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 Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4, 6-8, 11-13, & 15-20 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 recites the limitations "the distal portion" & “the anatomy” in lines 5-6. There is insufficient antecedent basis for these limitations in the claim; for examination purposes the examiner is considering "the distal portion" to be –the portion— and “the anatomy” to be –an anatomy—.
Claim 6 recites the limitation "the electrical and thermal energy " in line 2. There is insufficient antecedent basis for the limitation “thermal energy” in the claim. Independent claim 1 introduces “activating the electrosurgical elements to deliver electrical energy”; it is unclear if the “thermal energy”, of claim 6, is different than or the same as the electrical energy, as introduced in claim 1, which renders the claim indefinite; for examination purposes the examiner is considering “the electrical and thermal energy" to be –the electrical energy—.
Claim 7 recites the limitation “delivering the electrical and thermal energy with about 20W to about 100W, preferably 20W to 30W”. First, there is insufficient antecedent basis for the limitation “thermal energy” in the claim; independent claim 1 introduces “activating the electrosurgical elements to deliver electrical energy”; it is unclear if the “thermal energy”, of claim 7, is different than or the same as the electrical energy, as introduced in claim 1, which renders the claim indefinite; for examination purposes the examiner is considering “the electrical and thermal energy" to be –the electrical energy—. Second, it is unclear as to which range of power is required by the limitation “20W to about 100W, preferably 20W to 30W” (e.g. is 20W to about 100W required by this limitation or is 20W to 30W required by this limitation), which renders the claim indefinite; for examination purposes the examiner is considering the range to be 20W to 30W.
Claim 8 recites the limitation "delivering the electrical and thermal energy as a short pulse having a duration of about 1 second to about 3 seconds and with about 20W to about 100W, preferably 20W to 60W”. First, there is insufficient antecedent basis for the limitation “thermal energy” in the claim; independent claim 1 introduces “activating the electrosurgical elements to deliver electrical energy”; it is unclear if the “thermal energy”, of claim 8, is different than or the same as the electrical energy, as introduced in claim 1, which renders the claim indefinite; for examination purposes the examiner is considering “the electrical and thermal energy" to be –the electrical energy—. Second, it is unclear as to which range of power is required by the limitation “20W to about 100W, preferably 20W to 60W” (e.g. is 20W to about 100W required by this limitation or is 20W to 60W required by this limitation), which renders the claim indefinite; for examination purposes the examiner is considering the range to be 20W to 60W.
Claim 11 recites the limitation "the electrosurgical circuit" in line 2. There is insufficient antecedent basis for this limitation in the claim; for examination purposes the examiner is considering "the electrosurgical circuit" to be –the electrosurgical elements—.
Claim 12 recites the limitation " the electrosurgical circuit" in line 2. There is insufficient antecedent basis for this limitation in the claim; for examination purposes the examiner is considering "the electrosurgical circuit" to be –the electrosurgical elements—.
Claim 13 recites the limitation " the electrosurgical circuit" in line 2. There is insufficient antecedent basis for this limitation in the claim; for examination purposes the examiner is considering "the electrosurgical circuit" to be –the electrosurgical elements—.
Claim 15 recites the limitation "the electrical and thermal energy " in line 2. There is insufficient antecedent basis for the limitation “thermal energy” in the claim. Independent claim 1 introduces “activating the electrosurgical elements to deliver electrical energy”; it is unclear if the “thermal energy”, of claim 15, is different than or the same as the electrical energy (e.g. it is unclear if a thermal energy is being delivered and an electrical energy is being delivered, or if just an electrical energy is being delivered), as introduced in claim 1, which renders the claim indefinite; for examination purposes the examiner is considering “the electrical and thermal energy" to be –the electrical energy—. Claim 16 is rejected by virtue of its dependency on claim 15.
Claim 17 recites the limitation " electrical and thermal energy " in line 2. There is insufficient antecedent basis for the limitation “thermal energy” in the claim. Independent claim 1 introduces “activating the electrosurgical elements to deliver electrical energy”; it is unclear if the “thermal energy”, of claim 17, is different than or the same as the electrical energy (e.g. it is unclear if a thermal energy is being delivered and an electrical energy is being delivered, or if just an electrical energy is being delivered), as introduced in claim 1, which renders the claim indefinite; for examination purposes the examiner is considering “the electrical and thermal energy" to be –the electrical energy—. Claims 18-20 are rejected by virtue of their dependency on claim 17.
