Detailed Action
This is the final office action for US application number 17/607,894. Claims are evaluated as filed on March 24, 2025.
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 .
Response to Arguments
Applicant's arguments filed March 24, 2025 have been fully considered but they are not persuasive. The rejections in this office action have been amended to address the amended claims. Examiner directs Applicant to the rejection below for a more in-depth description of the limitations.
As an initial matter, Examiner notes that 2 distinct claim sets were received March 24, 2025. MPEP 714(II)(C) requires claim amendments include status identifiers and markings to show the changes. Thus, the copy labeled as a “clean copy of the currently amended claims” is improper and has not been considered. Only the claim copy dated March 24, 2025 and including appropriate claim status and amendment markings have been considered.
With regards to Applicant’s comment that Examiner’s final finding regarding the traversed restriction requirement is noted and reserved (Remarks p. 26), Examiner notes that the intent of ‘reserved’ is unclear. In the interest of clarity, Examiner notes that MPEP 1893.03(d) provides that traversal must be presented at the time of election in order to be considered timely. Thus, future traversals regarding the restriction/election will be considered untimely.
With regards to Applicant’s comment that Examiner’s priority assessment and potential double patenting will be addressed if the Examiner pursues this issue accordingly (Remarks p. 26 and 27), Examiner notes that it is unclear what Applicant is implying by this statement. As Applicant has not amended the claims to negate the objections, the notes issues are outstanding and have thus been repeated below.
With regards to Applicant’s comments regarding the amendments to the drawings and claims (Remarks p. 26-28), Examiner agrees that the amendments to the drawings and the claims satisfy the previous drawing objections, claim objections, 35 USC 101 rejections, and 35 USC 112b rejections.
With regards to Applicant’s argument that the asserted Zwirnmann stop 18, 20 is not shown to prevent rotation of the disclosed assembly 10 around longitudinal axis 14 as paragraph 28 discloses that the relative position of 18 and 20 may be fixed along the longitudinal axis 14 and free to rotate about the longitudinal axis 14 even though translational movement is prevented and thus 18, 20 allow the assembly to rotate and thus the continued rotation may allow the tap to further bore a hole into the bone at the longitudinal position at which the assembly stops which is not permissible for the current invention that requires the tool to allow for manipulation of the bone by tightened engagement with the bone and positioning to prevent the tool from being further rotated to prevent further boring when the tool stop contacts the bone (Remarks p. 28-30), Examiner notes that there appear to be distinct differences between the argued scope, the claim scope, and the specific disclosure of the art. Firstly, Applicant has not claimed a method as appears to be implied by the presented arguments nor has Applicant claimed that an entirety of the tool is able to be prevented from rotation as appears to be implied by the presented arguments or which portion of the claimed tool the stop is “positioned to prevent…from being further rotated”. Secondly, Zwirnmann paragraph 28, as cited by Applicant specifically discloses that “translational movement along the longitudinal axis 14 is prevented”. Further, as cited on pages 13 and 14 of the non-final office action dated September 24, 2024 and in the rejection below, Zwirnmann paragraph 38 discloses that “the stop collar 18 is operably configured and dimensioned to cooperate with the shaft 22 and locking collar 20 to set and fix the penetration or effective length 28 of the adjustable length tap assembly 10” and paragraph 10 discloses a method of use including a steps of “forming a tapped bore in bone, contacting the stop collar against a surface to block advancement of the self-drilling tap” (*italic font added to quotes for easy identification of key words). Thus, while Applicant’s argued potential use may appear plausible, such further boring into the bone is directly contrary to the explicit disclosure of the art in regards to its capabilities and method of use and ignores the fact that the threads of the bore are freshly tapped/formed securely by the threads of the tool (which are configured to tap threads) and the stop is abutting the bone surface. Finally, Examiner notes that Applicant’s device would be equally capable of continued rotation due the shape of Applicant’s stop abutting a similarly smooth bone surface; however, the characteristics of the bone engaged with the tool have not been claimed. That is, there appears to be no differentiating, disclosed structural feature of Applicant’s stop that explicitly performs a method step of preventing rotation of the entirety of the tool into bone as Applicant’s argument implies.
With regards to Applicant’s argument regarding “operation distinctions” between the tool of Zwirnmann and Applicant’s invention (Remarks p. 30), Examiner notes that a method has not been claimed nor asserted in the rejections. Instead, each of claims has been rejected based on the BRI of the presented claims which are drawn to tools capable of performing various functions.
With regards to Applicant’s argument that neither Zwirnmann or Fang disclose devices capable of engaging and rotating a bone as required by the current claims or manipulation, movement, and rotation of bone (Remarks p. 31, 36, 38, and 41-42), Examiner again notes that no methods have been claimed. That is, manipulation, movement, and rotation of bone have not been claimed. Nonetheless, Examiner notes that Zwirnmann paragraph 10 discloses a method including steps of advancing cutting threads into bone and forming a tapped bore. Fang paragraph 18 discloses threads on a bone screw. Thus, contrary to Applicant’s arguments, both the threads of Zwirnmann and Fang are specifically disclosed to engage bone in a secure manner due to the threads and would thus be capable of engaging and rotating a bone.
