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 .
Response to Amendment
The amendment filed October 17th, 2025 has been entered. Claims 1, 8, & 24 are amended. Claims 1-30 remain pending; claims 10-23 are withdrawn from further consideration.
Response to Arguments
Applicant's arguments filed October 17th, 2025 have been fully considered but they are not persuasive. Applicant argues that Independent claims 1 & 24, as amended to include “wherein the tissue comprises mucosa and submucosa of a duodenum, and wherein the generated pulsed or modulated electric field is delivered to crypts of the mucosa of the duodenum”, overcome the previous rejection as Nagale does not teach or suggest delivering a pulsed or modulated electric field to crypts of the duodenal mucosa, nor does Nagale teach delivering the electric field to the submucosa and mucosa of a duodenum. In response to applicant's argument, the examiner notes that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Nagale discloses the system comprising the signal generator configured to deliver a pulsed waveform to the electrode array of the pulsed electric field device to generate a pulsed or modulated electric field to treat tissue ([0042]; the ablation electrodes are electrically coupled to the energy source; the energy source may be configured to deliver IRE energy), Nagale further discloses that “Although embodiments of the present disclosure are described with specific reference to systems and methods for mapping and ablating overactive tissue(s) within the bladder, it should be appreciated that the present disclosure may be applicable to mapping and ablating a variety of organs, including, for example, the gastrointestinal (GI) tract, stomach (e.g., irritable bowel disease, cancer, obesity etc.), uterus (e.g., fibroids, uterine bleeding etc.), esophagus, heart and vascular system” in [0024]; Although Nagale does not explicitly disclose delivering the IRE energy to the crypts of the mucosa of the duodenum and to submucosa and mucosa of a duodenum, Nagale does disclose that the device is capable of delivering the pulsed or modulated waveform to ablate a variety of organs such as the gastrointestinal (GI) tract, and as it is known that the duodenum is part of the GI tract it is the examiners position that the system of Nagale would be capable of delivering the IRE energy to the crypts of the mucosa of the duodenum and to submucosa and mucosa of a duodenum.
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, 4, 6, 24-25, 27, & 29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nagale et al. (previously presented-US 20170035497 A1), hereinafter “Nagale”.
Regarding claim 1, Nagale discloses a tissue treatment system comprising: a pulsed electric field device comprising: an elongate body ([0028]; Figure 1—element 10); and an expandable member comprising a compressed configuration, an expanded configuration ([0028]; Figure 1—element 20), an electrode array ([0029]; Figure 1—element 40), and a fluid opening ([0037]; Figures 11A-11B—element 49), wherein, in the expanded configuration, the pulsed electric field device is configured to dilate tissue ([0033]; the expandable member 20 may be formed of a relatively rigid material that resists deformation as it compresses against tissue; it is the examiners position that the expandable member would be capable of dilating tissue) and to apply suction to the tissue via the fluid opening of the expandable member ([0037]); and a signal generator configured to deliver a pulse waveform to the electrode array to generate a pulsed or modulated electric field to treat the tissue, wherein the tissue comprises mucosa and submucosa of a duodenum, and wherein the generated pulsed or modulated electric field is delivered to crypts of the mucosa of the duodenum ([0024], [0042], & [0047]; “the present disclosure may be applicable to mapping and ablating a variety of organs, including, for example, the gastrointestinal (GI) tract, stomach”; the electrodes may be coupled to an energy source; various energy sources may be used (e.g. IRE energy); as the system is capable of ablating a variety of organs including the gastrointestinal (GI) tract (which is known to contain the duodenum) it is the examiners position that the system would be capable of delivering the pulsed or modulated electric field to the mucosa and submucosa of a duodenum and to the crypts of the mucosa of the duodenum).
Regarding claim 4, Nagale discloses all of the limitations of claim 1, as described above.
Nagale further discloses wherein the pulsed electric field device is configured to dilate one or more of mucosa and submucosa of a duodenum ([0033]; the expandable member 20 may be formed of a relatively rigid material that resists deformation as it compresses against tissue; it is the examiners position that the expandable member would be capable of dilating one or more of mucosa and submucosa of a duodenum).
Regarding claim 6, Nagale discloses all of the limitations of claim 1, as described above.
Nagale further discloses wherein the fluid opening is between adjacent electrodes of a plurality of electrodes of the electrode array ([0037]; Figures 11A-11C—elements 40 & 49).
