DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/12/2025 (“11/12/25 Amendment") has been entered, and fully considered.
Response to Amendment
3. In the 11/12/25 Amendment, claims 1-20 were amended. No claims were cancelled, or newly added. Therefore, claims 1-20 remain pending in the application.
4. The 11/12/25 Amendment has overcome the claim objection previously set forth in the Final Office Action mailed 07/14/25 (“07/14/25 Action”).
5. The prior rejection of independent claim 1 under § 103 has been updated to address the new claim limitations, and maintained. Applicant’s arguments are addressed in detail below in the “Response to Arguments” section.
6. New rejections under § 112(d) are set forth herein, necessitated by Applicant’s Amendment.
Claim Rejections - 35 USC § 112(d)
7. The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
8. Claim 11 is rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
9. In the 11/12/25 Amendment, claim 11 was amended to recite:
11. The method of claim , wherein the handle comprises an actuator, further comprising manipulating the actuator so that the probe tip moves between (i) a retracted position wherein the probe tip resides within the distal end of the instrument to (ii) an exposed position wherein the probe tip resides beyond the distal end of the instrument.
10. As amended, claim 11 fails to depend from another claim, and therefore fails to further limit the subject matter of another claim.
11. Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
12. For purposes of examination, dependent claim 11 will be treated as depending from dependent claim 8.
Claim Rejections - 35 USC § 103
13. 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.
14. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
15. Claims 1-4, 7-15, & 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2019/0223943 to Forsyth et al. (“Forsyth”) in view of U.S. Patent No. 10,136,943 to Cosman, Jr. et al. (“Cosman”).
16. Regarding claim 1, Forsyth teaches a method of treating a patient having a mass of undesired tissue [a tumor (720) - ¶’s [0075], [0076]], the method comprising:
advancing a distal end [distal tip (704) - ¶[0076]; FIGS. 14A-14B] of an instrument [cannula (700) - ¶[0076]; FIGS. 14A-14B] into a luminal structure of a body of the patient [see ¶[0076] (“the distal tip 704 may be blunted to allow atraumatic passage through a body lumen such as a biliary duct, lymph vessel or duct, urethra, mammary duct, digestive passageway, blood vessel, or other body passageway, as the case may be”)], wherein the instrument [(700)] includes (i) an energy delivery body [any of electrodes (706) comprises an energy delivery body - ¶’s [0020], [0077]; FIGS. 14A-14B] extendible from the distal end [(704)] of the instrument [e.g., ¶’s [0018], [0020], [0077], claim 1; FIGS. 14A-14B] and (ii) a handle disposed near a proximal end of the instrument [as broadly as claimed, the proximal end of cannula (700) may be grasped by a user, thereby serving as a “handle”], wherein the energy delivery body is configured to deliver pulsed electric field energy [irreversible electroporation (“IRE”) pulses - ¶’s [0072], [0079], [0080]] toward the mass of undesired tissue [¶’s [0078], [0079]; FIGS. 14A-14B], wherein the pulsed electric field energy comprises packets [pulse sets, e.g., ¶[0073]] of biphasic pulses [¶[0083]];
***
positioning a return electrode on the patient [external return electrode (740) - ¶’s [0078], [0079]; FIGS. 14A-14B];
***
delivering the pulsed electric field energy [IRE] via the energy delivery body in a monopolar fashion utilizing the return electrode to the mass of undesired tissue electrode [(740)] [see ¶[0078] (“a first lesion field is generated at 770 by the use of a monopolar thermal or IRE therapy delivery using the needle electrodes 706 and an external return electrode 740”); note also ¶’s [0078], [0080]] so as to cause at least priming of cells of the mass of undesired tissue for premature death [e.g., ¶’s [0074], [0080]; NOTE: the recitation of “at least priming” is being interpreted as priming of cells for premature death, or worse (i.e., cell death);]
A. Using the Handle to Extend the Energy Delivery Body
The relied-upon embodiment of Forsyth does not explicitly teach:
using the handle to cause the energy delivery body [(706)] to extend from the distal end of the instrument [(700)] for delivering the pulsed electric field energy toward the mass of undesired tissue.
However, Forsyth, in a separate embodiment [FIG. 7], teaches a handle that allows for extension of the energy delivery body [see ¶[0068] (“FIG. 7 shows an illustrative system. The system 400 includes a therapy device 410 having a relatively complex handle structure including individual actuators 410 for manipulating the tissue piercing electrodes (individually, as groups, or as the entire array) at the distal tip of the apparatus…”); see also ¶’s [0017], [0019], [0083]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify the relied-upon embodiment of Forsyth to include a handle that enables use thereof to cause the energy delivery body [(706)] to extend from the distal end of the instrument [(700)] for delivering the pulsed electric field energy toward the mass of undesired tissue, since such a modification would provide a practitioner with a convenient manner by which to easily control deployment/retraction of the energy delivery body, thereby facilitating the procedure for the practitioner.
