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.
Claim Rejections - 35 USC § 103
3. 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
4. Claims 1, 2, 8, 9, 11-13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Moak WO 2018/165277 (herein referred to as “Moak”), and in view of Wang U.S. 2022/0226039 (herein referred to as “Wang”).
5. Regarding Claim 1, Moak teaches a medical system (Fig. 1), comprising:
a. a sheath (Fig. 4, ref num 110), including an elongate body having a proximal portion and a distal portion (Fig. 4, ref num 110 has a proximal and distal end);
b. one or more sheath electrodes located on the distal portion (Fig. 4, ref nums 140d, 140c; pg. 9, lines 12-13, “The embodiment shown in Figure 4 has an additional electrode, 140d, located proximal to electrode 140c near the distal end of the sheath 110”);
c. a handle attached to the proximal portion (see Fig. 3, handle attached to proximal end of ref num 110); and
d. one or more first couplers capable of electrically coupling to a control system (Fig. 3, ref nums 147a-c);
e. a dilator including an elongate body having a proximal portion and a tapered distal portion (see Fig. 1 and 4, ref num 130 having a proximal end and distal tapered end);
f. one or more dilator electrodes located on the tapered distal portion (Fig. 4, ref nums 140a, 140b);
g. a hub attached to the proximal portion of the dilator (Fig. 3, ref num 112).
Moak fails to teach one or more second couplers located on the hub, wherein the one or more first couplers is configured to electrically couple with the one or more second couplers.
Wang teaches a medical system of analogous art (Figs. 2-3), wherein the system comprises a hub (Fig. 3, ref num 240) such that one or more second couplers are located on the hub (Fig. 3, ref num 242), as well as the system comprising one or more first couplers (Fig. 2, ref num 230). The one or more first couplers is configured to electrically couple with the one or more second couplers (Fig. 4, ref nums 242 and 230 are electrically coupled; para 0036, “the coupler 240 attached to the cannula 206 so that the coupler contacts 242 engage and electrically couple to the cannula contacts 230”). This couples the cannula to the energy source (para 0036). 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 Moak to include one or more second couplers that are electrically coupled with the first couplers in order to facilitate energy connection to the tool.
6. Regarding Claim 2, Moak teaches the sheath elongate body includes a lumen extending from the proximal portion to the distal portion and is configured to receive the dilator (pg. 5, lines 19 and 27, “A lumen extends between the proximal and distal ends of the sheath 110… The dilator 120 is positioned within the lumen of sheath 110”).
7. Regarding Claim 8, Moak fails to teach electrical connection is made between the one or more dilator electrodes and the control system when the one or more first couplers couples with the one or more second couplers.
Wang teaches electrical connection is made between the one or more tip electrodes and the control system when the one or more first couplers couples with the one or more second couplers (para 0027, “The active tip 212 of the cannula 206 is electrically coupled to one of the cannula contacts 230; para 0036, “the coupler 240 attached to the cannula 206 so that the coupler contacts 242 engage and electrically couple to the cannula contacts 230”). This couples the cannula and tip electrode to the energy source (para 0036). 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 Moak to include one or more second couplers that are electrically coupled with the first couplers in order to facilitate energy connection to the tool, specifically the dilator electrodes.
8. Regarding Claim 9, Moak teaches the one or more first couplers include a conductive surface (pg. 6, lines 12-14, “These electrode(s) 140 can connected by a wire 145 extending proximally on or through the dilator 120 outer surface to a lead 147 that is in electrical conductance with the electrode 140 (leads 147a/147b/147c shown in Figure 3)”).
9. Regarding Claim 11, Moak fails to teach the one or more first couplers or the one or more second couplers includes a contact that is proud of an insulated surface.
Wang teaches a contact that is proud of an insulated surface (Fig. 6A and 6B, ref num 250 is the insulated surface; ref nums 242 is proud from the insulating material ref num 250). The insulated surface allows the user to grip this area, but still provides electrical connection via the contact (para 0046). 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 Moak to have an insulated surface so that the user can facilitate the coupling but still provide electrical connection.
10. Regarding Claim 12, Moak fails to teach the one or more first couplers or the one or more second couplers includes a plurality of insulated regions.
