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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11 December 2025 has been entered.
Response to Amendment
This Office Action is responsive to the amendment filed on 11 December 2025. As directed by the amendment: claims 1 and 4 have been amended and claims 2 and 3 are cancelled. Claims 1 and 4-9 currently stand pending in the application.
Response to Arguments
Applicant's arguments, filed 11 December 2025, as to the rejections under 35 U.S.C. 102(a)(2), have been fully considered but they are not persuasive. As to Akallal (US 11,534,183), Applicant contends that Akallal does not describe that the lateral surfaces of either of the jaws 14J extend from a morphology-adapted surface substantially parallel to a geometric axis parallel to an anteroposterior direction. Applicant contends that the surface of the left jaw 14J in FIG. 4 is in contact with the articular process 6 and thus would extend in a direction that forms an angle with the anteroposterior direction. Examiner respectfully submits that the coupling face at 24 is on the lamina, which is adjacent to the spinous process 3, where the lamina is generally understood to extend substantially perpendicularly to the anteroposterior direction extending through the spinous process since it extends off to the side of the spinous process to connect with the articular process 6. Although the view of FIG. 4 of Akallal does not show the curvature of the guide/coupling face (better shown in FIG. 3), there is a curvature to the guide/coupling face and the underlying bone (they are not flat in the plane of the page). Then, because the lateral surfaces of the jaws/positioning studs 14J extend down on either side of the bone in a direction substantially perpendicular to the coupling face to wrap around the sides of the bone, the lateral surfaces of the jaws/positioning studs 14J are substantially perpendicular to the lamina (which the coupling face is on, and since they are substantially perpendicular to the coupling face) and thus substantially parallel to a geometric axis parallel to an anteroposterior direction since the lamina is substantially perpendicular to the anteroposterior direction (perpendicular to perpendicular is parallel). Examiner also notes that these limitations are intended use, and based on the particular patient’s bone structure (e.g. the curvature of the processes and lamina), and the shape of the morphology adapted surface compatible with the particular patient’s bone structure, lateral surfaces of the jaws/positioning studs are fully capable of extending more or less parallel to an anteroposterior direction. Examiner also notes that an anteroposterior direction could be in relation to a position of the surgeon.
Applicant further contends that Akallal provides no disclosure that the lateral surface of the right jaw 14J extends from the morpho-adapted surface in a manner substantially parallel to a geometric axis parallel to the anteroposterior direction. Applicant contends that Akallal neither describes, nor shows in the figures, the surfaces of the jaw 14J actually in contact with the articular process 6. Examiner respectfully submits that the lateral surface of the right jaw 14J is the elongated surface along the edge of the guide that extends up and away from the morphology-adapted surface 24 in FIG. 3. Akallal discloses that the jaws 14J apply opposing contact to the process to prevent sliding along directions in which the jaws oppose one another (col. 10 / lines 41-43), i.e. the jaws extend substantially perpendicularly to the morphology-adapted surface, as also seen in FIGS. 3-4. Even if the jaw is curved along its length, it has a lateral surface that extends substantially perpendicularly away from the morphology-adapted surface in order to extend along/wrap around a side of the bone.
Claim Objections
Claims 1 and 4-9 are objected to because of the following informalities: language. Appropriate correction is required. The following amendments are suggested:
Claim 1 / line 4: “which is configured to guide a surgical instrument”
Claim 4 / line 3: “which is configured to be located in anteroposterior”
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 4-9 are rejected under 35 U.S.C. 102(a)(2) as anticipated by U.S. Patent No. US 11,534,183 to Akallal et al. (hereinafter, “Akallal”).
