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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/14/2025 has been entered.
Response to Arguments
Applicant's arguments filed 11/14/2025 have been fully considered but they are not persuasive.
Applicant argues that the claim requires the tool body to be monolithic and have a single continuous body wall. The Applicant argues that Ware is not monolithic and that such a modification would be hindsight and impossible rendering Ware’s tool useless for its intended purpose. The examiner respectfully disagrees as Ware et al discloses the present invention relates generally to devices, systems, and methods for implanting and testing multi-conductor electrical leads within a body. It is noted that the applicant is using “teaching away” in a much broader sense that it is legally accepted. For a reference to be considered to teach away from a proposed modification such reference must criticize, discredit, or otherwise discourage the proposed combination. In re Fulton, 73 USPQ2d 1141 (Fed. Cir. 2004). The applicant is further advised that disclosed examples and/or preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments, even if such nonpreferred embodiments are described as somewhat inferior. See In re Susi, 169 USPQ 423 (CCPA 1971), and In re Gurley, 31 USPQ2d 1130 (Fed. Cir. 1994). In this case, while Ware et al does disclose allowing for rotation of the knob to actuate a fixation helix, this is not an optional use. Paragraph [0007] discloses the knob mechanism can be actuated to selectively engage or disengage a terminal pin of the implantable lead. Meaning that a modification without having the knob mechanism engage or disengage would not render the implant tool useless for its intended purpose. In such an instance the device would still function for implanting and testing multi-conductor electrical leads within a body. Paragraph [0045] discloses that the tool can be used for implanting and testing the lead within a body to evaluate the viability of a potential fixation site, the function and location of the lead can be tested by connecting a proximal, terminal end of the lead to several electrical conductions of the pacing system analyzer. Ware operates without the fixation element being engaged and therefore the modification of the implant tool as a monolithic structure is not impossible and does not render the tool useless for its intended purpose. Paragraph [0047] discloses that in some embodiments the implant tool may be used to extend and/or retract the fixation helix. However, this embodiment does not constitute a teaching away from a broader disclosure and does not result in the device being useless.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). The examiner notes that the instant disclosure recites in published paragraph [0030] the “tool body 102 can be monolithic or formed from several components connected to each other” and does not provide any advantage for the monolithic design and therefore has not provided any criticality of the tool body being monolithic. MPEP 2144.04(V)(B) provides legal precedent for several parts being secured together as a single unit requires only routine skill in the art.
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) 1-4, 8, 10, 11, 15, 17, 18, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ware et al (US Publication 2011/0160824) in view of Yang et al (US Publication 2022/0088395).
Referring to Claim 1, Ware et al teaches a lead conversion tool, comprising: a tool body (e.g. Figure 15, Element 58) including a central lumen (e.g. Figure 15, Lumen 132) extending along a longitudinal axis from a distal tool end to a proximal tool end, wherein the central lumen includes a locking lumen segment having a connector body subsegment (e.g. see annotated Figure 15 below) sized to receive a connector body of a lead in a first friction fit and a pin subsegment sized to receive a connector pin of the lead in a second friction fit that is tighter than the first friction fit (e.g. Paragraphs [0055], [0067] and [0068] discloses the difference in diameter acts as a clutch mechanism to hold terminal pin 44 tightly). However, Ware et al does not disclose the tool body is monolithic and has a single, continuous body wall including a first portion defining the connector body subsegment and a second portion defining the pin subsegment, and wherein the first portion is non-rotatable relative to the second portion such that application of a torque to the tool body above a predetermined threshold causes the tool body and the connector pin to rotate relative to the connector body.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have the tool body is monolithic and has a single, continuous body wall including a first portion defining the connector body subsegment and a second portion defining the pin subsegment, and wherein the first portion is non-rotatable relative to the second portion such that application of a torque to the tool body above a predetermined threshold causes the tool body and the connector pin to rotate relative to the connector body, since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art (see MPEP 2144.04(V)(B)).
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In addition, Yang et al teaches that it is known to use applying torque (rotation) to an adapter relative to the proximal end of the lead (connector body) as set forth in Paragraphs [0010]-[0013], [0033], [0041]-[0042] and [0058] (rotational electrical coupling within the adapter body, the rotational electrical coupling configured to electrically connect the lead electrical connector to the adapter electrical connector and includes a first conductive component configured to be electrically connected to the lead electrical connector and rotatable within the adapter body with the proximal portion of the implantable medical lead) to provide mitigation of noise that may corrupt the signal, therefore reducing the time and effort needed for the implantation procedure (e.g. Paragraph [0042]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Ware et al, with applying torque (rotation) to an adapter relative to the proximal end of the lead (connector body) (rotational electrical coupling within the adapter body, the rotational electrical coupling configured to electrically connect the lead electrical connector to the adapter electrical connector and includes a first conductive component configured to be electrically connected to the lead electrical connector and rotatable within the adapter body with the proximal portion of the implantable medical lead) as taught by Yang et al, since such a modification would provide the predictable results of mitigation of noise that may corrupt the signal, therefore reducing the time and effort needed for the implantation procedure.
