Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Examiner acknowledges claims 1, 3, 4, 5 and 14 have been amended. Claims 27, 28 and 32 were canceled in a previous amendment. Claims 1- 26, 29-31 and 33-44 are now pending in the present application.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-5, 7-8, 10-11, 14-15, 18-21 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Germain et al. (US Patent No 20160157916).
Regarding claim 1, Germain teaches an electrosurgical apparatus comprising: a housing (handle portion 104, para [0041]); a shaft extending from the housing and disposed along a longitudinal axis (see shaft 105 in fig. 1, para [0041]); an electrically conducting member (conductive sleeve 160, para [0049]); a cylindrical distal tip coupled to a distal end of the shaft (see fig 3, which shows the distal end of the end effector 115 with a cylindrical orientation), the distal tip including an interior, an outer wall (see fig 5A for working end 110 which is the distal tip), and at least one port (annular channel 146, para [0045]), the at least one port extending through the outer wall in a circumferential direction perpendicular the longitudinal axis (see figs 5A-6 for the annular channel 146 disposed through the outer wall of element 115 and found perpendicular through the longitudinal direction, para [0044]), the electrically conducting member at least partially disposed in the interior of the distal tip adjacent the at least one port (see fig 5A for conductive sleeve 160 disposed in the working end 110, which is adjacent the port opening 146) and configured to energize inert gas provided via the shaft to the interior of the distal tip such that plasma is ejected from the at least one port (the fluid flow restriction caused by the gap 145, as will be described below, is designed to focus electrical energy density to generate plasma in gap 145, para [0044], wherein the fluid can be a gas, see for example [0067] explaining how water vapor is used to ionize the gas for plasma treatment), wherein the at least one port arcs along the outer wall perpendicular to the longitudinal axis (see figs 5A-6 for the annular channel 146 disposed through the outer wall of element 115 and found perpendicular through the longitudinal direction, para [0044], wherein this specific configuration creates an annular and circular ablation region 150 around the longitudinal axis, [0045]-[0046]), the at least one port has a predetermined arc length in the circumferential direction such that the at least one port provides plasma in a 180-degree tissue treatment area about the longitudinal axis (see fig 8A for the ablation region 150 which is seen to generate a working plasma from the port 146 which is capable of having a treatment area 180 degrees oriented around the longitudinal axis seen in the figure, furthermore the ablation body portion is rotatable so that the working end is capable of providing a 180 degree treatment area about the longitudinal axis, [0061]).
Regarding claim 2, Germain teaches the electrosurgical apparatus of claim 1, wherein the predetermined arc length is slightly less than half of a Circumference of the distal tip.
Germain teaches the plasma ablation region 150 is adjacent and radially inward of the annular channel 146 in the planar surface 148 (para [0045]). The finely controlled plasma can be generated to have different geometries dependent upon the operating parameters of power, fluid inflows and fluid outflows. Therefore, as the plasma can be controlled to have different geometries it would teach the arc length as being less than half the circumference. See also Figure 8A-8B.
Regarding claims 3-5, Germain teaches the electrosurgical apparatus of claim 1, wherein the interior of the distal tip includes an inner wall transverses the longitudinal axis (see fig 5A for the slanted annular gap 145 which transverses the longitudinal axis, para [0044]) at a predetermined angle such that the plasma generated by the electrosurgical apparatus and the inert gas provided to the distal tip is directed through the at least one port to the exterior of the distal tip (the fluid flow restriction caused by the gap 145, as will be described below, is designed to focus electrical energy density to generate plasma in gap 145, para [0044]).
Germain also teaches the electrosurgical apparatus of claim 1, wherein the distal tip includes at least one second port extending through the outer wall of the distal tip in a circumferential direction perpendicular the longitudinal axis (see fig 5A for the slanted annular gap 145 which is perpendicular the longitudinal axis, para [0044]), the at least one second port diametrically opposed from the at least one first port (see fig 6. For the second port found on the opposite side of the larger annual channel 146 or first port for receiving the end of the ceramic member 144 which diametrically opposed and lays radially with respect to the longitudinal axis, see also para [0044]).
