DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 February 19, 2026 has been entered.
Claim Rejections - 35 USC § 103
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.
Claims 1, 3-5, 7-10, 17-19, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over International Patent Application Publication No. WO 2017/066475 A1 (Phan) in view of U.S. Patent Application Publication No. 2016/0331553 (Tanaka) and U.S. Patent Application Publication No. 2010/0249795 (DiMauro).
Regarding claims 1 and 26, Phan discloses a system for delivering a spinal implant into a spinal facet joint space via a posterior approach (the system is capable of delivering a spinal implant via any approach, including posterior), the system comprising: a spinal implant (308) comprising first and second securement apertures (360) configured to receive a fastener (142) to fixedly secure the implant within the spinal facet joint (intervertebral joint space, see page 2, lines 6-14); a first tool (300) defining two longitudinally extending lumens (302a and 470) and comprising a proximal end (306/500) and a distal end (304/400), the spinal implant received at the distal end (see Fig. 36); a driver tool (600) received in one (302a) of the two longitudinally extending lumens and configured to engage the spinal implant during delivery of the spinal implant to the spinal facet joint (see page 18, line 32 – page 19, line 6); and a second tool (710) defining a longitudinally extending shaft (772) and a distal end (774/778), the fastener (142) coupled to the second tool distal end (see Fig. 42 and page 21, lines 5-25), wherein the second tool is received in one (470) of the two lumens of the first tool to deliver the fastener to one of the securement apertures of the spinal implant (see Figs. 38-45).
Phan discloses one of the longitudinally extending lumens (302a) extending parallel to a longitudinal axis of the first tool (see Fig. 36), but fails to disclose the other longitudinally extending lumen (470, for delivery of a fastener into a securement aperture) having at least a portion extending parallel to the longitudinal axis of the first tool such that the two lumens of the first tool extending parallel to each other. However, Tanaka discloses a tool (300) for delivering a spinal implant, the tool including a lumen (304) for delivery of a fastener into a securement aperture (see Figs. 7A and 7B), wherein the lumen has a proximal portion (extending along Axis A, see Fig. 7B) extending parallel to a longitudinal axis of the tool (see Figs. 7A and 7B). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify lumen 470 of the Phan to include a proximal portion extending parallel to the longitudinal axis of the first tool (and thus, parallel to the other lumen of the first tool) as suggested by Tanaka in order to facilitate a user securing a bone screw into an implant and vertebra a sufficient amount and in a minimally invasive manner by allowing for automatic detachment of the bone screw from a delivery device when the bone screw is secured to the implant and vertebra due to the shape of the lumen (see Tanaka, paragraph [0064]).
Phan discloses wherein the spinal implant further comprises a first engagement feature (one of features 340) and a second engagement feature (other of features 340), wherein the first engagement feature is defined by the rear surface and the top surface of the main body (see Fig 37B), and the second engagement features is defined by the rear surface and the bottom surface of the main body (see Fig. 37B), the first engagement feature configured to receive a corresponding engagement feature (341) on the first tool. Phan fails to disclose the engagement features defined at least partially in different corners on different sides surfaces of the implant. However, it would be obvious to move the engagement features 340 to diagonally opposite corners defined by the rear surface, a side surface, and at least one of the top or bottom surface as such a modification merely involves a relocation of the position of the engagement features, which would not affect the operation of the spinal implant the engagement features. See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.). Additionally, there is no evidence in the record that the particular position of the engagement features in the corners of the spinal implant are critical or achieve a specific function, and are thus anything more than a design choice. See In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice).