B. Electrical Connection
Forsyth (as modified) does not teach:
mating a distal end of an energy plug having an exposed connection wire to the handle so that the exposed connection wire makes contact with an inner lumen of the energy delivery body in a manner that allows transmission of pulsed electric field energy from a generator to the energy delivery body while a proximal end of the energy plug is connected to the generator.
Cosman, in a similar field of endeavor, relates generally to a system and method for applying energy, particularly high-frequency (HF) energy, to a living body for the purpose of tissue ablation [col. 1, ll. 16-22; see also col. 2, ll. 49-52 (“Another example of probes for high-frequency tissue ablation includes microwave (MW) antennae. Another example of probes for tissue ablation are irreversible-electroporation (IRE) probes”)].
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FIG. 7C OF COSMAN
With reference to FIGS. 7A-7C, Cosman teaches that it was known to mate a distal end of an energy plug [(782A); FIG. 7C] having an exposed connection wire [wire (750); FIG. 7C] to a handle [broadly, proximal hub (782) may be grasped by a user, thereby serving as a “handle”] so that the exposed connection wire [(750)] makes contact with an inner lumen of the energy delivery body [to conductive shaft tube (787) at junction (751); FIG. 7C] in a manner that allows transmission of energy from a generator [via generator connection wire (784) having a connector (784A); FIG. 7B] to the energy delivery body [(787)] while a proximal end of the energy plug is connected to the generator [via connector (784A); FIG. 7B] [see, e.g., col. 28, line 60 - col. 29, line 2; col. 29, line 29 - col. 30, line 17; FIGS. 7A-7C].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify Forsyth, which teaches tissue penetrating electrodes passing through a cannula shaft that include inner fluid delivery lumens there-through [e.g., ¶’s [0010], [0020]] to utilize a known, art-recognized configuration for energizing such electrodes, including, e.g., mating a distal end of an energy plug having an exposed connection wire to the handle so that the exposed connection wire makes contact with an inner lumen of the energy delivery body in a manner that allows transmission of pulsed electric field energy from a generator to the energy delivery body while a proximal end of the energy plug is connected to the generator, since such a particular known energy-transmission technique was recognized as part of the ordinary capabilities of one skilled in the art (as demonstrated by Cosman), and one of ordinary skill in the art would have been capable of applying this known technique to the known device of Forsyth, and the results [energizing an electrode via an exposed connection wire joined to an inner lumen thereof at the handle] would have been entirely predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Further, such a modification would provide the benefit/advantage of simplifying the design of Forsyth by eliminating the need to run a conductor for an extendable electrode along the entire length of the device.
17. Regarding claim 2, the combination of Forsyth and Cosman teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Forsyth further teaches:
delivering an additional therapy to the patient, wherein the additional therapy comprises radiotherapy, chemotherapy, immunotherapy, targeted therapy, focal therapy, gene therapy, plasmid therapy, or a combination thereof [NOTE: Applicant defines “focal therapies” as therapies comprising the delivery of treatment with thermal energies to cause thermal ablation, examples of which include radiofrequency ablation (RFA), microwave ablation (MWA), & High-Intensity Focused Ultrasound (HIFU) – see Applicant’s as-filed Specification at, e.g., ¶’s [00126], [00223], [00362], & [00370]. Forsyth discloses delivering an additional therapy to the patient comprising a focal therapy. For example, Forsyth discloses the use of IRE in combination with additional therapies such as thermal ablation – see Forsyth, e.g., ¶[0005] (“The present inventors have also recognized that it may be desirable for a physician to be able to combine IRE and one or more additional therapies such as thermal ablation”); ¶[0073] (“In some examples, IRE and thermal treatments are combined into one overall therapy regimen as by, for example, alternating between pulses of longer duration (which generate thermal effects) and shorter duration (which generate IRE-type effects) within a therapy pulse set”); ¶’s [0079], [0080], & ¶[0088] (“The method of FIG. 16, as well as any other of the examples herein, may be further combined with additional therapy elements, such as for example, the delivery of a laser ablation (by, for example, inserting a separate optical instrument or including one or more optical fibers in a therapy apparatus similar to those shown above). For example, an optical therapy apparatus may be inserted and used to perform laser-based ablation, with IRE then delivered via electrodes on the laser apparatus to mitigate tract seeding. Ultrasound or other vibrational therapy may be added as well. For example, rather than an electrical therapy as the “thermal” therapy, followed by IRE to deal with tract seeding possibilities, an ultrasound instrument may be provided and used in a first step, with electrodes provided thereon to allow use of IRE to complete the procedure prior to withdrawal of the ultrasound instrument”)],
wherein the delivering the pulsed electric field energy occurs prior to the delivering the additional therapy [see ¶’s [0073], [0074] (“In another example, IRE is used before thermal output. IRE can reduce impedance in affected tissue. By first reducing impedance, the thermal output of a subsequent stage can generate a greater quantity of thermal affect with reduced voltage output, as the lowered impedance allows higher current at a given voltage, where it is recognized that the square of the current yields the heating effect of a given therapy”); and ¶’s [0079], [0080]].
