Detailed Action
This office action is for US application number 18/697,668 evaluates the claims as filed on March 2, 2026.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 2, 2026 has been entered.
Response to Arguments
Applicant's arguments filed March 2, 2026 have been fully considered but they are not persuasive. The rejections in this office action have been amended to address the amended claims. Examiner asserts that Examiner asserts that Choe and Forstein teach all the newly-amended limitations and are capable of performing the functions as claimed. Examiner directs Applicant to the rejection below for a more in-depth description of the limitations.
With regards to Applicant’s argument that Choe’s dependent claim 9 recites that the tip and the plate hole are shaped for engagement in any relative orientation (Remarks p. 9), Examiner agrees and notes that the relevance of quoting a dependent claim that is not disclosed to read on the cited embodiment is unclear. It appears that Applicant intends for this to refute Examiner’s previous comment that Applicant asserted that the guide of Choe is able to be adjusted in any direction via the spherical tip; however claim 9 makes no mention of the spherical tip nor is the tip of the guide disclosed to be exclusively spherical. Thus, Examiner maintains that support in the disclosure of Choe for Applicant’s assertion that the guide of Choe is able to be adjusted in any direction via the spherical tip has not been identified.
With regards to Applicant’s argument that the tip 164 adapted to interface with the inner wall of the bone plate hole is not the equivalent of being “rigidly affixed” as recited in amended claim 1 (Remarks p. 9), Examiner notes that such has not been asserted and is therefore moot.
With regards to Applicant’s argument that Choe’s temporary fixator may be operated similar to a screwdriver and a coupling mechanism would not be necessary and therefore not inherent to the disclosure of Choe (Remarks p. 10), Examiner notes that Choe’s temporary fixator 150 is not disclosed by Choe to operate similar to a screwdriver and instead discloses interfaces such as a bone-gripping tip 158 and a spherical or otherwise rounded or shaped tip 164 which do not appear to be capable of engaging a screw. Further, it has not been asserted that Choe discloses a coupling mechanism or that such would be necessary or inherent to the disclosure of Choe; thus, this argument is moot.
With regards to Applicant’s argument that modifying Choe with the threaded connection of Forstein to rigidly affix the device to the plate would alter the principle of operation by preventing “engagement in any relative orientation” see MPEP 2143.01 VI (Remarks p. 10), Examiner notes that it is unclear how enabling the guide to rigidly affix the device to the plate hole, i.e. by adding threads, would prevent engagement in any relative orientation or where “engagement in any relative orientation” is encompassed as a principle of operation of the device of Choe. It appears based on Applicant’s arguments, that Applicant intends that the tip of Choe is spherical and that adding threads to a spherical surface prevents engagement in any relative orientation; however, while adding threads to a spherical surface would prevent sliding between relative orientations that are larger than the thread depth, such does not inherently prevent engagement in any particular orientation. Further, a spherical surface that provides sliding between relative orientations does not appear to be the principle of operation of Choe, which does not even specifically mention this argued feature. Instead, Choe discloses that tip 164 can be spherical, otherwise rounded, or shaped (¶32) and specifically discloses use to pull/push a bone (60) and bone plate (150) toward one another by driving the push rod (154) into bone through the bone plate hole (82), threadably rotating the guide (152) relative to the push rod so that tip 164 pushes against the inner wall 81 of the hole 82, bringing the bone and the bone plate toward one another, and that the interfacing of the guide tip and the inner wall of hole allows adjustment of the relative position of the fixation device 80 on the bone 60 in any direction as illustrated in Fig. 10. Thus, the principle of operation appears to be that one can pull/push a bone and bone plate via relative rotation of the guide and push rod. Modifying the interface/mechanism between the bone plate hole surface and the tip of the guide to include threads would not change the principle of operation and would instead support the device functioning as disclosed by providing a secure attachment to the bone plate that would result in more controlled relative movement between the bone and the bone plate. Such an improvement does not require a substantial reconstruction ore redesign of the elements or change the basic principle under which the device was designed to operate as addressed via MPEP 2143.01 VI.
With regards to Applicant’s argument that neither Choe nor Forstein discloses a push rod comprising a blunt, sharpened, or spiked tip to realign and maintain the position of the bone segment relative to the bone plate during subsequent fixation of the bone plate to the fractured bone segment as Choe at best discloses a shaft for inserting a screw (Remarks p. 10-12), Examiner suggests review of the disclosure of Choe in its entirety. Choe Figs. 11-15C show push rod tips 158 that are shown to be blunt, sharpened, or spiked. With regards to the assertion that Choe at best discloses a shaft for inserting a screw, Examiner refers Applicant to Figs. 1-8, which show the targeting device 100 described in paragraphs 23-27; where paragraph 25 specifically discloses the procedure for after the bone plate 80 is placed relative to the bone that culminates in paragraph 26 with inserting screws 88 into any of the holes 82 not used in attaching the device 100, and paragraph 33 discloses adjustment of the relative position of the fixation device 80 on the bone 60 in any direction via relative rotation of 154 and 152 to push/pull the bone and bone plate.
In the interest of providing the utmost clarity with regards to Applicant’s interpretation of the guide of Choe having a spherical tip, Examiner has provided a second rejection in view of Choe and Forstein below that specifically identifies the guide as having the disclosed shaped tip.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
As to claim 2, the specification appears to lack proper antecedent basis for “the coupling mechanism includes external threads for threadably engaging one of the plurality of screw holes formed in the bone plate” in lines 1-2 that is in addition to “a coupling mechanism comprising external threads configured to engage one of the plurality of screw holes in the bone plate to rigidly affix the guide to the bone plate” of claim 1 lines 9-11. That is, Applicant has disclosed external threads 138 as shown in Fig. 3 and described in paragraph 31 but the original disclosure appears to be silent to another/additional external threads as provided by claim 2. Thus, the specification fails to provide proper antecedent basis for “the coupling mechanism includes external threads for threadably engaging one of the plurality of screw holes formed in the bone plate” in claim 2 lines 1-2. Examiner suggests cancelling claim 2.