With regards to Applicant’s argument that neither Zwirnmann or Buser disclose or teach a tool having one or two legs of a tool stop in the same plane as the peg leg 12 does not appear to restrict rotation and therefore does not function as the claimed tool stop (Remarks p. 31-32 and 37), Examiner note that, in much the same way as the shape of the stop of Zwirnmann and that of Applicant’s disclosure, the stop legs 12 of Buser are capable of restricting rotation when the contacting a surface while the threads are threaded into tissue. As cited on at least page 20 of the non-final office action dated September 24, 2024, Buser paragraph 51 specifically discloses that “12 acts as a stop once it contacts … of the patient to prevent further penetration into the patient's body cavity”. That is, in as much as Applicant’s stop is capable of preventing rotation when it contacts as surface due to friction with the surface and the threaded engagement of the top, so also is the resultant device of the combination of Zwirnmann and Buser.
With regards to Applicant’s argument that neither Zwirnmann or Roberts disclose devices relevant to the current Application as neither discloses manipulation, movement, and rotation of bone (Remarks p. 32-33 and 38-39), Examiner again notes that no methods have been claimed. That is, manipulation, movement, and rotation of bone have not been claimed. Nonetheless, Examiner notes that the disclosed capabilities of Zwirnmann are discussed above and below and Roberts col. 3 line 66 – col. 4 line 3 disclose insertion trough skin, tissue, a dense outer layer of bone, and into bone marrow. Thus, the device of Roberts would be capable of manipulation, movement, and rotation of bone when inserted as far in as explicitly disclosed.
With regards to Applicant’s argument that Ames does not disclose manipulation, movement, and rotation of bone as Examiner’s cited col. 3 lines 5-10 refers to a tool for drilling but not manipulation, movement, and rotation of bone (Remarks p. 33, 35, and 39-40), Examiner again notes that no methods have been claimed. That is, manipulation, movement, and rotation of bone have not been claimed. Nonetheless, Examiner notes that Ames discloses drilling into bone, i.e. manipulating and moving bone, where a drill bit positioned in bone would necessarily be capable of rotating bone.
With regards to Applicant’s argument that neither Zwirnmann or Aspden disclose or teach manipulation, movement, and rotation of bone as Fig. 17 refers to a tool for drilling and injection (Remarks p. 34-35, 38, 39, 41-42), Examiner again notes that no methods have been claimed. That is, manipulation, movement, and rotation of bone have not been claimed. Nonetheless, Examiner notes that the disclosed capabilities of Zwirnmann are discussed above and below and Examiner notes that Aspden Fig. 17 shows the tool having drilled into and threadedly engaged in bone. Thus, such is capable of manipulation, movement, and rotation of bone as shown in Fig. 17.
With regards to Applicant’s argument that the absence of a stop in the device of Aspden will allow further rotation and cause further drilling rather than allowing for manipulation, movement, and rotation of bone (Remarks p. 34-35), Examiner notes that there is no limitation that specifies that drilling must stop or be limited in order for the device to be capable of manipulation, movement, and rotation of bone as appears to be argued. Further, Aspden has not been relied upon as a primary reference as appears to be implied by these arguments. Instead, Aspden is a teaching reference as used in the non-final office action and the rejections below.
With regards to Applicant’s argument that the Aspden device is intended for injecting liquid into bone would be larger than a tool used in a metatarsal head (Remarks p. 35), Examiner notes that this appears to be irrelevant to the rejection which instead uses/used Aspden to teach having a guide hole and guide to enable insertion over the guide to ensure accurate positioning. Further, this argued difference is not claims.
With regards to Applicant’s argument that Zwirnmann nor Buser disclose two legs of a tool stop in the same plane such that the tool remains substantially flat when placed on a flat surface (Remarks p. 36-38), Examiner notes that Buser shows the legs of 12 appearing to be in the same plane and thus, as detailed in the non-final office and action and the rejection below, it would be an obvious matter of design choice to specify that such are indeed substantially in the same plane when selecting a known tool stop shape and orientation.
With regards to Applicant’s arguments on pages 42- 54, Examiner notes that such substantively repeat the arguments addressed above and refers Applicant to the above responses/explanations and below rejections for further details.
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 62/843,453, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Application No. 62/843,453 fails to provide adequate support for said handling end is positioned for connection to an external drill of claims 11, 34, and 78, a knob at said handling end of claims 12, 35, and 79, a grooved handle at said handling end of claims 13, 36, and 80, a domed handle at said handling end of claims 14, 37, and 81, a square handle at said handling end of claims 15, 38, and 82, a triangle handle at said handling end of claims 16, 39, and 83, a circle handle at said handling of claims 17, 40, and 84, and an engagement surface for attachment of an external tool of claims 19, 42, 43, 86, 87.