Regarding claim 7, Germain teaches the electrosurgical apparatus of claim 1, further comprising a support tube (sleeve 180, para [0050]) having a proximal and a distal end, wherein the proximal end of the support tube is disposed through the distal end of the shaft (see fig 5A for proximal end of sleeve 180 continues through the shaft portion of working end 110 or shaft, para [0050]) and coupled to the interior of the shaft (see fig 5A for sleeve 180 continuing through the interior of shaft 105) and the distal end of the support tube is disposed through a proximal end of the distal tip and coupled to the interior of the distal tip, the support tube configured to couple the distal tip to the distal end of the shaft and to provide support to the coupling of the distal tip to the distal end of the shaft (see distal end of the sleeve 180 coupled to the element 115 of the tip 100, para [0050], this sleeve is used to provide the support to the distal tip found at the end of the shaft).
Regarding claim 8, Germain teaches the electrosurgical apparatus of claim 7, wherein the support tube is made of a non-conducting material (sleeve 180 is insulating, para [0050]).
Regarding claim 10, Germain teaches the electrosurgical apparatus of claim 1, wherein the electrically conducting member is a support tube having a proximal and a distal end (conductive sleeve 160 having distal end 158 and proximal end 176, para [0049]), wherein the proximal end of the support tube is disposed through the distal end of the shaft and coupled to the interior of the shaft (fig.5A see tube 160 extends through shaft coupled to the interior of the shaft, see also para [0046]) and the distal end of the support tube is disposed through a proximal end of the distal tip and coupled to the interior of the distal tip (see fig 5A for the distal end of the tube 160 coupled to the non-conductive tube 175 of the distal tip 110), the support tube configured to couple the distal tip to the distal end of the shaft and to provide support to the coupling of the distal tip to the distal end of the shaft.
Regarding claim 11, Germain teaches the electrosurgical apparatus of claim 1, further comprising a coupling member disposed between the shaft and the distal tip, the coupling member configured to couple the distal tip to the shaft (coupling member sleeve 118 located axially between the shaft and the distal tip 110, para [0047]).
Regarding claim 14, Germain teaches the electrosurgical apparatus of claim 1, wherein the interior of the distal tip includes a channel in a distal end of the distal tip (see fig 5A for distal end of tube 175 which contains an opening 176 that receives conducting member 160) , the channel positioned distally to the at least one port in alignment with the longitudinal axis (see fig 9b, in which the slot 176 opens up to the chamber 177 which extends distally past the port 145 in the longitudinal direction) to securely receive a distal end of the electrically conducting member such that a portion of the electrically conducting member is disposed adjacent to the at least one port (see also fig 5A for the slot opening 176 configured adjacent to the port opening 145).
Regarding claim 15, Germain teaches the electrosurgical apparatus of claim 14, wherein the electrically conducting member includes a bent distal end disposed in the slot, the bent distal end configured to prevent distal tip from being decoupled from the shaft (the non-conductive sleeve 175 disposed in the slot is a flexible, non-kinkable PEEK that can flex and bend as the working end is articulated, para [0049]).
Regarding claim 18, Germain teaches the electrosurgical apparatus of claim 1, wherein the distal tip includes at least one protrusion and a distal end of the shaft includes at least one slot configured to receive the protrusion such that the distal tip is securely coupled to the distal end of the shaft (the movement of handle portion 128a about pivot 130 causes the upper handle end block 132 to engage and move flanges 133a, 133b of the inner sleeve 120b distally to thus articulate the working end 110, para [0042], in this case the flanges act as the protrusion slot combination).
Regarding claim 19, Germain teaches the electrosurgical apparatus of claim 18, wherein the at least one slot includes a first portion aligned along the longitudinal axis and a second portion extending perpendicularly to the longitudinal axis.
Germain teaches two different slotted portions 122a and 122b which can have any configuration of slot depth, orientation and shape to provide a desired range of articulated shapes, torque resistance and the like (para [0041]). And therefore, can take upon a parallel and perpendicularly aligned slot.
Regarding claim 20, Germain teaches the electrosurgical apparatus of claim 1, further comprising a connector (see connector housing 300, para [0062]) and a cable having a first end and a second end, the first end of the cable coupled to the housing and the second end of the cable coupled to the connector (see fig 1, cables connecting the housing 104 to the controller 195, Rf source 200 which are contained within the connector housing 300), the connector configured to be coupled to an electrosurgical generator to receive electrosurgical energy and the inert gas to be provided to the housing via the cable (receive the RF source 200 and the fluid source 170, para [0062]).
