DETAILED ACTION
The following is a Non-Final Office Action on the merits.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Response to Amendment
Acknowledgment is made to the amendment received 9/17/2026.
Applicant’s amendments are sufficient to overcome the specification and claim objections set forth in the previous office action.
Applicant’s amendments are sufficient to overcome the 35 USC 112(b)/second paragraph rejections set forth in the previous office action.
Priority
This application is filed as a divisional of 16/748480 where original claim 1 is the same as amended claim 4 of 16/748480 presented on 1/16/2024. There was no restriction requirement set forth in 16/748480 and independent claims 1 & 4 were viewed as being drawn to the same embodiment, where claim 4 was a broader claim than claim 1. Further, original dependent claims 34-35 are drawn towards the embodiment with the distal and proximal assemblies. Claim 4 was cancelled to allow claim 1 in the parent application, and thus, the Examiner believes that the current application should be a continuation instead of a divisional.
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 13 is 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 13 recites the limitation "the at least five spines”; however, claim 8, upon which claim 13 depends, recites both the first and second assemblies comprising “at least five spines” and thus it is unclear to which assembly the “at least five spines” refers to in claim 13. For purposes of examination, it will be interpreted as referring to either.
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.
Claims 1-6 & 8-12 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Fuimaono et al. (2003/0125614, previously cited) in view of Hummel et al. (5,551,426), Young et al. (2006/0095029) and Gough et al. (5,980,517, previously cited).
Concerning claims 1 & 8, as illustrated in at least Figs. 1-4 & 7, Fuimaono et al. disclose a catheter (catheter 10; [0013]), comprising:
an elongated catheter body (elongated catheter body 12; [0018]); and
a first distal assembly distal of the catheter body (mapping assembly 18 mounted at the distal end of the catheter body 12; [0013]) and a second distal assembly distal of the first assembly (Fuimaono et al. fail to disclose a second distal assembly distal of the first assembly. However, Hummel et al. teach that various intracardiac mapping catheters are often used for both ablation and mapping and thus one of ordinary skill in the art would look to various mapping and ablation catheters, including Young et al. who disclose a device (200) comprising a probe body (212), a first distal assembly (250) distal of the probe body (212) and a second distal assembly (225) distal of the first assembly (250), the first and second distal assemblies (250, 225) comprising spines (256, 226) having attached proximal ends at mounting assemblies on shaft 220 and/or shaft 290 and free distal ends. At the time of the invention, it would have been obvious to one of ordinary skill in the art to modify the invention of Fuimaono et al. to further comprise a second distal assembly distal of the first assembly with the same characteristics as the first distal assembly in order to provide the benefit of forming a lesion(s) with the same or different deployed electrode profiles to achieve a desired lesion shape/size as taught by Young et al. ([0055-0057], [0061-0063], [0068]; Fig. 8-13) and in view of the teachings of Hummel that intracardiac mapping catheters are also used to ablate (Col. 2, ll. 22-30)), each of the first and second distal assemblies comprising a mounting assembly and at least two spines, each of the at least two spines having a proximal end attached to the mounting assembly and a free distal end (plurality of spines 14, totaling at least 5 spines, have proximal ends mounted at the distal end of catheter body 12 via mounting assembly 31 and free distal ends; [0018], [0031-0034], Fig. 2),
wherein each of the at least two spines comprises:
a support arm having shape memory (support arm 24 comprising a metal or plastic material having shape memory; [0016], [0021]);
a non-conductive covering in surrounding relation to the support arm (non-conductive coating 26 in surrounding relation to the support arm 24; [0016]); and
at least one electrode (ring electrode 28 mounted on each non-conductive covering 26; [0020]);
