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 .
Response to Amendment
The Amendment filed December 01, 2025 has been entered. Currently, claims 19 and 29 have been amended, and claim 19-38 are pending in the application.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 19-23, and 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Mauch (U.S. Patent No. 8956352 B2), and further in view of Webster (U.S. Patent No. 5893885 A).
Regarding independent claim 19, Mauch discloses an elongate medical device assembly (10) comprising:
an elongate shaft body (16, 20, 22) (Col. 8, lines 12-29 & Fig. 1) having an outer diameter (i.e., see dashed line in annotated Fig. 5B below); and
at least one annular electrode (24) configured to deliver ablative energy (Col. 19, lines 24-26; Col. 19, lines 34-38 & Figs. 5A-5B), the at least one annular electrode disposed on the elongate shaft body (Col. 10, lines 29-35),
the at least one annular electrode comprising a first edge and a second edge (see annotated Fig. 5B below), the first edge comprising a rounded edge which extends around a circumference of the at least one annular electrode Col. 22, lines 61-67 – Col. 23, lines 1-4);
wherein the outer diameter of the first edge is less than an outer diameter of an axial center of the at least one annular electrode (see Fig. 5B), and
wherein the elongate shaft body is formed of an electrically nonconductive, flexible material/polymer (Col. 15, lines 61-66), and the at least one annular electrode may be adhered to the elongate shaft body (Col. 10, lines 29-32).
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However, Mauch does not disclose wherein at least a portion of the elongate shaft body covers at least a portion of each of the first edge and the second edge of the at least one annular electrode.
Webster, in the same field of endeavor, teaches a multi-electrode ablation catheter (10) comprising a catheter body (11, 12) with an elongate flexible and dielectric (i.e., polyurethane) tubular construction (Col. 3, lines 1-6 and lines 16-22) and a plurality of ring electrodes (21) (Col. 3, lines 57-58 & Fig. 1), wherein the electrodes may be adhered/fixed in place to the catheter body with polyurethane (34) (Col. 4, lines 35-36 & Fig. 4). As seen in Fig. 4, the polyurethane (34) covers at least a portion of both sides/edges of the ring electrodes, and since this strong, flexible adhesive is of the same material as the catheter body, the Examiner is interpreting this component as being an extension/being part of the catheter body.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the dielectric material of the elongate shaft body of Mauch to be the polyurethane material taught by Webster, since they both are known equivalents in the art and they would yield the same predictable results of providing a strong, flexible, and non-conductive shaft body.
Moreover, it would have been obvious to one of ordinary skill in the art to have substituted the adhesive which held together the annular electrode to the elongate shaft body of Mauch with the polyurethane component located on both the first and the second edges of the electrode of Webster since they both are known equivalents in the art and they would yield the same predictable results of providing a strong and flexible attachment style.
Regarding claim 20, Mauch/Webster combination discloses wherein the first edge comprises a radially-inward edge or a radially-outward edge. Examiner is interpreting a radially-inward or radially-outward edge as an edge that either curves downwards or upwards, respectively. Fig. 5B of Mauch illustrates the first edge comprising a radially-inward edge since it is curving downwardly towards the shaft body.
Regarding claim 21, Mauch/Webster combination discloses wherein the second edge comprises a rounded edge which extends around the circumference of the annular electrode and an outer diameter of the second edge is less than an outer diameter of the axial center of the annular electrode (see Fig. 5B of Mauch).
Regarding claim 22, Mauch/Webster combination discloses wherein the first edge comprises a radially-inward edge and the second edge comprises a radially-outward edge. Examiner is interpreting a radially-inward or radially-outward edge as an edge that either curves downwards or upwards, respectively. Fig. 5B of Mauch illustrates the first edge comprising a radially-inward edge since it is curving downwardly towards the shaft body, while the second edge comprises a radially-outward edge sine it is curving upwardly towards the shaft body.
Regarding claim 23, Mauch/Webster combination discloses wherein the at least one annular electrode is configured to deliver at least one of radiofrequency ablative energy and high intensity focused ultrasound ablative energy (Mauch, Col. 6, lines 25-30).
Regarding claim 27, Mauch/Webster combination discloses wherein a length of the annular electrode is about 1 millimeter to about 1.3 millimeter (Mauch, Col. 21, lines 1-2).
