Detailed Action
This office action is for US application number 18/882,062 evaluates the claims as filed on July 7, 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 July 7, 2026 has been entered.
Response to Arguments
Applicant's arguments filed July 7, 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 Boucher, Bono, Willert, Landanger, and Brannon 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 none of the cited references teach “the first thread having a first crest defining a first channel that extends partially along a helix of the first crest …. such that the first crest is divided along the first channel” as the rejection misconstrues Bono’s 22a, 24a, 22b, 24b, 22c, 24c as such refer to different peaks of lead 22 and 24 and not to one peak or crest and none of these peaks are divided by a first channel as claimed and Bono instead teaches two separate thread grooves (large 36 and small 37) running parallel to one another are separated by the peaks/crests (Remarks p. 8-9), Examiner agrees that Bono’s 22a, 24a, 22b, 24b, 22c, 24c refer to different peaks of lead 22 and 24 and that Bono teaches two separate thread grooves as large 36 and small 37, i.e. as disclosed in col. 1 lines 28-45. As specifically disclosed by Bono, these are all features of a thread 19 (e.g. “Dual lead thread 19 comprises a first lead 22 and a second lead 24.” (col. 3 lines 6-7) and “First lead 22 and second lead 24 of dual lead thread 19” (col. 4 lines 19-20)). That is, as disclosed by Bono, there is a thread 19 that has two leads 22, 24 and is an offset thread (Fig. 4, col. 3 lines 9-11) where the leads spiral together along the shaft (col. 3 lines 9-11). Each of the leads form a series of adjacent ridges that form peaks (22a-22f and 24a-24f, Fig 4, col. 3 lines 16-17) that are separated by small groove 37 (col. 3 lines 39-45). Bono specifically delineates each turn of the thread crests of 22/24 as a-f (Fig. 4, col. 3 lines 18-27). That is, as specifically taught by Bono the thread 19 has a plurality of crests (22a and 24a, 22b and 24b, 22c and 24c, 22d and 24d, 22e and 24e, 22f and 24f, Fig. 4, col. 3 lines 18-27), where each of the plurality of crests define a channel (37, Fig. 4, col. 3 lines 39-45) that extends partially along a helix of the crest such that the crest is divided along the channel (Fig. 4, col. 3 lines 43-45); wherein a channel has been interpreted as “a long gutter, groove, or furrow” (https://www.merriam-webster.com/dictionary/channel). Thus, Bono specifically teaches the argued limitation where thread 19 is specifically disclosed to have a crest (22a and 24a, 22b and 24b, 22c and 24c, 22d and 24d, 22e and 24e, 22f and 24f, Fig. 4, col. 3 lines 18-27) defining a channel (37, Fig. 4, col. 3 lines 39-45) that extends partially along a helix of the crest such that the crest is divided along the channel (Fig. 4, col. 3 lines 43-45). As there appears to be some confusion regarding this matter, Examiner has enlarged a portion of Bono Fig. 4 below and labeled such accordingly in the interest of clarifying the record.
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With regards to Applicant’s argument that Willert discloses that added groove 1202 does not extend beyond the shape of the original screw/shaft (¶69) and therefore teaches that such does not extend to a tapered end and therefor fails to teach that the root notch extends through the distal surface as claimed (Remarks p. 9), Examiner notes that if one reads all of paragraph 69 and considers the entirety of the cited sentence, one can more clearly discern the disclosure of Willert, which provides that “Here, a spiral groove 1202 is added to the shaft between adjacent threads. The spiral groove 1202 increases the surface area of the shaft portion between the threads. … Here, the added groove does not extend beyond the shape of the original screw/shaft, and is an addition to the same (i.e. is recessed into the existing shaft of the threaded screw).”. That is, the groove is disclosed to be fully recessed into the shaft of the screw. It has not been asserted that Willert discloses a tapered end as argued, Willert does not show either end of the screw in the figures, and it does not appear that Willert ¶69 discloses that the groove 1202 extends or doesn’t extend to tapered end. Instead, in regards to the rejection of the claimed limitations, Boucher Figs. 3 and 4 show/disclose that the threads 150 and 160 extend to and define the tapered end and distal surface and Willert teaches that the notch 1202 extends along the threads and therefore the combination discloses that the notch extends through the distal surface (Boucher Figs. 3 and 4; Willert Fig. 12A, ¶69).
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 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boucher et al. (US 5,443,509, hereinafter “Boucher”) in view of Bono et al. (US 6,129,730, hereinafter “Bono”).
