DETAILED ACTION
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-8, 11-17, 19 and 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 1, the recitation “an inflatable member proximate the distal end of the elongated sheath, the device configured and the inflatable member positioned eccentrically about the distal end of the elongated sheath to inflate the inflatable member..” renders the claim vague and indefinite because the balloon is eccentrically positioned only after the balloon is inflated. Further, it is unclear which part of the device is configured to inflate the inflatable member. It is suggested that Applicant recite the elongated sheath to be configured to inflate the inflatable member.
In claim 14, the recitation “…the inflatable member is positioned eccentrically about the distal end of the elongated sheath such that, when inflated, the inflatable member…” renders the claim vague and indefinite because the interaction of structure to result in the method step is not clearly recited. The balloon is eccentrically positioned only after inflation.
Appropriate correction is required.
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.
Claim(s) 1-4, 7-8 and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Ralph et al. (US 7927339) in view of Rabiner (US 7806900).
Regarding claim 1, Ralph et al. disclose an orthopedic guidewire positioning device (i.e. capable of being used as a guidewire centering device) including: (a) fracture reduction cannula or elongated sheath 18 (Fig. 9) extending between a proximal end and a distal end; (b) the elongated sheath further comprising a guidewire channel extending through the elongated sheath to a guidewire opening at the distal end of the elongated sheath, the guidewire channel configured or capable of receiving a guide pin 108 or guidewire such that a distal end of the guide wire extends out of the guidewire opening at the distal end of the elongated sheath (Fig. 10b); (c) a circumferential or sidewall opening 70 in sheath 18; and (d) an inflatable member 86 (Fig. 22) proximate the distal end of the elongated sheath, the device configured to inflate the inflatable member such that the inflatable member extends away from a first side of the elongated sheath as it inflates to deflect the distal end of the elongated sheath in a direction opposite a direction along which the inflatable member extends (Figs. 19-22, 21a, 22a, col. 5, lines 26-67, col. 6 col. 7, lines 1-45, col. 11, lines 8-67 and col. 12, lines 1-62).
Regarding the recitation “inflatable member positioned eccentrically about the distal end of the elongated sheath,” upon inflation, the balloon in the Ralph device is eccentrically positioned about the sheath because it is inflated through the sidewall opening (Fig. 22).
Regarding claim 2, Ralph et al. disclose a syringe or inflation element 101 configured to deliver fluid to the inflatable member 86 wherein actuation of the inflation element inflates the inflatable member only on the first side of the inflation lumen (col. 8, lines 46-53).
Regarding claim 3, Ralph et al. disclose the inflatable member 86 to be connected to a fluid conduit 88 extending from the inflatable member 86 towards the proximal end of the elongated sheath 18 (Figs. 11 and 21, col. 7, lines 62-67, col. 8, lines 1-41, col. 11, lines 8-67 and col. 12, lines 1-30).
Regarding claim 4, Ralph et al. disclose the fluid conduit 88 to be separate from the guidewire channel (lumen of fracture reduction cannula 18) (Fig. 10b, 11 and 21, col. 11, lines 8-67 and col. 12, lines 1-30).
Regarding claims 7 and 8, Ralph et al. disclose the inflatable member to extend through a sidewall opening of the elongated sheath 18 (Figs. 20-22).
Regarding claim 11, Ralph et al. disclose a working handle 52 (Fig. 8) wherein rotation of the working handle rotates the elongated sheath and the inflatable member.
Regarding claims 12 and 13, the guidewire is not positively recited and is interpreted to not be part of the claims. The Ralph et al. device is configured to receive a suitably sized guide pin or guidewire that is used in orthopedic procedures (Fig. 28).
Although Ralph et al. disclose the inflatable member 86 to have radio opaque markers 91 (Fig. 11 and col. 11, lines 37-51), Ralph et al. do not disclose the distal end of the sheath to include a radiopaque marker.
Rabiner et al. disclose providing one or more markers on the proximal end and distal end of a balloon and/or catheter to determine the position of the balloon and/or catheter within the bone.
It would have been obvious to one of ordinary skill in the art to have substituted the radiopaque marker on the expandable structure of Ralph et al. with a radiopaque marker on a distal end of the sheath or cannula as taught by Rabiner since this amounts to simple substitution of one type of positioning feature for another to determine the correct position of the balloon and delivery device in bone.
Claim(s) 1-6, 11-14, and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Boden et al. (US 8617585) in view of Weikel et al. (US 7666205).
Regarding claim 1, Boden et al. disclose an orthopedic guidewire positioning device (i.e. capable of being used as a guidewire centering device) including: (a) elongated sheath 702 (Fig. 7) extending between a proximal end and a distal end; (b) the elongated sheath further comprising a guidewire channel extending through the elongated sheath to a guidewire opening (770) at the distal end of the elongated sheath, the guidewire channel configured or capable of receiving a guide pin or guidewire such that a distal end of the guidewire extends out of the guidewire opening at the distal end of the elongated sheath; (c) an inflatable member 716, 718 (Fig. 22) proximate the distal end of the elongated sheath, the device configured to inflate the inflatable member such that the inflatable member extends away from a first side of the elongated sheath as it inflates to deflect the distal end of the elongated sheath in a direction opposite a direction along which the inflatable member extends; and (d) radiopaque markers 712, 714 on a distal end of the sheath 702 (Figs. 5, 7, col. 5, lines 8-67, col. 6 and col. 7, lines 1-38).
