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 .
Election/Restrictions
Applicant’s election without traverse of Group III item h (claims 53, 56-57, 59-63, and 79-81) in the reply filed on 01/15/2026 is acknowledged.
Claims 1-52, 54-55, 58, and 64-78 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/15/2026.
Claims 53, 56-57, 59-63, and 79-81 are pending and under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/10/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 80 is objected to because of the following informalities: the phrase “in particularly” should be amended to either recite “in particular” or “particularly”. Appropriate correction is required.
Claim 81 is objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claims 79 and 80. See MPEP § 608.01(n). Accordingly, the claim 81 may not be further treated on the merits. Nevertheless, for the practice of compact prosecution, claim 81 will be examined below.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 53, 56-57, 59-63, and 79-81 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 53, it is unclear what “it”, in line 3” is referring to. Applicant should clarify that “it” is the controlled thermal therapy and imaging system.
Claim 53 recites the limitation "the target tissue" in lines 4 and 8. There is insufficient antecedent basis for this limitation in the claim.
Claim 53 recites the limitation "the therapeutic and imaging apparatus" in lines 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 53 recites the limitation "the recessed channel" in lines 5 and 8. There is insufficient antecedent basis for this limitation in the claim.
Claim 53 recites the limitation "the imaging " in lines 10. There is insufficient antecedent basis for this limitation in the claim.
Claim 53 recites the limitation "the apparatus" in lines 11. There is insufficient antecedent basis for this limitation in the claim.
Claim 53 recites the limitation "the radiofrequency ablation method" in lines 14. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 53, are the “electric vacuum pump 70, manometer 71, radiofrequency generator 250, and an optical (400 nm - 2000 nm) imaging device 160” of lines 15-16 the same or different than the “electric vacuum pump 70, manometer 71, radiofrequency generator 250, and an optical (400 nm - 2000 nm) imaging device 160” of lines 4, 6, 8, and 10, respectively. Both phrases are modified by the article “a” thus implying two separate and distinct devices.
Claim 56 recites the limitation "the diameter" in lines 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 56 recites the limitation "the range" in lines 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 56 recites the limitation "the human gastrointestinal tract" in lines 4. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 56, are the “radiofrequency-based 90-degree therapeutic and optical imaging apparatus 220, or 90-degree therapeutic and optical imaging apparatus using the radiofrequency ablation method and a MEMS mirror 260” of lines 2-4 the same or different than the “radiofrequency-based 90-degree therapeutic and optical imaging apparatus 220, or 90-degree therapeutic and optical imaging apparatus using the radiofrequency ablation method and a MEMS mirror 260” of lines 15-16 of claim 53. Both phrases are modified by the article “a” thus implying two separate and distinct systems.
Claim 57 recites the limitation "the whole" in lines 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 57 recites the limitation "the alternating current" in lines 5. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 59, it is unclear what “it”, in line 1 is referring to.
Claim 59 recites the limitation "the distal end" in lines 3. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 59, are the “a radiofrequency-based 360-degree therapeutic and optical imaging apparatus 200 or a radiofrequency-based 90-degree therapeutic and optical imaging apparatus 220” of lines 2-3 the same or different than the “a radiofrequency-based 360-degree therapeutic and optical imaging apparatus 200 or a radiofrequency-based 90-degree therapeutic and optical imaging apparatus 220” of lines 15-16 of claim 53. Both phrases are modified by the article “a” thus implying two separate and distinct systems.
Claim 60 recites the limitation "the alternating current" in lines 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 60 recites the limitation "the 90-degree electrode array 222" in lines 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 60, are the “a radiofrequency-based 90-degree therapeutic and optical imaging apparatus 220” of lines 4 the same or different than the “a radiofrequency-based 90-degree therapeutic and optical imaging apparatus 220” of lines 15-16 of claim 53. Both phrases are modified by the article “a” thus implying two separate and distinct systems.
Regarding claim 61, it is unclear what “it”, in line 1 is referring to.
Regarding claim 61, are the “a radiofrequency-based 90-degree therapeutic and optical imaging apparatus 220” of lines 4 the same or different than the “a radiofrequency-based 90-degree therapeutic and optical imaging apparatus 220” of lines 15-16 of claim 53. Both phrases are modified by the article “a” thus implying two separate and distinct systems.