Alternatively, Phan discloses the engagement features 340 may be “slots, U-shaped apertures or other feature configured to receive a corresponding engagement feature 341 on the screw guide 400. When engaged, the features 340, 341 serve to secure the fixation member 308 and screw guide 400 for delivery. Engagement feature 341 may be shaped as a pin, u-shaped protrusion, or other configurations that match the corresponding shape of feature 340 (see Figs. 37E, 37F and 37G)” (see page 20, lines 9-18). Additionally, DiMauro discloses a spinal implant (71) secured to a tool (1), wherein the spinal implant includes engagement features (recesses adjacent attachment surface 75) defined at least partially in a corner defined by the rear surface, a side surface, and at least one of the top or bottom surfaces of the spinal implant (see Fig. 4), the implant engagement features configured for receiving corresponding engagement features (13 and 29) of the tool. Thus, it would be obvious to have the engagement features of Phan have a configuration suggested by DiMauro, as Phan suggests using any engagement feature configuration that involves using matching corresponding shapes between the engagement features that serve to secure the spinal implant and implant delivery device together (see Phan, page 20, lines 9-18).
Regarding claim 3, it would have been prima facie obvious to modify the system of Phan to include a third tool (another 71/142) received in one of the two lumens of the first tool to deliver a second fastener (142) to the other of the two securement apertures of the spinal implant (other 360), as such a modification merely involves a duplication of parts, and it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art unless a new and unexpected result is produced. See In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). In the present case, the duplicated tool merely performs the same function as the original tool in delivering a fastener to a securement aperture.
Regarding claim 4, Phan discloses wherein the fastener is a bone screw (142), and the second tool and/or third tool (710/142) includes a breakable junction (friction fit, see page 22, lines 11-20) between the longitudinally extending shaft (772) and the bone screw such that the bone screw detaches from the shaft after deployment in one of the securement apertures of the spinal implant (see page 22, lines 11-20).
Regarding claim 5, Phan discloses the implant further comprising: a main body (314) comprising opposing top and bottom surfaces (316/318), opposing front and rear surfaces (320/330), opposing side surfaces (332), and having a longitudinal axis (longitudinal axis extending straight along aperture 355 and extending through the front and rear surfaces) extending through the main body; the first securement aperture (360) extending through at least a portion of the rear and top surface (see page 19, lines 7-21 and Figs. 36-45; aperture 360 with an upward trajectory) and the second securement aperture (360) extending through at least a portion of the rear and bottom surface (see page 19, lines 7-21 and Figs. 36-37D; aperture 360 with a downward trajectory); and the first and second securement apertures extending through the main body at offset angles relative to the longitudinal axis of the main body (see page 19, lines 7-21 and Figs. 36-45).
Regarding claim 7, Phan discloses wherein the first engagement feature defined on the main body is a keyway feature (340) and the corresponding engagement feature on the first tool is a corresponding key (341) (see page 20, lines 9-18).
Regarding claim 8, Phan discloses wherein the first engagement feature is a symmetrical groove, an asymmetrical groove or indentation (340) that is complementary to at least one engagement feature (341) on an implant delivery device (300).
Regarding claim 9, Phan fails to disclose wherein the first engagement feature (340) is a protrusion in the rear surface that is complementary to at least one engagement feature on an implant delivery device; Phan instead discloses the at least one engagement feature is a slot/aperture (340) in the rear surface that is complementary to least at one pin (341) on the implant delivery device (300) (see page 20, lines 9-18). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the system of Phan to have the implant engagement feature (340) be the pin and the engagement feature (341) of the implant delivery device (300) be the slot/aperture as it has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art and is an obvious modification. See In re Gazda, 219 F.2d 449, 104 USPQ 400 (CCPA 1955).
Regarding claim 10, Phan discloses the implant further comprising: at least one retaining feature (334) associated with at least one of the top or bottom surfaces of the main body to frictionally engage the implant within the spinal facet joint (see page 19, line 22 – page 20, line 8), wherein the at least one retaining feature includes a trailing face spaced apart from the rear surface of the implant (see Figs. 37B-37D; trailing face of projections 334 are spaced from rear surface 330, i.e., the projections 334 do not extend all the way to the rear surface 330).
