DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 3 and 17 are cancelled. A complete action on the merits of pending claims 1, 2, 4-16, and 18-22 appears herein.
Response to Arguments
Applicant's arguments filed 06/12/2026 have been fully considered but they are not persuasive.
Applicant argues “Hacker does not disclose "wherein the transition passage forms an inlet cross section that decreases along the transition passage and along the arcuate swept path to an outlet cross section in connection with the lumen." For this reason, the teachings of Hacker, alone or in combination, would not anticipate the elements of amended claim 1. The Office Action alleges, on page 5, that Hacker discloses an arcuate swept path by stating, "[t]he transition between the bottom surface (72) of the internal aspiration collection chamber and the distal linear surface (62) is curved." Therefore, by the logic applied in the Office Action, any alleged arcuate path in Hacker is at the bottom of the aspiration chamber opposite the aperture. Therefore, applying the logic of the Office Action, cross-sectional decreases in the aspiration chamber in Hacker occur near the aperture, which are opposite the alleged arcuate path in Hacker.”
Examiner respectfully disagrees. As seen in attached “Annotated Hacker Fig. 4” below, the arcuate swept path formed by the portions of aspiration collection chamber (22) labelled “Curve 1” and “Curve 2” are located on the opposite end of said aspiration chamber as the aperture (aspiration inlet (46)). Furthermore, the arcuate swept path formed by “Curve 1” and “Curve 2” leads to/from an outlet cross section, (Fig. 6, Char. 58: outlet) wherein the cross section of chamber (22) decreases as along said arcuate swept path towards the outlet cross section.
Annotated Hacker Fig. 4
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Applicant further argues “Amended claim 1 recites an inlet cross section that decreases along the arcuate swept path, which is structurally opposite Hacker. Amended claim 1 states that the cross section decreases near the lumen, rather than near the aperture.”
Examiner respectfully disagrees. Claim 1 merely requires the cross section decreases along the transition passage and along the arcuate swept path. Furthermore, the inlet cross section that decreasing along the arcuate swept path is not structurally opposite Hacker. As seen in attached Annotated Hacker Fig. 4 above, Hacker teaches an inlet (Fig. 6, Char. 22: aspiration collection chamber) cross section that decreases, both in the radial and longitudinal directions of the inlet, due to the curved path formed by the curves in said inlet labelled “Curve 1” and “Curve 2.”
Applicant further argues “Hacker does not disclose "wherein a cross section of the internal passage forming the transition passage is swept from the longitudinal axis along the lumen to the at least one aperture extending laterally from the longitudinal axis," as recited in pending claim 4.”
Examiner respectfully disagrees and contends that, as seen in attached “Annotated Hacker Fig. 4” above, the swept path formed by “Curve 1” and “Curve 2” extends from the longitudinal axis (52) towards aspiration inlet (46), which extends laterally from longitudinal axis (52).
Applicant further argues “Hacker teaches the opposite of claim 4. In particular, the "swept path" of the transition passage does not appear to be considered in the pending rejection. Though not limiting to the scope of the claims, general understanding of a swept path may include a path that is continuous and without abrupt or sudden changes.”
Examiner respectfully disagrees. The “swept path” of the transition passage is considered, as shown by the reference to the curved transition between the bottom surface (72) and distal linear surface (62) in the rejection to claim 4 further discussed below. As best understood by examiner, the definition of a “swept path” given by applicant above is not recited/discussed anywhere in their specification. Even if said definition can be applied to the term “swept path,” Examiner contends that, given broadest reasonable interpretation, a “swept path” can generally be interpreted as a curved path and not a path “without abrupt or sudden changes.”
Applicant further argues “The channel and the aspiration collection chamber of Hacker each vary in size, space, and shape, meaning a cross section of the channel cannot be swept to the cross section of the aspiration collection chamber, as evidenced by Column 2, lines 51-56 of Hacker, which states, "[t]he internal aspiration collection chamber may be formed from a first section and a second section, whereby the first section has a larger cross-sectional area than the second section and the first section is positioned closer to the active electrode than the second section.”
Examiner respectfully contends that the current claim language does not require a constant size, space, or shape of/between the lumen (aspiration chamber (22)) and/or the outlet cross section. (outlet (58)) As discussed above, the term “swept,” given broadest reasonable interpretation, can be interpreted as curved. As shown in attached “Annotated Hacker Fig. 4” above, Hacker teaches a swept (curved) path from longitudinal axis (52) towards aperture (46) due to “Curve 1” and “Cure 2.”