As to claim 7, the specification appears to lack proper antecedent basis for “the distal end of the push rod includes a tip arranged and configured to contact the fractured bone segment” in lines 1-3 that is in addition to “the distal end comprising a blunt, sharpened, or spiked tip arranged and configured to contact a patient's fractured bone segment” of claim 1 lines 4-6. That is, Applicant has disclosed tip 158 as shown in Fig. 4 and described in paragraph 32 to be a blunt, sharpened, or spiked tip but the original disclosure appears to be silent to another/additional tip as provided by claim 7. Thus, the specification fails to provide proper antecedent basis for “the distal end of the push rod includes a tip arranged and configured to contact the fractured bone segment” in claim 7 lines 1-3. Examiner suggests cancelling claim 7.
As to claim 10, the specification appears to lack proper antecedent basis for “affixing the guide to the bone plate comprises threadably engaging a distal end of the guide to a the one of the plurality of screw holes in the bone plate” in lines 1-3 that is in addition to “a coupling mechanism comprising external threads configured to engage one of the plurality of screw holes in the bone plate to rigidly affix the guide to the bone plate” of claim 8 lines 8-10. That is, Applicant has disclosed external threads 138 as shown in Fig. 3 and described in paragraph 31 but the original disclosure appears to be silent to another/additional engagement between the distal end and one of the screw holes as provided by claim 10. Thus, the specification fails to provide proper antecedent basis for “affixing the guide to the bone plate comprises threadably engaging a distal end of the guide to a the one of the plurality of screw holes in the bone plate” in claim 10 lines 1-3. Examiner suggests cancelling claim 10 or amending to clarify.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the for “the coupling mechanism includes external threads for threadably engaging one of the plurality of screw holes formed in the bone plate” in claim 2 lines 1-2 that is in addition to “a coupling mechanism comprising external threads configured to engage one of the plurality of screw holes in the bone plate to rigidly affix the guide to the bone plate” of claim 1 lines 9-11, the distal end of the push rod includes a tip arranged and configured to contact the fractured bone segment” in claim 7 lines 1-3 that is in addition to “the distal end comprising a blunt, sharpened, or spiked tip arranged and configured to contact a patient's fractured bone segment” of claim 1 lines 4-6, and “affixing the guide to the bone plate comprises threadably engaging a distal end of the guide to a the one of the plurality of screw holes in the bone plate” in claim 10 lines 1-3 that is in addition to “a coupling mechanism comprising external threads configured to engage one of the plurality of screw holes in the bone plate to rigidly affix the guide to the bone plate” of claim 8 lines 8-10 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 2, 7, and 10 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
As to claim 2, “the coupling mechanism includes external threads for threadably engaging one of the plurality of screw holes formed in the bone plate” in lines 1-2 that is in addition to “a coupling mechanism comprising external threads configured to engage one of the plurality of screw holes in the bone plate to rigidly affix the guide to the bone plate” of claim 1 lines 9-11 appears to be new matter. That is, Applicant has disclosed external threads 138 as shown in Fig. 3 and described in paragraph 31 but the original disclosure appears to be silent to another/additional external threads as provided by claim 2. Thus, “the coupling mechanism includes external threads for threadably engaging one of the plurality of screw holes formed in the bone plate” in claim 2 lines 1-2 constitutes new matter. Examiner suggests cancelling claim 2.
As to claim 7, “the distal end of the push rod includes a tip arranged and configured to contact the fractured bone segment” in lines 1-3 that is in addition to “the distal end comprising a blunt, sharpened, or spiked tip arranged and configured to contact a patient's fractured bone segment” of claim 1 lines 4-6 appears to be new matter. That is, Applicant has disclosed tip 158 as shown in Fig. 4 and described in paragraph 32 to be a blunt, sharpened, or spiked tip but the original disclosure appears to be silent to another/additional tip as provided by claim 7. Thus, “the distal end of the push rod includes a tip arranged and configured to contact the fractured bone segment” in claim 7 lines 1-3 constitutes new matter. Examiner suggests cancelling claim 7.
As to claim 10, “affixing the guide to the bone plate comprises threadably engaging a distal end of the guide to a the one of the plurality of screw holes in the bone plate” in lines 1-3 that is in addition to “a coupling mechanism comprising external threads configured to engage one of the plurality of screw holes in the bone plate to rigidly affix the guide to the bone plate” of claim 8 lines 8-10 appears to be new matter. That is, Applicant has disclosed external threads 138 as shown in Fig. 3 and described in paragraph 31 but the original disclosure appears to be silent to another/additional engagement between the distal end and one of the screw holes as provided by claim 10. Thus, “affixing the guide to the bone plate comprises threadably engaging a distal end of the guide to a the one of the plurality of screw holes in the bone plate” in claim 10 lines 1-3 constitutes new matter. Examiner suggests cancelling claim 10 or amending to clarify.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 4 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
As to claim 4, “the push rod is configured to rotate relative to the guide to cause the push rod to realign the fractured bone segment” in lines 1-3 does not appear to further limit over claim 1 lines 4-6 and 13-17, which provide that “a push rod including a proximal end and a distal end, the distal end comprising a blunt, sharpened, or spiked tip arranged and configured to contact a patient's fractured bone segment to realign a position of the bone segment” in claim 1 lines 4-6 and “the push rod being configured to advance relative to the affixed guide through the engaged screw hole when rotated within the longitudinal bore in the guide until the blunt, sharpened, or spiked tip contacts and engages with the fractured bone segment to realign and maintain the position of the bone segment relative to the bone plate during subsequent fixation of the bone plate to the fractured bone segment” in claim 1 lines 13-17. That is, claim 1 lines 4-6 provide that the push rod is configured to realign the fractured bone segment and claim 1 lines 13-17 provide that the push rod is configured to rotate relative to the guide to cause the push rod, i.e. “configured to advance relative to the affixed guide through the engaged screw hole when rotated within the longitudinal bore in the guide”, until the tip engages the bone segment to realign the fractured bone segment. Thus, claim 4 does not further limit over claim 1. Examiner suggests cancelling claim 4.
