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 .
2. 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.
Response to Arguments
4. Applicant's arguments filed 10/03/2025 have been fully considered but they are not persuasive. Regarding Claim 1, the examiner relied upon Table 1 found in Doraiswamy (U.S. 2022/0142817) to teach the limitation that “a pitch multiple is defined by dividing a lay pitch of the wire rope by a diameter of the wire rope, and the wire rope has as pitch multiple in a range of 8 to 12”. However, the applicant contests that Table 1 is not supported in any of the provisional applications to which Doraiswamy claims priority (App. No. 62/872,494; App. No. 62/874,946; App. No. 62/945,160). The applicant further reasons that this would negate their respective filing dates, rendering Doraiswamy unable to be cited for those limitations. However, the examiner disagrees.
5. While ‘Table 1’ itself is not found explicitly in any singular provisional application to which Doraiswamy claims priority to, the content that is recited within ‘Table 1’ is found within the provisional applications. For example, in Provisional Application No. 62/945,160 (filing date 12/8/2019) states that “the pitch (separate between each ring) can be between about 0.0001” and about 0.1”, such as about 0.0001”, 0.0005”, 0.001”, 0.002”, 0.003”, 0.005”, 0.01”, 0.05”, 0.1”, or ranges including any two of the foregoing values” (see paragraph 0087 of the provisional application’s specification). Provisional Application No. ‘160 also states that “the wire tubing OD [outer diameter] can be between 0.005” to 0.10”…” (see paragraph 0014 of the provisional application’s specification). Further, in Provisional Application No. 62/874,946 (filing date 7/16/2019) states “The rings can include a proximal end, distal end, and a coiled section… the coiled section has a variable outer diameter along its length. The rings can be made of a smaller diameter shape memory wire or tube (e.g., about 5-30 µm wire diameter and 150-500 µm device outer diameter)…” (see paragraph 0005 of the provisional application’s specification), as well as states “the pitch (separate between each ring) can be between about 0.0001” and about 0.1”, such as about 0.0001”, 0.0005”, 0.001”, 0.002”, 0.003”, 0.005”, 0.01”, 0.05”, 0.1”, or ranges including any two of the foregoing values” (see paragraph 0077 of the provisional application’s specification). Provisional Application No. 62/872,494 (filing date 7/10/2019) states “the pitch (separate between each ring) can be between 0.0001” to 0.1”…” (see paragraph 0066 of the provisional application’s specification) and “the wire tubing OD [outer diameter] can be between 0.001” to 0.10”…” (see paragraph 0014 of the provisional application’s specification).
6. So, while the exact replication of ‘Table 1’ found in application 17/604,382 is not recited in any provisional application, the data presented in the table is found in multiple of the provisional applications. Therefore, the filing dates of these provisional applications may be relied upon when considering application 17/604,382. This renders said application applicable when considering it for prior art. Therefore, the previous rejections stand.
Claim Rejections - 35 USC § 103
7. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
8. Claims 1, 3-4, 11, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Moon U.S. 2017/0000646 (herein referred to as “Moon”) and in view of Doraiswamy U.S. 2022/0142817 (herein referred to as “Doraiswamy”) and Jia U.S. 2012/0078242 (herein referred to as “Jia”).
