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 .
Election/Restrictions
Applicant’s election without traverse of the species of Figs. 7A-7E in the reply filed on August 18, 2026 is acknowledged.
Information Disclosure Statement
The information disclosure statement filed July 8, 2025 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because NPL citation number four (“Reunion: Sacroiliac Joint Fusion System”) fails to include a publication date. Accordingly, that document has not been considered. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
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 projections on the outer surface of the sleeve (claim 18) 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.
The drawings are objected to because the features of the structure are difficult to see due to the shading of the figures (Figs. 1A-7E). 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 14 is objected to because of the following informalities: “the first threaded portion” should be “the threaded first portion” and “the second threaded portion” should be “the threaded second portion” to maintain consistency with claim 1. Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Lindner (US 2019/0133660 A1) in view of Miller et al. (US 2023/0165613 A1).
Claim 1. Lindner discloses a bone anchor system comprising:
a sleeve (screw 1) that includes: (a) a central sleeve channel (through-hole 17) that traverses the sleeve and extends from a proximal end of the sleeve to a distal end of the sleeve (see para. 0032), (b) a threaded first portion and a threaded second portion (portion shown in Fig. 2 with bone thread 18) on an outer surface of the sleeve, (d) a central sleeve axis (see axis shown in Fig. 2 extending along through-hole 17) that extends from the proximal end of the sleeve to the distal end of the sleeve, and (e) a plurality of threads (thread portions 28 and 29) on a wall of the central sleeve channel;
a rod (head element 2) that includes: (a) a central rod channel (through-hole 16) that traverses the rod and extends from a proximal end of the rod to a distal end of the rod (see Fig. 2), (b) a head (head 6) on the proximal end of the rod, the head including a circular cross-section (see para. 0031 and Fig. 2); (c) a central rod axis (see axis shown in Fig. 2 extending along through-hole 16) that extends from the proximal end of the rod to the distal end of the rod, and (e) a plurality of threads (thread portions 30 and 31) on an outer surface of the rod;
wherein: (a) the rod is proportioned to slide within the central sleeve channel, and (b) the plurality of threads on the outer surface of the rod are configured to screw into the plurality of threads on the wall of the central sleeve channel (see para. 0035) (Fig. 2; paras. 0028-0037).
Lindner fails to disclose (b) a threaded first portion on an outer surface of the sleeve and (c) a third portion on the outer surface of the sleeve and existing between the first and second portions (claim 1).
Miller teaches a bone anchor system comprising: a sleeve (screw 100) that includes (b) a threaded first portion (see Fig. 1A inset) distal to a threaded second portion (see Fig. 1A inset) on an outer surface of the sleeve and (c) a third portion (see Fig. 1A inset) on the outer surface of the sleeve located between the first and second portions, wherein the threaded first portion has a first thread pitch and the threaded second portion has a second thread pitch, wherein the first thread pitch is larger than the second thread pitch (see Fig. 1A), and wherein the third portion provides a threaded transition between the threaded first portion and the threaded second portion (see Fig. 1A) (Figs. 1A-1B; paras. 0025-0027).
[AltContent: textbox (Threaded
First Portion)][AltContent: textbox (Threaded
Second Portion)][AltContent: textbox (Third
Portion)]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Lindner such that the sleeve includes (b) a threaded first portion on an outer surface of the sleeve and (c) a third portion on the outer surface of the sleeve and existing between the first and second portions (claim 1), as suggested and configured by Miller, as such a configuration would enable the threaded second portion to be better secured to cortical bone and the first threaded portion to be better secured to cancellous bone.
Claims 2-6 are rejected under 35 U.S.C. 103 as being unpatentable over Lindner (US 2019/0133660 A1) in view of Miller et al. (US 2023/0165613 A1) as applied to claim 1 above, and further in view of Petric et al. (US 2021/0228361 A1).
