DETAILED ACTION
This action is pursuant to the claims filed on August 12, 2025. Claims 1-8, and 10-20 are pending. Claims 9 is/are canceled. A first action on the merits of claims 1-8 and 10-20 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.
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 1-4, 6-8, 11, and 15-20 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Burke et al. (U.S. PGPub. No. 2012/0271335).
In regards to independent claim 1, Burke discloses a flexible catheter tip (a cardiac mapping assembly 10 comprising a distal basket assembly 12 in Figs. 1 and 2) comprising:
an inboard understructure (one of the splines 14 as shown in Figs. 1-2, see specifically Fig. 13) comprising a first inboard arm understructure (one of the medial spline portions 64 of the spline 14 in Fig. 13), a second inboard arm understructure (another medical spline portion 64 of the spline 14 in Fig. 3), and an inboard understructure distal end portion that connects a distal end of the first inboard arm understructure to a distal end of the second inboard arm understructure (distal spline portion 66 which connect the two medial spline portions 64 in Fig. 13),
wherein the inboard understructure distal end portion comprises a rectangular cross-sectional aligned with a reference plane (a plane that is defined along the longitudinal axis ‘L-L’ which intersects with the distal portion 64 of the spline 14; the cross-sectional area of the intersecting distal portion 64 aligns with the plane; [0164]: “the splines… are desirably thin, flat, planar elements” which implies that the cross-sectional area is rectangular shaped), and wherein a cross-sectional width of the inboard understructure distal end portion parallel to the reference plane is less than a cross-sectional width of the first inboard arm understructure and the second inboard arm understructure ([0123]: the examiner further notes that the claims do not recite that the cross-sectional width of the first and second in board arm understructures are aligned with the reference plane, therefore, the cross-sectional rectangular shape of the medial portion 64 is greater than the width portion 88 and/or thickness portion 100 at the distal portion 66 near or at the distal tip 16; the examiner notes that both the width and the thickness of the distal portion 66 are parallel to the plane defined by the longitudinal axis and the thickness is being interpreted as the cross-sectional width),
wherein the first inboard arm understructure comprises a first proximal inboard mounting arm (one of the proximal sections 62 in Fig. 13) and the second inboard arm understructure comprises a second proximal inboard mounting arm (another proximal section 62 in Fig. 13), wherein a cross-sectional width of the first proximal inboard mounting arm and the second proximal inboard mounting arm is less than the first inboard arm understructure and the second inboard arm understructure (proximal section 62 comprises a notch 174 as shown in exemplary Fig. 32A; since the cross-sectional shape is the same from the medial portion 64 to the proximal portion 62 except for the notch portion 172, the portion of the spline at the notch comprises a thickness substantially less than the thickness of the medial section 64, [0149]);
first inboard arm electrodes supported by and spaced along a length of the first inboard arm understructure (the medial portion 64 of the loop as shown in Fig. 13 comprises a plurality of electrodes which is shown in exemplary Figs. 33A-33B along the length of the splines), and second inboard arm electrodes supported by and spaced along a length of the first inboard arm understructure, and (the other medial portion 64 of the loop as shown in Fig. 13 comprises a plurality of electrodes which is shown in exemplary Figs. 33A-33B along the length of the splines).
In regards to claim 2, Burke further discloses wherein the inboard understructure distal end portion comprises a first distal element, a second distal element and a distal end portion connected to and between the first and second distal element (Fig. 22B shows the distal end portion 66 of the spline 14; note that the reduced portion 88 is disposed between the two tapering portions 86 which read on the first and second distal elements).
In regards to claim 3, Burke further discloses wherein the inboard understructure distal end portion is a flared head portion (the Examiner notes that ‘a flared’ head portion is broad and that any curvature of the spline portion 14 reads on the limitation; Fig. 24 illustrates that the distal end 66 being curved or flared).
In regards to claim 4, Burke further discloses wherein a cross-sectional width of the flared head portion parallel to the reference plane is from 0.007 inches to 0.009 inches ([0122]-[0123]: the thickness T1 is between 0.002 inches to about 0.012 inches; note that T2 is substantially smaller along the lines of 0.003 inches to 0.004 inches or less).
In regards to claim 6, Burke further discloses wherein the first proximal inboard mounting arm extending proximally from the first inboard arm understructure; and the second proximal inboard mounting arm extends proximally from the second inboard arm understructure (the proximal portion 62 extends from the medial portions 64 as shown in exemplary Fig. 12).
In regards to claim 7, Burke further discloses wherein the inboard understructure is formed from nitinol ([0152]: spline material may be a shape memory material such as a shape memory nitinol).