As to claim 1, Boucher discloses a bone screw (101, Figs. 3 and 4) comprising: a shaft portion (110) having a terminal end (right end as shown in Fig. 3, Figs. 3 and 4) and a first thread (150) terminating at the terminal end (Figs. 3 and 4, col. 5 lines 36-37), the terminal end defining a distal surface (162, 152) facing away from a proximal head (Fig. 4), the first thread having a first crest (peak of 150, Fig. 3), wherein the first crest defines the distal surface of the terminal end (as 152, Fig. 4, col. 5 lines 36-41); further comprising a second thread (160) terminating at the terminal end (Figs. 3 and 4, col. 5 lines 36-37), the second thread including a second crest (peak of 160, Fig. 3), wherein the second thread defines the distal surface of the terminal end (as 162, Fig. 4, col. 5 lines 36-41).
Boucher is silent to the first crest defining a first channel that extends partially along a helix of the first crest and through the distal surface of the terminal end such that the first crest is divided along the first channel.
Bono teaches a similar bone screw (10, Figs. 1-4) comprising: a shaft portion (18) having a terminal end (right portion as shown in Fig. 4 including at least one revolution of thread 19, Fig. 4) and a thread (19) terminating at the terminal end (as defined, Figs. 3 and 4), the thread having a crest (22a and 24a, 22b and 24b, 22c and 24c, 22d and 24d, 22e and 24e, 22f and 24f, i.e. see illustration of the enlarged portion of Fig. 4, Fig. 4, col. 3 lines 18-27) defining a channel (37, Fig. 4, col. 3 lines 39-45) that extends partially along a helix of the crest such that the crest is divided along the channel (Fig. 4, col. 3 lines 43-45).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify each thread and crest thereof as disclosed by Boucher by adding a channel as taught by Bono in order to increase the average thread depth while maintaining thread pitch to achieve a desirable pullout value in bone to provide greater pullout values than an ordinary double thread (Bono col. 3 lines 46-60).
As a result, as to claim 1, the combination of Boucher and Bono discloses a first thread (Boucher 150; Bono 19) having a first crest (Boucher peak of 150, Fig. 3) defining a first channel (Bono 37, Fig. 4, col. 3 lines 39-45) that extends partially along a helix of the first crest (Bono Fig. 4, col. 3 lines 43-45) and through the distal surface of the terminal end (Boucher Figs. 3 and 4, col. 5 lines 36-41; Bono Fig. 4) such that the first crest is divided along the first channel (Bono Fig. 4, col. 3 lines 43-45); further comprising a second thread (Boucher 160; Bono 19) having a second channel (Bono 37) that extends partially along a helix of the second crest (Bono Fig. 4, col. 3 lines 43-45) and through the distal surface of the terminal end (Boucher Figs. 3 and 4, col. 5 lines 36-41; Bono Fig. 4) such that the second crest is divided along the second channel (Bono Fig. 4, col. 3 lines 43-45).
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Claim(s) 2-4, 6, and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boucher and Bono in view of Willert et al. (US 2012/0172935, hereinafter “Willert”).
As to claims 2-4 and 6, the combination of Boucher and Bono discloses the invention of claim 1 as well as a second thread (160) having a second crest (peak of 160, Fig. 3) disposed along the shaft portion (Fig. 3) and terminating at the terminal end (Figs. 3 and 4, col. 5 lines 36-37) such that the bone screw is a dual-lead threaded screw (Bono abstract, col. 3 lines 6-7, col. 4 lines 19-20), and wherein the first thread further defines a first root (root/trough of Boucher 150, Fig. 3) and a helix of the first root extends from the terminal end (Boucher Figs. 3 and 4) and the second thread further defines a second root (root/trough of Boucher 160, Fig. 3) and a helix of the second root extends from the terminal end (Boucher Figs. 3 and 4). As to claim 3, the combination of Boucher and Bono discloses that the second crest has a second channel (Boucher 160; Bono 19, 37) that extends along a helix of the second crest (Bono Fig. 4, col. 3 lines 43-45) from the terminal end (Boucher Figs. 3 and 4, col. 5 lines 36-41; Bono Fig. 4) such that the second crest is divided along the second channel (Bono Fig. 4, col. 3 lines 43-45). As to claim 4, the combination of Boucher and Bono discloses that the shaft portion includes an aperture (140) extending along its length (Fig. 3) and having a cylindrical sidewall at the terminal end (Figs. 3 and 4), and wherein the distal surface defines a plane that is substantially perpendicular to a longitudinal axis of the bone screw (Figs. 3 and 4). As to claim 6, the combination of Boucher and Bono discloses that at least one of the first or the second channels does not extend through the cylindrical sidewall (Boucher Figs. 3 and 4; Bono Figs. 3 and 4).