Claim 4. Lindner discloses wherein:
the central sleeve channel includes first, second, and third inner diameters (the first inner diameter is taken at thread portion 28; the second inner diameter is taken at thread portion 29, and the third inner diameter is taken at widened portion 21);
the first inner diameter is distal to the second and third inner diameters and the second inner diameter is between the first and third inner diameters (see Fig. 2);
the second inner diameter is less than the third inner diameter (see Fig. 2) (Fig. 2; paras. 0028-0037).
Claim 5. Lindner discloses wherein the first inner diameter is less than the second inner diameter (see Fig. 2) (Fig. 2; paras. 0028-0037).
Claim 6. Lindner discloses, wherein a portion of the central sleeve channel tapers outwardly as it extends proximally (see Fig. 2, which shows a proximally-extending outward taper located below widened portion 19) (Fig. 2; paras. 0028-0037).
Lindner and Miller fail to disclose wherein the sleeve includes first and second apertures in a sidewall of the sleeve, an axis which is orthogonal to the central sleeve axis, traverses the first and second apertures but not the rod (claim 2), and wherein the sleeve includes first and second apertures in a sidewall of the sleeve, the first aperture includes a long axis parallel to the central sleeve axis, the first aperture includes a short axis orthogonal to the long axis of the first aperture, the first aperture includes a length measured along the long axis of the first aperture and a width measured along the short axis of the first aperture, the length of the first aperture is greater than the width of the first aperture (claim 3).
However, Miller teaches that the threaded first portion includes apertures (fenestrations 22) (Figs. 1A-1B; paras. 0025-0027).
Petric teaches a bone anchor system comprising: a sleeve (shank 302) that includes a central sleeve channel (cannulations 307 and 309) having a central sleeve axis (axis A-A), a threaded first portion (portion of shank 302 below cannulation 307 as shown in Fig. 3) on an outer surface of the sleeve, wherein the sleeve includes first and second apertures (see Fig. 3 inset) in a sidewall of the sleeve, an axis (axis extending into the page in Fig. 3) which is orthogonal to the central sleeve axis, traverses the first and second apertures, wherein the first and second apertures allow for the egress of bone cement and/or ingress of bone tissue (see para. 0162) (Fig. 3; para. 0162).
[AltContent: textbox (First Aperture (front side of fenestration 303))][AltContent: textbox (Second Aperture (back side of fenestration 303))]
Petric also teaches a bone anchor system comprising: a sleeve (shank 302) that includes a central sleeve channel (cannulations 307 and 309) having a central sleeve axis (axis A-A), a threaded first portion (portion of shank 302 below cannulation 307 as shown in Fig. 3) on an outer surface of the sleeve, wherein the sleeve includes first and second apertures (see Fig. 3 inset) in a sidewall of the sleeve, the first aperture includes a long axis (see Fig. 3) parallel to the central sleeve axis, the first aperture includes a short axis (see Fig. 3) orthogonal to the long axis of the first aperture, the first aperture includes a length measured along the long axis of the first aperture and a width measured along the short axis of the first aperture, the length of the first aperture is greater than the width of the first aperture (see Fig. 3), wherein the first and second apertures allow for the egress of bone cement and/or ingress of bone tissue (see para. 0162) (Fig. 3; para. 0162)
[AltContent: textbox (First Aperture)][AltContent: textbox (Second Aperture)]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the system of Lindner such that the sleeve includes first and second apertures in a sidewall of the sleeve, an axis which is orthogonal to the central sleeve axis, traverses the first and second apertures (claim 2), wherein the first and second apertures are located in the threaded first portion, as suggested by Miller and Petric, to allow for the egress of bone cement and/or ingress of bone tissue. In view of such a modification, the axis which is orthogonal to the central sleeve axis would not traverse the rod (claim 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the system of Lindner such that the sleeve includes first and second apertures in a sidewall of the sleeve, the first aperture includes a long axis parallel to the central sleeve axis, the first aperture includes a short axis orthogonal to the long axis of the first aperture, the first aperture includes a length measured along the long axis of the first aperture and a width measured along the short axis of the first aperture, the length of the first aperture is greater than the width of the first aperture (claim 3), wherein the first and second apertures are located in the threaded first portion, as suggested by Miller and Petric, to allow for the egress of bone cement and/or ingress of bone tissue.
