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 .
Claim Objections
Claims 6 and 19 are objected to because of the following informalities: Claims 6 and 19 recite “a directed selected from” which should be amended to recite similar to –a direction selected from—in order to fix an inadvertent typographical error. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
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: “protective unit to prevent at least one of current or voltage above a safe level,…” in claim 3,7,12 and 20.
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. Specifically, “protective unit” has been interpreted to include one or more “over-voltage protector 91 or over-current protector 92” and equivalents thereof as disclosed in the specification, see para. [0006],[0009] of published application US 2026/0054056.
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 following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2, 4 and 6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2021/102195 to Franke et al. (Franke).
In reference to at least claim 1
Franke discloses a system for stimulating a tissue target in a body (e.g. “In addition to use in electrical stimulation, the wire structure electrode is used to transfer thermal energy within the body., para. [0063]) the system comprising: comprising: a helical wire rope structure electrode (e.g. “wire structure electrode”, para. [005], “Different embodiments of the wire structure electrode include without limitation a "folded wire structure," "rolled wire structure," a "wrapped wire structure, "a "twisted or braided wire structure," and a "combination wire structure”, para. [0027]) having a hollow core all along a length with first and second ends (e.g. “hollow core”, para. [00103], [00112]) configured for loading into a dispenser in a substantially linear form all along the length for injection (e.g. pre-implant substantially linear, Fig. 24(a), para. [0073]), and said helical wire rope structure electrode being further configured for bending or bunching to deform from said substantially linear form into a plurality of irregular shapes in the body when injected (e.g. post-implant include a plurality of irregular shapes, Figs. 24(b), “with a first end 1h injected and bunched at a nerve at 40%, an interconnection area at 10%, and a second end 1i bunched in the subcutaneous region at 50%.” para. [0073]), the plurality of irregular shapes including at least a first of the irregular shapes being located at the first end near a tissue target and a second of the irregular shapes being located in a subcutaneous area (e.g. a first irregular shape located near a nerve and a second irregular shape located near the skin, Figs. 24(b), “with a first end 1h injected and bunched at a nerve at 40%, an interconnection area at 10%, and a second end 1i bunched in the subcutaneous region at 50%.” para. [0073]) and the helical wire rope structure electrode configured to transmit electricity passively along all the length between said first irregular shape and said second irregular shape (e.g. “transmit energy”, para. [002], “transmission of energy”, para. [005], [0055], “use in electrical stimulation…is used to transfer thermal energy”, para. [0063]), and an external pulse generator (EPG) for generating an electrical waveform (e.g. “By extruding an wire structure electrode 1 from its targeted tissue to form a collector near the skin's surface, a direct electrical interface can be formed between the wire structure electrode 1 and the patch electrodes of a TENS device 37, which serves as an external generator with modifiable pulse parameters., para. [0083]) and configured to transmit electricity through an electrical path across the skin to the second irregular shape in the subcutaneous area (e.g. Fig. 33, para.[0083]-[0086]).
In reference to at least claim 2
Franke discloses wherein the EPG is configured to provide the waveform transcutaneously through at least two interfacing points to the helical wire rope structure (e.g. transcutaneously, Figs. 33-34, para. [0082]-[0086]). Franke further discloses multiple interfacing points with the along the wire structure electrode (e.g. Figs. 25(a)-25(d), para. [0074] Figs. 25 (b) -(d) illustrate how different embodiments may have a reinforcer (e.g., glue or other material adding rigidity) in differing patterns and for different distances of the rolled wire based structure. Glue or silicone, bits of metal or nonconductive material may be affixed to the wire structure to create intermittent rigidity, as with the glue or silicone).
In reference to at least claim 4
Franke discloses a partial coating on the helical wire rope structure between the first and second ends, said partial coating comprising at least one discontinuity selected from the group of holes, gaps and perforations (e.g. “A wire structure electrode comprising at least one highly conductive and biocompatible wire compacted into primary loops and folds with voids comprising a bulk shape comprising a roughened and porous surface and secondary loops protruding from said roughened and porous surface of said bulk shape,.”. claim 10, para. [00116]).