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 of this title, 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 and 6-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Choe et al. (US 2007/0276401, hereinafter “Choe”) in view of Forstein et al. (US 2006/0173458, hereinafter “Forstein”).
The claimed phrase “formed” is being treated as a product by process limitation; that is the product reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113.
As to claims 1-4 and 7, Choe discloses a bone alignment system (80, 100, 150, Figs. 1-15C) arranged and capable of aligning a fractured bone segment (Figs. 8 and 10, ¶33 discloses using 154 to pull/push a bone fragment/portion with 150 to allow adjustment of the relative position of the fixation device/plate 80 on the bone 60 in any direction), the bone alignment system comprising: a bone plate (80) including a plurality of screw holes (82s); a push rod (154, Figs. 10-14, 15B and 15C) including a proximal end (155 and to the right as shown in Figs. 15B and 15C, Figs. 5B and 15C) and a distal end (156 and to the left as shown in Figs. 15B and 15C, Figs. 5B and 15C), the distal end comprising a blunt, sharpened, or spiked tip (158, Figs. 11-15C, ¶31) arranged and capable of contacting a patient's fractured bone segment to realign a position of the bone segment (Fig. 10, ¶33 discloses using 154 to pull/push a bone fragment/portion with 150 to allow adjustment of the relative position of the fixation device/plate 80 on the bone 60 in any direction); and a guide (152) arranged and capable of associating the push rod with the bone plate (Fig. 10, ¶s 32 and 33), the guide including a proximal end (157 and to the right as shown in Figs. 11, 12, and 15A, Figs. 11, 12, and 15A), a distal end (164 and to the left as shown in Figs. 11, 12, and 15A, Figs. 11, 12, and 15A), and a longitudinal bore (opening within 152 disclosed to receive 154 as shown in Figs. 10-12 and comprising internal threading in ¶32, Figs. 10-12) extending from the proximal end to the distal end (¶31 discloses 154 being received in 152, i.e. as shown in Figs. 10-12, ¶32 discloses 157 including internal threading for rotational coupling with 155 of 154), the distal end of the guide comprising a mechanism (adaptations of ¶32, Figs. 10-12 and 15A, where ¶32 discloses that 164 is adapted to interface in contact with an inner wall of hole 82, and ¶33 discloses that the interfacing of the 164 and the inner wall 81 of the hole 82 allows adjustment of the relative position of the fixation device 80 on the bone 60 in any direction) capable of engaging one of the plurality of screw holes in the bone plate (Fig. 10, ¶s 32 and 33) capable of affixing the guide to the bone plate (¶33 discloses that the interface allows adjustment of the relative position of 80 on the bone in any direction, i.e. in order to both adjust in both a pushing and a pulling direction, there must be sufficient affixation to enable such adjustment), and the push rod being capable of inserting within the longitudinal bore formed in the guide (Figs. 10, 11, and 12, ¶31), the push rod being capable of advancing relative to the affixed guide through the engaged screw hole when rotated within the longitudinal bore in the guide (Figs. 10-12, ¶s 31 and 32; where ¶32 discloses rotational coupling of 152 and 154 via internal threading of 157 and threaded portion 155 respectively) until the blunt, sharpened, or spiked tip contacts and engages with the fractured bone segment (¶33) to realign and maintain the position of the bone segment relative to the bone plate (Fig. 10, ¶s 25, 26, and 33, where ¶25 discloses the procedure for after the bone plate 80 is placed relative to the bone that culminates in ¶26 with inserting screws 88 into any of the holes 82 not used in attaching the device 100, and ¶33 discloses adjustment of the relative position of the fixation device 80 on the bone 60 in any direction via relative rotation of 154 and 152 to push/pull the bone and bone plate) during subsequent fixation of the bone plate to the fractured bone segment (via screws 88, Fig. 10, ¶s 25, 26, and 32; where Fig. 10 shows many unobstructed 82s through which a screw could be inserted while the positions shown of 150 are maintained, ¶25 discloses the procedure for after the bone plate 80 is placed relative to the bone that culminates in ¶26 with inserting screws 88 into any of the holes 82 not used in attaching the device 100, and ¶32 discloses rotational coupling between the guide and the push rod via 155 and threading within 157). As to claim 3, Choe discloses that the push rod includes external threads (155, Figs. 15B and 15C, ¶s 31 and 32) capable of threadably engaging internal threads formed on a portion of the guide (¶s 31 and 32). As to claim 4, Choe discloses that the push rod is capable of rotating relative to the guide (¶32 discloses rotational coupling between the guide and the push rod via 155 and threading within 157) capable of causing the push rod to realign the fractured bone segment (¶33 discloses using 154 to pull/push a bone fragment/portion with 150 to allow adjustment of the relative position of the fixation device/plate 80 on the bone 60 in any direction). As to claim 7, Choe discloses that the distal end of the push rod includes a tip (in as much as Applicants, 158, Figs. 11-15C, ¶31) arranged and capable of contacting the fractured bone segment (Figs. 11-13, ¶s 31-33).
Choe is silent to the mechanism being a coupling mechanism comprising external threads configured to engage one of the plurality of screw holes in the bone plate to rigidly affix the guide to the bone plate. As to claim 2, Choe is silent to the coupling mechanism includes external threads for threadably engaging one of the plurality of screw holes formed in the bone plate.
