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 .
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 2-8 and 19 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.
Claims 2, 5, 6, and 19 each recite the limitations “the first bayonet mount” and “the second bayonet mount.” There is insufficient antecedent basis for these limitations in the claims. Examiner recommends changing each instance to read --the first bayonet mount portion-- and --the second bayonet mount portion-- to match the language in independent claims 1 and 16. Dependent claims 3-4 and 7-8 are necessarily rejected as depending upon a rejected base claim.
Additionally, claims 2, 5, and 19 recite the limitation “the contact force sensor.” There is insufficient antecedent basis for this limitation in the claims. Examiner recommends changing each instance to read --the contact force sensor assembly-- to match the language in independent claims 1 and 16.
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.
Claims 16-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Govari et al. (US PGPub No. 2021/0077180), hereinafter Govari.
Regarding claim 16, Govari discloses a medical device (Fig. 1: catheter 14) 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”);
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).
Regarding claim 17, Govari discloses the device of claim 16 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).
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.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Govari.
Govari discloses the device of claim 16 as described previously. Govari is considered to further teach the limitation of a slot formed into the contact force sensor assembly, and a protrusion extending from the end effector retention hub, the slot being configured to receive the protrusion, because the structure of a bayonet mount as well known in the art includes a slot on one side of a coupling configured to receive a protrusion on the other side of the coupling, and it would have been obvious in light of Govari’s teaching to provide the slot on the contact force sensor assembly, and the protrusion on the end effector retention hub, since it has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art. In re Einstein, 8 USPQ 167.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Govari in view of Chou et al. (US PGPub No. 2020/0015876), hereinafter Chou.
Govari discloses the device of claim 16 as described previously, but 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 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Govari in view of Jarrard (US PGPub No. 2014/0088588).
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). As described previously in the rejection of claim 16, Govari further teaches a contact force sensor assembly disposed at the distal end of the tubular shaft and configured to detect a force applied to the medical probe, 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. 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.
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 teaches the limitations of claims 9-11 for the same reasons set forth previously in the rejection of claim 17. 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 further in view of Chou.
Govari in view of Jarrard teaches the device of claim 1 as described previously. The combination in view of Chou teaches wherein the spine retention hub comprises a spray port configured to direct a fluid toward the at least one electrode, for the same reasons set forth previously in the rejection of claim 18.
Claims 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Govari in view of Jarrard and further in view of Werneth et al. (US PGPub No. 2009/0149848), hereinafter Werneth, and Sandquist et al. (US PGPub No. 2025/0057589, effectively filed 22 December 2021), hereinafter Sandquist.
Regarding claims 13-14, Govari in view of Jarrard 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, or wherein the electrodes on first and second spines may be proximally and distally staggered. However, in an analogous art Werneth teaches an ablation probe with a retention member that prevents shaft electrodes from sliding proximally or distally along the shaft, which provides further security in addition to adhesive and eliminates a sharp edge at each electrode end (Fig. 3B: shaft electrodes 121, fillet material 132 extending generally transverse to shaft; par. 0142: “In addition to adhesive applied to the inner diameter of each electrode, and crimping, swaging or otherwise modifying of one or more ends, a fillet material, fillet 132 for tip electrode 131 and fillet 122 for shaft electrodes 121 may be included. Fillet material is preferably an adhesive, configured to further secure each electrode as well as eliminate a sharp edge at each electrode end;” examiner interprets fillet 132 as a retention member, as broadly as claimed). 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 probe of the combined reference by providing a retention member for each electrode, as taught by Werneth, in order to provide further security and eliminate a sharp edge at each electrode end, as taught by Werneth.
Werneth further teaches a staggered configuration for electrodes on multiple arms of an expandable/collapsible assembly, which allows compact volume when the assembly is collapsed (Fig. 18A and par. 0190: “Mounted to the two carrier arms 133 are electrodes 121, preferably shown in the staggered configuration shown in FIG. 18A, such as to allow compact volume when carrier arms 133 are in the linear state”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the probe of the combined reference by staggering the positions of electrodes on adjacent spines, as suggested by Werneth, in order to allow compact volume when the assembly is collapsed, as taught by Werneth.
