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 § 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.
Claim(s) 8-14 is/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.
Claim 8 recites the limitation “further comprising: removing the first guide wire from the bone” in lines 1-2, which renders the claim indefinite, since it is unclear if the limitation is referring back to the same limitation line 15 of claim 1 or to an additional first guide wire being removed. For the purpose of compact prosecution, claim 8 is being interpreted as referring back to the limitation in claim 1 and not to an additional limitation. In order to overcome the rejection, the office suggests that the limitation “removing the first guide wire from the bone” in lines 1-2 of claim 8 be deleted.
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.
Claim(s) 1 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 10 of U.S. Patent No. 12,137,956 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The table below shows the application claims and the patent claims side by side for direct comparison, with the differences between the claims are highlighted below by bolding all the limitations that differ, italicizing additional limitations, and underlining limitations that will be addressed below.
Application Claims:
Patent Claims:
1. A method of intramedullary fracture fixation, the method comprising:
delivering a first guide wire having at least two diameters across fractured portions of a fractured bone, the first guide wire comprising a first trailing portion having a first diameter and a first leading portion having a second diameter greater than the first diameter, wherein the delivering comprises extending the first leading portion of the first guide wire across a medullary canal of the bone until a leading tip of the first guide wire is substantially flush with an outer surface of the bone; selecting a first cannulated elongate implant by determining a length of the first cannulated elongate implant based on a position of the first guide wire in the bone; slidably mounting the first cannulated elongate implant onto the first trailing portion of the first guide wire; inserting the first cannulated elongate implant into the bone guided by the first guide wire, wherein ends of the first cannulated elongate implant do not protrude from the outer surface of the
bone; and removing the first guide wire from the bone.
10. A method of intramedullary fracture fixation, the method comprising: delivering a guide wire having at least two diameters across fractured portions of a fractured bone, the guide wire comprising a first, trailing portion having a first diameter and a second, leading portion including at least a first segment and a second segment, the first segment having a second diameter greater than the first diameter, the second segment having a third outer diameter that is smaller than the second diameter, wherein the first segment is disposed between the second segment and the first portion, wherein the guide wire comprises a first free end and a second free end opposite the first free end, wherein the first portion includes the first free end of the guide wire, wherein the delivering comprises extending the second portion of the guide wire across a medullary canal of the bone until a leading tip of the guide wire is substantially flush with an outer surface of the bone; selecting a cannulated elongate implant by determining a length of the cannulated elongate implant based on a position of the guide wire in the bone; slidably mounting the cannulated elongate implant onto the first portion of the guide wire; inserting the cannulated elongate implant into the bone guided by the guide wire, wherein ends of the cannulated elongate implant do not protrude from the outer surface of the bone; and removing the guide wire from the bone.
As is evident from the table above, Patent claim 10 discloses all of the features of application claim 1, with additional limitations not required by application claim 1. Patent claim 10 uses slightly different wording, e.g. “a guide wire” instead of “a first guide wire”, “a second, leading portion” instead of “a first leading portion”; “a cannulated elongate implant” instead of “a first cannulated elongate implant”; and “slidably mounting the cannulated elongate implant onto the first portion of the guide wire” instead of “slidably mounting the first cannulated elongate implant onto the first trailing portion of the first guide wire”. However, it is clear that the limitations in the Patent claims refer to the same features in the application claims, since they require all the same structure.
Claim(s) 1, 8-13 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 11, 13, 15-17 of U.S. Patent No. 12,137,956 B2 and in view of Blitz (U.S. Pub. No. 2020/0085477 A1, hereinafter “Blitz”).
The table below shows the application claims and the patent claims side by side for direct comparison, with the differences between the claims are highlighted below by bolding all the limitations that differ, italicizing additional limitations, and underlining limitations that will be addressed below.
