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 .
Drawings
The drawings were received on February 15, 2026. These drawings have not been entered.
The drawings are objected to because it is difficult to see the structure due to the shading (note that the drawings submitted on February 15, 2026 are still shaded and are not line drawings). 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.
Specification
The amendment to the specification received on February 15, 2026 has been entered.
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.
Claims 1, 3-7, 10-12, 14, and 16-19 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 has been amended to change the alphabetic designation of the steps such that previously-presented step b is now step c and previously-presented step c is now step d. As such, now step e recites repeating step c. However, the specification does not provide support for repeating step c (providing a strap). Instead, the specification provides support for repeating step d (passing the front section of the strap). Accordingly, claim 1 contains new matter as do claims 3-7, 10-12, 14, and 16-19, which depend from claim 1.
Claim 4 is 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Due to the amendment to claim 1 reciting that the strap comprises a synthetic material, claim 4 contains new matter as the specification fails to provide support for a synthetic ligament or tendon. Instead, the specification indicates that the synthetic material may be a non-metallic cerclage (see pg. 6).
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.
Claims 1, 3-5, 7, 10-12, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Barker et al. (US 5,540,703 A) in view of Grob (US 2020/0170676 A1).
Claim 1. Barker discloses a method of stabilizing the spine of a patient in need thereof, comprising:
b. providing a first vertebra (vertebra C2) having a spinous process having a first fastening edge (defined by the hole through the spinous process; see col. 12, ll. 44-55) and a second vertebra (unlabeled vertebra below vertebra C2) having a spinous process having a second fastening edge (defined by the lower surface of the spinous process), wherein the first fastening edge and the second fastening edge are arranged opposite each other and facing away from each other (see Figs. 38 and 39);
c. providing a strap (cable 70) comprising synthetic material (see col. 2, ll. 19-25) and extending in a longitudinal direction from a front section (end of cable 70 adjacent needle 81; see col. 12, ll. 44-55 and Fig. 37) to a rear section (opposite end of cable 70);
d. passing the front section of the strap around the first fastening edge (see Fig. 37), then from the first fastening edge to the second fastening edge and then around the second fastening edge (see Fig. 38);
e. optionally passing the front section of the strap from the second fastening edge to the first fastening edge and repeating step c;
f. tensioning the strap (see col. 12, ll. 11-25) such that the first vertebra and the second vertebra are fixated relative to each other (see col. 12, ll. 44-55);
g. fastening the front section to the rear section while the strap is being tensioned (see col. 12, ll. 11-25) (Figs. 23-32 and 37-39; col. 11, l. 49 through col. 12, l. 25 and col. 12, ll. 44-55).
Claim 3. Barker discloses wherein the step of fastening the front section to the rear section includes at least one of knotting, suturing, sewing, stitching, knitting or felting the front section to the rear section (see col. 12, ll. 11-25) (Figs. 23-32 and 37-39; col. 11, l. 49 through col. 12, l. 25 and col. 12, ll. 44-55).
Claim 4. Barker discloses wherein the strap comprises a non-metallic cerclage (see col. 2, ll. 19-25), a ligament or a tendon (Figs. 23-32 and 37-39; col. 11, l. 49 through col. 12, l. 25 and col. 12, ll. 44-55).
Claim 5. Barker discloses wherein the strap comprises a front fastening fiber (cable 70 is a braid and thus has front fastening fibers adjacent needle 81) connected to a main body of the strap in or near the front section and a rear fastening fiber (cable 70 is a braid and thus has rear fastening fibers at end 73) connected to the main body of the strap in or near the rear section, wherein the rear fastening fiber forms a loop (eye 78) configured for receiving the front fastening fiber (see Figs. 30 and 38) (Figs. 23-32 and 37-39; col. 11, l. 49 through col. 12, l. 25 and col. 12, ll. 44-55).
Claim 7. Barker discloses wherein the step of tensioning the strap comprises creating a tension knot (see col. 12, ll. 11-25) between the front fastening fiber and the rear fastening fiber (see col. 12, ll. 11-25), tensioning at least the front fastening fiber (applying tension to cable 70 would also apply tension to front fastening fibers) and tightening the tension knot (see col. 12, ll. 11-25) (Figs. 23-32 and 37-39; col. 11, l. 49 through col. 12, l. 25 and col. 12, ll. 44-55).
Claim 10. Barker discloses wherein one of the two vertebra is a cranial vertebra (vertebra C2) and the other of the two vertebra is a caudal vertebra (unlabeled vertebra below vertebra C2), wherein the cranial vertebra has a hole drilled in its spinous process which hole serves as one of the first fastening edge and the second fastening edge (see col. 12, ll. 44-55) (Figs. 23-32 and 37-39; col. 11, l. 49 through col. 12, l. 25 and col. 12, ll. 44-55).
