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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 28 April 2026 has been entered. Claims 1, 6-8, and 16 are currently amended. Claims 19-20 are canceled. Claims 1-18 are pending in the application.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-11 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Just et al. (US PGPub No. 2019/0239811), hereinafter Just, in view of Govari et al. (US PGPub No. 2021/0077180), hereinafter Govari, and further in view of Shelton, IV et al. (US PGPub No. 2019/0099181), hereinafter Shelton.
Regarding claim 1, Just teaches a medical device (Fig. 1: catheter system 10) 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: elongated catheter body 20);
a spine retention hub comprising a plurality of slots disposed on an outer cylindrical surface of the spine retention hub and extending radially inward from the outer cylindrical surface of the spine retention hub to receive respective spine members (Figs. 4 and 8: third element 42, channels 46 in outer cylindrical surface 44; par. 0050: “The third element 42 can comprise a generally cylindrical member having an outer radial surface 44 including a plurality of channels 46. Each of the plurality of channels 46 can be configured to receive the proximal end portion 126 of each of the plurality of splines 124”),
and an expandable basket assembly coupled to the spine retention hub (Fig. 4: electrode support structure 122),
the expandable basket assembly comprising a plurality of spines disposed in a respective plurality of slots of the spine retention hub (Fig. 4: splines 124 with proximal end portions 126; par. 0050: “the plurality of channels 46 can be configured to receive the proximal end portion 126 of each of the plurality of splines 124”),
and at least one electrode coupled to each of the plurality of spines (Figs. 2 and 4; par. 0045: “one or more of the plurality of splines 124 can have one or more electrodes (such as electrodes 54 shown in FIG. 2) mounted on the non-conductive covering of each of the plurality of splines 124”),
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 (par. 0039: “The electrode support structure 22 is configured to be radially outwardly expandable relative to its axis (A) to an expanded arrangement as shown in FIGS. 1-3. The electrode support structure 22 is also configured to be radially inwardly collapsible relative to its axis (A) to a collapsed arrangement”).
Just does not teach 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, and the spine retention hub being coupled to the contact force sensor assembly and having a second bayonet mount portion.
However, in an analogous art, Govari teaches an RF ablation catheter with a contact force sensor assembly disposed at the distal end of a tubular shaft and configured to detect a force applied to the medical probe (Fig. 9: force sensor 312 disposed at distal end of tubular shaft 302; par. 0094: “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, and an end effector hub being coupled to the contact force sensor assembly and having a second bayonet mount portion (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”).
Govari teaches that providing an end effector of an RF ablation catheter with a contact force sensor, as disclosed, allows an operator to confirm sufficient contact with tissue or determine what type of tissue is in contact with the end effector (par. 0056: “the highlighted electrodes may be confirmed by an operator as being in sufficient contact with tissue based on the direction of the force vector. […] if the force vector indicates that the applied force is low, and the direction of the force is consistent with the highlighted electrodes, and the highlighted electrodes indicate that many of the electrodes are in contact with tissue, the operator may assume that the catheter is in a region of soft tissue […] if the force vector indicates that the applied force is high, and the direction of the force is consistent with the highlighted electrode(s), and the highlighted electrode(s) indicate that one or two electrodes are in contact with the tissue, the operator may assume that the catheter is in a region of hard tissue”). 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 Just by adding a contact force sensor assembly with a bayonet coupling, as taught by Govari, in order to allow an operator to confirm sufficient contact with tissue or determine what type of tissue is in contact with the end effector, as taught by Govari.
Govari is silent with respect to the specific configuration of the bayonet coupling and does not explicitly teach wherein the spine retention hub having a second bayonet mount portion disposed on and extending radially inward from an inner cylindrical surface of the spine retention hub configured to couple the spine retention hub to the contact force sensor assembly by interlocking with the first bayonet mount portion. However, in an analogous art, Shelton teaches surgical end effectors with components utilizing bayonet couplings wherein one side of the coupling has a bayonet mount portion disposed on and extending radially inward from an inner cylindrical surface configured to interlock with another bayonet mount portion (Figs. 88-89: end effector 16300 having inwardly extending bayonet pins 16318 configured to interlock with slot 16156 in shaft assembly 16100; see also par. 0573). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to substitute Shelton’s specific bayonet coupling configuration for Govari’s unspecified bayonet coupling, since one of ordinary skill in the art would have been capable of performing such a substitution in light of Shelton’s teaching, and the substitution would have yielded predictable results, namely, an interlocking bayonet coupling that seats or unseats the end effector (basket assembly) from the contact force sensor using rotation and axial movement.