Wang teaches an insulated region (Fig. 6A and 6B, ref num 250) that extends through multiple regions of the coupler (Fig. 6A, 6B, ref num 240). The insulated surface allows the user to grip this area, but still provides electrical connection via the contact (para 0046). 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 Moak to have insulated regions so that the user can facilitate the coupling but still provide electrical connection.
11. Regarding Claim 13, Moak teaches the control system is configured to determine position of the dilator with respect to the sheath (pg. 6, lines 14-15, “The electrode(s) is suitable for electromagnetic positioning”; pg. 7, lines 4-7, “Using such a guidance system, the magnetic-field sensor detects the strength of magnetic fields generated by magnetic coils placed below or near the patient, and the generated data is used to triangulate the position of the distal end 135 of the needle 130”).
12. Regarding Claim 15, Moak teaches the one or more sheath electrodes includes two sheath electrodes (Fig. 4, ref num 140c and 140d) and the one or more dilator electrodes includes two electrodes (Fig. 4, ref nums 140a and 140b). While Moak does not explicitly teach four sheath electrodes, they do teach that additional electrodes may be used in order improve resolution and location data of the tool (pg. 8). 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 Moak to have four sheath electrodes, as this provides additional location data, improving the resolution of the data.
13. Regarding Claim 16, Moak teaches a medical system (Fig. 1), comprising:
a. a sheath (Fig. 4, ref num 110), including an elongate body having a proximal portion and a distal portion (Fig. 4, ref num 110 has a proximal and distal end);
b. one or more sheath electrodes located on the distal portion (Fig. 4, ref nums 140d, 140c; pg. 9, lines 12-13, “The embodiment shown in Figure 4 has an additional electrode, 140d, located proximal to electrode 140c near the distal end of the sheath 110”);
c. a handle attached to the proximal portion (see Fig. 3, handle attached to proximal end of ref num 110); and
d. one or more first couplers (Fig. 3, ref nums 147a-c);
e. a dilator including an elongate body having a proximal portion and a tapered distal portion (see Fig. 1 and 4, ref num 130 having a proximal end and distal tapered end);
f. one or more dilator electrodes located on the tapered distal portion (Fig. 4, ref nums 140a, 140b);
g. a hub attached to the proximal portion of the dilator (Fig. 3, ref num 112); and
i. wherein the system is configured to determine the position of the dilator with respect to the sheath (pg. 6, lines 14-15, “The electrode(s) is suitable for electromagnetic positioning”; pg. 7, lines 4-7, “Using such a guidance system, the magnetic-field sensor detects the strength of magnetic fields generated by magnetic coils placed below or near the patient, and the generated data is used to triangulate the position of the distal end 135 of the needle 130”).
Moak fails to teach one or more second couplers located on the hub, wherein the one or more first couplers is configured to receive the one or more second couplers.
Wang teaches a medical system of analogous art (Figs. 2-3), wherein the system comprises a hub (Fig. 3, ref num 240) such that one or more second couplers are located on the hub (Fig. 3, ref num 242), as well as the system comprising one or more first couplers (Fig. 2, ref num 230). The one or more first couplers is configured to electrically couple with the one or more second couplers (Fig. 4, ref nums 242 and 230 are electrically coupled; para 0036, “the coupler 240 attached to the cannula 206 so that the coupler contacts 242 engage and electrically couple to the cannula contacts 230”). This couples the cannula to the energy source (para 0036). 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 Moak to include one or more second couplers that are electrically coupled with the first couplers in order to facilitate energy connection to the tool.
14. Regarding Claim 17, Moak teaches the one or more first couplers include a conductive surface (pg. 6, lines 12-14, “These electrode(s) 140 can connected by a wire 145 extending proximally on or through the dilator 120 outer surface to a lead 147 that is in electrical conductance with the electrode 140 (leads 147a/147b/147c shown in Figure 3)”).
15. Regarding Claim 19, Moak fails to teach the one or more first couplers or the one or more second couplers includes a contact that is proud of an insulated surface.
