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 Arguments
Applicant's arguments filed December 31st, 2025 have been fully considered but they are not persuasive. Applicant’s amendments and arguments to further define the location of their first distal surface region, second distal surface region and first proximal surface region as well as their extension in a superior direction or inferior direction is anticipated by Studer et al. and Bauer. The annotated figures below show the location of the respective proximal and distal regions which extend in a superior (upward direction) relative to the main body of the implant. Further, both pieces of art teach first and second peaks extend outwardly in the superior direction and a valley is formed and extends in an inward direction relative to the peaks to form the valley. As a result, Applicant’s amendments, arguments and remarks do not overcome the prior art of record.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Regarding the rejections below, like elements will be normal typeface and additional elements with be bolded. Claims 1-20 are rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,042,399. Although the claims at issue are not identical, they are not patentably distinct from each other because: Claim 1 of the application recites:
An intervertebral implant, comprising: a bone contacting outer member having an elongate geometry; and a support member having an elongate geometry; wherein the support member is attached to the outer member; wherein the outer member is non-linear; wherein the outer member has a bone contacting outer surface configured to contact a vertebra; wherein the geometry of the outer member provides a first distal surface region, a second distal surface region, and a first proximal surface region located between the first distal surface region and the second distal surface region; wherein the first distal surface region, the first proximal surface region, and the second distal surface region are all oriented outwardly on a superior side or an inferior side of the implant such that the first distal surface region and the second distal surface region extend in a superior direction or an inferior direction; and wherein the support member attaches to the outer member at a portion of the outer member that includes the first proximal surface region.
Claim 1 of Patent 12,042,399 recites:
An intervertebral implant, comprising: a bone contacting outer member having an elongate geometry; and a support member having an elongate geometry; wherein the support member is attached to the outer member; wherein the outer member has a central member curve; and wherein the central member curve is non-linear; wherein the outer member has a bone contacting outer surface configured to contact a vertebra; wherein the geometry of the outer member provides a first distal surface region, a first proximal surface region and a second distal surface region, wherein the first distal surface region, the first proximal surface region and the second distal surface region are all oriented outwardly on a superior side or an inferior side of the implant; and wherein the support member attaches to the outer member at a portion of the outer member that includes the first proximal surface region.
Claim 10 of the Application recites: An implant, comprising: a body; an outer member having an elongate, non-linear geometry, the outer member attached to the body; and a support member having an elongate geometry, the support member attached to the body and attached to the outer member; the outer member having an outwardly facing surface portion; wherein the support member is integrally formed with the outer member.
Claim 10 of Patent 12,042,399 recites:
An implant, comprising: a body; a bone contacting outer member having an elongate, non-linear geometry, the outer member attached to the body; and a support member having an elongate geometry, the support member attached to the body and attached to the outer member; the outer member having an outwardly facing surface portion; wherein the support member is integrally formed with the outer member on an internal side of the outer member opposite the outwardly facing surface portion of the outer member.
Claim 14 of the Application recites: An implant, comprising: an outer member having an elongate, non-linear geometry; and a support member having an elongate geometry; wherein the support member is attached to the outer member; wherein the non-linear geometry of the outer member forms a first peak extending outwardly in a superior direction, a second peak extending outwardly in a superior direction, and a valley extending inwardly between the first peak and the second peak; and wherein the support member attaches to the outer member at a portion of the outer member that includes the valley.
Claim 14 of Patent 12,042,399 recites: An implant, comprising: a bone contacting outer member having an elongate, non-linear geometry; and a support member having an elongate geometry; wherein the support member is attached to the outer member; wherein the outer member has a bone contacting outer surface; wherein the non-linear geometry of the outer member forms a first peak extending outwardly in a superior direction, a second peak extending outwardly in a superior direction, and a valley extending inwardly between the first peak and the second peak; and wherein the support member attaches to the outer member at a portion of the outer member that includes the valley.
Claims 2-9, 11-13 and 15-20 which depend from independent claims 1, 10 and 14 are verbatim and will not be copied for brevity.