Claim 12. Barker discloses wherein after fastening the front section to the rear section, the strap exerts a tensile force on the first vertebra and on the second vertebra in a tensile force direction that is essentially in parallel to the direction of extension of the spine between the first vertebra and the second vertebra (due to the positioning of cable 70 as shown in Fig. 39, the tensile force applied by cable 70 would be essentially in a direction parallel to the direction of extension of the spine) (Figs. 23-32 and 37-39; col. 11, l. 49 through col. 12, l. 25 and col. 12, ll. 44-55).
Barker fails to disclose performing a preparatory surgical step comprising a laminotomy on at least one of the first vertebra and the second vertebra (claim 1), wherein during the step of tensioning the strap, a tension force from 50 N to 70 N is applied (claim 1), wherein the caudal vertebra has a hole drilled in its spinous process which hole serves as the other of the first fastening edge and the second fastening edge (claim 10), wherein the distance in the longitudinal direction between a front end of the front section and a front end of the rear section of the strap in a relaxed state ranges from 300% to 500% of the distance between the first fastening edge and the second fastening edge (claim 11), and wherein a distance in the longitudinal direction between a front end of the front section and a front end of the rear section of the strap in a relaxed state ranges from 350% to 450% of a distance between the first fastening edge and the second fastening edge (claim 19).
However, as stated above, Barker teaches a hole drilled in the spinous process of the cranial vertebra (see col. 12, ll. 44-55).
Grob teaches a method of stabilizing the spine of a patient comprising performing a preparatory surgical step comprising a laminotomy on at least one of a first vertebra and a second vertebra (see Fig. 2c; see also para. 0067), wherein the laminotomy treats spinal stenosis by enlarging the spinal canal (see para. 0004) (Fig. 2c; paras. 0004 and 0067).
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 method of Barker to include performing a preparatory surgical step comprising a laminotomy on at least one of the first vertebra and the second vertebra (claim 1), as suggested by Grob, as such can be used to treat spinal stenosis in patients afflicted by such a condition. 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 method of Barker such that the caudal vertebra has a hole drilled in its spinous process which hole serves as the other of the first fastening edge and the second fastening edge (claim 10) as opposed to the other of the first fastening edge and the second fastening edge being a lower surface of the spinous process, as such would be a more secure way to attach the strap to the spinous process in comparison to wrapping the strap around the spinous process, thereby reducing the possibility of the strap slipping loose. 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 method of Barker such that during the step of tensioning the strap, a tension force from 50 N to 70 N is applied (claim 1), the distance in the longitudinal direction between a front end of the front section and a front end of the rear section of the strap in a relaxed state ranges from 300% to 500% of the distance between the first fastening edge and the second fastening edge (claim 11), and a distance in the longitudinal direction between a front end of the front section and a front end of the rear section of the strap in a relaxed state ranges from 350% to 450% of a distance between the first fastening edge and the second fastening edge (claim 19), since 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 6 is rejected under 35 U.S.C. 103 as being unpatentable over Barker et al. (US 5,540,703 A) in view of Grob (US 2020/0170676 A1) as applied to claim 5 above, and further in view of Azuero et al. (US 2013/0079778 A1).
Barker and Grob fail to teach wherein the front fastening fiber and/or the rear fastening fiber are each connected to the main body of the strap by a stitch (claim 6).
Azuero teaches a strap (strap 64) having a front fastening fiber (at first braided end 68; braids are comprised of fibers) and a rear fastening fiber (at second braided end 70; braids are comprised of fibers), wherein the front and rear fastening fibers can be connected to the strap by a stitch (see para. 0038, which states that first and second braided ends 68 and 70 can be sewn to the strap) (Figs. 6A-6E; para. 0038).
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 method of Barker such that the front fastening fiber and/or the rear fastening fiber are each connected to the main body of the strap by a stitch (claim 6), as suggested by Azuero, as such is a well-known way to secure braided fibers to a strap.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Barker et al. (US 5,540,703 A) in view of Grob (US 2020/0170676 A1) as applied to claim 1 above, and further in view of Bonutti (US 2006/0089646 A1).
Barker and Grob fail to teach wherein after fastening the front section to the rear section, the strap exerts a tensile force on the first vertebra and on the second vertebra in a tensile force direction that includes a vector component in the dorsal direction (claim 14).
Bonutti teaches that a strap (suture 100) is secured to adjacent spinous processes (spinous processes 164) and also to the bone adjacent the facet joint between the adjacent spinous processes (see Fig. 9) and that such a configuration can provide additional stability to the spine (see para. 0129; note that para. 0129 refers to Fig. 10, which labels facet joint 76, and that suture 100 is clearly secured adjacent the facet joint in Fig. 9) (Figs. 9-10; para. 0129).
