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 .
Response to Arguments
Claim 3 has been amended. Claim objection has been withdrawn.
Applicant’s arguments, filed February 17, 2026, with respect to the rejection(s) of claim(s) 1-12 and 17-19 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made. Please direct attention to rejection below, specifically reference Tieu, regarding the amended limitations of wherein the tip tie tube is disposed within and coupled to a distal end of the expandable member and slidably disposed over a distal portion of the stylet.
Regarding independent claim 13, and amended claim 19, Applicant argues that the combination of Boucher and Poor fail to disclose or suggest a protective sleeve configured to be slidable displaceable over the outer tube. Examiner respectfully disagrees.
Col. 6, Lines 4-7 of Poor read: “The braid arrangement provides for ease in bending (flexibility) while the higher elastic modulus provides for optimal torsional strength.”
Col. 6, Lines 12-17 of Poor read: Additionally, the braided structure greatly improves the torsional strength of the stylet so that rotational force applied at the proximal end may be transferred to the distal end. This increase in torsional strength is provided without any substantial decrease in the deflection capability of the distal tip of the stylet. Braided structure 18 is coupled to outer member 5 in at least one location.
Examiner contends that while sleeve 18 is couple to outer tube 5, its braided structure allows for slidable displacement as the tube is bended, or as rotational force is implied. The coupling of sleeve 18 to outer tube 5 would not force the entirety of the sleeve to remain static as the outer tube is bended or rotated. The braided structures allows for slidable displacement over the outer tube in order to provide torsional strength to the structure.
Allowable Subject Matter
Claims 16 and 20 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, and upon overcoming the double patenting rejection.
The following is a statement of reasons for the indication of allowable subject matter:
The prior art fails to teach or disclose wherein the protective sleeve is disposed around the expandable member when the bone displacement device is in a package state, and is releaseably coupled to the handle when the bone displacement device is in a ready state, and wherein a distal end of the protective sleeve comprises a funnel shape.
The prior art fails to teach or disclose further comprising displacing the protective sleeve proximally from a bone displacement device package state where the protective sleeve surrounds the expandable member to a bone displacement device ready state where the protective sleeve is releasably coupled to the handle, and wherein a distal end of the protective sleeve comprises a funnel shape.
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.
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Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,986,229. Although the claims at issue are not identical, they are not patentably distinct from each other because both the granted patent and present application disclose a bone displacement device. The device comprises an elongate outer tube, an elongate stylet coaxially disposed within the outer tube, wherein the stylet comprises a tubular shaft and a plurality of pull wires disposed within a lumen of the shaft, the plurality of pull wires are configured to be pulled proximally. The device comprises a handle coupled to a proximal portion of the outer tube and the stylet, wherein the handle comprises a rotatable grip, wherein the plurality of pull wires are coupled to a pull member disposed within the rotatable grip, and wherein the rotatable grip engages with threads of the pull member to displace the pull member proximally and distally. The device includes an expandable member disposed adjacent a distal end of the outer tube, and a tip tie tube disposed within the expandable member and coupled to a distal end of the expandable member and slidably disposed over a distal portion of the stylet, wherein the tip tie tube is displaced proximally relative to the distal portion of the stylet when the expandable member is expanded, and is displaced distally relative to the distal portion of the stylet when the expandable member is contracted.
Both the granted patent and present application disclose a bone displacement system. The system comprises a bone displacement device that comprises an elongate outer tube, an elongate stylet coaxially disposed within the outer tube, wherein the stylet comprises a tubular shaft and a plurality of pull wires disposed within a lumen of the shaft, the plurality of pull wires are configured to be pulled proximally, a handle coupled to a proximal end of the outer tube and the stylet, wherein the handle comprises a rotatable grip, wherein the plurality of pull wires are coupled to a pull member disposed within the rotatable grip, and wherein the rotatable grip engages with threads of the pull member to displace the pull member proximally or distally. The system includes an expandable member disposed adjacent a distal end of the outer tube, and a tip tie tube disposed within the expandable member and coupled to a distal end of the expandable member and slidably disposed over a distal portion of the stylet, wherein the tip tie tube is displaced proximally relative to the distal portion of the stylet when the expandable member is expanded, and is displaced distally relative to the distal portion of the stylet when the expandable member is contracted, and a protective sleeve configured to be slidably displaceable over the outer tube.