Forstein teaches a similar bone alignment system (250, 255, 258, Fig. 41) arranged and configured to align a fractured bone segment (abstract), the bone alignment system comprising: a bone plate (255) including a plurality of screw holes (257s); a rod (shown in Fig. 41 inserted within and extending from 258, Fig. 41); and a guide (258) arranged and capable of associating the push rod with the bone plate (Fig. 41), the guide including a proximal end (upper end of 258 as shown in Fig. 41, Fig. 41), a distal end (lower end of 258 as shown in Fig. 41, Fig. 41), and a longitudinal bore (opening shown holding the rod in Fig. 41, Fig. 41), the distal end of the guide comprising a coupling mechanism (¶115 discloses that 258 is threaded into screw hole 257, i.e. 258 is threaded) comprising external threads (¶115 disclose that 258 is threaded into screw hole 257, i.e. 258 is threaded) capable of engaging one of the plurality of screw holes in the bone plate (Fig. 41, ¶115) capable of rigidly affixing the guide to the bone plate (¶115), and the push rod being capable inserting within the longitudinal bore formed in the guide (Fig. 41). As to claim 2, Forstein teaches that the coupling mechanism includes external threads (in as much as Applicant’s, ¶115 disclose that 258 is threaded into screw hole 257, i.e. 258 is threaded) capable of threadably engaging one of the plurality of screw holes formed in the bone plate (Fig. 41, ¶115).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the mechanism/interface of the guide tip and plate surface as well as screw heads as disclosed by Choe to be threaded as taught by Forstein in order to fix the relative positions (Forstein ¶115) to fix the position of bone fragments relative to the bone plate (Forstein ¶s 93 and 100) to aid in pulling/pushing a bone fragment and the bone plate (Choe ¶33) by securing the guide to the plate to enhance control of the relative positions of the bone and plate.
As to claim 6, Choe discloses the invention of claim 4 and appears to disclose that following removal of the push rod and the guide from the bone plate, a bone fastener (88) can be inserted into one of the plurality of screw holes with which the guide is capable of being engaged (Figs. 2 and 9 show that the screw holes are similarly sized and are thus capable of receiving screws 88 when the push rod and guide are not inserted therein).
Forstein further teaches that following removal of the rod and the guide from the bone plate (¶100), a bone fastener (screw of ¶100, ¶100) can be inserted into one of the plurality of screw holes with which the guide is capable of being engaged (¶100).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to clarify the apparent disclosure of Choe to specifically include, following removal of the rod and the guide from the bone plate, a bone fastener inserted into the screw hole used by the guide as taught by Forstein in order to fix the position of bone fragments relative to the bone plate (Forstein ¶93).
As to claims 8-13, Choe discloses a method (Figs. 1-15C) of aligning and securing a fractured bone segment (bone fragment/portion of ¶33, Figs. 8 and 10) to a bone plate (80) including a plurality of screw holes (82s, ¶33 discloses using 154 to pull/push a bone fragment/portion with 150 to allow adjustment of the relative position of the fixation device/plate 80 on the bone 60 in any direction), the method comprising: positioning a bone plate (80) comprising a plurality of screw holes (82s) across a patient's bone (Figs. 8 and 10) including a fracture (bone fragment/portion of ¶33); securing a first portion of the bone plate to the patient's bone (¶26 discloses inserting screws 88 into any of the holes 82 not used in attaching the device 100); securing a second portion of the bone plate to the patient's bone (¶26 discloses inserting screws 88 into any of the holes 82 not used in attaching the device 100); identifying one or more bone fragments requiring alignment (¶33 discloses using 154 to pull/push a bone fragment/portion with 150 to allow adjustment of the relative position of the fixation device/plate 80 on the bone 60 in any direction); affixing a guide (152) to the bone plate (Fig. 10, ¶33 discloses that the interface allows adjustment of the relative position of 80 on the bone in any direction, i.e. in order to both adjust in both a pushing and a pulling direction, there must be sufficient affixation to enable such adjustment); the guide comprising a mechanism (adaptations of ¶32, Figs. 10-12 and 15A, where ¶32 discloses that 164 is adapted to interface in contact with an inner wall of hole 82, and ¶33 discloses that the interfacing of the 164 and the inner wall 81 of the hole 82 allows adjustment of the relative position of the fixation device 80 on the bone 60 in any direction) capable of engaging one of the plurality of screw holes in the bone plate (Fig. 10, ¶s 32 and 33) capable of affixing the guide to the bone plate (¶33 discloses that the interface allows adjustment of the relative position of 80 on the bone in any direction, i.e. in order to both adjust in both a pushing and a pulling direction, there must be sufficient affixation to enable such adjustment); inserting a push rod (154) comprising a blunt, sharpened, or spiked tip (158, Figs. 11-15C, ¶31) on a distal end of the push rod (Figs. 11-15C) into the guide (Figs. 10-12, ¶31 discloses 154 being received in 152, i.e. as shown in Figs. 10-12, ¶132 discloses 157 including internal threading for rotational coupling with 155 of 154); advancing the push rod through the engaged screw hole until the blunt, sharpened, or spiked tip contacts the fractured bone segment (Fig. 10, ¶31 discloses that threaded portion 156 terminates at bone-gripping tip 158, ¶33 discloses using to pull/push a bone fragment/portion with 150 to allow adjustment of the relative position of the fixation device/plate 80 on the bone 60 in any direction), the push rod capable of advancing relative to the affixed guide when rotated within a bore (opening within 152 disclosed to receive 154 as shown in Figs. 10-12 and comprising internal threading in ¶32, Figs. 10-12) in the guide (Figs. 10-12, ¶s 31 and 32; where ¶32 discloses rotational coupling of 152 and 154 via internal threading of 157 and threaded portion 155 respectively); realigning the fractured bone segment (¶33 discloses using to pull/push a bone fragment/portion with 150 to allow adjustment of the relative position of the fixation device/plate 80 on the bone 60 in any direction); maintaining a position of the realigned fractured bone segment (Fig. 10, ¶s 25, 26, and 33, where ¶25 discloses the procedure for after the bone plate 80 is placed relative to the bone that culminates in ¶26 with inserting screws 88 into any of the holes 82 not used in attaching the device 100, and ¶33 discloses adjustment of the relative position of the fixation device 80 on the bone 60 in any direction via relative rotation of 154 and 152 to push/pull the bone and bone plate); and securing bone fixation elements (88s) through additional screw holes (82s) of the plurality of screw holes in the bone plate to secure the bone plate to the fractured bone segment (¶26 discloses inserting