Claim 19 recites the limitation "the measured electrical response" in line 2. There is insufficient antecedent basis for this limitation in the claim; for examination purposes the examiner is considering "the measured electrical response " to be –a measured electrical response—.
Claim 20 recites the limitation "the measured electrical response" in line 2. There is insufficient antecedent basis for this limitation in the claim; for examination purposes the examiner is considering "the measured electrical response " to be –a measured electrical response—.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 5, & 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Aklog et al. (US 20160157880 A1), hereinafter “Aklog”.
Regarding claim 1, Aklog discloses a method for dividing a fibrous structure ([0005]), the method comprising: positioning, proximate the fibrous structure, a device having an expandable member and electrosurgical elements ([0035], [0046], & [0074]; Figures 2 & 12C—elements 200, 400, & 500; the device 200 with balloon 400 in the deflated state may be navigated into a position proximate the transverse carpal ligament and oriented such that cutting element 500 (which is configured to utilize electrical and/or thermal energy to divide fibrous wall and may include unipolar or bipolar leads) is pointed towards the transverse carpal ligament); expanding the expandable member outwards to tension the fibrous structure across the electrosurgical elements ([0035] & [0075]; Figure 12D—element 400; after confirming that the cutting element 500 is properly positioned and oriented, the balloon 400 may be inflated to apply sufficient tension to the transverse carpal ligament such that it is stretched taut across cutting element 500); and activating the electrosurgical elements to deliver electrical energy to the tensioned fibrous structure in a manner that results in division of the tensioned fibrous structure ([0076]; Figure 12E—element 500; the cutting element 500 may be energized for cutting the transverse carpal ligament, such that cutting elements 500 may be energized to weaken a contacted portion of the transverse carpal ligament such that it may be divided in combination with the tension applied by balloon 400).
Regarding claim 2, Aklog discloses all of the limitations of claim 1, as described above.
Aklog further discloses wherein the step of positioning includes orienting the electrosurgical elements to face the fibrous structure ([0074]; Figure 12C—element 500; the device is oriented such that the cutting element 500 is pointed towards the transverse carpal ligament).
Regarding claim 3, Aklog discloses all of the limitations of claim 2, as described above.
Aklog further discloses orienting the electrosurgical elements in a direction substantially transverse to the fibrous structure ([0041] & [0074]; Figures 4A & 12C—element 500).
Regarding claim 5, Aklog discloses all of the limitations of claim 1, as described above.
Aklog further discloses wherein the step of expanding the expandable member further serves to manipulate a position of an anatomical structure located near the expandable member ([0042] & [0075]; Figure 12D—element 400; the balloon pushes nearby tendons, nerves or other anatomical structures outward from device 200 when inflated).
Regarding claim 9, Aklog discloses all of the limitations of claim 1, as described above.
Aklog further discloses wherein the step of activating includes monitoring an internal pressure in the expandable member to detect a change in pressure indicative of complete division of the fibrous structure ([0071] & [0078]; complete division of the fibrous wall may be confirmed by measuring corresponding reduction in balloon pressure associated with dividing fibrous wall).
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 4 is rejected under 35 U.S.C. 103 as being unpatentable over Aklog in view of Bloom et al. (US 20130085493 A1), hereinafter “Bloom”.
Regarding claim 4, as best understood in view of the 112(b) rejection above, Aklog discloses all of the limitations of claim 1, as described above.
Aklog further discloses positioning, beyond the fibrous structure, a portion of the expandable member having a shaped profile; and in the step of expanding, the shaped profile of the distal portion of the expandable member engages the anatomy beyond the fibrous structure during division ([0042]).
Aklog does not disclose the portion of the expandable member having the shaped profile with a larger diameter than that of the proximal portion of the expandable member; the shaped profile to minimize migration of the device during division.