Both the granted patent and present application disclose a method of displacing bone that comprises obtaining a bone displacement device that comprises an elongate outer tube, an elongate stylet coaxially disposed within the outer tube, wherein the stylet comprises a tubular shaft and a plurality of pull wires disposed within a lumen of the shaft, the plurality of pull wires are configured to be pulled proximally. The device includes a handle coupled to a proximal end of the outer tube and the stylet, wherein the handle comprises a rotatable grip, wherein the plurality of pull wires are coupled to a pull member disposed within the rotatable grip, and wherein the rotatable grip engages with threads of the pull member to displace the pull member proximally or distally. The device includes an expandable member disposed adjacent a distal end of the outer tube, and a tip tie tube disposed within the expandable member and coupled to a distal end of the expandable member and slidably disposed over a distal portion of the stylet, wherein the tip tie tube is displaced proximally relative to the distal portion of the stylet when the expandable member is expanded, and is displaced distally relative to the distal portion of the stylet when the expandable member is contracted, inserting a distal portion of the bone displacement device into a bone, articulating a distal portion of the stylet, and expanding the expandable member.
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, 7-13, 15, 17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 2008/0065137 to Boucher et al. in view of U.S. Patent Pub. No. 2016/0120584 to Tieu in view of U.S. Patent No. 6,607,496 to Poor et al.
As to Claim 1, Boucher discloses a bone displacement device (48, Fig. 3, [0037]). The device comprises an elongate outer tube (16, Fig. 4, [0038]), an elongate stylet (18) coaxially disposed within the outer tube (Fig. 4, [0038]), wherein the stylet comprises a tubular shaft (within 50, Fig 8, [0043]). A handle (24) is coupled to a proximal portion of the outer tube and the stylet (Fig. 4, [0077]), and an expandable member (56) is disposed adjacent a distal end of the outer tube [0037].
As to Claim 9, Boucher discloses a bone displacement device further comprising an elongate inner tube (20) coaxially disposed between the outer tube (16) and the stylet (18, Fig. 4, [0038-0041]).
As to Claim 10, Boucher discloses a bone displacement device wherein a proximal portion of the expandable member is sealingly coupled to a tie layer (at 20, [0041]), and the tie layer is sealingly coupled to a distal portion of the outer tube (at 18, [0041]).
As to Claim 11, Boucher discloses a bone displacement device wherein the expandable member is a balloon [0037].
As to Claim 12, Boucher discloses a bone displacement device wherein the handle comprises a side port (38) and a valve member disposed within the side port [0040, 0042].
As to Claim 13, Boucher discloses a bone displacement system (Fig. 3, [0030]). The system comprises a bone displacement device (48, Fig. 3, [0037]). The device comprises an elongate outer tube (16, Fig. 4, [0038]), an elongate stylet (18) coaxially disposed within the outer tube (Fig. 4, [0038]), wherein the stylet comprises a tubular shaft (within 50, Fig 8, [0043]). A handle (24) is coupled to a proximal portion of the outer tube and the stylet (Fig. 4, [0077]), and an expandable member (56) is disposed adjacent a distal end of the outer tube [0037].
