DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-7, 9-11, 13, 28, 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tempco et al. (U.S. Pub. No. 2019/0343567 A1, hereinafter “Tempco”) in view of Moseley et al. (U.S. Patent 12,035,953 B1, hereinafter “Moseley”).
Tempco discloses, regarding claim 1, a threaded bone implant (12, see Figs. 1-3) comprising: an elongate body (18) comprising a first portion (see annotated Fig. 1 below), a second portion distal to the first portion (see annotated Fig. 1 below), and a third portion distal to the second portion (see annotated Fig. 1 below), wherein the third portion is longer than the first portion (see annotated Fig. 1 below) and includes a fenestration region (see annotated Fig. 1 below) with a plurality of fenestrations (66) therethrough (see para. [0040]), wherein a volume of the plurality of fenestrations decreases proximally from a distal end of the third portion (see annotated Fig. 3 below, note that since the thickness of the wall with the fenestrations decreases proximally from a distal end of the third portion, the volume of the plurality of fenestrations decreases proximally from a distal end of the third portion).
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Regarding claim 2, wherein the second portion is immediately distal to the first portion (see annotated Fig. 1 above), and wherein the third portion is immediately distal to the second portion (see annotated Fig. 1 above).
Regarding claim 3, wherein the first and second portions each have greater strength than the third portion (see annotated Fig. 1 above, note that the first and second portions are free from fenestrations and are therefore being considered to have a greater strength than the third portion).
Regarding claim 5, wherein the plurality of fenestrations have gyroid configurations (see para. [0041] “cylindrical, round, oval, oblong, … polygonal having … arcuate side portions”).
Regarding claim 6, wherein the fenestration region has a width at a distal end of the fenestration region that is greater than a width at a proximal and of the fenestration region, and wherein the width tapers in a distal to proximal direction (see annotated Fig. 3 above, note the thickness / width of the wall with the fenestrations decreases proximally from a distal end of the third portion).
Regarding claim 7, wherein the first and second portions are solid and do not have any fenestrations (see annotated Fig. 1 above, note that the first and the second portions are free of fenestrations and therefore being considered solid).
Regarding claim 9, wherein the fenestration region transitions to a support rib in the second portion (see annotated Fig. 3 above).
Regarding claim 10, wherein the fenestration region has a helical configuration (see Figs. 1-4, note fenestration region disposed around helical threads).
Regarding claim 11, wherein the first, the second, and the third portion each include at least one thread (46, 28, see also annotated Fig. 1 above).
Regarding claim 13, wherein all threads have a general “V” shape (see Fig. 2, note threads have general “V” shape).
Regarding claim 30, further comprising a thread (28) with a thread height (e.g. thread height of 28) that is uniform or constant along an entire length of the thread (see Fig. 1, note thread height of 28 is constant along entire length of 14).
Tempco discloses in one embodiment that the threaded bone implant may have a passageway through all or a portion of the elongate body (see para. [0053]) and a plurality of lateral fenestrations in communication with the passageway (see para. [0053]) and that the distal tip may be self-drilling (see para. [0045]), and shows in Figure 1, that the first and second portions do not have fenestrations (see annotated Fig. 1 above). However, Tempco fails to explicitly disclose regarding claim 1, in the embodiment shown in Figures 1-3, an inner cannula in communication with a plurality of fenestrations therethrough; and regarding claim 7, wherein the first and second portions do not have any fenestrations that communicate with the inner cannula; and regarding claim 28, wherein a distal tip region includes a plurality of cutting surface.
Moseley discloses a threaded bone implant (see Fig. 2B), with a fenestrated region (128 of 110c) and solid regions (110a and 110b), wherein the threaded bone implant includes an inner cannula (118), wherein the inner cannula is in communication with the fenestrated region (via 130), and wherein the solid portions are not in communication with the inner cannula (see Fig. 2B, note that there are no lateral channels between the external surfaces of 110a and 110b and the inner cannula 118), and wherein a distal tip (108) includes a plurality of cutting surface (122, see Fig. 2A) in order to enable bone graft to be packed into the cannula and be delivered to the fenestrated region to better promote bony ingrowth (see lines 27-41 of column 7) and in order to provide flutes that aid in self-drilling and also self-harvest the drilled bone to further promote bone ingrowth of the implant (see lines 4-13 of column 7).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the elongate body in Tempco to include an inner cannula that is in communication with the fenestrated region / plurality of fenestrations in the third portion and does not communicate with the solid first and second portions in view of Moseley in order to enable bone graft to be packed into the cannula and be delivered to the fenestrated region to better promote bony ingrowth and to modify the distal tip region of Tempco to include a plurality of cutting surface in view of Moseley in order to provide flutes that aid in self-drilling and also self-harvest the drilled bone to further promote bone ingrowth of the implant.