The disclosure of the prior-filed application, Application No. 62/908562, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Application No. 62/908562 fails to provide adequate support for at least a tool stop being positioned to prevent said surgical tool from being further rotated around said main body axis and to prevent further boring into the bone when said tool stop contacts the bone of claims 1-5, 8, 11-19, 21-28, 31, 34-43, 45-50, 53, 67-72, 75, and 78-87.
The disclosure of the prior-filed application, Application No. 29/733,468, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Application No. 29/733,468 fails to provide adequate support for at least a tool stop being positioned to prevent said surgical tool from being further rotated around said main body axis and to prevent further boring into the bone when said tool stop contacts the bone of claims 1-5, 8, 11-19, 21-28, 31, 34-43, 45-50, 53, 67-72, 75, and 78-87, said handling end is positioned for connection to an external drill of claims 11, 34, and 78, a knob at said handling end of claims 12, 35, and 79, a grooved handle at said handling end of claims 13, 36, and 80, a domed handle at said handling end of claims 14, 37, and 81, a square handle at said handling end of claims 15, 38, and 82, a triangle handle at said handling end of claims 16, 39, and 83, a circle handle at said handling of claims 17, 40, and 84, and an engagement surface for attachment of an external tool of claims 19, 42, 43, 86, 87, the positioning guide/guide wire of claims 21-28, 31, 34-43, 45-50, 53, 67-72, 75, and 78-87.
Accordingly, claims 11-17, 19, 34-40, 42, 43, 78-84, 86, and 87 are considered as of May 5, 2020 and claims 1-5, 8, 18, 19, 21-28, 31, 41-43, 45-50, 53, 67-72, 75, and 85 are considered as of May 5, 2019.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Applicant is advised that should claim 42 be found allowable, claim 43 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Applicant is advised that should claim 86 be found allowable, claim 87 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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, 11, and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zwirnmann (US 2004/0092940).
As to claim 1, Zwirnmann discloses a surgical tool (12, Figs. 1-11) capable of use for engaging and manipulating a bone (abstract, ¶s 10 and 28) comprising: a tool body (Fig. 1) having a main body axis (horizontal as shown in Fig. 2), a threaded end (13, 34, Figs. 2 and 3), and a handling end (30, right end as shown in Figs. 2 and 3, ¶29); said threaded end having threads (16, Figs. 2 and 3, ¶28) and a tool stop (18, 20, Fig. 2, ¶28); said handling end being positioned capable of allowing a user to grasp, manipulate, and rotate said tool body around said main body axis (Figs. 1 and 2, ¶s 29 and 37 disclose connecting to a handle or a drill); said threads being positioned capable of allowing said surgical tool to bore into and engage the bone when said tool body is rotated in a boring direction around said main body axis (Figs. 1-3, ¶s 10 and 28), said threads allowing for tightening engagement with the bone as said tool body is rotated in the boring direction around said main body axis (Figs. 1-3, ¶s 10 and 28); said tool stop being positioned capable of preventing said surgical tool from being further rotated around said main body axis and to prevent further boring into the bone when said tool stop contacts the bone (Figs. 1 and 2, ¶s 28 and 38); and said surgical tool allowing for manipulation, movement, and rotation of the bone with said surgical tool when said tool is in tightened engagement with the bone (Figs. 1 and 2, ¶s 10 and 28).
As to claim 11, Zwirnmann discloses that said handling end is positioned for connection to an external drill (Fig. 1, ¶29) capable of use for rotation of said surgical tool around said main body axis (¶s 10 and 29).
As to claim 19, Zwirnmann discloses an engagement surface (surfaces of 30, Figs. 1 and 2) capable of use for attachment of an external tool (Fig. 1, ¶29) capable of rotating said tool body around said main body axis (¶s 10 and 29).
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) 2 and 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zwirnmann in view of Fang et al. (US 2014/02777187, hereinafter “Fang”).
As to claim 2, Zwirnmann discloses the invention of claim 1 as well as said threads positioned to bore into and engaging the bone by said tool body being rotated around said main body axis (Figs. 1 and 2, ¶s 10 and 28).
Zwirnmann is silent to the directionality of the threads, i.e., that said threads engage the bone by said tool body being rotated around said main body axis in a right, clockwise direction.
Fang teaches a similar surgical tool (100, Fig. 1, ¶18) capable of use for engaging and manipulating a bone (¶18) comprising: a tool body (Fig. 1) having a main body axis (vertical axis as shown in Fig. 1), a threaded end (104 and below as shown in Fig. 1), and a handling end (102); said threaded end having threads (112) and a tool stop (lower surface of 102 as shown in Fig. 1); said handling end being positioned to allow a user to grasp, manipulate, and rotate said tool body around said main body axis (¶17 discloses receiving a driving instrument for driving 100 into bone); said threads being positioned capable of allowing said surgical tool to engage the bone when said tool body is rotated in a direction around said main body axis (Fig. 1, ¶18); and said surgical tool allowing for manipulation, movement, and rotation of the bone with said surgical tool when said tool is in tightened engagement with the bone (Fig. 1, ¶18); wherein said threads are positioned to bore into and engage the bone by said tool body being rotated around said main body axis in a right, clockwise direction (¶18).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to specify the direction of the threads as disclosed by Zwirnmann so that said threads engage the bone by said tool body being rotated around said main body axis in a right, clockwise direction as taught by Fang in order to specify a known direction for rotating a threaded shaft into bone (Fang ¶18).