Regarding claim 21, Germain teaches the electrosurgical apparatus of claim 20, further comprising a stranded wire that couples the electrically conducting member to the cable, the stranded wire is configured to provide electrosurgical energy to the electrically conducting member (see fig 1, RF source wire for RF source 160 must be connected with the conductive member 180 in order to supply RF energy to the treatment end 110).
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) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Germain et al. (US Patent No 20160157916).
Regarding claim 9, Germain teaches the electrosurgical apparatus of claim 7, wherein the support tube is coupled to the shaft and distal tip via an adhesive.
Germain teaches that the sleeve 180 must be bonded to the distal end 182 (para [0050]) and furthermore teaches that adhesives are a suitable means for bonding (para [0049]) and therefore it would have been obvious for one skilled in the art to use an adhesive to bond the support tube with the distal tip.
Claim(s) 12, 13, 16, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Germain et al. (US Patent No 20160157916) in view of Fischer (US Patent No 6346108).
Regarding claim 12, Germain teaches the electrosurgical apparatus of claim 11, further comprising a support tube having a proximal and a distal end, wherein the proximal end of the support tube is disposed through the distal end of the shaft and coupled to the interior of the shaft, the distal end of the support tube is disposed through a proximal end of the distal tip and coupled to the interior of the distal tip as previously described in claims 7 and 10.
However, Germain does not teach the coupling member is formed via injection molding between the distal end of the shaft and the proximal end of the distal tip over the support tube.
The analogous probe for coagulation and ablation as disclosed by Fischer does teach creating insulating members via injection molding (column 2, line 12-15).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the electrosurgical apparatus of Germain with the injection molding method of Fischer in order to provide a more rapid and effective process of manufacturing the coupling member as disclosed by Fischer.
Regarding claim 13, the combination teaches the electrosurgical apparatus of claim 12, wherein the outer wall of the distal tip is configured as an elliptic paraboloid with a blunted tip converging toward the distal end (see Germain fig 4, depicting the distal end 115 as an elliptic paraboloid with a blunted tip).
Regarding claim 16, the combination teaches the electrosurgical apparatus of claim 1, wherein the distal tip includes a cap (see Germain fig 5A, cap 115) that is formed via injection molding over a distal end of the electrically conducting member to prevent the distal tip from being decoupled from the shaft (from Fischer, column 2, line 12-15).
Regarding claim 17, the combination teaches the electrosurgical apparatus of claim 1, wherein the distal tip is formed via injection molding over a distal end of the electrically conducting member to prevent the distal tip from being decoupled from the shaft (from Fischer, column 2, line 12-15).
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Germain et al. (US Patent No 20160157916) in view of Barton (US Patent No 20040034342).
Regarding claim 22, Germain teaches the electrosurgical apparatus of claim 1,
Germain does not teach the shaft includes at least one marking disposed a predetermined distance from one of a distal end of the distal tip or a center of the at least one port, such that when the at least one marking becomes visible to a user as the distal tip and shaft are pulled from patient tissue, the user is alerted to deactivate the electrosurgical apparatus.
However, the analogous medical optic cable with methods for improving treatment disclosed by Barton does include at least one marking disposed a predetermined distance from one of a distal end of the distal tip or a center of the at least one port (see fig 8 indicating regions 130 and 140), such that when the at least one marking becomes visible to a user as the distal tip and shaft are pulled from patient tissue, the user is alerted to deactivate the electrosurgical apparatus (to define the treatment region 150 and depth of treatment, para [0036]).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the electrosurgical apparatus of Germain with the preferred treatment methods of Barton in order to obtain an ideal treatment region for ablation and coagulation as disclosed by Barton.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Germain et al. (US Patent No 20160157916) in view of Karni (US Patent No 9215788).
Regarding claim 6, Germain teaches the electrosurgical apparatus of claim 4, wherein the at least one first port and at least one second port are configured such that the at least one first port and at least one second port to provide plasma a 360-degree tissue treatment area about the longitudinal axis (the shaft 105 is rotatable relative to handle 104 by manipulation of rotation collar 135 that is rotatably coupled to projecting portion 136 of the handle, para [0042], therefore the treatment area of the working end can be 360 degrees via the rotatable element).