Regarding claim 28, Mauch/Webster combination discloses wherein the at least one annular electrode is disposed on the elongate shaft body (Mauch, Col. 10, lines 29-35).
Claims 29-33, 35, and 37-38 are rejected under 35 U.S.C. 103 as being unpatentable over Mauch (U.S. Patent No. 8956352 B2), in view of Govari (E.P. Application No. 2679190 A1), and further in view of Webster (U.S. Patent No. 5893885 A).
Regarding independent claim 29, Mauch discloses an elongate medical device assembly (10) comprising:
an elongate shaft body (16, 20, 22) (Col. 8, lines 12-29 & Fig. 1) having an outer diameter (i.e., see dashed line in annotated Fig. 5B below); and
at least one annular electrode (24) configured to deliver ablative energy (Col. 19, lines 24-26; Col. 19, lines 34-38 & Figs. 5A-5B), the at least one annular electrode disposed on the elongate shaft body (Col. 10, lines 29-35),
the at least one annular electrode comprising a first edge and a second edge (see annotated Fig. 5B below), the first edge comprising a rounded edge which extends around a circumference of the at least one annular electrode Col. 22, lines 61-67 – Col. 23, lines 1-4);
wherein the outer diameter of the first edge is less than an outer diameter of an axial center of the at least one annular electrode (see Fig. 5B), and
wherein the elongate shaft body is formed of an electrically nonconductive, flexible material/polymer (Col. 15, lines 61-66), and the at least one annular electrode may be adhered to the elongate shaft body (Col. 10, lines 29-32).
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However, Mauch does not disclose the first edge comprises a chamfer edge.
Govari, in the same field of endeavor, teaches a system (10) comprising a catheter and a plurality of ring electrodes (pa. 0042, 0049), wherein the electrodes comprise peripheral sections (91) that are chamfered (see Fig. 7).
It would have been an obvious matter of design choice to one having ordinary skill in the art at before the effective filing date of the claimed invention to have substituted the rounded edges of Mauch with the chamfer edges taught by Govari, since applicant has not disclosed that the specific shape of the electrode edges solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with either a rounded or chamfer edge.
However, Mauch/Govari combination do not teach wherein at least a portion of the elongate shaft body covers at least a portion of each of the first edge and the second edge of the at least one annular electrode.
Webster, in the same field of endeavor, teaches a multi-electrode ablation catheter (10) comprising a catheter body (11, 12) with an elongate flexible and dielectric (i.e., polyurethane) tubular construction (Col. 3, lines 1-6 and lines 16-22) and a plurality of ring electrodes (21) (Col. 3, lines 57-58 & Fig. 1), wherein the electrodes may be adhered/fixed in place to the catheter body with polyurethane (34) (Col. 4, lines 35-36 & Fig. 4). As seen in Fig. 4, the polyurethane (34) covers at least a portion of both sides/edges of the ring electrodes, and since this strong, flexible adhesive is of the same material as the catheter body, the Examiner is interpreting this component as being an extension/being part of the catheter body.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the dielectric material of the elongate shaft body of Mauch to be the polyurethane material taught by Webster, since they both are known equivalents in the art and they would yield the same predictable results of providing a strong, flexible, and non-conductive shaft body.
Moreover, it would have been obvious to one of ordinary skill in the art to have substituted the adhesive which held together the annular electrode to the elongate shaft body of Mauch with the polyurethane component located on both the first and the second edges of the electrode of Webster since they both are known equivalents in the art and they would yield the same predictable results of providing a strong and flexible attachment style.
Regarding claim 30, Mauch/Govari/Webster combination discloses wherein the first edge comprises a radially-inward edge or a radially-outward edge. Examiner is interpreting a radially-inward or radially-outward edge as an edge that either curves downwards or upwards, respectively. Fig. 5B of Mauch illustrates the first edge comprising a radially-inward edge since it is curving downwardly towards the shaft body.
Regarding claim 31, Mauch/Webster combination discloses wherein the second edge comprises a rounded edge which extends around the circumference of the annular electrode and an outer diameter of the second edge is less than an outer diameter of the axial center of the annular electrode (see Fig. 5B of Mauch).
However, they do not teach wherein the second edge comprises a chamfer edge.
