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 .
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 (i.e., changing from AIA to pre-AIA ) 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.
Election/Restrictions
Applicant’s election without traverse of Invention I in the reply filed on 07 May 2026 is acknowledged.
Claim Objections
Claim 22 is objected to because of the following informalities: “of any one of claim 1” should be amended to --of claim 1--. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5, 7-8 and 22-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Govari et al. (US 2021/0187241).
Regarding claim 1, Govari discloses an end effector for a medical device (see Fig. 1), the end effector comprising: a unitary spine frame (see expandable assembly 22, Fig. 4, see also [0072]) comprising: a proximal end (as shown in Fig. 4), a distal end comprising a crown (see distal end where the spines are connected together with a nose connector 30, Figs. 4-5), and a plurality of spines integral with the crown (see plurality of flexible polymer circuit strips 24, Fig. 4), the plurality of spines being configured to bow radially outward from a longitudinal axis (see Figs. 6A-6B) and to move between an expanded configuration (see Fig. 6B) and a collapsed configuration (see Fig. 6A), the unitary spine frame defining a teardrop shaped profile in the collapsed configuration (as shown in Fig. 6A), the teardrop shaped profile having a bulbous distal region that tapers to a trailing proximal region, the bulbous distal region including the plurality of spines expanding outward with respect to the longitudinal axis from the crown in a proximal direction and the plurality of spines tapering toward the longitudinal axis for the smaller proximal region with a transition region between the bulbous distal region and the trailing proximal region (as shown in Fig. 6A); at least one electrode being disposed on each spine in the bulbous distal region (as shown in Fig. 3); and at least two electrodes being disposed on each spine in the trailing proximal region (as shown in Fig. 2).
Regarding claim 2, Govari further discloses each spine being movable such that: in the collapsed configuration, a widest diameter of the plurality of spines is disposed at a first location along the longitudinal axis that is more proximal to the crown than the proximal end, and in the expanded configuration, a widest diameter of the plurality of spines is disposed at a second location along the longitudinal axis that is spaced from the first location (see different locations of the widest diameter as shown in Figs. 6A-6B).
Regarding claim 3, Govari further discloses the second location being spaced from the first location in a direction towards the proximal end (as can be appreciated in Figs. 6A-6B).
Regarding claim 4, Govari further discloses an annulus running at least partially through the crown and covering a terminal end of the crown (see opening formed by the proximal end of the nose cap 32 that extends through the crown and covers the terminal end of the crown in Fig. 5).
Regarding claim 5, Govari further discloses a first single axis sensor attached to the crown (see single axis position sensor 86 attached to the crown when the distal end is assembled, [0085], Fig. 17).
Regarding claim 7, Govari further discloses a dual axis sensor, a flex circuit, or a triple axis sensor disposed proximal the proximal end (see ends 42 of the flexible circuit disposed proximal the exposed proximal end of the spines, [0063], Fig. 4).
Regarding claim 8, Govari further discloses a proximal end of each spine comprising a tab that engages in a complementarily shaped recess in a spine coupler (see first ends 42 that comprise a tab that engages complimentarily shaped recess formed between the spine coupler 16 and retainer ring 84, [0063] and [0086], Figs. 4 and 20).
Regarding claims 22 and 23, Govari further discloses at least three electrodes attached to each spine, and the at least three electrodes of each spine being attached towards the distal end (as shown in Fig. 4).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Govari in view of Blumenkranz (US 2017/0367767).
Regarding claim 6, Govari discloses the limitations of claim 1, however fails to further teach a second single axis sensor disposed within one spine of the plurality of spines.
Blumenkranz teaches an end effector of a flexible medical device (see Figs. 4-5) comprising a single axis sensor disposed within the flexible section of the end effector (see flexible coil 420, [0016] and [0024], Fig. 4). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified at least one spline of the plurality of splines as disclosed by Govari to include a second single axis sensor disposed within the spine in light of Blumenkranz, the motivation being to provide the additional advantage of independently measuring the shape of the spines (see Blumenkranz [0016]).
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Govari in view of Govari et al. (US 2010/0036285) (“Govari ‘285”).
Regarding claims 9 and 10, Govari discloses the limitations of claim 1, however fails to further disclose a wire loop extending along each of the plurality of spines to define a magnetic field location sensor for each spine, and at least one wire looping helically about each of the plurality of spines to define a magnetic field location sensor.
Govari ‘285 teaches an end effector for a medical device (see Figs. 1 and 4) comprising a wire loop looping helically along each of a plurality of spines to define a magnetic field location sensor for each spine (see coils 22, [0046], Fig. 4). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the spines as disclosed by Govari to further include a wire loop extending along each of the plurality of spines to define a magnetic field location sensor for each spine, and at least one wire looping helically about each of the plurality of spines to define a magnetic field location sensor in light of Govari ‘285, the motivation being to provide the additional advantage of bend angle or radius of curvature of the distal end of the device as well as precise location of each of the spine structures for contact mapping (see Govari ‘285 [0046] and [0055]).