Germain does not teach wherein in the plasma is simultaneously applied in a 360-degree tissue treatment area around the longitudinal axis.
However, the analogous plasma treatment system of Karni does teach a distal end effector containing two different slots (holes 16, see fig 7) to allow the plasma is simultaneously applied in a 360-degree tissue treatment area around the longitudinal axis (see fig 7, in which the plasma treatment 8 is applied in a 360-degree treatment area to the tissue which is around the longitudinal axis, also [0045] discloses that the holes 16 allow for a ring type discharge around the longitudinal axis).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the electrosurgical apparatus of Germain with the plasma treatment system of Karni in order to effectively deliver the plasma treatment to a wider range of tissue to be treated on the patient as disclosed by Karni, [0045].
Claim(s) 23-26, 29-31, 33, 35-44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Germain et al. (US Patent No 20160157916) in view of Karni (US Patent No 9215788) further in view of El-Sayed (University College London Hospital Medical Article: doi: 10.21037/gpm-2020-pfd-10).
Regarding claim 23, 39, 40 Germain teaches a method for using an electrosurgical device to tighten tissue (see para [0059]), the method comprising: accessing a subdermal tissue plane via an incision through tissue; inserting a distal tip of the electrosurgical device into the subdermal tissue plane (see fig 7, preferred embodiment of device inserted sub dermally into patient knee); activating the electrosurgical device to generate and apply plasma electrosurgical energy to the subdermal tissue plane via the distal tip; and heating tissue in the subdermal tissue plane to a predetermined temperature to tighten the tissue (see para [0059] and [0060] for the plasma generation device designed to be used in the subdermal tissue plane including heating the tissue with a plasma), moving the distal tip through the subdermal tissue plane to heat at least one different tissue (see [0083] in which the method of applying the end effector to the different target regions within the tissue is disclosed).
Germain does not teach when the electrosurgical device is activated, the tissue is heated above the predetermined temperature at a time duration of at least 0.04 seconds.
However, the analogous plasma treatment system of Karni does teach that the ignition stage can take from several milliseconds to several microseconds depending on the intended parameter, para [48]. And therefore, it would have been obvious for one skilled in the art to have the predetermined time duration parameter fall within the stated range to be at least 0.04 seconds.
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the method for using an electrosurgical device defined by Germain with the specific time range duration disclosed by Karni in order to get the most ideal treatment parameters as disclosed by Karni.
The combination does not teach the predetermined temperature is at least approximately 85 degrees Celsius.
However, the analogous minimally invasive electrosurgical method disclosed by El-Sayed in the research article teaches wherein the predetermined temperature is at least approximately 85 degrees Celsius (see the thermal tissue effects section, under Desiccation and Coagulation, wherein the gradual rise of the treatment temperature will be used between 60-95 degrees Celsius, therefore teaching and overlapping the claimed temperature of greater than 85 degrees).
Therefore, it would have been obvious for one skilled in the art to combine the electrosurgical method of Germain and Karni with the specific treatment temperature taught by El-Sayed in order to achieve the most ideal treatment temperature in clinical setting as disclosed by El-Sayed.
Regarding claim 24, the combination teaches the method of claim 23, wherein a waveform including a predetermined power curve is applied to an electrode of the electrosurgical device when the electrosurgical device is activated (see Germain para [0042] explaining the actuation of the device and then para [0046] and [0060] which disclose a waveform power curve applied to the RF electrode).
Regarding claim 25, the combination teaches the method of claim 23, wherein the activating step includes applying power to an electrode of the electrosurgical device is at a range between 24 and 32 Watts.
From Germain, the generator can be a conventional generator known in the art to achieve desired results, para [0062] and therefore it would be obvious for one skilled in the art to apply a range of 24 to 32 watts in order to optimize plasma delivery and power.
Regarding claim 26, the combination teaches the method of claim 24, wherein the predetermined power curve is configured such that the generated electrosurgical energy is pulsed (see Karni column 11, line 22-32 for pulsed electrosurgical energy).