It is clear that all of the elements of claims 1, 10 and 14 of the Application are to be found in claims 1, 10 and 14 of the Patent. The differences between claims 1, 10 and 14 of the Application and claims 1, 10 and 14 of the patent lies in the fact that the patent includes more elements/details and are thus more specific. The inventions of claims 1, 10 and 14 of the Patent are in effect a “species” of the “generic” invention of claims 1, 10 and 14 of the Application. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). The same reasoning and logic applies to claims 2-9, 11-13 and 15-20 which depend from these independent claims. Since claims 1-20 of the Application are anticipated by claims 1-20 of the patent, they are not patentably distinct from claims 1-20 of the Patent.
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 1-8, 10-11, 13-18 and 20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Bauer (US 2018/0193152).
Regarding claim 1, Bauer discloses an intervertebral implant, comprising a bone contacting outer member (90, figures 11a-11c) having an elongate geometry (figures 11a-11c) ; and a support member (91) having an elongate geometry (figures 11a-11c); wherein the support member is attached to the outer member (¶69, ¶29); wherein the outer member is non-linear (figures 11a-11c, the ends are curved and angled respectively); wherein the outer member has a bone contacting outer surface (92) configured to contact a vertebra (¶69); wherein the geometry of the outer member provides a first distal surface region (see figure below), a second distal surface region (see figure below), and a first proximal surface region (see figure below) located between the first distal surface region and the second distal surface region (see figure below), wherein the first distal surface region, the first proximal surface region, and the second distal surface region are all oriented outwardly on a superior side (see figure below) or an inferior side (see figure below) of the implant such that the first distal surface region and the second distal surface region extend in a superior direction or an inferior direction (see figure below); and wherein the support member attaches to the outer member at a portion of the outer member that includes the first proximal surface region (figures 11a-11c). Regarding claim 2, Bauer discloses the support member has a curved path that includes an arch-like path (figure 3c).
Regarding claim 3, Bauer discloses the outer member has a greater length than the support member (figures 11a-11c).
Regarding claim 4, Bauer discloses the geometry of the outer member provides a third distal surface region (see figure below) and a second proximal surface region (see figure below) disposed between the second distal surface region and the third distal surface region (figures 11a-11c).
Regarding claim 5, Bauer discloses the third distal surface region and the second proximal surface region are oriented outwardly on the same side of the implant as the first distal surface region (see figure below).
Regarding claim 6, Bauer discloses the outer member is configured to engage a vertebra so as to form a space for protecting bone growth between the vertebra and the proximal surface region (¶69).
Regarding claim 7, Bauer discloses the implant has an open interior (figures 11a-11c, the lattice is porous and extends entirely through the implant) and wherein the implant is configured to receive a bone growth promoting material (¶28) such that the bone growth promoting material can extend continuously through the open interior of the implant and into the space for protecting bone growth between the vertebra and the proximal surface region (if one so chooses to apply a coating or deposit a bone growth promoting material therein).
Regarding claim 8, Bauer discloses the non-linear outer member has a central member curve with a geometry such that the outer member has an arch-like geometry (figure 3c at the third distal surface region).
Regarding claim 10, Bauer discloses an implant, comprising a body (9/9’/9”); an outer member (90) having an elongate, non-linear geometry (figures 11a-11c, the ends are curved and angled respectively), the outer member attached to the body (figures 11a-11c); and a support member (91) having an elongate geometry (figures 11a-11c), the support member attached to the body and attached to the outer member (¶69, ¶29); the outer member having an outwardly facing surface portion (see figure below); wherein the support member is integrally formed with the outer member (¶69, ¶29); and wherein the non-linear geometry of the outer member forms a first peak (see figure below) extending outwardly, a second peak (see figure below) extending outwardly, and a valley (see figure below) extending inwardly, with the valley forming a space for protecting bone growth that is located between the first peak and the second peak.
Regarding claim 11, Bauer discloses the non-linear geometry of the outer member includes an arch-like geometry (figure 3c).
Regarding claim 13, Bauer discloses the non-linear geometry of the outer member forms a first peak extending outwardly (see figure below), a second peak extending outwardly (see figure below), and a valley extending inwardly (see figure below), with the valley forming a space for protecting bone growth that is located between the first peak and the second peak (figure 3c).