9. Regarding Claim 1, Moon teaches a capsulotomy apparatus (Fig. 1, ref num 100) for incising an anterior capsule covering a crystalline lens (para 0027), the capsulotomy apparatus comprising:
a. an electrode part (Fig. 2, ref num 110/111) of a circular loop shape (Fig. 2, ref num 110/111 has circular shape) configured to be inserted into the incision site of the cornea (para 0028) to make a circular incision in the anterior capsule located below the cornea (para 0028);
b. wherein the electrode part is formed of a wire rope (Fig. 3, ref num 112) and has a plurality of pitch spots (Fig. 3, ref num 112a, understood based on their twisted configuration) on a bottom surface of the electrode part (Fig. 3, para 0032);
c. wherein each of the plurality of pitch spots is an area of the electrode part where a distance to a living tissue of the anterior capsule is shortest when the electrode part is inserted through the incision site of the cornea and positioned above the anterior capsule (Fig. 1 shows incision site, ref num 22, where the device is positioned above the anterior capsule, ref num 50; the pitch spots, i.e. the twisting of the wire, para 0032, will having the shortest distance to the tissue when inserted above the anterior capsule, para 0031);
d.1 wherein the wire rope comprises a plurality of twisted strands (para 0030, “the wire portion 112 may be formed by twisting a plurality of wire members 112a”; see Fig. 3);
d.2 the plurality of pitch spots formed due to regular twisting of the strands (para 0030); and,
d.3 the plurality of twisted strands of the wire rope recover their original phase while moving a distance of a lay pitch (para 0030, “when the wire portion 112 includes one wire member 112a instead of a plurality of wire members 112a, it is difficult for the circular incision tool 111 to sufficiently maintain an original shape”; para 0043, “is formed by twisting the plurality of minute wires 112b and the plurality of wire members 112a, the circular incision tool 111 is not only preventing from being deformed”; see shape of ref num 111 in Fig. 4 compared to shape of ref num 111 in Fig. 3).
Moon fails to teach (c) the plurality of pitch spots are arranged at regular intervals, (d.2) incision bubbles are formed around each of the plurality of pitch spots by applying an electric pulse to the electrode part and to perform incision at regular spot intervals; (d.4) a pitch multiple is defined by dividing a lay pitch of the wire rope by a diameter of the wire rope, and (d.5) the wire rope has a pitch multiple in a range of 8 to 12.
Doraiswamy teaches an apparatus of analogous art (Fig. 4A), wherein the apparatus comprises a wire rope with a plurality of pitch spots arranged at regular intervals (Fig. 4B, ref num 401 has pitch spots; Fig. 11C shows regular intervals of pitch; para 0202). The wire rope also has a lay pitch (Table I, shown after para 0013, where there is a broad range of ‘Helical Pitch’ between 0.0001 to 10, measured in mm) and a diameter (Table I, shown after para 0013, where there is a broad range of ‘Wire Diameter’ between 0.0001 to 1, measured in mm). Since a pitch multiple is defined as dividing a layer pitch of the wire rope by a diameter of the wire rope, then the wire rope of Doraiswamy would have a range/variable pitch multiple dependent on the selected lay pitch (i.e., the ‘Helical Pitch’) and the wire diameter as defined in the disclosure. Since the broad range of the lay pitch (i.e., the ‘Helical Pitch’) may be selected between 0.0001 to 10 mm and the broad range of the wire diameter may be selected between 0.0001 to 1 mm, then the pitch multiple may fall between a range of 8 to 12 (for example, if the helical pitch is 8 mm, and the wire diameter is 1 mm, then the pitch multiple would be 8/1 = 8; another example, if the helical pitch is 2 mm, and the wire diameter is 0.1667 mm, the pitch multiple would be 2/0.1667 = 11.99). Doraiswamy also teaches that the varying size of the device, i.e., changing the wire diameter and/or the lay pitch (i.e., helical pitch) improves the control of the device, as well as provides customization based on the patient (para 0026, 0031). While Doraiswamy does not explicitly teach that the device is a capsulotomy apparatus, the device is fitted for use within the eye, as well as they discusses that the tension/dimensions of the device, such as the lay pitch (i.e., the helical pitch) and the wire diameter, are crucial to the placement and restorability of the device (para 0013, 0210). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Moon to have the plurality of pitch spots of the wire rope be arranged at regular intervals, as well as define a pitch multiple by dividing a lay pitch of the wire rope by a diameter of the wire rope, such that the pitch multiple is in a range of 8 to 12, since this would provide the benefit of fitting the device to the specific dimensions needed by the patient, as well as provide restorability to the wire rope when transformed between a compressed configuration and a second deployed configuration (Doraiswamy, para 0054, 0070).
