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
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the second electrical insulation material covering a portion of the distal core wire portion, the first electrical insulation material covering a portion of the shaft portion, and the first electrical insulation material comprising portions of different, stepped thicknesses must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 16 and 31-32 are objected to because of the following informalities:
In claims 16 and 32, “an electrosurgical generator” should read --the electrosurgical generator--.
In claim 31, lines 3-4, “the apparatus includes” should read --the apparatus including--.
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: “an activator unit” in claims 15 and 31.
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 13-14, 22, and 29-30 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.
In dependent claims 13 and 29, it is unclear whether the limitation “a tapered thickness” is the same thickness as the first thickness recited earlier in independent claims 1 and 17, which renders the scope of the claims unclear. For examination purposes, this limitation will be read as wherein the first thickness is tapered.
In dependent claims 14 and 30, it is unclear whether the limitation “portions of different, stepped thicknesses” is part of the first thickness recited earlier in independent claims 1 and 17, which renders the scope of the claims unclear. For examination purposes, this limitation will be read as wherein the first thickness comprises portions of different, stepped thicknesses.
In claim 22, it is unclear whether the process of machining the transition portion is recited as part of the claimed method of using the electrosurgical guidewire, which renders the scope of the claim unclear. For examination purposes, this limitation will be read as wherein the transition portion is not actively being machined in the claimed method.
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 1-4, 6-10, 13-14, 17-20, 22-26, and 29-30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Leung et al. (US PGPub No. 2022/0151681), hereinafter Leung.
Regarding claims 1 and 17, Leung discloses an electrosurgical guidewire (par. 0048: “an RF guidewire is provided as illustrated in FIGS. 1A-1B”), comprising:
a core wire (Figs. 4A, 7A-7C, 8: core wire 202) including: a distal core wire portion located at a distal portion of the electrosurgical guidewire (Figs. 7A-7C and 8: tapered distal portion of core wire 202), a shaft portion located at a proximal portion of the electrosurgical guidewire and including an electrical connection portion configured to provide an electrical connection to an electrosurgical generator (Figs. 7A-7C and 8: proximal shaft portion of core wire 202; par. 0026: “a core wire for receiving the energy from the electrical energy source”),
and an active electrode (Fig. 8: electrode tip 112);
a first electrical insulation material with a first thickness covering the distal core wire portion (Fig. 8: insulation 114 covering distal section of core wire 202);
and a second electrical insulation material with a second thickness covering the shaft portion (Fig. 8: insulation 114 also covering proximal section of core wire 202),
wherein the first thickness is greater than the second thickness (Fig. 8: increased thickness of insulation 114 at distal section covering thinner distal core wire 202).
Leung further discloses the method steps of guiding the guidewire into a patient (Fig. 5 and par. 0142: “at step 510, the apparatus distal end portion is inserted into the body vessel 604”) and vaporizing tissue within the patient using the active electrode (Fig. 5: step 520; par. 0143: “Creating the channel first portion 610 includes delivering the energy into the occlusion harder portion 606”).
Regarding claims 2 and 18, Leung discloses the device and method of claims 1 and 17 as described previously. Leung further discloses wherein the active electrode is located at a distal end of the distal core wire portion (Fig. 8: electrode 112 at distal end of core wire 202).
Regarding claims 3 and 19, Leung discloses the device and method of claims 1 and 17 as described previously. Leung further discloses wherein the distal core wire portion further comprises a non-uniform surface for securing the first electrical insulation material to the distal core wire portion (par. 0055: “the inner polymer layer 115 may comprise a melt-processable polymer that can flow around and into any irregularities on the surface of core wire 202”).
Regarding claims 4, 6, 20, and 22, Leung discloses the device and method of claims 1 and 17 as described previously. Leung further discloses further comprising a transition portion, extending between the distal core wire portion and the shaft portion, and covered by at least one of the first electrical insulation material or the second electrical insulation material (Fig. 8: tapered portion of core wire 202 extending between proximal shaft and thinner distal core wire portion and covered by insulation material 114).
Claims 6 and 22 are rejected for the same reasons set forth for claim 4 because the recitation of “wherein the transition portion comprises a machined portion” is regarded as a product-by-process limitation. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Regarding claims 7 and 23, Leung discloses the device and method of claims 1 and 17 as described previously. Leung further discloses wherein the core wire comprises stainless steel (par. 0051: “the core wire 202 may comprise stainless steel”).
Regarding claims 8 and 24, Leung discloses the device and method of claims 1 and 17 as described previously. Leung further discloses wherein at least one of the first electrical insulation material or the second electrical insulation material comprises at least one of PTFE, PET, FEP, PEBA, or lubricious hydrophobic polymeric coating (par. 0055: “the insulation layer 114 comprises a combination of FEP and PTFE polymers”).
Regarding claims 9 and 25, Leung discloses the device and method of claims 1 and 17 as described previously. Leung further discloses wherein the first electrical insulation material comprises a heat shrink tubing (par. 0055: “a two layer heat shrink layer may be used comprising an inner polymer layer 115”).
