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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Information Disclosure Statement
The information disclosure statements dated 6/27/2025 and 9/15/2025 have been considered and made of record.
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 unit for generating and emitting electric pules” in claim 1; and
“a unit for measuring the electric conductivity of a material” in claim 1.
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.
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 10-18 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.
As discussed above in the “Claim Interpretation” section, the claim limitation “a unit for measuring the electric conductivity of a material” 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 instant disclosure is silent with respect to any corresponding structure related to this claim element. Therefore, 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.
Claims 11-18 are indefinite because they depend from an indefinite claim and do not cure the deficiencies of the claim from which they depend.
Claims 10-18 are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. As described above in the rejection under 35 USC 112(b), the disclosure is devoid of any structure that performs the function in the claim regarding the claim element “a unit for measuring the electric conductivity of a material”. The specification does not demonstrate that applicant has made an invention that achieves the claimed function because the invention is not described with sufficient detail that one of ordinary skill in the art can reasonably conclude that the inventor had possession of the claimed invention.
Claims 11-18 are rejected because they depend from rejected claim 10 and do not cure the deficiencies of the claim from which they depend.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 14 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 14, which depends from claim 10, recites that the at least one adjustable resistor can be “a digital potentiometer” while claim 10 requires that the adjustable resistor has an electric resistance value that can be “adjusted by sliding a contact over a resistive element”. A digital potentiometer is not construct and/or operated in this manner. As a result, claim 14 does not include all of the limitations of the claim upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 10-18 are rejected under 35 U.S.C. 103 as being unpatentable over Marshall, III (US 4,946,793) in view of Byrd et al. (US 2019/0307500).
With respect to claim 10, the reference of Marshall, III discloses:
A device, comprising a unit for generating and emitting electric pulses (10, 20, 30), two or more electrodes (1220, 1230) or plates of a capacitor that are arranged in one electric circuit (Fig. 1) with said unit, and a treatment space (Chamber)(60) arranged between said electrodes or plates so that the treatment space can be penetrated by the emitted electric pulses and an electric field resulting therefrom, wherein at least one additional adjustable resistor (Shunt) (50) (R1-R8) is arranged in said electric circuit, and wherein a unit for measuring the electric conductivity (col. 4, lines 43-50; col. 5, lines 3-19; and col. 9, line 52, to col. 10, line 3) of a material to be treated in the treatment space is provided to generate data for automatically adjusting said at least one adjustable resistor.
Claim 10 differs by reciting that the electric resistance value of the at least one additional adjustable resistor can be adjusted by sliding a contact over a resistive element.
The reference of Marshall, III discloses that “The device for matching the impedance can be manually or automatically controlled, such as through a computer, to selectively switch in one or a plurality of parallel resistances until the impedance of the chamber matches the impedance of the pulse forming network” (col. 5, lines 3-7) and also contemplates the use of more complex parallel or series impedance matching networks (col. 10, lines 39-47).
The reference of Byrd et al. discloses that it is known in the art of electroporation to employ a variable impedance (27) within the electric circuit wherein the variable impedance is a variable resistance which can be a rheostat or a potentiometer (¶[0050]-[0051]).
In view of these teachings and in the absence of a showing of unexpected results, it would have been obvious to one of ordinary skill in the art to employ a rheostat or a potentiometer within the electric circuit of the reference of Marshall, III for the known and expected result of providing an alternative means recognized in the art to achieve the same result of matching the impedance of the chamber with the impedance of the pulse forming network.
With respect to claim 11, while the reference of Marshall, III discloses the use of an adjustable resistor in parallel with the electrodes (Fig. 9), claim 11 differs by reciting that an adjustable resistor is positioned in series with the electrodes.
The reference of Marshall, III also contemplates the use of more complex parallel or series impedance matching networks (col. 10, lines 39-47).
The reference of Byrd et al. also discloses that “the resistors may be connected in series, parallel or any combination of series and parallel connections to produce a desired system impedance” (¶[0051]).
In view of these teachings and in the absence of a showing of unexpected results, it would have been well within the purview of one having ordinary skill in the art to employ an electric circuit wherein the adjustable resistor is connected in series for the known and expected result of using an alternative means recognized in the art to achieve the same result, match the resistance or impedance with the sample to be electrically treated as discussed by the reference of Marshall, III.
With respect to claims 12 and 13, the at least one adjustable resistor is in a parallel connection with the electrodes (Fig. 9) and arranged in the electric circuit.
With respect to claim 14, the structure resulting from the combination of references as discussed above with respect to claim 10 would encompass a device that includes a potentiometer or rheostat (¶[0051] of Byrd et al.).
With respect to claim 15, the unit for generating and emitting electric pulses (10, 20, 30) can generate electric pulses, so that a voltage increase takes place between the two or more electrodes of 10% to 90% of a target voltage of the electric pulses within a period of 0.1 to 1000 ns, the electric pulses have a pulse duration of 5 ns to 50000 ns, and the electric pulses, upon reaching the target voltage, have an electric field strength of 0.5 kV/cm to 100 kV/cm (col. 8, lines 12-22).
