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 08 October 2025 has been entered. Claims 1-2, 5-6, 16, and 19 are currently amended. Claims 1-20 are pending in the application. Applicant’s amendments to the claims have overcome each and every rejection under 35 U.S.C. 112(b) and the double patenting rejection previously set forth in the Non-Final Office Action mailed 08 May 2025.
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 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Govari et al. (US PGPub No. 2021/0077180), hereinafter Govari, in view of Jarrard (US PGPub No. 2014/0088588) and further in view of Kordis et al. (US PGPub No. 2012/0271140), hereinafter Kordis.
Regarding claim 1, Govari teaches a medical probe, comprising: a tubular shaft including a proximal end and a distal end, the tubular shaft extending along a longitudinal axis of the medical probe (Fig. 1: catheter 14);
a contact force sensor assembly disposed at the distal end of the tubular shaft and configured to detect a force applied to the medical device (Fig. 5: force sensor sub-assembly; Fig. 10D: force sensor 312; par. 0082: “Together flexible circuit 180, first portion 114 of flexible circuit 110, and helical beam coupling member 190 form a force sensor sub-assembly that receives electrical signals from, and provides electrical signals to, console 24, which may process received signals to determine forces, e.g., sub-gram forces, exerted on tip 18 of catheter 14;” par. 0094: “The balloon catheter 300 includes a force sensor 312 disposed proximate the distal tip 304 of the insertion tube 302 and configured to output at least one force signal indicative of a magnitude and a direction of a force applied by the inflatable balloon 306 when inflated on the tissue”);
the contact force sensor assembly comprising a first bayonet mount portion configured to couple the contact force sensor assembly to an end effector retention hub by interlocking with a second bayonet mount portion on the end effector retention hub (par. 0095: “The force sensor 312 is connected to the insertion tube 302 and the inflatable balloon 306 using a lower coupler 314 and an upper coupler 316, respectively. The lower coupler 314 and the upper coupler 316 may use any suitable coupling mechanism, for example, but not limited, a screw fitting, a bayonet fitting, or a pressure fit coupling”),
the second bayonet mount portion disposed on an inner surface of the spine retention hub (Figs. 9-10A: coupling mechanism on the inner side of upper coupler 316);
wherein the end effector retention hub is configured to receive at least a portion of the end effector (Figs. 9-10F: end effector of balloon catheter 300 secured to coupler 316).
Govari teaches wherein the end effector is an inflatable balloon and does not teach wherein the end effector retention hub is a spine retention hub comprising a plurality of slots to receive respective spine members, and the end effector is an expandable basket assembly coupled to the spine retention hub, the expandable basket assembly comprising a plurality of spines disposed in a respective plurality of slots of the spine retention hub and at least one electrode coupled to each of the plurality of spines, the plurality of spines extending along the longitudinal axis and configured to bow radially outward from the longitudinal axis when the expandable basket assembly is transitioned from a collapsed form to an expanded form.
However, in an analogous art, Jarrard teaches a medical probe with an end effector hub including a spine retention hub comprising a plurality of slots to receive respective spine members (Fig. 2B: proximal alignment retainer 144a; par. 0037: “Proximal alignment retainer 144a may be […] attached to a proximal end of each of the plurality of legs 142”),
and an expandable basket assembly (Fig. 2B: plurality of legs 142; par. 0036: “energy emitting portion 140 may include an expandable basket having a plurality of legs 142”) coupled to the spine retention hub, the expandable basket assembly comprising a plurality of spines disposed in a respective plurality of slots of the spine retention hub (par. 0037: “the plurality of legs 142 may be configured to converge at distal portion 132 of elongate member 130 at a proximal sleeve 138a and a proximal alignment retainer 144a”),
and at least one electrode coupled to each of the plurality of spines (par. 0038: “at least one electrode may be located along the length of at least one of the plurality of legs 142”),
the plurality of spines extending along the longitudinal axis and configured to bow radially outward from the longitudinal axis when the expandable basket assembly is transitioned from a collapsed form to an expanded form (Fig. 2B: plurality of legs 142 bowing radially outward from longitudinal axis in expanded form).
Jarrard further teaches that inflatable balloons and expandable basket assemblies are both known in the art as obvious alternatives to one another (par. 0036: “The expandable member of energy emitting portion 140 may be any suitable expandable member known to those skilled in the art including, but not limited to, a balloon or cage. In one embodiment, as illustrated in FIG. 2B, energy emitting portion 140 may include an expandable basket having a plurality of legs 142”). In light of Jarrard’s teaching, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to substitute an expandable basket assembly as taught in Jarrard for the inflatable balloon taught in Govari, since both elements were known in the art as obvious alternatives of one another, and the substitution would have yielded predictable results, namely, an expandable end effector that may expand without the use of an inflation medium.