Bloom teaches a method of delivering an electrosurgical expandable member to target tissue, the expandable member having the shaped profile with a larger diameter than that of the proximal portion of the expandable member; the shaped profile to minimize migration of the device during division ([0030]; the expandable member can have a double diameter (with a smaller diameter proximal end and a larger diameter distal end) for stability).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the expandable member, as disclosed by Aklog, to include the expandable member having the shaped profile with a larger diameter than that of the proximal portion of the expandable member, the shaped profile to minimize migration of the device during division, as taught by Bloom, as both references and the claimed invention are directed toward electrosurgical methods comprising expandable members. As disclosed by Bloom, the balloon can have a double diameter (with a smaller diameter proximal end and a larger diameter distal end) for stability and to facilitate mounting to the catheter, enhancing the stability of the balloon can ensure that the exposed electrosurgical elements can be steadily placed in contact with target tissue ([0030] & [0053]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the expandable member, as disclosed by Aklog, to include the expandable member having the shaped profile with a larger diameter than that of the proximal portion of the expandable member, the shaped profile to minimize migration of the device during division, as taught by Bloom, as such a modification would increase the stability of the device to ensure that the exposed electrosurgical elements can be steadily placed in contact with target tissue.
Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Aklog in view of Davies (US 20130046305 A1), hereinafter “Davies”.
Regarding claim 6, as best understood in view of the 112(b) rejection above, Aklog discloses all of the limitations of claim 1, as described above.
Aklog does not disclose wherein the step of activating includes delivering the electrical and thermal energy as a short pulse having a duration of about 1 second to about 3 seconds.
Davies teaches a method of cutting a tissue structure comprising activating electrosurgical elements to deliver electrical energy to the tissue structure ([0022]); wherein the step of activating includes delivering the electrical and thermal energy as a short pulse having a duration of about 1 second to about 3 seconds ([0028]-[0032] & [0071]; the pulsed electrical energy, typically in the radiofrequency range, comprises at least one pulse having a time period of 1 second).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the method of delivering the electrical energy, as disclosed by Aklog, to include delivering the electrical energy as a short pulse having a duration of about 1 second to about 3 seconds, as taught by Davies, as both references and the claimed invention are directed toward methods of electrosurgically cutting tissue. As disclosed by Aklog, the electrosurgical elements deliver radiofrequency energy to cut tissue ([0046]). As disclosed by Davies, the electrosurgical elements deliver radiofrequency energy to perforate/cut tissue, the radiofrequency energy may be delivered in a single pulse having a time period of 1 second, which provides greater safety by cutting at a slower and more controllable rate ([0022], [0031], [0050], & [0071]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method of delivering the electrical energy, as disclosed by Aklog, to include delivering the electrical energy as a short pulse having a duration of about 1 second to about 3 seconds, as taught by Davies, as such a modification would provide for a known and suitable time period for delivering radiofrequency energy in order to cut tissue and would further provide greater safety by cutting at a slower and more controllable rate.
Regarding claim 7, as best understood in view of the 112(b) rejection above, Aklog discloses all of the limitations of claim 1, as described above.
Aklog does not disclose wherein the step of activating includes delivering the electrical and thermal energy with about 20W to about 100W, preferably 20W to 30W.
Davies teaches a method of cutting a tissue structure comprising activating electrosurgical elements to deliver electrical energy to the tissue structure ([0022]); wherein the step of activating includes delivering the electrical and thermal energy with about 20W to about 100W, preferably 20W to 30W ([0028]-[0032], & [0071]; the pulsed electrical energy, typically in the radiofrequency range, comprises a power level 2 W to 25 W, or between 25 W to about 100 W).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the method of delivering the electrical energy, as disclosed by Aklog, to include delivering the electrical energy with about 20W to about 100W, preferably 20W to 30W, as taught by Davies, as both references and the claimed invention are directed toward methods of electrosurgically cutting tissue. As disclosed by Aklog, the electrosurgical elements deliver radiofrequency energy to cut tissue ([0046]). As disclosed by Davies, the electrosurgical elements deliver radiofrequency energy to perforate/cut tissue, the radiofrequency energy may comprise power level ranges between 2 Watts and 100 Watts ([0022], [0050], & [0071]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method of delivering the electrical energy, as disclosed by Aklog, to include delivering the electrical energy with about 20W to about 100W, preferably 20W to 30W, as taught by Davies, as such a modification would provide for a known and suitable power level for delivering radiofrequency energy in order to produce the predictable result of cut tissue.
Regarding claim 8, as best understood in view of the 112(b) rejection above, Aklog discloses all of the limitations of claim 1, as described above.
Aklog does not disclose wherein the step of activating includes delivering the electrical and thermal energy as a short pulse having a duration of about 1 second to about 3 seconds and with about 20W to about 100W, preferably 20W to 60W.
