. Additionally, this amendment to claim 1 overcomes the embodiment shown in Fig. 8 of Mizuno et al. as this embodiment also shows plate-shaped strips (45a, 45b) connected in parallel to a conductor (8) rather than in series.
Applicant argues on pp. 9-10 that Mizuno et al. does not teach an electroporation device that is capable of creating an arc discharge, which is required by independent claim 1 of the instant application, as the conditions described in Mizuno et al. (low voltage, insulating oil between the electrodes, and smooth electrodes) make creating an arc discharge physically impossible, and the Examiner agrees.
Applicant has amended claim 1 to overcome the objection previously set forth in the Final Office Action mailed 9/17/2025; accordingly, the objection to claim 1 has been withdrawn.
Specification
The disclosure is objected to because of the following informalities: it is recommended that “This application is a national stage application under 35 U.S.C. § 371 of PCT Application PCT/JP2019/049952, filed December 19, 2019, which claims benefit to Japanese Patent Application JP2018-238147, filed December 20, 2018; said applications incorporated herein by reference.” be added on page 1 after the Title. 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 limitations are:
"holding portion configured to hold a solution containing a foreign substance and a cell" in claims 1, 3, 9, 10, and 12;
"discharge generating portion... configured to generate an arc discharge" in claims 1-3, 5-8, and 12;
"conductive portion configured to electrically connect the holding portion and the discharge generating portion in series" in claim 1;
"power amount control portion configured to control an amount of electric energy of the pulsed electric current supplied to the holding portion" in claims 1-3, 7, and 9-10;
"power supply portion" in claims 2-4 and 12;
"dark current control portion configured to control a dark current" in claim 7;
"cycle adjustment portion configured to cyclically apply a voltage to the discharge generating portion" in claim 8.
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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-10 and 1 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 1, 3, 9, 10, and 12, the claim limitation “holding portion” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description in the specification fails to disclose the corresponding structure, material, or acts to the function, as will be discussed in the 35 U.S.C. 112(b) section below. Therefore, the claim limitation lacks adequate written description support under 35 U.S.C. 112(a).
Regarding claims 2-4 and 12, the claim limitation “power supply portion” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description in the specification fails to disclose the corresponding structure, material, or acts to the function, as will be discussed in the 35 U.S.C. 112(b) section below. Therefore, the claim limitation lacks adequate written description support under 35 U.S.C. 112(a).
Regarding claim 7, the claim limitation “dark current control portion” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description in the specification fails to disclose the corresponding structure, material, or acts to the function, as will be discussed in the 35 U.S.C. 112(b) section below. Therefore, the claim limitation lacks adequate written description support under 35 U.S.C. 112(a).
Regarding claim 8, the claim limitation “cycle adjustment portion” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description in the specification fails to disclose the corresponding structure, material, or acts to the function, as will be discussed in the 35 U.S.C. 112(b) section below. Therefore, the claim limitation lacks adequate written description support under 35 U.S.C. 112(a).
Dependent claims are rejected for the same reason as the base claim(s) upon which they depend.
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 1-10 and 12 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.
Regarding claims 1, 3, 9, 10, and 12, the claim limitation “holding portion” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The “holding portion” is only described in the written description as provided with a pair of electrodes and a container (para. 0023) and which is configured to hold a solution between the pair of electrodes (para. 0023). The written description does not appear to disclose any actual structure for this feature to perform the function of holding. There for the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Regarding claims 2-4, the claim limitation “power supply portion” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The “power supply portion” is only described in the written description as configured to apply voltage to the discharge generating portion (para. 0035). The written description does not appear to disclose any actual structure for this feature to perform the function of supplying power. There for the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Regarding claim 7, the claim limitation “dark current control portion” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The “dark current control portion” is only described in the written description as suppressing an influence of dark current by restricting electric current supplied by the power supply portion and controlling electric current for charging the condenser (para. 0030). The written description does not appear to disclose any actual structure for this feature to perform the function of controlling dark current. There for the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Regarding claim 8, the claim limitation “cycle adjustment portion” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The “cycle adjustment portion” is only described in the written description as configured to cyclically apply a voltage to the discharge generating portion at a predetermined interval (para. 0014). The written description does not appear to disclose any actual structure for this feature to perform the function of adjusting cycles. There for the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Allowable Subject Matter
Claims 1-10 and 12 would be allowable if rewritten or amended to overcome the rejections under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph and 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Regarding independent claim 1, Mizuno et al. teaches an electroporation device (abstract “apparatus that introduces an exogenous substance into a small amount of cells… by electrical action”) comprising: a holding portion (Fig. 8 container 12) configured to hold a solution containing a foreign substance and a cell (abstract “cell suspension liquid that contains the cell and the exogenous substance is supplied to a container”); a discharge generating portion including a pair of electrodes disposed at a predetermined gap, placed outside the holding portion (Fig. 8 rectangular plate-shaped strips 45a, 45b; para. 0137 “electrically conductive material such as metal”); a conductive portion configured to electrically connect the holding portion and the discharge generating portion (Fig. 8 conductor 8), and to supply, to the holding portion, a pulsed electric current generated by the discharge generating portion (para. 0005 “high-voltage pulse”); and a power amount control portion configured to control an amount of electric energy of the pulsed electric current supplied to the holding portion (para. 0101 “a dial for adjusting the voltage that is supplied”).
However, as Applicant points out in the remarks dated 12/17/2025, Mizuno et al. does not fairly teach “a conductive portion configured to electrically connect the holding portion and the discharge generating portion in series” or a discharge generating portion “configured to generate an arc discharge”. Regarding the connection in series, Mizuno et al. discloses “a conductive portion configured to electrically connect the holding portion and the discharge generating portion” in parallel, but does not disclose this connection in series as required by independent claim 1 of the instant application. Regarding generating an arc discharge, Mizuno et al. does not disclose an electroporation device capable of creating an arc discharge as required by independent claim 1 of the instant application. The prior art of record, alone or in combination, does not disclose, teach, or suggest the noted features within the claim environment.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEY LOPEZLIRA whose telephone number is (703)756-5517. The examiner can normally be reached Mon - Fri: 8:30-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ASHLEY LOPEZLIRA/Examiner, Art Unit 1799
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799