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 .
Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because the drawings contain deficient line quality. All drawings must be made by a process which will give them satisfactory reproduction characteristics. Every line, number, and letter must be durable, clean, black (except for color drawings), sufficiently dense and dark, and uniformly thick and well-defined. Refer to 37 CFR 1.84(l). See Figures 1-11.
Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
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: “the signal generator-evaluation unit” in claims 1, 3, and 5-13.
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 4 and 8-11 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.
Claims 4 and 8 recite a limitation wherein “a further electrode” is “situated between the two electrodes arranged next to each other.” The meaning of this limitation is unclear because it is unclear exactly how two electrodes can be arranged next to each other while another electrode is situation between them. For examination purposes, the further electrode will be read as another electrode of the plurality of electrodes.
Claim 9 recites the limitation “the electrical signal” in line 2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, this limitation will be read as --the first electrical signal--. Dependent claim 11 is necessarily rejected as depending upon a rejected base claim.
Claim 10 recites the limitations “the first electrical signal” and “the second electrical signal” but depends on claim 1, which does not recite these limitations. There is therefore insufficient antecedent basis for the limitations in the claim. For examination purposes, this claim will be read as depending on claim 3, which does recite the limitations.
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 1-3, 5, 10, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zarins et al. (US PGPub No. 2017/0245926), hereinafter Zarins.
Regarding claim 1, Zarins discloses a device for the irreversible electroporation of a tissue of a patient (Fig. 4: pulsed electric field apparatus 200), said device comprising:
a catheter (Fig. 5A: catheter 302) including: a proximal end (Fig. 4: proximal end of probe 210), and a distal electrode arranged at a distal end of the catheter (Fig. 5A: distal electrode 306b);
a membrane arranged between the distal end and the proximal end and adapted to assume a first and a second form state (Fig. 5A and par. 0046: “the centering element 304 comprises an inflatable balloon”);
a plurality of electrodes arranged on the membrane (par. 0047: “As an alternative or in addition to placement of the electrodes 306 along the central shaft of catheter 302, as in FIG. 5A, the electrodes 306 may be attached to the centering element 304 such that they contact the wall of the renal artery RA”);
and a signal generator-evaluation unit coupled to the proximal end of the catheter and adapted to carry out a tissue impedance determination or an ablation (Fig. 4: PEF generator 50).
Regarding claim 2, Zarins discloses the device of claim 1 as described previously. Zarins further discloses further comprising a proximal electrode arranged at the proximal end of the catheter (Fig. 5A: proximal shaft electrode 306a).
Regarding claims 3 and 5, Zarins discloses the device of claim 1 as described previously. Zarins further discloses wherein the signal generator-evaluation unit is adapted to deliver a first electrical signal into the tissue via an electrode constellation, and wherein the signal generator-evaluation unit is adapted to determine at least one local tissue impedance from an electrical current signal transmitted into the tissue and an electrical voltage signal received from the tissue (par. 0057: “In order to collect the desired monitoring data, additional monitoring electrodes optionally may be provided in proximity to the monitored tissue. The distance between such monitoring electrodes preferably would be specified prior to therapy delivery and used to determine conductivity from impedance or conductance measurements. For the purposes of the present invention, the imaginary part of impedance may be ignored such that impedance is defined as voltage divided by current”).
Regarding claim 10, Zarins discloses the device of claim 3 as described previously. Zarins further discloses further comprising a body surface counter electrode connected to the signal generator-evaluation unit, wherein the distal electrode and the counter electrode is configured as a first electrode pair (par. 0047: “the electrodes 306 may be used together or individually in conjunction with a separate patient ground pad for monopolar use”).
Regarding claim 13, Zarins discloses a method for the irreversible electroporation of a tissue of a patient, comprising the steps: providing a catheter including: a proximal end, and a distal electrode arranged at a distal end of the catheter (Figs. 4-5A: probe 210 and catheter 302 with distal electrode 306b);
a membrane arranged between the distal end and the proximal end and adapted to assume a first and a second form state (Fig. 5A and par. 0046: “the centering element 304 comprises an inflatable balloon”);
a plurality of electrodes arranged on the membrane (par. 0047: “As an alternative or in addition to placement of the electrodes 306 along the central shaft of catheter 302, as in FIG. 5A, the electrodes 306 may be attached to the centering element 304 such that they contact the wall of the renal artery RA”);
providing a signal generator-evaluation unit connected to the proximal end of the catheter (Fig. 4: PEF generator 50);
and carrying out a tissue impedance determination or carrying out a tissue impedance determination and subsequently carrying out an ablation (par. 0056: “electroporation may be monitored directly using, for example, conductivity measurements or impedance measurements, such as Electrical Impedance Tomography (“EIT”) and/or other electrical impedance/conductivity measurements like an electrical impedance or conductivity index;” examiner notes that as the limitations of this claim are stated in the alternative, the prior art is considered to read on the claim when only one of the limitations is met).