Applicant further argues “Further, Hacker includes a threaded portion along the distal end of the channel that engages a support arm that protrudes into the aspiration collection chamber. The threaded portion along the distal tip creates various cross sections along the channel, and the protrusion into the aspiration chamber creates an inconsistent cross section for the aspiration chamber. The inconsistent cross sections of Hacker, then, cannot be consistent with a cross section that "is swept from a longitudinal axis along the lumen to the at least one aperture," as described in claim 4.”
Examiner respectfully disagrees and contends that, as discussed above, the term “swept,” given broadest reasonable interpretation, can be interpreted as curved. As shown in attached “Annotated Hacker Fig. 4” above, Hacker teaches a swept (curved) path from longitudinal axis (52) towards aperture (46) due to “Curve 1” and “Cure 2.” Furthermore, the claim language requires the cross section to decrease along the arcuate swept path. Therefore, as best understood by examiner given applicant’s definition
Applicant further argues “Hacker does not expressly or inherently teach, nor would it have informed the person of ordinary skill of the supply electrode positioning relative to the return electrode along any length of the distal tip. In addition to the deficiencies of the disclosure, the Office Action does not set forth any reasoning for how Hacker reads on claim 10 other than simply citing Fig. 5 of Hacker, which lacks evidence that Hacker inherently describes claim 10.”
Examiner respectfully contends that, as further discussed in the rejection of claim 10 below, Hacker teaches an edge of the outer surface (44) of return electrode (38) is generally parallel/equidistant from active electrode (14) along at least half of the length of active electrode (14), as shown in attached “Annotated Hacker Fig. 5” below.
Annotated Hacker Fig. 5
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Applicant further argues “Hacker teaches uneven spacing between the supply electrode and the return electrode along the distal end of the electrode length. Specifically, Hacker discloses the return electrode extending beyond the distal end of the supply electrode and arcing back towards the supply electrode at the distal end of the device. The curvature at the distal end of the return electrode creates an unequal distance between the return electrode and the supply electrode along at least 25% of the electrode length disclosed in Hacker. Moving distally to proximally, the distance between the supply electrode and the return electrode in Hacker gradually increases along at least 25% of the length of the supply electrode.”
Examiner respectfully contends that, as further discussed in the rejection to claim 10 below, Hacker teaches at least the proximal half of the supply electrode length is generally parallel/equidistant from the return electrode as shown in attached “Annotated Hacker Fig. 5” above.
Applicant further argues “Considered as a whole and based on the express disclosure, Hacker has a different approach than what is recited in claim 10 with a different structure that is neither disclosed expressly or inherently. That is, Hacker does not teach the spacing between the supply electrode and the return electrode being approximately equidistant along at least 25% of the length of the active electrode and instead Hacker discloses the spacing between the electrodes tapering specifically along the distal end portion. Accordingly, Hacker does not expressly or inherently disclose every element of claim 10 for at least these reasons and withdrawal of the rejection is respectfully requested.”
Examiner respectfully contends that, as further discussed in the rejection to claim 10 below, Hacker teaches at least the proximal half of the supply electrode length is generally parallel/equidistant from the return electrode as shown in attached “Annotated Hacker Fig. 5” above. The tapering at the distal end of electrodes is not prohibited by the current claim language of claim 10.
Applicant further argues “One of ordinary skill in the art would not use the teachings of Aluru to derive claim 9. Any alleged perimeter edge that Aluru may disclose is not evenly spaced from the return electrode along the distal end portion, which Aluru alleges is a functional advantage. As illustrated in annotated FIG. 2B, D1 represents a first distance from a distal portion of the alleged perimeter edge of the active electrode to the return electrode and D2 represents a second distance from a distal portion of the alleged perimeter edge of the active electrode to the return electrode. As shown, the distance between the active electrode 104 and the return electrode varies from the length D1 to the much shorter length D2, along the distal end portion of the active electrode 104. Aluru states, in Column 12, lines 40-46, that "[d]istal portion 120 includes at least one return electrode 112 and at least one active electrode 104. As shown in more detail in FIG. 2B, return electrode 112 encircles at least a portion of the shaft distal portion 120 and may extend distally and proximally relative to the active electrode 104 so that the active electrode 104 is generally surrounded or at least partially encircled." (emphasis added). Aluru goes on to state, in Column 12, line 65-Column 13, line 1, "this configuration of the return electrode 112 shown in FIG. 2B is believed to maintain a more uniform tissue effect along the proximal and distal portions of the lateral sides of the active electrode 104," illustrating that Aluru would lead a person of ordinary skill in the art to vary spacing between the perimeter edge of the supply electrode to the return electrode in contradiction to the evenly spaced configuration claimed.”