With respect to claim 16, the reference of Marshall, III discloses:
A method for treating isolated cell material (erythrocytes)(Examples 1-5)(col. 1, lines 36, to col. 2, line 2) of unicellular or multicellular organisms, or unicellular or multicellular organisms of a size of less than 1 cm diameter, for targeted inactivation, the extraction of bioactive compounds, and the stimulation of cell growth and/or cellular compounds, performed in a device according to claim 10 (See discussion of claim 10 above), comprising the steps:
a) introducing cell material into the treatment space of the device (Ex. 3); and
b) applying an electric field (Ex. 3) to said treatment space with the unit for generating and emitting electric pulses and the two or more electrodes or plates of a capacitor that are arranged in one electric circuit with said unit, wherein said treatment space is arranged between said electrodes or plates, wherein the load of said electric field is adjusted to the cell material to be treated by adjusting at least one adjustable resistor, wherein the step of adjusting said at least one adjustable resistor is carried out before step b) by determining the electric conductivity of the cell material to be treated and automatically adjusting said at least one adjustable resistor depending on said determined electric conductivity (Ex. 3).
With respect to claim 17, since the method of claim 16 involves the use of the device of claim 10, the method would also involve the use of the measuring unit (col. 4, lines 43-50; col. 5, lines 3-19; and col. 9, line 52, to col. 10, line 3) of Marshall, III.
With respect to claim 18, the unit for generating and emitting electric pulses (10, 20, 30) can generate electric pulses, so that a voltage increase takes place between the two or more electrodes of 10% to 90% of a target voltage of the electric pulses within a period of 0.1 to 1000 ns, the electric pulses have a pulse duration of 5 ns to 50000 ns, and the electric pulses, upon reaching the target voltage, have an electric field strength of 0.5 kV/cm to 100 kV/cm (col. 8, lines 12-22). Based on considerations such as the specifics of the cells employed and/or the desired result of the electric field, it would have been well within the purview of one having ordinary skill in the art to determine the optimal pulse generating conditions through routine experimentation.
Response to Arguments
Claim objections
The objection of claim 16 has been withdrawn in view of the amendment to claim 16 and related comments on page 4 of Applicants’ response dated 9/15/2025.
35 USC 112(a),(b) and (f)
The rejections of claims 10-18 which do not involve claim interpretation under 35 USC 112(f) have been withdrawn in view of the amendments to claims 10, 16 and 17 and related comments on page 4 of Applicants’ response dated 9/15/2025.
With respect to claim interpretation under 35 USC 112(f) and related rejection of claims 10-18 under 35 USC 112(a) and (b), Applicants are of the position that the rejections are improper for the following reasons (pages 5-6 of the response dated 9/15/2025):
i) Secondly, the Examiner again objects to the term "a unit for measuring the electric conductivity of a material". Applicant notes that it is not correct that the description is absolutely silent on the structure of a respective unit. On page 5, last paragraph of the specification it is clearly stated that "such units for measuring the electric conductivity of a material are known in the art and need not be discussed in detail here".
In other words, the specification informs the skilled reader that conventional units for measuring the electric conductivity of a material are to be used in the framework of the present invention. The present invention is not about the design of a new unit for measuring the electric conductivity of a material.
As outlined in the specification, such units for measuring the electric conductivity are fundamentally known to a skilled person. Merely as an example, and without any limitation, Applicant herewith submits an excerpt from Wkipedia (see attachment) related to an "electrical conductivity meter". Applicant respectfully submits that it is not necessary to describe in detail fundamentally known basic components of electrical engineering, which are moreover only used as a tool for carrying out the actual invention.
ii) Applicant is unable to follow the basis of said rejection. In the present specification, particularly in the embodiments shown in figures 1 to 8 and the related description, there is detailed disclosure the present invention can be carried out. Applicant also respectfully submits that the disclosure in the figures and the accompanying specification is specific enough to show that the Applicant has made an invention that achieves the claimed function. Again, it is respectfully noted that the individual components and units of the device are very well known to a skilled person. The present invention is about achieving a specific effect by using known components and units. Applicant cannot see why there should be any doubts that the invention can be performed as claimed.
In response, Applicants’ comments appear to be drawn to enable of the invention and whether one of ordinary skill in the art could make and/or use the invention. This is not found to be persuasive because enablement of a device requires only the disclosure of sufficient information so that a person of ordinary skill in the art could make and use the device. A 35 USC 112(f) disclosure, however, serves the very different purpose of limiting the scope of the claim to the particular structure disclosed, together with equivalents. It is not enough for the applciants simply to state or later argue that persons of ordinary skill in the art would know what structures to use to accomplish the claimed function. The inquiry is whether one of skill in the art would understand the specification itself to disclose a structure, not simply whether that person would be capable of implementing that structure (MPEP 2181 (II)(A)).
35 USC 102 and 103
The rejections of claims 10 and 12-18 under 35 USC 102(a)(1) and claim 11 35 USC 103 over the reference of Marshall, III (US 4,946,793) have been withdrawn in view of the amendments to claims 10 and 16 and corresponding comments on pages 7-8 of Applicants’ response dated 9/15/2025. Note: New grounds of rejection have been made under 35 USC 103 over the combination of the references of Marshall, III (US 4,946,793) in view of Byrd et al. (US 2019/0307500).
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 WILLIAM H BEISNER whose telephone number is (571)272-1269. The examiner can normally be reached on Mon-Fri from 8am to 5pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MICHAEL A MARCHESCHI, can be reached at telephone number (571)272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/William H. Beisner/
Primary Examiner
Art Unit 1799
WHB
Prosecution Insights