Regarding claim 24, Nagale discloses a pulsed electric field device ([0042] & [0047]) comprising: an elongate body ([0028]; Figure 1—element 10); and an expandable member comprising a compressed configuration, an expanded configuration ([0028]; Figure 1—element 20), an electrode array ([0029]; Figure 1—element 40), and a fluid opening ([0037]; Figures 11A-11B—element 49), wherein, in the expanded configuration, the pulsed electric field device is configured to dilate tissue ([0033]; the expandable member 20 may be formed of a relatively rigid material that resists deformation as it compresses against tissue; it is the examiners position that the expandable member would be capable of dilating tissue) and to suction tissue to the expandable member via the fluid opening ([0037]); wherein the tissue comprises mucosa and submucosa of a duodenum, and wherein the generated pulsed or modulated electric field is delivered to crypts of the mucosa of the duodenum ([0024], [0042], & [0047]; “the present disclosure may be applicable to mapping and ablating a variety of organs, including, for example, the gastrointestinal (GI) tract, stomach”; as the system is capable of ablating a variety of organs including the gastrointestinal (GI) tract (which is known to contain the duodenum) it is the examiners position that the system would be capable of delivering the pulsed or modulated electric field to the mucosa and submucosa of a duodenum and to the crypts of the mucosa of the duodenum).
Regarding claim 25, Nagale discloses all of the limitations of claim 24, as described above.
Nagale further discloses wherein the expandable member comprises a flexible circuit ([0029]).
Regarding claim 27, Nagale discloses all of the limitations of claim 24, as described above.
Nagale further discloses wherein the expandable member is configured to dilate mucosa and submucosa tissue of a duodenum in the expanded configuration ([0033]; the expandable member 20 may be formed of a relatively rigid material that resists deformation as it compresses against tissue; it is the examiners position that the expandable member would be capable of dilating one or more of mucosa and submucosa of a duodenum).
Regarding claim 29, Nagale discloses all of the limitations of claim 24, as described above.
Nagale further discloses wherein the wherein the fluid opening is between adjacent electrodes of a plurality of electrodes of the electrode array ([0037]; Figures 11A-11C—elements 40 & 49).
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.
Claims 2-3, 26, & 30 are rejected under 35 U.S.C. 103 as being unpatentable over Nagale in view of Viswanathan et al. (previously presented-US 20180311497 A1), hereinafter “Viswanathan”.
Regarding claims 2-3, Nagale discloses all of the limitations of claim 1, as described above.
Nagale does not disclose proximal and distal dilators coupled to the elongate body, wherein the expandable member is disposed between the proximal and distal dilators.
Viswanathan teaches a pulsed electric field device comprising an expandable member comprising a compressed configuration, an expanded configuration ([0040] & [0087]; Figure 3B—element 320), an electrode array ([0091]; Figure 3B—element 320), and proximal and distal dilators coupled to the elongate body, wherein the expandable member is disposed between the proximal and distal dilators (claim 2)([0086] & [0088]; Figure 3B—elements 360 & 362); wherein a maximum diameter of at least one of the proximal and distal dilators is equal to or greater than an outer diameter of the expandable member in the compressed configuration (claim 3) ([0089] & [0097]).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the pulsed electric field device, as disclosed by Nagale, to include proximal and distal dilators coupled to the elongate body wherein the expandable member is disposed between the proximal and distal dilators, as taught by Viswanathan, as both references and the claimed invention are directed toward pulsed electric field devices comprising expandable assemblies. As disclosed by Viswanathan, the proximal and distal balloons may aid in stabilizing and fixing the position of the expandable assembly relative to target tissue ([0089]). 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 pulsed electric field device, as disclosed by Nagale, to include proximal and distal dilators coupled to the elongate body wherein the expandable member is disposed between the proximal and distal dilators, as taught by Viswanathan, as such a modification would further aid in stabilizing and fixing the position of the expandable assembly relative to target tissue.
Regarding claim 26, Nagale discloses all of the limitations of claim 24, as described above.
Nagale does not disclose proximal and distal dilators coupled to the elongate body, wherein the expandable member is disposed between the proximal and distal dilators.
