DETAILED ACTION
The following is a Non-Final Office Action on the merits.
In view of the pre-brief appeal conference request filed on 3/30/2026, PROSECUTION IS HEREBY REOPENED. A new ground(s) of rejection for claim 21 is set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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 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.
Response to Pre-Appeal Brief Arguments
Applicant's arguments regarding claims 1 & 27 have been fully considered but they are not persuasive.
In response to Applicant's argument that Edwards, directed to a RF stylet handle, and Ginnebaugh, directed to an electrosurgical forceps handle, are non-analogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, both Ginnebaugh and Edwards are regarded as analogous art as they relate to surgical systems transmitting energy to tissue and one of ordinary skill in the art would be motivated to look to the insulated handles of either Edwards or Ginnebaugh to provide the benefit of preventing any spurious RF current from being transferred to the operating surgeon as taught by Edwards (Col. 11, ll. 15-28) and/or to provide insulation from RF emissions while the surgical instrument is connected to the power source as taught by Ginnebaugh et al. ([0067]). Both Edwards and Ginnebaugh teach protecting the operator of the device from the transmitted energy.
The Examiner notes the claim fails to recite specific structure regarding the handle (e.g., materials, specific sizes, etc.).
In response to Applicant’s arguments that Lee fails to disclose a “conductive plate” as the ring 834 of Lee “is not a plate”, the Examiner respectfully disagrees. For reference, “plate” can be defined as: “a smooth, flat, relatively thin, rigid body of uniform thickness” (www.ahdictionary.com), “a plate is a flat piece of metal, especially on machinery or a building” (www.collinsdictionary.com), or “a smooth flat thin piece of material” (www.merriam-webster.com). The “conductive ring 834” of Lee meets the above definition and is therefore a “conductive plate”.
The Examiner notes the claim fails to recite specific structure regarding the plate (e.g., specific shape that is not a ring, multiple plates).
Applicant’s arguments regarding claim 21 are persuasive and the rejection is withdrawn.
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 21-26 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 21 recites the limitation "the distal and proximal surfaces" in ll. 6-7. There is insufficient antecedent basis for this limitation (“the...proximal” surface lacks antecedent basis) in the claim.
Claim 21 recites the limitation "the distal and proximal surfaces" in ll. 6-7 and “a proximal surface of the guidewire” in ll. 9-10. It is unclear if the two recited proximal surfaces are the same or different from one another. For purposes of examination, they will be interpreted as being the same.
Claims 22-26 depend from claim 21 are thus also rejected.
Claim Interpretation
Claims 6 & 25 recite the limitation “the anatomical structure comprising a heart and the tissue comprising a septum between first and second cavities of the heart” which is considered a functional limitation as it depends from claims 1 & 21 which recite “configured to be inserted into an anatomical structure”.
Claim 21 recites the limitation “at least a section of the guidewire, other than the distal proximal surfaces, being coated with an electrically insulating layer” which is interpreted as at least the section of the guidewire between the distal and proximal surfaces is coated with the electrically insulating layer, and does not preclude insulation from also being present on the proximal surface.
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: “fixation assembly” in claims 3, 22 & 27.
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 (i.e., a controllable fixation grip and a fixation knob).
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 § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Urbanski et al. (2020/0060710, previously cited) in view of Lee et al. (2002/0161421, previously cited) and either Edwards et al. (5,542,915, previously cited) or Ginnebaugh et al. (2011/0288369, previously cited).
Concerning claim 1, Urbanski et al. disclose a tissue puncture system (assembly 100; Fig. 1A), comprising:
(a) a guidewire, which is configured to be inserted into an anatomical structure of a patient and to puncture tissue of the anatomical structure by conducting administering therapeutic energy via an electrical signal from a power source and applying to the tissue electrical current induced between a distal surface of the guidewire and the tissue (RF guidewire 10 that has a distal electrode tip 10d for delivering radiofrequency energy in order to puncture tissue; [0069]).
