DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. Applicant’s amendment of claims 4 and 7 in the reply filed on 29 July 2026 is acknowledged.
Drawings
3. The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims.
a. Therefore, the “wherein the second implant comprises a plurality of passages, each of the plurality of passages extending between a first window on a first side of the shank on a second window on a second side of the shank” (claim 4) 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.
Claim Rejections - 35 USC § 112
4. 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.
5. Claims 4-6 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.
a. Claim 4 recites the limitation “wherein the second implant comprises a plurality of passages, each of the plurality of passages extending between a first window on a first side of the shank on a second window on a second side of the shank”. The specification, as originally filed, does not describe “passages” extending from one window to another window. Figures 86A-86C of the instant application shows implant 102 (i.e., the “a second implant” recited in claim 1) as comprising a single passage 173 extending from one window 172 of shank 132 to an opposing window 172 of shank 132. Claims 5, 6 depend from claim 4.
During the response filed 29 July 2026 the Applicant argues “Applicant submits that the originally filed disclosure reasonably conveys possession of the features of claim 4. The specification describes that any of the secondary implants described herein may have windows, including windows in one or more anchors of the secondary implant, and that the windows may provide an interface between an inner portion of the anchor, such as an inner cannula or inner passage, and the external environment. See paragraph [0443]”.
The Examiner respectfully disagrees. That paragraph is referring to “secondary implant 104” (e.g., Figures 87A, 87B), which comprises a threaded central opening (126), a first lateral window (178), and a second lateral window (178). This “secondary implant 104” is the recited “a first implant” from independent claim 1.
The “wherein the second implant comprises a plurality of passages, each of the plurality of passages extending between a first window on a first side of the shank and a second window on a second side of the shank” of claim 4 refers to implant 102, which comprises a head (130); a shank (132) extending distally from the head; and a plurality of threads (103) extending from the shank. As indicated in the rejection above, the specification, as originally filed, does not describe “passages” extending from one window to another window. Figures 86A-86C of the instant application shows implant 102 (i.e., the “a second implant” recited in claim 1) as comprising a single passage 173 extending from one window 172 of shank 132 to an opposing window 172 of shank 132.
Claim Rejections - 35 USC § 103
6. 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.
7. Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over LDR Medical (WO 2016/016474 A1) in view of Suh et al. (US PG Pub No. 2020/0268518 A1; cited in Applicant’s IDS).
Referring to Figures 1A-1D, 3A-3E, and 7B, LDR Medical ‘6474 discloses a joint implant system, comprising:
a first implant (2) configured to be received in a joint (facet) of a patient, the first implant comprising a body (23) comprising a threaded central opening (clearly shown in Figures 1D, 3D, and 7B); and
a second implant (1) comprising:
a head (3 and/or 18);
a shank (10) extending distally from the head; and
a plurality of threads (12) extending from the shank;
wherein the threaded central opening of the first implant is configured to receive the head of the second implant (Figures 1A-1D and 3A); and
LDR Medical ‘6474 discloses the invention as claimed, including anchors (21) extending from the first implant and positioned lateral to and on opposing sides of the second implant when the second implant is received within the threaded central opening, except for particularly disclosing the first implant as comprising a first lateral window and a second lateral window. However, this is already known in the art.
For example:
Suh et al. ‘8518 teaches a joint implant system, comprising:
a first implant (Figures 6A, 6B, 6E, 6G, and 6H – implant 600) configured to be received in a joint of a patient (Abstract), the first implant comprising a body comprising a threaded central opening (608), a first lateral window (620), and a second lateral window (620); and
a second implant (Figures 23A, 23B, 23C, 24A, 24B, and 24C – implant 2404; further, see at least paragraph [0068]) comprising:
a head (clearly shown in Figures 23A, 23B, 23C, 24A, 24B, and 24C);
a shank extending distally from the head (clearly shown in Figures 23A, 23B, 24A, and 24B); and
a plurality of threads extending from the shank (clearly shown in Figures 23A, 23B, 24A, and 24B);
wherein the threaded central opening of the first implant is configured to receive the head of the second implant (Figures 23A, 23B, 23C, 24A, 24B, and 24C – implant 2404; further, see at least paragraph [0068]); and
wherein the first lateral window (620) and the second lateral window (620) are configured to be positioned lateral to and on opposing sides of the second implant when the second implant is received within the threaded central opening (Figures 24A and 24B).