Jia teaches a device of analogous art (Fig. 1), wherein the device provides pulsed energy to the working end of the apparatus (Fig. 1, ref num 110). This forms incision bubbles around the loop electrode at its pitch spots (para 0029). By applying the electric pulse, incision is performed at regular spot intervals (para 0027, “produces high-frequency pulses for application to the eye through cutting electrode 120”; para 0031). This reduces the collateral damage caused by overheating to the target area (para 0029). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Moon to have the energy application produce incision bubbles in order to reduce the collateral damage usually caused to the target area by overheating.
10. Regarding Claim 3, Moon teaches the wire rope forms the electrode part of a circular loop shape and a neck part that extends from one area of the electrode part (Fig. 3, ref nums 110, 115); and the neck part extends as portions of the wire rope at both ends of the electrode part come into contact into a straight form see Fig. 3, ref num 115 displays this), and an insulating layer is formed on an outer surface of the neck part (Fig. 3, ref num 113, para 0030-0031).
11. Regarding Claim 4, Moon teaches the neck part (Fig. 3, ref num 115) formed by one area of the wire rope has one end connected to the electrode part (see Fig. 3, ref num 115, left side is connected to electrode part, ref num 110) and the other end branched to formed a leg part (to the right, ref num 115 forms the leg part), and the leg part is fixed and coupled to a moving member (Fig. 3, ref num 115 is connected to moving member, ref num 122).
12. Regarding Claim 11, Moon fails to teach incision bubbles are formed around the plurality of pitch spots by applying radiofrequency pulses to the electrode part.
Jia teaches a device of analogous art (Fig. 1), wherein the device provides pulsed energy to the working end of the apparatus (Fig. 1, ref num 110). This forms incision bubbles around the loop electrode at its pitch spots (para 0029). This reduces the collateral damage caused by overheating to the target area (para 0029). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Moon to have the energy application produce incision bubbles in order to reduce the collateral damage usually caused to the target area by overheating.
13. Regarding Claim 14, Moon fails to teach the regular intervals at which the plurality of pitch spots arranged are identical to each other.
Doraiswamy teaches an apparatus of analogous art (Fig. 4A), wherein the apparatus comprises a wire rope with a plurality of pitch spots arranged at regular intervals, at which the plurality of pitch spots arranged are identical to each other (Fig. 4B, ref num 401 has pitch spots; Fig. 11C shows regular intervals of pitch that are identical; para 0202). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Moon to have the plurality of pitch spots arranged at regular intervals as it would have been an obvious matter of design choice to make the different portions of the wire rope of whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
14. Claims 2 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Moon, Doraiswamy, and Jia, and further in view of Auld U.S. 2011/0118734 (herein referred to as “Auld”) and Da Silva U.S. 2006/0142750 (herein referred to as “Da Silva”).
15. Regarding Claim 2, Moon fails to teach a generator electrically connected to the electrode part to apply an electric pulse for capsulotomy, wherein the electric pulse consists of a first pulse group and a second pulse group, the second pulse group is applied subsequently after application of the first pulse group, and the first and second pulse groups include respectively a plurality of mini-pulses, and a peak voltage of the plurality of mini-pulses of the second pulse group is 2.5 times to 3 times a peak voltage of the plurality of mini-pulses of the first pulse group.
Auld teaches a capsulotomy apparatus of analogous art (Fig. 1) wherein the apparatus comprises an electrode part (Fig. 1, ref num 120) and a generator electrically connected to the electrode part (Fig. 1, ref num 110 connected to ref num 120) to apply an electric pulse for capsulotomy (para 0024). The pulse generator is operated and monitored by a user, and also operated by feedback status (para 0031). The pulsed electric field is used to perform the cutting action in the eye (para 0023). Since Moon already teaches the energy being applied to the target area, then it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Moon to apply a pulse electric field, which is a well-known energy application, in order to cut the target area.