In regards to claim 8, Burke further discloses an outboard understructure (another spline 14 forming, in part, the basket assembly as shown in Figs. 1-2) comprising a first outboard arm understructure (one of the medial spline portions 64 of the spline 14 in Fig. 13), a second outboard arm understructure (another medial spline portion 64 of the spline 14 in Fig. 3), and a distal coupler for coupling the outboard understructure to the inboard understructure (distal tip 16 as shown in Figs. 26A-26E comprises a top part 104 and a bottom part 108 in which the distal portions 66 of the splines 14 are securely disposed within the distal tip 16, [0127]);
first outboard arm electrodes supported by and spaced along a length of the first outboard arm understructure; and second outboard arm electrodes supported by and spaced along a length of the second outboard arm understructure, second outboard arm electrodes supported by and spaced along a length of the second outboard arm (Figs. 33A-33B discloses that the splines 14 comprises a plurality of electrodes 186 along the length of the splines), wherein the outboard understructure is formed from a second continuous element that comprises a rectangular or square cross-section (Fig. 22A-22D illustrates the continuous spline 14 that are formed from the two medial portions 64; [0164]: “the splines… are desirably thin, flat, planar elements”).
In regards to claim 11, Burke further discloses wherein the outboard understructure comprises a first proximal outboard mounting arm and a second proximal outboard mounting arm (the another spline 14 comprises proximal portions 62 as shown in exemplary Fig. 13); the first proximal outboard mounting arm extends proximally from the first outboard arm understructure; and the second proximal outboard mounting arm extends proximally from the second outboard arm understructure (Fig. 13 shows that each of the medial portions 64 extends to its respective proximal portion 62).
In regards to claim 15, Burke further discloses wherein a distal end of the inboard understructure is connected to a distal end of the outboard understructure with a distal coupler (distal tip 16 as shown in Figs. 26A-26E comprises a top part 104 and a bottom part 108 in which the distal portions 66 of the splines 14 are securely disposed within the distal tip 16, [0127]).
In regards to claims 16-17, Burke further discloses wherein each of the inboard understructure and the outboard understructure is made of a single unitary piece of material (Fig. 22A-22D illustrates the continuous spline 14 that forms the two medial portions 64; [0152]: spline material may be a shape memory material such as a shape memory nitinol).
In regards to independent claim 18, Burke discloses a catheter (catheter 10 in Figs. 1-2) comprising:
a catheter shaft (catheter body or shaft 20) comprising a proximal end (portion of the catheter shaft 20 connected to the handle 28) and a distal end (portion of the shaft 20 connected to the spline basket 12); and
a flexible tip (a cardiac mapping assembly 10 in Figs. 1 and 2) attached to the distal end of the catheter shaft, wherein the flexible tip assembly comprises:
an inboard understructure (one of the splines 14 as shown in Figs. 1-2, see specifically Fig. 13) comprising a first inboard arm understructure (one of the medial spline portions 64 of the spline 14 in Fig. 13), a second inboard arm understructure (another medical spline portion 64 of the spline 14 in Fig. 3), and an inboard understructure distal end portion that connects a distal end of the first inboard arm understructure to a distal end of the second inboard arm understructure (distal spline portion 66 which connect the two medial spline portions 64 in Fig. 13, [0164]: “the splines… are desirably thin, flat, planar elements”),
wherein the inboard understructure distal end portion comprises a rectangular cross-sectional aligned with a reference plane (a plane that is defined along the longitudinal axis ‘L-L’ which intersects with the distal portion 64 of the spline 14; the cross-sectional area of the intersecting distal portion 64 aligns with the plane; [0164]: “the splines… are desirably thin, flat, planar elements” which implies that the cross-sectional area is rectangular shaped), and wherein a cross-sectional width of the inboard understructure distal end portion parallel to the reference plane is less than a cross-sectional width of the first inboard arm understructure and the second inboard arm understructure ([0123]: the examiner further notes that the claims do not recite that the cross-sectional width of the first and second in board arm understructures are aligned with the reference plane, therefore, the cross-sectional rectangular shape of the medial portion 64 is greater than the width portion 88 and/or thickness portion 100 at the distal portion 66 near or at the distal tip 16; the examiner notes that both the width and the thickness of the distal portion 66 are parallel to the plane defined by the longitudinal axis and the thickness is being interpreted as the cross-sectional width),
first inboard arm electrodes supported by and spaced along a length of the first inboard arm understructure (the medial portion 64 of the loop as shown in Fig. 13 comprises a plurality of electrodes which is shown in exemplary Figs. 33A-33B along the length of the splines); and second inboard arm electrodes supported by and spaced along a length of the first inboard arm understructure, and (the other medial portion 64 of the loop as shown in Fig. 13 comprises a plurality of electrodes which is shown in exemplary Figs. 33A-33B along the length of the splines).
In regards to claim 19, Burke further discloses wherein the inboard understructure distal end portion comprises a first distal element (one of the tapering portion from 86 to 88 in Figs. 22A-2B), a second distal element (the other tapering portion from 86 to 88 in Figs. 22A-2B) and a distal end portion connected to an between the first and second distal elements (portion 88 in Figs. 22A-22B).