As to claim 3, Zwirnmann discloses the invention of claim 1 as well as said threads positioned to bore into and engaging the bone by said tool body being rotated around said main body axis (Figs. 1 and 2, ¶s 10 and 28).
Zwirnmann is silent to the directionality of the threads, i.e., that said threads engage the bone by said tool body being rotated around said main body axis in a left, counterclockwise direction.
Fang teaches a similar surgical tool (100, Fig. 1, ¶18) capable of use for engaging and manipulating a bone (¶18) comprising: a tool body (Fig. 1) having a main body axis (vertical axis as shown in Fig. 1), a threaded end (104 and below as shown in Fig. 1), and a handling end (102); said threaded end having threads (112) and a tool stop (lower surface of 102 as shown in Fig. 1); said handling end being positioned to allow a user to grasp, manipulate, and rotate said tool body around said main body axis (¶17 discloses receiving a driving instrument for driving 100 into bone); said threads being positioned capable of allowing said surgical tool to engage the bone when said tool body is rotated in a direction around said main body axis (Fig. 1, ¶18); and said surgical tool allowing for manipulation, movement, and rotation of the bone with said surgical tool when said tool is in tightened engagement with the bone (Fig. 1, ¶18); wherein said threads are positioned to bore into and engage the bone by said tool body being rotated around said main body axis in a left, counterclockwise direction (¶18).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to specify the direction of the threads as disclosed by Zwirnmann so that said threads engage the bone by said tool body being rotated around said main body axis in a left, counterclockwise direction as taught by Fang in order to specify a known direction for rotating a threaded shaft into bone (Fang ¶18).
Claim(s) 4, 5, and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zwirnmann in view of Buser et al. (US 2006/0276818, hereinafter “Buser”).
As to claim 4, Zwirnmann discloses the invention of claim 1 as well as the tool stop being round (Fig. 1).
Zwirnmann is silent to said tool stop having at least one leg extending outwardly from said tool body; said handling end having at least one handle extending outwardly from said tool body; and said at least one leg of said tool stop and said at least one handle of said handling end lying substantially within a plane shared with said main body axis wherein said surgical tool remains substantially flat when placed on a flat surface.
Buser teaches a similar surgical tool (Figs. 1 and 6-8, ¶52) comprising: a tool body (Fig. 1), a patient-engaging end (54 and to the left and shown in Fig. 1, Fig. 1), and a handling end (portion to the right of 54 as shown in Fig. 1, Fig. 1); said patient-engaging end having a tool stop (Figs. 6-8, ¶s 51, 52, and 57); said handling end being positioned capable of allowing a user to grasp, manipulate, and rotate said tool body around said main body axis (Fig. 1); said tool stop being positioned capable of preventing said surgical tool from being further inserted when said tool stop contacts a patient surface (¶s 51 and 52); said tool stop having at least one leg (portion of 12 to the left of 13, portion of 12 to the right of 13 as shown in Figs. 6 and 8, Figs. 6 and 8) extending outwardly from said tool body (Figs. 6 and 8); said handling end having at least one handle (60) extending outwardly from said tool body (Fig. 1).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the round tool stop and the handle end as disclosed by Zwirnmann to have two side wings or legs on the tool stop and provide a handle as taught by Buser in order to provide a known alternate geometric shape suitable for the intended purpose of being a stop member (Buser ¶57) as well as provide a known handle shape (Buser Fig. 1; Zwirnmann ¶28). It would have been an obvious matter of design choice to one skilled in the art before the effective filing date of the claimed invention to specify that said at least one leg of said tool stop and said at least one handle of said handling end of the combination of Zwirnmann and Buser lie substantially within a plane shared with said main body axis wherein said surgical tool remains substantially flat when placed on a flat surface since Applicant has not disclosed that such is anything more than one of numerous shapes or configurations a person ordinary skill in the art would find obvious for a freely to rotatable tool stop (¶8) as one of a finite number of positions achievable by the tool stop.
As to claim 5, Zwirnmann discloses the invention of claim 1 as well as the tool stop being round (Fig. 1).
Zwirnmann is silent to said tool stop having two legs extending outwardly from said tool body; said handling end having two handles extending outwardly from said tool body; and both of said legs of said tool stop and both of said handles of said handling end lying substantially within a plane shared with said main body axis wherein said surgical tool remains substantially flat when placed on a flat surface.
