DETAILED ACTION
This action is pursuant to the claims filed on February 19, 2025. Claims 1-20 are pending. A first action on the merits of claims 1-20 is as follows.
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 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.
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.
Claim 1-3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6 of U.S. Patent No. 11,850,051.
In regards to claim 1, Although the claims at issue are not identical, they are not patentably distinct from each other because the more specific patent claims encompass the broader application claims. Following the rationale in In re Goodman, where applicant has once been granted a patent containing a claim for a specific narrow invention, applicant may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
In regards to claim 2, Claim 1 of Patent ‘051 claims that each of the first, second and third closed-loop member, each comprising a first spine and a second spine. Although the claim does not explicitly recite that the splines are parallel to the longitudinal axis, based upon the arrangement of each of the closed-loop members extending along the longitudinal axis tubular member, each of the spines would inherently extend along the longitudinal axis of the tubular member.
In regards to claim 3, Claim 6 of the Patent ‘051 anticipates the claimed limitations of claim 3.
In regards to claim 13, Claim 1 of Patent ‘051 claims more specific catheter than the broadly claimed catheter of the instant application. Although Claim 1 of Patent ‘051 does not specifically recite the use of the catheter such as delivering the catheter and deploying the end effector, these are obvious method steps in order to use the claimed catheter for its intended purpose of mapping the heart. Therefore, incorporating these obvious and routine method steps to use the catheter for its intended purpose of electrophysiology involves routine skill in the art.
Claim 1-3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6 of U.S. Patent No. 12,251,224.
In regards to claim 1, Although the claims at issue are not identical, they are not patentably distinct from each other because the more specific patent claims encompass the broader application claims. Following the rationale in In re Goodman, where applicant has once been granted a patent containing a claim for a specific narrow invention, applicant may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer. Specifically, in order for the first, second and third loop members of Patent ‘224 to function as a three-axis magnetic sensor, note that each of the loops are all at an angle with respect to each other, forming the recited the first and second generally planar surface intersects the first and second orthogonal planes, while the third generally planar surface insects only one of the first and second orthogonal planes.
In regards to claim 2, Claim 1 of Patent ‘224 claims that each of the first, second and third closed-loop member, each comprising a first spine and a second spine. Although the claim does not explicitly recite that the splines are parallel to the longitudinal axis, based upon the arrangement of each of the closed-loop members extending along the longitudinal axis tubular member, each of the spines would inherently extend along the longitudinal axis of the tubular member.
In regards to claim 3, Claim 5 of the Patent ‘224 anticipates the claimed limitations of claim 3.
In regards to claim 13, Although the claims at issue are not identical, they are not patentably distinct from each other because the more specific patent claims encompass the broader application claims. Following the rationale in In re Goodman, where applicant has once been granted a patent containing a claim for a specific narrow invention, applicant may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer. Specifically, in order for the first, second and third loop members of Patent ‘224 to function as a three-axis magnetic sensor, note that each of the loops are all at an angle with respect to each other, forming the recited the first and second generally planar surface intersects the first and second orthogonal planes, while the third generally planar surface insects only one of the first and second orthogonal planes. Although Claim 1 of Patent ‘224 does not specifically recite the use of the catheter such as delivering the catheter and deploying the end effector, these are obvious method steps in order to use the claimed catheter for its intended purpose of mapping the heart. Therefore, incorporating these obvious and routine method steps to use the catheter for its intended purpose of electrophysiology involves routine skill in the art.
Allowable Subject Matter
Claims 1-20 would be allowable if a proper terminal disclaimer is filed in the next submission.
In regards to independent claim 1, Hoitink et al. (U.S. PGPub. No. 2016/0143588) discloses a catheter for electrophysiology application (Fig. 1 generally shows a catheter configured for high density mapping of tissue surface in the heart, [0006]; catheter in Fig. 8F shows a specific end effector configuration), comprising:
a tubular member extending along a longitudinal axis from a proximal portion to a distal portion (an elongate catheter body 12 in Fig. 1 extending from the handle 16 to the distal end effector 15), the distal portion having a cross-section disposed about the longitudinal axis (this is any arbitrary cross-section along the longitudinal axis of the body 12), the cross-section intersecting first and second orthogonal planes that extend along the longitudinal axis (the cross-section extending along the longitudinal axis of the body 12 is along a x-y plane and therefore, the first orthogonal plane can be a x-z plane and the second orthogonal plane can be a y-z plane); and
an end effector coupled to the distal portion, the end effector comprising first, second and third closed-loop members (the three loops X1, X2 and X3 form the end effector 15 configured to be attached to a distal end of the body 12 as shown in Fig. 8F), and the end effector having an unrestrained configuration (Fig. 8F is an unrestrained configuration as it is not within a delivery or guiding sheath) in which:
each of the closed-loop member comprises a pair of ends coupled to the distal portion of the tubular member and a contiguous looped path extending between the pair of ends define a generally planar surface (X1, X2, and X3 comprises two ends that connect to the body 12 and each of the loops define a plane; [0063]: As shown in FIG. 8C-8F, the spines of the array are looped such that a pair of spaced-apart spines are formed from a single continuous spine turned back on itself with a U-section 17U its two ends anchored in the distal end of the connector tubing 46.).
Hoitink discloses that in the array of FIG. 8F, the spines comprising three intersecting loops where the three intersecting loops have locations that intersect. In other words, Hoitink is silent as to whether the first and second generally planar surface intersects the first and second orthogonal planes, while the third generally planar surface insects only one of the first and second orthogonal planes as required in independent claim 1.
Pappone (U.S. PGPub. No. 2018/0042667) discloses a catheter for electrophysiology application (distal portion 206 comprising mapping electrodes 228 to collect ECG data in Fig. 7), the catheter including a tubular member (shaft 208) and an end effector coupled to the distal portion, wherein the end effector comprises three closed-loop members (Fig. 7 shows three loops extending from the distal end of the shaft aperture, each formed by two extending arms 210-220, 212-218, and 214-216 pairs). However, Pappone also fails to disclose the first and second generally planar surface intersects the first and second orthogonal planes, while the third generally planar surface insects only one of the first and second orthogonal planes as required in independent claim 1. Pappone discloses that each pair of ends of the closed-loop member are arranged in parallel with respect to each other (see the proximal portion of the loops in Fig. 5C).
Therefore, Hoitink, and Pappone, whether alone or in combination with another prior art, does not explicitly disclose in the unrestrained configuration, the first and second generally planar surfaces of the first and second closed-loop member, respectively intersecting with the first and second orthogonal planes, while the third generally planar surface of the third closed-loop member insects only one of the first and second orthogonal planes as required in independent claim 1 and similarly recited in independent claim 13. Accordingly, claims 2-12 and 14-20 claim allowable subject matter as being dependent on independent claims 1 and 13.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EUNHWA KIM whose telephone number is (571)270-1265. The examiner can normally be reached 9AM-5:30PM.
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/EUN HWA KIM/Primary Examiner, Art Unit 3794 7/31/2026
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