As to Claim 17, Boucher discloses a method of displacing bone [0006-0008] including obtaining a bone displacement device (48, Fig. 3, [0037]). The device comprises an elongate outer tube (16, Fig. 4, [0038]), an elongate stylet (18) coaxially disposed within the outer tube (Fig. 4, [0038]), wherein the stylet comprises a tubular shaft (within 50, Fig 8, [0043]) and a pull wire (52) disposed within the shaft (Figs. 6-8, [0043]), a handle (24) coupled to a proximal portion of the outer tube and the stylet (Fig. 4, [0077]), and an expandable member (56) disposed adjacent a distal end of the outer tube [0037]. The method includes inserting a distal portion of the bone displacement device into a bone (Fig. 11, [0116]) and expanding the expandable member (Fig. 12 and [0117]).
As to Claims 1, 7-13, 15, 17, and 19, Boucher discloses the claimed invention except for further comprising a tip tie tube disposed within and coupled to a distal end of the expandable member and slidably disposed over a distal portion of the stylet, wherein the tip tie tube is displaced proximally relative to the distal portion of the stylet when the expandable member is expanded and is displaced distally relative to the distal portion of the stylet when the expandable member is contracted, wherein the tip tie tube comprises a braided material, wherein a distal portion of the expandable member is sealingly coupled to the tip tie tube, and the tip tie tube is sealingly coupled to a distal portion of the inner tube, a protective sleeve configured to be slidably displaceable over the outer tube, wherein the protective sleeve comprises a tubular member and a grip coupled to the tubular member.
Tieu discloses a bone displacement device and method wherein a tip tie tube (120) is disposed within (seen within 150, Fig. 4) and coupled to [0037] a distal end (at 151) of the expandable member (150, [0038]) and slidably disposed over a distal portion of the stylet (140, [0040], Fig. 4) in order to allow for the tip tie tube to slide along the stylet during expansion of the expandable member [0040].
Poor discloses a bone displacement device and method (Col. 9, Lines 21-38) comprising a tip tie tube (18) coupled to a distal end of the expandable member (over 5) and slidably disposed over a distal portion of the stylet (Fig. 4A, Col. 6, Lines 8-30). The tip tie tube (18) is displaced proximally relative to the distal portion of the stylet when the expandable member is expanded (deflection of Col. 9, Lines 21-38), and is displaced distally relative to the distal portion of the stylet when the expandable member is contracted (deflection of Col. 9, Lines 21-38). The tip tie tube comprises a braided material (braided structure 18). A distal portion of an expandable member (at 15) is sealingly coupled to the tip tie tube (Col. 6, Lines 8-30), and the tip tie tube is sealingly coupled to a distal portion of the inner tube (at 5, Col. 6, Lines 8-30). A protective sleeve (18) is configured to be slidably displaceable over the outer tube (5, Figs. 4A-4B, Col. 6, Lines 4-30). The protective sleeve (18) comprises a tubular member (Figs. 4A and 4B) and a grip (4) coupled to the tubular member (seen in Fig. 6, Col. 7, Lines 46-48). The protective sleeve (18) is disposed around the expandable member when the bone displacement device is in a package state (Col. 6, Lines 8-30, Col. 9, Lines 21-38), and is coupled to the handle (4) when the bone displacement device is in a ready state (Fig. 6, Col. 7, Lines 46-48) in order to increase torsional strength along a distal end of the stylet (Col. 2, Lines 66-67 – Col. 3, Lines 1-15).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the bone displacement device of Boucher with the tip tie tube configuration of Tieu to in order to allow for the tip tie tube to slide along the stylet during expansion of the expandable member and with the tip tie tube material and sleeve modification of Poor in order to increase torsional strength along a distal end of the stylet.
Claims 2-5, 14, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 2008/0065137 to Boucher et al. in view of U.S. Patent Pub. No. 2016/0120584 to Tieu. in view of U.S. Patent No. 6,607,496 to Poor et al. in view of U.S. Patent Pub. No. 2018/0264321 to Scheibe.
As to Claims 2 and 14, Boucher discloses a pull wire (52) disposed within the shaft (Figs. 6-8, [0043]).