Referring to Claim 2, Ware et al in view of Yang et al teaches the lead conversion tool of claim 1, wherein the connector body subsegment of the locking lumen segment has a larger diameter than the pin subsegment of the locking lumen segment (e.g. Figure 15).
Referring to Claim 3, Ware et al in view of Yang et al teaches the lead conversion tool of claim 1, wherein the central lumen includes a funnel lumen segment proximal to the locking lumen segment (e.g. see annotated Figure 15 above).
Referring to Claim 4, Ware et al in view of Yang et al teaches the lead conversion tool of claim 1 further comprising a side slot extending through the body wall of the tool body from the central lumen to a surrounding environment (e.g. Figure 4, slot 68).
Referring to Claim 8, Ware et al in view of Yang et al teaches the lead conversion tool of claim 1 further comprising a plurality of relief slots extending longitudinally from the distal tool end through the body wall radially outward of the connector body subsegment (e.g. Figure 4, Element 68).
Referring to Claim 10, Ware et al teaches a lead conversion tool, comprising: a tool body including a central lumen extending along a longitudinal axis from a distal tool end to a proximal tool end, wherein the central lumen includes a locking lumen segment and a funnel segment, wherein the locking lumen segment includes a connector body subsegment (e.g. see annotated Figure 15 above) sized to receive a connector body of a lead in a first friction fit and a pin subsegment sized to receive a connector pin of the lead in a second friction fit (e.g. Paragraphs [0055], [0067] and [0068] discloses the difference in diameter acts as a clutch mechanism to hold terminal pin 44 tightly); and wherein the funnel segment tapers from a proximal opening at the proximal tool end to a distal opening adjacent to the pin subsegment, and wherein the distal opening has a smaller diameter than the pin subsegment (e.g. see annotated Figure 15 above). However, Ware et al does not disclose the tool body is monolithic and has a single, continuous body wall including a first portion defining the connector body subsegment and a second portion defining the pin subsegment, wherein the first portion is non-rotatable relative to the second portion such that application of a torque to the tool body above a predetermined threshold causes the tool body and the connector pin to rotate relative to the connector body.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have the tool body is monolithic and has a single, continuous body wall including a first portion defining the connector body subsegment and a second portion defining the pin subsegment, and wherein the first portion is non-rotatable relative to the second portion such that application of a torque to the tool body above a predetermined threshold causes the tool body and the connector pin to rotate relative to the connector body, since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art (see MPEP 2144.04(V)(B)).
In addition, Yang et al teaches that it is known to use applying torque (rotation) to an adapter relative to the proximal end of the lead (connector body) as set forth in Paragraphs [0010]-[0013], [0033], [0041]-[0042] and [0058] (rotational electrical coupling within the adapter body, the rotational electrical coupling configured to electrically connect the lead electrical connector to the adapter electrical connector and includes a first conductive component configured to be electrically connected to the lead electrical connector and rotatable within the adapter body with the proximal portion of the implantable medical lead) to provide mitigation of noise that may corrupt the signal, therefore reducing the time and effort needed for the implantation procedure (e.g. Paragraph [0042]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Ware et al, with applying torque (rotation) to an adapter relative to the proximal end of the lead (connector body) (rotational electrical coupling within the adapter body, the rotational electrical coupling configured to electrically connect the lead electrical connector to the adapter electrical connector and includes a first conductive component configured to be electrically connected to the lead electrical connector and rotatable within the adapter body with the proximal portion of the implantable medical lead) as taught by Yang et al, since such a modification would provide the predictable results of mitigation of noise that may corrupt the signal, therefore reducing the time and effort needed for the implantation procedure.
Referring to Claim 11, Ware et al in view of Yang et al teaches the lead conversion tool of claim 10, wherein the pin subsegment has a smaller diameter than the connector body subsegment (e.g. see annotated Figure 15 above).
Referring to Claim 15, Ware et al in view of Yang et al teaches the lead conversion tool of claim 10, wherein the second friction fit that is tighter than the first friction fit (e.g. Paragraphs [0055], [0067] and [0068]).