18. Regarding claim 3, the combination of Forsyth and Cosman teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Forsyth further teaches:
delivering an additional therapy to the patient, wherein the additional therapy comprises radiotherapy, chemotherapy, immunotherapy, targeted therapy, focal therapy, gene therapy, plasmid therapy, or a combination thereof [NOTE: Applicant defines “focal therapies” as therapies comprising the delivery of treatment with thermal energies to cause thermal ablation, examples of which include radiofrequency ablation (RFA), microwave ablation (MWA), & High-Intensity Focused Ultrasound (HIFU) – see Applicant’s as-filed Specification at, e.g., ¶’s [00126], [00223], [00362], & [00370]. Forsyth discloses delivering an additional therapy to the patient comprising a focal therapy. For example, Forsyth discloses the use of IRE in combination with additional therapies such as thermal ablation – see Forsyth, e.g., ¶[0005] (“The present inventors have also recognized that it may be desirable for a physician to be able to combine IRE and one or more additional therapies such as thermal ablation”); ¶[0073] (“In some examples, IRE and thermal treatments are combined into one overall therapy regimen as by, for example, alternating between pulses of longer duration (which generate thermal effects) and shorter duration (which generate IRE-type effects) within a therapy pulse set”); ¶’s [0079], [0080], & ¶[0088] (“The method of FIG. 16, as well as any other of the examples herein, may be further combined with additional therapy elements, such as for example, the delivery of a laser ablation (by, for example, inserting a separate optical instrument or including one or more optical fibers in a therapy apparatus similar to those shown above). For example, an optical therapy apparatus may be inserted and used to perform laser-based ablation, with IRE then delivered via electrodes on the laser apparatus to mitigate tract seeding. Ultrasound or other vibrational therapy may be added as well. For example, rather than an electrical therapy as the “thermal” therapy, followed by IRE to deal with tract seeding possibilities, an ultrasound instrument may be provided and used in a first step, with electrodes provided thereon to allow use of IRE to complete the procedure prior to withdrawal of the ultrasound instrument”)],
wherein delivering the pulsed electric field energy occurs after delivering the additional therapy [see ¶[0073] (“In another example, an IRE output is generated after a thermal output”); and ¶’s [0079], [0080]].
19. Regarding claim 4, the combination of Forsyth and Cosman teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Forsyth further teaches:
delivering an additional therapy to the patient, wherein the additional therapy comprises radiotherapy, chemotherapy, immunotherapy, targeted therapy, focal therapy, gene therapy, plasmid therapy, or a combination thereof [NOTE: Applicant defines “focal therapies” as therapies comprising the delivery of treatment with thermal energies to cause thermal ablation, examples of which include radiofrequency ablation (RFA), microwave ablation (MWA), & High-Intensity Focused Ultrasound (HIFU) – see Applicant’s as-filed Specification at, e.g., ¶’s [00126], [00223], [00362], & [00370]. Forsyth discloses delivering an additional therapy to the patient comprising a focal therapy. For example, Forsyth discloses the use of IRE in combination with additional therapies such as thermal ablation – see Forsyth, e.g., ¶[0005] (“The present inventors have also recognized that it may be desirable for a physician to be able to combine IRE and one or more additional therapies such as thermal ablation”); ¶[0073] (“In some examples, IRE and thermal treatments are combined into one overall therapy regimen as by, for example, alternating between pulses of longer duration (which generate thermal effects) and shorter duration (which generate IRE-type effects) within a therapy pulse set”); ¶’s [0079], [0080], & ¶[0088] (“The method of FIG. 16, as well as any other of the examples herein, may be further combined with additional therapy elements, such as for example, the delivery of a laser ablation (by, for example, inserting a separate optical instrument or including one or more optical fibers in a therapy apparatus similar to those shown above). For example, an optical therapy apparatus may be inserted and used to perform laser-based ablation, with IRE then delivered via electrodes on the laser apparatus to mitigate tract seeding. Ultrasound or other vibrational therapy may be added as well. For example, rather than an electrical therapy as the “thermal” therapy, followed by IRE to deal with tract seeding possibilities, an ultrasound instrument may be provided and used in a first step, with electrodes provided thereon to allow use of IRE to complete the procedure prior to withdrawal of the ultrasound instrument”)],
wherein the delivering the pulsed electric field energy occurs during a treatment session of the delivering the additional therapy [see ¶[0073] (“In some examples, IRE and thermal treatments are combined into one overall therapy regimen as by, for example, alternating between pulses of longer duration (which generate thermal effects) and shorter duration (which generate IRE-type effects) within a therapy pulse set”); and ¶’s [0079], [0080]].