Regarding claim 17, Phan discloses a system for delivering a spinal implant into a spinal facet joint space via a posterior approach (the system is capable of delivering a spinal implant via any approach, including posterior), the system comprising: a spinal implant according to claim 11 (see analysis of claim 11 below with regard to Phan alternatively modified by DiMauro); a first tool (300) defining two longitudinally extending lumens (302a and 470) and comprising a proximal end (306/500) and a distal end (304/400), the spinal implant received at the distal end (see Fig. 36); a driver tool (600) received in one (302a) of the two longitudinally extending lumens and configured to engage the spinal implant during delivery of the spinal implant to the spinal facet joint (see page 18, line 32 – page 19, line 6); and a second tool (710/142) defining a longitudinally extending shaft (778) and a fastener (142), wherein the second tool is received in one (470) of the two lumens of the first tool to deliver the fastener to one of the securement apertures of the spinal implant (see Figs. 38-45).
Phan discloses one of the longitudinally extending lumens (302a) extending parallel to a longitudinal axis of the first tool (see Fig. 36), but fails to disclose the other longitudinally extending lumen (470, for delivery of a fastener into a securement aperture) having at least a portion extending parallel to the longitudinal axis of the first tool such that the two lumens of the first tool extending parallel to each other. However, Tanaka discloses a tool (300) for delivering a spinal implant, the tool including a lumen (304) for delivery of a fastener into a securement aperture (see Figs. 7A and 7B), wherein the lumen has a proximal portion (extending along Axis A, see Fig. 7B) extending parallel to a longitudinal axis of the tool (see Figs. 7A and 7B). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify lumen 470 of the Phan to include a proximal portion extending parallel to the longitudinal axis of the first tool (and thus, parallel to the other lumen of the first tool) as suggested by Tanaka in order to facilitate a user securing a bone screw into an implant and vertebra a sufficient amount and in a minimally invasive manner by allowing for automatic detachment of the bone screw from a delivery device when the bone screw is secured to the implant and vertebra due to the shape of the lumen (see Tanaka, paragraph [0064]).
Regarding claim 18, it would have been prima facie obvious to modify the system of Phan to include a third tool (another 71/142) received in the one of the two lumens of the first tool to deliver a second fastener (142) to the other of the two securement apertures of the spinal implant (other 360), as such a modification merely involves a duplication of parts, and it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art unless a new and unexpected result is produced. See In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). In the present case, the duplicated tool merely performs the same function as the original tool in delivering a fastener to a securement aperture.
Regarding claim 19, Phan discloses wherein the fastener is a bone screw (142), and the second tool (710/142) includes a breakable junction (friction fit, see page 22, lines 11-20) between the longitudinally extending shaft (778) and the bone screw such that the bone screw detaches from the shaft after deployment in one of the securement apertures of the spinal implant (see page 22, lines 11-20).
Claims 11-16 are rejected under 35 U.S.C. 103 as being unpatentable over Phan in view of DiMauro.
Regarding claim 11, Phan discloses a spinal implant (308) for implantation within a spinal facet joint (intervertebral joint space, see page 2, lines 6-14), the implant comprising: a main body (314) including: opposing top and bottom surfaces (316/318); opposing front and rear surfaces (320/330); opposing side surfaces (332); and a longitudinal axis (longitudinal axis extending straight along aperture 355 and extending through the front and rear surfaces) extending through the main body; at least one retaining feature (334) associated with at least one of the top or bottom surfaces of the main body to frictionally engage the implant within the spinal facet joint (see page 19, line 22 – page 20, line 8); a first securement aperture (360) extending through at least a portion of the top surface (see page 19, lines 7-21 and Figs. 36-45); aperture 360 with an upward trajectory) and a second securement aperture (360) extending through at least a portion of the bottom surface (see page 19, line 7-21 and Figs. 36-37D, aperture 360 with a downward trajectory), the first and second securement apertures extending through the main body at offset angles relative to the longitudinal axis of the main body (see page 19, lines 7-21 and Figs. 36-45).