Viswanathan teaches a pulsed electric field device comprising an expandable member comprising a compressed configuration, an expanded configuration ([0040] & [0087]; Figure 3B—element 320), an electrode array ([0091]; Figure 3B—element 320), and proximal and distal dilators coupled to the elongate body, wherein the expandable member is disposed between the proximal and distal dilators ([0086] & [0088]; Figure 3B—elements 360 & 362).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the pulsed electric field device, as disclosed by Nagale, to include proximal and distal dilators coupled to the elongate body wherein the expandable member is disposed between the proximal and distal dilators, as taught by Viswanathan, as both references and the claimed invention are directed toward pulsed electric field devices comprising expandable assemblies. As disclosed by Viswanathan, the proximal and distal balloons may aid in stabilizing and fixing the position of the expandable assembly relative to target tissue ([0089]). 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 pulsed electric field device, as disclosed by Nagale, to include proximal and distal dilators coupled to the elongate body wherein the expandable member is disposed between the proximal and distal dilators, as taught by Viswanathan, as such a modification would further aid in stabilizing and fixing the position of the expandable assembly relative to target tissue.
Regarding claim 30, Nagale discloses all of the limitations of claim 24, as described above.
Nagale does not disclose wherein the pulsed electric field device further comprises a handle coupled to the elongate body and wherein the handle is configured to transition the expandable member between a rolled configuration and an unrolled configuration.
Viswanathan teaches a pulsed electric field device comprising an expandable member comprising a compressed configuration, an expanded configuration ([0040] & [0087]; Figure 3B—element 320); a handle coupled to the elongate body and wherein the handle is configured to transition the expandable member between a rolled configuration and an unrolled configuration ([0065]; the device may include a handle that is coupled to the expandable member to transform the expandable member between a compressed and expanded configuration; the examiner is considering the rolled configuration to be the compressed configuration and the unrolled configuration to be the expanded configuration).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the pulsed electric field device, as disclosed by Nagale, to include a handle configured to transition the expandable member between a rolled configuration and an unrolled configuration, as taught by Viswanathan, as both references and the claimed invention are directed toward pulsed electric field devices comprising expandable assemblies. As disclosed by Nagale, the expandable member is configured to transition between an expanded and collapsed configuration ([0028]). As disclosed by Viswanathan, the device may include a handle that is configured to affect transforming the expandable member between a first collapsed configuration and second expanded configuration ([0065]). 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 pulsed electric field device, as disclosed by Nagale, to include a handle configured to transition the expandable member between a rolled configuration and an unrolled configuration, as taught by Viswanathan, as such a modification would allow for a user to manipulate the expandable member in order to transition the expandable member between a collapsed and expanded configuration.
Claims 5 & 28 are rejected under 35 U.S.C. 103 as being unpatentable over Nagale in view of Stankus et al. (previously presented-US 20130138081 A1), hereinafter “Stankus”.
Regarding claim 5, Nagale discloses all of the limitations of claim 4, as described above.
Nagale further discloses wherein the pulsed electric field device is configured to dilate one or more of mucosa and submucosa of the duodenum ([0033]; the expandable member 20 may be formed of a relatively rigid material that resists deformation as it compresses against tissue; it is the examiners position that the expandable member would be capable of dilating one or more of mucosa and submucosa of a duodenum).
Nagale does not disclose a ratio of dilated to undilated tissue is between about 0.40 and about 0.60, and a ratio of dilated to undilated tissue is between about 0.15 and about 0.35.
Stankus teaches an expandable member configured to dilate a vessel ([0048] & [0067]; Figure 2—elements 30/40) such that a ratio of dilated to undilated tissue is between about 0.40 and about 0.60, and a ratio of dilated to undilated tissue is between about 0.15 and about 0.35 ([0050]; the luminal area occupied by the expandable member when expended against the luminal vessel wall is between 1 to 50%).
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 Nagale, to include the expandable member configured to dilate the vessel such that a ratio of dilated to undilated tissue is between about 0.40 and about 0.60, and a ratio of dilated to undilated tissue is between about 0.15 and about 0.35, as taught by Stankus, as both references and the claimed invention are directed toward therapeutic devices comprising expandable assemblies for engaging a vessel wall. As disclosed by Stankus, the expandable member preferably has an expandable member to vessel ratio, which represents the percent of the luminal area occupied by the expandable member when expanded against the luminal vessel wall, between 1 and 50% ([0050]). 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 Nagale, to include the expandable member configured to dilate the vessel such that a ratio of dilated to undilated tissue is between about 0.40 and about 0.60, and a ratio of dilated to undilated tissue is between about 0.15 and about 0.35, as taught by Stankus, as such a modification would provide for a suitable and known expandable member to vessel ratio in order to engage a vessel wall. The examiner further notes that it would have been obvious to one having ordinary skill in the art at the time the invention was made to include a ratio of dilated to undilated mucosa of the duodenum is between about 0.40 and about 0.60, and a ratio of dilated to undilated submucosa of the duodenum is between about 0.15 and about 0.35, 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 28, Nagale discloses all of the limitations of claim 27, as described above.