Regarding claims 2-4, the combination teaches the device of claim 1 as described previously. Govari’s teaching of a bayonet coupling is considered to further read on 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. Shelton further teaches 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 (Fig. 89 and par. 0573: “the bayonet pin 16318 is aligned with the slot 16156 in the connector assembly 16150 and the bayonet pin 16320 is aligned with the slot 16158”). In light of Shelton’s teaching, iit 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 claim 16, Just teaches a medical device (Fig. 1: catheter system 10) comprising: an end effector of the medical device (Fig. 4: electrode support structure assembly 112), an end effector retention hub configured to receive at least a portion of the end effector to secure the end effector to the end effector retention hub, the end effector retention hub comprising a plurality of slots disposed on an outer surface of the end effector retention hub and extending radially inward from an outer cylindrical surface of the end effector retention hub to receive respective end effectors (Figs. 4 and 8: third element 42, channels 46 in outer cylindrical surface 44; par. 0050: “The third element 42 can comprise a generally cylindrical member having an outer radial surface 44 including a plurality of channels 46. Each of the plurality of channels 46 can be configured to receive the proximal end portion 126 of each of the plurality of splines 124”).
Just does not teach a contact force sensor assembly configured to detect a force applied to an end effector of the medical device, the contact force sensor assembly comprising a first bayonet mount portion, the end effector retention hub comprising a second bayonet mount portion configured to couple the end effector retention hub to the contact force sensor assembly by interlocking with the first bayonet mount portion. However, Just in view of Govari teaches these limitations for the same reasons set forth in the rejection of claim 1.
Just in view of Govari and further in view of Shelton further teaches wherein the second bayonet mount portion is disposed on an inner cylindrical surface of the end effector retention hub, for the same reasons set forth in the rejection of claim 1. The combination does not explicitly teach wherein the second bayonet mount portion extends radially outward from the inner cylindrical surface of the end effector retention hub. However, Shelton further teaches wherein the first bayonet mount portion extends radially outward from an inner surface of a shaft assembly (Fig. 88: slot 16156), and it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to reverse the interlocking parts of the bayonet mount such that the bayonet mount portion extending radially outward is on the end effector rather than the contact force sensor assembly, 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.
Regarding claims 6-8, 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 2-4.
Regarding claims 9-11 and 17, the combination teaches the devices of claims 1 and 16 as described previously. Govari further teaches 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).
Claims 12 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Just in view of Govari and Shelton and further in view of Chou et al. (US PGPub No. 2020/0015876), hereinafter Chou.
Just in view of Govari and Shelton teaches the devices of claims 1 and 16 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 Just in view of Govari and Shelton and further in view of Goedeke et al. (US PGPub No. 2018/0161577), hereinafter Goedeke.
Just in view of Govari and Shelton teaches the device of claim 1 as described previously. Just further teaches 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 (par. 0051: “The electrodes 54 mounted on each of the plurality of splines 24, 124 can comprise ring electrodes”).
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.
Response to Arguments
Applicant’s arguments, filed 28 April 2026, 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 Just and Shelton. As described previously, Just teaches a spine retention hub comprising a plurality of slots disposed on an outer cylindrical surface of the spine retention hub and extending radially inward from the outer cylindrical surface, and Shelton teaches a second bayonet mount portion disposed on and extending radially inward from an inner cylindrical surface of an end effector.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Parihar et al. (US Patent No. 10,206,738) teaches bayonet couplings with slots extending radially outward from an inner cylindrical surface (see Figs. 19 and following).
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JOANNE M RODDEN can be reached at (303) 297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.E.L./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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