As to Claims 2-5, 14, and 18, Boucher, Tieu, and Poor disclose the claimed invention except for wherein the stylet further comprises a plurality of pull wires disposed within the shaft, wherein the handle comprises a rotatable grip, and wherein the plurality of pull wires are coupled to a pull member disposed within the rotatable grip, wherein the pull member comprises male threads configured to engage with female threads of the rotatable grip, wherein the pull member is displaced proximally when the rotatable grip is rotated in a first direction to apply a tension force to the plurality of pull wires, and displaced distally when the rotatable grip is rotated in a second direction to release the tension force from the plurality of pull wires, and wherein a distal portion of the stylet articulates when the tension force is applied to the plurality of pull wires.
Scheibe discloses a steerable medical device and method (100, Fig. 2, [0042]). A plurality of pull wires (167, 169, 187, 189, [0050]) are coupled to a pull member (154) disposed within a shaft (within 104, Fig. 5, [0051-0052]). A handle (104) comprises a rotatable grip (128 and 132, [0049]) and wherein the rotatable grip (128) engages with threads of the pull member to displace the pull member [0052]. The plurality of pull members (167, 169, 187, 189) are coupled to a proximal end of the pull member (154, seen in Fig. 5). The pull member (154) is displaced proximally when the rotatable grip (128) is rotated in a first direction to apply a tension force to the plurality of pull wires [0052], and displaced distally when the rotatable grip is rotated in a second direction to release the tension force from the plurality of pull wires [0052], and wherein a distal portion of the stylet articulates when the tension force is applied to the plurality of pull wires [0052]. The pull member (154) comprises male threads configured to engage with female threads of the rotatable grip (128, insertion configuration of 154 within 128, [0052-0054]). The method includes articulating a distal portion of the stylet (108, seen in Fig. 11, [0063]). The pull member (154) is displaced along a longitudinal axis of the device [0052-0054] in order to allow for controlled tension of the pullwires to control the expandable member [0054].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the bone displacement device of Boucher, Tieu, and Poor with the plurality of pull wires and rotatable grip modification of Scheibe in order to allow for controlled tension of the pullwires to control the expandable member.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 2008/0065137 to Boucher et al. in view of U.S. Patent Pub. No. 2016/0120584 to Tieu in view of U.S. Patent No. 6,607,496 to Poor et al. in view of U.S. Patent Pub. No. 2018/0264321 to Scheibe in view of U.S. Patent Pub. No. 2013/0006232 to Pellegrino et al.
As to Claim 6, Boucher, Tieu, Poor, and Scheibe disclose the claimed invention except for wherein the male threads comprise a proximal male thread stop and a distal male thread stop, wherein the female threads comprise a proximal female thread stop and a distal female thread stop, wherein the proximal male thread stop is configured to engage with the proximal female thread stop to limit proximal displacement of the pull member, wherein the distal male thread stop is configured to engage with the distal female thread stop to limit distal displacement of the pull member,
Pellegrino discloses a bone displacement device (201, Fig. 8). The male threads comprise a proximal male thread stop (270) and a distal male thread stop (258, [0172]), wherein the female threads comprise a proximal female thread stop (240) and a distal female thread stop (258, [0172]). The proximal male thread stop (270) is configured to engage with the proximal female thread stop (240) to limit proximal displacement of the pull member and wherein the distal male thread stop (258) is configured to engage with the distal female thread stop (258) to limit distal displacement of the pull member (described in [0172-0174]). The method includes articulating a distal portion of the stylet [0170] in order to allow for control of articulation of the distal portion of the stylet to steer along a desired path [0170].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the bone displacement device of Boucher, Tieu, Poor, and Scheibe with the thread stop modification of Pellegrino in order to allow for control of articulation of the distal portion of the stylet to steer along a desired path.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER J BECCIA whose telephone number is (571)270-7391. The examiner can normally be reached Mon - Fri 8:30-5:00.
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/CHRISTOPHER J BECCIA/Primary Examiner, Art Unit 3775
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