Nagale further discloses wherein the expandable member is configured to dilate one or more of mucosa and submucosa of the duodenum ([0033]; the expandable member 20 may be formed of a relatively rigid material that resists deformation as it compresses against tissue; it is the examiners position that the expandable member would be capable of dilating one or more of mucosa and submucosa of a duodenum).
Nagale does not disclose a ratio of dilated to undilated tissue is between about 0.40 and about 0.60, and a ratio of dilated to undilated tissue is between about 0.15 and about 0.35.
Stankus teaches an expandable member configured to dilate a vessel ([0048] & [0067]; Figure 2—elements 30/40) such that a ratio of dilated to undilated tissue is between about 0.40 and about 0.60, and a ratio of dilated to undilated tissue is between about 0.15 and about 0.35 ([0050]; the luminal area occupied by the expandable member when expended against the luminal vessel wall is between 1 to 50%).
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 Nagale, to include the expandable member configured to dilate the vessel such that a ratio of dilated to undilated tissue is between about 0.40 and about 0.60, and a ratio of dilated to undilated tissue is between about 0.15 and about 0.35, as taught by Stankus, as both references and the claimed invention are directed toward therapeutic devices comprising expandable assemblies for engaging a vessel wall. As disclosed by Stankus, the expandable member preferably has an expandable member to vessel ratio, which represents the percent of the luminal area occupied by the expandable member when expanded against the luminal vessel wall, between 1 and 50% ([0050]). 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 Nagale, to include the expandable member configured to dilate the vessel such that a ratio of dilated to undilated tissue is between about 0.40 and about 0.60, and a ratio of dilated to undilated tissue is between about 0.15 and about 0.35, as taught by Stankus, as such a modification would provide for a suitable and known expandable member to vessel ratio in order to engage a vessel wall. The examiner further notes that it would have been obvious to one having ordinary skill in the art at the time the invention was made to include a ratio of dilated to undilated mucosa of the duodenum is between about 0.40 and about 0.60, and a ratio of dilated to undilated submucosa of the duodenum is between about 0.15 and about 0.35, 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.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Nagale in view of Soden et al. (previously presented-US 20150328449 A1), hereinafter “Soden”.
Regarding claim 7, Nagale discloses all of the limitations of claim 4, as described above.
Nagale further discloses wherein the system is configured to apply suction to the tissue ([0037]).
Nagale does not disclose suction at a pressure of about 10 mmHg and about 200 mmHg.
Soden teaches a pulsed electric field device configured to apply suction to tissue ([0083]; Figure 1—element 10) at a pressure of about 10 mmHg and about 200 mmHg ([0145]; a pressure between 0 and 700mmHg is employed to grip 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 suction, as disclosed by Nagale, to include the suction at a pressure of about 10 mmHg and about 200 mmHg, as taught by Soden, as both references and the claimed invention are directed toward pulsed electric field devices configured to apply suction to grip tissue. As disclosed by Nagale, the device is configured to apply suction to tissue to hold tissue in place ([0037]). As disclosed by Soden, the device is configured to apply suction to tissue at a pressure between 0 and 700mmHg to hold and grip tissue. 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 suction, as disclosed by Nagale, to include the suction at a pressure of about 10 mmHg and about 200 mmHg, as taught by Soden, as such a modification would provide for a suitable and known suction pressure in order to produce the predictable result of holding tissue in place. The examiner further notes that it would have been obvious to one having ordinary skill in the art at the time the invention was made to include to include the suction at a pressure of about 10 mmHg and about 200 mmHg, 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.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Nagale in view of Long (previously presented-US 20160100879 A1), hereinafter “Long”, and Jaafar (previously presented-US 20010044596 A1), hereinafter “Jaafar”.
Regarding claim 8, Nagale discloses all of the limitations of claim 1, as described above.
Nagale further discloses wherein the signal generator is configured to deliver the pulse waveform to the electrode array to generate the pulsed or modulated electric field configured to generate cell lysis ([0042] & [0047]; the electrodes may be coupled to an energy source; various energy sources may be used (e.g. IRE energy)).
Nagale does not disclose limiting thermal heating of tissue to less than 13°C up to a tissue depth of about 1.5 mm.