Urbanski et al. fail to specifically disclose (b) a handle, which is configured to: (i) electrically connect between the power source and a proximal-most end of a proximal surface of the guidewire by selectively extending the proximal surface into the handle, and (ii) move the distal surface to the tissue. However, Lee et al. disclose a tissue system comprising a guidewire (101) and a handle (proximal end electrical connector that can be used with any sort of guidewire; [0004], [0022]), the handle being configured to: (i) electrically connect between a power source and a proximal-most end of a proximal surface of the guidewire by selectively extending the proximal surface into the handle (inner conductor contact 163 includes an electrically conductive material 159 that may be built up around the inner conductor 103 which facilitates the easy insertion of the proximal end 153 of the guidewire 101 into the connector where first collet 203 makes contact with inner conductor contact 163 of inner conductor 103 to establish a signal path between the power source, center pin 263, proximal collet 203, inner conductor contact 163 and inner conductor 103; [0040], [0046], [0053] // or // lever 1004 actuates carrier 808 from a closed or free position to an open position such that, in the closed position, carrier 808 fixes guidewire 101 in position where the proximal surface (any part of guidewire in connector 804) is electrically coupled to a power source via conductive ring 834 and outer connector contact 824; [0071-0073]), and (ii) move the distal surface to the tissue (connector can be moved to move the guidewire 101). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Urbanski et al. to further comprise (b) a handle, which is configured to: (i) electrically connect between the power source and a proximal-most end of a proximal surface of the guidewire by selectively extending the proximal surface into the handle, and (ii) move the distal surface to the tissue in order to provide the benefit of a handle that is easily removed and reattached to permit device exchange without removing the guidewire and provides electrical connection as taught by Lee et al. ([0025], [0031-0032]; Fig. 1-3 or Fig. 8-9).
Urbanski in view of Lee fail to specifically disclose the handle sized to electrically isolate the therapeutic energy administered by the guidewire from an outer surface of the handle. However, Edwards et al. disclose a surgical system comprising a handle that prevents any spurious RF current from being transferred to the operating surgeon (Col. 11, ll. 15-28). In the alternative, Ginnebaugh et al. disclose a surgical system comprising a handle (11) that also provides electrical insulation from RF emissions while the surgical instrument is connected to an RF generator ([0067]). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Urbanski et al. in view of Lee et al. such that the handle is sized to electrically isolate the therapeutic energy administered by the guidewire from an outer surface of the handle in order to provide the benefit of preventing any spurious RF current from being transferred to the operating surgeon as taught by Edward et al. and that provides electrical insulation from RF emissions while the surgical instrument is connected to an RF generator as taught by Ginnebaugh et al.
Concerning claim 2, Urbanski et al. disclose at least a section of the guidewire, other than the distal surface is coated with an electrically insulating layer ([0070]).
Concerning claim 3, Lee et al. further disclose the handle (connector // or // 804) comprises: (i) an inner hollow tube, which is extended along an axis of the handle (connector // or // 804) and is configured to contain a given section of the guidewire (101), and to electrically isolate the given section from an outer surface of the handle (connector // or // 804), and (ii) a fixation assembly (203 & 230 // or // 1004), which is configured to fixate the proximal surface (163 // or // any part of guidewire 101 in connector 804) to a cable (253 pin connects to cable // or // pin connects to cable) that is electrically coupling between the handle (connector // or // 804) and the power source ([0032], [0046-0047], [0051], [0053-0057], [0067-0073]; Fig. 2-3 & 8-10).
Concerning claim 4, Lee et al. further disclose the fixation assembly (203 & 230 // or // 1004) comprising (i) a controllable fixation grip (203 // or // 808), which is positioned at a proximal end of the inner hollow tube, and is electrically connected to the electrical connection (253 // or // 822, 824 and pin connects to cable), and (ii) a fixation knob (230 // or // connector can be configured such that axial movement can be produced when one component can be rotated relative to another, as with a cam or threads, which inherently is a knob; [0070]), which is configured to control the controllable fixation grip (203 // or // 808) to grip and to release the proximal surface of the guidewire (101) ([0032], [0046-0047], [0051], [0053-0057], [0070-0071; Fig. 2-3 & 8-10).
