Detailed Action
This is the final office action for US application number 18/882,062. Claims are evaluated as filed on March 16, 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 .
Response to Arguments
Applicant's arguments filed March 16, 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 that the first cut extends partially along a helix of the first crest and through a distal surface (Remarks p. 7), Examiner notes that, as detailed in the rejection below, Boucher discloses a first thread (150) that forms a distal surface of the bone screw (Fig. 4, col. 5 lines 36-39), Bono teaches adding cut (37) to the thread (19, Fig. 4) to increase average thread dept 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). Thus, as a result, the combination of Boucher and Bono reads on the argued limitation.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
As to claim 4, the specification appears to lack proper antecedent basis for “the distal surface defines a plane that is perpendicular to a longitudinal axis of the bone screw”. That is, the specification is silent as to features of the distal surface and the drawings provide no clearly discernable indicator that such is plane is perpendicular to such an axis. Thus, the specification fails to provide proper antecedent basis for “the distal surface defines a plane that is perpendicular to a longitudinal axis of the bone screw”. Examiner suggests amending as “the distal surface defines a plane that is substantially perpendicular to a longitudinal axis of the bone screw”.
As to claim 16, the specification appears to lack proper antecedent basis for “the first cut extends further along a longitudinal axis of the bone screw than the first root cut”. That is, the specification is silent to such a comparison and the drawings provide no clearly discernable view that would enable one to clearly conclude that the cut of the crest extends further longitudinally than the cut of the root. Thus, the specification fails to provide proper antecedent basis for “the first cut extends further along a longitudinal axis of the bone screw than the first root cut”. Examiner suggests identification of support in the original disclosure or cancelling claim 16.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “the first cut extends further along a longitudinal axis of the bone screw than the first root cut” of claim 16 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim(s) 9 is/are objected to because of the following informalities:
Claim 9 line 2 should read “the depth being beyond [[the]] a root of the first thread.”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 4-7, 12, and 16 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
As to claims 4-7 and 12, “the distal surface defines a plane that is perpendicular to a longitudinal axis of the bone screw” of claim 4 appears to be new matter. That is, the specification is silent as to features of the distal surface and the drawings provide no clearly discernable indicator that such is plane is perpendicular to such an axis. Thus, “the distal surface defines a plane that is perpendicular to a longitudinal axis of the bone screw” constitutes new matter. Examiner suggests amending as “the distal surface defines a plane that is substantially perpendicular to a longitudinal axis of the bone screw”.
As to claim 16, “the first cut extends further along a longitudinal axis of the bone screw than the first root cut” appears to be new matter. That is, the specification is silent to such a comparison and the drawings provide no clearly discernable view that would enable one to clearly conclude that the cut of the crest extends further longitudinally than the cut of the root. Thus, “the first cut extends further along a longitudinal axis of the bone screw than the first root cut” constitutes new matter. Examiner suggests identification of support in the original disclosure or cancelling claim 16.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 13-19 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim(s) 13 recites/recite the limitation "the terminal end" in line 7. There is insufficient antecedent basis for this limitation in the claim. Examiner is interpreting this as referring to, and suggests amending as, “the first and the second threads terminating at the distal surface
Claim(s) 18 recites/recite the limitation "the first and second cuts of the first and second crests" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Examiner is interpreting this as referring to, and suggests amending as, “bone screw of claim [[17]]14, wherein a segment of the first and second cuts of the first and second crests, respectively, extend through [[the]]a sidewall and into [[the]]an aperture defined by the distal surface”.
Claim(s) 14-16 and 19 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for its/their dependence on one or more rejected base claims.
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 and 12 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”).
The claimed phrase “cut” is being treated as a product by process limitation; that is the product reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113.
As to 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 including a first crest (peak of 150, Fig. 3), wherein the first thread extends through 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 extends through the distal surface of the terminal end (as 162, Fig. 4, col. 5 lines 36-41).
Boucher is silent to the first thread including a first cut, wherein the first cut 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 cut.
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 including a crest (22a, 24a, 22b, 24b, 22c, 24c, Fig. 4) and a cut (37), wherein the cut extends partially along a helix of the crest such that the crest is divided along the cut (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 by adding a cut 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 1, the combination of Boucher and Bono discloses a first thread (Boucher 150; Bono 19) including a first cut (Bono 37), wherein the first cut 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 cut (Bono Fig. 4, col. 3 lines 43-45); further comprising a second thread (Boucher 160; Bono 19) including a second cut (Bono 37), wherein the second cut 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 cut (Bono Fig. 4, col. 3 lines 43-45).
As to claim 12, the combination of Boucher and Bono discloses the invention of claim 1.
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) 2-4 and 6 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”).
The claimed phrase “cut” is being treated as a product by process limitation; that is the product reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113.
As to claims 2 and 3, 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), and wherein the first thread further defines a first root (root/trough of Boucher 150, Fig. 3) and a helix of the first root 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 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 cut (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 cut (Bono Fig. 4, col. 3 lines 43-45).