Application Claims:
Patent Claims:
1. A method of intramedullary fracture fixation, the method comprising:
delivering a first guide wire having at least two diameters across fractured portions of a fractured bone, the first guide wire comprising a first trailing portion having a first diameter and a first leading portion having a second diameter greater than the first diameter, wherein the delivering comprises extending the first leading portion of the first guide wire across a medullary canal of the bone until a leading tip of the first guide wire is substantially flush with an outer surface of the bone; selecting a first cannulated elongate implant by determining a length of the first cannulated elongate implant based on a position of the first guide wire in the bone; slidably mounting the first cannulated elongate implant onto the first trailing portion of the first guide wire; inserting the first cannulated elongate implant into the bone guided by the first guide wire, wherein ends of the first cannulated elongate implant do not protrude from the outer surface of the
bone; and removing the first guide wire from the bone.
8. The method of claim 1, further comprising: removing the first guide wire from the bone; delivering a second guide wire having at least two diameters across the fractured portions of the fracture bone, the second guide wire comprising a second trailing portion having a third diameter and a second leading portion having a fourth diameter greater than the third diameter, wherein the delivering comprises extending the second leading portion of the second guide wire across the medullary canal of the bone until a leading tip of the second guide wire is substantially flush with the outer surface of the bone; selecting a second cannulated elongate implant by determining a length of the second cannulated elongate implant based on a position of the second guide wire in the bone; slidably mounting the second cannulated elongate implant onto the second trailing portion of the second guide wire; inserting the second cannulated elongate implant into the bone guided by the second guide wire; and removing the second guide wire from the bone.
10. The method of claim 8, wherein delivering the second guide wire is performed after removing the first guide wire from the bone.
11. A method of intramedullary fracture fixation, the method comprising: delivering a first guide wire having at least two diameters across fractured portions of a fractured bone, the first guide wire comprising a first, trailing portion having a first diameter and a second, leading portion having a second diameter greater than the first diameter, wherein the delivering comprises extending the second portion of the first guide wire across a medullary canal of the bone until a leading tip of the first guide wire is substantially flush with an outer surface of the bone; selecting a first cannulated elongate implant by determining a length of the first cannulated elongate implant based on a position of the first guide wire in the bone; slidably mounting the first cannulated elongate implant onto the first portion of the first guide wire; inserting the first cannulated elongate implant into the bone guided by the first guide wire; removing the first guide wire from the bone; delivering a second guide wire having at least two diameters across fractured portions of a fracture bone, the second guide wire comprising a first, trailing portion having the first diameter and a second, leading portion having the second diameter greater than the first diameter, wherein the delivering comprises extending the second portion of the second guide wire across the medullary canal of the bone until a leading tip of the second guide wire is substantially flush with the outer surface of the bone; selecting a second cannulated elongate implant by determining a length of the second cannulated elongate implant based on a position of the second guide wire in the bone; slidably mounting the second cannulated elongate implant onto the first portion of the second guide wire; inserting the second cannulated elongate implant into the bone guided by the second guide wire; and removing the second guide wire from the bone, wherein a root diameter surface of the first implant is in contact with a root diameter surface of the second implant, and wherein delivering the second guide wire is performed after removing the first guide wire from the bone.
9. The method of claim 8, wherein each of the first and second cannulated elongate implants terminates at or prior to the outer surface of the bone, and/or wherein ends of each of the first and second cannulated elongate implants do not protrude into tissue surrounding the bone.
13. The method of claim 11, wherein each of the first and second implants terminates at or prior to the outer surface of the bone.
11. The method of claim 8, wherein delivering the second guide wire is performed after delivering the first guide wire and before inserting the first cannulated elongate implant.
15. The method of claim 11, wherein delivering the second guide wire is performed after delivering the first guide wire and before inserting the first implant.
12. The method of claim 8, wherein the delivering comprises extending the second leading portion of the second guide wire across the medullary canal of the bone in a cross pattern with a tunnel in the bone created by the first leading portion of the first guide wire.
16. The method of claim 11, wherein the delivering comprises extending the second portion of the second guide wire across the medullary canal of the bone in a cross pattern with the tunnel in the bone created by the second portion of the first guide wire.