Concerning claim 5, Lee et al. further disclose the controllable fixation grip (203// or // 808) comprises one or more electrically conductive plates (203 // or // 834), which are electrically connected to the electrical connection (253 // or // 822, 824 and pin connects to cable) and are configured to be moved relative to a wall of the inner hollow tube, and wherein the fixation knob (230 // or // knob see claim 4) is configured to move the one or more electrically conductive plates (203 // or // 834) in: (i) a first direction (radially inward) for coupling between the one or more electrically conductive plates (203 // or // 834) and the proximal surface, and (ii) a second direction (radially outward) for decoupling between the one or more electrically conductive plates (203 // or // 834) and the proximal surface ([0032], [0047], [0053-0057], [0070-0071; Fig. 2-3 & 8-10)
Claim(s) 6-7 & 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Urbanski et al. (2020/0060710, previously cited) in view of Lee et al. (2002/0161421, previously cited) and either Edwards et al. (5,542,915, previously cited) or Ginnebaugh et al. (2011/0288369, previously cited), as applied to claim 1, in further view of Ortiz et al. (2012/0150172, previously cited).
Concerning claims 6-7 & 9-10, Urbanski et al. further disclose the tissue puncture system comprising the power source (inherent RF source) ([0069]). Urbanski et al. in view of Lee et al. and either Edwards et al. or Ginnebaugh et al. fail to disclose the tissue puncture system further comprising the power source configured to generate the electrical signal comprising a voltage of at least 1000 volts, the anatomical structure comprising a heart and the tissue comprising a septum between first and second cavities of the heart, and, in response to placing the distal surface on the septum and applying the electrical signal, the guidewire being configured to carry out a transseptal puncture in the septum between the first and second cavities, the electrical signal being a pulsed IRE signal, a unipolar pulsed signal or a bipolar pulsed signal. However, Ortiz et al. disclose a tissue puncture system comprising a power source configured to generate the electrical signal comprising a voltage of at least 1000 volts, the electrical signal being a pulsed monopolar or bipolar IRE signal. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Urbanski et al. in view of Lee et al. and either Edwards et al. or Ginnebaugh et al. such that the power source is configured to generate the electrical signal comprising a voltage of at least 1000 volts, the electrical signal being a pulsed IRE signal, a unipolar pulsed signal or a bipolar pulsed signal in order to provide the benefit of valid treatment pulses such that the treatment is non-thermal and does not destroy connective and scaffolding structure in the target zone as taught by Ortiz et al. ([0005], [0026], [0055]) The modified invention of Urbanski et al. in view of Lee et al., either Edwards et al. or Ginnebaugh et al. and further in view of Ortiz et al. teach a tissue puncture system capable of puncturing the septum by applying the signal.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Urbanski et al. (2020/0060710, previously cited) in view of Lee et al. (2002/0161421, previously cited) and either Edwards et al. (5,542,915, previously cited) or Ginnebaugh et al. (2011/0288369, previously cited), as applied to claim 1, in further view of Davies et al. (2011/0224666, previously cited).
Concerning claim 8, Urbanski et al. further disclose the tissue puncture system comprising the power source (inherent RF source) ([0069]). Urbanski et al. in view of Lee et al., either Edwards et al. or Ginnebaugh et al. fail to specifically disclose the tissue puncture system further comprising an indifferent electrode, the indifferent electrode being configured to be coupled to a skin of the patient, to thereby form an electrical circuit comprising the distal surface, a body and the skin of the patient, and the indifferent electrode, and wherein the power source being configured to generate the electrical signal comprising comprises a unipolar signal. However, Davies et al. disclose a tissue puncture system comprising a unipolar system where an electrical circuit comprises a distal surface (112), a patient’s tissue, and an indifferent electrode (130). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Urbanski et al. in view of Lee et al., either Edwards et al. or Ginnebaugh et al. such that the tissue puncture system further comprises an indifferent electrode, the indifferent electrode being configured to be coupled to a skin of the patient, to thereby form an electrical circuit comprising the distal surface, a body and the skin of the patient, and the indifferent electrode, and wherein the power source being configured to generate the electrical signal comprising comprises a unipolar signal in order to provide the benefit of providing a return path for the RF energy when operated in either mode as taught by Davies et al. ([0058-0059], [0068]; Fig. 1-2).