Claim(s) 12, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tempco and in view of Moseley, as applied to claims 1 and 11 above.
Tempco and in view of Moseley discloses all of the features of the claimed invention, as previously set forth above, in the embodiment shown in Figures 1-3, except regarding claim 12, wherein a common or main thread extends from a distal end to a proximal end of a thread length of the elongate body; and regarding claim 20, wherein a thread extends from a proximal end to a distal end of a thread length, and wherein the thread has a constant thread height along its length.
Tempco discloses in an alternative embodiment shown in Figure 5, wherein a common or main thread (28) extends from a distal end to a proximal end of a thread length of the elongate body with a constant thread height (see para. [0032] “threads 28 are continuous along shaft 18”) in order to facilitate and/or enhance engagement with tissue (see para. [0032]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the elongate body in the embodiment shown in Figures 1-3 of Tempco and in view of Moseley to include a common or main thread extending from a distal end to a proximal end of a thread length of the elongate body in view of an alternative embodiment in Tempco in order to facilitate and/or enhance engagement with tissue.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tempco and in view of Moseley, as applied to claims 1, 4 and 7 above, and in further view of Sutikia (U.S. Pub. No. 2019/0262048 A1, hereinafter “Sutika”).
Tempco and in view of Moseley discloses all of the features of the claimed invention, as previously set forth above, Tempco further discloses, regarding claim 8, wherein the third portion includes a lattice structure (58) about an inner core (see para. [0053] “cannulated configuration and a plurality of lateral fenestrations in communication with the passageway”) having a helical configuration (see Fig. 1); however, fails to disclose, regarding claim 8, wherein the first and second portions include lattice structure about an inner core, and in a helical configuration.
Sutika discloses a bone anchor (60, see Fig. 17) with a lattice structure (62) in a helical configuration with threads (see Fig. 18, see para. [0056]) in order enable the bone screw to better inhibit or resist movement (see para. [0056]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the first and second portions of the bone anchor in Tempco and in view of Moseley to include a lattice structure in a helical configuration in further view of Sutika in order to enable the bone screw to better inhibit or resist movement.
Claim(s) 14-15, 21-27, 29 and 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tempco and in view of Moseley, as applied to claims 1 and 11 above, and in further view of Armstrong et al. (U.S. Pub. No. 2014/0012334 A1, hereinafter “Armstrong”).
Tempco and in view of Moseley discloses all of the features of the claimed invention, as previously set forth above, except regarding claim 14, wherein the third region includes a distal dual lead region and a single lead region proximal to the distal dual lead region; and regarding claim 15, wherein a second lead in the distal dual lead region gradually transitions in height to a minor diameter; regarding claim 21, wherein the first portion has a greater core diameter than the second portion, wherein there is a rapid transition in diameter wherein the second portion meets the first portion; regarding claim 22, wherein the rapid transition has a length from 1-5 mm in length between the smaller diameter in the second portion and the larger diameter in the first portion; and regarding claim 23, wherein the difference in diameter between the second portion and first portion is from .5 mm to 3 mm; regarding claim 24, wherein the third portion has a length from 10 mm - 40 mm; regarding claim 25, wherein the combined length of the first and second portions is from 10 mm to 25 mm; regarding claim 26, wherein the first portion has a length from 4 mm to 7 mm; regarding claim 27, wherein the third portion is longer than the first and second sections combined; regarding claim 29, wherein the second portion is sized to be placed within a pedicle, and the third portion is sized to be placed in a vertebral body; and regarding claim 31, further comprising a multi-lead thread along the length of at least first portion.
