DETAILED ACTION
The following is a Final Office Action on the merits.
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 Amendment
Acknowledgment is made to the amendment received 6/26/2026.
Applicant’s amendments are sufficient to overcome the 35 USC 112(b)/second paragraph rejections set forth in the previous office action.
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 & 27. The examiner notes that while claim 22 also recites “fixation assembly”, the fixation assembly comprises the “screw assembly” which does set forth sufficient structure so as not to invoke 35 USC 112(f)/6th paragraph.
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 § 102
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) 27 & 29-30 is/are rejected under 35 U.S.C. 102(a)(1) and/or 102(a)(2) as being anticipated by Ouchi (6,395,003).
Concerning claim 27, as illustrated in at least Fig. 1, Ouchi discloses a tissue puncture system (flexible and electrically conductive guide wire 2 is capable of puncturing tissue; Col. 3, ll. 54-64, Col. 4, ll. 49-59), 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 and electrically conductive guide wire 2 is capable of puncturing tissue when connected to a HF power source via connector 11; Col. 3, ll. 54-64, Col. 4, ll. 49-59); and
(b) a handle (electrically insulating housing 13; Col. 3-4, ll. 61-5) comprising:
(i) an elongate conductive plate sized and configured to provide continuity for delivery of the electrical current from the power source to the tissue (conductive block 12 connects the high-frequency power source to guide wire 2 can by energized with a high-frequency current; Col. 3-4, ll. 65-5), and
(ii) a fixation assembly, which is configured to fixate a proximal surface of the guidewire to the elongate conductive plate that is electrically coupled between the handle and the power source (a root portion of the connector 11 is screwed in a conductive block 12 which is built in electrically insulating housing 13 such that the proximal end of the guide wire 2 is press-secured onto the conductive block 12 by the screwed connector 11 thus connecting the high-frequency power to the guide wire 2; Col. 3-4, ll. 61-5).
Concerning claim 29, Ouchi discloses the handle (13) comprising: (i) an inner hollow tube, which is extended along an axis of the handle (13) and is configured to contain a given section of the guidewire (2), and to electrically isolate the given section from an outer surface of the handle (13) (Col. 3-4, ll. 61-5).
Concerning claim 30, Ouchi discloses the fixation assembly comprising: (i) a controllable fixation grip (surface head of screw part of connector 11), which is positioned at a proximal end of the inner hollow tube (13), and is configured to electrically connect connected to a cable (200) of the power source, and (ii) a fixation knob (top portion of connector 11), which is configured to control the controllable fixation grip to grip and to release the proximal surface of the guidewire (2) (Col. 3-4, ll. 61-5; Fig. 1).
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, the guidewire including (RF guidewire 10 that has a distal electrode tip 10d for delivering radiofrequency energy in order to puncture tissue; [0069]), the guidewire including an electrically insulating layer (guidewire 10 is a flexible wire which is generally electrically insulated save for selected distal regions such as the distal electrode tip 10d; [0070]).
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]), and (ii) move the distal surface to the tissue (connector can be moved to move the guidewire 101), and (iii) contact the electrically insulating layer and thereby secure the guidewire to the handle (guidewire 101 comprises an insulating area 162 that is contacted by the handle: see guidewire area between two conductive collets 207, 203 that is contacted by an of the handle in Fig. 2 and secured by rotation of cap 230; [0051]). 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, (ii) move the distal surface to the tissue; and (iii) contact the electrically insulating layer and thereby secure the guidewire to the handle 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) and is configured to contain a given section of the guidewire (101), and to electrically isolate (see labeled insulator 510 in Fig. 5) the given section from an outer surface of the handle (connector), and (ii) a fixation assembly (203, 240 & 230), which is configured to fixate the proximal surface (163) to a cable (253 pin connects to cable) that is electrically coupling between the handle (connector) and the power source ([0032], [0046-0047], [0051], [0053-0057]; Fig. 2-3 & 5).
Concerning claim 4, Lee et al. further disclose the fixation assembly (203, 240 & 230) comprising (i) a controllable fixation grip (203), which is positioned at a proximal end of the inner hollow tube, and is electrically connected to the electrical connection (253 and pin connects to cable), and (ii) a fixation knob (230), which is configured to control the controllable fixation grip (203) to grip and to release the proximal surface of the guidewire (101) ([0032], [0046-0047], [0051], [0053-0057]; Fig. 2-3).
Concerning claim 5, Lee et al. further disclose the controllable fixation grip (203) comprises one or more electrically conductive element (203), which are electrically connected to the electrical connection (253 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) is configured to move the one or more electrically conductive plates (203) in: (i) a first direction (radially inward) for coupling between the one or more electrically conductive plates (203) and the proximal surface, and (ii) a second direction (radially outward) for decoupling between the one or more electrically conductive element (203) and the proximal surface ([0032], [0047], [0053-0057]; Fig. 2-3). Lee et al. fails to disclose the conductive elements to be conductive plates. However, in the embodiment of Fig. 5, the proximal conductive element (508) is elongated and plate-shaped. It would have been obvious to one having ordinary skill in the art at the time the invention the invention was effectively filed to modify the invention of Urbanski et al. in view of Lee et al. such that the conductive element is a plate shape and thus is of whatever desired or expedient form or shape as Applicant appears to place to no criticality on the shape and, since a change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
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. (2020/0060710, previously cited) in view of Lee et al. (2002/0161421, previously cited) and Williams et al. (6,799,991, previously cited).