In regards to claim 20, Burke further discloses wherein the inboard understructure distal end portion is a flared head portion (distal tip 16 as shown in exemplary Fig. 24), and the first distal element is a first flared element (one of the curved or flared portion 78 in Fig. 24) and the second distal element is a second flared element (another curved or flared portion 78 in Fig. 24).
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 5 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Burke, and further in view of De La Rama et al. (hereinafter ‘De La Rama’, U.S. PGPub. No. 2011/0118726).
In regard to claims 5 and 10, Burke discloses the invention substantially as claimed in claim 1 and 8/1 and discussed above.
However, Burke does not disclose wherein each of the first inboard arm understructure and the second inboard arm understructure is elongated and aligned with the reference plane and wherein each of the first outboard arm understructure and the second outboard arm understructure is elongated and aligned with the reference plane.
De La Rama teaches a basket assembly of a catheter (electrode assembly 20 in Fig. 1) comprising a plurality of splines (spines 24) wherein the splines are configured to be aligned with a reference plane aligned along a longitudinal axis (plane defined along the longitudinal axis 16). The examiner notes that two of the oppositely positioned splines of De La Rama is analogous to the understructure of Burke so as to provide a sufficient stiffness to avoid or minimize bending in the expandable arrangement of the basket assembly ([0024]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the inboard and outboard arms of Burke such that it is aligned with the reference plane defined by the longitudinal axis as taught by De La Rama, as doing to provides a sufficient stiffness to avoid or minimize bending in the expandable arrangement of the basket assembly ([0024]).
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, 5-8, 10-11, 13-16 and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 4, 6-10 and 14 of U.S. Patent No. 12,121,357.
In regards to claim 1, every limitation is recited in the conflicting reference patent claim 1.
In regard to claims 2-3, claim 3 of Patent ‘357 recites the inboard understructure distal portion. The claim recites “a sloped first inboard arm connected portion and a sloped second inboard arm connected portion” which anticipates the claimed “a first flared element” and “a second flared element”.
In regards to claim 5, claim 1 of Patent ‘357 recites the same limitation.
In regards to claim 6, claim 4 of Patent ‘357 recites the same limitation.
In regards to claim 7, claim 9 of Patent ‘357 recites the same limitation.
In regards to claim 8, claim 1 of Patent ‘357 recites the same limitation.
In regards to claim 10, claim 1 of Patent ‘357 recites the same limitation.
In regards to claim 11, claim 1 of Patent ‘357 recites the same limitation.
In regards to claim 13, claim 1 of Patent ‘357 recites the same limitation.
In regards to claim 14, claim 6 of Patent ‘357 recites the same limitation.
In regards to claim 15, claim 8 of Patent ‘357 recites the same limitation.
In regards to claim 16, claim 10 of Patent ‘357 recites the same limitation.
In regards to claim 18, every limitation is recited in the conflicting reference patent claim 14.
In regard to claims 19-20, claim 3 of Patent ‘357 recites the inboard understructure distal portion. The claim recites “a sloped first inboard arm connected portion and a sloped second inboard arm connected portion” which anticipates the claimed “a first flared element” and “a second flared element”.
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.
Allowable Subject Matter
Claims 13 and 14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
In regard to claims 13-14, Burke fails to disclose an interlock arrangement between the inboard understructure proximal mounting arm portions and the outboard understructure proximal mounting arm portions as claimed.
Rather, the inboard and outboard understructure proximal mounting arm portions are interlocked on an anchor (proximal anchor 176 in Figs. 32B-32C comprises a plurality of alignment detent 184 which interlocks with a notch 174 of each of the splines 14, [0149]).
De La Rama (U. S. PGPub. No. 2014/0200639) discloses a catheter comprising a flexible catheter tip (see Fig 1) comprising inboard understructure and outboard understructure (inner arms 212 and 213 and outer arms 211 and 214 in exemplary Fig. 2A) arranged in a planar manner. However, De La Rama does not disclose the interlock arrangement between the inboard and outboard understructure proximal mounting arm portions. Similar to Burke, these understructures are interlocked with the bushing (206 in Fig. 44) so that the inboard and outboard mounting arms are secured to the distal end of the catheter (see Fig. 44).
Taken together, there is no motivation to eliminate the bushing or the anchor of Burke or De La Rama so that the proximal mounting arm portions are interlocked with each other via its respective frame locks as required in claim 14. Accordingly, claim 14 is allowed as being dependent on claim 13.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. De La Rama (U. S. PGPub. No. 2014/0200639) discloses a catheter comprising a flexible catheter tip (see Fig 1) comprising inboard understructure and outboard understructure (inner arms 212 and 213 and outer arms 211 and 214 in exemplary Fig. 2A). Fig. 3-7 illustrates the cylindrical nature of the understructures. However, modifying the cylindrical understructure into a planar flat understructure is taught by the Burke reference ([0164]: “the splines… are desirably thin, flat, planar elements”).
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JOSEPH STOKLOSA can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EUN HWA KIM/Primary Examiner, Art Unit 3794 6/23/2026
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