Armstrong discloses a bone screw (30, see Figs. 1-2), with first portion (36), a second portion (34), and a third portion (32), wherein the third portion includes a distal dual lead region (e.g. portion closer to tip, see para. [0025] “dual”) and a single lead region proximal (e.g. region near 34, see para. [0025] “single”) a second lead in the distal dual lead region gradually transitions in height to a minor diameter (see Figs. 1-2, see paras. [0025]-[0026]) in order to better configure the bone screw to engage the surrounding bone (see paras. [0025]-[0026]); wherein the first portion has a greater core diameter than the second portion (see Figs. 1-2, see paras. [0024] and [0026]), wherein there is a rapid transition in diameter wherein the second portion meets the first portion (see para. [0026]) in order to cut a lead into the bone that is greater than the previous portion to strengthen the connection as well as prevent against infection (see para. [0026]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the third portion in Tempco and in view of Moseley to include a distal dual / multi lead to a single proximal lead in further view of Armstrong in order to better configure the bone screw to engage the surrounding bone. And it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the first portion in Tempco and in view of Moseley to have a greater core diameter / rapid transition in further view of Armstrong in order to cut a lead into the bone that is greater than the previous portion to strengthen the connection as well as prevent against infection. With regard to claims 22 and 23, it would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the rapid transition in Tempco and in view of Moseley in further view of Armstrong to have a length from 1-5 mm and the difference in diameter from .5 mm to 3 mm, since Armstrong discloses varying the length, width, diameter and thickness (see para. [0019]) to best match the bone it is designed to be set into (see para. [0019]), and it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. With regard to claims 24-29, it would have been obvious to one having ordinary skill in the art a time the invention was made to construct the portions in Tempco and in view of Moseley and in further view of Armstrong to have third portion with a length from 10 mm - 40 mm; the combined length of the first and second portions to be from 10 mm to 25 mm; the first portion to have a length from 4 mm to 7 mm; for the third portion to be longer than the first and second sections combined; and the second portion to be sized to be placed within a pedicle, and the third portion to be sized to be placed in a vertebral body since Armstrong discloses varying the length, width, diameter and thickness (see para. [0019]) to best match the bone it is designed to be set into (see para. [0019]), and it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim(s) 16-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tempco and in view of Moseley, as applied to claims 1 and 11 above, and in further view of Taylor (US Pub No. 2008/0249579 A1, hereinafter “Taylor”).
Tempco and in view of Moseley discloses all of the features of the claimed invention, as previously set forth above, except regarding claim 16, wherein the first and second portions are dual lead sections with a first thread and a second thread; regarding claim 17, wherein the second thread starts at the transition between the second and third portion, and wherein the start of the second thread includes a plurality of cutting teeth and a height less than a height of the second thread in a region proximal to the cutting teeth; regarding claim 18, wherein the first lead has a greater thickness at a crest than the second lead, and wherein the first lead has a square crest shape; and regarding claim 19, wherein the first thread has a greater thread height than the second thread.
Taylor discloses a bone screw (50, see Fig. 1) with a first and second portions (l2) and a third portion (l1), wherein the first and second portions have dual lead sections with a first thread and a second thread (74, 76, see para. [0022]), wherein the second thread starts at the transition between the second and third portion (86, see Fig. 1), and wherein the start of the second thread includes a plurality of cutting teeth (58) and a height less than a height of the second thread in a region proximal to the cutting teeth (see Fig. 1); wherein the first lead has a greater thickness at a crest than the second lead (see para. [0026] “w1, w2”); wherein the first thread has a greater thread height than the second thread (see para. [0022] variable thread pitch / tapering outer thread diameter) in order to provide increase fixation strength and stability (see para. [0022]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the first and second portions in Tempco and in view of Moseley to include dual lead sections with first and second threads in further view of Taylor in order to in order to provide increase fixation strength and stability. With regard to claim 18, it would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the first lead to have a square crest shape crest in Tempco and in view of Moseley in further view of Taylor, since Taylor discloses various crest configurations / shapes are suitable (see para. [0023]), and, 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 purchase into the bone. In re Dailey and Eilers, 149 USPQ 47 (1966).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-3, 5-31 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The Applicant asserts that Tempco ‘565 fails to disclose, regarding amended claim 1, at least a third portion that is longer than the first portion and includes a fenestration region with a plurality of fenestrations therethrough in communication with an inner cannula, wherein a volume of the plurality of fenestrations decreases proximally from a distal end of the third portion.
As set forth above, new reference Tempco ‘567 discloses, regarding amended claim 1, a third portion that is longer than the first portion and includes a fenestration region with a plurality of fenestrations therethrough (see annotated Fig. 1 above, note that the third portion in Tempco ‘567 is longer than the third portion in Tempco ‘565), wherein a volume of the plurality of fenestrations decreases proximally from a distal end of the third portion (see annotated Fig. 3 above). In addition, Moseley is relied upon to better teach the plurality of fenestrations being in communication with an inner cannula which was taught in reference to one embodiment in para. [0047] of Tempco ‘565 and para. [0053] of Tempco ‘567).
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
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/M.C.G/ Examiner, Art Unit 3773 /EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773