Claims 21, 25 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Govari.
Regarding claim 21, Govari discloses the limitations of claim 2, however Govari fails to specifically teach the proximal end and the second location being spaced by a third length, and the second location and the crown being spaced by a fourth length, a ratio of the third length to the fourth length being approximately 1 to 1.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Govari to have a ratio of the third length to the fourth length being approximately 1 to 1 since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Govari would not operate differently with the claimed ratio since the device is expandable/collapsible to meet this ratio and the device would function appropriately having the claimed ratio. Further, applicant places no criticality on the ratio claimed, indicating simply that a ratio of L3 to L4 is “approximately” 1 to 1 (specification pp. [0070]).
Regarding claim 25, Govari discloses the limitations of claim 4, however fails to specifically teach the annulus having a rounded outermost surface.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the outermost surface of the annulus to be rounded. 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. See MPEP 2144(IV)(B). Currently, there is no evidence of record showing unexpected results for such a change in shape.
Regarding claim 27, Govari discloses the limitations of claim 1, however Govari fails to specifically teach the end effector as configured to fit within a 13.5 French sheath.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Govari to have the end effector be configured to fit within a 13.5 French sheath since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Govari would not operate differently with the claimed sizing since the device is an intravascular catheter intended to pass through vasculature and the device would function appropriately having the claimed sizing. Further, applicant places no criticality on the specific size claimed, indicating that the sheath can be either 12 Fr or 13.5 Fr in diameter (specification pp. [0053]).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Govari in view of De La Rama et al. (US 2011/0118726).
Regarding claim 24, Govari discloses the limitations of claim 22, however fails to further disclose wherein the at least three electrodes of one spine being staggered relative to the at least three electrodes of an adjacent spine.
De La Rama teaches an end effector for a medical device (see Figs. 1 and 3-6) wherein the electrodes on each adjacent spine are staggered relative to the electrodes on the adjacent spines (see [0029], Fig. 1). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the at least three electrodes as disclosed by Govari to be staggered relative to the at least three electrodes of an adjacent spine in light of De La Rama, the motivation being to reduce the likelihood of stenosis (see De La Rama [0006]).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Govari in view of Marecki et al. (US 2017/0143227).
Regarding claim 26, Govari discloses the limitations of claim 4, however fails to disclose the annulus comprising at least one annulus projection that engages in at least one slot in the crown.
Marecki teaches an end effector for a medical device (see Figs. 1-3B) comprising an annulus comprising at least one annulus projection that engages in at least one slot in a crown (see annulus of distal cap 370 comprising a plug/gasket 356 as a projection that engages with the slots of the crown of the splines, [0085], Figs. 9A-10). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the annulus as disclosed by Govari to further comprise at least one annulus projection that engages in at least one slot in the crown in light of Marecki, the motivation being to provide the additional advantage of firmly securing the splines to the distal cap and sealing any remaining gaps between the splines and the distal cap (see Marecki [0085]).
Claims 28 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Govari in view of Fuimaono et al. (US 2006/0009689).
Regarding claim 28, Govari discloses an actuator shaft connected to a distal portion of the plurality of spines (see 12 and 18, Fig. 1) and coupled to an actuator (see [0059]). However, Govari fails to further disclose at least one reference electrode disposed on the actuator shaft.
Fuimaono teaches an end effector for a medical device (see Fig. 2) comprising one or more reference ring electrodes mounted on the catheter body (see [0040]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the actuator shaft as disclosed by Govari to further include at least a plurality of reference electrodes in light of Fuimaono, the motivation being to provide the additional advantage of aiding the physician to use the electrodes located on the catheter to perform electrophysiological mapping (see Fuimaono [0040]).
Regarding claim 29, Govari in view of Fuimaono teaches the limtiations of claim 28. Govari in view of Fuimaono fails to specifically teach wherein the at least one reference electrode comprises three reference electrode disposed at three distinct locations on the actuator shaft, however duplicating the reference electrodes of Govari in view of Fuimaono such that there were three references electrodes in distinct locations on the actuator shaft would have only amounted to an obvious duplication of parts for one of ordinary skill in the art for the same expected result of additional electrodes to reference electrical signals to. It has been held that mere duplication of the parts of a device has no patentable significance unless a new and unexpected result is produced. In re Harza, 274 F.2d 669, 124 USPQ 378 (MPEP 2144.04 (VI)(B)).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN W COLLINS whose telephone number is (408)918-7607. The examiner can normally be reached M-F 9:00 AM-5:00 PM ET.
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/SEAN W COLLINS/Primary Examiner, Art Unit 3794
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