20. Regarding claim 7, the combination of Forsyth and Cosman teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Forsyth further teaches:
delivering an additional therapy to the patient, wherein the additional therapy comprises radiotherapy, chemotherapy, immunotherapy, targeted therapy, focal therapy, gene therapy, plasmid therapy, or a combination of any of these [NOTE: Applicant defines “focal therapies” as therapies comprising the delivery of treatment with thermal energies to cause thermal ablation, examples of which include radiofrequency ablation (RFA), microwave ablation (MWA), & High-Intensity Focused Ultrasound (HIFU) – see Applicant’s as-filed Specification at, e.g., ¶’s [00126], [00223], [00362], & [00370]. Forsyth discloses delivering an additional therapy to the patient comprising a focal therapy. For example, Forsyth discloses the use of IRE in combination with additional therapies such as thermal ablation – see Forsyth, e.g., ¶[0005] (“The present inventors have also recognized that it may be desirable for a physician to be able to combine IRE and one or more additional therapies such as thermal ablation”); ¶[0073] (“In some examples, IRE and thermal treatments are combined into one overall therapy regimen as by, for example, alternating between pulses of longer duration (which generate thermal effects) and shorter duration (which generate IRE-type effects) within a therapy pulse set”); ¶’s [0079], [0080], & ¶[0088] (“The method of FIG. 16, as well as any other of the examples herein, may be further combined with additional therapy elements, such as for example, the delivery of a laser ablation (by, for example, inserting a separate optical instrument or including one or more optical fibers in a therapy apparatus similar to those shown above). For example, an optical therapy apparatus may be inserted and used to perform laser-based ablation, with IRE then delivered via electrodes on the laser apparatus to mitigate tract seeding. Ultrasound or other vibrational therapy may be added as well. For example, rather than an electrical therapy as the “thermal” therapy, followed by IRE to deal with tract seeding possibilities, an ultrasound instrument may be provided and used in a first step, with electrodes provided thereon to allow use of IRE to complete the procedure prior to withdrawal of the ultrasound instrument”)].
21. Regarding claim 8, the combination of Forsyth and Cosman teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Forsyth further teaches wherein the energy delivery body [any of electrodes (706)] comprises a probe having a probe tip [see ¶[0077] - electrodes (706) are described as tissue-piercing electrodes or needle electrodes, and are therefore considered probes with probe tips], wherein at least a portion of the mass of undesired tissue resides outside of the luminal structure, and wherein the method further comprises penetrating a wall of the luminal structure with the probe tip [¶’s [0072], [0076] (“the distal tip 704 may be blunted to allow atraumatic passage through a body lumen such as a biliary duct, lymph vessel or duct, urethra, mammary duct, digestive passageway, blood vessel, or other body passageway, as the case may be”), [0077], [0082], [0083] (“Insertion 810 may make use of an existing lumen or channel of the patient (such as using a blood vessel or other duct/vessel in the patient) or may comprise piercing tissue with an instrument designed for such piercing. Once inserted to a location that is desirable, the treatment apparatus may deploy one or more electrodes, as indicated at 820. In some example, tissue piercing electrodes, such as in the modified Leveen-style devices shown above, may be extended out of internal lumens of the therapy device to pierce tissue or otherwise position electrodes for use. A therapy is then delivered, as indicated at 830”); FIG. 15].
22. Regarding claim 9, the combination of Forsyth and Cosman teaches all of the limitations of claim 8 for the reasons set forth in detail (above) in the Office Action.