13. The method of claim 8, wherein the delivering comprises extending the second leading portion of the second guide wire across the medullary canal of the bone to be substantially parallel with a tunnel in the bone created by the first leading portion of the first guide wire.
17. The method of claim 11, wherein the delivering comprises extending the second portion of the second guide wire across the medullary canal of the bone to be substantially parallel with the tunnel in the bone created by the second portion of the first guide wire.
As is evident from the table above, Patent claim 11 uses slightly different wording from application claims 1 and 8, for example: “the second portion” instead of “the first leading portion”; “the first portion” instead of “the first trailing portion”; “first trailing portion” instead of “second trailing portion”; “the first diameter” instead of “a third diameter”; “the second diameter” instead of “a fourth diameter”’; “the second portion” instead of “the second leading portion”; and “the first portion” instead of “the second trailing portion”. However, it is clear that the limitations in Patent claim 11 refer to the same features in the application claims 1 and 8, since they require the same structure. In addition, Patent claims 13 and 15 use slightly different wording from application claims 9 and 11, for example: “the first and second implants” instead of “the first and second cannulated elongate implants”; and “the first implant” instead of “the first cannulated elongate implant”. However, it is clear that the limitations in Patent claims 13 and 15 refer to the same features in the application claims 9 and 11, since Patent claim 11 from which Patent claims 13 and 15 depend from recite “a first cannulated elongate implant” and “a second cannulated elongate implant”. And Patent claims 16-17 use slightly different wording from application claims 12-13, for example: “the second portion” instead of “the first leading portion”. However, it is clear that the limitations in Patent claims 16-17 refer to the same features in the application claims 12-13, since they require the same structure. Patent claim 11 discloses all of the features of application claims 1 and 8, except regarding claim 1, wherein ends of the first cannulated elongate implant do not protrude from the outer surface of the bone. And that Patent claim 13 discloses all of the features of claim 9, except regarding claim 9, and/or wherein ends of each of the first and second cannulated elongate implants do not protrude into tissue surrounding the bone.
Blitz discloses a method of intramedullary fracture fixation (see Fig. 44), delivering a cannulated elongate implant (10), wherein ends of the cannulated elongate implant do not protrude from the outer surface of the bone (see Fig. 44) in order to enable the cannulated elongate implant to be inserted at different angles to achieve bone fracture repairs in small bones without the implant protruding from the bone (see paras. [0004], [0009], [0011], and [0156]) to be flush with an exterior surface of the bone (see para. [0082]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method of delivering the first and second cannulated elongate implants in Patent claim 11, so that the ends of the cannulated elongate implant do not protrude from the outer surface of the bone in view of Blitz in order to enable the cannulated elongate implant to be inserted at different angles to achieve bone fracture repairs in small bones without the implant protruding from the bone to be flush with an exterior surface of the bone.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 4-5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by DaCosta et al. (U.S. Pub. No. 2015/0045839 A1, hereinafter “DaCosta”).
DaCosta discloses, regarding claim 1, a method of intramedullary fracture fixation (see Figs. 8-13), the method comprising: delivering a first guide wire (100) having at least two diameters (see annotated Fig. 2 below) across fractured portions of a fractured bone (see Fig. 8, see also step 400 in Fig. 13), the first guide wire comprising a first trailing portion having a first diameter (see annotated Fig. 2 below) and a first leading portion having a second diameter (see annotated Fig. 2 below) greater than the first diameter (see annotated Fig. 2 below), wherein the delivering comprises extending the first leading portion of the first guide wire across a medullary canal of the bone until a leading tip of the first guide wire is substantially flush with an outer surface of the bone (see annotated Fig. 8 below); selecting a first cannulated elongate implant (200) by determining a length of the first cannulated elongate implant based on a position of the first guide wire in the bone (see Fig. 8, see also step 430 in Fig. 13); slidably mounting the first cannulated elongate implant onto the first trailing portion of the first guide wire (see Fig. 10, see para. [0030]); inserting the first cannulated elongate implant into the bone guided by the first guide wire (see Fig. 10), wherein ends of the first cannulated elongate implant do not protrude from the outer surface of the bone (see annotated Fig. 12 below); and removing the first guide wire from the bone (see Fig. 11, see para. [0030]).
