DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 November 10, 2025 has been entered.
Response to Arguments
Applicant’s arguments with respect to the rejection(s) of the amended claim(s) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is set forth below.
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.
Claims 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6, 7, and 12 of U.S. Patent No. 11,865,237 in view of Gambale et al. (US 5,060,660). Although the claims at issue are not identical, they are not patentably distinct from each other because the patent discloses a catheter assembly comprising: a catheter body extending between a proximal segment proximate to a hub of the catheter assembly to a distal segment (Claim 1, Col. 19, lines 40-43), the distal segment including an end portion, the catheter body includes: a frame member extending between the proximal and distal segments, and proximal to the end portion (Claim 1, Col. 19, lines 45-47); a floating sleeve coupled around the frame member and extending between the proximal and distal segments and proximal to the end portion (Claim 1, Col. 19, lines 49-51), wherein the floating sleeve is configured to move relative to the frame member (Claim 1, Col. 19, lines 57-60); and a clearance extending between the frame member and the floating sleeve; and wherein the catheter body is configured for deflection between an initial configuration and a deflected configuration; in the initial configuration, the clearance includes a first spacing along a length of the catheter body; and in the deflected configuration the clearance includes a second spacing less than the first spacing (Claim 1, Col. 19, line 61-Col. 20, line 3). The patent fails to explicitly disclose a hub including a fluid passage. However, Gambale et al. (henceforth Gambale) teaches (Figure 1) a steerable balloon catheter comprising a hub (18) including a fluid passage (for balloon inflation fluid; Col. 4, line 66-Col. 5, line 2). It would have been obvious to one of ordinary skill in the art at the time of filing to modify the patent device to comprise the hub of Gambale so as to allow for a means of passing fluid through the shaft of the catheter to inflate the distal balloon as taught by Gambale.
Regarding claims 2, 9, and 10, the subject matter is known from claim 2 of the patent wherein in the deflected configuration the sleeve is frictionally engaged with the frame member thereby indicating reduced clearance; all of the additional structure of claim 9 is known from claim 1 of the patent).
Regarding claims 3, 11, and 12, the subject matter is known from claim 1 of the patent.
Regarding claims 4 and 5, the subject matter is known from claim 1 of the patent.
Regarding claim 6, the subject matter is known from claim 3 of the patent.
Regarding claim 7, the subject matter is known from claim 6 of the patent.
Regarding claim 8, the subject matter is known from claim 7 of the patent.
Regarding claims 13 and 14, the subject matter is known from claim 1 of the patent.
Regarding claim 15, the subject matter is known from claim 1 of the patent wherein any arbitrary length portion of the floating sleeve may be considered a segment as claimed.
Regarding claim 16, the subject matter is known from claim 12 of the patent.
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hammerslag et al. (US 5,203,772).
Regarding claim 1, Hammerslag et al. (henceforth Hammerslag) discloses (Figure 12) a catheter assembly comprising: a catheter body (distal segment of steering device) extending from a proximal segment proximate to a distal portion of a hub (see annotated figure below) of the catheter assembly to a distal portion (the wire portion extends to the proximal end of the device), the distal segment including an end portion (e.g., at anchor point 168), the catheter body includes: a frame member (see annotated figure below, the frame is formed by wires 170 and ribbon 110) extending between the proximal and distal portions (Figure 12), and proximal to the end portion (it can be seen in Figure 12 to extend proximally); a floating sleeve (wound wire loop 111) coupled around the frame member and extending between the proximal and distal portions (Figure 12, see annotated figure below), and proximal to the end portion (Figure 12, the sleeve is proximal to the end portion and extends proximally therefrom), wherein the floating sleeve is configured to move relative to the frame member (e.g., Figures 2-3 depict the general working of the steering end which is applicable to the embodiment of Figure 12; see Col. 18, lines 15-17 which disclose connecting the ribbon to the frame member via wire guides which allows the ribbon to move relative to the frame member during steering deflection); and a clearance extending between the frame member and the floating sleeve (gap between sleeve and frame, the ribbon is attached via guides 172 and anchor 168); and wherein the catheter body is configured for deflection between an initial configuration and a deflected configuration (Figures 1-3 depict how the steering end functions, as the frame member 110 and 170 are manipulated the ribbon will deflect relative to the body 111 to effect the steering of the device); in the initial configuration, the clearance includes a first spacing along a length of the catheter body; and in the deflected configuration the clearance includes a second spacing less than the first spacing (Figures 2-3, the frame member abuts the floating sleeve in the deflected configuration and in all embodiments). Hammerslag fails to explicitly disclose the hub includes a fluid passage.