Forsyth further teaches advancing the probe tip up to 20 cm beyond the wall of the luminal structure [e.g., ¶’s [0072], [0076], [0077], [0082], [0083]; NOTE: the claimed range of “up to 20 cm away” is being interpreted as a range extending from a value slightly greater than 0 cm away to 20 cm away; one skilled in the art would readily appreciate that extension of a tip of any of electrodes (706) into a tissue (e.g., tumor) to be treated beyond the wall of the luminal structure would comprise an extension greater than 0 cm].
23. Regarding claim 10, the combination of Forsyth and Cosman teaches all of the limitations of claim 8 for the reasons set forth in detail (above) in the Office Action.
Forsyth further teaches wherein the energy delivery body comprises a conductive tube that extends from the handle to the probe tip, and wherein the mating the distal end of the energy plug to the handle allows electrification of the conductive tube from contact with the exposed connection wire to the probe tip [NOTE: Forsyth was modified above in the rejection of claim 1 to energize the conductive bodies of the tissue penetrating electrodes (706) that pass through the cannula shaft (see ¶’s [0010], [0057], [0077]-[0079], [0080] regarding conductivity and lumen structure of the electrodes (706)) in order to supply energy to the probe tips].
24. Regarding claim 11, the combination of Forsyth and Cosman teaches all of the limitations of claim 8 for the reasons set forth in detail (above) in the Office Action [NOTE: see the rejection under § 112(d) above, wherein it is stated that claim 11 will be treated as depending from claim 8 for purposes of examination].
Forsyth (as modified) further teaches wherein the handle comprises an actuator [actuator (410) - ¶[0068]; FIG. 7], further comprising manipulating the actuator [(410)] so that the probe tip moves between (i) a retracted position wherein the probe tip resides within the distal end of the instrument [e.g., Abstract, ¶’s [0017], [0019], [0083]] to (ii) an exposed position wherein the probe tip resides beyond the distal end of the instrument [e.g., Abstract, ¶’s [0017], [0019], [0083]; FIG. 14A].
25. Regarding claim 12, the combination of Forsyth and Cosman teaches all of the limitations of claim 11 for the reasons set forth in detail (above) in the Office Action.
Forsyth further teaches wherein the manipulating the actuator [(410)] comprises manipulating a sliding mechanism [e.g., ¶’s [0017], [0019], [0068]; FIG. 7].
26. Regarding claim 13, the combination of Forsyth and Cosman teaches all of the limitations of claim 8 for the reasons set forth in detail (above) in the Office Action.
Forsyth further teaches wherein the probe [(706)] is at least partially insulated so as to restrict delivery of the pulsed electric field energy from the probe, and wherein the method further comprises exposing at least a portion of the probe tip from insulation [e.g., ¶[0073]].
27. Regarding claim 14, the combination of Forsyth and Cosman teaches all of the limitations of claim 8 for the reasons set forth in detail (above) in the Office Action.
Forsyth further teaches wherein the probe comprises a plurality of probe elements [plurality of electrodes (706) - ¶’s [0077]-[0079], [0083]; FIGS. 14A, 14B], and wherein the method further comprises independently advancing at least one of the plurality of probe elements in relation to at least another of the plurality of probe elements [e.g., ¶’s [0017] (“the plurality of tissue penetrating electrodes may include at least a first tissue penetrating electrode having a first mechanical coupling and a second tissue penetrating electrode having a second mechanical coupling, wherein the first and second mechanical couplings are separately actuatable to allow the first and second tissue penetrating electrodes to be advanced independent of one another”), [0019], [0068]; FIG. 7].
28. Regarding claim 15, the combination of Forsyth and Cosman teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Forsyth further teaches wherein the delivering the pulsed electric field energy is in a manner so as to cause premature death of cells of the mass of undesired tissue [e.g., ¶[0080]].
29. Regarding claim 17, the combination of Forsyth and Cosman teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Forsyth further teaches wherein the luminal structure comprises a blood vessel, an esophagus, a stomach, a pancreatic duct, a biliary duct, a small intestine, a large intestine, a colon, a rectum, a bladder, a urethra, a urinary collecting duct, a uterus, a vagina, a fallopian tube, a ureter, a renal tubule, a spinal canal, a spinal cord, an airway, a nasal cavity, a mouth, a heart chamber, a heart lumen, a kidney lumen, or an organ lumen [see ¶[0076] (“the distal tip 704 may be blunted to allow atraumatic passage through a body lumen such as a biliary duct, lymph vessel or duct, urethra, mammary duct, digestive passageway, blood vessel, or other body passageway, as the case may be”); see also ¶[0083]].