Regarding claim 61, are the “a 360-degree electrode array 202” of lines 2 the same or different than the “a 360-degree electrode array 202” of lines 5 of claim 57. Both phrases are modified by the article “a” thus implying two separate and distinct systems.
Regarding claim 62, it is unclear what “it”, in line 1 is referring to.
Regarding claim 62, are the “a 360-degree electrode array 202” of lines 2 the same or different than the “a 360-degree electrode array 202” of lines 5 of claim 57. Both phrases are modified by the article “a” thus implying two separate and distinct systems.
Claim 62 recites the limitation "the bottom of the opening" in lines 2 and 4. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 63, it is unclear what “it”, in line 2 is referring to.
Claim 63 recites the limitation "the target mucosal tissue" in lines 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 63 recites the limitation " the opening" in lines 3. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 63, are the “a 360-degree opening 201” of lines 3 the same or different than the “a 360-degree opening 201” of lines 3 of claim 57. Both phrases are modified by the article “a” thus implying two separate and distinct systems.
Claim 63 recites the limitation "the body with a 90-degree opening 221" in lines 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 63 recites the limitation "the alternating current" in lines 5. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 63, it is unclear if the electrodes of apparatus 200 and 220 are the same or different from the electrode array of claim 57.
Claim 79 recites the limitation "the parts" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 79 recites the limitation "the casing" in lines 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 80 recites the limitation "the biocompatible material" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 80 recites the limitation "the range" in lines 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 80 recites the limitation "the body with a 90- degree opening 221" in lines 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 80 recites the limitation "the front cover with a 90-degree opening 172" in lines 6. There is insufficient antecedent basis for this limitation in the claim.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 80 recites the broad recitation of the opening being broadly transparent, and the claim also recites a specific optical transmittance range that the opening is transparent at which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Rejections 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 53 and 56 is/are rejected under 35 U.S.C. 103 as being unpatentable over Caplan et al. (US 20150045825)(Hereinafter Caplan) in view of Miller et al. (US 20230071306)(Hereinafter Miller) and Rajagopalan et al. (US 20130345670)(Hereinafter Rajagopalan).
Regarding claim 53, Caplan teaches A 0 to 360-degree active angle controlled thermal therapy and imaging system to be used in endoscopic medical diagnostic applications, endoscopic medical therapy applications and radiofrequency ablation treatment applications (Fig. 19 [0113] “The tissue expansion device may be inserted through a lumen of a body access device, such as an endoscope.” [0114] “an imaging device integral to or inserted through an endoscope; an imaging assembly integral to the tissue expansion device” and [0205].), characterized in that it comprises:
an electric vacuum pump 70 that creates a negative pressure necessary to pull the target tissue into the recessed channel of the therapeutic and imaging apparatus (Fig. 19(340) [0125] “Vacuum can be applied to openings 131a and 131b such as to draw tissue toward and/or into openings 131a and 131b.” [0093] “a vacuum or other negative pressure may be used to manipulate tissue and/or to maintain proximity between a portion of a tissue expansion device or assembly, and tissue.”),
[controller for adjusting pressure] is connected in series to the electric vacuum pump 70 and continuously measures the negative pressure value ([0098] “A numerous range of vacuum pressure levels can be applied, such as a vacuum of 5 to 45 cmHg below atmospheric pressure, such as a vacuum between 5 and 20 cmHg below atmospheric pressure.” [0178] “The vacuum source 340 may be set to a pre-determined vacuum pressure and/or it may be operator adjustable.”),
a radiofrequency generator 250 that exposes the target tissue pulled into the recessed channel of the apparatus to radiofrequency ablation (Fig. 19(330) [0202] “if treatment element 322b is an RF electrode array, and EDU 330 comprises an RF generator, controller 360 may be programmed to provide a specific amount of RF energy for a defined period of time…Controller 360 may be configured for manual control, so that the operator first initiates the energy delivery, then allows the treatment element 322b to ablate the tissue for some time period, after which the operator terminates the energy delivery.”),
an optical (400 nm - 2000 nm) imaging device 160 that performs the imaging of the target tissue pulled into the apparatus with negative pressure (Fig. 19 (370) [0203] “Imaging device 370 may be configured to be inserted into the patient and may comprise a visual light camera; an ultrasound imager; an optical coherence domain reflectometry (OCDR) imager; and/or an optical coherence tomography (OCT) imager” Examiner notes that light cameras have a wavelength of 400-700 nm and OCT has the length between 800-1300 nm.),
a radiofrequency-based 360-degree therapeutic and optical imaging apparatus 200, or a radiofrequency-based 90-degree therapeutic and optical imaging apparatus 220, or a 90-degree therapeutic and optical imaging apparatus using the radiofrequency ablation method and a MEMS mirror 260, at least one of which is connected to an electric vacuum pump 70, manometer 71, radiofrequency generator 250, and an optical (400 nm - 2000 nm) imaging device 160 to provide radiofrequency ablation therapy and imaging (See Fig. 19 that that has imaging and RF therapy capabilities.).
