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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/08/2026 has been entered.
Response to Amendment
The Amendment filed March 10, 2026 has been entered. Currently, claims 19 and 29 have been amended, and claims 19-38 are pending in the application.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show the second edge comprising a rounded edge, as described in claim 21 as described in the specification [pa. 0041]. As seen in Figure 5C, the top corner of the electrode is the feature that appears to be rounded, while the side edges remain flat/straight. For examination purposes, Examiner will interpret “a rounded edge” the same as a rounded corner with a flat edge. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 21-22 and 31-32 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 21 recites the limitation "the circumference of the annular electrode" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. Claim 22 is also rejected because it is dependent on claim 21.
Claim 31 recites the limitation "the circumference of the annular electrode" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. Claim 32 is also rejected because it is dependent on claim 31.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 19-20, 23, 27-30, 35, and 37-38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Falwell (U.S. Application No. 20060241366 A1).
Regarding independent claims 19 and 29, Falwell discloses an elongate medical device assembly (100) (pa. 0104 & Fig. 1) comprising:
an elongate shaft body (110, including distal end tip assembly 140 which comprises a cylindrically-shaped plastic slider 1910) having an outer diameter (pa. 0106, 0180 & Fig. 19); and
at least one annular electrode (1846) configured to deliver ablative energy (pa. 0104, 0179), the at least one annular electrode disposed on the elongate shaft body (see Fig. 18), the at least one annular electrode comprising a first edge and a second edge (see annotated Fig. 19 below);
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wherein the at least one annular electrode comprises a continuous curve extending from the first edge to the second edge such that a thickness of the first edge is less than a thickness of an axial center of the at least one annular electrode (see Fig. 19), and wherein at least a portion of the elongate shaft body (i.e., the cylindrically-shaped plastic slider 1910) covers at least a portion of each of the first edge and the second edge of the at least one annular electrode (see Fig. 19).
Regarding claims 20 and 30, Falwell discloses wherein the first edge comprises a radially-inward edge or a radially-outward edge (see Fig. 19).
Examiner is interpreting a radially-outward edge or a radially-inward as the upper and lower corners of the edges/ends of the electrode, respectively. In this case, Figure 19 of Falwell illustrates the first edge comprising a radially-inward lower corner since it is the lowermost corner of the electrode’s first edge, and a radially-outward upper corner since it is the uppermost corner of the electrode’s first edge.
Regarding claims 23 and 35, Falwell 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 (pa. 0104).
Examiner highlights that the claim language only requires at least one of radiofrequency ablative energy and high intensity focused ultrasound ablative energy.
Regarding claims 27 and 37, Falwell discloses wherein a length of the annular electrode is about 1 millimeter to about 1.3 millimeter (pa. 0112).
Regarding claims 28 and 38, Falwell discloses wherein the at least one annular electrode is disposed on the elongate shaft body (see Fig. 18).
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 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Falwell as applied to claim 19, and further in view of Mauch (U.S. Patent No. 8956352 B2).
Regarding claim 21, Falwell discloses an outer diameter of the second edge is less than an outer diameter of the axial center of the annular electrode (see Fig. 19).
However, Falwell does not disclose wherein the second edge comprises a rounded edge which extends around the circumference of the annular electrode.
Mauch, in the same field of endeavor, teaches an elongate medical device assembly (10) comprising an elongate shaft body (16, 20, 22) (Col. 8, lines 12-29 & Fig. 1) having an annular electrode (24) configured to deliver ablative energy (Col. 19, lines 24-29). The annular electrode comprises a first edge and a second edge, the second edge comprising a rounded edge which extends around a circumference of the at least one annular electrode, wherein the rounded edges reduce mechanical irritation to the vessel wall and provide a more consistent current density when energy is delivered compared to electrodes with square or sharper ends (Col. 22, lines 61-67 – Col. 23, lines 1-4 & Figs. 5A-5B).
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 second edge of the electrode of Falwell to be rounded, as taught by Mauch, for the purpose of reducing mechanical irritation to the vessel wall and provide a more consistent current density when energy is delivered.
Regarding claim 22, Falwell/Mauch combination discloses wherein the first edge comprises a radially-inward edge and the second edge comprises a radially-outward edge (Falwell, see Fig. 19).
Examiner is interpreting a radially-outward edge or a radially-inward as the upper and lower corners of the edges/ends of the electrode, respectively. In this case, Figure 19 of Falwell illustrates the first edge comprising a radially-inward lower corner since it is the lowermost corner of the electrode’s first edge, and the second edge comprising a radially-outward upper corner since it is the uppermost corner of the electrode’s second edge.