wherein a first spine of the at least two spines of the first distal assembly has a different length than a second spine of the at least two spines of the first distal assembly, wherein a first spine of the at least two spines of the second distal assembly has a different length than a second spine of the at least two spines of the second distal assembly, and wherein the free distal ends of the at least two spines of the first and second distal assemblies are configured to trace a plurality of circumferences along an inner tissue surface of a tubular region (While Fuimaono et al. disclose what appears to be spines of different lengths forming a cup-shape ([0037]; Fig. 7), Fuimaono et al. in view of Hummel et al. and Young et al. fail to disclose a first spine of the at least two spines of the first distal assembly has a different length than a second spine of the at least two spines of the first distal assembly, wherein a first spine of the at least two spines of the second distal assembly has a different length than a second spine of the at least two spines of the second distal assembly, and wherein the free distal ends of the at least two spines of the first and second distal assemblies are configured to trace a plurality of circumferences along an inner tissue surface of a tubular region. However, Gough et al. disclose a catheter (12) comprising an elongated catheter body (14) and a distal assembly comprising a plurality of spines (16). Gough et al. further disclose that any number of cell necrosis geometries can be achieved via at least the adjustable length of each spine and the number of energy delivery devices. Gough et al. further gives various examples of cell necrosis geometries, including, but not limited to: spherical, semi-spherical, spheroid, triangular, semi-triangular, square, semi-square, rectangular, semi-rectangular, conical, semi-conical, quadrilateral, semi-quadrilateral, semi-quadrilateral, rhomboidal, semi-rhomboidal, trapezoidal, semi-trapezoidal, combinations of the preceding, geometries with non-planar sections or sides, free-form and the like. At the time of the invention, it would have been obvious to one of ordinary skill in the art to modify the invention of Fuimaono et al. in view of Hummel et al. and Young et al. such that a first spine of the at least two spines of the first distal assembly has a different length than a second spine of the at least two spines of the first distal assembly, wherein a first spine of the at least two spines of the second distal assembly has a different length than a second spine of the at least two spines of the second distal assembly, and wherein the free distal ends of the at least two spines of the first and second distal assemblies are configured to trace a plurality of circumferences along an inner tissue surface of a tubular region in order to provide the benefit defining the periphery or boundary of a selected tissue mass for treatment to thus provide a variety of different geometries, not always symmetrical, that can be ablated as taught by Gough et al. (Col. 3, ll. 51-56, Col. 4, ll. 17-43, Col. 6, ll. 17-25; Fig. 1) and in view of the teachings of Hummel as discussed above that intracardiac mapping catheters are also used to ablate (Col. 2, ll. 22-30)
Concerning claim 2, Young et al. further disclose the second distal assembly (250) has a generally straight proximal portion (proximal end of spine 256) extending from the mounting assembly (220) of the first distal assembly (225) ([0054]; Fig. 8).
Concerning claim 3, Young et al. further disclose the generally straight proximal portion (proximal end of spine 256) has a fixed relationship to the mounting assembly (220) of the first distal assembly (225) ([0054]; Fig. 8).
Concerning claim 4, Young et al. further disclose the generally straight proximal portion (proximal end of spine 256) is adapted for telescopic movement relative to the mounting assembly of the first distal assembly(225) ([0057]; Fig. 9).
Concerning claim 5-6, the modified invention of Fuimaono et al. in view of Young et al. and Gough et al. disclose the distal ends of the at least two-spines of the first distal assembly are configured to trace a first generally helical pattern from about 0 degrees to about 360 degrees and the distal ends of the at least two-spines spines of the second distal assembly are configured to trace a second generally helical pattern from about 360 degrees to about 720 degrees when the distal assemblies are manipulated in an appropriate manner to achieve the desired pattern (see rejection of claim 1).
Concerning claim 9, Fuimaono et al. disclose at least one of the first or second distal assemblies has a unibody support structure (34 or 32) ([0031]; Fig. 3-4)
Concerning claim 10, Pham et al. teach one of the distal assemblies to be concentric with the second of the distal assemblies (at least Fig. 9-13), and thus the modified invention of Fuimaono et al. in view of Pham et al. and Gough et al. disclose the first distal assembly includes a first unibody structure as taught by Fuimaono et al. and the second distal assembly includes a second unibody structure as taught by Fuimaono et al.
Concerning claim 11, Fuimaono et al. disclose the first unibody support structure (32 or 34) comprises a distal edge from which extends each support arm (24) of the at least two spines of the first distal assembly (Fig. 2).
The Examiner notes the claim fails to recite the proximal-most end of the support arm extending directly from the distal edge.