The combination of Boucher and Bono is silent to a root notch that extends partially along the helix of the first root from the terminal end.
Willert teaches a similar bone screw (1200, Fig. 12A, ¶69) comprising: a shaft portion (Fig. 12a) having a thread (604, Fig. 12a, ¶64) having a crest (610 as labeled on Fig. 6, Fig. 12a, ¶64) that extends along a helix (Fig. 12A); wherein the thread further defines a root (Fig. 12A) and a root notch (1202, Fig. 12A, ¶69) that extends partially along a helix of the root (Fig. 12A, ¶69).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify each thread root as disclosed by the combination of Boucher and Bono by adding a root notch as taught by Willert in order to increase the surface area of the root between the crests (Willert ¶69 and abstract) to increase in anchoring the bone screw within the bone once inserted therein, and thereby reduce the possibility for the screw backing out after insertion (Willert abstract).
As a result, as to claim 2, the combination of Boucher, Bono, and Willert discloses a second thread (Boucher 160; Bono 19; Willert 604) having a second crest (Boucher peak of 160, Fig. 3) disposed along the shaft portion (Fig. 3) and terminating at the terminal end (Boucher Figs. 3 and 4, col. 5 lines 36-37) such that the bone screw is a dual-lead threaded screw (Bono abstract, col. 3 lines 6-7, col. 4 lines 19-20), and wherein the first thread further defines a first root (root/trough of Boucher 150, Fig. 3) and a root notch (Willert 1202, Fig. 12A, ¶69) that extends partially along a helix of the first root (Boucher Figs. 3 and 4; Willert Fig. 12A, ¶69) from the terminal end (Boucher Figs. 3 and 4) and the second thread further defines a second root (root/trough of Boucher 160, Fig. 3) and a second root notch (Willert 1202, Fig. 12A, ¶69) that extends partially along a helix of the second root (Boucher Figs. 3 and 4; Willert Fig. 12A, ¶69) from the terminal end (Boucher Figs. 3 and 4).
As to claim 12, the combination of Boucher, Bono, and Willert discloses the invention of claim 4.
The combination of Boucher and Bono is silent to the cylindrical sidewall includes a notch at the terminal end.
Bono further teaches that the cylindrical sidewall includes a notch (15) at the terminal end (Figs. 3 and 4).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the cylindrical sidewall at the terminal end as disclosed by the combination of Boucher and Bono to include a notch as taught by Bono in order to provide a self-tapping feature (Bono col. 4 lines 11-12).
Claim(s) 5 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boucher, Bono, and Willert in view of Landanger et al. (FR 2971413 and corresponding machine translation as cited on the PTO-892 dated December 18, 2025, hereinafter “Landanger”).
As to claim 5, the combination of Boucher, Bono, and Willert discloses the invention of claim 4 as well as each of the first and second channels extend into the respective first and second thread to a depth (Boucher Figs. 3 and 4; Bono Fig. 4) as well as the screw having a cutting edge (Boucher 154, 164) for cutting aggressively into bone tissue (Boucher col. 5 lines 54-59).
The combination of Boucher, Bono, and Willert is silent to the depth being through the cylindrical sidewall and into the aperture, i.e. at least the first and the second channels extending through the cylindrical sidewall and into the aperture.
Landanger teaches a similar bone screw (1) comprising: a shaft portion (2, 5) having a terminal end (lower portion of 2 and 5 as shown in Figs. 1 and 2, Figs. 1 and 2) and a thread (8) terminating at the terminal end (Figs. 1 and 2), the terminal end defining a distal surface (at the right end as shown in Figs. 1 and 2, Figs. 1 and 2), the thread having a crest (Figs. 1 and 2) defining a channel (7, 6, Figs. 1 and 2, translation top of page 4) that extends partially along a helix (Figs. 1 and 2, translation top of page 4) such that the crest is divided along the channel (Figs. 1 and 2), the shaft portion includes an aperture (translation page 3 discloses being cannulated); wherein a portion of the channel extends into the thread and the shaft portion to a depth beyond a root of the thread (Figs. 1 and 2, translation top of page 4); wherein the depth extends into an aperture (Fig. 4, translation middle of page 3) for sliding over a guide wire (100, Fig. 4, translation middle of page 3), i.e. at least the channel extends through the sidewall and into the aperture (Figs. 1, 2, and 4) at and adjacent to the distal surface (Figs. 1, 2, and 4).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the terminal end along each of the first and second channels as disclosed by the combination of Boucher, Bono, and Willert to add a channel depth at a portion that extends through the sidewall and into the aperture at and adjacent to the distal surface as taught by Landanger in order to provide a known a self-tapping capacity (Landanger translation bottom of page 3; Bono col. 4 lines 11-15) configured in relation to a channel (Landanger translation top of page 4; Bono Fig. 3) while being slidable over a guide wire (Landanger Fig. 4, translation middle of page 3).