Figure 28A of Suh et al. ‘8518 shows an embodiment wherein the anchors (604, 606) lack openings (like LDR Medical ‘6474), and Figures 28B and 28C of Suh et al. ‘8518 show lateral windows having different shapes.
Suh et al. ‘8518 teaches the windows allow long-term stabilization ([0057]) while promoting bone in growth and/or outgrowth ([0067]). Therefore, it would have been obvious to a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to have combined the teaching of the first implant comprising a first lateral window and a second lateral window, as taught by Suh et al. ‘8518, with the invention of LDR Medical ‘6474, in order to allow long-term stabilization while promoting bone in growth and/or outgrowth.
As noted by the United States Supreme Court, if a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability. For the same reason, if a technique has been used to improve one device, and a person of ordinary skill would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill. KSR, 127 S. Ct. at 1740. "When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product is not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show it was obvious under 35 U.S.C. 103." KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82USPQ2d 1385, 1396 (2007).
Regarding claim 2, LDR Medical ‘6474 teaches wherein the first implant is configured to be received within a facet joint of the patient (page 1, lines 6-15).
Regarding claim 3, LDR Medical ‘6474 in view of Suh et al. ‘8518 teaches wherein the first lateral window and the second lateral window are configured to receive bone graft (LDR Medical ‘6474 – page 22, lines 1-5; Suh et al. ‘8518 – [0067], [0115], [0122]). Notice, the “bone graft” is not positively claimed, and the windows of Suh et al. ‘8518 are capable of receiving bone graft.
Regarding claim 4, LDR Medical ‘6474 teaches wherein the second implant (1) comprises a plurality of passages (Figures 1A, 1B, 1D, 3A, 3B, and 3C – passages connecting windows 15), each of the plurality of passages extending between a first window (15) on a first side of the shank on a second window (15) on a second side of the shank.
Regarding claim 5, LDR Medical ‘6474 in view of Suh et al. ‘8518 teaches wherein at least one of the plurality of passages is positioned to align with the first lateral window and the second lateral window (when the first implant receives, e.g., by threading or rotation or manipulation, the second implant).
Regarding claim 6, Figures 1A, 1B, 1D, 3A, 3B, and 3C of LDR Medical ‘6474 clearly show wherein at least one of the plurality of passages is perpendicular to a central axis of the shank.
Regarding claim 7, LDR Medical ‘6474 in view of Suh et al. ‘8518 teaches wherein the first implant comprises a first wedge-shaped anchor (LDR Medical ‘6474 - anchor 21; Suh et al. ‘8518 - anchor 604) and a second wedge-shaped anchor (LDR Medical ‘6474 - anchor 21; Suh et al. ‘8518 - anchor 606), wherein the first lateral opening is positioned within the first wedge-shaped anchor and the second lateral opening is positioned within the second wedge-shaped anchor (clearly shown in Figures 6A, 6B, 6E, 6G, and 6H of Suh et al. ‘8518).
8. Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over LDR Medical (WO 2016/016474 A1) in view of Suh et al. (US PG Pub No. 2020/0268518 A1; cited in Applicant’s IDS), as applied to claim 1 above, and further in view of Donner et al. (US PG Pub No. 2019/0083271 A1).
LDR Medical ‘6474 in view of Suh et al. ‘8518 discloses the invention as claimed, except for particularly disclosing further comprising a joint locator configured to be advanced into the joint. However, this is already known in the art. For example, Donner et al. ‘3271 teaches (Figures 27A-27D) it is well-known to use a joint locator (joint finder 532) to locate the joint in order to prepare the site for a fusion procedure ([0338]). Therefore, it would have been obvious to a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to have combined the teaching of further comprising a joint locator configured to be advanced into the joint, as taught by Donner et al. ‘3271, with the invention of LDR Medical ‘6474 in view of Suh et al. ‘8518, to locate the joint in order to prepare the site for a fusion procedure.
9. Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over LDR Medical (WO 2016/016474 A1) in view of Suh et al. (US PG Pub No. 2020/0268518 A1; cited in Applicant’s IDS), as applied to claim 1 above, and further in view of Donner et al. (US PG Pub No. 2019/0083271 A1).