Concerning claim 12, the modified invention fails to teach the first unibody support structure is disposed concentrically to the second unibody support member. However, Young et al. teach the first and second distal assemblies and deployment mechanisms to be concentric with respect to one another (Figs. 8-13). It would have been obvious to one having ordinary skill in the art at the time the invention the invention was effectively filed to modify the invention of Fuimaono et al. in view of Hummel et al., Young et al. and Gough et al. such that the first unibody support structure is disposed concentrically to the second unibody support member, since it appears applicant places no criticality on the claimed location and it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Claim 7 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Fuimaono et al. (2003/0125614, previously cited) in view of Pham et al. (2006/0095029, previously cited) and Gough et al. (5,980,517, previously cited), as applied to claim 1, in further view of Morris et al. (2002/0120261, previously cited).
Concerning claim 7, Fuimaono et al. in view of Young et al. and Gough et al. fail to disclose the generally straight proximal portion of the second distal assembly includes a plunger having a cam surface adapted to deflect the at least two spines of the first distal assembly. However, Morris et al. disclose a catheter (10) comprising an elongated catheter body (24e) and a distal assembly comprising at least two spines (18) deployable from the catheter body (24e), where the spines (18) are deflected by a plunger having a cam surface (16). At the time of the invention, it would have been obvious to one of ordinary skill in the art to modify the invention of Fuimaono et al. in view of Young et al. and Gough et al. such that the generally straight proximal portion of the second distal assembly includes a plunger having a cam surface adapted to deflect the at least two spines of the first distal assembly in order to provide the benefit of controllably advancing the spines from the catheter body as taught by Morris et al. ([0104-0105]; Fig. 32A & 36B)
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 1-2 & 5-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 10,537,286 in view of Young et al. (2006/0095029). Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite: a catheter (a catheter), comprising: an elongated catheter body (an elongated catheter body); and a first distal assembly distal of the catheter body (a distal assembly distal of the elongated catheter body) and a second distal assembly distal of the first assembly (The patent fails to disclose a second distal assembly distal of the first assembly. However, Young et al. disclose a device (200) comprising a probe body (212), a first distal assembly (250) distal of the probe body (212) and a second distal assembly (225) distal of the first assembly (250), the first and second distal assemblies (250, 225) comprising spines (256, 226) having attached proximal ends at mounting assemblies on shaft 220 and/or shaft 290 and free distal ends. At the time of the invention, it would have been obvious to one of ordinary skill in the art to modify the invention of the patent to further comprise a second distal assembly distal of the first assembly with the same characteristics as the first distal assembly in order to provide the benefit of forming a lesion(s) with the same or different deployed electrode profiles to achieve a desired lesion shape/size as taught by Young et al.. ([0055-0057], [0061-0063], [0068]; Fig. 8-13)), each of the first and second distal assemblies comprising a mounting assembly and at least two spines, each of the at least two spines having a proximal end attached to the mounting assembly and a free distal end (each of the at least four spines having a proximal end fixedly attached to a distal end of the elongated catheter body and a free distal end), wherein each of the at least two spines comprises: a support arm having shape memory (a support arm having shape memory); a non-conductive covering in surrounding relation to the support arm (a non-conductive covering in surrounding relation to the support arm); and at least one electrode (at least one electrode); wherein a first spine of the at least two spines of the first distal assembly has a different length than a second spine of the at least two spines of the first distal assembly, wherein a first spine of the at least two spines of the second distal assembly has a different length than a second spine of the at least two spines of the second distal assembly, and wherein the free distal ends of the at least two spines of the first and second distal assemblies are configured to trace a plurality of circumferences along an inner tissue surface of a tubular region (wherein the at least four spines are arranged in a radial pattern about a longitudinal axis of the distal assembly and a length of each of the at least four spines increases in radial progression about the longitudinal axis, and when the distal assembly is in an expanded arrangement, each of the at least four spines extends radially outward from the catheter body). Concerning claim 2, the patent disclose the second distal assembly has a generally straight proximal portion extending from the mounting assembly of the first distal assembly (“wherein when the distal assembly is in a collapsed arrangement, each of the at least four spines is disposed generally along the longitudinal axis of the elongated catheter body”). Concerning claims 5-6, the patent discloses the distal ends of the at least two spines of the first and second distal assemblies are configured to trace a first and second generally helical pattern and the distal ends of the at least two spines of the first distal assembly are configured to trace the first generally helical pattern from about 0 degrees to about 360 degrees and the distal ends of the at least two spines of the second distal assembly trace the second generally helical pattern from about 360 degrees to about 720 degrees. (when moved appropriately the claimed arrangement of the spines in claim 1 are capable of this limitation). Concerning claim 7, the patent discloses the generally straight proximal portion of the second distal assembly includes a plunger having a cam surface adapted to deflect the at least two spines of the first distal assembly (“a plunger having a cam surface to deflect the at least four spines”).