The combination of Moon-Auld fails to teach the electric pulse consists of a first pulse group and a second pulse group, the second pulse group is applied subsequently after application of the first pulse group, and the first and second pulse groups each include a plurality of mini-pulses, and a peak voltage of the second pulse group is 2.5 times to 3 times a peak voltage of the first pulse group.
Da Silva teaches a device that applies pulsed electric energy to a target area (0040-0045). The pulsed electric energy comprises of a first and second pulse groups (para 0051). The plurality of pulse groups may have different voltage peaks (para 0052), wherein the second pulse group may have a higher energy/voltage compared to the first pulse group (para 0052, “increasing pulse series with each successive pulse having a higher energy can also be used”). By adjusting the levels of voltage between pulse groups allows for better control of the temperature profile of the tissue in order to prevent burns (para 0052). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Moon to include multiple pulse groups when applying the electric pulse in order to control unwanted burns in the tissue, as well as have the peak voltage of the second pulse group be 2.5-3 times the peak voltage of the first pulse group since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
16. Regarding Claim 10, Moon as modified teaches the capsulotomy apparatus of claim 2 (see claim 2 rejection above), wherein the total duration of application of the first pulse group and the second pulse group is in a range of 1 ms to 200 ms (Da Silva, para 0017, 0039, 0043), such that the duration of the second pulse group is 1/4 to 2/3 of a duration of the first pulse group (Da Silva, para 0043, 0052), the first pulse group and the second pulse group each include RF mini-pulses (Da Silva, para 0044, 0005, 0017, 0039) and a voltage amplitude of the first group is less than or equal to 60% of a voltage amplitude of the second pulse group (Da Silva, para 0052, “increasing pulse series with each successive pulse having a higher energy can also be used”). By adjusting the levels of voltage between pulse groups, as well as the duration of application, this allows for better control of the temperature profile of the tissue in order to prevent burns (para 0052). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Moon to include multiple pulse groups when applying the electric pulse in order to control unwanted burns in the tissue, as well as have the voltage amplitude of the first pulse group be less than or equal to 60% of a voltage amplitude of the second pulse group since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
17. Claims 6 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Moon and in view of Doraiswamy, Auld, and Da Silva.
18. Regarding Claim 6, Moon teaches a surgical apparatus (Fig. 1, ref num 100) for making an incision in a living tissue (para 0027), the surgical apparatus comprising:
a. a hand piece (Fig. 2, ref num 124) including an electrode part (Fig. 2, ref num 110/111) of circular loop-shape (Fig. 2, ref num 110/111 has circular shape);
c. wherein the electrode part is formed of a wire rope (Fig. 3, ref num 112) and has a plurality of pitch spots (Fig. 3, ref num 112a ) arranged on a bottom surface of the electrode part (Fig. 3, para 0032);
d. wherein each of a plurality of pitch spots is an area of the electrode part where a distance facing living tissues is shortest when the electrode part is positioned above the living tissues (Fig. 1 shows incision site, ref num 22, where the device is positioned above the anterior capsule, ref num 50; the pitch spots, i.e., the twisting of the wire, para 0032, will having the shortest distance to the tissue when inserted above the anterior capsule, para 0031);
g.1 wherein the wire rope comprises a plurality of twisted strands (para 0030, “the wire portion 112 may be formed by twisting a plurality of wire members 112a”; see Fig. 3);
g.2 the plurality of pitch spots formed due to regular twisting of the strands (para 0030); and,
g.3 the plurality of twisted strands of the wire rope recover their original phase while moving a distance of a lay pitch (para 0030, “when the wire portion 112 includes one wire member 112a instead of a plurality of wire members 112a, it is difficult for the circular incision tool 111 to sufficiently maintain an original shape”; para 0043, “is formed by twisting the plurality of minute wires 112b and the plurality of wire members 112a, the circular incision tool 111 is not only preventing from being deformed”; see shape of ref num 111 in Fig. 4 compared to shape of ref num 111 in Fig. 3).