In reference to at least claim 6
Franke discloses wherein the helical wire rope structure electrode comprises a wire rope comprising strands twisted in a first direction and then coiled in a directed selected from the first direction and a direction opposite the first direction (e.g. “a bulk shape comprising a plurality of highly conductive wires twisted or braided together,”, claim 12).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 3 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2021/102195 to Franke et al. (herein Franke) in view of US 2006/0271108 to Libbus et al. (Libbus).
In reference to at least claim 3
Franke discloses a system according to claim 1 but does not explicitly teach at least one protective unit to prevent at least one of current or voltage above a safe level, the at least one protective unit including at least one protective unit located within one of the EPG and the electrical path from the EPG to the helical wire rope structure electrode.
Libbus discloses a neural stimulation system that includes a protective unit to prevent current or voltage above a safe level (e.g. Figs. 1-7, para. [0027]: Implantable medical device 110 includes a neural stimulation circuit 130. Neural stimulation circuit 130 delivers the neural stimulation pulses and includes a safety control system to prevent the patient from potential harmful effects associated with the delivery of the neural stimulation pulses. the safety control system detects safety-control events such as excessive or other inadequate deliveries of the neural stimulation pulses and/or unintended effects that develop in the patient with the delivery of the neural stimulation pulses. In response to a detection of such a safety-control event, the safety control system suspends or adjusts the delivery of the neural stimulation pulses).
It would have been obvious to a person skilled in the art before the effective filing date of the claimed invention to modify the system of Franke to include a protective unit such as a safety control system within the stimulation circuit, as taught by Libbus, in order to protect the patient from potential harmful effects associated with the delivery of stimulation pulses including unintended delivery of the stimulation pulses and unintended effects associated with the delivery of the stimulation pulses (‘108, para. [0003], [0024])
In reference to at least claim 7
Franke modified by Libbus renders obvious a system according to claim 3. Libbus further discloses that at least one protective unit includes at least one protective unit having indicia indicating a particular limitation for at least one of the current and the voltage, the indicia including at least one indicia selected from the group of markings, colors, and specific shapes (e.g. “parameter limiting module 448 and a stimulation switching module 450”, para. [0038], “Parameter limiting module 448 sets a value of a stimulation parameter to a threshold value of that parameter when the value of the stimulation parameter exceeds the threshold value”, para. [0039]). It would have been well within the level of ordinary skill in the art to use indicia including specifics markings or colors for indicating the stimulation parameter values and their relationship to a threshold value such as a color of green indicating a current or voltage value is within safe limits and a color of red indicating a current or voltage value being outside of safe limits.
Claim(s) 5 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2021/102195 to Franke et al. (Franke).
In reference to at least claim 5
Franke discloses a system according to claim 4 and further discloses at least one wicking agent (e.g. para. [005]: Although the wire structure electrode can be dense and has high charge injection capacity because of the high surface area, in many embodiments it is not entirely solid and maintains voids or empty spaces into which additional agents can be intermingled to provide various materials to provide benefits). Additionally, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include a wicking agent, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice, see MPEP 2144.07.
In reference to at least claim 8
Franke discloses a system according to claim 1 and further discloses the wire structure electrode including an inner diameter and an outer diameter (e.g. Figs. 23a-25d) and disclose the wire structure electrode having a small diameter (e.g. “a smaller diameter (e.g., 25 micron) wire structure electrode into live biological tissue chronically”, para. [0023]-[0024]). It would have been an obvious matter of design choice to modify Franke to have a ratio of the inner diameter to the outer diameter being greater than 1:4, since applicant has not disclosed that having a ratio of the inner diameter to the outer diameter being greater than 1:4 solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs.
