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 .
Response to Amendment
This Office Action is responsive to the amendment filed on 27 April 2026. As directed by the amendment: claims 1 and 4 have been amended, claims 2 and 3 are cancelled, and claims 10 and 11 are newly added. Claims 1 and 4-11 currently stand pending in the application.
The amendments to the claims are sufficient to overcome the claims objections presented in the previous Office Action, which are accordingly withdrawn.
Response to Arguments
Applicant's arguments, filed 27 April 2026, 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 fails to disclose the first positioning stud to be configured to be disposed along the lower edge of the lamina, the second positioning stud to be configured to be disposed along the isthmus lateral edge, and the morphology-adapted surface configured to abut the posterior face of the lamina. Applicant contends that Akallal discloses the superior articular process but fails to identify or discuss the inferior or lower articular process or the isthmus lateral edge, and thus the orientation of the vertebra in Akallal’s FIG. 4 is different than that of the figures of the present application. Examiner respectfully submits that, since the isthmus connects the inferior and superior articular processes, and since Akallal’s guide spans across many regions of one side of the vertebra as in FIG. 4, then Akallal’s guide at one stud is disposed along a lateral edge of the isthmus, even if from another angle than as shown in the figures of the instant application. Even if Akallal’s figures do not show the studs disposed along the lower edge of the lamina and along the isthmus lateral edge, and the morphology-adapted surface abutting the posterior face of the lamina, this is language of intended use in apparatus claims. Akallal’s guide is fully capable of application to the claimed anatomical features, particularly since Akallal discloses that features that the guide may be specifically designed to be placed in apposition with include, but are not limited to the transverse process, lamina and/or articular process (such as superior articular process) and/or spinous process (col. 8 / lines 26-30). The guide being placed against the lamina would allow the studs to wrap around in abutment with the lower edge of the lamina and the isthmus lateral edge, to prevent sliding of the guide with respect to the lamina. The language “such as superior articular process” indicates that Akallal contemplates other articular processes, and not only superior articular processes; therefore, an inferior articular process as referenced in the application would also be within the disclosure of Akallal.
Applicant contends, as to the Office action’s assertion that Akallal’s lateral surface of the right jaw 14J is adjacent to the lateral edge of the isthmus, that “adjacent” does not mean “in contact” and that the lateral surface in Akallal is at a distance from the lateral edge of the isthmus. Examiner notes that the claims do not require “in contact.” The limitation that the lateral surface of the second stud abuts against the lateral edge of the isthmus has been newly added by the current claim amendments, and was thus not previously rejected. Any language in the previous Office action regarding the lateral surface being adjacent to the lateral edge of the isthmus was to meet the claimed limitation that the lateral surface extends tangentially to the lateral edge of the isthmus. As above, the anatomical features against which the guide is placed is language of intended use; when the guide is placed against the lamina and the studs wrap around the lower edge of the lamina and the isthmus lateral edge (contemplated as one of various applications by Akallal), the lateral surface of one stud will abut or be in contact with the lateral edge of the isthmus, since Akallal requires the studs to abut the adjacent bone surfaces to prevent relative sliding of the guide out of position. Examiner notes that since the isthmus connects the inferior and superior articular processes, even if Akallal’s guide is placed on the superior articular process, it is capable of abutting the portion or edge of the isthmus adjacent to the superior articular process.
As to claims 4 and new claim 11, Applicant contends that the lateral surface of the right jaw 14J in Akallal does not face the morphologically adapted surface, but extends perpendicular to it. The lateral surface faces the articular process and as such, is not oriented toward the main part, but rather is oriented away from the main part. Examiner respectfully submits that although the stud itself/as a whole extends perpendicularly away from the morphologically adapted surface/main part, the lateral surface, which is the side surface of the stud that abuts the adjacent bone, does face the main region of the morphologically adapted surface because they are both internal facing surfaces of a structure that wraps around the bone, similarly as to internal walls of a box that face inward and thus toward each other.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1 and 4-11 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
As to claim 1, the limitations “the morphology-adapted surface abutting the posterior face of the lamina” (lines 15-16) and “and which abuts against the lateral edge of the isthmus” (line 34) include a human organism in their scope and are thus drawn to non-statutory subject matter. Amendment is suggested to “the morphology-adapted surface configured to abut the posterior face of the lamina” and “and which is configured to abut against the lateral edge of the isthmus”.
As to claim 10, the limitation “the at least one cannula is spaced from the bone material” (lines 2-3) includes a human organism in its scope and is thus drawn to non-statutory subject matter. Amendment is suggested to “the at least one cannula is configured to be spaced from the bone material”.