Moon fails to teach (b) a generator configured to transmit electrical energy to the electrode part; (c) the plurality of pitch spots are arranged at regular intervals; (e) wherein the generator applies electric pulse wave made of two consecutive pulse groups to the electrode part; (f) the two consecutive pulse groups include a first pulse group and a second pulse group, each pulse group includes mini-pulses, a peak voltage of the first pulse group is less than a peak voltage of the second pulse group, and a duration of the first pulse group is longer than a duration of the second pulse group; and, (g.4) a pitch multiple is defined by dividing a lay pitch of the wire rope by a diameter of the wire rope, such that (g.5) the wire rope has a pitch multiple in a range of 8 to 12.
Doraiswamy teaches an apparatus of analogous art (Fig. 4A), wherein the apparatus comprises a wire rope with a plurality of pitch spots arranged at regular intervals (Fig. 4B, ref num 401 has pitch spots; Fig. 11C shows regular intervals of pitch; para 0202). The wire rope also has a lay pitch (Table I, shown after para 0013, where there is a broad range of ‘Helical Pitch’ between 0.0001 to 10, measured in mm) and a diameter (Table I, shown after para 0013, where there is a broad range of ‘Wire Diameter’ between 0.0001 to 1, measured in mm). Since a pitch multiple is defined as dividing a layer pitch of the wire rope by a diameter of the wire rope, then the wire rope of Doraiswamy would have a range/variable pitch multiple dependent on the selected lay pitch (i.e., the ‘Helical Pitch’) and the wire diameter as defined in the disclosure. Since the broad range of the lay pitch (i.e., the ‘Helical Pitch’) may be selected between 0.0001 to 10 mm and the broad range of the wire diameter may be selected between 0.0001 to 1 mm, then the pitch multiple may fall between a range of 8 to 12 (for example, if the helical pitch is 8 mm, and the wire diameter is 1 mm, then the pitch multiple would be 8/1 = 8; another example, if the helical pitch is 2 mm, and the wire diameter is 0.1667 mm, the pitch multiple would be 2/0.1667 = 11.99). Doraiswamy also teaches that the varying size of the device, i.e., changing the wire diameter and/or the lay pitch (i.e., helical pitch) improves the control of the device, as well as provides customization based on the patient (para 0026, 0031). While Doraiswamy does not explicitly teach that the device is a capsulotomy apparatus, the device is fitted for use within the eye, as well as they discusses that the tension/dimensions of the device, such as the lay pitch (i.e., the helical pitch) and the wire diameter, are crucial to the placement and restorability of the device (para 0013, 0210). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Moon to have the plurality of pitch spots of the wire rope be arranged at regular intervals, as well as define a pitch multiple by dividing a lay pitch of the wire rope by a diameter of the wire rope, such that the pitch multiple is in a range of 8 to 12, since this would provide the benefit of fitting the device to the specific dimensions needed by the patient, as well as provide restorability to the wire rope when transformed between a compressed configuration and a second deployed configuration (Doraiswamy, para 0054, 0070).
Auld teaches a medical device of analogous art (Fig. 1) wherein the apparatus comprises an electrode part (Fig. 1, ref num 120) and a generator electrically connected to the electrode part (Fig. 1, ref num 110 connected to ref num 120) to apply an electric pulse for capsulotomy (para 0024). The pulse generator is operated and monitored by a user, and also operated by feedback status (para 0031). The pulsed electric field is used to perform the cutting action in the eye (para 0023). Since Moon already teaches the energy being applied to the target area, then it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Moon to apply a pulse electric field, which is a well-known energy application, in order to cut the target area.