Examiner respectfully contends that, as further discussed in the rejection to claim 9 below, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Aluru teaches maintaining a consistent distance between an active electrode and a return electrode provides a more uniform tissue effect along the areas of the active and return electrodes with said consistent distance. (Col. 12, Line 53 – Col. 13, Line 1) Changing the return electrode (38) of Hacker to incorporate the teachings of Aluru and be parallel to and evenly spaced with the active electrode (14) of Hacker along the entire length/perimeter of active electrode (14), as proposed in the rejection to claim 9 below, would result in a more uniform tissue effect along the perimeter of the active electrode.
Applicant further argues “With regard to claim 14, the references fail to disclose the features set forth in claim 14. Hacker fails to disclose "conducting the control signal across an insulating gap generates an edge ablation region extending about the distal end portion of the ablation device between the supply electrode and the return electrode," as set forth in claim 14. Specifically, Hacker does not disclose an edge ablation region as claimed. The control signal in Hacker is conducted across an uneven insulation gap. The control signal being conducted along an uneven insulation gap creates an ablation region that corresponds to the shape of the face of the active electrode. In this case, Hacker only discloses an ablation region that is disc- shaped. In order to ablate tissue, the exterior face of the active electrode in Hacker must face the tissue, such that the disc-shaped ablation region interacts with the tissue. Hacker does not conduct the signal across an approximately consistent insulation gap. Based on these limited teachings, there is no instruction that can be relied upon to teach, suggest, or otherwise disclose the edge ablation region of claim 14 that extends beyond. Advantageously, extending the ablation region along the distal end of the apparatus may allow the device to effectively access and treat tissue along the distal edge of the apparatus, which may be beneficial in arthroscopic procedures where accessibility in the joint space is limited.”
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). As further discussed in the rejection to claim 14 below, Aluru teaches maintaining a consistent distance between an active electrode and a return electrode provides a more uniform tissue effect along the areas of the active and return electrodes with said consistent distance. (Col. 12, Line 53 – Col. 13, Line 1) In the rejection to claim 14, the return electrode (38) of Hacker was modified to incorporate the teachings of Aluru and be parallel/equidistant from the active electrode (14) of Hacker as doing so would provide the more uniform tissue effect taught by Aluru.
Furthermore, the ablation region would radiate from the distal end portion (electrode assembly 12) and wouldn’t only be focused on whatever’s immediately facing the outer surface (42) of active electrode (14). (e.g. The ablative energy would be emitted as a field surrounding the electrode assembly (12))
Applicant further argues “Examples of the operation and advantages of the edge ablation region extending along the distal end of the apparatus are described throughout the application. For example, in paragraph [0040], the disclosure describes the edge ablation region as providing for the distal electrode portion to extend into narrow cavities that may not accommodate the comparatively enlarged portions of the proximal electrode portion. In contrast, Hacker does not teach, suggest, or provide motivation for modifying the electrode position for penetrating and extending into narrow cavities within the joint. Hacker cannot be relied upon to provide relevant information related to an edge ablation region because Hacker the disclosed ablation treatment is only discussed as being orthogonal to the shaft, immediately adjacent the face of the active electrode.”
Examiner respectfully contends that, the term “edge ablation region” appears to merely refer to the edges of the field of ablative energy emitted by the electrodes. The bipolar electrodes of Hacker would produce a similar field of ablative energy and would therefore produce a similar “edge ablation region.” The current language of Claim 14 does not require the electrode to penetrate and/or extend into narrow cavities within a joint. The field of ablative energy emitted by Hacker isn’t only emitted from the outer surface/face of active electrode (14). As best understood by examiner, there is no teaching/recitation in Hacker that the ablative energy is only emitted from the outer face of the active electrode in a direction orthogonal to the longitudinal axis (52).
