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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on February 18, 2025 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities: in paragraphs [0100] and [0101], “802” is used to refer to the second electrode and the first portion of the second electrode, respectively. However, according to the rest of the specification, the second electrode should be “302'”, the first portion of the electrode should be “800”, and “802” should instead refer to the second portion of the second electrode. Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities: on line 6, “electrode;” should be “electrode”. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: on line 3, “a first of the plurality of tubes” should be “a first tube of the plurality of tubes” and on lines 4-5, “a second of the plurality of tubes” should be “a second tube of the plurality of tubes”. Appropriate correction is required.
Claim 37 is objected to because of the following informalities: on line 2, “a first of the plurality of tubes” should be “a first tube of the plurality of tubes”, on line 4, “a second of the plurality of tubes” should be “a second tube of the plurality of tubes”, and on line 6 “a third of the plurality of tubes” should be “a third tube of the plurality of tubes”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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.
Claim(s) 1, 8-9, 11, 12, 17-18, 20-21, 23 are rejected under 35 U.S.C. 102(a)(1) as being taught by US 20070060920 A1 (Weitzner).
Regarding Claim 1, Weitzner teaches a probe for an electrosurgical device for treating tissue, the probe comprising:
an elongated shaft [50] having a proximal end, a distal end, and a longitudinal axis (see Fig. 2);
a first electrode [74] selectively extending from the distal end of the shaft (see Fig. 4);
and a second electrode [76] selectively extending from the distal end of the shaft, wherein the second electrode is spaced from the first electrode (see para. 0036, “Because both electrically conductive snares 74 and 76 can be selectively movable between retracted and expanded states, the operator can precisely control the amount of exposed conductive material serving to pass current between the snares).
Regarding Claim 8, Weitzner teaches at least a first portion (e.g., all of the exposed portion of [76]) of the second electrode is retractable relative to the first electrode (compare [76] relative to [74] in Figs. 3-6).
Regarding Claim 9, Weitzner teaches the first portion of the second electrode is longitudinally retractable into the shaft (compare Figs. 3-6).
Regarding Claim 11, Weitzner teaches retraction of the first portion of the second electrode changes a surface area of the second electrode exposed to the tissue (compare Figs. 3-6).
Regarding Claim 12, Weitzner teaches the first electrode has a substantially identical shape as the second electrode (see Figs. 4 and 6).
Regarding Claim 17, Weitzner teaches the first electrode and the second electrode have a first configuration relative to one another in an electrosurgical coagulation mode (see Fig. 6 and para. 0035, “the one electrically conductive snare would act as a monopolar electrode to assist in cutting through the target tissue while acting to coagulate and/or cauterize the underlying tissue site”).
Regarding Claim 18, Weitzner teaches the first electrode and the second electrode have a second configuration relative to one another in an electrosurgical resection mode (see e.g., the alternative configuration of Fig. 7; see also para. 0041).
Regarding Claim 20 and 21, Weitzner teaches a first of the second electrode portion (e.g., a first portion representing all of [76]) is selectively moveable thereby reducing a surface area of the second electrode exposed to the tissue (compare Figs. 3-6).
Regarding Claim 23, Weitzner teaches a surface area of the first electrode is no more than at least twice as large as a surface area of the second portion of the second electrode (a surface area will always be no more than at least twice as large as another surface area; e.g., the two can be roughly the same size).
Claim(s) 1, 8-9, 11-13, 20 are rejected under 35 U.S.C. 102(a)(2) as being taught by US 20090299362 A1 (Long et al.).
Regarding Claim 1, Long teaches a probe for an electrosurgical device [100] for treating tissue, the probe comprising:
an elongated shaft [12] having a proximal end, a distal end, and a longitudinal axis (see Figs. 11-12);
a first electrode [18] selectively extending from the distal end of the shaft (see Figs. 11-12);
and a second electrode [24] selectively extending from the distal end of the shaft, wherein the second electrode is spaced from the first electrode (see Figs. 11-12);
Regarding Claim 8, Long teaches at least a first portion [e.g., 30, 32] of the second electrode [24] is retractable relative to a second portion [54] of the second electrode (compare Figs. 11-12).
Regarding Claim 9, Long teaches the first portion [30, 32] of the second electrode is longitudinally retractable into the shaft (compare Figs. 11-12).
Regarding Claim 11, Long teaches retraction of the first portion [30, 32] of the second electrode changes a surface area of the second electrode exposed to the tissue (compare Figs. 11-12).
Regarding Claim 12, Long teaches the first electrode has a different shape from the second electrode (see Figs. 11-12).
Regarding Claim 13, Long teaches an illumination device [132] positioned at the distal end of the shaft (see para. 0038, “the distal end of the endoscopic portion 124 may comprise a light source”).