However, Caplan does not teach a manometer for determining the pressure. Miller, in the same field of endeavor, teaches a gastrointestinal system used to ablate mucosal and sub-mucosal layers through the duodenum using RF energy (Abstract and [0041]), and further teaches a manometer for determining the pressure ([0121] “Such peristaltic wave sensors may include one or more of stretch sensors, strain gauge transducers, manometers (manometry)”) to show the changes in pressure ([0121]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Caplan, with the manometer for determining the pressure of Miller, because such a modification would allow to show the changes in pressure.
However, Caplan and Miller do not teach a 360-degree electrode RF therapeutic apparatus. Rajagopalan, in the same field of endeavor, teaches an elongated catheter for treating gastrointestinal tissue via ablation, and further teaches a radiofrequency-based 360-degree therapeutic and optical imaging apparatus 200 ([0276] “shaft 311 and electrodes 324 may be rotated between successive energy applications in order to perform a 360.degree. ablation.”) to perform a full circumferential tissue treatment ([0276]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Caplan, with the 360-degree electrode RF therapeutic apparatus of Rajagopalan, because such a modification would allow to perform a full circumferential tissue treatment.
Regarding claim 56, Caplan teaches characterized in that the diameter of the radiofrequency-based 360-degree therapeutic and optical imaging apparatus 200, or radiofrequency-based 90-degree therapeutic and optical imaging apparatus 220, or 90-degree therapeutic and optical imaging apparatus using the radiofrequency ablation method and a MEMS mirror 260 is in the range of 10 mm to 20 mm for appropriate intervention in the human gastrointestinal tract ([0109] “shaft 101 is inserted into the patient anatomy void of an endoscope, such as when shaft 101 has a relatively continuous diameter of approximately 13 mm or less” [0110] “Shaft 101 may comprise an insertable or "working" length configured to provide access to one or more body locations such as one or more gastrointestinal body locations.” [0095] “The tissue may comprise one or more locations within a patient's body, such as tissue comprising a body lumen such as one or more portions of the gastrointestinal tract.”).
Claim(s) 57, 59-63, and 79-81 is/are rejected under 35 U.S.C. 103 as being unpatentable over Caplan et al. (US 20150045825)(Hereinafter Caplan) in view of Miller et al. (US 20230071306)(Hereinafter Miller), Rajagopalan et al. (US 20130345670)(Hereinafter Rajagopalan), Vakoc (US 20160192976)(Hereinafter Vakoc), and Auge et al. (US 20120221003)(Hereinafter Auge).
Regarding claim 57, Caplan teaches characterized in that the radiofrequency- based 360-degree therapeutic and optical imaging apparatus 200 comprises:
a body with a … opening 201 that forms the whole of the radiofrequency-based 360-degree therapeutic and optical imaging apparatus 200 (Fig. 19 (350 endoscope, which includes camera 352, RF delivery 330, and vacuum source 340) See [0190].),
a 360-degree electrode array 202 that transmits the … current for therapeutic purposes to the radiofrequency-based 360-degree therapeutic and optical imaging apparatus 200 ([0143] “Electrode 152 is connected to one or more wires, not shown but traveling proximally to a control unit configured to cause electrode 152 to apply an electric field in and/or around reservoir 151. While electrode 152 is shown as a single electrode, multiple electrodes may be employed.” [0202] “treatment element 322b is an RF electrode array, and EDU 330 comprises an RF generator, controller 360 may be programmed to provide a specific amount of RF energy for a defined period of time.”).