Claim(s) 21-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Urbanski et al. (WO2019/215618) in view of Lee et al. (2002/0161421, previously cited) and Williams et al. (6,799,991).
Concerning claim 21, as illustrated in Figs. 5A-C, Urbanski et al. disclose a tissue puncture system (assembly 100 for puncturing tissue, including RF guidewire 10; [0060], [0062]), comprising:
(a) a guidewire, which is configured to be inserted into an anatomical structure of a patient and to puncture tissue of the anatomical structure by conducting an electrical signal from a power source and applying to the tissue electrical current induced between a distal surface of the guidewire and the tissue (flexible puncture device 112 comprises Rf guidewire that is operable to deliver energy in order to puncture tissue; [0060], [0062]), at least a section of the guidewire, other than the distal and proximal surfaces, being coated with an electrically insulating layer (RF guidewire 10 is a flexible wire which is generally electrically insulated save for selected distal regions such as the distal electrode tip 118d, the wire comprising a stainless steel core with a PTFE or FIFE coating; [0063], [0096], [0102] [0104], [0169]); and
(b) a handle (hub/handle; [0103]).
Urbanski et al. fail to the handle is configured to: (i) electrically connect between the power source and a proximal surface of the guidewire, and (ii) move the distal surface to the tissue. However, Lee et al. disclose a tissue system comprising a guidewire (802) having a non-insulated proximal surface (812) and a handle (proximal end electrical connector 800 that can be used with any sort of guidewire and receives proximal end of guidewire 802; [0004], [0067]), which is configured to: (i) electrically connect between the power source and a non-insulated proximal surface of the guidewire (inner conductor contact 812 and/or outer conductor contact 814 electrically connect between a power source and the guidewire 802 via connector 800 contacts 822, 824; [0067-0068]), and (ii) move the distal surface to the tissue (connector 800 can be moved to move the guidewire 802). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Urbanski et al. such that the handle is configured to: (i) electrically connect between the power source and a proximal surface of the guidewire, and (ii) move the distal surface to the tissue in order to provide the benefit of a handle that is easily removed and reattached to permit device exchange without removing the guidewire and provides electrical connection as taught by Lee et al. ([0025], [0031-0032]; Fig. 1-3).
Lee et al. teach the electrical connection to be between a conductive proximal surface of the guidewire and the power source, and thus the modified invention of Urbanski et al. in view of Lee et al. fail to teach the handle configured to electrically connect between the power source and the insulative proximal surface of the guidewire by penetrating the electrically insulating layer. However, Williams et al. disclose a connector configured to both electrically connect and physically connect a medical electrical lead (60) coated with an electrically insulating layer (62) to a power source by penetrating the electrically insulating layer with a sharp edge (64). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Urbanski et al. in view of Lee et al. such that the handle is configured to electrically connect between the power source and the proximal surface of the guidewire by penetrating the electrically insulating layer in order to provide the benefit of establishing both a mechanical connection and an electrical connection with the guidewire having a proximal surface coated with an insulative coating of Urbanski et al. as taught by Williams et al. (Col. 4, ll. 53-65; Fig. 2), thus providing the predictable result of a handle capable of working with guidewires having conductive or insulative proximal surfaces.
Claim 22 is rejected upon the same rationale as applied to claim 3.
Claim 23 is rejected upon the same rationale as applied to claim 4.
Claim 24 is rejected upon the same rationale as applied to claim 5.
Claim(s) 25-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Urbanski et al. (WO2019/215618) in view of Lee et al. (2002/0161421, previously cited) and Williams et al. (6,799,991), as applied to claim 21, in further view of Ortiz et al. (2012/0150172, previously cited).
Claim 25 is rejected upon the same rationale as applied to claim 6.