Regarding claim 29, and 30 and 42 and 43 the combination teaches the method of claim 23, wherein inert gas is provided at a predetermined flow rate when the electrosurgical device is activated to generate plasma.
Although the combination does not explicitly disclose a predetermined flow rate Karni (column 10 lines 63-67) and Germain (para [0053] and [0054]) both disclose using ideal fluid parameters to obtain the most ideal plasma generation in which it would be obvious for one skilled in the art to use the ideal predetermined flow rate to obtain the most ideal plasma arc.
Regarding claim 31, 41, 44, the combination teaches the method of claim 29, wherein the inert gas is helium (see Karni, helium gas, para [06]).
Regarding claim 33,34 Germain teaches a method for using an electrosurgical device to tighten tissue (see para [0059]), the method comprising: accessing a subdermal tissue plane via an incision through tissue; inserting a distal tip of the electrosurgical device into the subdermal tissue plane (see fig 7, preferred embodiment of device inserted sub dermally into patient knee); activating the electrosurgical device to generate and apply electrosurgical energy to the subdermal tissue plane via the distal tip; heating tissue in the subdermal tissue plane to a predetermined temperature (see para [0059] and [0060] for the plasma generation device designed to be used in the subdermal tissue plane including heating the tissue with a plasma)to tighten the tissue,; and moving the distal tip through the subdermal tissue plane to heat at least one different tissue, (see [0083] in which the method of applying the end effector to the different target regions within the tissue is disclosed).
Germain does not teach when the electrosurgical device is activated, the tissue is heated above the predetermined temperature at a time duration of at least 0.04 seconds.
However, the analogous plasma treatment system of Karni does teach that the ignition stage can take from several milliseconds to several microseconds depending on the intended parameter, para [48]. And therefore, it would have been obvious for one skilled in the art to have the predetermined time duration parameter fall within the stated range to be at least 0.04 seconds.
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the method for using an electrosurgical device defined by Germain with the specific time range duration disclosed by Karni in order to get the most ideal treatment parameters as disclosed by Karni.
The combination does not teach the predetermined temperature is at least approximately 85 degrees Celsius.
However, the analogous minimally invasive electrosurgical method disclosed by El-Sayed in the research article teaches wherein the predetermined temperature is at least approximately 85 degrees Celsius (see the thermal tissue effects section, under Desiccation and Coagulation, wherein the gradual rise of the treatment temperature will be used between 60-95 degrees Celsius, therefore teaching and overlapping the claimed temperature of greater than 85 degrees).
Therefore, it would have been obvious for one skilled in the art to combine the electrosurgical method of Germain and Karni with the specific treatment temperature taught by El-Sayed in order to achieve the most ideal treatment temperature in clinical setting as disclosed by El-Sayed.
Regarding claim 35, 37, 38 the combination does not explicitly teach the removal of the device from the subdermal layer, and cleaning the device using a bristle brush, however anyone skilled in the art would have known this as an obvious step in the medical treatment method which does not have any pertinent effect on the novelty of the limitations and device methodology claimed.
Regarding claim 36, the combination teaches the method of claim 23, further comprising performing suction in the subdermal tissue plane before using the electrosurgical device to tighten tissue (from Germain, the device will suction fluid from the arthroscopic working space into the interior chamber 177 of the device through annular gap 146—and then outwardly through lumen 185 into the collection reservoir 192. In other words, the inflows and outflows will not be in equilibrium when the RF is not actuated, resulting in suctioning of fluid from the working space, para [0053]).
Claim(s) 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Germain et al. (US Patent No 20160157916) in view of Karni (US Patent No 9215788) further in view of El-Sayed (University College London Hospital Medical Article: doi: 10.21037/gpm-2020-pfd-10) further in view of Ginggen (US Patent No 20160192961).
Regarding claim 34, the combination of Germain, Karni and El-Sayed teach the method of claim 33.
The combination furthermore does not teach wherein a distal tip of the electrosurgical device is moved through the subdermal tissue plane at a predetermined speed, wherein the predetermined speed is greater than 1 centimeter per second.
However, the analogous method and apparatus for skin treatment disclosed by Ginggen does teach wherein a distal tip of the electrosurgical device is moved through the subdermal tissue plane at a predetermined speed, wherein the predetermined speed is at least 1 centimeter per second (see from Ginggen, [0276], in which the speed of the skin penetrating component may be about 0.1 m/s, which is at least 1 cm/s as presently claimed).