Davies teaches a method of cutting a tissue structure comprising activating electrosurgical elements to deliver electrical energy to the tissue structure ([0022]); wherein the step of activating includes delivering the electrical and thermal energy as a short pulse having a duration of about 1 second to about 3 seconds and with about 20W to about 100W, preferably 20W to 60W ([0028]-[0032] & [0071]; the pulsed electrical energy, typically in the radiofrequency range, comprises at least one pulse having a time period of 1 second).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the method of delivering the electrical energy, as disclosed by Aklog, to include delivering the electrical energy as a short pulse having a duration of about 1 second to about 3 seconds and with about 20W to about 100W, preferably 20W to 60W, as taught by Davies, as both references and the claimed invention are directed toward methods of electrosurgically cutting tissue. As disclosed by Aklog, the electrosurgical elements deliver radiofrequency energy to cut tissue ([0046]). As disclosed by Davies, the electrosurgical elements deliver radiofrequency energy to perforate/cut tissue, the radiofrequency energy may be delivered in a single pulse having a time period of 1 second, and the radiofrequency energy may comprise power level ranges between 2 Watts and 100 Watts, these parameters of delivering radiofrequency energy provide greater safety by cutting at a slower and more controllable rate ([0022], [0031], [0050], & [0071]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method of delivering the electrical energy, as disclosed by Aklog, to include delivering the electrical energy as a short pulse having a duration of about 1 second to about 3 seconds and with about 20W to about 100W, preferably 20W to 60W, as taught by Davies, as such a modification would provide for a known and suitable time period and power level for delivering radiofrequency energy in order to cut tissue and would further provide greater safety by cutting at a slower and more controllable rate.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Aklog in view of Yoon (US 4535773 A), hereinafter Yoon.
Regarding claim 10, Aklog discloses all of the limitations of claim 1, as described above.
Aklog does not disclose wherein the step of activating includes monitoring an external force applied to the expandable member to detect a change in force indicative of complete division of the fibrous structure.
Yoon teaches a method of dividing a tissue structure using a member ([Col. 16, line 36 – Col. 17, line 4]), comprising monitoring an external force applied to the member to detect a change in force indicative of complete division of the structure ([Col. 15, line 64 – Col. 17, line 4]; the member may be constructed with one or more sensors which are configured to sense the pressure occurring at the distal end of the member during penetration due to resistance by the tissue, when the member breaks through the tissue the sudden absence of tissue resistance decreases the pressure which indicates complete puncture).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the indication of complete division of the fibrous structure, as disclosed by Aklog, to include monitoring an external force applied to the member to detect a change in force indicative of complete division of the structure, as taught by Yoon, as both references and the claimed invention are directed toward surgical devices for puncturing tissue. As disclosed by Aklog, complete division of the wall may be confirmed by inspection, lighting elements, an imaging modality, or some other suitable technique (e.g. measuring a corresponding reduction in balloon pressure associated with dividing fibrous wall and relieving the pressure within anatomical compartment) ([0071]). As disclosed by Yoon, the complete division of the tissue wall may be determined by measuring pressure occurring at the distal end of the member due to resistance by the tissue during cutting of the tissue, a sudden absence of resistance decreases the pressure on the member indicates completion of cutting of the tissue wall ([Col. 15, line 64 – Col. 17, line 4]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, motivated to modify the indication of complete division of the fibrous structure, as disclosed by Aklog, to include monitoring an external force applied to the member to detect a change in force indicative of complete division of the structure, as taught by Yoon, as such a modification would provide for a known and suitable technique for producing the predictable result of indicating complete division of the tissue structure.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Aklog in view of Brannan (US 20190090929 A1), hereinafter “Brannan”.
Regarding claim 11, as best understood in view of the 112(b) rejection above, Aklog discloses all of the limitations of claim 1, as described above.
Aklog does not disclose wherein the step of activating includes monitoring an impedance of the electrosurgical circuit to detect when the impedance reaches a threshold level indicative of complete division of the fibrous structure.