Wang teaches a contact that is proud of an insulated surface (Fig. 6A and 6B, ref num 250 is the insulated surface; ref nums 242 is proud from the insulating material ref num 250). The insulated surface allows the user to grip this area, but still provides electrical connection via the contact (para 0046). 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 Moak to have an insulated surface so that the user can facilitate the coupling but still provide electrical connection.
16. Claims 3-7 are rejected under 35 U.S.C. 103 as being unpatentable over Moak and Wang, and further in view of Long U.S. 2023/0248380 (herein referred to as “Long”).
17. Regarding Claim 3, Moak fails to teach the hub includes an upper surface, and the one or more second couplers extends from the upper surface, and wherein a rotational lock is formed between the sheath and the dilator when the one or more first couplers are coupled with the one or more second couplers.
Long teaches a medical system of analogous art (Fig. 1), wherein the system comprises a hub (Fig. 1, ref num 102) that includes an upper surface (see Fig. 1, ref num 102 has an upper surface depending on its orientation, i.e., towards ref num 110), such that one or more couplers extend from the upper surface (Fig. 1, ref num 110 extends from the upper surface of ref num 102), and wherein a rotational lock is formed between a sheath and a dilator when one or more first couplers are coupled with the one or more second couplers (Fig. 1, ref num 150 and 160 are the first and second couplers; Figs. 1 and 2A-C show the rotational lock between the sheath and dilator, ref num 120 and 130, via ref nums 252 and 262; para 0032, “each of the locking features 262 can be configured (e.g., shaped and sized) to bend or deflect the corresponding locking members 252 inwardly (toward the longitudinal axis X) to facilitate locking/coupling of the first cap 150 to the second cap 160… aligning the locking members 252 with the corresponding locking features 262 can include rotating the first cap 150 (e.g., about the longitudinal axis X) relative to the second cap 160”). This prevents unwanted movement of the dilator once advanced to the desired location (para 0016, “Because the first cap is coupled to the dilator, the interaction between the first and second caps when coupled can secure the dilator relative to the catheter to inhibit or even prevent the dilator from moving proximally and/or distally relative to the catheter”). 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 Moak and included a rotational lock between the sheath and dilator in order to prevent unwanted movement by the dilator.
18. Regarding Claim 4, Moak fails to teach the one or more first couplers and the one or more second couplers have corresponding shapes.
Long teaches the first and second couplers have corresponding shapes (para 0032, “each of the locking features 262 can be configured (e.g., shaped and sized) to bend or deflect the corresponding locking members 252 inwardly (toward the longitudinal axis X) to facilitate locking/coupling of the first cap 150 to the second cap 160. In the illustrated embodiment, individual ones of the locking features 262 are configured (e.g., shaped, sized, positioned) to releasably receive a corresponding one of the locking members 252”). This facilitates a fit between the first and second couplers when mating them (para 0032). 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 Moak to have the first and second couplers have corresponding shapes to facilitate the locking feature between the couplers.
19. Regarding Claims 5, 6, and 7, Moak fails to teach a cross-section of the one or more first couplers and the one or more second couplers is symmetrical (claim 5) OR asymmetrical (claim 6), and that the cross-section includes one or more concave portion and one or more convex portion.
Long teaches various shapes of the first and second couplers (para 0031, “In the illustrated embodiment, the first cap 150 and the second cap 160 have circular shapes. In other embodiments, the first cap 150 and/or the second cap 160 can have a triangular, square, rectangular, rectilinear, curvilinear, or any other suitable shape. In at least some embodiments, the first cap 150 and the second cap 160 can have a same shape. In other embodiments, the first cap and the second cap can have different shapes”). The cross-section includes one or more concave and convex portions (Fig. 2A, ref num 252 is convex portion, ref num 262 is concave portion). It would have been an obvious matter of design choice to make the different portions of the cross-sections of the first and second couplers 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. Claims 10 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Moak and Wang, and further in view of Misener U.S. 2022/0401702 (herein referred to as “Misener”).
21. Regarding Claims 10 and 18, Moak fails to teach the one or more first couplers or the one or more second couplers includes an insulated housing configured to confine a brush.