Claims 1-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 11,998,357 in view of Young et al. (2006/0095029). Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite: a catheter (a catheter), comprising: an elongated catheter body (an elongated catheter body); and a first distal assembly distal of the catheter body (a distal assembly distal of the elongated catheter body) and a second distal assembly distal of the first assembly (The patent fails to disclose a second distal assembly distal of the first assembly. However, Young et al. disclose a device (200) comprising a probe body (212), a first distal assembly (250) distal of the probe body (212) and a second distal assembly (225) distal of the first assembly (250), the first and second distal assemblies (250, 225) comprising spines (256, 226) having attached proximal ends at mounting assemblies on shaft 220 and/or shaft 290 and free distal ends. At the time of the invention, it would have been obvious to one of ordinary skill in the art to modify the invention of the patent to further comprise a second distal assembly distal of the first assembly with the same characteristics as the first distal assembly in order to provide the benefit of forming a lesion(s) with the same or different deployed electrode profiles to achieve a desired lesion shape/size as taught by Young et al. ([0055-0057], [0061-0063], [0068]; Fig. 8-13)), each of the first and second distal assemblies comprising a mounting assembly and at least two spines, each of the at least two spines having a proximal end attached to the mounting assembly and a free distal end (each of the at least four spines having a proximal end fixedly attached to a distal end of the elongated catheter body and a free distal end), wherein each of the at least two spines comprises: a support arm having shape memory (a support arm having shape memory); a non-conductive covering in surrounding relation to the support arm (a non-conductive covering in surrounding relation to the support arm); and at least one electrode (at least one electrode); wherein a first spine of the at least two spines of the first distal assembly has a different length than a second spine of the at least two spines of the first distal assembly, wherein a first spine of the at least two spines of the second distal assembly has a different length than a second spine of the at least two spines of the second distal assembly, and wherein the free distal ends of the at least two spines of the first and second distal assemblies are configured to trace a plurality of circumferences along an inner tissue surface of a tubular region (wherein the at least four spines are arranged in a radial pattern about a longitudinal axis of the distal assembly and a length of each of the at least four spines increases in radial progression about the longitudinal axis, and when the distal assembly is in an expanded arrangement, each of the at least four spines extends radially outward from the catheter body, and wherein the distal assembly is moveable between the expanded arrangement, in which each of the at least four spines extends radially outward from the catheter body, and a collapsed arrangement, in which each of the at least four spines is disposed generally along a longitudinal axis of the catheter body). Concerning claim 2, the patent discloses the second distal assembly has a generally straight proximal portion extending from the mounting assembly of the first distal assembly (“spines form a substantially straight line”, either claim 2 or 4). Concerning claim 3, the patent discloses the generally straight proximal portion has a fixed relationship to the mounting assembly of the first distal assembly (see claims 1 & 2 proximal ends are fixedly attached to distal end of catheter which is taken to be mounting assembly). Concerning claims 5-6, the distal ends of the at least two spines of the first and second distal assemblies are configured to trace a first and second generally helical pattern and the distal ends of the at least two spines of the first distal assembly are configured to trace the a first generally helical pattern from about 0 degrees to about 360 degrees and the distal ends of the at least two spines of the second distal assembly trace the a second generally helical pattern from about 360 degrees to about 720 degrees (radially progressive length spines of the independent claims are capable of this pattern when moved appropriately). Concerning claim 9, the patent discloses at least one of the first or second distal assemblies has a unibody support structure (“unibody support structure”).
Allowable Subject Matter
Claim 13 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the prior art, neither alone nor in combination teach “wherein the at least five spines comprise a first spine disposed adjacent to a second spine, the second spine disposed adjacent to a third spine, the third spine disposed adjacent to a fourth spine, and the fourth spine disposed adjacent to a fifth spine, the second spine being longer than the first spine, the third spine being longer than the second spine, the fourth spine being longer than the third spine, and the fifth spine being longer than the fourth spine”.