screws 88 into any of the holes 82 not used in attaching the device 100). As to claim 9, Choe discloses that realigning the fractured bone segment comprises moving the fractured bone fragment away from the bone plate (Fig. 10, ¶33 discloses using 154 to pull/push a bone fragment/portion with 150 to allow adjustment of the relative position of the fixation device/plate 80 on the bone 60 in any direction, where review of Fig. 10 shows that using 154 to push the bone fragment/portion would move the bone fragment/portion away from the bone plate). As to claim 10, Choe discloses affixing the guide to the bone plate comprises engaging a distal end of the guide to the one of the plurality of screw holes in the bone plate (Fig. 10, ¶s 32, 33, and 26, where ¶33 discloses that the interface allows adjustment of the relative position of 80 on the bone in any direction, i.e. in order to both adjust in both a pushing and a pulling direction, there must be sufficient affixation to enable such adjustment, where ¶26 discloses inserting bone screw 88 into any of the bone plate holes other than those engaged with assembly 120 of targeting device 100). As to claim 11, Choe discloses that the step of realigning the fractured bone segment comprises advancing the push rod against the fractured bone segment until a sufficient separation of the fractured bone segment from the bone plate is achieved (¶33 discloses using 154 to pull/push a bone fragment/portion with 150 to allow adjustment of the relative position of the fixation device/plate 80 on the bone 60 in any direction, where review of Fig. 10 shows that using 154 to push the bone fragment/portion would move the bone fragment/portion away from the bone plate). As to claim 12, Choe discloses that advancing the push rod includes threadably engaging the push rod to the guide (via threads internal on 157 and 155, Figs. 11-12, 15B, and 15C, ¶s 31 and 32, where ¶32 discloses rotational coupling between the guide and the push rod via 155 and threading within 157) so that rotation of the push rod advances the push rod, and hence the fractured bone segment, relative to the bone plate (Figs. 10-15C, ¶s31-33, where ¶33 discloses using 154 to pull/push a bone fragment/portion with 150 to allow adjustment of the relative position of the fixation device/plate 80 on the bone 60 in any direction). As to claim 13, Choe discloses maintaining the push rod in contact with the fractured bone segment during subsequent fixation (via screws 88, Fig. 10, ¶s 25, 26, and 32; where Fig. 10 shows many unobstructed 82s through which a screw could be inserted while the positions shown of 150 are maintained, ¶25 discloses the procedure for after the bone plate 80 is placed relative to the bone that culminates in ¶26 with inserting screws 88 into any of the holes 82 not used in attaching the device 100, ¶32 discloses rotational coupling between the guide and the push rod via 155 and threading within 157, and ¶26 discloses inserting screws 88 into any of the holes 82 not used in attaching the device 100) capable of maintaining the realigned position of the fractured bone segment relative to the bone plate (Fig. 10 shows many unobstructed 82s through which a screw could be inserted while the positions shown of 150 are maintained, ¶25 discloses the procedure for after the bone plate 80 is placed relative to the bone that culminates in ¶26 with inserting screws 88 into any of the holes 82 not used in attaching the device 100, ¶32 discloses rotational coupling between the guide and the push rod via 155 and threading within 157, ¶26 discloses inserting screws 88 into any of the holes 82 not used in attaching the device 100).
Choe is silent to the mechanism being a coupling mechanism comprising external threads configured to engage one of the plurality of screw holes in the bone plate to rigidly affix the guide to the bone plate. As to claim 10, Choe is silent to the engaging comprises threadably engaging, e.g. via the coupling mechanism.
Forstein teaches a similar method (Fig. 41) of aligning and securing a fractured bone segment (abstract) to a bone plate (255) including a plurality of screw holes (257s), the method comprising: positioning a bone plate (255) comprising a plurality of screw holes (257s) across a patient's bone including a fracture (abstract); securing a first portion of the bone plate to the patient's bone (¶s 93 and 100); securing a second portion of the bone plate to the patient's bone (¶93); affixing a guide (258) to the bone plate (Fig. 41, ¶115), the guide comprising a coupling mechanism (¶115 discloses that 258 is threaded into screw hole 257, i.e. 258 is threaded) comprising external threads (¶115 disclose that 258 is threaded into screw hole 257, i.e. 258 is threaded) capable of engaging one of the plurality of screw holes in the bone plate (¶115) capable of rigidly affixing the guide to the bone plate (¶115), inserting a rod (shown in Fig. 41 inserted within and extending from 258, Fig. 41) into the guide (Fig. 41); and securing bone fixation elements (screw of ¶100, ¶100) through additional screw holes (257s) in the bone plate to secure the bone plate to the fractured bone segment (¶s 100 and 101). As to claim 10, Forstein teaches affixing the guide to the bone plate comprises threadably engaging (in as much as Applicant’s, Fig. 41, ¶115) a distal end of the guide to a screw hole of the plurality of screw holes in the bone plate (in as much as Applicant’s, Fig. 41, ¶115 discloses that 258 is threaded into screw hole 257).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the mechanism/interface of the guide tip and plate surface as well as screw heads as disclosed by Choe to be threaded as taught by Forstein in order to fix the relative positions (Forstein ¶115) to fix the position of bone fragments relative to the bone plate (Forstein ¶s 93 and 100) to aid in pulling/pushing a bone fragment and the bone plate (Choe ¶33) by securing the guide to the plate to enhance control of the relative positions of the bone and plate.
As to claim 14, Choe discloses the invention of claim 10 and appears to disclose removing the push rod and the guide (¶24 discloses removing 100), and inserting an additional bone fixation element (88) into the fractured bone segment through the one of the plurality of screw holes previously engaged by the guide and the push rod (Figs. 2 and 9 show that the screw holes are similarly sized and are thus capable of receiving screws 88 when the push rod and guide are not inserted therein).
Forstein further teaches removing the rod and the guide (¶100), and inserting an additional bone fixation element (screw of ¶100, ¶100) into the fractured bone segment through the one of the plurality of screw holes previously occupied by the guide and the rod (¶100).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to clarify the apparent disclosure of Choe to specifically include removing the push rod and the guide and inserting an additional bone fixation element into the fractured bone segment through the screw hole previously occupied by the guide and the push rod as taught by Forstein in order to fix the position of bone fragments relative to the bone plate (Forstein ¶93).