Claims 24-26, and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Falwell as applied to claims 19 and 29, and further in view of Swanson (U.S. Patent No. 6023638 A).
Regarding claims 24 and 36, Falwell discloses wherein the elongate shaft body comprises a flexible spine, and wherein the at least one annular electrode is disposed on the spine (pa. 0113-0114 & Fig. 3).
However, Falwell does 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 Falwell for the purpose of allowing a user to ablate a greater surface area in a target site.
Regarding claim 25, Falwell discloses the invention substantially as claimed in claims 19 and 24 discussed above.
However, it does 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 Falwell for the purpose of allowing a user to ablate a greater surface area in a target site.
Regarding claim 26, Falwell discloses further comprising an introducer, wherein the medical device assembly is configured to be advanced and retracted from the introducer (pa. 0225).
However, Falwell does not disclose 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 Falwell for the purpose of allowing a user to ablate a greater surface area in a target site.
Claims 31-33 are rejected under 35 U.S.C. 103 as being unpatentable over Falwell as applied to claim 29, and in view of Govari (E.P. Application No. 2679190 A1).
Regarding claim 31, Falwell discloses an outer diameter of the second edge is less than an outer diameter of the axial center of the annular electrode (see Fig. 19).
However, Falwell does not disclose wherein the second edge comprises a chamfer edge which extends around the circumference of the annular electrode.
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 modified the edges of the electrode of Falwell 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 any shaped-edge.
Regarding claim 32, Falwell/Govari combination discloses wherein the first edge comprises a radially-inward edge and the second edge comprises a radially-outward edge (Falwell, see Fig. 19).
Examiner is interpreting a radially-outward edge or a radially-inward as the upper and lower corners of the edges/ends of the electrode, respectively. In this case, Figure 19 of Falwell illustrates the first edge comprising a radially-inward lower corner since it is the lowermost corner of the electrode’s first edge, and the second edge comprising a radially-outward upper corner since it is the uppermost corner of the electrode’s second edge.
Regarding claim 33, Falwell discloses the invention substantially as claimed in claim 29 discussed above.
However, Falwell does 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).
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 modified the edges of the electrode of Falwell with the partial 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 any shaped-edge.
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Falwell as applied to claim 29 above, and further in view of Schmulewitz (D.E. Application No. 69830087 T2).
Regarding claim 34, Falwell discloses the invention substantially as claimed in claim 29 discussed above.
However, Falwell does 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 Falwell to be a full chamfer edge, as taught by Schmulewitz, in order to aid in introducing and advancing the medical device into biological tissue (Schmulewitz, page 6, second to last paragraph).
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 1-2, 6-8, 13, and 21 of U.S. Application No. 20160346038 A1, in view of Falwell (U.S. Application No. 20060241366 A1).
Regarding instant claims 19 and 29, it is the Examiner’s position that copending claims 1-2, 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 of the electrode, a first edge, a second edge, and a continuous curve. 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 1-2, 6-8, 13, and 21 exist in that the copending claims fail to provide an annular electrode “configured to deliver ablative energy”. Falwell, however, provides for a similar system as that of the copending claim and specifically contemplates the modifying the annular electrode to include ablative properties (pa. 0104). 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 ablative properties of the annular electrode of Falwell in combination with the elongate medical device in copending claims 1-2, 6-8, 13, and 21 to provide for a combined annular electrode with the desired electrical characteristics.
Claims 19-24, 27-33, 35-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5 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, 5 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 continuous curve). 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 5-7, filed 03/10/2026, with respect to the 103 rejection of independent claim 19 under Mauch in view of Webster, and with respect to the 103 rejection of independent 29 under Mauch, Govari, and Webster 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 the at least one annular electrode comprises a continuous curve extending from the first edge to the second edge such that a thickness is defined
over the prior art previously cited given that they 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 19-20, 23, 27-30, 35, and 37-38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Falwell (U.S. Application No. 20060241366 A1).
Claims 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Falwell as applied to claim 19, and further in view of Mauch (U.S. Patent No. 8956352 B2).
Claims 24-26, and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Falwell as applied to claims 19 and 29, and further in view of Swanson (U.S. Patent No. 6023638 A).
Claims 31-33 are rejected under 35 U.S.C. 103 as being unpatentable over Falwell as applied to claim 29, and in view of Govari (E.P. Application No. 2679190 A1).
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Falwell as applied to claim 29 above, and further in view of Schmulewitz (D.E. Application No. 69830087 T2).
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
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/A.V.G./Examiner, Art Unit 3794
/Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794
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