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, including a proximal surface, 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 including a screw assembly and defining a guidewire axis of which the guidewire is extended along when inside of the handle, the screw assembly including a screw thread revolved around the guidewire axis, the handle being configured to: (i) axially rotate and translate the screw assembly about the guidewire axis to thereby 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 (101) having a non-insulated proximal surface (proximal surface of guidewire includes insulating material 155 and conductive material 103/163) and a handle (proximal end electrical connector that can be used with any sort of guidewire; [0004], [0022]), including a screw assembly and defining a guidewire axis of which the guidewire is extended along when inside of the handle, the screw assembly including a screw thread revolved around the guidewire axis (cap 230 is screwably displaced along the connector body 240 where the threads revolve around the longitudinal axis of the guidewire 101; [0051]), the handle being configured to: (i) the axially rotate and translate the screw assembly about the guidewire axis to thereby electrically connect between the power source the proximal surface of the guidewire (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]), 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. 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 and thereby passing through the electrically insulating layer and thus contact the proximal surface of the guidewire. 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 configured to electrically connect between the power source and the insulative proximal surface of the guidewire by penetrating and thereby passing through the electrically insulating layer and thus contact the proximal surface of the guidewire 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.
Concerning claim 22, Lee further discloses the handle (connector) comprising: (i) an inner hollow tube, which is extended along an axis of the handle (connector) and is configured to contain a portion of the guidewire (100), and to electrically isolate the portion from an outer surface of the handle (see labeled insulator 510 in Fig. 5), and (ii) a fixation assembly (203, 240 & 230) of which the screw assembly (230, 240) is a portion of, which is the fixation assembly being configured to fixate the proximal surface (163) to a cable (253 pin connects to cable) that is electrically coupled between the handle (connector) and the power source ([0032], [0046-0047], [0051], [0053-0057]; Fig. 2-3 & 5).
Concerning claim 23, Lee further discloses the fixation assembly (203, 240 & 230)comprising: (i) a controllable fixation grip (203), which is positioned at a proximal end of the inner hollow tube, and is electrically connected to the cable (253 and pin connects to cable), and(ii) a fixation knob (230) as part of the screw assembly (230, 240), which is configured to control the controllable fixation grip (203) to grip and to release the proximal surface of the guidewire (101), the fixation knob (230) being configured to rotate about the guidewire axis, the fixation knob (230) being sized to allow for a portion of the electrically insulating layer (155) to pass therethrough, the fixation knob (230) being configured to rotate around the guidewire axis to thereby secure the guidewire (100) to the handle (100) ([0032], [0046-0047], [0051], [0053-0057]; Fig. 2-3).
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. (2020/0060710, previously cited) 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 (proximal end electrical connector that can be used with any sort of guidewire; [0004], [0022]), (i) a conductive element sized and configured for delivery of the electrical current from the power source (conductive 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]), and (ii) a fixation assembly, which is configured to fixate the proximal surface to the conductive element that is electrically coupled between the handle and the power source (cap 230 may be screwably displaced and pushes solid components of the cap or body onto the angle sides of 242 of the first collet 203 to secure the guidewire 101 and establish a signal path between the power source, center pin 263, proximal collet 203, inner conductor contact 163 and inner conductor 103; [0040], [0046], [0051], [0053]). 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). Lee et al. fails to disclose the conductive elements to be conductive plates. However, in the embodiment of Fig. 5, the proximal conductive element (508) is elongated and plate-shaped. It would have been obvious to one having ordinary skill in the art at the time the invention the invention was effectively filed to modify the invention of Urbanski et al. in view of Lee et al. such that the conductive element is a plate shape and thus is of whatever desired or expedient form or shape as Applicant appears to place to no criticality on the shape and, since a change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47. 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.
Claim 29 is rejected upon the same rationale as provided for claim 3.
Claim 30 is rejected upon the same rationale as provided for claim 4.
Response to Arguments
Applicant's arguments regarding the 35 USC 112(f)/6th paragraph interpretation have been fully considered but they are not persuasive. As discussed above, the 3-prong analysis (see MPEP 2181) is satisfied: (1) the claim limitation uses a substitute term (“fixation assembly”) that is a generic placeholder for performing the claimed function; (2) the term “assembly” is modified by functional language; and (3) the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function. The fixation assembly is a generic placeholder and recites function of fixating. The rest is directed to the structural coupling between cable, handle and the power source and thus does not further limit any structure of the fixation assembly.
In response to the Office action that finds that 35 U.S.C. 112(f) is invoked, if applicant does not want to have the claim limitation interpreted under 35 U.S.C. 112(f), applicant may: (1) present a sufficient showing to establish that the claim limitation recites sufficient structure to perform the claimed function so as to avoid interpretation under 35 U.S.C. 112(f); or (2) amend the claim limitation in a way that avoids interpretation under 35 U.S.C. 112(f) (e.g., by reciting sufficient structure to perform the claimed function).
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Akerfeldt (WO 98/43318) teaches a handle with a screw assembly aligned with a guidewire axis to clamp the guidewire and secure it within the handle (Fig. 2 & 7).
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.
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794
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