Applicant further argues “An edge ablation region was not known in the art prior to Applicant's disclosure. The Office Action has provided no express or inherent reasoning that a person of ordinary skill in the art would be motivated to modify the electrode positioning to create an edge ablation field. Therefore, any allegation in the Office Action that Hacker teaches an edge ablation region was derived using impermissible hindsight.”
Examiner contends that Hacker being silent regarding an “edge ablation region” does not mean an “edge ablation region” is not present. The field of ablative energy emitted by Hacker isn’t only emitted from the outer surface/face of active electrode (14). As best understood by examiner, there is no teaching/recitation in Hacker that the ablative energy is only emitted from the outer face of the active electrode in a direction orthogonal to the longitudinal axis (52). As discussed above, the bipolar electrodes of Hacker would produce a similar field of ablative energy and would therefore produce a similar “edge ablation region.”
Applicant further argues “With regard to claim 18, the references fail to disclose the features set forth in claim 18. Bagaoisan is generally directed to sealing a vascular puncture. Therefore, Bagaoisan fails to remedy the shortcomings of Hacker and Aluru to disclose "passing an acting end of the ablation device through a rigid cylindrical access envelope having a diameter and a length, wherein the diameter is less than two times a width of the elongated shaft and the length is at least two times the width," as set forth in amended claim 18.”
Examiner respectfully contends that, as further discussed in the rejection to claim 18 below, Bagaoisan was not relied on to teach any ablation features. Bagaoisan was used to teach an outer sheath structure (rigid access envelope) configured to facilitate the insertion of a surgical instrument/device into a target tissue. The rigid access envelope of Bagaoisan has diameter less than two times a width of inserted surgical instrument/device (Fig. 6B) and a length at least two times the width. (Fig. 6B)
Applicant further argues “Bagaoisan is non-analogous art and unrelated to claim 18. Bagaoisan teaches plugging an opening within a patient with a sealant using a cartridge, sealant, and a pushing member. Plugging an opening with a sealant is unrelated to delivering an ablation treatment.”
In response to applicant's argument that Bagaoisan is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Bagaoisan is reasonably pertinent to the particular problem with which the inventor is concerned due to Bagaosian being directed towards a surgical catheter device configured to be inserted into a target tissue to treat said tissue.
Applicant further argues “Claim 18, which depends from claim 14, is a method for delivering an ablation treatment. One of ordinary skill in the art would not look to a device including a cartridge, sealant, and pushing member for instruction on bipolar ablation. Further, Bagaoisan does not recite instructions, teachings, suggestions, or motivation for modifying the device in Bagaoisan for a method of ablation treatment, or for passing an acting end of the ablation device through a rigid cylindrical access envelope. An ablation device is not a cartridge, and one of ordinary skill in the art would not look to sealing apparatus for ablation treatment.”
Examiner respectfully contends that, as discussed above, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Bagaoisan is reasonably pertinent to the particular problem with which the inventor is concerned due to Bagaosian being directed towards a surgical catheter device configured to be inserted into a target tissue to treat said tissue. As further discussed in the rejection to claim 18 below, Bagaoisan teaches a surgical device (cartridge 120) configured to be delivered to a target tissue zone through a rigid cylindrical access envelope (protective introducer sheath (20)). Using an introducer sheath to deliver a surgical device to a target tissue zone minimizes the risk of damage to both the surgical device and surrounding tissue during navigation.
Applicant’s arguments, see Remarks, filed 06/12/2026, Regarding prior art reference Swanson with respect to the rejection(s) of claim(s) 5, 12, 13, 19, and 20 under U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Hacker (US 2018/0140349 A1) in view of Heim (US 2006/0025757 A1).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4 and 11 of U.S. Patent No. 10,335,225. Although the claims at issue are not identical, they are not patentably distinct from each other because they comprise overlapping subject matter with minor grammatical differences.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-4, 6-8, and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hacker (US 2018/0140349 A1).