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.
Claims 4, 6-9, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Zarins in view of Cao et al. (US PGPub No. 2017/0105793), hereinafter Cao.
Zarins teaches the device of claim 3 as described previously but does not explicitly teach switching between pairs of electrodes and thus does not teach determining at least two local tissue impedances using different combinations of electrode pairs (constellations), or a second operating phase in which the signal generator-evaluation unit is adapted to generate an electrical voltage signal in accordance with a burst-signal protocol to be chosen and to transmit said signal into the tissue via a first electrode pair; wherein two adjacent electrodes of the plurality of electrodes, in the second form state, are configured as the first electrode pair. However, in an analogous art, Cao teaches an irreversible electroporation device with circumferentially adjacent and longitudinally adjacent electrode pairs, wherein a controller is configured to determine at least two local tissue impedances using different combinations of electrode pairs (Figs. 1-4 and 7: electrodes 142, 144, 343, 344, 346, 348, 442, 444; par. 0007: “The controller may be configured to measure an impedance of tissue disposed between pairs of circumferentially adjacent electrodes and pairs of longitudinally adjacent electrodes;” par. 0052: “Prior to treatment, controller 110 may send test pulses between each pair of adjacent electrodes (both circumferentially adjacent electrodes and longitudinally adjacent electrodes) in order to create a detailed map of the tissue surrounding the energy delivery device”), and wherein a generator is configured to generate an electrical voltage signal to be transmitted into tissue via two adjacent electrodes of the plurality of electrodes (Fig. 2 and par. 0032: “energy delivery device 120 may be configured as a bipolar device whereby energy flows from one or more electrodes of the first pole, through tissues surrounding or otherwise adjacent to a body lumen, to one or more electrodes of the second pole”).
Cao teaches interrogating the tissue impedance between different electrode pairs and subsequently delivering energy through adjacent electrodes as a means by which to detect tissue in need of treatment and target the tissue for ablation while reducing the amount damage to healthy tissue (par. 0050: “the impedance of tissue disposed between circumferentially- and/or longitudinally-spaced adjacent electrodes may be measured in order to create a virtual map of tissue surrounding an energy delivery device. The virtual map may be used to differentiate between healthy tissue and cancerous tissue (e.g., tumors) in order to selectively treat cancerous tissue and reduce the amount of healthy tissue that is damaged;” par. 0052: “once the impedance measurements are collected, controller 110 may determine based on an analysis of those measurements, that the measured impedance between electrode pairs 142a-144a, 144a-142b, 142b-144b, 144b-142c, and 142c-144c indicates that cancerous tissue is disposed between those pairs. For example, the impedance measured between the pairs 142a-144a, 144a-142b, 142b-144b, 144b-142c, and 142c-144c may be below an impedance threshold indicative of cancerous tissue between those electrode pairs. Controller 110 or an operator then may utilize that determination to selectively deliver electroporation therapy between electrode pairs 142a-144a, 144a-142b, 142b-144b, 144b-142c, and 142c-144c”).
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 Zarins by incorporating the configuration taught by Cao of impedance interrogation between multiple electrode pairs for selective delivery of electroporation therapy between electrode pairs, in order to reduce the amount of healthy that is damaged during ablation, as taught by Cao.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Zarins.
Zarins teaches the device of claim 2 as described previously. Zarins further teaches wherein the electrodes are connected to the signal generator-evaluation unit via the proximal end of the catheter by electrical lines arranged externally on the catheter (Fig. 4 and par. 0041: “The electrode(s) 212, for example, may be mounted on a catheter and electrically coupled to a pulse generator 50 via wires 211”), but is silent with respect to insulation of the electrical lines and does not explicitly teach wherein the electrical lines are insulated from one another and with respect to the immediate surroundings. However, the examiner takes official notice it is old and notoriously well known, and is capable of instant and unquestionable demonstration as being well-known, to provide insulation on electrical wires used for connecting electrical components.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVINA E LEE whose telephone number is (571)272-5765. The examiner can normally be reached Monday through Friday between 8:00 AM and 5:30 PM (ET).
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/D.E.L./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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