Furthermore, absent a teaching as to criticality that a ratio of the inner diameter to the outer diameter being greater than 1:4, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement, see MPEP 2144.04. Additionally, it would have been an obvious matter of design choice to have the ratio of the inner diameter to the outer diameter being greater than 1:4, since such a modification would have involved a mere change in the size of the component. A change in size is generally recognized as being within the ordinary skill in the art, see MPEP 2144.04.
Claim(s) 10-11,13-19 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2021/102195 to Franke et al. (Franke) in view of US 2017/0239483 to Mathur et al. (Mathur).
In reference to at least claim 10
Franke discloses a system for stimulating a tissue target in a body (e.g. “In addition to use in electrical stimulation, the wire structure electrode is used to transfer thermal energy within the body., para. [0063]) the system comprising: comprising: a helical wire rope structure electrode (e.g. “wire structure electrode”, para. [005], “Different embodiments of the wire structure electrode include without limitation a "folded wire structure," "rolled wire structure," a "wrapped wire structure, "a "twisted or braided wire structure," and a "combination wire structure”, para. [0027]) having a hollow core all along a length with first and second ends (e.g. “hollow core”, para. [00103], [00112]) configured for loading into a dispenser in a substantially linear form all along the length for injection of a portion of the length into a body (e.g. pre-implant substantially linear, Fig. 24(a), para. [0073]), and said helical wire rope structure electrode being further configured for bending or bunching to deform from said substantially linear form into at least one irregular shape at any location along the length inside the body for self-anchoring without tines, hooks or sutures when injected (e.g. post-implant include a plurality of irregular shapes, Figs. 24(b), “with a first end 1h injected and bunched at a nerve at 40%, an interconnection area at 10%, and a second end 1i bunched in the subcutaneous region at 50%.” para. [0073]; “The novel aspects of the rolled wire structure provide a unique way to anchor it on or near a tissue target. Disclosed herein is a method of suture-less integration of a rolled wire structure near a target tissue in a body, para. [00115], [0116], [007]), and the helical wire rope structure electrode configured to transmit electricity passively along all the length (e.g. “transmit energy”, para. [002], “transmission of energy”, para. [005], [0055], “use in electrical stimulation…is used to transfer thermal energy”, para. [0063]), an external pulse generator (EPG) for generating an electrical waveform (e.g. “By extruding an wire structure electrode 1 from its targeted tissue to form a collector near the skin's surface, a direct electrical interface can be formed between the wire structure electrode 1 and the patch electrodes of a TENS device 37, which serves as an external generator with modifiable pulse parameters., para. [0083]) and configured to transmit electricity through an electrical path across the skin to the second irregular shape in the subcutaneous area (e.g. Fig. 33, para.[0083]-[0086]). Franke discloses that a direct electrical interface can be formed between the wire structure electrode 1 and the patch electrodes of a TENS device 37, which serves as an external generator with modifiable pulse parameters (e.g. Fig. 33, para. [0083]).
However, Franke does not explicitly disclose the second end being configured to extend as an external tail beyond the skin, and a lead from the EPG and an electrical connection to the external tail.
Mathur discloses a neurostimulation treatment system in which a lead partly extends from implanted electrodes, i.e. an external tail beyond the skin, and connects to a lead from an external pulse generator (e.g. Figs. 2A-2B, para. [0004], [0059]-[0061]; claim 1: a partly implanted neurostimulation lead extends from one or more implanted neurostimulation electrodes to an external pulse generator (EPG) supported in an affixation device secured to the patient, a proximal portion of an implantable neurostimulation lead is electrically coupled to the external pulse generator, the lead may be secured at the percutaneous incision with surgical tape 17 and further secured and sealed with an adherent patch covering the lead and percutaneous incision).
It would have been obvious to a person skilled in the art before the effective filing date of the claimed invention to modify the system of Franke to include the second end extending as an external tail beyond the skin, a lead from the EPG and providing an electrical connection to the external tail, as taught by Mathur, in order to provide an apparatus that allows for trial nerve stimulation that can determine improved assessment of efficacy that can easily recognize the benefit and effectiveness of treatment (e.g. ‘483, para. [0055]-[0056]).