Regarding claim 1, Hacker teaches
an elongated shaft comprising a lumen extending along a longitudinal axis from a proximal end portion to a distal end portion; (Fig. 1-3, Char. 30: shaft)
a supply electrode (Fig. 3, Char. 14: active electrode) forming an electrode face directed laterally from the longitudinal axis at the distal end portion, (Fig. 3) the electrode face comprising at least one aperture in connection with the lumen; (Fig. 3, Char. 46: aspiration inlet)
a return electrode extending along the distal end portion of the elongated shaft; (Fig. 6, Char. 38: return electrode) and
an insulator interposed between the supply electrode and the return electrode, (Fig. 3 and 6, Char. 40: insulator) the insulator forming a transition passage of the lumen interconnecting the at least one aperture to the lumen (Fig. 6) along an arcuate swept path; (Fig. 6 and attached “Annotated Hacker Fig. 4” below: The portions of aspiration collection chamber (22) labelled “Curve 1” and “Curve 2” form an arcuate swept path)
wherein the transition passage forms an inlet (Fig. 6, Char. 22: aspiration collection chamber) cross section that decreases along the transition passage and along the arcuate swept path to an outlet cross section in connection with the lumen. (Fig. 4 and 6; and attached “Annotated Hacker Fig. 4” below: the cross section of collection chamber (22) decreases along the portions labelled “Curve 1” and “Curve 2” that form the arcuate swept path towards the outlet (58))
Annotated Hacker Fig. 4
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Regarding claim 2, Hacker further teaches the elongated shaft extends to a distal extent of the ablation apparatus and the return electrode extends over a portion of the distal extent. (Fig. 6)
Regarding claim 4, Hacker further teaches a cross section of the internal passage forming the transition passage is swept from the longitudinal axis along the lumen to the at least one aperture extending laterally from the longitudinal axis. (Fig. 6: The transition between the bottom surface (72) of the internal aspiration collection chamber and the distal linear surface (62) is curved)
Regarding claim 6, Hacker further teaches the elongated shaft forms a tapered end portion opposing the electrode face. (Fig. 5-6)
Regarding claim 7, Hacker further teaches the elongated shaft tapers gradually along the longitudinal axis to a distal extent of the ablation apparatus on a first side opposing the electrode face as well as a second side and a third side extending along opposing sides of the electrode face. (Fig. 3, 5-6)
Regarding claim 8, Hacker further teaches the tapered end portion tapers along a slope that increases with increasing proximity to the distal extent. (Fig. 5-6)
Regarding claim 10, Hacker further teaches the supply electrode extends approximately equidistant from the return electrode along at least a distal 25% of an electrode length Le of the supply electrode. (Attached “Annotated Hacker Fig. 5” below: the section of active electrode (14) labelled “Parallel Section” comprises at least half of the length of active electrode (14) and is generally parallel/equidistant from the portion of the return electrode labelled “Edge 1”)
Annotated Hacker Fig. 5
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Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 9, 11, 14-16, 21, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Hacker (US 2018/0140349 A1), as applied to claim 1 above, and further in view of Aluru (US 9,254,166 B2).
Regarding claim 9, Hacker, as applied to claim 1 above, teaches the supply electrode forms a perimeter edge adjacent to the insulator and extends from a proximal electrode portion to a distal electrode portion. (Hacker Fig. 4 and 6)
Hacker, as applied to claim 1 above, is silent regarding wherein the perimeter edge is evenly spaced from the return electrode along the distal end portion.
Aluru, in a similar field of endeavor, teaches an ablation device comprising an active electrode (Fig. 2B, Char. 104: active electrode) and a return electrode (Fig. 2B, Char. 112: return electrode) separated by an insulative support member; (Fig. 2B, Char. 150: support member) wherein maintaining substantially consistent distance between the active electrode and return electrode provides more uniform tissue effect. (Col. 12, Line 53 – Col. 13, Line 1)
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 Hacker, as applied to claim 1 above, to incorporate the teachings of Aluru, and configure the return electrode (38) of Hacker to be of whatever form or shape was desired or expedient, including configuring the portion of return electrode (38) labelled “Edge 1” in attached Hacker Fig. 5 above to be parallel to active electrode (14) of Hacker, such that the active electrode (14) and “Edge 1” of return electrode (38) are evenly spaced from each other along the entire lengths and distal edge of active electrode (14). Doing so would result in a more uniform tissue effect along the perimeter of the active electrode, as suggested in Aluru. (Col. 12, Line 63 – Col. 13, Line 1) 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.
