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
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 (i.e., changing from AIA to pre-AIA ) 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.
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) 21-22, 24-33, 35-39 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Huebner et al. (US Pub 2015/0012048).
With respect to claim 21, Huebner discloses a guide wire (see fig 2 below) having multiple diameters and configured to deliver a cannulated orthopedic implant (fig 2, 50), the guide wire comprising: a first portion (see fig 2 below) having a first outer diameter of D1; and a second portion (see fig 2 below), the second portion including a first segment (see fig 2 below), a second segment (see fig 2 below), and a third, tapering segment (see fig 2 below), the first segment having a second outer diameter D2 that is greater than D1 (76 is bigger than 78), the second segment having a third outer diameter D3 (fig 2 top end has a smaller diameter than 76) that is smaller than D2, the third, tapering segment extending between the first segment and the second segment (see fig 2 below),wherein the cannulated orthopedic implant is configured to be slidably mounted onto the first portion of the guide wire (can be because it has the width of the cannula), wherein D2 is substantially the same as a minor or root diameter of the cannulated orthopedic implant (fig 2 shows the implant having the width of 76). With respect to claim 22, Huebner discloses wherein a free end of the second segment of the second portion comprises a sharp tip (see fig 2 below). With respect to claim 24, Huebner discloses an outer diameter of the third, tapering segment transitions from D2 to D3 (end of the 3rd segment tapers). With respect to claim 25, Huebner discloses wherein the first segment is longer than the second segment and the third, tapering segment (when 76 is located near the top end of 74 the 1st segment would be longer than the 2nd segment). With respect to claim 26, Huebner discloses wherein the first portion has a uniform outer diameter of D1 (has the diameter of a wire). With respect to claim 27, Huebner discloses further comprising a transition portion (See fig 2 below)between the first portion and the second portion. With respect to claim 28, Huebner discloses wherein the transition portion transitions from an outer diameter of D1 to D2 (fig 2 shows a step down from D2 to D1).
With respect to claim 29, Huebner discloses a kit (paragraph 89) for an intramedullary fracture system, the kit comprising: a first elongate implant (fig 2, 50), the first elongate implant being cannulated (received on the wire) and having a first implant shaft outer diameter (fig 2), a root or minor diameter (threaded ad unthreaded diameter) and a first implant cannulation diameter (for the wire); and a guide wire having multiple diameters and configured to deliver the first elongate implant into a fractured bone by intramedullary fixation, the guide wire comprising: a first portion (see fig 2 below) having a first outer diameter of D1; and a second portion (see fig 2 below), the second portion including a first segment (see fig 2 below), a second segment (see fig 2 below), and a third, tapering segment (see fig 2 below), the first segment having a second outer diameter D2 that is greater than D1 (76 is bigger than 78), the second segment having a third outer diameter D3 (fig 2 top end has a smaller diameter than 76) that is smaller than D2, the third, tapering segment extending between the first segment and the second segment (see fig 2 below),wherein the cannulated orthopedic implant is configured to be slidably mounted onto the first portion of the guide wire (can be because it has the width of the cannula), wherein D2 is substantially the same as a minor or root diameter of the cannulated orthopedic implant (fig 2 shows the implant having the width of 76). With respect to claim 30, Huebner discloses further comprising a second elongate implant (paragraph 89, kit including multiple fasteners) configured to be implanted with the first elongate implant by intramedullary fixation, the second elongate implant being cannulated and having a second implant shaft outer or a second implant root or minor diameter and a second implant cannulation diameter (Fig 2), wherein D2 of the guide wire is substantially the same as the second implant shaft outer diameter or second implant root or minor diameter (fig 2), and the second implant cannulation diameter is configured to accommodate the first portion of the guide wire (fig 2). With respect to claim 31, Huebner discloses further comprising a second guide wire, wherein the second guide wire is identical to the guide wire (multiple guides included). With respect to claim 32, Huebner discloses wherein the first and/or second elongate implants are threaded (Fig 2). With respect to claim 33, Huebner discloses wherein a free end of the second segment of the second portion of the guide wire comprises a sharp tip (see fig 2 below).
