DETAILED ACTION
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 .
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) 1-4, 7-9 and 11-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ralph et al. (US 7927339).
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); and (c) 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 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 9, Ralph et al. disclose the inflatable member 86 to have radio opaque markers 91 (Fig. 11 and col. 11, lines 37-51).
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).
Claim(s) 1, 10-14, 17-18 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Boden et al. (US 8617585).
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; and (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 (Figs. 5, 7, col. 5, lines 8-67, col. 6 and col. 7, lines 1-38).
Regarding claim 10, Boden et al. disclose radiopaque markers 712, 714 on a distal end of the sheath 702 (Fig. 7 and col. 5, lines 36-42).
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); (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).
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) 2-6 and 19 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 2, Boden et al. disclose inflatable members or balloons that are symmetric about a longitudinal axis of the sheath (Fig. 8).
Regarding claims 4-6, Boden et al. disclose the first balloon inflating tube or conduit 734 to extend through the proximal end 704 of sheath 702 and can lead to the first balloon 716 wherein the balloon inflating tube 734 can be removably (interpreted to mean removably installed in the lumen or sidewall channel (i.e. defined by a sidewall) of the housing sheath 702 or substantially permanently connected to housing 702 (col. 6, lines 16-32).
Weikel et al. disclose providing an inflatable member that is shaped to allow for an easier approach to the bone cavity or to correspond to the portion of the bone which is to restored wherein several balloon configurations are illustrated wherein the inflatable member is inflated only on a first side of the elongated sheath 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 provided an inflatable member with an offset configuration, as taught by Weikel et al., because this amounts to choosing from a finite number of identified, predictable solutions, namely symmetric and asymmetric shapes of balloons, with a reasonable expectation of enabling the balloon to conform to particular bone anatomy and cavity shape.
The method step of claim 19 is performed when the device of the combination of Boden et al. and Weikel et al. is inflated after accessing the intramedullary canal of a bone.
Claim(s) 9 is rejected under 35 U.S.C. 103 as being unpatentable over Boden et al. (US 8617585) in view of Ralph et al. (US 7927339).
Boden et al. disclose all elements of the claimed invention except for the balloon or inflatable member to have a radiopaque marker.
Ralph et al. disclose an inflatable member 86 to have radio opaque markers 91 (Fig. 11 and col. 8, lines 46-53).
It would have been obvious to one of ordinary skill in the art to have provided radiopaque markers on the inflatable member or balloon of Boden et al. wherein so doing would amount to substitution of one type of indicator (for e.g. making the balloon of radiopaque material as disclosed by Boden et al.) with another type of indicator (providing a marker on the balloon, as taught by Ralph et al.) would amount to simple substitution of one known type of indicator for another for the predictable result of fluoroscopic or other real-time monitoring of placement of the claimed device.
Claim(s) 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Boden et al. (US 8617585) in view of Cerynik (US 10820934).
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 Boden 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.
Conclusion
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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February 7, 2026
/Anu Ramana/Primary Examiner, Art Unit 3775