Regarding claim 14, Bauer discloses an implant, comprising an outer member (91) having an elongate, non-linear geometry (figures 11a-11c); and a support member (90) having an elongate geometry (figure 11a-11c); wherein the support member is attached to the outer member (¶69, ¶29); wherein the non-linear geometry of the outer member forms a first peak extending outwardly in a superior direction (see figure below), a second peak extending outwardly in a superior direction (see figure below), and a valley extending inwardly (see figure below) between the first peak and the second peak; and wherein the support member attaches to the outer member at a portion of the outer member that includes the valley (figure 3c, as each row peaks and valleys connects to the outer member).
Regarding claim 15, Bauer discloses the valley forms a space for protecting bone growth (figure 3c).
Regarding claim 16, Bauer discloses the implant has an open interior (figures 11a-11c, ¶69) and wherein the implant is configured to receive a bone growth promoting material (¶28) such that the bone growth promoting material can extend continuously through the open interior of the implant and into the space for protecting bone growth between the vertebra and the valley of the outer member (if one so chooses to apply a coating or deposit a bone growth promoting material therein).
Regarding claim 17, Bauer discloses the non-linear geometry of the outer member provides a third peak (see figure below) and a second valley (see figure below) disposed between the second peak and the third peak. Regarding claim 18, Bauer discloses the non-linear geometry of the outer member includes an arch-like geometry (figure 3c).
Regarding claim 20, Bauer discloses the support member (90) is integrally formed with the outer member (91, ¶69, ¶29) on an internal side of the outer member opposite the bone contacting outer surface of the outer member (figures 11a-11c).
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Claims 1, 9-10, 12, 14 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Studer et al. (US 2006/0052872).
Regarding claim 1, Studer et al. disclose an intervertebral implant, comprising a bone contacting outer member (1) having an elongate geometry (figure 7a) ; and a support member (15) having an elongate geometry (figure 7a-7d); wherein the support member is attached to the outer member (figure 7a); wherein the outer member is non-linear (outer member is “T” shaped); wherein the outer member has a bone contacting outer surface (see figure below) configured to contact a vertebra; wherein the geometry of the outer member provides a first distal surface region (see figure below), a first proximal surface region (see figure below), and a second distal surface region (see figure below), wherein the first distal surface region, the first proximal surface region, and the second distal surface region are all oriented outwardly on a superior side (see figure below) or an inferior side (see figure below) of the implant; and wherein the support member attaches to the outer member at a portion of the outer member that includes the first proximal surface region (figures 7a-7d).
Regarding claim 9, Studer et al. disclose wherein non-linear central member curve has a geometry such that the outer member has generalized helical geometry (figures 7a-7d, ¶59).
Regarding claim 10, Studer et al. disclose an implant, comprising a body (2); an outer member (1) having an elongate, non-linear geometry (“T” shaped, figure 7a), the outer member attached to the body (via 16); and a support member (15) having an elongate geometry (figures 7a-7d), the support member attached to the body and attached to the outer member (figures 7a-7d); the outer member having an outwardly facing surface portion (see figure below); wherein the support member is integrally formed with the outer member (figures 7a-7d) wherein the non-linear geometry of the outer member forms a first peak (see figure below) extending outwardly, a second peak (see figure below) extending outwardly, and a valley (see figure below) extending inwardly, with the valley forming a space for protecting bone growth that is located between the first peak and the second peak. Regarding claim 12, Studer et al. discloses the non-linear geometry of the outer member includes a generalized helical geometry (figures 7a-7d, ¶59).
Regarding claim 14, Studer et al. disclose an implant, comprising an outer member (15) having an elongate, non-linear geometry (figures 7a-7d, ¶59); and a support member (1/2) having an elongate geometry (figures 7a-7d); wherein the support member is attached to the outer member (figures 7a-7d); wherein the non-linear geometry of the outer member forms a first peak extending outwardly in a superior direction (see figure below), a second peak extending outwardly in a superior direction (see figure below), and a valley extending inwardly (see figure below) between the first peak and the second peak; and wherein the support member attaches to the outer member at a portion of the outer member that includes the valley (figures 7a-7d).
Regarding claim 19, Studer et al. disclose the non-linear geometry of the outer member includes a generalized helical geometry (figures 7a-7d, ¶59).
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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 MATTHEW JAMES LAWSON whose telephone number is (571)270-7375. The examiner can normally be reached Mon - Fri 6:30-3:00.
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/MATTHEW J LAWSON/Primary Examiner, Art Unit 3619