Regarding claim 11, Hacker, as applied to claim 1 above, is silent regarding the approximately equidistant spacing between the supply electrode and the return electrode includes an average spacing that is evenly spaced on average over the distal end portion including variations in a perimeter edge of the supply electrode and a return edge of the return electrode.
Aluru, in a similar field of endeavor, teaches an ablation device comprising an active electrode (Fig. 2B, Char. 104: active electrode) and a return electrode (Fig. 2B, Char. 112: return electrode) separated by an insulative support member; (Fig. 2B, Char. 150: support member) wherein maintaining substantially consistent distance between the active electrode and return electrode provides more uniform tissue effect. (Col. 12, Line 53 – Col. 13, Line 1)
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 Hacker, as applied to claim 1 above, to incorporate the teachings of Aluru, and configure the return electrode (38) of Hacker to be of whatever form or shape was desired or expedient, including a shape such that the supply electrode and the return electrode include an average spacing that is evenly spaced on average over the distal end portion including variations in a perimeter edge of the supply electrode and a return edge of the return electrode. Doing so would result in a more uniform tissue effect along the perimeter of the active electrode, as suggested in Aluru. (Col. 12, Line 63 – Col. 13, Line 1) 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.
Regarding claim 14, Hacker teaches
supplying a control signal to a supply electrode of an ablation device; (Par. [0023]: Energy is transferred between active electrode (14) and return electrode (38))
conducting the control signal through the supply electrode to a return electrode across an insulating gap, (Fig. 5-6 and Par. [0023]: Energy is transferred between active electrode (14) and return electrode (38)) and conducting the control signal across an insulating gap generates an edge ablation region extending about the distal end portion of the ablation device between the supply electrode and the return electrode; (Par. [0030]; The field of ablative energy would radiate around the entire electrode assembly (12)) and
communicating fluid through a lumen extending through an elongated shaft of the ablation device. (Par. [0025])
Hacker, as applied to claim 14 above, is silent regarding wherein the insulating gap is approximately constant over a distal end portion of the supply electrode.
Aluru, in a similar field of endeavor, teaches an ablation device comprising an active electrode (Fig. 2B, Char. 104: active electrode) and a return electrode (Fig. 2B, Char. 112: return electrode) separated by an insulative support member; (Fig. 2B, Char. 150: support member) wherein the active electrode and return electrode are equally spaced from each other along the length of the insulative support member. (Fig. 2B)
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 Hacker, as applied to claim 1 above, to incorporate the teachings of Aluru, and configure the return electrode (38) of Hacker to be of whatever form or shape was desired or expedient, including shaped such that the insulating gap is approximately constant over a distal end portion of the supply electrode. Doing so would result in a more uniform tissue effect along the perimeter of the active electrode, as suggested in Aluru. (Col. 12, Line 63 – Col. 13, Line 1) 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.
Regarding claim 15, the combination of Hacker/Aluru, as applied to claim 14 above, teaches the communicating fluid through a lumen of the ablation device comprises: communicating the fluid through at least one aspiration port (Hacker: Par. [0025]) extending laterally from the lumen and through the supply electrode. (Hacker: Fig. 4-6)
Regarding claim 16, the combination of Hacker/Aluru, as applied to claim 15 above, teaches the communicating fluid through a lumen of the ablation device further comprises: steering the fluid along an arcuate path (Hacker: Fig. 4 and 6; and attached “Annotated Hacker Fig. 4” below: the cross section of collection chamber (22) decreases along the portions labelled “Curve 1” and “Curve 2” that form the arcuate swept path towards the outlet (58)) from the at least one aspiration port to the lumen. (Hacker: Fig. 6 and Par. [0025])
Annotated Hacker Fig. 4
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Regarding claims 21 and 22, the combination of Hacker/Aluru, as applied to claim 14 above, teaches the edge ablation region extends distally beyond the distal end portion of the ablation device thereby ablating tissue beyond the distal tip; and maneuvering the distal end portion of the ablation device to ablate tissue along a face of an active electrode and beyond a perimeter of the active electrode simultaneously. (Hacker: Par. [0030]; The field of ablative energy produced by electrodes (14 and 38) would radiate around the entire electrode assembly (12), thereby extending distally beyond the distal end portion of the ablation device and ablating tissue therein.)
Claim(s) 5, 12, 13, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Hacker (US 2018/0140349 A1), as applied to claim 1 above, and further in view of Heim (US 2006/0025757 A1).