Regarding claim 11, the syringe housings (702, 736, 752) have flanges that can function as a handle to enable rotation of the sheath (col. 6, lines 4-67 and col. 7, lines 1-38).
Regarding claims 12 and 13, the guidewire is not positively recited and the Boden et al. device is configured to receive a suitably sized and shaped guidewire that is used in orthopedic procedures wherein a reamer is placed over the guidewire (col. 7, lines 8-15).
Regarding claim 14, Boden et al. disclose a method for navigating (or moving over) a guidewire in an intramedullary space, the method including: (a) inserting an elongated sheath 202, 702 (Figs. 2 and 7) into an intramedullary space along an insertion pathway, the elongated sheath 202, 702 extending between a proximal end and a distal end and including a guidewire lumen or channel extending through the elongated sheath and configured to receive a guidewire (Fig. 2 , col. 2, lines 66-67 and col. 3, lines 1-25); (b) inflating an inflatable member proximate the distal end of the elongated sheath, wherein inflation of the inflatable member deflects the distal end of the elongated sheath relative to the insertion pathway (Fig. 7); and (c) after deflecting the distal end of the elongated sheath, further inserting the elongated sheath into the intramedullary space (“one or more radiopaque markers are provided on the device to enable positioning of the device in bone so that a drug delivery region straddles a fracture in the bone” (col. 4, lines 2-13)). Positioning of the elongated sheath to straddle the fracture in the bone inherently includes any repositioning such as withdrawing and further insertion of the sheath.
Regarding claim 17, Boden et al. disclose sheath 202 is connected to a working
handle (any one of syringes 720 in Fig. 7), wherein the method includes manipulating or rotating the working handle to rotate the sheath and the inflatable member about the insertion pathway (col. 6, lines 16-67).
Regarding claims 18 and 20, Boden et al. disclose inflating the inflatable member such that the inflatable member extends away from a first side of the elongated sheath as it inflates to deflect the distal end of the elongated sheath away from the first side of the elongated sheath as it contacts the bone (obstruction) surrounding the intramedullary canal (Fig. 10).
Weikel et al. disclose providing an inflatable member that is shaped by providing sidewall opening(s) on the catheter (elongated sheath or delivery device) so that the inflatable member is inflated only on a first side of the elongated sheath (eccentrically positioned) as shown in Fig. 9 (Figs. 5-9 and 31, col. 14, lines 7-67, col. 15).
It would have been obvious to one of ordinary skill in the art to have utilized a side opening, as taught by Weikel et al., so that the balloon is eccentrically positioned about the elongated sheath to enable the balloon to conform to particular bone anatomy and cavity shape.
The claimed method steps are performed when the device of Boden et al. and the combination of Boden et al. and Weikel et al. is inflated after accessing the intramedullary canal of a bone.
Claim(s) 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Boden et al. (US 8617585) and Weikel et al. (US 7666205), as applied to claim 14, further in view of Cerynik (US 10820934).
The combination of Boden et al. and Weikel et al. disclose all elements of the claimed invention except for: (1) utilizing the elongated sheath to position a guidewire in the intramedullary space; and (2) installing a reamer over the guidewire.
Regarding claim 15, Boden et al. disclose all elements of the claimed invention except for explicitly disclosing utilizing sheath 702 for positioning a guidewire received in the lumen of sheath 702 and guidewire received through the distal end opening 770 (Fig. 7 and col. 7, lines 8-15).
Regarding claim 16, Boden et al. disclose inserting a bone reamer into the bone canal over the guide wire (col. 4, lines 23-29 and col. 7, lines 43-50).
Cerynik discloses utilizing an expandable sheath to center a guidewire wherein “an incision is created for access to a surgical site followed by insertion of the guidewire into the incision and through the surgical site, and determining if the guidewire is centered within the surgical site. If the guidewire is not centered within the surgical site, the method further includes removing the guidewire from the surgical site, positioning the expander at the first end, reinserting the guidewire into the incision and through the surgical site, and actuating the actuator to expand the expander and center the guidewire (col. 1, lines 62-67 and col. 2. lines, 1-6).
Therefore, it would have been obvious to one of ordinary skill in the art to have utilized the sheath of the combination of Boden et al. and Weikel et al. to reposition the guidewire, as taught by Cerynik, to ensure proper centering of the guidewire thereby enabling correct positioning of an intramedullary rod or nail.
Response to Arguments
Applicant’s arguments have been carefully considered by the Examiner.
Applicant’s arguments with respect to the rejections under 35 USC 103(a) over Boden et al. in view of Weikel et al. are not persuasive because Weikel et al. teach positioning sidewall openings on a balloon catheter such that the resulting balloon shape is eccentric.
New grounds of rejection have been made in this office action.
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 Anu Ramana whose telephone number is (571)272-4718. The examiner can normally be reached 8:00 am-5:00 pm.
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July 25, 2026
/Anu Ramana/Primary Examiner, Art Unit 3775
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