Misener teaches a medical system of analogous art (Figs. 1, 13, and 14), wherein the system comprises couplers with an insulated housing (Fig. 14, ref num 198, insulation, ref num 192), such that the insulated housing confines a brush (Fig. 14, ref num 202; para 0115, “the two electrical contacts 200 within the needle hub 192 directly or indirectly establish electrical connections with other electrical contacts including two brushes 202 in the intraosseous drill 190”). The brush facilitates connection between the couplers and the tool (para 0115). 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 Moak to have a brush confined in an insulated housing in order to safely provide electrical connection to the tool.
22. Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Moak and Wang, and further in view of Davies U.S. 2017/0360498 (herein referred to as “Davies”).
23. Regarding Claim 14, Moak fails to teach a display for displaying one or more anatomical images, parameters, and positioning information.
Davies teaches a system of analogous art (Figs. 1 and 3), wherein the system comprises a display for displaying anatomical images (para 0046, “Step 210 includes creating anatomical landmarks by using ICE for identifying key anatomical features and displaying the anatomical features on the EAM screen (e.g. a CARTO® screen image)…”; see Fig. 2). This allows for the user to identify the target region, and successfully transmit the desired treatment to said region (Fig. 2, ref nums 250-270). 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 Moak to include a display in order to relay information to the user and successfully treat the target area.
23. Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Moak, and in view of Long and Davies.
24. Regarding Claim 20, Moak teaches a medical system (Fig. 1), comprising:
a. a sheath (Fig. 4, ref num 110), including an elongate body having a proximal portion and a distal portion (Fig. 4, ref num 110 has a proximal and distal end);
b. one or more sheath electrodes located on the distal portion (Fig. 4, ref nums 140d, 140c; pg. 9, lines 12-13, “The embodiment shown in Figure 4 has an additional electrode, 140d, located proximal to electrode 140c near the distal end of the sheath 110”);
c. a handle attached to the proximal portion (see Fig. 3, handle attached to proximal end of ref num 110); and
e. a dilator including an elongate body having a proximal portion and a tapered distal portion (see Fig. 1 and 4, ref num 130 having a proximal end and distal tapered end);
f. one or more dilator electrodes located on the tapered distal portion (Fig. 4, ref nums 140a, 140b);
g. a hub attached to the proximal portion of the dilator (Fig. 3, ref num 112).
Moak fails to teach one or more sockets; one or more plugs located on the hub, wherein the one or more sockets is configured to receive the one or more plugs; and a display for displaying one or more anatomical images, parameters, and positioning information.
Long teaches a medical system of analogous art (Fig. 1), wherein the system comprises a hub (Fig. 1, ref num 140) such that one or more plugs extend from the hub (Fig. 1, ref num 150/252). Further, Long teaches one or more sockets that are configured to receive the one or more plugs (Fig. 2A, 262; para 0032, “each of the locking features 262 can be configured (e.g., shaped and sized) to bend or deflect the corresponding locking members 252 inwardly (toward the longitudinal axis X) to facilitate locking/coupling of the first cap 150 to the second cap 160… aligning the locking members 252 with the corresponding locking features 262 can include rotating the first cap 150 (e.g., about the longitudinal axis X) relative to the second cap 160”). This prevents unwanted movement of the dilator once advanced to the desired location (para 0016, “Because the first cap is coupled to the dilator, the interaction between the first and second caps when coupled can secure the dilator relative to the catheter to inhibit or even prevent the dilator from moving proximally and/or distally relative to the catheter”). 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 Moak and included sockets and plugs in order to prevent unwanted movement by the dilator.
Davies teaches a system of analogous art (Figs. 1 and 3), wherein the system comprises a display for displaying anatomical images (para 0046, “Step 210 includes creating anatomical landmarks by using ICE for identifying key anatomical features and displaying the anatomical features on the EAM screen (e.g. a CARTO® screen image)…”; see Fig. 2). This allows for the user to identify the target region, and successfully transmit the desired treatment to said region (Fig. 2, ref nums 250-270). 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 Moak to include a display in order to relay information to the user and successfully treat the target area.
Conclusion
25. 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.
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/ANNIE L SHOULDERS/Examiner, Art Unit 3794