Regarding claims 5, 12 and 13, Hacker, as applied to claim 1 above, is silent regarding the electrode face forms an ovular shape comprising a proximal electrode portion and a distal electrode portion, and a major axis of the ovular shape extends parallel to the longitudinal axis; wherein the electrode face of the supply electrode forms a distal electrode portion that tapers outward from the longitudinal axis of the apparatus to a proximal end portion; and wherein the proximal electrode portion forms a first arc comprising a first radius and the distal electrode portion forms a second arc comprising a second radius, wherein the first radius is greater than the second radius.
Heim, in a similar field of endeavor, teaches bipolar electrodes may be any shape. (Par. [0043])
Absent a statement of criticality AND unexpected results, 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 Hacker, as applied to claim 1 above, to incorporate the teachings of Heim, and configure the active electrode (14) of Hacker to be of whatever form or shape was desired or expedient, including the claimed ovular shape of claims 5, 12, and 13. 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.
Regarding claim 19, Hacker teaches
an elongated shaft comprising a lumen extending along a longitudinal axis from a proximal end portion to a distal end portion; (Fig. 1-3, Char. 30: shaft)
a supply electrode forming an electrode face (Fig. 4, Char. 14: active electrode) directed laterally from the longitudinal axis (Fig. 4-6) at the distal end portion and comprising at least one aperture in connection with the lumen, (Fig. 3, Char. 46: aspiration inlet) the electrode face having a shape comprising: (Fig. 3)
a proximal electrode portion forming a first arc comprising a first radius; (Fig. 3: The proximal half of active electrode (14)) and
a distal electrode portion forming a second arc comprising a second radius; (Fig. 3: The distal half of active electrode (14))
a return electrode extending along the distal end portion of the elongated shaft; (Fig. 6, Char. 38: return electrode) and
an insulator interposed between the supply electrode and the return electrode, (Fig. 3 and 6, Char. 40: insulator) the insulator forming a transition passage of the lumen interconnecting the at least one aperture to the lumen. (Fig. 6)
Hacker, as applied to claim 19 above, is silent regarding the shape of the electrode face being an ovular shape comprising a first major axis parallel to the longitudinal axis; and wherein the first radius is greater than the second radius.
Heim, in a similar field of endeavor, teaches bipolar electrodes may be any shape. (Par. [0043])
Absent a statement of criticality AND unexpected results, 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 Hacker, as applied to claim 19 above, to incorporate the teachings of Heim, and configure the active electrode (14) of Hacker to be of whatever form or shape was desired or expedient, including the claimed shape of claim 19. 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.
Regarding claim 20, the combination of Hacker/Heim, as applied to claim 19 above, teaches the distal end portion of the ablation apparatus forms a torpedo shape that tapers to a distal extent of the ablation apparatus along opposing edges of electrode face and along a rear surface opposite the electrode face. (Hacker Fig. 3 and 6)
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hacker (US 2018/0140349 A1), in view of Aluru (US 9,254,166 B2), as applied to claim 14 above, and further in view of Bagaoisan (US 2010/0168789 A1).
Regarding claim 18, the combination of Hacker/Aluru, as applied to claim 14 above, is silent regarding passing an acting end of the ablation device through a rigid cylindrical access envelope having a diameter and a length, wherein the diameter is less than two times a width of the elongated shaft and the length is at least two times the width.
Bagaoisan, in a similar field of endeavor, teaches passing an acting end of a surgical device (Fig. 6B, Char. 120: cartridge) through a rigid cylindrical access envelope having a diameter and a length, (Fig. 1B and 6B, Char. 20: introducer sheath; Par. [0039]: Introducer sheath may be formed from a substantially rigid tubular body) wherein the diameter is less than two times a width of the elongated shaft (Fig. 6B) and the length is at least two times the width. (Fig. 6B)
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 the combination of Hacker/Aluru, as applied to claim 14 above, to incorporate the teachings of Bagaoisan, and pass an acting end of the ablation device through a rigid cylindrical access envelope having a diameter and a length, wherein the diameter is less than two times a width of the elongated shaft and the length is at least two times the width. Doing so would minimize the risk of accidental damage from occurring to surrounding tissue and/or the instrument (10) of Hacker from occurring during navigation to/from the target treatment zone.
Conclusion
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/N.S.B./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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