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Regarding claim 4, further comprising: slidably advancing a driver along the first trailing portion of the first guide wire until a driver head portion of the driver engages a driver interface of the first cannulated elongate implant; and delivering, using the driver, the first cannulated elongate implant through a tunnel in the bone created by the first leading portion of the first guide wire (see paras. [0028] and [0030] “tool” and “threading the screw 200 over the guide pin 100”).
Regarding claim 5, wherein the first cannulated elongate implant comprises a first implant minor diameter (e.g. diameter of cannula 210), wherein the first implant minor diameter is substantially the same as the second diameter of the first guide wire (see Fig. 10, note that the diameter of cannula 210 and the second diameter of 110 appear to be substantially the same).
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.
Claim(s) 8-11, 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over DaCosta, as applied to claim 1 above, and in view of Orsak (U.S. Pub. No. 2011/0118792 A1, hereinafter “Orsak”).
DaCosta discloses all of the features of the claimed invention, as previously set forth above, except regarding claim 8, further comprising: removing the first guide wire from the bone; delivering a second guide wire having at least two diameters across the fractured portions of the fracture bone, the second guide wire comprising a second trailing portion having a third diameter and a second leading portion having a fourth diameter greater than the third diameter, wherein the delivering comprises extending the second leading portion of the second guide wire across the medullary canal of the bone until a leading tip of the second guide wire is substantially flush with the outer surface of the bone; selecting a second cannulated elongate implant by determining a length of the second cannulated elongate implant based on a position of the second guide wire in the bone; slidably mounting the second cannulated elongate implant onto the second trailing portion of the second guide wire; inserting the second cannulated elongate implant into the bone guided by the second guide wire; and removing the second guide wire from the bone; regarding claim 9, wherein each of the first and second cannulated elongate implants terminates at or prior to the outer surface of the bone, and/or wherein ends of each of the first and second cannulated elongate implants do not protrude into tissue surrounding the bone; regarding claim 10, wherein delivering the second guide wire is performed after removing the first guide wire from the bone; regarding claim 11, wherein delivering the second guide wire is performed after delivering the first guide wire and before inserting the first cannulated elongate implant; and regarding claim 14, wherein the first guide wire is the second guide wire.
Orsak discloses a kit for an intramedullary fracture system (see Fig. 16, see paras. [0050]-[0051]), wherein the kit comprises a second guide wire (see para. [0050]) and a second elongate implant (200-2, see para. [0051]); wherein delivering the second guide wire is performed after removing the first guide wire from the bone (see para. [0050] “reposition the k-wires”); wherein delivering the second guide wire is performed after delivering the first guide wire and before inserting the first cannulated elongate implant (see paras. [0050]-[0051] “until the desired position of the k-wires has been achieved” and “bone screw fixation devices 200-1, 200-2 may be inserted over the respective k-wires”); and wherein the first guide wire is the second guide wire (see para. [0050] “reposition the k-wires”) in order to provide the surgeon with additional guide wires and elongate implants to achieve fracture fixation when additional bone fragments need to be secured (see paras. [0050]-[0051]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method in Dacosta to include delivering a second guide wire comprising a second trailing portion having a third diameter and a second leading portion having a fourth diameter greater than the third diameter, inserting a second cannulated elongate implant into the bone guided by the second guide wire in view of Orsak in order to provide the surgeon with additional guide wires and elongate implants to achieve fracture fixation when additional bone fragments need to be secured.
Claim(s) 15-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tipirneni et al. (U.S. Pub. No. 2011/0295252 A1, hereinafter “Tipirneni”) in view of Orsak (U.S. Pub. No. 2011/0118792 A1, hereinafter “Orsak”).