LDR Medical ‘6474 in view of Suh et al. ‘8518 discloses the invention as claimed, except for particularly disclosing further comprising a cutting tool. However, this is already known in the art. For example, Donner et al. ‘3271 teaches utilizing a cutting tool (drill – [0216]) in order to form a pilot hole at the joint ([0216], [0261]). Therefore, it would have been obvious to a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to have combined the teaching of further comprising a cutting tool, as taught by Donner et al. ‘3271, with the invention of LDR Medical ‘6474 in view of Suh et al. ‘8518, in order to form a pilot hole at the joint.
Response to Arguments
10. Applicant's arguments filed 29 July 2026 have been fully considered but they are not persuasive.
a. Regarding rejection under 35 U.S.C. 103 as being unpatentable over LDR Medical (WO 2016/016474 A1) in view of Suh et al. (US PG Pub No. 2020/0268518 A1; cited in Applicant’s IDS), the Applicant argues “In contrast, Suh describes a wedging cage with longitudinal members adapted to be positioned between the sacrum and ilium with fixation or axial screws used to fasten and secure the wedging cage to adjacent pelvic bones. See Suh, paragraph [0066] and Abstract. The openings 620 of Suh, cited in the Office Action as the lateral windows, are not positioned in bone-piercing rods, but instead are positioned along portions of a wedging cage positioned between a sacrum and ilium.”. The Examiner respectfully disagrees.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
LDR Medical ‘6474 is explained above (see rejection).
Suh et al. ‘8518 teaches a joint implant system, comprising:
a first implant (Figures 6A, 6B, 6E, 6G, and 6H – implant 600) configured to be received in a joint of a patient (Abstract), the first implant comprising a body comprising a threaded central opening (608), a first lateral window (620), and a second lateral window (620); and
a second implant (Figures 23A, 23B, 23C, 24A, 24B, and 24C – implant 2404; further, see at least paragraph [0068]) comprising:
a head (clearly shown in Figures 23A, 23B, 23C, 24A, 24B, and 24C);
a shank extending distally from the head (clearly shown in Figures 23A, 23B, 24A, and 24B); and
a plurality of threads extending from the shank (clearly shown in Figures 23A, 23B, 24A, and 24B);
wherein the threaded central opening of the first implant is configured to receive the head of the second implant (Figures 23A, 23B, 23C, 24A, 24B, and 24C – implant 2404; further, see at least paragraph [0068]); and
wherein the first lateral window (620) and the second lateral window (620) are configured to be positioned lateral to and on opposing sides of the second implant when the second implant is received within the threaded central opening (Figures 24A and 24B).
Figure 28A of Suh et al. ‘8518 shows an embodiment wherein the anchors (604, 606) lack openings (like LDR Medical ‘6474), and Figures 28B and 28C of Suh et al. ‘8518 show lateral windows having different shapes.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Suh et al. ‘8518 teaches the windows allow long-term stabilization ([0057]) while promoting bone in growth and/or outgrowth ([0067]). Therefore, it would have been obvious to a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to have combined the teaching of the first implant comprising a first lateral window and a second lateral window, as taught by Suh et al. ‘8518, with the invention of LDR Medical ‘6474, in order to allow long-term stabilization while promoting bone in growth and/or outgrowth.
As noted by the United States Supreme Court, if a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability. For the same reason, if a technique has been used to improve one device, and a person of ordinary skill would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill. KSR, 127 S. Ct. at 1740. "When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product is not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show it was obvious under 35 U.S.C. 103." KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82USPQ2d 1385, 1396 (2007).
b. The NON-FINAL REJECTION mailed on 29 April 2026 relied on rejection under 35 U.S.C. 103 as being unpatentable over LDR Medical (WO 2016/016474 A1) in view of Suh et al. (US PG Pub No. 2020/0268518 A1; cited in Applicant’s IDS).
Notice, however, the recited claimed subject matter is broad enough that a 102(a)(1) can be also made solely in view of Suh et al. (US PG Pub No. 2020/0268518 A1; cited in Applicant’s IDS), as indicated above.
Conclusion
11. THIS ACTION IS MADE FINAL. 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 Examiner Javier G. Blanco whose telephone number is (571)272-4747. The examiner can normally be reached on M- F (10am-7:30pm).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, SPE Jerrah C. Edwards, at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAVIER G BLANCO/ Primary Examiner, Art Unit 3774
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