Regarding Claim 20, Long teaches a first portion [30, 32] of the second electrode is selectively moveable thereby reducing a surface area of the second electrode exposed to the tissue (compare Figs. 11-12).
Claim(s) 1, 12, 17, 20-21, 23 are rejected under 35 U.S.C. 102(a)(2) as being taught by US 20230036033 A1 (Banerjee et al.).
Regarding Claim 1, Banerjee teaches a probe for an electrosurgical device [10] for treating tissue (see Fig. 1), the probe comprising:
an elongated shaft [22] having a proximal end, a distal end, and a longitudinal axis (see Fig. 1);
a first electrode [302] selectively extending from the distal end of the shaft (see Fig. 5; see also para. 0013, “the electrosurgical instrument may further include a first actuator coupled to the housing and configured to selectively couple to each of the electrode tips for deploying and retracting the electrode tips relative to the shaft”);
and a second electrode [304] selectively extending from the distal end of the shaft, wherein the second electrode is spaced from the first electrode (see Fig. 5).
Regarding Claim 12, Banerjee teaches the first electrode has a different shape from the second electrode (see Fig. 5).
Regarding Claim 17, Banerjee teaches the first electrode and the second electrode have a first configuration relative to one another in an electrosurgical coagulation mode (see para. 0006, “distal tips to allow for various use scenarios such as, for example, tissue cutting, tissue coagulation, tissue cutting and coagulation, etc).
Regarding Claim 20, Banerjee teaches a first portion of the second electrode (e.g., the exposed portion of [304]) is selectively moveable thereby reducing a surface area of the second electrode exposed to the tissue (see Fig. 2; see also para. 0025).
Regarding Claim 21, Banerjee teaches the first portion of the second electrode represents no less than at least 90%, or 80% or 70% of a total surface area of the second electrode (e.g., a portion that constitutes all of the second electrode).
Regarding Claim 23, Banerjee teaches a surface area of the first electrode is no more than at least twice as large as a surface area of the second portion of the second electrode (the surface area of an electrode will always be no more than at least twice as large as the surface of any other electrode; e.g., the two can be roughly the same size).
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) 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over US 20090299362 A1 (Long et al.).
Regarding Claims 21 and 22, Long does not explicitly teach a first portion of the second electrode that represents no less than at least 90%, or 80% or 70% of a total surface area of the second electrode nor a second portion of the second electrode that remains stationary that is no less than at least 10%, 20% or 30% of the total surface area of the second electrode. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the device of Long include a first portion [30, 32] and second portion [54] that fall within the claimed range since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” (see Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984)). In the instant case, the device of Long would not operate differently with the claimed relative surface areas between the second and first portions considering the prongs that constitute the first portion [30, 32] of the electrode each appear to have a surface area that is at least larger than that of the second portion [54] and therefore foreseeably fall within the claimed ranges (e.g. each of the prongs might reasonably be 35% of the surface area for a total of 70% for the first portion and 30% for the remainder second portion). Furthermore, applicant places no criticality on the range claimed, indicating simply that the diameter “optionally” be within the claimed ranges (see Specification [0029-0030]).
Claim(s) 7, 36-38, 40-43 are rejected under 35 U.S.C. 103 as being unpatentable over US 20190059988 A1 (Davison et al.) in view of US 20230036033 A1 (Banerjee et al.).
Regarding Claim 36, Banerjee teaches a probe for an electrosurgical device [10] for treating tissue (see Fig. 1), the probe comprising:
an elongated shaft [22] having a proximal end, a distal end, and a longitudinal axis (see Fig. 1);
a first electrode [302] selectively extending from the distal end of the shaft (see Fig. 5; see also para. 0013, “the electrosurgical instrument may further include a first actuator coupled to the housing and configured to selectively couple to each of the electrode tips for deploying and retracting the electrode tips relative to the shaft”);
and a second electrode [304] selectively extending from the distal end of the shaft, wherein the second electrode is spaced from the first electrode (see Fig. 5).
Banerjee further teaches inflow and outflow ports [46] for an irrigating fluid (see Fig. 2; see also para. 0024) around where the electrode tips and suction and irrigation ports [46] are also located (see Fig. 2). However, Banerjee fails to explicitly teach that each of the electrodes have channels extending to a port and connecting to distinct tubes.
Davison teaches a first electrode [70] defining a first inflow port [74] for an irrigating fluid, a second electrode [80] defining a second inflow port [84] for the irrigating fluid, and an outflow port [52] positioned between the first electrode and the second electrode and spaced a distance from the first inflow port and the second inflow port, wherein the outflow port is configured to receive the irrigating fluid (see Figs. 4-5; see also para. 0054).