The combination is silent with respect to the specific placement of the spine retention slots and does not explicitly teach wherein the slots are disposed on an outer surface of the spine retention hub. However, in an analogous art, Kordis teaches a spine retention hub with slots disposed on an outer surface of the hub (Figs. 31A-31D: slots 168 on the outer surface of anchor 158), which provides the advantages of allowing fastening of basket splines made of any material, as well as variable positioning of the basket splines to aid in collapsing into a sheath (par. 0148: “Some non-limiting advantages of the anchor 158 of the present invention include, but are not limited to, ease of allowing fastening or gathering of basket splines 14 made of any material; may be fabricated from any suitable material or multiple materials; allows for variable positioning (length and angular) of the basket splines 14 to ensure even collapsing into the recovery sheath device”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of the combined reference by placing the spine retention slots on the outer surface of the spine retention hub, as taught by Kordis, in order to allow for fastening of basket splines made of any material and variable positioning of the splines to aid in collapsing into a sheath, as taught by Kordis.
Regarding claims 2-4 and 6-8, the combination teaches the device of claim 1 as described previously. Govari is considered to further teach the limitations of a generally L-shaped recess/slot, namely, having a first slot portion extending generally longitudinally and a second slot portion extending generally transversely from the end of the first slot portion, on one side of a coupling; and a protrusion on the other side of the coupling, wherein the slot is configured to receive the protrusion; because these limitations merely recite the structure of a bayonet mount as well known in the art. Govari does not teach wherein the protrusion comprises a generally L-shaped member, comprising a first protrusion portion extending generally longitudinally away from the spine retention hub and a second protrusion portion extending generally transversely from an end of the first protrusion portion. However, given that the particular shape of the protrusion does not significantly affect the function of a bayonet mount coupling as long as the protrusion can be received by the slot, it would have been an obvious matter of design choice to make the protrusion of whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Regarding claim 5, the combination teaches the device of claim 2 as described previously but does not explicitly teach wherein the first bayonet mount comprises at least two slots formed into the contact force sensor, and wherein the second bayonet mount comprises at least two protrusions extending from the spine retention hub, the at least two slots being configured to receive the at least two protrusions. However, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide a second slot and corresponding second protrusion in the device of the combined reference, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Regarding claims 9-11, the combination teaches the device of claim 1 as described previously. Govari further discloses wherein the contact force sensor assembly comprises:
a body having a generally cylindrical shape (Fig. 5: beam coupling member 190);
a coil configured to generate a magnetic field (Figs 2 and. 4: coils 118, 170, 172, 184; par. 0084: “Whichever set of coils receives power from console 24 may be considered a transmitter (i.e., one of flex circuit 110 or 180) because it emits an electromagnetic field”);
a sensor configured to detect the magnetic field generated by the coil (par. 0084: “The set of coils that is not powered by console 24 may be considered a receiver in as much as it functions like an antenna in response to the electromagnetic field from the transmitter”);
and a helical spring formed into the body and configured to permit the body to deflect when a force is applied to the end effector (Fig. 5: helical beam coupling member 190).
Examiner notes that claim 11 recites a product-by-process limitation for forming the helical spring. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 777 F.2d 695, 698; 227 USPQ 964, 966 (Fed. Cir. 1985).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Govari in view of Jarrard and Kordis and further in view of Chou et al. (US PGPub No. 2020/0015876), hereinafter Chou.
Govari in view of Jarrad and Kordis teaches the device of claim 1 as described previously. The combination does not teach wherein the end effector hub comprises a spray port configured to direct a fluid toward an electrode of the end effector. However, in related electrosurgical art, Chou teaches providing an irrigation port on an ablation catheter (Fig. 7A: irrigation port 131) in order to deliver cooling fluid to tissue prior to, during, or after delivery of energy by an ablation element (par. 0561: “System 10 can be configured to deliver fluid to tissue proximate irrigation port 131, such as a cooling fluid delivered prior to, during, and/or after delivery of energy by ablation element 130 (e.g. delivery of RF ablation energy)”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of the combined reference by providing an irrigation port on the end effector hub, as taught by Chou, in order to deliver cooling fluid to tissue prior to, during, or after delivery of energy by the electrode, as taught by Chou.
Claims 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Govari in view of Jarrard and Kordis and further in view of Goedeke et al. (US PGPub No. 2018/0161577), hereinafter Goedeke.