Buser teaches a similar surgical tool (Figs. 1 and 6-8, ¶52) comprising: a tool body (Fig. 1), a patient-engaging end (54 and to the left and shown in Fig. 1, Fig. 1), and a handling end (portion to the right of 54 as shown in Fig. 1, Fig. 1); said patient-engaging end having a tool stop (Figs. 6-8, ¶s 51, 52, and 57); said handling end being positioned capable of allowing a user to grasp, manipulate, and rotate said tool body around said main body axis (Fig. 1); said tool stop being positioned capable of preventing said surgical tool from being further inserted when said tool stop contacts a patient surface (¶s 51 and 52); said tool stop having two legs (portion of 12 to the left of 13, portion of 12 to the right of 13 as shown in Figs. 6 and 8, Figs. 6 and 8) extending outwardly from said tool body (Figs. 6 and 8); said handling end having two handles (portion of 60 above the middle of the tool body, portion of 60 below the middle of the tool body as shown in Fig. 1, Fig. 1) extending outwardly from said tool body (Fig. 1).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the round tool stop and the handle end as disclosed by Zwirnmann to have two side wings or legs on the tool stop and provide two handles as taught by Buser in order to provide a known alternate geometric shape suitable for the intended purpose of being a stop member (Buser ¶57) as well as provide a known handle shape (Buser Fig. 1; Zwirnmann ¶28). It would have been an obvious matter of design choice to one skilled in the art before the effective filing date of the claimed invention to specify that both of said legs of said tool stop and both of said handles of said handling end of the combination of Zwirnmann and Buser lie substantially within a plane shared with said main body axis wherein said surgical tool remains substantially flat when placed on a flat surface since Applicant has not disclosed that such is anything more than one of numerous shapes or configurations a person ordinary skill in the art would find obvious for a freely to rotatable tool stop (¶8) as one of a finite number of positions achievable by the tool stop.
As to claim 8, Zwirnmann discloses the invention of claim 1 as well as the tool stop being round (Fig. 1).
Zwirnmann is silent to said tool comprises at least one peg leg.
Buser teaches a similar surgical tool (Figs. 1 and 6-8, ¶52) comprising: a tool body (Fig. 1), a patient-engaging end (54 and to the left and shown in Fig. 1, Fig. 1), and a handling end (portion to the right of 54 as shown in Fig. 1, Fig. 1); said patient-engaging end having a tool stop (Figs. 6-8, ¶s 51, 52, and 57); said handling end being positioned capable of allowing a user to grasp, manipulate, and rotate said tool body around said main body axis (Fig. 1); said tool stop being positioned capable of preventing said surgical tool from being further inserted when said tool stop contacts a patient surface (¶s 51 and 52); said tool stop comprises at least one peg leg (portion of 12 to the left of 13, portion of 12 to the right of 13 as shown in Figs. 6 and 8, Figs. 6 and 8, where peg has been interpreted as “a projecting piece used as a support or boundary marker” (https://www.merriam-webster.com/dictionary/peg)).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the round tool stop as disclosed by Zwirnmann to have two peg legs on the tool stop as taught by Buser in order to provide a known alternate geometric shape suitable for the intended purpose of being a stop member (Buser ¶57).
Claim(s) 12, 13, and 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zwirnmann in view of Roberts et al. (US 5,372,583, hereinafter “Roberts”).
As to claims 12, 13, and 17, Zwirnmann discloses the invention of claim 1 as well as said handling end for connecting to a handle or drill (¶29) capable of allowing rotation of said surgical tool around said main body axis (¶10).
As to claim 12, Zwirnmann is silent to a knob at said handling end. As to claim 13, Zwirnmann is silent to a grooved handle at said handling end. As to claim 17, Zwirnmann is silent to a circle handle at said handling end.
Roberts teaches a similar surgical tool (Figs. 1-5) capable of engaging and manipulating a bone (44, 46, Fig. 1, col. 4 lined 1-3) comprising: a tool body (Figs. 3 and 4) having a main body axis (vertical as shown in Fig. 4, Fig. 4), a patient-engaging end (36), and a handling end (54, 56, 58, Fig. 3); said patient-engaging end having a tool stop (30, Figs. 1-3 and 5); said handling end being positioned capable of allowing a user to grasp, manipulate, and rotate said tool body around said main body axis (Fig. 1, col. 3 lines 66-68); said tool stop being positioned to prevent said surgical tool from being further inserted when said tool stop contacts the patient (Figs. 1 and 2); and said surgical tool allowing for manipulation, movement, and rotation of the bone with said surgical tool when said tool is in tightened engagement with the bone (Fig. 1, col. 3 lines 66-68). As to claim 12, Roberts teaches a knob at said handling end (54, Fig. 3). As to claim 13, Roberts teaches to a grooved handle at said handling end (54, 72, Fig. 3, col. 4 lines 22-23). As to claim 17, Roberts teaches a circle handle at said handling end (56, Fig. 3, col. 4 lines 24-25).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the handle end as disclosed by Zwirnmann to have the handle as taught by Roberts in order to enable the user to apply firm downward pressure while simultaneously rotating the tool (col. 3 lines 10-15 and 65-68) via a known handle style (Zwirnmann ¶29; Roberts Fig. 3).