30. Regarding claim 18, the combination of Forsyth and Cosman teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Forsyth further teaches delivering a liquid through the energy delivery body [e.g., ¶’s [0010] (“at least one of the tissue penetrating elongate electrodes may comprise a fluid delivery lumen therethrough”), [0057], [0083]].
31. Regarding claim 19, the combination of Forsyth and Cosman teaches all of the limitations of claim 18 for the reasons set forth in detail (above) in the Office Action.
Forsyth further teaches wherein the liquid comprises suspensions, mixtures, chemicals, fluids, chemotherapy agents, immunotherapy agents, micelles, liposomes, embolics, nanoparticles, drug-eluting particles, genes, plasmids, or proteins, or any combination thereof [e.g., “fluids” - ¶’s [0057]-[0059], [0083]].
32. Regarding claim 20, the combination of Forsyth and Cosman teaches all of the limitations of claim 18 for the reasons set forth in detail (above) in the Office Action.
Forsyth further teaches wherein the liquid comprises a conductive solution [¶’s [0057]-[0059], e.g., saline] and wherein delivering the pulsed electric field energy coordinates with delivering the liquids so that the liquid creates a liquid electrode [e.g., ¶’s [0058]-[0059]].
33. Claims 5 & 6 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Forsyth and Cosman, as applied to claim 1 above, and further in view of U.S. Patent Application Publication No. 2019/0282294 to Davalos et al. ("Davalos").
34. Regarding claim 5, the combination of Forsyth and Cosman teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Forsyth further teaches:
delivering an additional therapy to the patient, wherein the additional therapy comprises radiotherapy, chemotherapy, immunotherapy, targeted therapy, focal therapy, gene therapy, plasmid therapy, or a combination thereof [NOTE: Applicant defines “focal therapies” as therapies comprising the delivery of treatment with thermal energies to cause thermal ablation, examples of which include radiofrequency ablation (RFA), microwave ablation (MWA), & High-Intensity Focused Ultrasound (HIFU) – see Applicant’s as-filed Specification at, e.g., ¶’s [00126], [00223], [00362], & [00370]. Forsyth discloses delivering an additional therapy to the patient comprising a focal therapy. For example, Forsyth discloses the use of IRE in combination with additional therapies such as thermal ablation – see Forsyth, e.g., ¶[0005] (“The present inventors have also recognized that it may be desirable for a physician to be able to combine IRE and one or more additional therapies such as thermal ablation”); ¶[0073] (“In some examples, IRE and thermal treatments are combined into one overall therapy regimen as by, for example, alternating between pulses of longer duration (which generate thermal effects) and shorter duration (which generate IRE-type effects) within a therapy pulse set”); ¶’s [0079], [0080], & ¶[0088] (“The method of FIG. 16, as well as any other of the examples herein, may be further combined with additional therapy elements, such as for example, the delivery of a laser ablation (by, for example, inserting a separate optical instrument or including one or more optical fibers in a therapy apparatus similar to those shown above). For example, an optical therapy apparatus may be inserted and used to perform laser-based ablation, with IRE then delivered via electrodes on the laser apparatus to mitigate tract seeding. Ultrasound or other vibrational therapy may be added as well. For example, rather than an electrical therapy as the “thermal” therapy, followed by IRE to deal with tract seeding possibilities, an ultrasound instrument may be provided and used in a first step, with electrodes provided thereon to allow use of IRE to complete the procedure prior to withdrawal of the ultrasound instrument”)].
While Forsyth teaches the desirability of augmenting IRE with the injection of fluids containing drugs, biologics, or other substances [Forsyth, ¶[0005]], the combination of Forsyth and Cosman does not teach:
wherein the additional therapy comprises chemotherapy, and
wherein the delivering the pulsed electric field energy comprises delivering pulsed electric field energy so as to condition the mass of undesired tissue to synergistically increase the effect of the chemotherapy.
Davalos, in a similar field of endeavor, teaches a method of treating tissue in a patient that comprises, inter alia, causing non-thermal irreversible electroporation of a tissue, and administering an additional treatment that can be selected from the group consisting of: tissue resection, thermal ablation, non-thermal ablation, chemotherapy, radiation therapy, immunotherapy, biologic therapy, genetic therapy, and combinations thereof [Davalos, e.g., ¶’s [0006], [0096]].