The combination of Moon-Auld fails to teach the electric pulse consists of a first pulse group and a second pulse group, the second pulse group is applied subsequently after application of the first pulse group, and the first and second pulse groups each include a plurality of mini-pulses, and a peak voltage of the second pulse group is 2.5 times to 3 times a peak voltage of the first pulse group.
Da Silva teaches a device that applies pulsed electric energy to a target area (0040-0045). The pulsed electric energy comprises of a first and second pulse groups (para 0051). The plurality of pulse groups may have different voltage peaks (para 0052), wherein the second pulse group may have a higher energy/voltage compared to the first pulse group (para 0052, “increasing pulse series with each successive pulse having a higher energy can also be used”). By adjusting the levels of voltage between pulse groups allows for better control of the temperature profile of the tissue in order to prevent burns (para 0052). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Moon to include multiple pulse groups when applying the electric pulse in order to control unwanted burns in the tissue, as well as have the peak voltage of the second pulse group be 2.5-3 times the peak voltage of the first pulse group since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
19. Regarding Claim 15, Moon fails to teach the regular intervals at which the plurality of pitch spots arranged are identical to each other.
Doraiswamy teaches an apparatus of analogous art (Fig. 4A), wherein the apparatus comprises a wire rope with a plurality of pitch spots arranged at regular intervals, at which the plurality of pitch spots arranged are identical to each other (Fig. 4B, ref num 401 has pitch spots; Fig. 11C shows regular intervals of pitch that are identical; para 0202). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Moon to have the plurality of pitch spots arranged at regular intervals as it would have been an obvious matter of design choice to make the different portions of the wire rope of whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
20. Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Moon, Doraiswamy, and Jia, and further in view of Keller U.S. 2014/0207137 (herein referred to as “Keller”).
21. Regarding Claim 5, Moon fails to teach the electrode part includes an electrode made of an electrically conductive material and an insulating layer coated on an outer surface of the electrode; and the insulting layer is formed on upper and side surfaces of the electrode so that, when the electrode part is applied to face the living tissue in which an incision is to be made, a bottom surface of the insulating layer comes into contact with the living tissue while a bottom surface of the electrode that is not coated is spaced a predetermined distance apart from the tissues.
Keller teaches a surgical device of analogous art (Fig. 4), wherein the device includes an electrode part (Fig. 11A/11B, ref num 200 and Figs. 11A2/11A3/11A4, ref num 300). The electrode part includes an electrode (Fig. 11A2, ref num 4300) made of an electrically conductive material (Fig. 11A2, ref num 303, para 0076) and an insulating layer coated on an outer surface of the electrode (Fig. 11A3, ref num 301, para 0076, “the bottom edge 301A of the insulating support ring 301 does not have conductive material”). The insulating layer is formed on upper and side surfaces of the electrode (see Fig. 11A2, ref num 301 is found above ref num 303, as well as on the side) so that when the electrode part is applied to face the living tissue in which an incision is to be made (para 0076, 0090), a bottom surface of the insulating layer comes into contact with the living tissue (in another embodiment, Fig. 22A-C, insulating material, ref num 243, comes into contact with the tissue on the bottom side of the electrode, para 0090). The bottom surface of the electrode that is not coated with the insulating material is spaced a predetermined distance apart from the tissue (see tissue, ref num 240, and electrode 241, Fig. 22A-C). This insulation provides direction of the current flow from the electrode to the tissue by preventing current flow on the tissue except where the conductive areas of the electrode are exposed (para 0077). Since this is readily known in the field, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Moon to include a coated insulation portion of the electrode in order to better direct where the treatment current be directed in the device to the tissue (Keller, para 0077).
22. Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Moon, Doraiswamy, Auld, and Da Silva, and further in view of Jia.
23. Regarding Claim 7, Moon fails to teach incision bubbles are formed around each of the plurality of pitch spots by applying an electric pulse to the electrode part.