As to claim 15, Zwirnmann discloses the invention of claim 1 as well as said handling end for connecting to a handle or drill (¶29) capable of allowing rotation of said surgical tool around said main body axis (¶10).
Zwirnmann is silent to a square handle at said handling end.
Roberts teaches a similar surgical tool (Figs. 1-5, col. 5 line 42 discloses that handle portion 54 is square) capable of engaging and manipulating a bone (44, 46, Fig. 1, col. 4 lined 1-3) comprising: a tool body (Figs. 3 and 4) having a main body axis (vertical as shown in Fig. 4, Fig. 4), a patient-engaging end (36), and a handling end (54, 56, 58, Fig. 3); said patient-engaging end having a tool stop (30, Figs. 1-3 and 5); said handling end being positioned capable of allowing a user to grasp, manipulate, and rotate said tool body around said main body axis (Fig. 1, col. 3 lines 66-68); said tool stop being positioned to prevent said surgical tool from being further inserted when said tool stop contacts the patient (Figs. 1 and 2); and said surgical tool allowing for manipulation, movement, and rotation of the bone with said surgical tool when said tool is in tightened engagement with the bone (Fig. 1, col. 3 lines 66-68); further comprising a square handle at said handling end (col. 5 line 42 discloses that handle portion 54 is square).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the handle end as disclosed by Zwirnmann to have the square handle as taught by Roberts in order to enable the user to apply firm downward pressure while simultaneously rotating the tool (col. 3 lines 10-15 and 65-68) via a known handle style (Zwirnmann ¶29; Roberts Fig. 3, col. 5 lines 42-43).
As to claim 16, Zwirnmann discloses the invention of claim 1 as well as said handling end for connecting to a handle or drill (¶29) capable of allowing rotation of said surgical tool around said main body axis (¶10).
Zwirnmann is silent to a triangle handle at said handling end.
Roberts teaches a similar surgical tool (Figs. 1-5, col. 5 line 43 discloses that handle portion 54 is triangular) capable of engaging and manipulating a bone (44, 46, Fig. 1, col. 4 lined 1-3) comprising: a tool body (Figs. 3 and 4) having a main body axis (vertical as shown in Fig. 4, Fig. 4), a patient-engaging end (36), and a handling end (54, 56, 58, Fig. 3); said patient-engaging end having a tool stop (30, Figs. 1-3 and 5); said handling end being positioned capable of allowing a user to grasp, manipulate, and rotate said tool body around said main body axis (Fig. 1, col. 3 lines 66-68); said tool stop being positioned to prevent said surgical tool from being further inserted when said tool stop contacts the patient (Figs. 1 and 2); and said surgical tool allowing for manipulation, movement, and rotation of the bone with said surgical tool when said tool is in tightened engagement with the bone (Fig. 1, col. 3 lines 66-68); further comprising a square handle at said handling end (col. 5 line 42 discloses that handle portion 54 is triangular).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the handle end as disclosed by Zwirnmann to have the triangle handle as taught by Roberts in order to enable the user to apply firm downward pressure while simultaneously rotating the tool (col. 3 lines 10-15 and 65-68) via a known handle style (Zwirnmann ¶29; Roberts Fig. 3, col. 5 lines 42-43).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zwirnmann in view of Ames et al. (US 3,682,177, hereinafter “Ames”).
As to claim 14, Zwirnmann discloses the invention of claim 1 as well as said handling end for connecting to a handle or drill (¶29) capable of allowing rotation of said surgical tool around said main body axis (¶10).
Zwirnmann is silent to a domed handle at said handling end.
Ames teaches a similar surgical tool (Figs. 1-3) capable of use for engaging and manipulating a bone (abstract) comprising: a tool body (Figs. 1-3) having a main body axis (horizontal as shown in Fig. 2), a patient-engaging end (14), and a handling end (20, 22, 12, Figs. 1-3); said patient-engaging end having a tool stop (18); said handling end being positioned to allow a user to grasp, manipulate, and rotate said tool body around said main body axis (Figs. 1 and 2, col. 3 lines 5-10); said patient-engaging end being positioned capable of allowing said surgical tool to bore into and engage the bone when said tool body is rotated in a boring direction around said main body axis (Figs. 1 and 2, col. 3 lines 5-10); said tool stop being positioned capable of preventing said surgical tool from being further rotated around said main body axis and to prevent further boring into the bone when said tool stop contacts the bone (col. 3 lines 11-12); and said surgical tool allowing for manipulation, movement, and rotation of the bone with said surgical tool when said tool is in tightened engagement with the bone (Figs. 1 and 2, col. 3 lines 5-10); further comprising a domed handle (20) at said handling end (Figs. 1 and 2) capable of allowing rotation of said surgical tool around said main body axis (Figs. 1 and 2, col. 3 lines 5-10).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the handle end as disclosed by Zwirnmann to have the domed handle as taught by Ames in order to enable the user to apply pressure while rotating the tool (col. 3 lines 5-10) via a known handle style (Zwirnmann ¶29; Ames Fig. 1 and 2).