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Regarding claim 2, Hammerslag further discloses wherein in the deflected configuration (Figures 2 and 3), as the deflection increases the clearance decreases according to an angle of deflection (the floating sleeve abuts the frame member in the deflected configuration and therefore the clearance decreases to zero as claimed; the embodiment of Figures 2-3 is applicable to that of Figure 12 in function).
Regarding claim 3, Hammerslag further discloses wherein the frame member is movably coupled with the floating sleeve (Figures 1-3).
Regarding claim 4, Hammerslag further discloses one or more anchor segments (168, 172) proximate to each of the proximal and distal portions of the floating sleeve (Figure 12).
Regarding claim 5, Hammerslag further discloses wherein the one or more anchor segments include a first anchor segment (guide 172) coupled with the floating sleeve near the proximal portion of the assembly (it’s closer to the end of the hub as per Figure 12, see annotated figure above), a second anchor (168) segment coupled with the floating sleeve between the proximal portion of the assembly and the distal portion of the assembly (Figure 12, see annotated figure above), and a third anchor segment coupled with the floating sleeve near a distal end of the assembly (the third anchor segment may be considered the other of anchor 168, see annotated figure above, there are two of elements 168, one on each side of ribbon 110).
Regarding claim 6, Hammerslag further discloses wherein at least one of the frame member (170, 110) and the floating sleeve (111) are configured to telescopically articulate (Figure 12, the sleeve is a coil which can expand and contract relative to the frame member).
Regarding claim 7, Hammerslag further discloses wherein the frame member comprises a stiffening wire (ribbon 110 is formed from nitinol which is considered to meet the limitation of a stiffening wire as claimed; Col. 18, lines 6-8).
Regarding claim 8, Hammerslag further discloses wherein the floating sleeve (111) includes a distal floating sleeve segment (e.g., adjacent distal tip) having a first flexibility and a proximal floating sleeve segment (adjacent hub) having a second flexibility, and the first flexibility is greater than the second flexibility (the distal end of coil 111 is disclosed as a “floppy steering region” and it can be seen in Figure 4 that the coil spacing increases toward the distal end thereby increasing the flexibility in a section of the coil proximate the distal end as claimed; Col. 7, lines 32-38; Col. 21, lines 26-37).
Regarding claim 9, Hammerslag discloses (see annotated figure 12 above) a catheter assembly comprising: a catheter body (distal segment of steering device) extending distally from a proximal segment proximate to a distal portion of a hub (see annotated figure below) of the catheter assembly to a distal segment, the distal segment including an end portion (e.g., at anchor point 168) the catheter body is configured for deflection between an initial configuration and a deflected configuration (Figures 1-4 depict the deflection which is similarly applicable to the embodiment of Figure 12); wherein the hub includes a fluid passage (open portion of hub, Figure 12) the catheter body includes: a floating sleeve (wire loop 111) extending between the proximal segment and the distal segment (Figure 12; and a frame member (170, 110), having a frame mechanical characteristic different from a sleeve mechanical characteristic (it’s a movable steering assembly different from the coil), the frame member extending between the proximal segment and the distal segment (Figure 12), and proximate to the end portion (the frame extends from the distal end in a proximal direction and is proximate the end portion as claimed) and within the floating sleeve (Figure 12), the frame member having a clearance between a frame outer surface and sleeve inner surface of the floating sleeve (Figure 12; the ribbon is spaced from the coil so as to allow for deflection during steering along at least part of its body when anchored in the manner depicted in Figure 12); wherein in the clearance between the frame member outer surface and the floating sleeve inner surface decreases as an angle of deflection increases along the catheter body and as the catheter body transitions from the initial configuration and the deflected configuration (Figures 1-3, as the distal end is deflected the frame member abuts and frictionally engages the floating sleeve to reduce the distance between the frame member and the floating sleeve as claimed; the depiction of the embodiment of Figures 1-3 is applicable to the function of the embodiment of Figure 12 wherein the frame member is moved via wires 170 to effect a bending in the distal end as it moves relative to the sleeve).
Regarding claim 10, Hammerslag further discloses wherein the floating sleeve and the frame member are configured to brace each other as the catheter body transitions between the initial configuration and the deflected configuration (Figures 2 and 3 depict the frame and sleeve frictionally engaged and therefore bracing each other during deflection; the embodiment of Figure 12 utilizes anchors 168 to attach a portion of the ribbon to the sleeve member, but it still has freedom to move relative to the length of the sleeve as set forth above).
Regarding claim 11, Hammerslag further discloses wherein the frame member (170, 110) and the floating sleeve (111) are configured to move relative to each other (Figures 1-3 and 12 disclose the two elements as movably coupled as claimed).
Regarding claim 12, Hammerslag further discloses wherein the frame member and the floating sleeve are movably coupled and permit movement of the floating sleeve relative to the frame member (see again Figures 1-3 and 12 which disclose the frame member as movable relative to the coil 111).
