DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 28th, 2026 has been entered.
Response to Amendment
The amendment filed April 28th, 2026 has been entered. Claims 1, 8-9, 24, & 26-30 are amended. Claim 25 is canceled. Claims 31-37 are new. Claims 1-24 & 26-37 remain pending; claims 10-23 are withdrawn from further consideration.
Response to Arguments
Applicant’s arguments with respect to claims 1-9, 24, & 26-37 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument; as necessitate by amendment.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 4, 6, & 31-33 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Asirvatham et al. (US 20210059759 A1), in light of Burnett (US 20210251677 A1), hereinafter “Burnett”.
Regarding claim 1, Asirvatham discloses a tissue treatment system for treating a patient's duodenum, wherein the duodenum comprises mucosa and submucosa layers ([0016]), comprising: a pulsed electric field device comprising: an elongate body ([0039]; Figure 3—element 40); and an expandable member comprising a compressed configuration, an expanded configuration ([0038]; Figure 3—element 44), an electrode array ([0038]; Figure 3—element 48), and a fluid opening ([0038]; Figure 3—element 46), wherein, in the expanded configuration, the pulsed electric field device is configured to dilate tissue and to apply suction to the tissue via the fluid opening of the expandable member ([0028], [0040], & [0042]; Figure 3—elements 44 & 46; it is the examiner position that the balloon 44 would be capable of dilating tissue when in the expanded position); and a signal generator configured to deliver a therapeutically beneficial amount of electroporation energy to the electrode array and wherein the electrode array is configured to deliver the therapeutically beneficial amount of electroporation energy to a target region including at least the mucosa layer of the duodenum, wherein the signal generator is configured to deliver the therapeutically beneficial amount of electroporation energy to induce apoptosis in at least some of the cells within the target region, wherein the induced apoptosis is not due to heating, while maintaining tissue scaffolding and cellular structure within at least some of the cells induced to apoptosis, and wherein the delivered therapeutically beneficial amount of electroporation energy is configured to modulate an inflammation cell response at the target region and modulate a macrophage response at the target region ([0004], [0011], [0031], [0037], [0041], [0043], & [0050]; Figure 3—elements 48 & 50; the device can be passed through the stomach or duodenum of a patient; the electrodes are used to produce an electric field 50; the electrodes can perform irreversible electroporation or reversible electroporation and trigger cell death by the process of apoptosis rather than necrosis; although, Asirvatham is silent to the delivered therapeutically beneficial amount of electroporation energy configured to modulate an inflammation cell response at the target region and modulate a macrophage response at the target region, this process is a known result of apoptosis, in light of the teachings of Burnett, Burnett teaches that it is known for cells that undergo apoptotic mediated cell death to be subsequently cleared by macrophages and that apoptosis does not induce a host immune response, therefore reducing the risk of chronic inflammation ([0083]).
Regarding claim 4, Asirvatham, in light of Burnett, discloses all of the limitations of claim 1, as described above.
Asirvatham further discloses wherein the pulsed electric field device is configured to dilate one or more of mucosa and submucosa of a duodenum ([0011], [0031], & [0038]; the device may be delivered to the duodenum; it is the examiners position that the balloon, in the expanded configuration, would be capable of dilating one or more of mucosa and submucosa of a duodenum if so positioned).
Regarding claim 6, Asirvatham, in light of Burnett, discloses all of the limitations of claim 1, as described above.
Asirvatham further discloses wherein the fluid opening is between adjacent electrodes of a plurality of electrodes of the electrode array ([0038]; Figure 3—elements 46 & 48).
Regarding claim 31, Asirvatham, in light of Burnett, discloses all of the limitations of claim 1, as described above.
Asirvatham further discloses wherein the electroporation energy comprises irreversible electroporation energy ([0016]).
Regarding claim 32, Asirvatham, in light of Burnett, discloses all of the limitations of claim 1, as described above.
Asirvatham further discloses wherein the electroporation energy comprises reversible electroporation energy ([0016]).