Tipirneni discloses, regarding claim 15, a kit for an intramedullary fracture system, the kit comprising: a first elongate implant (1008, see Figs. 2X-2Y), the first elongate implant being cannulated (see Fig. 2Y, note cannulated to receive 1071) and having a first implant shaft outer diameter (e.g. diameter of outside 1008), a first implant minor diameter (e.g. minor diameter of threads 1014), and a first implant cannulation diameter (e.g. diameter of cannula that receives 1071); a first guide wire (1071) having at least two diameters (see annotated Fig. 2X below) and configured to deliver the first elongate implant into a fracture bone by intramedullary fixation (see Fig. 2Y), the first guide wire comprising a first trailing portion (see annotated Fig. 2Y below) having a first diameter (see annotated Fig. 2Y below) and a first leading portion (see annotated Fig. 2Y below) having a second diameter greater than the first diameter (see annotated Fig. 2Y below), the second diameter being substantially the same as the first implant outer diameter or the first implant minor diameter (see annotated Fig. 2Y below), the first implant cannulation diameter configured to accommodate the first trailing portion of the first guide wire (see Fig. 2Y).
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Regarding claim 17, wherein the first and/or second elongate implants are threaded (1014, 1015, see Fig. 2X).
Regarding claim 18, wherein the first implant cannulation diameter and the second implant cannulation diameter cannot accommodate the first leading portion of the first guide wire (see Fig. 2Y).
Tipirneni fails to explicitly disclose, regarding claim 15, and a second elongate implant configured to be implanted with the first implant by intramedullary fixation, the second elongate implant being cannulated and having a second implant shaft outer diameter, a second implant minor diameter, and a second implant cannulation diameter, wherein the second diameter of the first guide wire is substantially the same as the second implant shaft outer diameter or the second implant minor diameter, and the second implant cannulation diameter is configured to accommodate the first trailing portion of the first guide wire; and regarding claim 16, comprising a second guide wire having at least two diameters and configured to deliver the second elongate implant into the fracture bone for intramedullary fixation, the second guide wire comprising a second trailing portion having a third diameter and a second leading portion having a fourth diameter greater than the third diameter, the fourth diameter being substantially the same as the second implant shaft outer diameter or the second implant minor diameter, the second implant cannulation diameter configured to accommodate the third portion of the second guide wire.
Orsak discloses a kit for an intramedullary fracture system (see Fig. 16, see paras. [0050]-[0051]), wherein the kit comprises a second guide wire (see para. [0050]) and a second elongate implant (200-2, see para. [0051]) in order to provide the surgeon with additional guide wires and elongate implants to achieve fracture fixation when additional bone fragments need to be secured (see paras. [0050]-[0051]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the kit in Tipirneni to include a second elongate implant, and to include a second guide comprising a second trailing portion having a third diameter and a second leading portion having a fourth diameter greater than the third diameter, in view of Orsak in order to provide the surgeon with additional guide wires and elongate implants to achieve fracture fixation when additional bone fragments need to be secured.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tipirneni et al. (U.S. Pub. No. 2011/0295252 A1, hereinafter “Tipirneni”) in view of Impellizzeri (U.S. Pub. No. 2012/0016373 A1, hereinafter “Impellizzeri”).
Tipirneni discloses, regarding claim 19, a surgical kit for performing fracture fixation (see Figs. 2X and 2Y) using a cannulated implant (1008), the cannulated implant comprises a head (1020) and an at least partially threaded shaft (1014), the kit comprising: a guide wire (1071) having at least two diameters (see annotated Fig. 2X below) and configured to guide delivery of the cannulated implant into a fracture bone (see Fig. 2X), the guide wire comprising a first trailing portion having a first diameter (see annotated Fig. 2X above) and a first leading portion having a second diameter (see annotated Fig. 2X above) greater than the first diameter (see annotated Fig. 2X above), the second diameter being substantially the same as a minor diameter of the shaft of the cannulated implant (see annotated Fig. 2X above), the first diameter of the first trailing portion configured to slidably engage a cannulation of the cannulated implant (see Figs. 2X-2Y); and a driver (90, see Figs. 5A-5B) configured to engage the head of the implant to drive the implant into the bone (see para. [0131]).