Claims 7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Lindner (US 2019/0133660 A1) in view of Miller et al. (US 2023/0165613 A1) and Petric et al. (US 2021/0228361 A1) as applied to claim 6 above, and further in view of Zatta (US 2020/0138483 A1).
Claim 9. Lindner discloses a tulip (sleeve 3) configured to substantially surround the head of the rod (see Fig. 2) (Fig. 2; paras. 0028-0037).
Lindner, Miller, and Petric fail to teach wherein a portion of the rod tapers outwardly as it extends proximally, a transverse axis is orthogonal to the central sleeve axis and intersects both the portion of the central sleeve channel and the portion of the rod (claim 7).
Zatta teaches a bone anchor system comprising: a sleeve (body 200) that includes a central sleeve channel (bore 210), wherein a portion (see tapered portion near terminating end 214 as shown in Fig. 2) of the central sleeve channel tapers outwardly as it extends proximally (see Fig. 2); and a rod (insert 300), wherein the rod is received within the central sleeve channel, and wherein a portion (shaft portion 308) of the rod tapers outwardly as it extends proximally (see Fig. 5), a transverse axis is orthogonal to the central sleeve axis and intersects both the portion of the central sleeve channel and the portion of the rod (see Fig. 12, which shows that the tapered portion of the rod is nested within the tapered portion of the sleeve) (Figs. 2, 5, and 12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the system of Lindner such that a portion of the rod tapers outwardly as it extends proximally, a transverse axis is orthogonal to the central sleeve axis and intersects both the portion of the central sleeve channel and the portion of the rod (claim 7), as suggested by Zatta, in order to provide a more secure fit between the sleeve and the rod at the distal end of the rod.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Lindner (US 2019/0133660 A1) in view of Miller et al. (US 2023/0165613 A1), Petric et al. (US 2021/0228361 A1), and Zatta (US 2020/0138483 A1) as applied to claim 7 above, and further in view of Whipple (US 2008/0015596 A1).
Lindner, Miller, Petric, and Zatta fail to teach wherein the plurality of threads on the wall of the central sleeve channel are included entirely in a proximal third of the sleeve (claim 8).
However, Miller teaches that the proximal third (see Fig. 1A inset) of the sleeve is located within the threaded second portion (see Fig. 1A) (Figs. 1A-1B; paras. 0025-0027).
[AltContent: textbox (Threaded
First Portion)][AltContent: textbox (Threaded
Second Portion)][AltContent: textbox (Third
Portion)][AltContent: textbox (Proximal Third)][AltContent: textbox (Distal Third)]
Whipple teaches a bone anchor assembly comprising: a sleeve (member 14) including a central sleeve channel (recess 28) and a plurality of threads (threads 30) on a wall of the central sleeve channel; and a rod (shaft 40) received within the central sleeve channel, wherein the rod includes a plurality of threads (threads 50) that engage with the plurality of threads of the central sleeve channel (see Fig. 1), and wherein the plurality of threads on the wall of the central sleeve channel are included entirely in a proximal third (see Fig. 3B inset) of the sleeve (Figs. 1A-3B).
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[AltContent: textbox (Distal Third)][AltContent: connector][AltContent: connector][AltContent: arrow][AltContent: arrow][AltContent: arrow][AltContent: connector][AltContent: connector][AltContent: textbox (Proximal
Third)]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the system of Lindner such that the plurality of threads on the wall of the central sleeve channel are included entirely in a proximal third of the sleeve (claim 8), as suggested by Whipple, as such would be located in the threaded second portion, which is configured for engagement with cortical bone, and therefore any weakness created by the presence of the threads would be stabilized by the more compact cortical bone.