Regarding claims 10 and 26, Leung discloses the device and method of claims 1 and 17 as described previously. Leung further discloses wherein the second electrical insulation material comprises a spray coating (par. 0054: “a portion of the device 100 or the elongate member 102 may be spray coated with an insulative material”).
Regarding claims 13 and 29, Leung discloses the device and method of claims 1 and 17 as described previously. Leung further discloses wherein the first thickness is tapered (Fig. 8: insulation material 114 tapering in thickness over distal portion of core wire 202).
Regarding claims 14 and 30, Leung discloses the device and method of claims 1 and 17 as described previously. Leung further discloses wherein the first thickness comprises portions of different, stepped thicknesses (Fig. 2A: insulation layer 119D having portions of different, stepped thicknesses).
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.
Claims 11-12 and 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Leung.
Leung teaches the device and method of claims 1 and 17 as described previously. Leung does not explicitly teach wherein a portion of the distal core wire portion is covered by the second electrical insulation material, and wherein a portion of the shaft portion is covered by the first electrical insulation material. However, in light of the fact that Leung teaches insulation material covering both the distal core wire portion and the shaft portion (Fig. 8: insulation 114) as well as overlapping insulation layers (Fig. 8: insulation layer 117 overlapping with insulation layer 115) to provide a smooth outer finish (par. 0055: “a polymer combination may be used for the insulation layer 114. As an example, a two layer heat shrink layer may be used comprising an inner polymer layer 115 (which in some examples may be referred to as the second electrically insulating material or layer) and an outer polymer layer 117 (which in some examples may be referred to as the first electrically insulating material or layer). […] A process combining re-flow and heat-shrink is used and the dual polymer layer is heated to a temperature of about 660° F., allowing the inner FEP layer to flow around and encapsulate the one or more radiopaque bands 130 disposed on core wire 202. Whereas, the outer PTFE layer recovers to a pre-specified diameter around the FEP and provides a smooth outer finish”), it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to overlap insulation material on either the shaft portion or distal core wire portion in order to provide a smooth outer profile, as taught by Leung.
Claims 5 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Leung in view of Langberg (US Patent No. 5,257,635).
Leung teaches the device and method of claims 4 and 20 as described previously but does not explicitly teach wherein the transition portion further comprises an adhesive material. However, in a related electrosurgical art, Langberg teaches created a tapered transition region between an electrode and insulating material using an adhesive material (Fig. 3: conductive skirt 23; col 5, line 37-38: “Conductive epoxy fills this tapered region and forms a conductive skirt 23;” examiner interprets an epoxy as an adhesive material). In light of Langberg’s teaching, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to form the transition portion of Leung using a conductive epoxy as taught in Langberg, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. See also Ballas Liquidating Co. v. Allied industries of Kansas, Inc. (DC Kans) 205 USPQ 331.
Claims 15-16 and 31-32 are rejected under 35 U.S.C. 103 as being unpatentable over Leung in view of Sartor et al. (US PGPub No. 2006/0178667), hereinafter Sartor.
Regarding claims 15 and 31, Leung teaches the device of claim 1 and the method of claim 17 as described previously but does not explicitly teach an apparatus for coupling the electrosurgical guidewire to an electrosurgical generator, the apparatus including: an elongated flexible conductive element, an activator unit for selectively controlling energy to the electrosurgical guidewire, and a coupler for removably coupling the electrosurgical guidewire to the apparatus. However, in a related electrosurgical art, Sartor teaches an apparatus for coupling an electrosurgical instrument to an electrosurgical generator (Fig. 1: plug assembly 200 and electrosurgical handle 100), the apparatus including: an elongated flexible conductive element (Fig. 1: connecting wire 224), an activator unit for selectively controlling energy to the electrosurgical guidewire (Fig. 1: housing 102 having activation switches 120a-120c; par. 0105: “Each activation switch 120a-120c controls the transmission of RF electrical energy supplied from generator "G" to electrosurgical blade 106”), and a coupler for removably coupling the electrosurgical guidewire to the apparatus (Figs. 1 and 8: receptacle 104; par. 0102: “Electrosurgical pencil 100 further includes a blade receptacle 104 disposed at a distal end of housing 102, and a replaceable electrocautery end effector 106 operatively and removably connectable to blade receptacle 104”). Sartor teaches that providing a coupling apparatus with an activator unit allows a surgeon to adjust power output without having to turn away from the operating site (par. 0013) and that a removable coupler for an end effector allows an electrosurgical generator to be used with various surgical instruments (par. 0014). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide the electrosurgical system of Leung with the coupling apparatus taught by Sartor, in order to allow the surgeon to adjust power output without having to turn away from the operating site, and to use the electrosurgical generator with various surgical instruments, as taught by Sartor.
Regarding claims 16 and 32, the combination teaches the device of claim 15 and the method of claim 31 as described previously. Leung further teaches the electrosurgical generator (par. 0026: “an electrosurgical device for creating a channel through a region of tissue using energy provided by an electrical energy source”).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Helgeson et al. (US PGPub No. 2016/0346038) teaches a catheter shaft with insulations of varying thicknesses having tapered transition regions.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JOANNE M RODDEN can be reached at (303) 297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.E.L./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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