Claim(s) 18, 21, 24-26, 34, and 41-43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zwirnmann in view of Aspden et al. (US 5,824,087, hereinafter “Aspden”).
As to claim 18, Zwirnmann discloses the invention of claim 1 as well as said handling end for connecting to a handle or drill (¶29) capable of allowing rotation of said surgical tool around said main body axis (¶10).
Zwirnmann is silent to a proud T handle at said handling end.
Aspden teaches a similar surgical tool (Figs. 12-17) capable of use for engaging and manipulating a bone (Fig 17) comprising: a tool body (Fig. 12) having a main body axis (horizontal as shown in Fig. 12), a threaded end (4, Fig. 12, col. 5 lines 16-18), and a handling end (5, 6, left portion of tool as shown in Fig. 12, Fig. 12); said threaded end having threads (col. 5 lines 17-18); said handling end being positioned to allow a user to grasp, manipulate, and rotate said tool body around said main body axis (Fig. 17); said threaded end being positioned capable of allowing said surgical tool to engage the bone when said tool body is rotated in a boring direction around said main body axis (Fig. 17, col. 6 lines 4-8); and said surgical tool allowing for manipulation, movement, and rotation of the bone with said surgical tool when said tool is in tightened engagement with the bone (Fig. 17); further comprising a proud T handle (5, 6, Fig. 12) at said handling end (Figs. 12 and 17) capable of allowing rotation of said surgical tool around said main body axis (Figs. 12 and 17, col. 6 lines 4-8).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the handle end as disclosed by Zwirnmann to have the proud T handle as taught by Aspden in order to enable the user to apply pressure while rotating the tool (col. 6 lines 5-8) via a known handle style (Zwirnmann ¶29; Aspden Figs. 12 and 17).
As to claims 21, 24, and 25, Zwirnmann discloses a surgical tool (12, Figs. 1-11) capable of use for engaging and manipulating a bone (abstract, ¶s 10 and 28) comprising: a tool body (Fig. 1) having a main body axis (horizontal as shown in Fig. 2), a threaded end (13, 34, Figs. 2 and 3), and a handling end (30, right end as shown in Figs. 2 and 3, ¶29); said threaded end having threads (16, Figs. 2 and 3, ¶28) and a tool stop (18, 20, Fig. 2, ¶28); said handling end being positioned capable of allowing a user to grasp, manipulate, and rotate said tool body around said main body axis (Figs. 1 and 2, ¶s 29 and 37 disclose connecting to a handle or a drill); said threads being positioned capable of allowing said surgical tool to bore at the bone boring position into and engage the bone when said tool body is rotated in a boring direction around said main body axis (Figs. 1-3, ¶s 10 and 28), said threads allowing for tightening engagement with the bone as said tool body is rotated in the boring direction around said main body axis (Figs. 1-3, ¶s 10 and 28); said tool stop being positioned capable of preventing said surgical tool from being further rotated around said main body axis and to prevent further boring into the bone when said tool stop contacts the bone (Figs. 1 and 2, ¶s 28 and 38); and said surgical tool allowing for manipulation, movement, and rotation of the bone with said surgical tool when said tool is in tightened engagement with the bone (Figs. 1 and 2, ¶s 10 and 28). As to claim 34, Zwirnmann discloses that said handling end is positioned for connection to an external drill (Fig. 1, ¶29) capable of use for rotation of said surgical tool around said main body axis (¶s 10 and 29). As to claims 42 and 43, Zwirnmann discloses an engagement surface (surfaces of 30, Figs. 1 and 2) capable of use for attachment of an external tool (Fig. 1, ¶29) capable of rotating said tool body around said main body axis (¶s 10 and 29).
Zwirnmann is silent to said tool body having a guide hole extending through said tool body substantially along said main body axis; said guide hole allowing a positioning guide to extend at least partially through said tool body and into a bone at a bone boring position to align and guide said threads of said surgical tool to the bone boring position. As to claim 24, Zwirnmann is silent to the positioning guide is a guide wire. As to claim 25, Zwirnmann is silent to the positioning guide is a guide wire pre-embedded in the bone at the bone boring position.