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), the thread including a crest (610 as labeled on Fig. 6, Fig. 12a, ¶64) and a helix of the crest (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 from the terminal end (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 cut 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 to claims 4 and 6, the combination of Boucher, Bono, and Willert discloses the invention of claim 3 as well as 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, Bono, and Willert discloses that at least one of the first or the second cuts does not extend through the cylindrical sidewall (Boucher Figs. 3 and 4; Bono Figs. 3 and 4).
The combination of Boucher, Bono, and Willert is silent to the plane that is substantially perpendicular being perpendicular to the longitudinal axis of the bone screw.
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/construct the plane that is substantially perpendicular to the longitudinal axis of the bone screw the combination of Boucher, Bono, and Willert to be perpendicular, 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 a sharp cutting edge that is capable of cutting aggressively into bone tissue (Boucher col. 5 lines 54-59).
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”).
The claimed phrase “cut” is being treated as a product by process limitation; that is the product reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113.
As to claim 5, the combination of Boucher, Bono, and Willert discloses the invention of claim 4 as well as each of the first and second cut 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 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 thread including a crest (Figs. 1 and 2) and a cut (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 cut (Figs. 1 and 2); wherein a portion of the cut 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 cut 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 cut as disclosed by the combination of Boucher, Bono, and Willert to add a cut 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 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).
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 cut 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 thread including a crest (Figs. 1 and 2) and a cut (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 cut (Figs. 1 and 2); wherein a portion of the cut 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 cut 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 cuts as disclosed by the combination of Boucher, Bono, and Willert to add a cut 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).
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”).
The claimed phrase “cut” is being treated as a product by process limitation; that is the product reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113.
As to 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 cut having a depth (Bono d2).
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 including a first crest (Figs. 1 and 2) and a first cut (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 cut (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 cut 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 cut as disclosed by the combination of Boucher and Bono to add a cut 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 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).
As to claim 10, the combination of Boucher, Bono, and Landanger discloses the invention of claim 8 and appears to show that the first cut 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 cut 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 cut 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 cut 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 including a first crest (Figs. 1 and 2) and a first cut (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 cut (Figs. 1 and 2); wherein a portion of the first cut 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 cut as disclosed by the combination of Boucher and Bono to add a cut 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 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).
As to claim 20, Boucher discloses a bone screw (101, Figs. 3 and 4) comprising: a cannulated shaft portion (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 cut, wherein the first cut extends partially along the length of the first crest such that the first crest is divided split by first cut, wherein the first cut 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) having 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, 24a, 22b, 24b, 22c, 24c, Fig. 4) and a cut (37) that extends partially along a length of the crest such that the crest is split by the cut (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 cut (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 cut (Figs. 1 and 2); wherein the cut 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 cut 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 cut as disclosed by the combination of Boucher and Bono to add a cut 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 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).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bono in view of Brannon (US 2011/0098756).
The claimed phrase “cut” is being treated as a product by process limitation; that is the product reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113.
As to 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 cut (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 including 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 cut (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 forms a helix of the first root from the terminal end and through the distal surface (Figs. 3 and 4) and the second root forms a helix of the second root from the terminal end 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 cut that extends partially along the helix of the first root such that the first root is divided along the first root cut, and the second root has a second root cut that extends partially along the helix of the second root such that the second root is divided along the second root cut.
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 cut (1202, Fig. 12A, ¶69) that extends at least partially along a helix of the root and through a distal surface such that the root is divided along the root cut (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 cut 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 cut (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 cut (Boucher Figs. 3 and 4; Willert Fig. 12A), and a second root (Boucher root of 160, Fig. 3) has a second root cut (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 cut (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.
The claimed phrase “cut” is being treated as a product by process limitation; that is the product reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113.
As to 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 cut that extends partially along the helix of the first crest such that the first crest is divided along the first cut, and the second crest of the second thread has a second cut that extends partially along the helix of the second crest such that the second crest is divided along the second cut.
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) where the first and the second threads terminate (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 (abstract), wherein a crest of the thread (22a, 24a, 22b, 24b, 22c, 24c, Fig. 4) has a cut (37) 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 cut of 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 cut 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 cut (Bono 37) 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 cut (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 cut (Bono 37) 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 cut 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 cut extends further along a longitudinal axis of the bone screw than the first root cut.
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 cut and the first root cut the combination of Boucher, Bono, and Willert are configured such that the first cut extends further along the longitudinal axis of the bone screw than the first root cut, 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 cut ≥ first root cut or first cut ≤ first root cut, 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.
The claimed phrase “cut” is being treated as a product by process limitation; that is the product reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113.
As to 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 cuts 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) where the thread terminates (Figs. 1 and 2), wherein a crest (Figs. 1 and 2) of the thread has a cut (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 cut (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 cut 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 cut as disclosed by the combination of Boucher, Willert, and Bono to add a cut 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY SIPP whose telephone number is (313)446-6553. The examiner can normally be reached on Monday through Thursday, 6:30am-4pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached on 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMY R SIPP/Primary Examiner, Art Unit 3775
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