As to claim 7, the combination of Boucher, Bono, and Willert discloses the invention of claim 4 as well as a portion of each of the first and second channel extend into the respective first and second thread to a depth (Boucher Figs. 3 and 4; Bono Fig. 4) as well as the screw having a cutting edge (Boucher 154, 164) for cutting aggressively into bone tissue (Boucher col. 5 lines 54-59).
The combination of Boucher, Bono, and Willert is silent to the depth being through the cylindrical sidewall and into the aperture, i.e. a portion of at least the first and the second cuts extending through the cylindrical sidewall and into the aperture.
Landanger teaches a similar bone screw (1) comprising: a shaft portion (2, 5) having a terminal end (lower portion of 2 and 5 as shown in Figs. 1 and 2, Figs. 1 and 2) and a thread (8) terminating at the terminal end (Figs. 1 and 2), the terminal end defining a distal surface (at the right end as shown in Figs. 1 and 2, Figs. 1 and 2), the thread having a crest (Figs. 1 and 2) defining a channel (7, 6, Figs. 1 and 2, translation top of page 4) that extends partially along a helix (Figs. 1 and 2, translation top of page 4) such that the crest is divided along the channel (Figs. 1 and 2), the shaft portion includes an aperture (translation page 3 discloses being cannulated); wherein a portion of the channel extends into the thread and the shaft portion to a depth beyond a root of the thread (Figs. 1 and 2, translation top of page 4); wherein the depth extends into an aperture (Fig. 4, translation middle of page 3) for sliding over a guide wire (100, Fig. 4, translation middle of page 3), i.e. a portion of at least the channel extends through the sidewall and into the aperture (Figs. 1, 2, and 4) at and adjacent to the distal surface (Figs. 1, 2, and 4).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the terminal end along each of the first and second channels as disclosed by the combination of Boucher, Bono, and Willert to add a channel depth at a portion that extends through the sidewall and into the aperture at and adjacent to the distal surface as taught by Landanger in order to provide a known self-tapping capacity (Landanger translation bottom of page 3; Bono col. 4 lines 11-15) configured in relation to a channel (Landanger translation top of page 4; Bono Fig. 3) while being slidable over a guide wire (Landanger Fig. 4, translation middle of page 3).
Claim(s) 8-10 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boucher and Bono in view of Landanger et al. (FR 2971413 and corresponding machine translation, hereinafter “Landanger”).
As to claim 8, the combination of Boucher and Bono discloses the invention of claim 1 as well as a height of each of the first and second crest (Boucher Figs. 3 and 4) tapers as each of the first and second thread approaches the terminal end of the shaft portion (Boucher Fig. 3), each of the first and the second channel having a depth (Bono d2, Fig. 4).
The combination of Boucher and Bono is silent to the depth of the first cut varying as the first crest tapers.
Landanger teaches a similar bone screw (1) comprising: a shaft portion (2, 5) having a terminal end (lower portion of 2 and 5 as shown in Figs. 1 and 2, Figs. 1 and 2) and a first thread (8) terminating at the terminal end (Figs. 1 and 2), the first thread having a first crest (Figs. 1 and 2) defining a first channel (7, 6, Figs. 1 and 2, translation top of page 4) that extends partially along a helix (Figs. 1 and 2, translation top of page 4) such that the first crest is divided along the first channel (Figs. 1 and 2); wherein a height of the first crest tapers as the first thread approaches the terminal end of the shaft portion (Figs. 1 and 2, translation bottom of page 4), the first channel having a varying depth as the first crest tapers (Figs. 1 and 2, translation middle of page, translation top of page 4); wherein the depth extends into an aperture (Fig. 4, translation middle of page 3) for sliding over a guide wire (100, Fig. 4, translation middle of page 3).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the terminal end along each of the first and second channel as disclosed by the combination of Boucher and Bono to add a channel depth at a portion that gradually extends through the sidewall and into the aperture at and adjacent to the distal surface as taught by Landanger in order to provide a known self-tapping capacity (Landanger translation bottom of page 3; Bono col. 4 lines 11-15) configured in relation to a channel (Landanger translation top of page 4; Bono Fig. 3) while being slidable over a guide wire (Landanger Fig. 4, translation middle of page 3).
As to claim 10, the combination of Boucher, Bono, and Landanger discloses the invention of claim 8 and appears to show that the first channel has a length of 2.7 mm (Bono Figs. 1-4) given the typical size of a vertebra (Bono Fig. 1).