As to claims 1-4 and 7, Choe discloses a bone alignment system (80, 100, 150, Figs. 1-15C, ¶32 discloses shaped tip 164) arranged and capable of aligning a fractured bone segment (Figs. 8 and 10, ¶33 discloses using 154 to pull/push a bone fragment/portion with 150 to allow adjustment of the relative position of the fixation device/plate 80 on the bone 60 in any direction), the bone alignment system comprising: a bone plate (80) including a plurality of screw holes (82s); a push rod (154, Figs. 10-14, 15B and 15C) including a proximal end (155 and to the right as shown in Figs. 15B and 15C, Figs. 5B and 15C) and a distal end (156 and to the left as shown in Figs. 15B and 15C, Figs. 5B and 15C), the distal end comprising a blunt, sharpened, or spiked tip (158, Figs. 11-15C, ¶31) arranged and capable of contacting a patient's fractured bone segment to realign a position of the bone segment (Fig. 10, ¶33 discloses using 154 to pull/push a bone fragment/portion with 150 to allow adjustment of the relative position of the fixation device/plate 80 on the bone 60 in any direction); and a guide (152, ¶32 discloses shaped tip 164) arranged and capable of associating the push rod with the bone plate (Fig. 10, ¶s 32 and 33), the guide including a proximal end (157 and to the right as shown in Figs. 11, 12, and 15A, Figs. 11, 12, and 15A), a distal end (164 and to the left as shown in Figs. 11, 12, and 15A, Figs. 11, 12, and 15A, ¶32 discloses shaped tip 164), and a longitudinal bore (opening within 152 disclosed to receive 154 as shown in Figs. 10-12 and comprising internal threading in ¶32, Figs. 10-12) extending from the proximal end to the distal end (¶31 discloses 154 being received in 152, i.e. as shown in Figs. 10-12, ¶32 discloses 157 including internal threading for rotational coupling with 155 of 154), the distal end of the guide comprising a mechanism (adaptations of ¶32, Figs. 10-12 and 15A, where ¶32 discloses shaped tip 164 and that 164 is adapted to interface in contact with an inner wall of hole 82, and ¶33 discloses that the interfacing of the 164 and the inner wall 81 of the hole 82 allows adjustment of the relative position of the fixation device 80 on the bone 60 in any direction) capable of engaging one of the plurality of screw holes in the bone plate (Fig. 10, ¶s 32 and 33) capable of affixing the guide to the bone plate (¶33 discloses that the interface allows adjustment of the relative position of 80 on the bone in any direction, i.e. in order to both adjust in both a pushing and a pulling direction, there must be sufficient affixation to enable such adjustment), and the push rod being capable of inserting within the longitudinal bore formed in the guide (Figs. 10, 11, and 12, ¶31), the push rod being capable of advancing relative to the affixed guide through the engaged screw hole when rotated within the longitudinal bore in the guide (Figs. 10-12, ¶s 31 and 32; where ¶32 discloses rotational coupling of 152 and 154 via internal threading of 157 and threaded portion 155 respectively) until the blunt, sharpened, or spiked tip contacts and engages with the fractured bone segment (¶33) to realign and maintain the position of the bone segment relative to the bone plate (Fig. 10, ¶s 25, 26, and 33, where ¶25 discloses the procedure for after the bone plate 80 is placed relative to the bone that culminates in ¶26 with inserting screws 88 into any of the holes 82 not used in attaching the device 100, and ¶33 discloses adjustment of the relative position of the fixation device 80 on the bone 60 in any direction via relative rotation of 154 and 152 to push/pull the bone and bone plate) during subsequent fixation of the bone plate to the fractured bone segment (via screws 88, Fig. 10, ¶s 25, 26, and 32; where Fig. 10 shows many unobstructed 82s through which a screw could be inserted while the positions shown of 150 are maintained, ¶25 discloses the procedure for after the bone plate 80 is placed relative to the bone that culminates in ¶26 with inserting screws 88 into any of the holes 82 not used in attaching the device 100, and ¶32 discloses rotational coupling between the guide and the push rod via 155 and threading within 157). As to claim 3, Choe discloses that the push rod includes external threads (155, Figs. 15B and 15C, ¶s 31 and 32) capable of threadably engaging internal threads formed on a portion of the guide (¶s 31 and 32). As to claim 4, Choe discloses that the push rod is capable of rotating relative to the guide (¶32 discloses rotational coupling between the guide and the push rod via 155 and threading within 157) capable of causing the push rod to realign the fractured bone segment (¶33 discloses using 154 to pull/push a bone fragment/portion with 150 to allow adjustment of the relative position of the fixation device/plate 80 on the bone 60 in any direction). As to claim 7, Choe discloses that the distal end of the push rod includes a tip (in as much as Applicants, 158, Figs. 11-15C, ¶31) arranged and capable of contacting the fractured bone segment (Figs. 11-13, ¶s 31-33).
Choe is silent to the mechanism being a coupling mechanism comprising external threads configured to engage one of the plurality of screw holes in the bone plate to rigidly affix the guide to the bone plate. As to claim 2, Choe is silent to the coupling mechanism includes external threads for threadably engaging one of the plurality of screw holes formed in the bone plate.
Forstein teaches a similar bone alignment system (250, 255, 258, Fig. 41) arranged and configured to align a fractured bone segment (abstract), the bone alignment system comprising: a bone plate (255) including a plurality of screw holes (257s); a rod (shown in Fig. 41 inserted within and extending from 258, Fig. 41); and a guide (258) arranged and capable of associating the push rod with the bone plate (Fig. 41), the guide including a proximal end (upper end of 258 as shown in Fig. 41, Fig. 41), a distal end (lower end of 258 as shown in Fig. 41, Fig. 41), and a longitudinal bore (opening shown holding the rod in Fig. 41, Fig. 41), the distal end of the guide comprising a coupling mechanism (¶115 discloses that 258 is threaded into screw hole 257, i.e. 258 is threaded) comprising external threads (¶115 disclose that 258 is threaded into screw hole 257, i.e. 258 is threaded) capable of engaging one of the plurality of screw holes in the bone plate (Fig. 41, ¶115) capable of rigidly affixing the guide to the bone plate (¶115), and the push rod being capable inserting within the longitudinal bore formed in the guide (Fig. 41). As to claim 2, Forstein teaches that the coupling mechanism includes external threads (in as much as Applicant’s, ¶115 disclose that 258 is threaded into screw hole 257, i.e. 258 is threaded) capable of threadably engaging one of the plurality of screw holes formed in the bone plate (Fig. 41, ¶115).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the mechanism/interface of the shaped guide tip and plate surface as well as screw heads as disclosed by Choe to be threaded as taught by Forstein in order to fix the relative positions (Forstein ¶115) to fix the position of bone fragments relative to the bone plate (Forstein ¶s 93 and 100) to aid in pulling/pushing a bone fragment and the bone plate (Choe ¶33) by securing the guide to the plate to enhance control of the relative positions of the bone and plate.