The closest prior art is regarded as Fuimaono et al. (2003/0125614, previously cited) and Gough et al. (5,980,517, previously cited). Fuimaono et al. disclose a catheter comprising a catheter body and distal assembly having five spines, each having at least one electrode, and a shape memory, the spines being adjacent to one another. Fuimaono et al. fail to disclose a length of at least four spines when moving to the next adjacent spine. However, Gough et al. disclose a catheter comprising a catheter body and at least three spines. Gough et al. further disclose that any number of cell necrosis geometries can be achieved via at least the adjustable length of each spine and the number of energy delivery devices. Gough et al. further gives various examples of cell necrosis geometries, including, but not limited to: spherical, semi-spherical, spheroid, triangular, semi-triangular, square, semi-square, rectangular, semi-rectangular, conical, semi-conical, quadrilateral, semiquadrilateral, semi-quadrilateral, rhomboidal, semi- rhomboidal, trapezoidal, semi-trapezoidal, combinations of the preceding, geometries with non-planar sections or sides, free-form and the like, where a trapezoidal necrosis geometry would have a radial length of each of the spines increasing in radial progression about the longitudinal axis. (Col. 3, II. 51 -56, Col. 4, II. 17-43, Col. 6, II. 17- 25; Fig. 1) Gough et al. fails to specifically disclose a length of a next adjacent spine increasing for at least five spines.
Response to Arguments
Applicant’s arguments filed 9/17/2026 regarding claim 9 were found persuasive as the office action contained a typographical error where “24” should have been “34”. Accordingly, this action is made non-final.
Applicant’s arguments filed 9/17/2026 regarding the prior art references of Gough and Pham relating to ablation catheters and not mapping catheters are moot in view of the ground(s) of rejection in view of Hummel who teaches that intracardiac mapping catheters are often used for both mapping and ablation to reduce procedure time (Col. 2, ll. 22-30).
Applicant's arguments filed 9/17/2026 have been fully considered but they are not persuasive.
In response to Applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., catheter is used for ablating, Pg. 5) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to Applicant's argument that the “Fuimaono provides no disclosure that might suggest the apparatus could be used for ablation” (Pg. 5), a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In response to Applicant's argument that Gough, Young & Morris disclose structures that are not “configured to trace a plurality of circumferences along an inner tissue surface of a tubular region” due to sharp tips (Pgs. 8 & 15-18), 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).
In response to Applicant’s arguments that Fuimaono relates to a mapping device and the motivation of Gough relates to geometry of necrosis volumes (Pgs. 12-13), the Examiner notes that Fuimaono teaches using various deployed lengths of the spines to achieve a plurality of geometries formed by the distal ends of the spines to map a plurality of locations ([0036-0037]), and thus provides the suggestion to look to various catheter devices, including at least Gough, having various length spines to form a plurality of distal tip geometries. Further, the provided reference of Hummel et al. teach that a POSITA would look at various catheter devices, including those used only for ablation as intracardiac mapping catheters are often also used for ablation.
In response to Applicant’s arguments that different length spines as provided for in the modification of Fuimaono in view of Gough would not result in the “free distal ends” being “configured to trace a plurality of circumferences along an inner tissue surface of a tubular region” (Pgs. 13-14), the Examiner respectfully disagrees. Gough clearly teaches adjustable length spines to modify a geometry of the distal tips of the spines and thereby providing the benefit of modifying the location and overall geometry of the distal tips with respect to the tissue. As presented in an annotated Fig. 1 of Fuimaono below, one spine is illustrated with a shortened length which falls at a different circumferential location than the other spines and is thus capable of tracing a second circumference.
In response to Applicant’s arguments regarding the safe harbor and double patenting rejections, the Examiner respectfully disagrees. As noted above in the priority section, it is believed that this application should be a continuation. Further, since the parent application included claims to the double distal assembly and the Examiner notes that claim 4 of the parent (now claim 1 of the current application) was a broader claim, only requiring spines of two different lengths, than claim 1 of the parent, requiring four spines of different lengths in a radial progression.
In response to Applicant’s arguments regarding the double patenting rejections were not articulated, the Examiner notes some of the dependent claim rejections are withdrawn in light of applicant’s arguments while the remaining dependent claim rejections are further expanded upon in the double patenting section above.
Conclusion
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794
Prosecution Insights