The combination of Boucher, Bono, and Landanger is silent to an express disclosure that the first channel has a length of 2.7 mm.
Nonetheless, Landanger further discloses that the screw is a bone screw (translation page 3) having a length ranging from approximately 10 to 30 mm.
It would have been an obvious matter of design choice before the effective filing date of the claimed invention to specify that the first channel as disclosed by the combination of Boucher, Bono, and Landanger has a length of 2.7 mm, since such a modification would have involved a mere specification in the size of a component that is shown to extend over half the length of the screw (Boucher Figs. 3 and 4; Bono Fig. 4) for a screw that is at least 10 mm in length (Landanger translation page 3), such would extend for a length of at least 5 mm and thereby extend for a length of 2.7 mm. A change in size is generally recognized as being within the level of ordinary skill in the art and is commonly determined based upon the bone size in which the screw is to be inserted.
As to claim 9, the combination of Boucher and Bono discloses the invention of claim 1 as well as a portion of each of the first and the second channel extends into each of the respective first and the second thread and the shaft portion to a depth (Fig. 4) as well as the screw having a cutting edge (Boucher 154, 164) for cutting aggressively into bone tissue (Boucher col. 5 lines 54-59).
The combination of Boucher and Bono is silent to the depth being beyond a root of the first thread.
Landanger teaches a similar bone screw (1) comprising: a shaft portion (2, 5) having a terminal end (lower portion of 2 and 5 as shown in Figs. 1 and 2, Figs. 1 and 2) and a first thread (8) terminating at the terminal end (Figs. 1 and 2), the first thread having a first crest (Figs. 1 and 2) defining a first channel (7, 6, Figs. 1 and 2, translation top of page 4) that extends partially along a helix (Figs. 1 and 2, translation top of page 4) such that the first crest is divided along the first channel (Figs. 1 and 2); wherein a portion of the first channel extends into the first thread and the shaft portion to a depth beyond a root of the first thread at and adjacent to a distal surface (Figs. 1 and 2, translation top of page 4); wherein the depth extends into a cannulation/aperture (Fig. 4, translation middle of page 3) for sliding over a guide wire (100, Fig. 4, translation middle of page 3).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the terminal end along each of the first and second channel as disclosed by the combination of Boucher and Bono to add a channel depth at a portion that extends through the sidewall and into the aperture at and adjacent to the distal surface, i.e. to a depth beyond a root of the first thread, as taught by Landanger in order to provide a known self-tapping capacity (Landanger translation bottom of page 3; Bono col. 4 lines 11-15) configured in relation to a channel (Landanger translation top of page 4; Bono Fig. 3) while being slidable over a guide wire (Landanger Fig. 4, translation middle of page 3).
As to claim 20, Boucher discloses a bone screw (101, Figs. 3 and 4) comprising: a cannulated shaft (110 with cannulation 140, Figs. 3 and 4) defining a hollow center (Figs. 3 and 4) and a distal end of the bone screw (right end as shown in Fig. 3, Figs. 3 and 4) positioned opposite of a proximal end (left end as shown in Fig. 3, Figs. 3 and 4) and a first thread (150) terminating at the distal end of the bone screw ( at 152, Figs. 3 and 4, col. 5 lines 36-37), the first thread including a first crest (peak of 150, Fig. 3), wherein the first thread has a length that extends through the distal end (as 152, Fig. 4, col. 5 lines 36-41); further comprising a second thread (160) terminating at the terminal end (Figs. 3 and 4, col. 5 lines 36-37), the second thread including a second crest (peak of 160, Fig. 3), wherein the second thread extends through the distal end (as 162, Fig. 4, col. 5 lines 36-41).
Boucher is silent to the first thread including a first channel, wherein the first channel extends partially along the length of the first crest and through the distal end such that the first crest is split by the first channel, wherein the first channel extends through the shaft and into the hollow center of the shaft at the distal end.
Bono teaches a similar bone screw (10, Figs. 1-4) comprising: a shaft (18) defining a distal end of the bone screw (right portion as shown in Fig. 4 including at least one revolution of thread 19, Fig. 4) positioned opposite of a proximal end (left portion as shown in Fig. 4 including at least one revolution of thread 19, Fig. 4) and a thread (19) terminating at the distal end of the bone screw (as defined, Figs. 3 and 4), the thread including a crest (22a and 24a, 22b and 24b, 22c and 24c, 22d and 24d, 22e and 24e, 22f and 24f, i.e. see illustration of the enlarged portion of Fig. 4, Fig. 4, col. 3 lines 18-27) and a channel (37, Fig. 4, col. 3 lines 39-45) that extends partially along a length of the crest such that the crest is split by the channel (Fig. 4, col. 3 lines 43-45).