As to claim 6, Choe discloses the invention of claim 4 and appears to disclose that following removal of the push rod and the guide from the bone plate, a bone fastener (88) can be inserted into one of the plurality of screw holes with which the guide is capable of being engaged (Figs. 2 and 9 show that the screw holes are similarly sized and are thus capable of receiving screws 88 when the push rod and guide are not inserted therein).
Forstein further teaches that following removal of the rod and the guide from the bone plate (¶100), a bone fastener (screw of ¶100, ¶100) can be inserted into one of the plurality of screw holes with which the guide is capable of being engaged (¶100).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to clarify the apparent disclosure of Choe to specifically include, following removal of the rod and the guide from the bone plate, a bone fastener inserted into the screw hole used by the guide as taught by Forstein in order to fix the position of bone fragments relative to the bone plate (Forstein ¶93).
As to claims 8-13, Choe discloses a method (Figs. 1-15C, ¶32 discloses shaped tip 164) of aligning and securing a fractured bone segment (bone fragment/portion of ¶33, Figs. 8 and 10) to a bone plate (80) including a plurality of screw holes (82s, ¶33 discloses using 154 to pull/push a bone fragment/portion with 150 to allow adjustment of the relative position of the fixation device/plate 80 on the bone 60 in any direction), the method comprising: positioning a bone plate (80) comprising a plurality of screw holes (82s) across a patient's bone (Figs. 8 and 10) including a fracture (bone fragment/portion of ¶33); securing a first portion of the bone plate to the patient's bone (¶26 discloses inserting screws 88 into any of the holes 82 not used in attaching the device 100); securing a second portion of the bone plate to the patient's bone (¶26 discloses inserting screws 88 into any of the holes 82 not used in attaching the device 100); identifying one or more bone fragments requiring alignment (¶33 discloses using 154 to pull/push a bone fragment/portion with 150 to allow adjustment of the relative position of the fixation device/plate 80 on the bone 60 in any direction); affixing a guide (152, ¶32 discloses shaped tip 164) to the bone plate (Fig. 10, ¶33 discloses that the interface allows adjustment of the relative position of 80 on the bone in any direction, i.e. in order to both adjust in both a pushing and a pulling direction, there must be sufficient affixation to enable such adjustment); the guide comprising a mechanism (adaptations of ¶32, Figs. 10-12 and 15A, where ¶32 discloses shaped tip 164 and that 164 is adapted to interface in contact with an inner wall of hole 82, and ¶33 discloses that the interfacing of the 164 and the inner wall 81 of the hole 82 allows adjustment of the relative position of the fixation device 80 on the bone 60 in any direction) capable of engaging one of the plurality of screw holes in the bone plate (Fig. 10, ¶s 32 and 33) capable of affixing the guide to the bone plate (¶33 discloses that the interface allows adjustment of the relative position of 80 on the bone in any direction, i.e. in order to both adjust in both a pushing and a pulling direction, there must be sufficient affixation to enable such adjustment); inserting a push rod (154) comprising a blunt, sharpened, or spiked tip (158, Figs. 11-15C, ¶31) on a distal end of the push rod (Figs. 11-15C) into the guide (Figs. 10-12, ¶31 discloses 154 being received in 152, i.e. as shown in Figs. 10-12, ¶132 discloses 157 including internal threading for rotational coupling with 155 of 154); advancing the push rod through the engaged screw hole until the blunt, sharpened, or spiked tip contacts the fractured bone segment (Fig. 10, ¶31 discloses that threaded portion 156 terminates at bone-gripping tip 158, ¶33 discloses using to pull/push a bone fragment/portion with 150 to allow adjustment of the relative position of the fixation device/plate 80 on the bone 60 in any direction), the push rod capable of advancing relative to the affixed guide when rotated within a bore (opening within 152 disclosed to receive 154 as shown in Figs. 10-12 and comprising internal threading in ¶32, Figs. 10-12) in the guide (Figs. 10-12, ¶s 31 and 32; where ¶32 discloses rotational coupling of 152 and 154 via internal threading of 157 and threaded portion 155 respectively); realigning the fractured bone segment (¶33 discloses using to pull/push a bone fragment/portion with 150 to allow adjustment of the relative position of the fixation device/plate 80 on the bone 60 in any direction); maintaining a position of the realigned fractured bone segment (Fig. 10, ¶s 25, 26, and 33, where ¶25 discloses the procedure for after the bone plate 80 is placed relative to the bone that culminates in ¶26 with inserting screws 88 into any of the holes 82 not used in attaching the device 100, and ¶33 discloses adjustment of the relative position of the fixation device 80 on the bone 60 in any direction via relative rotation of 154 and 152 to push/pull the bone and bone plate); and securing bone fixation elements (88s) through additional screw holes (82s) of the plurality of screw holes in the bone plate to secure the bone plate to the fractured bone segment (¶26 discloses inserting screws 88 into any of the holes 82 not used in attaching the device 100). As to claim 9, Choe discloses that realigning the fractured bone segment comprises moving the fractured bone fragment away from the bone plate (Fig. 10, ¶33 discloses using 154 to pull/push a bone fragment/portion with 150 to allow adjustment of the relative position of the fixation device/plate 80 on the bone 60 in any direction, where review of Fig. 10 shows that using 154 to push the bone fragment/portion would move the bone fragment/portion away from the bone plate). As to claim 10, Choe discloses affixing the guide to the bone plate comprises engaging a distal end of the guide to the one of the plurality of screw holes in the bone plate (Fig. 10, ¶s 32, 33, and 26, where ¶33 discloses that the interface allows adjustment of the relative position of 80 on the bone in any direction, i.e. in order to both adjust in both a pushing and a pulling direction, there must be sufficient affixation to enable such adjustment, where ¶26 discloses inserting bone screw 88 into any of the bone plate holes other than those engaged with assembly 120 of targeting device 100). As to