Brannan teaches a method of dividing a tissue structure, comprising monitoring an impedance of the electrosurgical circuit to detect when the impedance reaches a threshold level indicative of complete division of the fibrous structure ([0066]; the complete division of the tissue structure can be determined based on the measured tissue impedance, for example when the measured impedance exceeds a predetermined threshold impedance tissue is determined to be cut).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the indication of complete division of the fibrous structure, as disclosed by Aklog, to include monitoring an impedance of the electrosurgical circuit to detect when the impedance reaches a threshold level indicative of complete division of the fibrous structure, as taught by Brannan, as both references and the claimed invention are directed toward surgical devices for cutting tissue. As disclosed by Aklog, complete division of the wall may be confirmed by inspection, lighting elements, an imaging modality, or some other suitable technique (e.g. measuring a corresponding reduction in balloon pressure associated with dividing fibrous wall and relieving the pressure within anatomical compartment) ([0071]). As disclosed by Brannan, the complete division of the tissue wall may be determined by measuring impedance, such that when impedance exceeds a predetermined threshold the tissue is determined to be cut ([0066]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, motivated to modify the indication of complete division of the fibrous structure, as disclosed by Aklog, to include monitoring an impedance of the electrosurgical circuit to detect when the impedance reaches a threshold level indicative of complete division of the fibrous structure, as taught by Brannan, as such a modification would provide for a known and suitable technique for producing the predictable result of indicating complete division of the tissue structure.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Aklog in view of Lennartz et al. (US 20210234993 A1; effectively filed 01/23/2020), hereinafter “Lennartz”.
Regarding claim 12, as best understood in view of the 112(b) rejection above, Aklog discloses all of the limitations of claim 1, as described above.
Aklog does not disclose monitoring an impedance of the electrosurgical circuit to detect a time rate of change in the impedance measurements indicative of complete division of the fibrous structure.
Lennartz teaches a method of dividing a tissue structure, comprising monitoring an impedance of the electrosurgical circuit to detect a time rate of change in the impedance measurements indicative of complete division of the fibrous structure ([0055]; change in impedance of the target anatomical structure over time provides feedback that indicated when the surgical operation (e.g. cutting) is complete).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the indication of complete division of the fibrous structure, as disclosed by Aklog, to include monitoring an impedance of the electrosurgical circuit to detect a time rate of change in the impedance measurements indicative of complete division of the fibrous structure, as taught by Lennartz, as both references and the claimed invention are directed toward surgical devices for cutting tissue. As disclosed by Aklog, complete division of the wall may be confirmed by inspection, lighting elements, an imaging modality, or some other suitable technique (e.g. measuring a corresponding reduction in balloon pressure associated with dividing fibrous wall and relieving the pressure within anatomical compartment) ([0071]). As disclosed by Lennartz, the completion of cutting tissue can be indicated based on changes in impedance of the target anatomical structure over time ([0055]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, motivated to modify the indication of complete division of the fibrous structure, as disclosed by Aklog, to include monitoring an impedance of the electrosurgical circuit to detect a time rate of change in the impedance measurements indicative of complete division of the fibrous structure, as taught by Lennartz, as such a modification would provide for a known and suitable technique for producing the predictable result of indicating complete division of the tissue structure.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Aklog in view of Hilal et al. (US 5344420 A), hereinafter “Hilal”.
Regarding claim 13, as best understood in view of the 112(b) rejection above, Aklog discloses all of the limitations of claim 1, as described above.
Aklog does not disclose monitoring a current in the electrosurgical circuit to detect a reduction in current indicative of complete division of the fibrous structure.
Hilal teaches a method of dividing a tissue structure, comprising monitoring a current in the electrosurgical circuit to detect a reduction in current indicative of complete division of the fibrous structure ([Col. 8, line 67 – Col. 9, line 16]; indicating penetration of the wall can include sensing changing electrical characteristics, for example a decrease in current magnitude).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the indication of complete division of the fibrous structure, as disclosed by Aklog, to include monitoring a current in the electrosurgical circuit to detect a reduction in current indicative of complete division of the fibrous structure, as taught by Hilal, as both references and the claimed invention are directed toward surgical devices for cutting tissue. As disclosed by Aklog, complete division of the wall may be confirmed by inspection, lighting elements, an imaging modality, or some other suitable technique (e.g. measuring a corresponding reduction in balloon pressure associated with dividing fibrous wall and relieving the pressure within anatomical compartment) ([0071]). As disclosed by Hilal, the completion of penetrating tissue can be determined based on a decrease in sensed current magnitude ([Col. 8, line 67 – Col. 9, line 16]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, motivated to modify the indication of complete division of the fibrous structure, as disclosed by Aklog, to include monitoring a current in the electrosurgical circuit to detect a reduction in current indicative of complete division of the fibrous structure, as taught by Hilal, as such a modification would provide for a known and suitable technique for producing the predictable result of indicating complete division of the tissue structure.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Aklog in view of Patterson et al. (US 6319242 B1), hereinafter “Patterson”.