Regarding claim 13, Hammerslag further discloses wherein at least one of the frame member and the floating sleeve are configured to be telescopically articulate relative to the other of the floating sleeve or the frame member (the coil 111 varies in pitch along its length and it can be seen in Figures 2-3 that the length of elements 110 and 111 varies depending on the degree of deflection of the relative coaxial structure; this is considered to meet the telescoping limitation as set forth; see also Col. 21, lines 26-37).
Regarding claim 14, Hammerslag further discloses a proximal anchor segment (172) and a distal anchor segment (168).
Regarding claim 15, Hammerslag further discloses wherein the floating sleeve (111) includes one or more floating sleeve segments and each of the one or more floating sleeve segments is interposed between the one of the one or more proximal anchor segment (172) and the distal anchor segment (168; any of the coils of 111 between 172 and 168 meet the limitation as a sleeve segment).
Regarding claim 16, Hammerslag further discloses a proximal anchor segment (172) coupling the proximate portion of the floating sleeve (111) and the frame member (110); a distal anchor segment (168) coupling a distal portion of the floating sleeve and the frame member (Figure 12); and a floating sleeve segment interposed between the proximal and distal anchor segments (any portion of coil 111 between the anchor segments); wherein the floating sleeve segment is decoupled from the frame member (the sleeve is not coupled to element 111 between the two anchor points to allow for relative motion between the two elements; e.g., Col. 19, lines 42-44).
Regarding claim 17, Hammerslag discloses (see annotated Figure 12 above) a method of applying a catheter assembly, comprising: inserting the catheter assembly into a passageway (it’s an angioplasty guidewire), the catheter assembly including: a catheter body (distal segment of steering device) extending from a position proximate to a distal portion of a hub of the catheter assembly to a distal segment of the catheter body (Figure 12), the distal segment including an end portion (e.g., at 20 or 56); wherein the hub includes a fluidic passage (the hub is open for the wires 170 to pass therethrough; the claim fails to require fluid to actively pass through the passage during use); the catheter body includes: a frame member (170, 110) extending proximally relative to the end portion of the distal segment and proximal to the end portion (Figure 12, the frame extends proximally from the distal end of the device as claimed); and a floating sleeve (formed by 111) spaced around the frame member (Figure 12); wherein the frame member and the floating sleeve are movable relative to each other (Figures 1-3, the embodiment of Figure 12 is relatively movable in the same manner to effect the steering of the distal end of the device); navigating the catheter assembly along the passageway toward a specified position (e.g., depicted in Figure 6; Col. 21, lines 43-61), wherein navigating the catheter assembly includes: deflecting at least a portion of the catheter body into a deflected configuration from an initial configuration (Figures 1 and 12): wherein in the initial configuration a first clearance is between an inner surface of the floating sleeve (111) and an outer surface of the frame member (adjacent ribbon 110 which is not engaged with 111 along its entire length but on via the anchor segments); and wherein as a degree of deflection of the catheter assembly increases the first clearance between the inner surface of the floating sleeve and the outer surface of the frame member decreases to a second clearance (Figures 1-3, in the deflected state the distance between the frame member and sleeve can be seen to have decreased so that they are frictionally engaged as claimed; the embodiment of Figure 12 works in the same manner to reduce a distance between the ribbon 110 and sleeve 110 during deflection).
Regarding claim 18, Hammerslag further disclose wherein the floating sleeve (110) includes one or more floating segments (e.g., portion of 111 between anchors 168 and 172) separated by one or more anchor segments (168 and 172): and wherein deflecting at least a portion of the catheter body includes telescopically articulating the one or more floating segments relative to the frame member (the coil 111 varies in pitch along its length and it can be seen in Figures 2-3 that the length of elements 110 and 111 varies depending on the degree of deflection of the relative coaxial structure; this is considered to meet the telescoping limitation as set forth; see also Col. 21, lines 26-37).
Regarding claim 19, Hammerslag further discloses wherein the one or more anchor segments includes a distal anchor segment (168), the method includes: constraining relative movement in one or more degrees of freedom between the floating sleeve (111) and the frame member (110) proximate to at least one of the one or more anchor segments (the ribbon is anchored to element 111 at the distal anchor segment which constrains the relative movement at that attachment point).
Regarding claim 20, Hammerslag further discloses navigating the catheter assembly includes advancing the catheter assembly towards a specified position (Col. 21, lines 43-61; guiding the assembly through the vasculature is considered to meet the pushing limitation as claimed).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN L ZAMORY whose telephone number is (571)270-1238. The examiner can normally be reached M-F 8:30am-4:30pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783