Claim 26 is rejected upon the same rationale as applied to claim 7.
Claim(s) 27-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Urbanski et al. (2020/0060710, previously cited) in view of Lee et al. (2002/0161421, previously cited).
Concerning claim 27, Urbanski et al. disclose a tissue puncture system (assembly 100; Fig. 1A), comprising:
(a) a guidewire, which is configured to be inserted into an anatomical structure of a patient and to puncture tissue of the anatomical structure by conducting administering therapeutic energy via an electrical signal from a power source and applying to the tissue electrical current induced between a distal surface of the guidewire and the tissue (RF guidewire 10 that has a distal electrode tip 10d for delivering radiofrequency energy in order to puncture tissue; [0069]).
Urbanski et al. fail to specifically disclose (b) a handle comprising: (i) a conductive plate, and(ii) a fixation assembly, which is configured to fixate the proximal surface to the conductive plate that is electrically coupled between the handle and the power source. However, Lee et al. disclose a tissue system comprising a guidewire (101) and a handle (connector body 804; [0067]), (i) a conductive plate sized and configured for delivery of the electrical current from the power source (conductive ring 834; [0071]), and (ii) a fixation assembly, which is configured to fixate the proximal surface to the conductive plate that is electrically coupled between the handle and the power source (lever 1004 actuates carrier 808 from a closed or free position to an open position such that, in the closed position, carrier 808 fixes guidewire 101 in position where the proximal surface (any part of guidewire in connector 804) is electrically coupled to a power source via conductive ring 834 and outer connector contact 824, all sized and configured to provide continuity for delivery of the electrical current from the power source to the guidewire; [0071-0073]). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Urbanski et al. to further comprise (b) a handle comprising: (i) a conductive plate sized and configured to provide continuity for delivery of the electrical current from the power source, and (ii) a fixation assembly, which is configured to fixate the proximal surface to the conductive plate that is electrically coupled between the handle and the power source in order to provide the benefit of a handle that is easily removed and reattached to permit device exchange without removing the guidewire and provides electrical connection as taught by Lee et al. ([0025], [0031-0032]; Fig. 8-9). The modified invention of Urbanski et al. in view of Lee et al. naturally follows that the conductive plate is sized and configured to provide continuity for delivery of the electrical current from the power source to the tissue, or, in the alternative, it would have been obvious to one of ordinary skill in the art to modify the invention of Urbanski et al. in view of Lee et al. such that the conductive plate is sized and configured to provide continuity for delivery of the electrical current from the power source to the tissue and thus is(are) of whatever desired or expedient size, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Claim 28 is rejected upon the same rationale as provided for claim 2.
Concerning claim 29, Lee et al. disclose the handle (804) comprises: (i) an inner hollow tube, which is extended along an axis of the handle (804) and is configured to contain a given section of the guidewire (101), and to electrically isolate the given section from an outer surface of the handle (804), and (ii) a fixation assembly (808), which is configured to fixate the proximal surface (any part of guidewire 101 in connector 804) to a cable (pin connects to cable) that is electrically coupling between the handle (804) and the power source ([0067-0073]; Fig. 8-10).
Concerning claim 30, Lee et al. disclose the fixation assembly (804) comprising (i) a controllable fixation grip (808), which is positioned at a proximal end of the inner hollow tube, and is electrically connected via contacts 822, 824 to the cable (pin connects to cable), and (ii) a fixation knob (connector can be configured such that axial movement can be produced when one component can be rotated relative to another, as with a cam or threads, which inherently is a knob; [0070]), which is configured to control the controllable fixation grip (203) to grip and to release the proximal surface of the guidewire (101) ([0070-0071]; Fig. 8-10).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Olsen et al. (2012/0035695) teach metal barbs penetrating insulation (Fig. 38). Passman et al. (2021/0401494) teach an advanceable and retractable guide wire (Fig. 21-22).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAYMI E DELLA whose telephone number is (571)270-1429. The examiner can normally be reached on M-Th 6:00 am - 4:45 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached on (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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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794