Phan discloses at least one first engagement feature (one of features 340) and a second engagement feature (other of features 340), the first engagement feature defined at least partially in the rear surface and the top surface of the main body (see Fig. 37B), the second engagement feature defined at least partially in the by the rear surface and a bottom surface of the main body (see Fig. 37B), the engagement features configured to receive an implant delivery device (300). Phan fails to disclose the engagement features defined at least partially in different corners on different side surfaces of the main body. However, it would be obvious to move the engagement features 340 to diagonally opposite corners defined by the rear surface, a side surface, and at least one of the top or bottom surface as such a modification merely involves a relocation of the position of the engagement features, which would not affect the operation of the spinal implant the engagement features. See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.). Additionally, there is no evidence in the record that the particular position of the engagement features in the corners of the spinal implant are critical or achieve a specific function, and are thus anything more than a design choice. See In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice).
Alternatively, Phan discloses the engagement features 340 may be “slots, U-shaped apertures or other feature configured to receive a corresponding engagement feature 341 on the screw guide 400. When engaged, the features 340, 341 serve to secure the fixation member 308 and screw guide 400 for delivery. Engagement feature 341 may be shaped as a pin, u-shaped protrusion, or other configurations that match the corresponding shape of feature 340 (see Figs. 37E, 37F and 37G)” (see page 20, lines 9-18). Additionally, DiMauro discloses a spinal implant (71) secured to a tool (1), wherein the spinal implant includes engagement features (recesses adjacent attachment surface 75) defined at least partially in a corner defined by the rear surface, a side surface, and at least one of the top or bottom surfaces of the spinal implant (see Fig. 4), the implant engagement features configured for receiving corresponding engagement features (13 and 29) of the tool. Thus, it would be obvious to have the engagement features of Phan have a configuration suggested by DiMauro, as Phan suggests using any engagement feature configuration that involves using matching corresponding shapes between the engagement features that serve to secure the spinal implant and implant delivery device together (see Phan, page 20, lines 9-18).
Regarding claim 12, Phan discloses wherein the two securement apertures (360) are operable to receive fasteners (142), optionally a bone screw.
Regarding claim 13, Phan discloses the implant further comprising at least one window (338), and optionally two windows, defined in the top and/or bottom surface of the main body (see Figs. 37B-37D).
Regarding claim 14, Phan discloses the implant further comprising one window (338) defined in each side surface of the main body (see Figs. 37B-37D and page 19, line 22 – page 20, line 8).
Regarding claim 15, Phan discloses wherein the at least one engagement feature is a keyway (340).
Regarding claim 16, Phan discloses wherein the at least one engagement feature is a symmetrical groove, an asymmetrical groove or indentation (340) that is complementary to features (341) on an implant delivery device (300).
Claims 2 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Phan in view of Tanaka and DiMauro, and further in view of U.S. Patent Application Publication No. 2010/0069912 (McCormack).
Regarding claim 2, Phan fails to disclose further comprising a guide tube defining a longitudinally extending lumen and configured to receive at least the first tool to deliver the spinal implant to the spinal facet joint space. However, McCormack discloses a spinal treatment system that comprises a guide tube (340; see Figs. 26A-26C) defining a longitudinally extending lumen (longitudinal channel, see paragraph [0184]) and configured to receive a tool to deliver a spinal implant to a spinal joint space (see paragraph [0184]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the system of Span to include a guide tube as suggested by McCormack in order to facilitate distraction of a spinal joint space and facilitate insertion of the spinal implant into the spinal joint space (see McCormack, paragraph [0184]).
Regarding claim 20, McCormack discloses a method of fusing adjacent vertebra defining a spinal facet joint (see paragraph [0019]), the method comprising: distracting a spinal facet joint using a guide tube (340); securing a spinal implant (354) to a distal end of a first tool (350) (see paragraph [0184] and Fig. 26B); inserting the first tool (350) and spinal implant (354) through the guide tube to deliver the implant to a spinal facet joint (see paragraph [0184]); implanting the spinal implant (354) into the spinal facet joint (see paragraph [0184]); positioning the spinal implant within the spinal facet joint (see paragraphs Fig. 26C and paragraph [0184]).