Claims 10-17 are rejected under 35 U.S.C. 103 as being unpatentable over Lindner (US 2019/0133660 A1) in view of Miller et al. (US 2023/0165613 A1), Petric et al. (US 2021/0228361 A1), and Zatta (US 2020/0138483 A1) as applied to claim 9 above, and further in view of Spratt et al. (US 2019/0365426 A1).
Claim 10. Lindner discloses wherein: the tulip includes a distal surface (see Fig. 2 inset) and a proximal surface (see Fig. 2 inset); the proximal surface provides an opening to a trough (chamber 7), the trough being configured to receive a fusion rod (see para. 0029); the distal surface includes an aperture (at seat 34) to encircle at least a portion of the rod; the proximal surface is coplanar with a first plane (see Fig. 2 inset) and the distal surface is coplanar with a second plane (see Fig. 2 inset) (Fig. 2; paras. 0028-0037).
[AltContent: connector][AltContent: connector]
Claim 11. Lindner in view of Miller teach wherein the third portion is threaded (see the rejection of claim 1 above).
Claim 12. Lindner discloses wherein the sleeve is a sacroiliac bone anchor (Fig. 2; paras. 0028-0037). Note that the sleeve of Lindner is capable of being implanted in the sacroiliac region and thus can be considered to be a sacroiliac bone anchor.
Claim 13. Lindner in view of Miller teach wherein the first portion includes a first thread pitch for a majority of the threads of the first portion, the second portion includes a second thread pitch for a majority of the threads of the second portion, the first thread pitch is unequal to the second thread pitch (see the rejection of claim 1 above).
Claim 14. Lindner in view of Miller teach wherein the first thread pitch is larger than the second thread pitch, the first threaded portion is distal to the second threaded portion (see the rejection of claim 1 above).
Claim 15. Lindner in view of Miller teach wherein the sleeve is a compression screw (see the rejection of claim 1 above) (note that due to the first thread pitch being larger than the second thread pitch, the sleeve can act as a compression screw).
Lindner, Miller, Petric, and Zatta fail to teach wherein the first and second planes are not parallel with each other (claim 10).
Spratt teaches a bone anchor system comprising: a rod-sleeve (anchor 12) including a head (head 18); and a tulip (receiver 14) configured to substantially surround the head of the rod-sleeve, wherein the tulip includes a distal surface (surface 34) and a proximal surface (surface 48), the proximal surface providing an opening to a trough (recess 30) configured to receive a fusion rod (rod 22), the distal surface including an aperture (at surface 35) to encircle at least a portion of the head of the rod-sleeve, wherein the proximal surface is coplanar with a first plane (plane Y) and the distal surface is coplanar with a second plane (plane X), and wherein the first and second planes are not parallel with each other (see Fig. 1E) to enable the rod-sleeve to have a greater range of motion (compare angles C and D) in one direction (see arrow A, which corresponds to angle C) than another direction (see arrow B, which corresponds to angle D) (see para. 0044) (Figs. 1A-1E).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the system of Lindner such that the first and second planes are not parallel with each other (claim 10), as suggested by Spratt, to enable the sleeve and rod to have a greater range of motion in one direction than another.
Regarding claim 16, which recites wherein the sleeve is a non-milled conduit, the rod is a milled conduit, and claim 17, which recites wherein the sleeve is a printed conduit, the Examiner notes that such claims are product-by-process claims. Patentable weight has only been given to the structure of the end product, not to the method of manufacture. The end product being considered the sleeve and rod as recited in claim 15. Manufacturing steps, such as non-milled, milled, and printed, are not given patentable weight in the claim. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Allowable Subject Matter
Claims 18-24 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIANNA N HARVEY whose telephone number is (571)270-3815. The examiner can normally be reached Mon.-Fri. 8:00am-5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached at (571)272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JULIANNA N HARVEY/Primary Examiner, Art Unit 3773
