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. 2-6 in the reply filed on September 11, 2025 is acknowledged.
Claim Objections
Claim 1 is objected to because of the following informalities: the words “is provided” (line 1) should be deleted. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: the words “is provided” (line 1) should be deleted. 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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Datta (US 2020/0360061 A1) in view of Blain et al. (US 2021/0251667 A1).
Claim 1. Datta discloses a method of treating a patient is provided, the method comprising:
forming a first lumen (lumen occupied by pedicle screw 42) in a pedicle on a first side of a pars fracture (pars fracture 32) (see Fig. 1);
positioning a first part (pedicle screw 42) of an implant (pars clamp 40 and pedicle screw 42, in combination) through the first lumen (see Fig. 1); and
securing the implant to a lamina (at laminar hook 44) on the second side of the pars fracture (see Fig. 1) (Figs. 1 and 2; paras. 0024-0031).
Claim 8. Datta discloses reducing a unilateral pars fracture (see Fig. 1) (Figs. 1 and 2; paras. 0024-0031).
Claim 9. Datta discloses applying compression to the pars fracture (see Fig. 1) (Figs. 1 and 2; paras. 0024-0031).
Claim 10. Datta discloses uniting fractured ends of the pars interarticularis (see Fig. 1) (Figs. 1 and 2; paras. 0024-0031).
Claim 14. Datta discloses a method of treating a patient is provided, the method comprising:
forming a first lumen (lumen occupied by pedicle screw 42) in a first pedicle on a first side of a first pars fracture (left pars fracture 32) (see Fig. 3);
positioning a first part (pedicle screw 42) of a first implant (pars clamp 40 and pedicle screw 42, in combination) through the first lumen (see Fig. 3);
securing the first implant to a lamina (at laminar hook 44) on the second side of the pars fracture (see Fig. 3);
forming a third lumen (lumen occupied by pedicle screw 42) in a second pedicle on a first side of a second pars fracture (right pars fracture 32) (see Fig. 3);
positioning a second part (pedicle screw 42) of a second implant (pars clamp 40 and pedicle screw 42, in combination) through the third lumen (see Fig. 3); and
securing the second implant to a lamina (at laminar hook 44) on the second side of the second pars fracture (see Fig. 1) (Figs. 2 and 3; paras. 0024-0031).
Claim 17. Datta discloses reducing a bilateral pars fracture (see Fig. 3) (Figs. 2 and 3; paras. 0024-0031).
Claim 18. Datta discloses applying compression to the first pars fracture and applying compression to the second pars fracture (see Fig. 3) (Figs. 2 and 3; paras. 0024-0031).
Claim 19. Datta discloses correcting a slip of a vertebra (see Fig. 3) (Figs. 2 and 3; paras. 0024-0031).
Claim 20. Datta discloses correcting a displaced fracture (see Fig. 3) (Figs. 2 and 3; paras. 0024-0031).
Datta fails to disclose forming a second lumen in the lamina (claim 1), positioning a bone tie through the first lumen and the second lumen, the bone tie comprising a distal end and a fastener section (claim 1), tightening the bone tie by passing the distal end of the bone tie through the fastener section of the bone tie (claim 1), wherein forming the first lumen comprises drilling a hole entirely through the pedicle (claim 2), wherein forming the first lumen comprises drilling a hole partially through the pedicle (claim 3), wherein forming the second lumen comprises drilling a hole entirely through the lamina (claim 4), wherein forming the second lumen comprises drilling a hole partially through the lamina (claim 5), wherein forming the second lumen comprises connecting the second lumen and the first lumen (claim 6), wherein positioning the bone tie comprises wrapping the bone tie around the outside portion of a vertebra (claim 7), removing the distal end of the bone tie (claim 11), removing the bone tie after the pars fracture heals (claim 12), wherein the bone tie comprises a bioabsorbable or bioresorbable material (claim 13), forming a second lumen in the first lamina (claim 14), positioning a first bone tie through the first lumen and the second lumen, the first bone tie comprising a distal end and a fastener section (claim 14), tightening the first bone tie by passing the distal end of the first bone tie through the fastener section of the first bone tie (claim 14), forming a fourth lumen in the second lamina (claim 14), positioning a second bone tie through the third lumen and the fourth lumen, the second bone tie comprising a distal end and a fastener section (claim 14), tightening the second bone tie by passing the distal end of the second bone tie through the fastener section of the second bone tie (claim 14), wherein forming the second lumen comprises connecting the second lumen and the first lumen (claim 15), and wherein forming the fourth lumen comprises connecting the fourth lumen and the third lumen (claim 16).