In reference to at least claim 11
Franke modified by Mathur renders obvious a system according to claim 10. Franke further discloses wherein the EPG is configured to provide the waveform through at least two interfacing points to the helical wire rope structure (e.g. transcutaneously provide a waveform, Figs. 33-34, para. [0082]-[0086]). Franke further discloses multiple interfacing points with the along the wire structure electrode (e.g. Figs. 25(a)-25(d), para. [0074] Figs. 25 (b) -(d) illustrate how different embodiments may have a reinforcer (e.g., glue or other material adding rigidity) in differing patterns and for different distances of the rolled wire based structure. Glue or silicone, bits of metal or nonconductive material may be affixed to the wire structure to create intermittent rigidity, as with the glue or silicone).
In reference to at least claim 13
Franke modified by Mathur renders obvious a system according to claim 10. Franke further discloses wherein the electrical connection comprises a conductive metal band (e.g. connector 21, Figs. 2B,3B, para. [0060], [0065]-[0066]; receptable 42, para. [0070],[0071],[0074]).
In reference to at least claim 14
Franke modified by Mathur renders obvious a system according to claim 13. Mathur further discloses wherein the conductive metal band is at least partially housed in an adhesive strip (e.g. connector 21 housed in an adhesive patch with surgical tape, Fig. 3A-3C, para. [0065]; “Such an EPG can be situated within an EPG adherent patch affixation device 10, or in any other affixation device described herein.”, para. [00068]), and wherein the conductive metal band has one end that is configured for contact with the external tail, and another end that is configured for contact with the EPG (e.g. connector 21 connects the tail of the implanted lead to the external pulse generator, Figs. 2B,3B, para. [0060], [0065]-[0066]; receptable 42, para. [0070],[0071],[0074]).
In reference to at least claim 15
Franke modified by Mathur renders obvious a system according to claim 10. Mathur further discloses wherein the electrical connection is a conductive clip connected to the EPG and is configured for attachment to the external tail (e.g. connector 21, Figs. 2B,3B, para. [0060], [0065]-[0066]; receptable 42, para. [0070],[0071],[0074]).
In reference to at least claim 16
Franke modified by Mathur renders obvious a system according to claim 10. It would have been an obvious matter of design choice to modify Franke modified by Mathur to include the electrical connection being a conductive hook and loop device, since applicant has not disclosed that having the electrical connection be a conductive hook and loop device solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs.
Furthermore, absent a teaching as to criticality that the electrical connection is a conductive hook and loop device, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement, see MPEP 2144.04. Additionally, applicant has disclosed that such conductive hook and loop devices are well known and readily available (e.g. para. [0079] of published application US 2026/005456), therefore it would have been well within the level of one having ordinary skill in the art to use such device for providing an electrical connection between the implanted electrode and the external pulse generator.
In reference to at least claim 17
Franke modified by Mathur renders obvious a system according to claim 10. Franke further discloses a partial coating on the helical wire rope structure between the first and second ends, said partial coating comprising at least one discontinuity selected from the group of holes, gaps and perforations (e.g. “A wire structure electrode comprising at least one highly conductive and biocompatible wire compacted into primary loops and folds with voids comprising a bulk shape comprising a roughened and porous surface and secondary loops protruding from said roughened and porous surface of said bulk shape,.”. claim 10, para. [00116]).
In reference to at least claim 18
Franke modified by Mathur renders obvious a system according to claim 17. Franke further discloses at least one wicking agent (e.g. para. [005]: Although the wire structure electrode can be dense and has high charge injection capacity because of the high surface area, in many embodiments it is not entirely solid and maintains voids or empty spaces into which additional agents can be intermingled to provide various materials to provide benefits). Additionally, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include a wicking agent, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice, see MPEP 2144.07.
In reference to at least claim 19
Franke modified by Mathur renders obvious a system according to claim 10. Franke further discloses wherein the helical wire rope structure electrode comprises a wire rope comprising strands twisted in a first direction and then coiled in a direction from the first direction and a direction opposite the first direction (e.g. “a bulk shape comprising a plurality of highly conductive wires twisted or braided together,”, claim 12).