Govari, in the same field of endeavor, teaches a system (10) comprising a catheter and a plurality of ring electrodes (pa. 0042, 0049), wherein the electrodes comprise peripheral sections (91) that are chamfered (see Fig. 7).
It would have been an obvious matter of design choice to one having ordinary skill in the art at before the effective filing date of the claimed invention to have substituted the rounded edges of Mauch with the chamfer edges taught by Govari, since applicant has not disclosed that the specific shape of the electrode edges solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with either a rounded or chamfer edge.
Regarding claim 32, Mauch/Govari/Webster combination discloses wherein the first edge comprises a radially-inward edge and the second edge comprises a radially-outward edge. Examiner is interpreting a radially-inward or radially-outward edge as an edge that either curves downwards or upwards, respectively. Fig. 5B of Mauch illustrates the first edge comprising a radially-inward edge since it is curving downwardly towards the shaft body, while the second edge comprises a radially-outward edge sine it is curving upwardly towards the shaft body.
Regarding claim 33, Mauch/Webster combination discloses the invention substantially as claimed in claim 29 discussed above.
However, they do not teach the chamfer edge being a partial chamfer.
Govari, in the same field of endeavor, teaches the chamfer edge is a partial chamfer which extends over less than a full thickness of the annular electrode (see Fig. 7).
Regarding claim 35, Mauch/Govari/Webster combination discloses wherein the at least one annular electrode is configured to deliver at least one of radiofrequency ablative energy and high intensity focused ultrasound ablative energy (Mauch, Col. 6, lines 25-30).
Regarding claim 37, Mauch/Govari/Webster combination discloses wherein a length of the annular electrode is about 1 millimeter to about 1.3 millimeter (Mauch, Col. 21, lines 1-2).
Regarding claim 38, Mauch/Govari/Webster combination discloses wherein the at least one annular electrode is disposed on the elongate shaft body (Mauch, Col. 10, lines 29-35).
Claims 24-26 are rejected under 35 U.S.C. 103 as being unpatentable over Mauch and Webster, as applied to claim 19 above, and further in view of Swanson (U.S. Patent No. 6023638 A).
Regarding claim 24, Mauch discloses wherein the elongate shaft body comprises a flexible spine (21), and wherein the at least one annular electrode is disposed on the spines (Col. 13, lines 23-32 & Figs. 3B-3C).
However, Mauch/Webster combination do not teach a plurality of flexible spines.
Swanson, in the same field of endeavor, teaches two different embodiments of ablation devices which either include a plurality of splines (30), as seen in Fig. 2, or a single spline, as seen in Figs. 25-28 (Col. 7, lines 61-63).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the number of spines in the medical device of Mauch for the purpose of allowing a user to ablate a greater surface area in a target site.
Regarding claim 25, Mauch/Webster combination discloses the invention substantially as claimed in claim 1 discussed above.
However, they do not disclose wherein the plurality of flexible spines form a basket assembly.
Swanson, in the same field of endeavor, teaches an ablation device which includes a plurality of splines (30) that forma basket structure (20) (Col. 7, lines 61-63 & Fig. 2).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the number of spines in the medical device of Mauch for the purpose of allowing a user to ablate a greater surface area in a target site.
Regarding claim 26, Mauch/Webster/Swanson combination discloses further comprising an introducer (1291) (Mauch, Col. 46, lines 2-12 & Figs. 16A-16B), wherein the basket assembly is configured to be advanced and retracted from the introducer (Mauch, Col. 40, lines 37-41 & Figs. 12A-12B).
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Mauch, Govari, and Webster as applied to claim 29 above, and further in view of Schmulewitz (D.E. Application No. 69830087 T2).
Regarding claim 34, Mauch/Govari/Webster discloses a partial chamfer edge (Govari, Fig. 7).
However, they do not disclose wherein the chamfer edge is a full chamfer which extends over a full thickness of the annular electrode.
Schmulewitz, in the same field of endeavor, teaches an energy application device (60) comprising an ablation electrode (65) with a full chamfer edge (64) which extends over a full thickness of the annular electrode (page 6, second to last paragraph & Fig 8A).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the shape of the electrode edge of Mauch to be a full chamfer edge, as taught by Schmulewitz, in order to aid introduce and advance the medical device into biological tissue (Schmulewitz, page 6, second to last paragraph)
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Mauch, Govari, and Webster, as applied to claim 29 above, and further in view of Swanson (U.S. Patent No. 6023638 A).