Tipirneni fails to disclose, regarding claim 19, wherein the kit includes a sizing tool.
Impellizzeri discloses a surgical kit for performing fracture fixation (see Figs. 8-13) using a cannulated implant (10, note cannula 10a), the kit comprising: a guide wire (6), wherein the kit further includes a sizing tool (1) in order to enable the surgeon to read numerical markers between the sizing tool and the guide wire (see paras. [0066]-[0068]) to enable the surgeon to determine the length of the orthopedic screw to be used (see para. [0068]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the kit in Tipirneni to include a sizing tool in view of Impellizzeri in order to enable the surgeon to read numerical markers between the sizing tool and the guide wire to enable the surgeon to determine the length of the orthopedic screw to be used.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tipirneni in view of Impellizzeri, as applied to claim 19 above, and in further view of Garvey et al. (U.S. Pub. No. 2016/0278789 A1, hereinafter “Garvey”).
Tipirneni in view of Impellizzeri discloses all of the features of the claimed invention, as previously set forth above, except regarding claim 20, further comprising a sterile sealed packaging, wherein the guide wire, the sizing tool, and the driver are enclosed within the sterile sealed packaging.
Garvey discloses a surgical kit for orthopedic procedures (300, see Fig. 3), wherein the implants and the instruments are provided in a sterile package (see paras. [0029] and [0046]) in order to provide the surgeon with a kit that is immediately ready for surgical application upon removal of the instruments from their respective packages without the need for pre-operation cleaning, sterilizing, or other processing (see para. [0046]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the surgical kit in Tipirneni in view of Impellizzeri to comprise a sterile sealed packaging in further view of Garvey in order to provide the surgeon with a kit that is immediately ready for surgical application upon removal of the instruments from their respective packages without the need for pre-operation cleaning, sterilizing, or other processing.
Allowable Subject Matter
Claim(s) 2-3, 6-7 is/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.
Claim(s) 12-13 would be allowable if a terminal disclaimer is filed to overcome the Nonstatutory Double Patenting Rejection and if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
A method of intramedullary fracture fixation comprising: delivering a first guide wire comprising a first trailing portion having a first diameter and a first leading portion having a second diameter greater than the first diameter, wherein the delivering comprises extending the first leading portion of the first guide wire across a medullary canal of the bone until a leading tip of the first guide wire is substantially flush with an outer surface of the bone; inserting the first cannulated elongate implant into the bone guided by the first guide wire, wherein ends of the first cannulated elongate implant do not protrude from the outer surface of the bone; and removing the first guide wire from the bone; and as per claim 2, placing a depth gauge adjacent to the first guide wire so that a leading tip of the depth gauge is substantially flush with an insertion point on the bone; and determining a position of the transition portion of the first guide wire relative to the depth gauge; and as per claim 6, wherein the first implant shaft outer diameter is substantially the same as the second diameter of the first guide wire; and as per claim 7, wherein the first implant cannulation diameter is configured to accommodate the first trailing portion of the first guide wire but cannot accommodate the first leading portion of the first guide wire; and as per claim 12, wherein the delivering comprises extending the second leading portion of the second guide wire across the medullary canal of the bone in a cross pattern with a tunnel in the bone created by the first leading portion of the first guide wire; and as per claim 13, wherein the delivering comprises extending the second leading portion of the second guide wire across the medullary canal of the bone to be substantially parallel with a tunnel in the bone created by the first leading portion of the first guide wire.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michelle C. Green whose telephone number is (571)270-7051. The examiner can normally be reached on Monday-Friday between 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo C. Robert, 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 an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/M.C.G/ Examiner, Art Unit 3773 /EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773
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