Landanger teaches a similar bone screw (1) comprising: a cannulated shaft (2, 5, Fig. 4, translation middle of page 3) defining a hollow center (shown positioned along 100 in Fig. 4, Fig. 4) and having a distal end of the bone screw (lower portion of 2 and 5 as shown in Figs. 1 and 2, Figs. 1 and 2) positioned opposite of a proximal end (upper portion of 2 and 5 as shown in Figs. 1 and 2, Figs. 1 and 2) and a thread (8) terminating at the distal end of the bone screw (Figs. 1 and 2), the thread including a crest (Figs. 1 and 2) and a channel (7, 6, Figs. 1 and 2, translation top of page 4) that extends partially along a length of the crest (Figs. 1 and 2, translation top of page 4) and through the distal end (Figs. 1 and 2) such that the crest is split by the channel (Figs. 1 and 2); wherein the channel extends through the shaft and into the hollow center of the shaft at the distal end (Figs. 1, 2, and 4, translation middle of page 3, translation top of page 4).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify each thread and crest as disclosed by Boucher by adding a channel as taught by Bono in order to increase average thread depth while maintaining thread pitch to achieve a desirable pullout value in bone to provide greater pullout values than an ordinary double thread (Bono col. 3 lines 46-60). One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the distal end along each of the first and second channel as disclosed by the combination of Boucher and Bono to add a channel depth at a portion that extends through the sidewall and into the aperture at and adjacent to the distal end surface as taught by Landanger in order to provide a known self-tapping capacity (Landanger translation bottom of page 3; Bono col. 4 lines 11-15) configured in relation to a channel (Landanger translation top of page 4; Bono Fig. 3) while being slidable over a guide wire (Landanger Fig. 4, translation middle of page 3).
As a result, as to claim 20, the combination of Boucher, Bono, and Landanger discloses a first thread (Boucher 150; Bono 19) terminating at a distal end of the bone screw (Boucher Figs. 3 and 4), the first thread including a first crest (Boucher peak of 150, Fig. 3) and a first channel (Bono 37, Fig. 4, col. 3 lines 39-45) that extends partially along a length of the first crest (Bono Fig. 4, col. 3 lines 43-45) and through the distal end (Boucher Figs. 3 and 4, col. 5 lines 36-41; Bono Fig. 4) such that the first crest is split by the first channel (Bono Fig. 4, col. 3 lines 43-45); further comprising a second thread (Boucher 160; Bono 19) including a second channel (Bono 37) that extends partially along a length of the second crest (Bono Fig. 4, col. 3 lines 43-45) and through the distal surface of the terminal end (Boucher Figs. 3 and 4, col. 5 lines 36-41; Bono Fig. 4) such that the second crest is split by the second channel (Bono Fig. 4, col. 3 lines 43-45).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boucher and Bono in view of Brannon (US 2011/0098756).
As to claim 11, the combination of Boucher and Bono discloses the invention of claim 1 as well as the first crest includes at least one side of the first channel (22a Figs. 3 and 4).
The combination of Boucher and Bono is silent to the first crest includes a groove.
Brannon teaches a similar bone screw (10, Figs. 1-5) comprising: a shaft portion (12) having a terminal end (lower portion as shown in Fig. 1, Fig. 1) and a first thread (18) terminating at the terminal end (Figs. 1 and 3), the first thread having a first crest (peaks of 18 as shown in Figs. 1, 4, and 5, Figs. 1, 4, and 5); wherein the first crest includes a groove (40, Figs. 1 and 5) on at least one side (Figs. 1 and 5).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the thread as disclosed by the combination of Boucher and Bono by adding a groove as taught by Brannon in order to improve intermediate connectivity with orthopedic materials or surfaces, tendons or separated tissue by placing the groove against the orthopedic material, tendons or soft tissue portions and bonding them together utilizing tissue interdigitation (Brannon ¶s 17 and 18) and angularly secure to surrounding material (Brannon ¶19) via an inlet for the receipt and transmission of orthopedic materials into the receiving surface or surrounding material along the screw to enhance the fixation of the screw (Brannon ¶20).
As a result, as to claim 11, the combination of Bono and Brannon discloses that the first crest includes a groove (Brannon 40, Figs. 1 and 5) on at least one side of the first channel (Brannon Figs. 3 and 4).
Claim(s) 13, 15, 17, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boucher in view of Willert.