Regarding claim 36, Govari discloses wherein the elongate shaft body comprises a spine (75), and wherein the at least one annular electrode is disposed on the spine (pa. 0049 & Figs. 4-5).
However, Mauch/Govari/Webster combination do not disclose a plurality of flexible spines.
Swanson, in the same field of endeavor, teaches two different embodiments of ablation devices which either include a plurality of splines (30), as seen in Fig. 2, or a single spline, as seen in Figs. 25-28 (Col. 7, lines 61-63).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the number of spines in the medical device of Mauch for the purpose of allowing a user to ablate a greater surface area in a target site.
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.
Claims 19-23, 27-33, 35, and 37-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 8, 13, and 21 of U.S. Application No. 20160346038 A1, in view of Mauch (U.S. Patent No. 8956352 B2).
Regarding instant claims 19 and 29, it is the Examiner’s position that copending claims 1, 6, 8, 13, and 21 are narrower in some aspects given that the copending claim recites a plurality of the limitations that overlap, or otherwise narrower in scope than, those in instant claims 19 and 29. These narrower aspects include the claimed elongate medical assembly, elongate shaft body, annular electrode, outer diameter, a rounded edge, and a chamfered edge. With respect to the narrower aspects, the Examiner notes that it has been held that the generic aspects of the instant invention would be anticipated by the narrower species aspects of the copending claim. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
With respect to the broader aspects of the copending claim, the Examiner notes that the difference between the instant claims 19 and 29 and the copending claims 1, 6, 8, 13, and 21 exist in that the copending claims fail to provide an annular electrode “configured to deliver ablative energy” and comprising “a second edge”. Mauch, however, provides for a similar system as that of the copending claim and specifically contemplates the modifying the annular electrode to include the second edge and the ablative properties (Col. 19, lines 24-26; Col. 19, lines 34-38 & Figs. 5A-5B). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have incorporated the second edge and the ablative properties of the annular electrode of Mauch in combination with the elongate medical device in copending claims 1, 8, 13, and 21 to provide for a combined annular electrode with the desired physical and electrical characteristics.
Claims 19-24, 27-33, 35-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 8 of U.S. Patent No. 11690670 B2.
Although the claims at issue are not identical, they are not patentably distinctfrom each other because the copending application claims anticipate the claims of theinstant application. Accordingly, the instant application claims 19 and 20 arenot patentably distinct from the copending application claims 1 and 8. Here,the more specific copending application claims encompass the broader instantapplication claims (i.e., the claimed elongate medical assembly, elongate shaft body, annular electrode, outer diameter, a first and second edge, a rounded edge, and a chamfered edge). Following the rationale in In re Goodman 11 F.3d 1046, 29 USPQ2d2010 (Fed. Cir. 1993), where applicant has once been granted a patent containing a claim for the specific narrow invention, applicant may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Response to Arguments
Applicant’s arguments, see pages 5-6, filed 12/01/2025, with respect to the 102 rejections of claims 19 and 29 under Mauch and under Govari have been fully considered and are persuasive. Specifically, Applicant’s amendments to the independent claims 19 and 29 to further require the elongate medical device to include wherein at least a portion of the elongate shaft body covers at least a portion of each of the first edge and the second edge of the at least one annular electrode is defined
over both Mauch and Govari given that neither do not contemplate this claimed structure. Therefore, the rejection has been withdrawn. However, upon further consideration, the following new grounds of rejection have been set forth in the action above:
Claims 19-23, and 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Mauch (U.S. Patent No. 8956352 B2), and further in view of Webster (U.S. Patent No. 5893885 A).
Claims 29-33, 35, and 37-38 are rejected under 35 U.S.C. 103 as being unpatentable over Mauch (U.S. Patent No. 8956352 B2), in view of Govari (E.P. Application No. 2679190 A1), and further in view of Webster (U.S. Patent No. 5893885 A).
It is the Examiner’s position that the newly filed rejections based on the
References above are tenable for at least the reasoning set forth in the action above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/A.V.G./Examiner, Art Unit 3794
/Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794
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