Davalos teaches that the additional treatments (which can include immunosuppressive treatment efforts like chemotherapy - ¶[0082]) may be administered as a downstream or secondary treatment [e.g., ¶[0086]], or, alternatively, prior to non-thermal ablation techniques [¶[0084]] like IRE [¶[0075]].
Davalos additionally teaches that delivering the pulsed electric field energy [in the form of IRE] comprises delivering pulsed electric field energy to synergistically increase the effect of the chemotherapy [Davalos teaches a method wherein patients received both chemotherapy and IRE – particularly wherein patients underwent chemotherapy prior to receiving IRE, and that the IRE resulted in several benefits enhancing the effect of chemotherapy – see ¶[0144] (“All patients underwent chemotherapy and 52% of patients received chemoradiation therapy for a median of 6 months prior to IRE. The initial results suggested that IRE reduced length of hospital stays, reduced local recurrence rates, and increased survival from 13 months to 28.3 months”)].
Accordingly, given that Forsyth is concerned with fighting tumors by combing IRE with one or more additional therapies (Forsyth, ¶[0005]), that Forsyth already teaches the desirability of augmenting IRE with the injection of fluids containing drugs, biologics, or other substances (Forsyth, ¶[0005]), and that Davalos teaches that it is common practice for an overall treatment plan to include delivery of multiple forms of treatment modalities to a patient, including chemotherapy (Davalos, e.g., ¶[0083]), it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Forsyth and Cosman such that the additional therapy comprises chemotherapy, and wherein the delivering the pulsed electric field energy comprises delivering pulsed electric field energy [in the form of IRE] so as to condition the mass of undesired tissue to synergistically increase the effect of the chemotherapy, as taught by Davalos, so as to provide the benefits/advantages of reduced length hospital stays, reduced local recurrence rates, and increased survival rates that are realized when IRE and chemotherapy are combined as joint treatment modalities [Davalos, ¶[0144]].
35. Regarding claim 6, the combination of Forsyth and Cosman teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
While Forsyth teaches the desirability of augmenting IRE with the injection of fluids containing drugs, biologics, or other substances [Forsyth, ¶[0005]], the combination of Forsyth and Cosman does not teach explicitly teach:
wherein the delivering of the pulsed electric field energy comprises delivering the pulsed electric field energy in a manner which causes an abscopal effect by the patient.
Davalos, in a similar field of endeavor, teaches a method of treating tissue in a patient that comprises, inter alia, causing non-thermal irreversible electroporation of a tissue, and administering an additional treatment that can be selected from the group consisting of: tissue resection, thermal ablation, non-thermal ablation, chemotherapy, radiation therapy, immunotherapy, biologic therapy, genetic therapy, and combinations thereof [Davalos, e.g., ¶’s [0006], [0096]].
Davalos further teaches that combining non-thermal ablation procedures, such as IRE, with a downstream or secondary treatment(s) of delivering immunotherapies to a subject has been shown to induce an abscopal effect in which the local non-thermal ablation promotes systematic immune responses leading to regression of tumors and/or cancer cells distant from the target or treatment site [Davalos, ¶[0110]].
Accordingly, given that Forsyth is concerned with fighting tumors by combing IRE with one or more additional therapies (Forsyth, ¶[0005]), that Forsyth already teaches the desirability of augmenting IRE with the injection of fluids containing drugs, biologics, or other substances (Forsyth, ¶[0005]), and that Davalos teaches that it is common practice for an overall treatment plan to include delivery of multiple forms of treatment modalities to a patient, including chemotherapy (Davalos, e.g., ¶[0083]), it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Forsyth and Cosman such that the additional therapy comprises delivering immunotherapies to a patient such that the delivering of the pulsed electric field energy [in the form of IRE] comprises delivering the pulsed electric field energy in a manner which causes an abscopal effect by the patient, as taught by Davalos, so as to provide the benefit/advantage of promoting systematic immune responses leading to regression of tumors and/or cancer cells distant from the target or treatment site [Davalos, ¶[0110]].
36. Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Forsyth and Cosman, as applied to claim 1 above, and further in view of U.S. Patent Application Publication No. 2012/0330306 to Long et al. ("Long").
37. Regarding claim 16, the combination of Forsyth and Cosman teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Forsyth further teaches that the instrument between the distal end and the handle is flexible [e.g., ¶[0083] (“Insertion 810 may make use of an existing lumen or channel of the patient (such as using a blood vessel or other duct/vessel in the patient)…”); note that the flexibility of the instrument would allow for insertion via a lumen or channel of the patient]. Additionally, it is the Examiner’s position that such flexibility would further allow the instrument of Forsyth/Cosman to be capable of insertion via a lumen of an endoscope.