Regarding claim 14, Aklog discloses all of the limitations of claim 1, as described above.
Aklog further discloses visualizing, via fluoroscopy or ultrasound, a shape of the expandable member indicating a complete division of the fibrous structure ([0074], [0078], & [0088]-[0089]; Figures 8A-8C & 12D-12E—element 110; complete division of the transverse carpal ligament may be confirmed by an imaging modality, such as an ultrasound probe; Figures 8A-8C portray the external force applied by the fibrous structure 110 to the expandable member 400 disappearing as the fibrous wall is divided).
Aklog does not disclose to detect when a deformation in the expandable member, created by force applied to the expandable member by the fibrous structure, disappears, thereby indicating the complete division of the fibrous structure.
Patterson et al. (US 6319242 B1) teaches a method member for dividing a structure comprising an expandable member ([Col. 22, lines 14-46]; Figures 18-20—element 100), the method comprising detecting when a deformation in the expandable member, created by force applied to the expandable member by the fibrous structure, disappears, thereby indicating the complete division of the structure ([Col. 22, lines 14-46]; Figures 19-20—element 100).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify visualizing, via flu ultrasound, a shape of the expandable member indicating a complete division of the fibrous structure, as disclosed by Aklog, to further include detecting when a deformation in the expandable member, created by force applied to the expandable member by the fibrous structure, disappears, thereby indicating the complete division of the structure, as taught by Patterson, as both references and the claimed invention are directed toward methods for cutting tissue. As disclosed by Aklog, complete division of the wall may be confirmed by inspection, lighting elements, an imaging modality, or some other suitable technique (e.g. measuring a corresponding reduction in balloon pressure associated with dividing fibrous wall and relieving the pressure within anatomical compartment) ([0071]). As disclosed by Patterson, effective removal of the tissue can be indicated by expandable member further expanding past the removed tissue ([Col. 22, lines 14-46]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify visualizing, via flu ultrasound, a shape of the expandable member indicating a complete division of the fibrous structure, as disclosed by Aklog, to further include detecting when a deformation in the expandable member, created by force applied to the expandable member by the fibrous structure, disappears, thereby indicating the complete division of the structure, as taught by Patterson, as such a modification would provide for a known and suitable technique for producing the predictable result of indicating complete division of the tissue structure.
Claims 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over Townley et al. (US 20210315638 A1; effectively filed 04/09/2020).
Regarding claim 15, as best understood in view of the 112(b) rejection above, Aklog discloses all of the limitations of claim 1, as described above.
Aklog further discloses delivering the electrical and thermal energy to stimulate any nerves proximal to the electrosurgical elements ([0050], [0052], [0055], & [0074]; a signal for stimulating nearby nerves is emitted).
Aklog does not disclose delivering the electrical and thermal energy approximately from about 1W to about 2W.
Townley teaches a method of stimulating nerves comprising delivering the electrical and thermal energy approximately from about 1W to about 2W ([0118]; the generator delivers stimulating energy pulses of 1-3 W via the electrodes to stimulate nerves in the tissue).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the power of the electrical energy for stimulating nerves, as disclosed by Aklog, to include delivering the electrical energy approximately from about 1W to about 2W, as disclosed by Townley, as both references and the claimed invention are directed toward electrosurgical methods for stimulating nerves in tissue. As disclosed by Aklog, a stimulating signal is delivered to stimulate nearby nerves ([0050] & [0052]). As disclosed by Townley, the electrical energy may be delivered at 1-3 W to stimulate nerves in the tissue ([0188]). It would have been obvious, to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the power of the electrical energy for stimulating nerves, as disclosed by Aklog, to include delivering the electrical energy approximately from about 1W to about 2W, as disclosed by Townley, as such a modification would provide for a suitable and known power level for producing the predictable result of stimulating nerves in tissue; and further it would have been obvious to one having ordinary skill in the art at the time the invention was made to include delivering the electrical energy approximately from about 1W to about 2W, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 16, Aklog in view of Townley disclose all of the limitations of claim 15, as described above.