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 4-11 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 configured to guide 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. 8 / lines 26-30, 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 since the guide and coupling face are fully capable of being applied on or in apposition to the posterior face of the lamina, col. 8 / lines 26-30), 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 since the guide and coupling face are fully capable of being applied on or in apposition to the posterior face of the lamina, col. 8 / lines 26-30), the morphology-adapted surface abutting the posterior face of the lamina when the coupling face is applied to 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; FIG. 4 shows the morphology-adapted surface abutting the posterior face of the lamina 5 which is adjacent to the articular process 6 such that a central portion of the morphology-adapted surface overlies and abuts the posterior face of the lamina, and even if not shown, the guide and coupling face are fully capable of such positioning, col. 8 / lines 26-30), FIG. 4, 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 (interpreted as language of intended use; the morphology-adapted surface and the studs are fully capable of matching 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 when the coupling face is placed in apposition with the posterior face of the lamina and the studs are placed alongside so as to abut the sides of the lamina at the lower edge and the lateral edge of the isthmus, col. 8 / lines 26-30, col. 10 / lines 41-43), 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 (interpreted as language of intended use; since the stud extends away from the morphology-adapted surface, it is fully capable of extending tangentially to at least a portion of the lower edge of the lamina so that in conjunction with the other stud, they apply opposing contact to the sides of the bone, e.g. the lamina, on which the coupling face is applied to prevent movement, col. 10 / lines 41-43), 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, and which abuts against the lateral edge of the isthmus when the coupling face is applied to said one half of the vertebra (interpreted as language of intended use; since the stud extends away from the morphology-adapted surface, it is fully capable of extending tangentially to and abutting against at least a part of the lateral edge of the isthmus so that the studs apply opposing contact to the sides of the bone, e.g. the lamina, on which the coupling face is applied to prevent movement, col. 10 / lines 41-43), 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 fully capable of being on the posterior face of 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 configured to be 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 (interpreted as language of intended use; at least part of the main region is or is capable of being in anteroposterior line with the posterior face of the lamina, col. 8 / lines 26-30, since the main region is fully capable of being placed on the posterior face of the lamina), FIGS. 3-4, the main region being substantially convex (see convex portions in FIG. 3; significantly or substantially 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 (interpreted as language of intended use; 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).
As to claim 10, Akallal discloses the surgical guide according to claim 1, wherein the body is further provided with at least one cannula (20, through which the aiming passage 18 is formed) (col. 10 / lines 44-47), configured to receive a removable bone anchor (interpreted as language of intended use; fully capable of receiving a bone anchor therethrough), wherein the at least one cannula is spaced from the bone material of the vertebra of the patient when the coupling face is applied to said one half of the vertebra (at least the proximal end of the cannula is spaced from the bone material since it is on the other side of the guide from the bone-facing side), FIG. 4.
As to claim 11, 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. 8 / lines 26-30, 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 since the guide and coupling face are fully capable of being applied on or in apposition to the posterior face of the lamina, col. 8 / lines 26-30), 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 since the guide and coupling face are fully capable of being applied on or in apposition to the posterior face of the lamina, col. 8 / lines 26-30), 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 (interpreted as language of intended use; the morphology-adapted surface and the studs are fully capable of matching 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 when the coupling face is placed in apposition with the posterior face of the lamina and the studs are placed alongside so as to abut the sides of the lamina at the lower edge and the lateral edge of the isthmus, col. 8 / lines 26-30, col. 10 / lines 41-43), 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 (interpreted as language of intended use; since the stud extends away from the morphology-adapted surface, it is fully capable of extending tangentially to at least a portion of the lower edge of the lamina so that in conjunction with the other stud, they apply opposing contact to the sides of the bone, e.g. the lamina, on which the coupling face is applied to prevent movement, col. 10 / lines 41-43), 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 (interpreted as language of intended use; since the stud extends away from the morphology-adapted surface, it is fully capable of extending tangentially to and abutting against at least a part of the lateral edge of the isthmus so that the studs apply opposing contact to the sides of the bone, e.g. the lamina, on which the coupling face is applied to prevent movement, col. 10 / lines 41-43), 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 fully capable of being on the posterior face of the lamina and the geometric axis is substantially perpendicular to the coupling face), 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 configured to be 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 (interpreted as language of intended use; at least part of the main region is or is capable of being in anteroposterior line with the posterior face of the lamina, col. 8 / lines 26-30, since the main region is fully capable of being placed on the posterior face of the lamina), FIGS. 3-4, the main region being substantially convex (see convex portions in FIG. 3; significantly or substantially 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.
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 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
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