Referring to Claim 17, Ware et al teaches a method, comprising: inserting a lead into a lead conversion tool having a tool body including a central lumen extending long a longitudinal axis from a distal tool end to a proximal tool end, wherein the central lumen includes a locking lumen segment having a connector body subsegment and a pin subsegment, wherein a connector body of the lead is received in the connector body subsegment in a first friction fit and a connector pin of the lead is received in the pin subsegment in a second friction fit that is tighter than the first friction fit (e.g. see annotated Figure 15 above and Paragraphs [0055], [0067] and [0068]); torquing the lead conversion tool such that the connector pin and the lead conversion tool rotate relative to the connector body (e.g. Paragraph [0082]). However, Ware et al does not disclose the tool body is monolithic and has a single, continuous body wall including a first portion defining the connector body subsegment and a second portion defining the pin subsegment, and wherein the first portion is non-rotatable relative to the second portion such that application of a torque to the tool body above a predetermined threshold causes the tool body and the connector pin to rotate relative to the connector body.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have the tool body is monolithic and has a single, continuous body wall including a first portion defining the connector body subsegment and a second portion defining the pin subsegment, and wherein the first portion is non-rotatable relative to the second portion such that application of a torque to the tool body above a predetermined threshold causes the tool body and the connector pin to rotate relative to the connector body, since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art (see MPEP 2144.04(V)(B)).
In addition, Yang et al teaches that it is known to use applying torque (rotation) to an adapter relative to the proximal end of the lead (connector body) as set forth in Paragraphs [0010]-[0013], [0033], [0041]-[0042] and [0058] (rotational electrical coupling within the adapter body, the rotational electrical coupling configured to electrically connect the lead electrical connector to the adapter electrical connector and includes a first conductive component configured to be electrically connected to the lead electrical connector and rotatable within the adapter body with the proximal portion of the implantable medical lead) to provide mitigation of noise that may corrupt the signal, therefore reducing the time and effort needed for the implantation procedure (e.g. Paragraph [0042]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Ware et al, with applying torque (rotation) to an adapter relative to the proximal end of the lead (connector body) (rotational electrical coupling within the adapter body, the rotational electrical coupling configured to electrically connect the lead electrical connector to the adapter electrical connector and includes a first conductive component configured to be electrically connected to the lead electrical connector and rotatable within the adapter body with the proximal portion of the implantable medical lead) as taught by Yang et al, since such a modification would provide the predictable results of mitigation of noise that may corrupt the signal, therefore reducing the time and effort needed for the implantation procedure.
Referring to Claim 18, Ware et al in view of Yang et al teaches the method of claim 17 further comprising inserting a stylet into a lead lumen of the lead through a funnel segment of the central lumen, wherein the funnel segment tapers from a proximal opening to a distal opening adjacent to the pin subsegment of the central lumen, and wherein the distal opening has a smaller diameter than the pin subsegment (e.g. Figure 15, stylet 36 and distal opening near element 204).
Referring to Claim 20, Ware et al in view of Yang et al teaches the method of claim 17 further comprising engaging an electrical connector to the connector pin within the pin subsegment of the central lumen through a connector opening extending through the body wall of the lead conversion tool (e.g. Paragraph [0056]).
Claim(s) 5, 6, 13, 14 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ware et al (US Publication 2011/0160824) in view of Yang et al (US Publication 2022/0088395), as applied above, and further in view of Schmitt (US Patent 8,850,676).
Referring to Claims 5 and 6, Ware et al in view of Yang et al teaches the lead conversion tool of claim 4, discloses slot 68 and a plurality of connector openings (e.g. Figure 6A Elements 74 and 76). However, Ware et al does not explicitly discloses wherein the side slot includes an intermittent slot having a plurality of slot segments; wherein the plurality of slot segments and the plurality of connector openings combine to form a continuous opening from the proximal tool end to the distal tool end.
Schmidt teaches that it is known to use a tool for loading a stylet or guidewire wherein the side slot includes an intermittent slot having a plurality of slot segments; wherein the plurality of slot segments and the plurality of connector openings combine to form a continuous opening from the proximal tool end to the distal tool end as set forth in Figure 1, Element 120 and Column 5 lines 40-50 to provide assistance with insertion and to allow the user to visually identify proper placement of the lead within the tool. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Ware et al, with extending the slot of 62 to the other end wherein the side slot includes an intermittent slot having a plurality of slot segments; wherein the plurality of slot segments and the plurality of connector openings combine to form a continuous opening from the proximal tool end to the distal tool end as taught by Schmidt, since such a modification would provide the predictable results of assistance with insertion and to allow the user to visually identify proper placement of the lead within the tool.
Referring to Claims 13 and 14, Ware et al in view of Yang et al teaches the lead conversion tool of claim 10 further comprising a side slot extending through the body wall of the tool body from the central lumen to a surrounding environment (e.g. Figure 4, slot 68). However, Ware et al does not disclose, wherein the side slot extends from the distal tool end to the proximal tool end; and extends through the funnel segment.