Regarding claim 33, Asirvatham, in light of Burnett, discloses all of the limitations of claim 1, as described above.
Asirvatham further discloses wherein the expandable member comprises an inflatable balloon ([0038]).
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 are rejected under 35 U.S.C. 103 as being unpatentable over Asirvatham, in light of Burnett, and in view of Viswanathan et al. (previously presented-US 20180311497 A1), hereinafter “Viswanathan”.
Regarding claims 2-3, Asirvatham, in light of Burnett, discloses all of the limitations of claim 1, as described above.
Asirvatham does not disclose proximal and distal dilators coupled to the elongate body, wherein the expandable member is disposed between the proximal and distal dilators (claim 2); 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).
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 Asirvatham, 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 Asirvatham, 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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Asirvatham, in light of Burnett, and in view of Stankus et al. (previously presented-US 20130138081 A1), hereinafter “Stankus”.
Regarding claim 5, Asirvatham, in light of Burnett, discloses all of the limitations of claim 4, as described above.
Asirvatham further discloses wherein the pulsed electric field device is configured to dilate one or more of mucosa and submucosa of the duodenum ([0011]).
Asirvatham 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 Asirvatham, 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 Asirvatham, 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 Asirvatham, in light of Burnett, and in view of Soden et al. (previously presented-US 20150328449 A1), hereinafter “Soden”.
Regarding claim 7, Asirvatham, in light of Burnett, discloses all of the limitations of claim 1, as described above.
Asirvatham further discloses wherein the system is configured to apply suction to the tissue ([0038]).
Asirvatham 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 Asirvatham, 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 Asirvatham, the device is configured to apply suction to tissue to collapse the tissue around the balloon ([0011] & [0038]). 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 Asirvatham, 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 9 is rejected under 35 U.S.C. 103 as being unpatentable over Asirvatham, in light of Burnett, and in view of Fraasch et al. (previously presented-US 20200138506 A1; effectively filed 11/07/2018), hereinafter “Fraasch”.
Regarding claim 9, Asirvatham, in light of Burnett, discloses all of the limitations of claim 1, as described above.
Asirvatham does not disclose wherein the therapeutically beneficial amount of electroporation energy 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 Asirvatham, 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 Asirvatham, 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.
Allowable Subject Matter
Claim 8 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 24, 26-30, & 34-37 are allowed.
The following is a statement of reasons for the indication of allowable subject matter:
Dependent claim 8 recites the limitation “wherein the signal generator is configured to limit thermal heating of tissue within the target region to less than 13°C up to a tissue depth of about 1.5 mm”. The Long reference (previously presented-US 20160100879 A1) provides a teaching for limiting 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). The Jaafar reference (previously presented-US 20010044596 A1) provides a teaching for up to a tissue depth of about 1.5 mm ([0016]); however neither of these references, nor the Asirvatham reference disclose the combination of the “a therapeutically beneficial amount of electroporation energy to the electrode array wherein the signal generator is configured to deliver the therapeutically beneficial amount of electroporation energy to induce apoptosis in at least some of the cells within the target region, wherein the induced apoptosis is not due to heating, while maintaining tissue scaffolding and cellular structure within at least some of the cells induced to apoptosis, and wherein the delivered therapeutically beneficial amount of electroporation energy is configured to modulate an inflammation cell response at the target region and modulate a macrophage response at the target region” (as required by claim 1) and also “wherein the signal generator is configured to limit thermal heating of tissue within the target region to less than 13°C up to a tissue depth of about 1.5 mm” (as required by claim 8). The examiner notes the no other reference or combination of references have been found to disclose fairly suggest or make obvious each and every limitation set forth in dependent claim 8. Independent claim 24 is indicated as allowed for substantially the same rationale as dependent claim 8. Dependent claims 26-30, & 34-37 are also indicated as allowed as they depend from independent claim 24.
Conclusion
Accordingly, claims 1-7, 9, & 31-33 are rejected. Claim 8 is objected to as being dependent upon a rejected base claim. Claims 24, 26-30, & 34-37 are allowed.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.D.T./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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