However, Caplan and Miller do not teach a 360-degree electrode array. Rajagopalan, in the same field of endeavor, teaches an elongated catheter for treating gastrointestinal tissue via ablation, and further teaches 360-degree electrode array 202 ([0276] “shaft 311 and electrodes 324 may be rotated between successive energy applications in order to perform a 360.degree. ablation.”) to perform a full circumferential tissue treatment ([0276]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Caplan, with the 360-degree electrode RF therapeutic apparatus of Rajagopalan, because such a modification would allow to perform a full circumferential tissue treatment.
However, Caplan, Miller, and Rajagopalan do not teach a body with a 360-degree opening 201. Vakoc, in the same field of endeavor, teaches an endoscopic mucosal therapy device ([0010]) via RF ablation ([0046]) and a vacuum (Abstract), and further teaches a body with a 360-degree opening 201 to (Fig. 4 shows vacuum port 405c at the tip of the cone shaped opening, what is considered 360 degrees because a circle, which is at the bottom of the cone and the beginning of the opening, is 360 degrees, and forces the suction of tissue.) to enhance the pulling of tissue through the negative pressure created ([0039]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Caplan, with the 360-degree opening 201 of Vakoc, because such a modification would allow to enhance the pulling of tissue through the negative pressure created.
However, Caplan, Miller, Vakoc, and Rajagopalan do not teach the transmitting of AC for therapeutic purposes. Auge, in the same field of endeavor, teaches the removal of tissue via a catheter (Abstract, Fig. 8, and [0010]), and further teaches the application of AC through electrodes ([0010]) to induce therapeutic effect of targeted tissue ([0010]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Caplan, with the AC therapy of Auge, because such a modification would allow to induce therapeutic effect of targeted tissue.
Regarding claim 59, Caplan teaches characterized in that it comprises a radiofrequency-based 360-degree therapeutic and optical imaging apparatus 200 or a radiofrequency-based 90-degree therapeutic and optical imaging apparatus 220, which can be mounted at the distal end of the insertion tube of a conventional endoscopy device (Fig. 19 (350 endoscope including 330 RF energy delivery and light camera 352) See [0190].).
Regarding claim 60, Caplan teaches characterized in that the 360- degree electrode array 202 or the 90-degree electrode array 222, which transmits the alternating current to the radiofrequency-based 360-degree therapeutic and optical imaging apparatus 200 or radiofrequency-based 90-degree therapeutic and optical imaging apparatus 220… ([0143] “Electrode 152 is connected to one or more wires, not shown but traveling proximally to a control unit configured to cause electrode 152 to apply an electric field in and/or around reservoir 151.”).
However, Caplan and Miller do not teach a 360-degree electrode array. Rajagopalan, in the same field of endeavor, teaches an elongated catheter for treating gastrointestinal tissue via ablation, and further teaches 360-degree electrode array 202 ([0276] “shaft 311 and electrodes 324 may be rotated between successive energy applications in order to perform a 360.degree. ablation.”) to perform a full circumferential tissue treatment ([0276]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Caplan, with the 360-degree electrode RF therapeutic apparatus of Rajagopalan, because such a modification would allow to perform a full circumferential tissue treatment.
However, neither Caplan, Miller, and Rajagopalan teach the electrodes made of copper metal. Although Caplan discloses the electrodes capable of applying an electric field, the electrode can be made of copper to be capable of delivering RF energy via electric field. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use copper electrodes, for the purpose of applying an electric field, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 61, Caplan teaches characterized in that it comprises a 360-degree electrode array 202 or a 90-degree electrode array 222 in a flexible form, which may be located on the radiofrequency-based 360-degree therapeutic and optical imaging apparatus 200 or radiofrequency- based 90-degree therapeutic and optical imaging apparatus 220 ([0143] “Electrode 152 is connected to one or more wires, not shown but traveling proximally to a control unit configured to cause electrode 152 to apply an electric field in and/or around reservoir 151. While electrode 152 is shown as a single electrode, multiple electrodes may be employed.” [0202] “treatment element 322b is an RF electrode array, and EDU 330 comprises an RF generator, controller 360 may be programmed to provide a specific amount of RF energy for a defined period of time.”).