Blain teaches a method of treating a patient comprising: forming a first lumen in a pedicle (see Fig. 34, step 1; see para. 0199) and a second lumen in a lamina (see Fig. 34, step 2; see para. 0199); positioning a bone tie (bone tie 100) through the first lumen and the second lumen (see Fig. 34, step 3; see para. 0199), the bone tie comprising a distal end (distal end 104) and a fastener section (fastener section 106); tightening the bone tie by passing the distal end of the bone tie through the fastener section of the bone tie (see Fig. 34, steps 4 and 5; see para. 0088); wherein forming the first lumen comprises drilling a hole entirely through the pedicle (see para. 0200); wherein forming the first lumen comprises drilling a hole partially through the pedicle (see Fig. 36); wherein forming the second lumen comprises drilling a hole entirely through the lamina (see para. 0200); wherein forming the second lumen comprises drilling a hole partially through the lamina (see Fig. 36); wherein forming the second lumen comprises connecting the second lumen and the first lumen (see Fig. 36); wherein positioning the bone tie comprises wrapping the bone tie around the outside portion of a vertebra (see Figs. 35 and 37); removing the distal end of the bone tie (see para. 0209); removing the bone tie after healing (see para. 0215); wherein the bone tie comprises a bioabsorbable or bioresorbable material (see para. 0215); and wherein the method is additionally performed with respect to a second pedicle and a second lamina (see para. 0201) (Figs. 1-5 and 34-38; paras. 0069-0097 and 0199-0215). The configuration of the bone tie is such that it can be attached to additional spinal structures (see para. 0216) and can be cut to the appropriate size during the surgical procedure (see para. 0218), thereby allowing a single bone tie to be customized to the needs of a particular patient during the surgical procedure.
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 Datta by substituting the bone tie of Blain for the first and second implants of Datta and forming a second lumen in the lamina (claim 1), positioning a bone tie through the first lumen and the second lumen, the bone tie comprising a distal end and a fastener section (claim 1), tightening the bone tie by passing the distal end of the bone tie through the fastener section of the bone tie (claim 1), wherein forming the first lumen comprises drilling a hole entirely through the pedicle (claim 2), wherein forming the first lumen comprises drilling a hole partially through the pedicle (claim 3), wherein forming the second lumen comprises drilling a hole entirely through the lamina (claim 4), wherein forming the second lumen comprises drilling a hole partially through the lamina (claim 5), wherein forming the second lumen comprises connecting the second lumen and the first lumen (claim 6), wherein positioning the bone tie comprises wrapping the bone tie around the outside portion of a vertebra (claim 7), removing the distal end of the bone tie (claim 11), removing the bone tie after the pars fracture heals (claim 12), wherein the bone tie comprises a bioabsorbable or bioresorbable material (claim 13), forming a second lumen in the first lamina (claim 14), positioning a first bone tie through the first lumen and the second lumen, the first bone tie comprising a distal end and a fastener section (claim 14), tightening the first bone tie by passing the distal end of the first bone tie through the fastener section of the first bone tie (claim 14), forming a fourth lumen in the second lamina (claim 14), positioning a second bone tie through the third lumen and the fourth lumen, the second bone tie comprising a distal end and a fastener section (claim 14), tightening the second bone tie by passing the distal end of the second bone tie through the fastener section of the second bone tie (claim 14), wherein forming the second lumen comprises connecting the second lumen and the first lumen (claim 15), and wherein forming the fourth lumen comprises connecting the fourth lumen and the third lumen (claim 16), as suggested by Blain, as the use of a bone tie is advantageous in that the configuration of the bone tie is such that it can be attached to additional spinal structures and can be cut to the appropriate size during the surgical procedure, thereby allowing a single bone tie to be customized to the needs of a particular patient during the surgical procedure.
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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/JULIANNA N HARVEY/Primary Examiner, Art Unit 3773