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 method of Barker such that the strap is also secured adjacent the facet joint between the spinous processes, as suggested by Bonutti, in order to provide additional stability to the spine. In view of such a modification, after fastening the front section to the rear section, the strap would exert a tensile force on the first vertebra and on the second vertebra in a tensile force direction that includes a vector component in the dorsal direction (claim 14) due to the positioning of the strap adjacent the facet joint.
Claims 1 and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Bevan et al. (US 5,725,582 A) in view of Grob (US 2020/0170676 A1).
Claim 1. Bevan discloses a method of stabilizing the spine of a patient in need thereof, comprising:
b. providing a first vertebra (upper vertebra 24) having a first fastening edge (defined by the upper surface of spinous process 23) and a second vertebra (lower vertebra 24) having a second fastening edge (defined by the lower surface of spinous process 23), wherein the first fastening edge and the second fastening edge are arranged opposite each other and facing away from each other (see Figs. 1-2);
c. providing a strap (implant 20) comprising a synthetic material (see abstract) and extending in a longitudinal direction from a front section (one of tails 25) to a rear section (the other of tails 25);
d. passing the front section of the strap around the first fastening edge (see Figs. 1-2), then from the first fastening edge to the second fastening edge and then around the second fastening edge (see Figs. 1-2);
e. optionally passing the front section of the strap from the second fastening edge to the first fastening edge and repeating step c (see Fig. 2, which shows that implant 20 is wrapped around spinous processes 23 twice);
f. tensioning the strap (see col. 5, ll. 38-47) such that the first vertebra and the second vertebra are fixated relative to each other (see col. 5, ll. 38-47);
g. fastening the front section to the rear section while the strap is being tensioned (see col. 5, ll. 38-47) (Figs. 1-2; col. 5, ll. 38-47).
Claim 16. Bevan discloses wherein the step of fastening the front section to the rear section includes overlapping the front section with the rear section (see Fig. 2) such that the front section and the overlapped rear section extend in opposite directions (see Fig. 2), and connecting the front section with the overlapped rear section (via element 26; see Fig. 2) (Figs. 1-2; col. 5, ll. 38-47).
Claim 18. Bevan discloses wherein at a position of the strap in which the front section has been fastened to the rear section (at element 26), the area occupied by the strap in a cross section orthogonal to the direction of extension of the spine (from top to bottom of the page as shown in Fig. 2) between the first vertebra and the second vertebra is less than 300% of the cross sectional area occupied by the strap at a position adjacent to the position in which the front section has been fastened to the rear section (immediately to the right of element 26 adjacent reference character 27) (see Fig. 2) (Figs. 1-2; col. 5, ll. 38-47).
Bevan fails to disclose performing a preparatory surgical step comprising a laminotomy on at least one of the first vertebra and the second vertebra (claim 1), wherein during the step of tensioning the strap, a tension force from 50 N to 70 N is applied (claim 1), and wherein at a position of the strap in which the front section has been fastened to the rear section, the strap has a maximum width of up to 10 mm in at least one of the following directions: dorsal direction or lateral direction (claim 17).
Grob teaches a method of stabilizing the spine of a patient comprising performing a preparatory surgical step comprising a laminotomy on at least one of a first vertebra and a second vertebra (see Fig. 2c; see also para. 0067), wherein the laminotomy treats spinal stenosis by enlarging the spinal canal (see para. 0004) (Fig. 2c; paras. 0004 and 0067).
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 method of Bevan to include performing a preparatory surgical step comprising a laminotomy on at least one of the first vertebra and the second vertebra (claim 1), as suggested by Grob, as such can be used to treat spinal stenosis in patients afflicted by such a condition. 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 method of Bevan such that during the step of tensioning the strap, a tension force from 50 N to 70 N is applied (claim 1) and at a position of the strap in which the front section has been fastened to the rear section, the thread has a maximum width of up to 10 mm in at least one of the following directions: dorsal direction or lateral direction (claim 17), since 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.
Response to Arguments
Applicant's arguments filed February 15, 2026 have been fully considered but they are not persuasive. Applicant’s arguments regarding the criticality of the tension force of 50 N to 70 N (see pgs. 9-11) are not persuasive. The disclosure as originally filed fails to provide support for such an alleged criticality. The last paragraph on pg. 8 of the specification (see also para. 0034 of the application publication) merely states “The tensioning and fastening may be performed in different ways and using different forces. In some variants, during the step of tensioning the strap, a tension force from 40 N to 90 N, preferably from 50 N to 70 N, is applied.” Applicant’s remarks regarding the advantages of a tension force of 50 N to 70 N (see pgs. 9-11) cannot take the place of evidence. Such statements are not evidence and must be supported by an appropriate affidavit or declaration (see MPEP 716.01(c)(II)). Thus, if a tension force of 50 N to 70 N is in fact critical as alleged by Applicant’s arguments, Applicant is required to provide an affidavit or declaration in support.
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.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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
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