As to claims 13, 15, 17, and 19, Boucher discloses a bone screw (101, Figs. 3 and 4) comprising: a head portion (left portion including 142 as shown in Fig. 3, Fig. 3); a shaft portion (110) threaded with a first thread (150) having a first root (root/trough of Boucher 150, Fig. 3) and a second thread (160) having a second root (root/trough of Boucher 160, Fig. 3); and a tip portion (right portion as shown in Fig. 3, Figs. 3 and 4) defining a distal surface (162, 152) facing away from the head portion (Figs. 3 and 4), the first and the second threads terminating at the distal surface (Figs. 3 and 4, col. 5 lines 36-37), wherein the first root extends partially along a helix of the first thread and through the distal surface (Figs. 3 and 4) and the second root extends partially along a helix of the second thread and through the distal surface (Figs. 3 and 4). As to claim 15, Boucher discloses that the tip portion includes an aperture (140) defined by the distal surface (Fig. 4). As to claim 17, Boucher discloses that the distal surface is located on a sidewall surrounding the aperture (as defined, Fig. 4). As to claim 19, Boucher discloses that the tip portion is tapered (Figs. 3 and 4, col. 2 lines 5-6).
Boucher is silent to the first root has a first root notch that extends partially along the helix of the first root such that the first root is divided along the first root notch, and the second root has a second root notch that extends partially along the helix of the second root such that the second root is divided along the second root notch.
Willert teaches a similar bone screw (1200, Fig. 12A, ¶69) comprising: a shaft portion (Fig. 12a) with a thread (604, Fig. 12a, ¶64) having a root (Fig. 12A), wherein the root has a root notch (1202, Fig. 12A, ¶69) that extends at least partially along a helix of the root such that the root is divided along the root notch (Fig. 12A, ¶69); wherein the thread has a crest (610 as labeled on Fig. 6, Fig. 12a, ¶64) and a helix of the crest (Fig. 12A).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the each of the first and second root as disclosed by Boucher by adding a root notch as taught by Willert in order to increase the surface area of the root between the crests (Willert ¶69 and abstract) to increase in anchoring the bone screw within the bone once inserted therein, and thereby reduce the possibility for the screw backing out after insertion (Willert abstract).
As a result, as to claim 13, the combination of Boucher and Willert discloses that a first root (Boucher root of 150, Fig. 3) has a first root notch (Willert 1202, Fig. 12A, ¶69) that extends partially along a helix of the first root (Boucher Fig. 3; Willert Fig. 12A) and through the distal surface (Boucher Figs. 3 and 4, col. 5 lines 36-41; Willert Fig. 12A) such that the first root is divided along the first root notch (Boucher Figs. 3 and 4; Willert Fig. 12A), and a second root (Boucher root of 160, Fig. 3) has a second root notch (Willert 1202, Fig. 12A, ¶69) that extends partially along a helix of the second root (Boucher Fig. 3; Willert Fig. 12A) such that the second root is divided along the second root notch (Boucher Fig. 3; Willert Fig. 12A).
Claim(s) 14 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boucher and Willert in view of Bono.
As to claim 14, the combination of Boucher and Willert discloses the invention of claim 13 as well as a first crest of the first thread (peak of 150, Fig. 3) extends as a helix of the first crest from a terminal end of the bone screw (as 152, Fig. 4, col. 5 lines 36-41), and a second crest of the second thread (peak of 160, Fig. 3) extends as a helix of the second crest from the terminal end (as 162, Fig. 4, col. 5 lines 36-41).
The combination of Boucher and Willert is silent to the first crest of the first thread has a first channel that extends partially along the helix of the first crest such that the first crest is divided along the first channel, and the second crest of the second thread has a second channel that extends partially along the helix of the second crest such that the second crest is divided along the second channel.
Bono teaches a similar bone screw (10, Figs. 1-4) comprising: a head portion (12, 28); a shaft portion (18) threaded with a thread (19) having a root (33); and a tip portion (right portion as shown in Fig. 4 including at least one revolution of thread 19, Fig. 4) defining a terminal end (right portion as shown in Fig. 4 including at least one revolution of thread 19, Fig. 4), the first and the second threads terminating at the terminal end (as defined, Figs. 3 and 4), wherein the root extends as a helix (Figs. 3 and 4), wherein the thread is a dual-lead thread (Bono abstract, col. 3 lines 6-7, col. 4 lines 19-20), wherein a crest of the thread (22a and 24a, 22b and 24b, 22c and 24c, 22d and 24d, 22e and 24e, 22f and 24f, i.e. see illustration of the enlarged portion of Fig. 4, Fig. 4, col. 3 lines 18-27) has a channel (37, Fig. 4, col. 3 lines 39-45) that extends partially along a helix of the first crest from a terminal end of the bone screw such that the crest is divided along the channel the crest (Fig. 4, col. 3 lines 43-45).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify each thread and crest as disclosed by Boucher and Willert by adding a channel as taught by Bono in order to increase average thread depth while maintaining thread pitch to achieve a desirable pullout value in bone to provide greater pullout values than an ordinary double thread (Bono col. 3 lines 46-60).