As to claim 1, Akallal discloses a patient-specific hemivertebral surgical guide, FIGS. 1-4, including a body which is provided with: an aiming passage (18), which links proximal and distal sides of the body to each other and which is suitable for guiding a surgical instrument (col. 10 / lines 44-47), and a coupling face, FIG. 3, which is arranged on the distal side of the body and which is patient-specific (col. 7 / lines 15-67; col. 8 / lines 26-30 and 42-48; col. 8 / line 58 – col. 9 / line 16; col. 9 / lines 34-37) and configured to be applied in bespoke contact with bone material of only one half, either left or right, of a vertebra of the patient, wherein the coupling face includes: a morphology-adapted surface (24), which is configured to be congruent with at least a part of a posterior face of a lamina of said one half of the vertebra (interpreted as language of intended use, and deemed anticipated by the prior art if said prior art is capable of said intended use; col. 9 / lines 19-20), FIG. 4, and which includes both a first peripheral portion (portion of surface 24 adjacent to/from which the first positioning stud 14J protrudes), which is configured to be located substantially in anteroposterior line with a lower edge of the lamina of said one half of the vertebra when the coupling face is applied to said one half of the vertebra (interpreted as language of intended use; since the studs 14J are in opposing contact to the articular process, one stud will be adjacent the lower edge of the lamina and thus the first peripheral portion adjacent to that stud will be located substantially in anteroposterior line with the lower edge of the lamina, as much as the instant application, or at least is capable of such positioning), and a second peripheral portion (portion of surface 24 adjacent to/from which the second positioning stud 14J protrudes), which is configured to be located substantially in anteroposterior line with a lateral edge of an isthmus of said one half of the vertebra when the coupling face is applied to said one half of the vertebra (interpreted as language of intended use; since the studs 14J are in opposing contact to the articular process, one stud will be adjacent the lateral edge of the isthmus and thus the second peripheral portion adjacent to that stud will be located substantially in anteroposterior line with the lateral edge of the isthmus, as much as the instant application, or at least is capable of such positioning), a first positioning stud (14J) protruding from the first peripheral portion of the morphology-adapted surface, and a second positioning stud (14J) protruding from the second peripheral portion of the morphology-adapted surface, FIG. 3, and wherein the morphology-adapted surface and the first and second positioning studs are shaped so as, when the coupling face is applied to said one half of the vertebra, to cooperate by matching shapes with the posterior face of the lamina, the lower edge of the lamina and the lateral edge of the isthmus of said one half of the vertebra, respectively, so as to maintain the body in a unique position on the vertebra (col. 9 / lines 34-37; col. 10 / lines 48-59); wherein the first positioning stud has a lateral surface (extending up and away from the morphology-adapted surface to the end of the first positioning stud), which extends from the first peripheral portion of the morphology-adapted surface and which is shaped so as to extend tangentially to at least a portion of the lower edge of the lamina of said one half of the vertebra when the coupling face is applied to said one half of the vertebra, FIGS. 3-4; wherein the second positioning stud has a lateral surface (extending up and away from the morphology-adapted surface to the end of the second positioning stud) which extends from the second peripheral portion of the morphology-adapted surface and which is shaped so as to extend tangentially to at least a part of the lateral edge of the isthmus of said one half of the vertebra when the coupling face is applied to said one half of the vertebra, FIGS. 3-4; and wherein the respective lateral surfaces of the first and second positioning studs extend from the morphology-adapted surface substantially parallel to a same geometric axis (substantially parallel to an axis substantially perpendicularly away from the morphology-adapted surface), the geometric axis extending in a substantially anteroposterior direction when the coupling face is applied to said one half of the vertebra (since the coupling face is on the lamina and the geometric axis is substantially perpendicular to the coupling face).
As to claim 4, Akallal discloses the surgical guide according to claim 1, wherein the morphology-adapted surface includes, apart from the first and second peripheral portions thereof, a main region (all other areas of the morphology-adapted surface) which is located in anteroposterior line with the posterior face of the lamina of said one half of the vertebra when the coupling face is applied to said one half of the vertebra (at least part of the main region is in anteroposterior line with the posterior face of the lamina, col. 8 / lines 26-30), FIGS. 3-4, the main region being substantially convex (see convex portions in FIG. 3; significantly convex at least in its convex portions), and wherein the respective lateral surfaces of the first and second positioning studs are both turned towards (since the surfaces face the morphology-adapted surface) and oriented transversely to the main region of the morphology-adapted surface, FIG. 3.
As to claim 5, Akallal discloses the surgical guide according to claim 1, wherein the aiming passage is arranged with respect to the coupling face so as to be aligned with a pedicle of said one half of the vertebra when the coupling face is applied to said one half of the vertebra (so as to implant a pedicle screw, col. 10 / lines 44-47).
As to claim 6, Akallal discloses the surgical guide according to claim 1, wherein the body is further provided with at least one cannula (26B) configured to receive a removable bone anchor (26), FIGS. 3-7B.
As to claim 7, Akallal discloses the surgical guide according to claim 6, wherein the at least one cannula extends longitudinally substantially parallel to the aiming passage (where substantially parallel includes deviation +/- 30%, and at least one of the cannulas is substantially parallel to the aiming passage since the cannulas and the aiming passage both pass through the coupling face).
As to claim 8, Akallal discloses the surgical guide according to claim 1, wherein the body includes: a proximal part (part immediately surrounding 18) which delimits the aiming passage, a distal part (edge part shown on the top in FIG. 3, which delimits at least part of the coupling face) which delimits the coupling face, and an intermediate part (part between the proximal and distal parts), which fixedly links the proximal and distal parts to each other, and which is tapered (taper shown in the area leading up to the top edge part in FIG. 3).
As to claim 9, Akallal discloses the surgical guide according to claim 1, wherein the body is made by additive manufacturing (col. 9 / lines 10-12).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRACY L KAMIKAWA whose telephone number is (571)270-7276. The examiner can normally be reached M-F 10:00-6:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong, can be reached at 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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/TRACY L KAMIKAWA/Examiner, Art Unit 3775