McCormack fails to disclose the method including using a second tool and a third tool. However, Phan discloses a spinal surgical method comprising: inserting a first tool (600) through a first interior channel (302a) formed in a second tool (300), the second tool comprising the first interior channel and a second interior channel (470); aligning an engagement feature (340) on a rear face (330) of a spinal implant (808) with a corresponding engagement feature (341) on the second tool; securing the spinal implant to a distal end of the first tool (see page 18, line 32 — page 19, line 6); positioning the spinal implant within the spinal joint and removing the first tool (see page 18, line 32 — page 19, line 6 and page 19, line 22- page 20, line 8); and inserting a third tool (710/142) having a securement feature (360) through a main body (314) of the spinal implant to place the securement feature into at least two of the adjacent vertebra to fixedly secure the spinal implant within the spinal joint (see page 11, line 37 — page 12, line 29). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to adapt the system of Phan for use with a spinal implant according to claim 11 (see analysis of claim 11 above) in treatment of the facet joint and in conjunction with the guide tube of McCormack in order to allow for secure fixation of the facet joint implant via bone screws while easing placement of the spinal implant via a distraction mechanism guide tube. Additionally, one of ordinary skill in the art would recognize it as necessary and/or obvious to remove the first tool once the implant is delivered as it would be dangerous to a patient to leave surgical tools inside the patient.
Response to Arguments
Applicant's arguments filed June 16, 2025 have been fully considered but they are not persuasive.
Applicant argues on page 7 of the Remarks that it would not be obvious to have the engagement features 340 in Phan moved to outside corners, as the change would require other changes to made to Phan’s implant. Applicant argues that moving the features 340 of Phan to outside corners would result in features 340 overlapping with apertures 360. The examiner disagrees. First, as shown in Fig. 37B, the features 340 could be moved to a pair of diagonally opposite corners without overlapping the apertures 360, which are located in a different pair of diagonally opposite corners. Second, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). The features 340 could be moved to one pair of diametrically opposite corners of the implant, while the apertures 360 are located in the other pair of diametrically opposite corners of the implant, and such a modification would not substantially change the principle of operation of the implant, or render the prior art unsatisfactory for its intended purpose.
Applicant argues on page 7 of the Remarks that the structural integrity of the implant would not be sound if features 340 were moved to the corners. However, arguments presented by applicant cannot take the place of evidence in the record. See In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984); In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997) (“An assertion of what seems to follow from common experience is just attorney argument and not the kind of factual evidence that is required to rebut a prima facie case of obviousness.”). Applicant provides no evidence that moving features 340 to the corners would affect the structural integrity of the implant. Additionally, DiMauro is evidence that an interbody implant maintains its structural integrity even when the corners are recessed.
Applicant argues on pages 7-8 of the Remarks that Phan discloses an alternative in Figs. 27/28 in which a similar feature are not in the corners but instead toward the center. However, the disclosure in Phan of alternative configurations does not necessarily negate a suggestion for modifying the prior art to arrive at the claimed invention. See In re Fulton, 391 F.3d 1195, 73 USPQ2d 1141 (Fed. Cir. 2004). Phan does not teach away, exclude, discredit, or criticize having the features 340 in the corners.
Applicant argues on page 8 of the Remarks that DiMauro does not disclose engagement features in the corners of the implant, but rather discloses a central protruding portion for engagement of the spinal implant by a tool. The examiner disagrees; the recesses adjacent the “central protruding portion” are where the spinal implant is engaged by the tool. DiMauro discloses a spinal implant (71) secured to a tool (1), wherein the spinal implant includes engagement features (recesses adjacent attachment surface 75) defined at least partially in a corner defined by the rear surface and at least one of the top or bottom surfaces of the spinal implant (see Fig. 4), the implant engagement features configured for receiving corresponding engagement features (13 and 29) of the tool. Thus, it would be obvious to have the engagement features of Phan have a configuration suggested by DiMauro, as Phan suggests using any engagement feature configuration that involves using matching corresponding shapes between the engagement features that serve to secure the spinal implant and implant delivery device together (see Phan, page 20, lines 9-18).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICHOLAS J PLIONIS whose telephone number is (571)270-3027. The examiner can normally be reached on Monday - Friday, 10:00 a.m. - 6:00 p.m. EST.
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/NICHOLAS J PLIONIS/Primary Examiner, Art Unit 3773