However, Caplan and Miller do not teach a 360-degree electrode RF therapeutic apparatus. Rajagopalan, in the same field of endeavor, teaches an elongated catheter for treating gastrointestinal tissue via ablation, and further teaches a radiofrequency-based 360-degree therapeutic and optical imaging apparatus 200 ([0276] “shaft 311 and electrodes 324 may be rotated between successive energy applications in order to perform a 360.degree. ablation.”) to perform a full circumferential tissue treatment ([0276]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Caplan, with the 360-degree electrode RF therapeutic apparatus of Rajagopalan, because such a modification would allow to perform a full circumferential tissue treatment.
Regarding claim 62, claim 53 is obvious over Caplan, Miller, and Rajagopalan. However, Caplan, Miller, and Rajagopalan do not teach 360-degree electrode array 202 which is located at the bottom of the opening in the body with a 360-degree opening 201. Vakoc, in the same field of endeavor, teaches an endoscopic mucosal therapy device ([0010]) via RF ablation ([0046]) and a vacuum (Abstract), and further teaches characterized in that it comprises a 360-degree electrode array 202 which is located at the bottom of the opening in the body with a 360-degree opening 201 of the radiofrequency-based 360-degree therapeutic and optical imaging apparatus 200 or a 90- degree electrode array 222 which is located at the bottom of the opening in the body with a 90-degree opening 221 of the radiofrequency-based 90-degree therapeutic and optical imaging apparatus 220 (Fig. 4 shows electrodes 501a and 501b at the bottom at the tip of the cone shaped opening, what is considered 360 degrees because a circle, which is at the bottom of the cone and the beginning of the opening, is 360 degrees, and forces the suction of tissue.) to enhance the pulling of tissue through the negative pressure created ([0039]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Caplan, with the 360-degree opening 201of Vakoc, because such a modification would allow to enhance the pulling of tissue through the negative pressure created.
Regarding claim 63, Caplan teaches An operation method of the thermal therapy and imaging system according to claim 57 or 58 characterized in that it comprises the following process steps (Fig. 19 [0123] “Numerous forms and locations of patient tissue can be expanded by the devices, systems and methods of the present inventive concepts. In some embodiments, the tissue to be expanded comprises submucosal tissue, such as submucosal tissue of the duodenum.”):
pulling the target mucosal tissue into the opening in the body with a … opening 201 or the body with a 90-degree opening 221 by a negative pressure ([0152] “Recess 155' can be positioned in a lumen of tissue, such as a lumen of the duodenum or other gastrointestinal lumen, such as to expand one or more layers of tissue, such as the submucosal layer of the duodenum. An opening 158' is positioned between lumen 107 and recess 155', such that an applied vacuum can be introduced to recess 155' via lumen 107, such as to draw tissue into recess 155' as shown as described in reference to FIGS. 10A and 10B hereabove.”),
transmitting the …current at a level of radiofrequency energy to the radiofrequency-based 360-degree therapeutic and optical imaging apparatus 200 using electrodes or the radiofrequency- based 90-degree therapeutic and optical imaging apparatus 220 using electrodes ([0143] “Electrode 152 is connected to one or more wires, not shown but traveling proximally to a control unit configured to cause electrode 152 to apply an electric field in and/or around reservoir 151. While electrode 152 is shown as a single electrode, multiple electrodes may be employed.” [0202] “treatment element 322b is an RF electrode array, and EDU 330 comprises an RF generator, controller 360 may be programmed to provide a specific amount of RF energy for a defined period of time.”).
However, Caplan does not teach the pulling mucosal tissues. Although Caplan is directed to the pulling of submucosal tissue through opening to the vacuum, the device of Caplan could also be used to pull mucosal tissues to ablate and treat target tissue ([0090]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Caplan, with the pulling of submucosal tissue through opening to the vacuum , because such a modification would allow to ablate and treat target tissue.