Jia teaches a device of analogous art (Fig. 1), wherein the device provides pulsed energy to the working end of the apparatus (Fig. 1, ref num 110). This forms incision bubbles around the loop electrode at its pitch spots (para 0029). This reduces the collateral damage caused by overheating to the target area (para 0029). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Moon to have the energy application produce incision bubbles in order to reduce the collateral damage usually caused to the target area by overheating.
24. Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Moon, Doraiswamy, Auld, and Da Silva, and further in view of Keller.
25. Regarding Claim 8, Moon teaches the electrode part includes a loop-shaped conductor electrode (Fig. 3, ref num 110/111) and an insulating layer coated on an outer surface of the electrode (Fig. 3, ref num 113, para 0031).
Moon fails to teach the insulating layer extends by as much as a predetermined length around a non-coated area formed at one side of the conductor electrode.
Keller teaches a surgical device of analogous art (Fig. 4), wherein the device includes an electrode part (Fig. 11A/11B, ref num 200 and Figs. 11A2/11A3/11A4, ref num 300). The electrode part includes an electrode (Fig. 11A2, ref num 4300) made of an electrically conductive material (Fig. 11A2, ref num 303, para 0076) and an insulating layer coated on an outer surface of the electrode (Fig. 11A3, ref num 301, para 0076, “the bottom edge 301A of the insulating support ring 301 does not have conductive material”). The bottom surface of the electrode that is not coated with the insulating material is spaced a predetermined distance apart from the tissue (see tissue, ref num 240, and electrode 241, Fig. 22A-C). This insulation provides direction of the current flow from the electrode to the tissue by preventing current flow on the tissue except where the conductive areas of the electrode are exposed (para 0077). Since this is readily known in the field, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Moon to include a coated insulation portion of the electrode in order to better direct where the treatment current be directed in the device to the tissue (Keller, para 0077).
26. Regarding Claim 9, Moon fails to teach the electrode part includes an electrode made of an electrically conductive material and an insulating layer coated on an outer surface of the electrode; the insulating layer is formed on an entirety of the outer surface of the electrode except for a non-coated area of the electrode; and the insulating layer extends around the non-coated area of the electrode to form both sidewalls of the non-coated area and form a space having one open surface.
Keller teaches a surgical device of analogous art (Fig. 4), wherein the device includes an electrode part (Fig. 11A/11B, ref num 200 and Figs. 11A2/11A3/11A4, ref num 300). The electrode part includes an electrode (Fig. 11A2, ref num 4300) made of an electrically conductive material (Fig. 11A2, ref num 303, para 0076) and an insulating layer coated on an outer surface of the electrode (Fig. 11A3, ref num 301, para 0076, “the bottom edge 301A of the insulating support ring 301 does not have conductive material”). The insulating layer is formed on upper and side surfaces of the electrode (see Fig. 11A2, ref num 301 is found above ref num 303, as well as on the side) so that when the electrode part is applied to face the living tissue in which an incision is to be made (para 0076, 0090), a bottom surface of the insulating layer comes into contact with the living tissue (in another embodiment, Fig. 22A-C, insulating material, ref num 243, comes into contact with the tissue on the bottom side of the electrode, para 0090). The bottom surface of the electrode that is not coated with the insulating material is spaced a predetermined distance apart from the tissue (see tissue, ref num 240, and electrode 241, Fig. 22A-C). This insulation provides direction of the current flow from the electrode to the tissue by preventing current flow on the tissue except where the conductive areas of the electrode are exposed (para 0077). Since this is readily known in the field, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Moon to include a coated insulation portion of the electrode in order to better direct where the treatment current be directed in the device to the tissue (Keller, para 0077).
Conclusion
27. THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
28. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNIE L SHOULDERS whose telephone number is (571)272-3846. The examiner can normally be reached Monday-Friday (alternate Fridays) 8AM-5PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at 571-272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ANNIE L SHOULDERS/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794