claim 11, Choe discloses that the step of realigning the fractured bone segment comprises advancing the push rod against the fractured bone segment until a sufficient separation of the fractured bone segment from the bone plate is achieved (¶33 discloses using 154 to pull/push a bone fragment/portion with 150 to allow adjustment of the relative position of the fixation device/plate 80 on the bone 60 in any direction, where review of Fig. 10 shows that using 154 to push the bone fragment/portion would move the bone fragment/portion away from the bone plate). As to claim 12, Choe discloses that advancing the push rod includes threadably engaging the push rod to the guide (via threads internal on 157 and 155, Figs. 11-12, 15B, and 15C, ¶s 31 and 32, where ¶32 discloses rotational coupling between the guide and the push rod via 155 and threading within 157) so that rotation of the push rod advances the push rod, and hence the fractured bone segment, relative to the bone plate (Figs. 10-15C, ¶s31-33, where ¶33 discloses using 154 to pull/push a bone fragment/portion with 150 to allow adjustment of the relative position of the fixation device/plate 80 on the bone 60 in any direction). As to claim 13, Choe discloses maintaining the push rod in contact with the fractured bone segment during subsequent fixation (via screws 88, Fig. 10, ¶s 25, 26, and 32; where Fig. 10 shows many unobstructed 82s through which a screw could be inserted while the positions shown of 150 are maintained, ¶25 discloses the procedure for after the bone plate 80 is placed relative to the bone that culminates in ¶26 with inserting screws 88 into any of the holes 82 not used in attaching the device 100, ¶32 discloses rotational coupling between the guide and the push rod via 155 and threading within 157, and ¶26 discloses inserting screws 88 into any of the holes 82 not used in attaching the device 100) capable of maintaining the realigned position of the fractured bone segment relative to the bone plate (Fig. 10 shows many unobstructed 82s through which a screw could be inserted while the positions shown of 150 are maintained, ¶25 discloses the procedure for after the bone plate 80 is placed relative to the bone that culminates in ¶26 with inserting screws 88 into any of the holes 82 not used in attaching the device 100, ¶32 discloses rotational coupling between the guide and the push rod via 155 and threading within 157, ¶26 discloses inserting screws 88 into any of the holes 82 not used in attaching the device 100).
Choe is silent to the mechanism being a coupling mechanism comprising external threads configured to engage one of the plurality of screw holes in the bone plate to rigidly affix the guide to the bone plate. As to claim 10, Choe is silent to the engaging comprises threadably engaging, e.g. via the coupling mechanism.
Forstein teaches a similar method (Fig. 41) of aligning and securing a fractured bone segment (abstract) to a bone plate (255) including a plurality of screw holes (257s), the method comprising: positioning a bone plate (255) comprising a plurality of screw holes (257s) across a patient's bone including a fracture (abstract); securing a first portion of the bone plate to the patient's bone (¶s 93 and 100); securing a second portion of the bone plate to the patient's bone (¶93); affixing a guide (258) to the bone plate (Fig. 41, ¶115), the guide comprising a coupling mechanism (¶115 discloses that 258 is threaded into screw hole 257, i.e. 258 is threaded) comprising external threads (¶115 disclose that 258 is threaded into screw hole 257, i.e. 258 is threaded) capable of engaging one of the plurality of screw holes in the bone plate (¶115) capable of rigidly affixing the guide to the bone plate (¶115), inserting a rod (shown in Fig. 41 inserted within and extending from 258, Fig. 41) into the guide (Fig. 41); and securing bone fixation elements (screw of ¶100, ¶100) through additional screw holes (257s) in the bone plate to secure the bone plate to the fractured bone segment (¶s 100 and 101). As to claim 10, Forstein teaches affixing the guide to the bone plate comprises threadably engaging (in as much as Applicant’s, Fig. 41, ¶115) a distal end of the guide to a screw hole of the plurality of screw holes in the bone plate (in as much as Applicant’s, Fig. 41, ¶115 discloses that 258 is threaded into screw hole 257).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the mechanism/interface of the shaped guide tip and plate surface as well as screw heads as disclosed by Choe to be threaded as taught by Forstein in order to fix the relative positions (Forstein ¶115) to fix the position of bone fragments relative to the bone plate (Forstein ¶s 93 and 100) to aid in pulling/pushing a bone fragment and the bone plate (Choe ¶33) by securing the guide to the plate to enhance control of the relative positions of the bone and plate.
As to claim 14, Choe discloses the invention of claim 10 and appears to disclose removing the push rod and the guide (¶24 discloses removing 100), and inserting an additional bone fixation element (88) into the fractured bone segment through the one of the plurality of screw holes previously engaged by the guide and the push rod (Figs. 2 and 9 show that the screw holes are similarly sized and are thus capable of receiving screws 88 when the push rod and guide are not inserted therein).
Forstein further teaches removing the rod and the guide (¶100), and inserting an additional bone fixation element (screw of ¶100, ¶100) into the fractured bone segment through the one of the plurality of screw holes previously occupied by the guide and the rod (¶100).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to clarify the apparent disclosure of Choe to specifically include removing the push rod and the guide and inserting an additional bone fixation element into the fractured bone segment through the screw hole previously occupied by the guide and the push rod as taught by Forstein in order to fix the position of bone fragments relative to the bone plate (Forstein ¶93).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY R SIPP whose telephone number is (313)446-6553. The examiner can normally be reached on Mon - Thurs 6-4.
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 or telephone the Examiner.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached on (571)272-4705. 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.
/AMY R SIPP/Primary Examiner, Art Unit 3775
Prosecution Insights