Aspden teaches a similar surgical tool (Figs. 12-17) capable of use for engaging and manipulating a bone (Fig 17) comprising: a tool body (Fig. 12) having a main body axis (horizontal as shown in Fig. 12), a threaded end (4, Fig. 12, col. 5 lines 16-18), a handling end (5, 6, left portion of tool as shown in Fig. 12, Fig. 12), and a guide hole (8) extending through said tool body substantially along said main body axis (Fig. 12, col. 6 lines 1-5); said threaded end having threads (col. 5 lines 17-18); said handling end being positioned to allow a user to grasp, manipulate, and rotate said tool body around said main body axis (Fig. 17); said guide hole allowing a positioning guide (guide wire of col. 5 line 63) to extend at least partially through said tool body and into a bone at a bone boring position to align and guide said threads of said surgical tool to the bone boring position (col. 6 lines 1-5); said threads being positioned capable of allowing said surgical tool to engage the bone when said tool body is rotated in a boring direction around said main body axis (Fig. 17, col. 6 lines 4-8); and said surgical tool allowing for manipulation, movement, and rotation of the bone with said surgical tool when said tool is in tightened engagement with the bone (Fig. 17). As to claim 24, Aspden teaches that the positioning guide is a guide wire (as defined, col. 5 line 63). As to claim 25, Aspden teaches to the positioning guide is a guide wire (as defined, col. 5 line 63) pre-embedded in the bone at the bone boring position (col. 5 line 63 – col. 6 line 5).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the tool as disclosed by Zwirnmann to have the guide hole and positioning guide as taught by Aspden in order to enable insertion over the positioning guide/guide wire inserted under fluoroscopic control to a desired site (col. 5 line 63 – col. 6 line 8) to ensure accurate positioning.
As to claim 26, the combination of Zwirnmann and Aspden discloses the invention of claim 21 as well as the positioning guide is a k-wire (col. 5 line 63 – col. 6 line 8) and a needle inserted in the guide hole has an inner diameter of about 4 mm and is inserted over the guide wire (col. 6 lines 10-14).
The combination of Zwirnmann and Aspden the positioning guide is 0.45 mm diameter k-wire.
It would have been an obvious matter of design choice before the effective filing date of the claimed invention specify that the k-wire that a cannulation of about 4 mm passes over of the combination of Zwirnmann and Aspden is 0.45 mm in diameter, since such a modification would have involved a mere clarification/change in the size of a component in order to predictably achieve sizing relative to the patient bone size (Aspden col. 8 lines 31-34). A change in size is generally recognized as being within the level of ordinary skill in the art.
As to claim 41, the combination of Zwirnmann and Aspden discloses the invention of claim 21 as well as said handling end for connecting to a handle or drill (¶29) capable of allowing rotation of said surgical tool around said main body axis (¶10).
The combination of Zwirnmann and Aspden is silent to a proud T handle at said handling end.
Aspden teaches a similar surgical tool (Figs. 12-17) capable of use for engaging and manipulating a bone (Fig 17) comprising: a tool body (Fig. 12) having a main body axis (horizontal as shown in Fig. 12), a threaded end (4, Fig. 12, col. 5 lines 16-18), and a handling end (5, 6, left portion of tool as shown in Fig. 12, Fig. 12); said threaded end having threads (col. 5 lines 17-18); said handling end being positioned to allow a user to grasp, manipulate, and rotate said tool body around said main body axis (Fig. 17); said threaded end being positioned capable of allowing said surgical tool to engage the bone when said tool body is rotated in a boring direction around said main body axis (Fig. 17, col. 6 lines 4-8); and said surgical tool allowing for manipulation, movement, and rotation of the bone with said surgical tool when said tool is in tightened engagement with the bone (Fig. 17); further comprising a proud T handle (5, 6, Fig. 12) at said handling end (Figs. 12 and 17) capable of allowing rotation of said surgical tool around said main body axis (Figs. 12 and 17, col. 6 lines 4-8).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the handle end as disclosed by the combination of Zwirnmann and Aspden to have the proud T handle as taught by Aspden in order to enable the user to apply pressure while rotating the tool (col. 6 lines 5-8) via a known handle style (Zwirnmann ¶29; Aspden Figs. 12 and 17).
Claim(s) 22 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zwirnmann and Aspden in view of Fang et al. (US 2014/02777187, hereinafter “Fang”).
As to claim 22, the combination of Zwirnmann and Aspden discloses the invention of claim 21 as well as said threads positioned to bore into and engaging the bone by said tool body being rotated around said main body axis (Figs. 1 and 2, ¶s 10 and 28).
The combination of Zwirnmann and Aspden is silent to the directionality of the threads, i.e., that said threads engage the bone by said tool body being rotated around said main body axis in a right, clockwise direction.
Fang teaches a similar surgical tool (100, Fig. 1, ¶18) capable of use for engaging and manipulating a bone (¶18) comprising: a tool body (Fig. 1) having a main body axis (vertical axis as shown in Fig. 1), a threaded end (104 and below as shown in Fig. 1), and a handling end (102); said threaded end having threads (112) and a tool stop (lower surface of 102 as shown in Fig. 1); said handling end being positioned to allow a user to grasp, manipulate, and rotate said tool body around said main body axis (¶17 discloses receiving a driving instrument for driving 100 into bone); said threads being positioned capable of allowing said surgical tool to engage the bone when said tool body is rotated in a direction around said main body axis (Fig. 1, ¶18); and said surgical tool allowing for manipulation, movement, and rotation of the bone with said surgical tool when said tool is in tightened engagement with the bone (Fig. 1, ¶18); wherein said threads are positioned to bore into and engage the bone by said tool body being rotated around said main body axis in a right, clockwise direction (¶18).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been