Govari in view of Jarrard and Kordis teaches the device of claim 1 as described previously. Jarrard further teaches, in another embodiment, wherein the at least one electrode comprises a body defining a hollow portion extending through the body of the electrode, the body configured to receive each of the plurality of spines, and that such an electrode would be suitable and known to those skilled in the art (Fig. 3B and par. 0055: “The at least one electrode 242 may be any suitable electrode known to those skilled in the art, including, but not limited to, an elongate electrode or a ring or dot electrode”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to choose a ring electrode for the electrode of the combined reference, since Jarrard teaches a ring electrode in the embodiment of Fig. 3B and further teaches that ring electrodes are known to those skilled in the art.
The combination does not teach wherein the plurality of spines each include at least one retention member extending generally transverse to the spine, the electrode retained by the at least one retention member, or in which the at least one retention member comprises a bow-shaped member. However, in a related electrosurgical art, Goedeke teaches providing a bow-shaped retention member for struts or splines that extends generally transverse to the spine (Fig. 23H and par. 0736: “a plurality of struts or splines 2382 each having a generally U-shaped trough;” examiner notes that in order to wrap around the spline, the trough must first extend in a direction generally transverse to the spline, and interprets the curved U-shape as a bow shape, as broadly as claimed), wherein the electrode is retained by the at least one retention member, so that spacing of the electrodes is maintained (par. 0736: “The U-shape may reduce the likelihood that the splines 2382 slide relative to each other and that the electrodes 2308 in each of the splines 2382 slide relative to each other, which can maintain spacing of the electrodes”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide the device of the combined reference with a bow-shaped retention member that retains at least one electrode, as taught by Goedeke, in order to maintain spacing of the electrodes, as taught by Goedeke.
Claims 16-17 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Govari in view of Kordis.
Regarding claim 16, Govari teaches a medical device comprising:
a contact force sensor assembly configured to detect a force applied to an end effector of the medical device (Fig. 5: force sensor sub-assembly; Fig. 10D: force sensor 312; par. 0082: “Together flexible circuit 180, first portion 114 of flexible circuit 110, and helical beam coupling member 190 form a force sensor sub-assembly that receives electrical signals from, and provides electrical signals to, console 24, which may process received signals to determine forces, e.g., sub-gram forces, exerted on tip 18 of catheter 14;” par. 0094: “The balloon catheter 300 includes a force sensor 312 disposed proximate the distal tip 304 of the insertion tube 302 and configured to output at least one force signal indicative of a magnitude and a direction of a force applied by the inflatable balloon 306 when inflated on the tissue”);
the contact force sensor assembly comprising a first bayonet mount portion configured to couple the contact force sensor assembly to an end effector retention hub by interlocking with a second bayonet mount portion on the end effector retention hub (par. 0095: “The force sensor 312 is connected to the insertion tube 302 and the inflatable balloon 306 using a lower coupler 314 and an upper coupler 316, respectively. The lower coupler 314 and the upper coupler 316 may use any suitable coupling mechanism, for example, but not limited, a screw fitting, a bayonet fitting, or a pressure fit coupling”),
the second bayonet mount portion disposed on an inner surface of the spine retention hub (Figs. 9-10A: coupling mechanism on the inner side of upper coupler 316);
wherein the end effector retention hub is configured to receive at least a portion of the end effector to secure the end effector to the end effector retention hub (Figs. 9-10F: end effector of balloon catheter 300 secured to coupler 316).
Govari does not explicitly teach wherein the end effector retention hub comprises a plurality of slots disposed on an outer surface of the end effector retention hub to receive respective end effectors. However, Govari in view of Kordis teaches this limitation for the same reasons set forth previously in the rejection of claim 1.
Regarding claim 17, the combination teaches the device of claim 16 as described previously. Govari further teaches the limitations of claim 17 for the same reasons set forth previously in the rejection of claims 9-10.
Regarding claims 19-20, the combination teaches the device of claim 16 as described previously. Govari further teaches the limitations of these claims for the same reasons set forth previously in the rejection of claims 2-3.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Govari in view of Kordis and further in view of Chou.
Govari in view of Kordis teaches the device of claim 16 as described previously. The combination in view of Chou teaches the limitations of claim 18 for the same reasons set forth previously in the rejection of claim 12.
Response to Arguments
Applicant’s arguments, filed 08 October 2025, with respect to the rejection(s) of claim(s) 1 and 16 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, in light of the amendments to the claims, the previous rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Govari and Kordis. As described previously, Govari teaches a bayonet mount connection on an inner side of an end effector retention hub, and Kordis teaches a plurality of slots on an outer surface of a spine retention hub.
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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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/D.E.L./Examiner, Art Unit 3794