It would have been obvious before the effective filing date of the claimed invention for a person having ordinary skill in the art to modify Banerjee to include the configuration of inflow and outflow ports as suggested in Davison and described above. Because the electrodes are located at the distalmost location of the device when extended, doing so would allow the irrigation ports to be closer to the treatment site and also allow the user of the device to better adjust the position of the ports by extending and retracting the electrodes (as opposed to having to move the whole shaft with the ports on the side of the shaft).
Regarding Claim 7 and 37, Banerjee teaches tubing for irrigation and suction extending along the shaft to the distal end (see para. 0023) where the electrode tips and suction and irrigation ports [46] are also located (see Fig. 2). However, Banerjee fails to explicitly teach that each of the electrodes have channels extending to a port and connecting to distinct tubes.
Davison teaches a plurality of tubes [e.g., 240, 242] extending along the shaft [200] to the distal end (see Fig. 21), wherein a first electrode [222] is connected to at least a first tube [240] of the plurality of tubes and has a channel [274] therein extending to a first port [246] defined by the first electrode, wherein the second electrode [224] is connected to at least a second tube [242] of the plurality of tubes and has a channel [276] therein extending to a second port defined by the second electrode, and wherein a third tube [210] of the plurality of tubes has a channel [212] therein extending to communicate with the outflow port [252, 254] (see Figs 23-24; see also Figs 16-17 for an alternative port [74] configuration integral with the electrodes).
It would have been obvious before the effective filing date of the claimed invention for a person having ordinary skill in the art to modify Banerjee to include the configuration of the irrigation tubes, channels, and ports connected to and defined by the electrodes as suggested in Davison and described above. Because the electrodes are located at the distalmost location of the device when extended, this configuration allows the irrigation flow to be closer to the treatment site and also allows the user of the device to better adjust the position of the ports by extending and retracting the electrodes (as opposed to having to move the whole shaft with the ports on the side of the shaft).
Regarding Claims 38 and 40, Davison suggests the device is capable of having “different rates of saline flow and/or other saline flow characteristics” (see para. 0076). Because the flow rate of a fluid through a port depends on the pump or source connected to the port, the ports in the combination of Banerjee and Davison described above would be capable of having a flow rate that is similar to the claimed invention if coupled with a source that can provide for such flow (it is noted that the referenced claims include no limitations describing the source or pump of the irrigating fluid). Possible flow rates would include, as per Claim 38, a flow rate of the irrigating fluid through the outflow port that is between 1.1 times and 6 times greater than a flow rate of the irrigating fluid through the first inflow port and the second inflow port collectively. It would also include, as per Claim 40, a flow rate of the irrigating fluid through the outflow port that is between 5 ml/min to 600 ml/min, inclusive, and through the first inflow port and the second inflow port collectively that is between 5 ml/min to 100 ml/min, inclusive.
Regarding Claim 41, the combination of Banerjee and Davison described above does not explicitly teach a distalmost edge of the first inflow port and the second inflow port is between 0.125 inches and 0.335 inches, inclusive, from the outflow port. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have a distalmost edge of the first inflow port and the second inflow port to be between 0.125 and 0.335 inches, inclusive, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” (see Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984)). In the instant case, although Davison is silent on the distance from the outflow port of the distalmost edge of the first inflow port and the second inflow port, the combination of Banerjee and Davison would not operate differently with the claimed range, as it is roughly in line with what would be expected given the overall size of such electrosurgical devices. Further, applicant places no criticality on the range claimed, indicating simply that the distance “can” be within the claimed ranges (see [0124] of the Specification). As such, the claimed range would be obvious in the combination of Banerjee and Davison.
Regarding Claim 42, Banerjee teaches an area of the outflow port is substantially the same as an area of the first inflow port (see para. 0024; see also Fig. 2, where the plurality of fluid ports [46] for suction and irrigation are substantially the same size).
Regarding Claim 43, Banerjee does not teach a boss configured to cover a portion of one of the first electrode or the second electrode, wherein the boss extends distally from the distal end of the elongate shaft. However, Davison teaches a boss [750] configured to cover a portion of one of the first electrode or the second electrode, wherein the boss extends distally from the distal end of the elongate shaft (see Figs. 35-36). It would have been obvious for a person having ordinary skill in the art to modify the combination of Banerjee and Davison described above to further include such a boss. Doing so could assist in irrigation, such as by providing fluid ports and a sponge member, as suggested by Davison (see para. 0077).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN M SARCENO ROBLES whose telephone number is (571)272-8786. The examiner can normally be reached M-F: 8:30AM - 5:00PM.
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/C.S./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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