Therefore, it would have been obvious for one skilled in the art to combine the electrosurgical method of Germain, Karni and El-Sayed with the specific treatment speed taught by Ginggen in order to achieve the most ideal treatment speeds in clinical setting as disclosed by Ginggen, [0276].
Response to Arguments
Applicant's arguments filed 09/18/2025 have been fully considered and are partially persuasive.
In regards to the applicants’ arguments about claims 1, 2-22 and 39-41 in light of Germain, regarding the amendment that a cylindrical distal tip containing at least one port disposed through the outer wall and oriented in a radial direction perpendicular about the longitudinal axis has been considered but is ultimately unpersuasive. Examiner would like to point out that the claim language as analyzed under a broadest reasonable interpretation still discloses at least one port disposed through the outer wall and oriented in a radial direction perpendicular about the longitudinal axis as the annular channel 145 is disposed through the outer wall and is still oriented in a radial direction perpendicular to the longitudinal axis, as seen in fig 5A. Furthermore, as the applicant is also arguing that the purpose of this port is to arc around the outer wall to provide a 180 degree plasma working area, examiner would also like to bring up the disclosure paragraphs [0045]-[0046] as well as [0061] from Germain which fully disclose that the specific configuration creates an annular and circular ablation region 150 around the longitudinal axis, as well as disclosing that the distal end is rotatable and therefore can provide at least a 180 degree plasma working area. Furthermore, applicant argues that the teachings of Germain do not disclose wherein an inert gas is provided and energized to disperse the plasma, however, examiner would like to bring applicants attention to Germain [0067] which specifically discloses how a vapor is used to be ionized for plasma treatment and thereby teaches the claimed limitation as broadly as claimed. Therefore, as Germain still contains the limitations for the claims 1, 2-22 and 39-41, they remain rejected under the prior art of record rejection of Germain.
Regarding claim 14, applicant argues that the slot is configured to be distal to the at least one treatment port has been considered but is ultimately unpersuasive. Examiner would like to bring applicants attention to fig 9b, in which the slot 176 opens up to the chamber 177 which extends distally past the port 145 and is in alignment with the longitudinal axis. Furthermore, applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Regarding claims 23 and 33, the argument that the previous prior art of record rejection of Duncan was not published prior to the effective filing date of the present application has been considered and found to be persuasive. Therefore, the previous prior art of record rejection in view of Duncan has been withdrawn. However, after further search and consideration it has been found that the new prior art of record of El-Sayed in the research article teaches the claim limitation that was previously disclosed by Duncan in which the predetermined temperature is at least approximately 85 degrees Celsius (see the thermal tissue effects section, under Desiccation and Coagulation, wherein the gradual rise of the treatment temperature will be used between 60-95 degrees Celsius, therefore teaching and overlapping the claimed temperature of greater than 85 degrees). Therefore, as the claim limitations which were previously taught by Duncan are now taught by El-Sayed, the claims 23 and 33 now remain rejected under the new prior art of record rejection of Germain in view of Karni further in view of El-Sayed set forth in the present office action.
Regarding claim 34, the argument that the previous prior art of record rejection of Duncan was not published prior to the effective filing date of the present application has been considered and found to be persuasive. Therefore, the previous prior art of record rejection in view of Duncan has been withdrawn. However, after further search and consideration it has been found that the new prior art of record of Ginggen does teach the limitation which was previously disclosed by Duncan wherein a distal tip of the electrosurgical device is moved through the subdermal tissue plane at a predetermined speed, wherein the predetermined speed is at least 1 centimeter per second (see from Ginggen, [0276], in which the speed of the skin penetrating component may be about 0.1 m/s, which is at least 1 cm/s as presently claimed). Therefore, as the claim limitations which were previously taught by Duncan are now taught by Ginggen, the claim 34 now remains rejected under the new prior art of record rejection of Germain in view of Karni further in view of El-Sayed further in view of Ginggen set forth in the present office action.
All other claims as being dependent on the previous argued claims also remain rejected on the new prior art of record rejection set forth.
Conclusion
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/KYLE M. BROWN/
Examiner, Art Unit 3794