With respect to claim 35, Huebner discloses surgical kit (paragraph 89) for performing fracture fixation using a cannulated implant (fig 2, 50), the implant comprises a head (See fig 2 below) and an at least partially threaded shaft (see fig 2 below), the kit comprising: a guide wire (See fig 2 below) having more than two diameters and configured to deliver the cannulated implant into a fractured bone by intramedullary fixation, the guide wire comprising: a first portion (see fig 2 below) having a first outer diameter of D1; and a second portion (see fig 2 below), the second portion including a first segment (see fig 2 below), a second segment (see fig 2 below), and a third, tapering segment (see fig 2 below), the first segment having a second outer diameter D2 that is greater than D1 (76 is bigger than 78), the second segment having a third outer diameter D3 (fig 2 top end has a smaller diameter than 76) that is smaller than D2, the third, tapering segment extending between the first segment and the second segment (see fig 2 below),wherein the cannulated orthopedic implant is configured to be slidably mounted onto the first portion of the guide wire (can be because it has the width of the cannula), wherein D2 is substantially the same as a minor or root diameter of the cannulated orthopedic implant (fig 2 shows the implant having the width of 76); a sizing tool (paragraph 49, depth indicators); and a driver (paragraph 89 and fig 2) configured to engage the head of the implant to drive the implant into the bone. With respect to claim 36, Huebner discloses further comprising a sterile sealed packaging (paragraph 89), wherein the guide wire, the sizing tool, and the driver are enclosed within the sterile sealed packaging (paragraph 89, sterile container). With respect to claim 37, Huebner discloses wherein the guide wire, the sizing tool, and/or the driver are configured for single use (paragraph 89, single use). With respect to claim 38, Huebner discloses wherein the guide wire, the sizing tool, and/or the driver are re-usable by being sterilized after each use (paragraph 89, multiple uses). With respect to claim 39, Huebner discloses wherein a free end of the second segment of the second portion of the guide wire comprises a sharp tip (See fig 2 below).
PNG
media_image1.png
734
338
media_image1.png
Greyscale
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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) 23, 34 and 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huebner et al. (US Pub 2015/0012048) in view of Sinnott et al. (US Pub 2017/0112552).
With respect to claims 23, 34 and 40, Huebner discloses the claimed invention except for the third tapering segment comprises one or more cutting flutes.
Sinnott discloses a guide (see figs 43 and 47 below) having a third tapering segment (fig 47, 1546) comprising one or more cutting flutes (see fig 47 below) to facilitate self-tapping of the bone (paragraph 114).
PNG
media_image2.png
730
589
media_image2.png
Greyscale
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Huebner to include the third tapering segment comprises one or more cutting flutes in view of Sinnott in order to facilitate self-tapping of the bone.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20130079776 A1 discloses a guide wire with multiple diameters and a sharp tip
US 20180243018 A1 discloses a guide wire with multiple diameters and a sharp tip
US 20150045839 A1 discloses a guide wire with multiple diameters and a sharp tip
US 20130211468 A1 discloses a guide wire with multiple diameters and a sharp tip and a sizing tool
US 20110295252 A1 discloses a guide wire with multiple diameters and a sharp tip
US 20130090658 A1 discloses a guide wire with multiple diameters and a sharp tip
US 20230293217 A1 discloses a guide wire with multiple diameters and a sharp tip
US 5259398 A discloses a guide wire with multiple diameters and a sharp tip
US 9763720 B2 discloses a guide wire with multiple diameters and a sharp tip
US 9993276 B2 discloses a guide wire with multiple diameters and a sharp tip
US 11633292 B2 discloses a guide wire and an implant
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEVEN J COTRONEO whose telephone number is (571)270-7388. The examiner can normally be reached Monday-Friday 9am-5pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached at (571) 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/S.J.C/Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773
Prosecution Insights