However, Caplan, Miller, and Rajagopalan do not teach a body with a 360-degree opening 201. Vakoc, in the same field of endeavor, teaches an endoscopic mucosal therapy device ([0010]) via RF ablation ([0046]) and a vacuum (Abstract), and further teaches pulling the target mucosal tissue into the opening in the body with a 360-degree opening 201 (Fig. 4 shows vacuum port 405c at the tip of the cone shaped opening, what is considered 360 degrees because a circle, which is at the bottom of the cone and the beginning of the opening, is 360 degrees, and forces the suction of tissue. [0039 mucosal tissue pulled laterally.) to enhance the pulling of tissue through the negative pressure created ([0039]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Caplan, with the 360-degree opening 201of Vakoc, because such a modification would allow to enhance the pulling of tissue through the negative pressure created.
However, Caplan, Miller, Vakoc, and Rajagopalan do not teach the transmitting of AC for therapeutic purposes. Auge, in the same field of endeavor, teaches the removal of tissue via a catheter (Abstract, Fig. 8, and [0010]), and further teaches the application of AC through electrodes ([0010]) to induce therapeutic effect of targeted tissue ([0010]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Caplan, with the AC therapy of Auge, because such a modification would allow to induce therapeutic effect of targeted tissue.
Regarding claim 79, Caplan teaches characterized in that the parts constituting the casing of the radiofrequency-based 360-degree therapeutic and optical imaging apparatus 200, or the radiofrequency-based 90-degree therapeutic and optical imaging apparatus 220, or the 90-degree therapeutic and optical imaging apparatus using the radiofrequency ablation method and a MEMS mirror 260 … ([0204] “System 300 may further include protective cap 380, configured to be positioned proximate tissue to prevent damage to certain tissue during energy delivery or other tissue treatment event.”).
However, neither Caplan, Miller, and Rajagopalan teach the that the parts constituting the casing is made of biocompatible material. Although Caplan discloses the cap used to protect a portion of the duodenum, which must be biocompatible because the cap is used while the catheter is in the duodenum. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use part of a casing that is biocompatible , for the purpose of protecting the Ampulla of Vater, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 80, Caplan teaches characterized in that the biocompatible material used in the radiofrequency-based 360-degree therapeutic and optical imaging apparatus 200, or the radiofrequency-based 90-degree therapeutic and optical imaging apparatus 220, or the 90-degree therapeutic and optical imaging apparatus using the radiofrequency ablation method and a MEMS mirror 260, or the body with a 360-degree opening 201, or the body with a 90-degree opening 221, or the front cover with a 90-degree opening 172 is transparent and in particularly, has an optical transmittance in the range of 400 nm to 2000 nm ([0190] “Endoscope 350 may include camera 352, such as a visible light, ultrasound and/or other visualization device used by the operator of system 300 prior to, during or after the treatment of target tissue 10, such as during insertion or removal of endoscope 350 and/or shafts 311a and 311b.” Examiner notes that the opening must be transparent in the range of 400-2000 nm for the visible light camera (in the range of 400-700 nm) to be capable of imaging tissue.).
Regarding claim 81, claim 53 is obvious over Caplan, Miller, and Rajagopalan. However, neither Caplan, Miller, and Rajagopalan teach the that the biocompatible material further has a light and workable form which has a high surface hardness, low water absorption and dimensional stability, and is resistant to scratches, chemicals, heat, ultraviolet rays, and atmospheric conditions. Although Caplan discloses the cap used to protect a portion of the duodenum, which must be biocompatible with light and workable form which has a high surface hardness, low water absorption and dimensional stability, and is resistant to scratches, chemicals, heat, ultraviolet rays, and atmospheric conditions because the cap is used while the catheter is in the duodenum. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use a biocompatible material that has light and workable form which has a high surface hardness, low water absorption and dimensional stability, and is resistant to scratches, chemicals, heat, ultraviolet rays, and atmospheric conditions, for the purpose of protecting the Ampulla of Vater, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Aljuri et al. (US 20200330118), see Fig, 15 of Vakoc US 20160192976 that has a 360 degree hole for RF ablation.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOUSSA M HADDAD whose telephone number is (571)272-6341. The examiner can normally be reached M-TH 8:00-6:00.
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/MOUSSA HADDAD/Examiner, Art Unit 3796
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796