Aklog further discloses repositioning the device in response to an observation of twitching in response to the delivery of the electrical and thermal energy to the electrosurgical elements ([0011], [0050], & [0056]; if the stimulation element is in the vicinity of a nerve, a corresponding reaction (e.g. twitching) is noted and the operator may deduce that the device is improperly positioned and the position and orientation of the device can be adjusted).
Regarding claim 17, as best understood in view of the 112(b) rejection above, Aklog discloses all of the limitations of claim 1, as described above.
Aklog further discloses activating nerve stimulation electrosurgical elements to deliver electrical and thermal energy to stimulate any nerves proximal to the nerve stimulation electrosurgical elements ([0048], [0050], & [0074]; a signal for stimulating nearby nerves is emitted to stimulating element 620).
Aklog does not disclose delivering the electrical and thermal energy approximately from about 1W to about 2W.
Townley teaches a method of stimulating nerves comprising delivering the electrical and thermal energy approximately from about 1W to about 2W ([0118]; the generator delivers stimulating energy pulses of 1-3 W via the electrodes to stimulate nerves in the tissue).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the power of the electrical energy for stimulating nerves, as disclosed by Aklog, to include delivering the electrical energy approximately from about 1W to about 2W, as disclosed by Townley, as both references and the claimed invention are directed toward electrosurgical methods for stimulating nerves in tissue. As disclosed by Aklog, a stimulating signal is delivered to stimulating elements to stimulate nearby nerves ([0050] & [0052]). As disclosed by Townley, the electrical energy may be delivered at 1-3 W to stimulate nerves in the tissue ([0188]). It would have been obvious, to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the power of the electrical energy for stimulating nerves, as disclosed by Aklog, to include delivering the electrical energy approximately from about 1W to about 2W, as disclosed by Townley, as such a modification would provide for a suitable and known power level for producing the predictable result of stimulating nerves in tissue; and further it would have been obvious to one having ordinary skill in the art at the time the invention was made to include delivering the electrical energy approximately from about 1W to about 2W, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 18, Aklog in view of Townley disclose all of the limitations of claim 17, as described above.
Aklog further discloses measuring an electrical response to the electrical and thermal energy delivered to the nerve stimulation electrosurgical elements ([0048] & [0049]; sensing elements detect nerve conduction during electrical stimulation of the nerve).
Regarding claim 19, as best understood in view of the 112(b) rejection above, Aklog in view of Townley disclose all of the limitations of claim 17, as described above.
Aklog further discloses repositioning the device in response to a change in the measured electrical response in response to the delivery of the electrical and thermal energy with to the nerve stimulation electrosurgical elements ([0011] & [0049]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Aklog in view of Townley and Schmitz et al. (US 20100331883 A1), hereinafter “Schmitz”.
Regarding claim 20, as best understood in view of the 112(b) rejection above, Aklog in view of Townley disclose all of the limitations of claim 17, as described above.
Aklog does not disclose wherein the electrosurgical elements are automatically disabled in response to a change in the measured electrical response in response to the delivery of the electrical and thermal energy with to the nerve stimulation electrosurgical elements.
Schmitz teaches a method of cutting tissue comprising stimulating nerves ([0181]), wherein the electrosurgical elements are automatically disabled in response to a change in the measured electrical response in response to the delivery of the electrical and thermal energy with to the nerve stimulation electrosurgical elements ([0181]; the energy delivery member may be automatically deactivated if the response to activation by the nerve stimulation indicates that the energy delivery member is in contact with or near a nerve).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the method of stimulating nerves, as disclosed by Aklog, to include wherein the electrosurgical elements are automatically disabled in response to a change in the measured electrical response in response to the delivery of the electrical and thermal energy with to the nerve stimulation electrosurgical elements, as taught by Schmitz, as both references and the claimed invention are directed toward method of cutting tissue and avoiding nerve tissue. As disclosed by Schmitz, the energy delivery member may be automatically deactivated in response to activated by the nerve stimulation indicating that the energy delivery member is in contact with or near nerve tissue, for added safety ([0088] & [0181]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method of stimulating nerves, as disclosed by Aklog, to include wherein the electrosurgical elements are automatically disabled in response to a change in the measured electrical response in response to the delivery of the electrical and thermal energy with to the nerve stimulation electrosurgical elements, as taught by Schmitz, as such a modification would provide for added safety to prevent the electrosurgical members from cutting non-target nerve tissue.
Conclusion
Accordingly, claims 1-20 are rejected.
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/M.D.T./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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