In reference to at least claim 21
Franke modified by Mathur renders obvious a system according to claim 10. Franke further discloses the wire structure electrode including an inner diameter and an outer diameter (e.g. Figs. 23a-25d) and disclose the wire structure electrode having a small diameter (e.g. “a smaller diameter (e.g., 25 micron) wire structure electrode into live biological tissue chronically”, para. [0023]-[0024]). It would have been an obvious matter of design choice to modify Franke to have a ratio of the inner diameter to the outer diameter being greater than 1:4, since applicant has not disclosed that having a ratio of the inner diameter to the outer diameter being greater than 1:4 solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs.
Furthermore, absent a teaching as to criticality that a ratio of the inner diameter to the outer diameter being greater than 1:4, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement, see MPEP 2144.04. Additionally, it would have been an obvious matter of design choice to have the ratio of the inner diameter to the outer diameter being greater than 1:4, since such a modification would have involved a mere change in the size of the component. A change in size is generally recognized as being within the ordinary skill in the art, see MPEP 2144.04.
Claim(s) 12 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2021/102195 to Franke et al. (herein Franke) in view of US 2017/0239483 to Mathur et al. (herein Mathur) as applied to claim 10 further in view of US 2006/0271108 to Libbus et al. (Libbus).
In reference to at least claim 12
Franke modified by Mathur renders obvious a system according to claim 10. However, Franke does not explicitly teach at least one protective unit to prevent at least one of current or voltage above a safe level, the at least one protective unit including at least one protective unit located within one of the EPG and the electrical path from the EPG to the helical wire rope structure electrode.
Libbus discloses a neural stimulation system that includes a protective unit to prevent current or voltage above a safe level (e.g. Figs. 1-7, para. [0027]: Implantable medical device 110 includes a neural stimulation circuit 130. Neural stimulation circuit 130 delivers the neural stimulation pulses and includes a safety control system to prevent the patient from potential harmful effects associated with the delivery of the neural stimulation pulses. the safety control system detects safety-control events such as excessive or other inadequate deliveries of the neural stimulation pulses and/or unintended effects that develop in the patient with the delivery of the neural stimulation pulses. In response to a detection of such a safety-control event, the safety control system suspends or adjusts the delivery of the neural stimulation pulses).
It would have been obvious to a person skilled in the art before the effective filing date of the claimed invention to further modify the system of Franke modified by Mathur to include a protective unit such as a safety control system within the stimulation circuit, as taught by Libbus, in order to protect the patient from potential harmful effects associated with the delivery of stimulation pulses including unintended delivery of the stimulation pulses and unintended effects associated with the delivery of the stimulation pulses (‘108, para. [0003], [0024]).
In reference to at least claim 20
Franke modified by Mathur and Libbus renders obvious a system according to claim 12. Libbus further discloses that at least one protective unit includes at least one protective unit having indicia indicating a particular limitation for at least one of the current and the voltage, the indicia including at least one indicia selected from the group of markings, colors, and specific shapes (e.g. “parameter limiting module 448 and a stimulation switching module 450”, para. [0038], “Parameter limiting module 448 sets a value of a stimulation parameter to a threshold value of that parameter when the value of the stimulation parameter exceeds the threshold value”, para. [0039]). It would have been well within the level of ordinary skill in the art to use indicia including specifics markings or colors for indicating the stimulation parameter values and their relationship to a threshold value such as a color of green indicating a current or voltage value is within safe limits and a color of red indicating a current or voltage value being outside of safe limits.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2011/0009728 to Schouenborg which discloses a medical electrode bundle and bundle array that includes a rope electrode structure. US Patent No. 10,357,174 to Santala which discloses an adjustable lead wire which includes a rope electrode structure. US Patent No. 5,366,493 to Zehner which discloses a double helix stimulation electrode.
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