Schmidt teaches that it is known to use a tool for loading a stylet or guidewire wherein the side slot extends from the distal tool end to the proximal tool end as set forth in Figure 1, Element 120 and Column 5 lines 40-50; and extends through the funnel segment as set forth in Figure 2A, Element 110 to provide assistance with insertion and to allow the user to visually identify proper placement of the lead within the tool. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Ware et al, with extending the slot of 62 from the distal tool end to the proximal tool end; and extends through the funnel segment as taught by Schmidt, since such a modification would provide the predictable results of assistance with insertion and to allow the user to visually identify proper placement of the lead within the tool.
Referring to Claim 19, Ware et al in view of Yang et al teaches the method of claim 17 further comprising passing a stylet through a side slot extending through the body wall of the lead conversion tool, wherein the stylet passes laterally through the side slot between the central lumen and a surrounding environment.
Schmidt teaches that it is known to use a tool for loading a stylet or guidewire wherein the side slot includes an intermittent slot having a plurality of slot segments; wherein the plurality of slot segments and the plurality of connector openings combine to form a continuous opening from the proximal tool end to the distal tool end as set forth in Figure 1, Element 120 and Column 5 lines 40-58 (slot 120 repeatedly pulled apart to place loading coupled around several successive catheter tips) to provide assistance with insertion and to allow the user to visually identify proper placement of the lead within the tool. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Ware et al, with extending the slot of 62 to the other end wherein the side slot includes an intermittent slot having a plurality of slot segments; wherein the plurality of slot segments and the plurality of connector openings combine to form a continuous opening from the proximal tool end to the distal tool end as taught by Schmidt, since such a modification would provide the predictable results of assistance with insertion and to allow the user to visually identify proper placement of the lead within the tool.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ware et al (US Publication 2011/0160824) in view of Yang et al (US Publication 2022/0088395) and Schmitt (US Patent 8,850,676), as applied above, and further in view of Farfel (US Patent 5,755,763).
Referring to Claim 7, Ware et al in view of Yang et al and Schmitt teaches the lead conversion tool of claim 5, except wherein one or more of the plurality of connector openings includes a guide surface tapering radially inward from an outer surface of the body wall to a clip surface.
Farfel teaches that it is known to use openings includes a guide surface tapering radially inward from an outer surface of the body wall to a clip surface as set forth in Column 6 lines 4-11 to provide a reduction in sharp edges which risks damaging patient tissue or electrical conductors. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Ware et al, with a guide surface tapering radially inward from an outer surface of the body wall to a clip surface as taught by Farfel, since such a modification would provide the predictable results of a reduction in sharp edges which risks damaging patient tissue or electrical conductors.
Claim(s) 9 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ware et al (US Publication 2011/0160824) in view of Yang et al (US Publication 2022/0088395), as applied above, and further in view of Carson et al (US Patent 5,669,790).
Referring to Claims 9 and 16, Ware et al in view of Yang et al teaches the claimed lead conversion tool except further comprising a pin sleeve within the pin subsegment, wherein the pin sleeve comprises a material softer than a material of the body wall. Carson et al teaches that it is known to use a pin sleeve within the pin subsegment, wherein the pin sleeve comprises a material softer than a material of the body wall as set forth in Figures 2 and 5, Elements 66 and 68 to provide increasing the contact surface area to reduce changes resulting from vibration. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Ware et al, with comprising a pin sleeve within the pin subsegment, wherein the pin sleeve comprises a material softer than a material of the body wall as taught by Carson et al, since such a modification would provide the predictable results of increasing the contact surface area to reduce changes resulting from vibration.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ware et al (US Publication 2011/0160824) in view of Yang et al (US Publication 2022/0088395), as applied above, and further in view of Hoecke et al (US Patent 7,753,696).
Referring to Claim 12, Ware et al in view of Yang et al teaches the lead conversion tool of claim 10, except wherein the proximal opening has a larger diameter than the connector body subsegment, the pin subsegment, and the distal opening. Hoecke et al teaches that it is known to use a proximal opening has a larger diameter than the connector body subsegment, the pin subsegment, and the distal opening as set forth in Figure 2B, Element 150 and Column 5 lines 30-40 to provide enabling the handle of the stylet to be engaged with the apparatus/tool. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Ware et al, with a proximal opening has a larger diameter than the connector body subsegment, the pin subsegment, and the distal opening as taught by Hoecke et al, since such a modification would provide the predictable results of enabling the handle of the stylet to be engaged with the apparatus/tool.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to William J Levicky whose telephone number is (571)270-3983. The examiner can normally be reached Monday-Thursday 8AM-5PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571)270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/William J Levicky/Primary Examiner, Art Unit 3796
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