Long teaches a pulsed electric field device configured to deliver a pulse waveform that is configured to limit thermal heating of tissue to less than 13°C ([0118]; a series of electrical pulses may be delivered to target tissue to induce IRE, the IRE dose may increase the temperature of tissue by a few degrees such as 0-10°C).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the pulsed or modulated electric field, as disclosed by Nagale, to include the pulsed or modulated electric field parameters for limiting thermal heating of tissue to less than 13°C, as taught by Long, as both references and the claimed invention are directed toward pulsed electric field devices for delivering a pulse waveform to tissue. As disclosed by Nagale, the device may deliver IRE energy to tissue ([0042]). As disclosed by Long, the device may deliver a series of pulses to induce IRE, such that the IRE dose may increase the temperature of tissue by a few degrees (e.g. 0-10°C) over a period of time ([0118]). 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 pulsed or modulated electric field, as disclosed by Nagale, to include the pulsed or modulated electric field parameters for limiting thermal heating of tissue to less than 13°C, as taught by Long, as such a modification would provide for a known and suitable thermal limit for inducing IRE. The examiner further notes that it would have been obvious to one having ordinary skill in the art at the time the invention was made to include to include the limiting of thermal heating of tissue to less than 13°C, 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.
Jaafar teaches a pulsed electric field device configured to deliver a pulse waveform that is configured to generate cell lysis up to a tissue depth of about 1.5 mm ([0016]).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the pulsed or modulated electric field, as disclosed by Nagale, to include the pulsed or modulated electric field parameters configured to generate cell lysis up to a tissue depth of about 1.5 mm, as taught by Jaafar, as both references and the claimed invention are directed toward pulsed electric field devices for delivering a pulse waveform to tissue. As disclosed by Nagale, the device may deliver IRE energy to tissue ([0042]). As disclosed by Jaafar, the device may deliver electroporation energy to tissue to inflict irreversible damage, the amplitude of the electric pulses may be selected to provide the electric field and pulse duration product above an upper electroporation limit at a depth of 1mm or less into vascular tissue so as to kill smooth muscle cells in the cylindrical layer of vascular tissue about 1 mm thick, while only causing temporary reversible changes to vascular tissue beyond 1 mm ([0015] & [0016]). 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 pulsed or modulated electric field, as disclosed by Nagale, to include the pulsed or modulated electric field parameters configured to generate cell lysis up to a tissue depth of about 1.5 mm, as taught by Jaafar, as such a modification would provide for a known and suitable tissue depth for generating cell lysis so as to kill smooth muscle cells in the cylindrical layer of vascular tissue about 1mm thick, while only causing temporary reversible changes to vascular tissue beyond 1 mm. The examiner further notes that it would have been obvious to one having ordinary skill in the art at the time the invention was made to include the pulsed or modulated electric field parameters configured to generate cell lysis up to a tissue depth of about 1.5 mm, 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.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Nagale in view of Fraasch et al. (previously presented-US 20200138506 A1; effectively filed 11/07/2018), hereinafter “Fraasch”.
Regarding claim 9, Nagale discloses all of the limitations of claim 1, as described above.
Nagale does not disclose wherein the pulse waveform comprises a power between 16,200 W and 96,800 W.
Fraasch teaches a pulsed electric field device configured to deliver a pulse waveform ([0085]), wherein the pulse waveform comprises a power between 16,200 W and 96,800 W ([0013]; pulse field ablation therapy can deliver an enormous amount of power over short period of time (e.g. dozens of kilowatts in pulses)).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the pulsed or modulated electric field, as disclosed by Nagale, to include wherein the pulse waveform comprises a power between 16,200 W and 96,800 W, as taught by Fraasch, as both references and the claimed invention are directed toward pulsed electric field devices for delivering a pulse waveform to tissue. As disclosed by Fraasch, pulse field ablation therapy can deliver an enormous amount of power over short period of time (e.g. dozens of kilowatts in pulses) ([0013]). 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 pulsed or modulated electric field, as disclosed by Nagale, to include wherein the pulse waveform comprises a power between 16,200 W and 96,800 W, as taught by Fraasch, as such a modification would provide for a known and suitable energy delivery parameters for delivering PFA therapy. The examiner further notes that it would have been obvious to one having ordinary skill in the art at the time the invention was made to include wherein the pulse waveform comprises a power between 16,200 W and 96,800 W, 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.
Conclusion
Accordingly, claims 1-9 & 24-30 are rejected.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARINA D TEMPLETON whose telephone number is (571)272-7683. The examiner can normally be reached M-F 8:00am to 5:00pm EST.
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/M.D.T./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794