However, the combination of Forsyth and Cosman does not explicitly teach:
wherein the instrument between the distal end and the handle is flexible and configured to be advanced via a lumen of an endoscope such that the handle is positioned proximal to the endoscope.
Long, in a similar field of endeavor, relates to the minimally invasive treatment of undesirable tissue through the use of irreversible electroporation (IRE) ablation techniques [e.g., ¶[0004]], and teaches that it was known to utilize an ablation system in conjunction with a flexible endoscope [¶[0038]], or, more particularly, to insert an electrical ablation device through a working channel of the endoscope for introduction to a tissue treatment site/region [¶[0039]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Forsyth and Cosman such that the device of Forsyth/Cosman be used with a flexible endoscope, e.g., via insertion of the device through a lumen of an endoscope, since use of an endoscope would provide the benefit/advantage of having a light source for illuminating the tissue treatment site, and/or a viewing port for enabling the acquisition of images of the tissue treatment site via an optical device (CCD Camera), thereby providing a practitioner with a better understanding of conditions at the tissue treatment site during a procedure in real-time. Further, it is the Examiner’s position that the handle of Forsyth/Cosman would be positioned proximal to the endoscope so as to allow for access to, and manipulation of, the actuators [Forsyth, FIG. 7].
Response to Arguments
38. As noted above, the 11/12/25 Amendment has overcome the claim objection previously set forth in the 07/14/25 Action. A new rejection under § 112(d) is set forth herein, necessitated by Applicant’s Amendment.
39. The rejection of independent claim 1 under § 103 based on the combination of Forsyth & Cosman has been updated to address the new claim limitations, and maintained.
40. Independent Claim 1
41. With regard to independent claim 1, Applicant first argues:
Applicant's structure permits modularity with respect to the handle and generator connections that was neither contemplated nor considered in the cited references. In Cosman, the structure cited in the Office action is within the alleged "handle" (proximal hub 782). There is no teaching or suggestion to "mat[e] a distal end of an energy plug having an exposed connection wire to the handle" as recited in claim 1.
11/12/25 Amendment, pg. 7, emphasis in original, emphasis added.
42. This argument is not persuasive, as Applicant appears to be improperly reading limitations into the claim. For example, claim 1 does not require that the connection to the handle be “releasable” or “separable.” As such, mating (joining) of an exposed connection wire to the handle during assembly (even if the connection becomes permanent) would still read on the limitation as currently claimed. Further, as noted in the body of the rejection above, energizing an electrode via an exposed connection wire joined to an inner lumen thereof at the handle, as taught by Cosman, would provide the benefit/advantage of simplifying the design of Forsyth by eliminating the need to run a conductor for an extendable electrode along the entire length of the device.
43. Concerning the new limitations of independent claim 1, Applicant argues:
Further, the alleged "handle" of Cosman does not permit "using the handle to cause the energy delivery body to extend from the distal end of the instrument for delivering the pulsed electric field energy toward the mass of undesired tissue," as recited in claim 1. The configuration of claim 1 where there is an energy plug mateable to the handle and between the handle and generator permits an easy-to-use handle design that helps with positioning and manipulation for proper energy deployment. Thus, it would be impermissible hindsight to pick and choose features of Forsyth and Cosman to arrive at the claimed invention.
11/12/25 Amendment, pg. 7.
44. The rejection of claim 1 has been updated herein to demonstrate how Forsyth satisfies this claim limitation.
45. Claim 16
46. Regarding amended dependent claim 16, Applicant argues:
Claim 16 stands rejected under 35 U.S.C. § 103 as being obvious over Forsyth in view of Cosman and Long. The Office action acknowledges that Forsyth and Cosman do not teach or suggest using an endoscope. With this response, claim 16 is further amended to specify the flexible nature of the instrument that permits the portion distal to the handle to be advanced in a lumen of an endoscope. Applicant submits that it would not have been obvious to modify the rigid shafts of Forsyth or Cosman with Long, as such modification would completely change the structural configurations shown in Forsyth/Cosman. Thus, the obviousness rejections should be withdrawn.
11/12/25 Amendment, pg. 7.
47. The rejection of claim 16 has been updated herein to demonstrate how the combination of Forsyth, Cosman, and Long satisfies this claim limitation.
Conclusion
48. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bradford C. Blaise whose telephone number is (571)272-5617. The examiner can normally be reached on Monday - Friday 8 AM-5 PM.
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/Bradford C. Blaise/Examiner, Art Unit 3794