The combination further does not teach wherein each spine includes a single cross-section extending approximately halfway along the length of the spine and thereafter dividing into at least two discrete cross sections to the end of the spine, wherein the discrete cross section corresponds to an electrode position. However, in an analogous art, Sandquist teaches an energy delivery probe with a resiliently deformable section along a shaft corresponding to an electrode position, which Sandquist teaches facilitates assembly (Figs. 9-10 and par. 0064: “FIG. 9 illustrates outer jacket 144 resiliently deformed inwardly as electrode 148A is moved in the direction P toward reduced-diameter segment 202a to seat within reduced-diameter segment 202a. […] To facilitate assembly, outer jacket 144 between the reduced-diameter segments 202 can be resilient in response to peristaltic deflection of a magnitude corresponding to a difference between the maximum outer cross-sectional dimension of outer jacket 144 between the reduced-diameter segments 202 and the minimum inner cross-sectional dimension of electrodes 148a;” wherein the resiliently deformable outer jacket performs the same function as the two discrete cross section of the invention, namely providing inward compressibility that allows an electrode to slide over the shaft/spine, such that they are functional equivalents). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the probe of the combined reference to include the resiliently deformable structure taught by Sandquist for each staggered electrode position, in order to facilitate assembly, as taught by Sandquist.
Regarding claim 15, the combination teaches the device of claim 13 as described previously. Sandquist further teaches a retention member that is bow-shaped (Fig. 9: reduced diameter segment 202a; examiner interprets the general U-shape of the reduced diameter segment to be bow-shaped, as broadly as claimed). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to substitute one known element (Sandquist’s retention member) for another (the retention member taught by Werneth), since the results would have been predictable, namely, Sandquist’s retention member would provide the same function of additional security and reducing the sharp edges of the electrode.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Govari in view of Jarrard and further in view of Werneth.
As previously described in the rejection of claim 1, Govari in view of Jarrard teaches a medical probe, comprising: a tubular shaft extending along a longitudinal axis of the medical probe; a contact force sensor assembly disposed at the distal end of the tubular shaft and configured to detect a force applied to the medical probe, the contact force sensor assembly comprising a first bayonet mount portion; a plurality of spines configured to bow radially outward from the longitudinal axis; a plurality of electrodes, each electrode of the plurality of electrodes attached to a spine of the plurality of spines; and a spine retention hub comprising a plurality of slots to receive respective spines of the plurality of spines, the spine retention hub having a second bayonet mount portion configured to couple the spine retention hub to the contact force sensor assembly by interlocking with the first bayonet mount portion.
The combination does not explicitly teach wherein each spine of the plurality of spines comprises a retention member that prevents each electrode from sliding proximally or distally along the spine. However, Werneth teaches an ablation probe with a retention member that prevents shaft electrodes from sliding proximally or distally along the shaft, which provides further security in addition to adhesive and eliminates a sharp edge at each electrode end (Fig. 3B: shaft electrodes 121, fillet material 132; par. 0142: “In addition to adhesive applied to the inner diameter of each electrode, and crimping, swaging or otherwise modifying of one or more ends, a fillet material, fillet 132 for tip electrode 131 and fillet 122 for shaft electrodes 121 may be included. Fillet material is preferably an adhesive, configured to further secure each electrode as well as eliminate a sharp edge at each electrode end;” examiner interprets fillet 132 as a retention member, as broadly as claimed). 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 probe of the combined reference by providing fillet material as a retention member for each electrode, as taught by Werneth, in order to provide further security and eliminate a sharp edge at each electrode end, as taught by Werneth.
The combination further does not explicitly teach wherein the plurality of electrodes are disposed on the plurality of spines in groupings, the groupings being disposed in alternating proximal and distal positions along adjacent spines. However, Werneth further teaches a staggered configuration for electrodes on multiple arms of an expandable/collapsible assembly, which allows compact volume when the assembly is collapsed (Fig. 18A and par. 0190: “Mounted to the two carrier arms 133 are electrodes 121, preferably shown in the staggered configuration shown in FIG. 18A, such as to allow compact volume when carrier arms 133 are in the linear state”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the probe of the combined reference by staggering the positions of electrodes on adjacent spines, as suggested by Werneth, in order to allow for compact volume when the assembly is collapsed, as taught by Werneth.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVINA E LEE whose telephone number is (571)272-5765. The examiner can normally be reached Monday through Friday between 8:00 AM and 5:30 PM (ET).
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/D.E.L./Examiner, Art Unit 3794