As a result, as to claim 14, the combination of Boucher, Willert, and Bono discloses a first crest of the first thread (Boucher peak of 150, Figs. 3 and 4) has a first channel (Bono 37, Fig. 4, col. 3 lines 39-45) that extends partially along a helix of the first crest (Bono Fig. 4, col. 3 lines 43-45) from a terminal end of the bone screw (Boucher Figs. 3 and 4, col. 5 lines 36-41; Bono Fig. 4) such that the first crest is divided along the first channel (Bono Fig. 4, col. 3 lines 43-45), and a second crest of the second thread (Boucher peak of 160, Figs. 3 and 4) has a second channel (Bono 37, Fig. 4, col. 3 lines 39-45) that extends partially along a helix of the second crest (Bono Fig. 4, col. 3 lines 43-45) from the terminal end (Boucher Figs. 3 and 4, col. 5 lines 36-41; Bono Fig. 4) such that the second crest is divided along the second channel of the second crest (Bono Fig. 4, col. 3 lines 43-45).
As to claim 16, the combination of Boucher, Willert, and Bono discloses the invention of claim 14 but is silent to the first channel extends further along a longitudinal axis of the bone screw than the first root notch.
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 the first channel and the first root notch of the combination of Boucher, Bono, and Willert are configured such that the first channel extends further along the longitudinal axis of the bone screw than the first root notch, since Applicant has not disclosed that such solve any stated problem or is anything more than one of numerous shapes or configurations a person ordinary skill in the art would find obvious for the purpose of providing an appropriate thread depth and root surface area from a finite number of solutions, i.e. first channel ≥ first root notch or first channel ≤ first root notch, in order to achieve a desirable pullout value in bone to provide greater pullout values than an ordinary double thread (Bono col. 3 lines 46-60) and to increase anchoring of the bone screw within the bone to reduce the possibility for the screw backing out after insertion (Willert abstract).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boucher, Willert, and Bono in view of Landanger.
As to claim 18, the combination of Boucher, Willert, and Bono discloses the invention of claim 14 as well as a segment of the first and second channels of the first and second crests, respectively, extend into the respective first and second thread to a depth (Boucher Figs. 3 and 4; Bono Fig. 4), the tip portion including an aperture (140) defined by the distal surface (Fig. 4) as well as a sidewall surrounding the aperture (as defined, Fig. 4) as well as the screw (Boucher 154, 164) for cutting aggressively into bone tissue (Boucher col. 5 lines 54-59).
The combination of Boucher, Willert, and Bono is silent to the segment of the first and second cuts extending through the sidewall and into the aperture.
Landanger teaches a similar bone screw (1) comprising: a head portion (4); a shaft portion (2, 5) threaded with a thread (8) having a root (Figs. 1 and 2); and a tip portion (lower portion of 2 and 5 as shown in Figs. 1 and 2, Figs. 1 and 2) defining a terminal end (lower portion of 2 and 5 as shown in Figs. 1 and 2, Figs. 1 and 2), the thread terminating at the terminal end (Figs. 1 and 2), wherein a crest (Figs. 1 and 2) of the thread has a channel (7, 6, Figs. 1 and 2, translation top of page 4) that extends partially along a helix (Figs. 1 and 2, translation top of page 4) such that the crest is divided along the channel (Figs. 1 and 2); wherein the tip portion includes an aperture (Figs. 3 and 4, translation middle of page 3) defined by a distal surface (Figs. 3 and 4, translation middle of page 3) and having a sidewall at the terminal end (Fig. 4) for sliding over a guide wire (100, Fig. 4, translation middle of page 3); wherein a segment of the channel of the crest extends through the sidewall and into the aperture at and adjacent to the distal surface (Figs. 1, 2, and 4, translation middle of page 3, translation top of page 4).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the distal surface of each of the first and second channel as disclosed by the combination of Boucher, Willert, and Bono to add a channel depth at a portion that extends through the sidewall and into the aperture at and adjacent to the distal surface as taught by Landanger in order to provide a known self-tapping capacity (Landanger translation bottom of page 3; Bono col. 4 lines 11-15) configured in relation to a cut (Landanger translation top of page 4; Bono Fig. 3) while being slidable over a guide wire (Landanger Fig. 4, translation middle of page 3).
Conclusion
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/AMY R SIPP/Primary Examiner, Art Unit 3775
