DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant’s election without traverse of Species 1 in the reply filed on 12/30/2025 is acknowledged. Claims 1-20 are pending.
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.
Claims 1 and 6-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,918,479 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the differences between the application claims and claim 1 of the patent lies in the fact that the patent claim includes the recitation of more elements and is thus more specific. Accordingly, the invention of claim 1 of the patent is in effect a “species” of the “generic” invention of claims 1 and 6-15 of the application. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the application claims are anticipated by claim 1 of the patent, they are not patentably distinct from claim 1 of the patent.
Claims 2-5 and 16-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,918,479 B2 in view of Yu et al. (U.S. 2008/0027547 A1).
Regarding claims 2-5, the patent claim does not explicitly address the contact surfaces of the lower portion.
Yu et al. disclose a prosthetic system for implantation between upper and lower vertebrae including a second lower contact surface that is textured, comprises an osteoconductive material, comprises an osteoinductive material, and substantially parallel to a first lower contact surface (see par. 0055 and Figs. 5 and 21 below) in the same field of endeavor for the purpose of providing bone ingrowth and implant stability.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the second lower contact surface as taught by Yu et al., in order to create a scaffold that guides new bone growth and promotes fusion between vertebrae thereby increasing the likelihood of achieving solid fusion.
Regarding claims 16-20, claim 1 of the patent does not explicitly disclose that the first and second articulating components are substantially identical.
Yu et al. discloses a prosthetic system for implantation between upper and lower vertebrae comprising first and second articulating components (see Fig. 21, elements 622 and 624) that are substantially identical in the same field of endeavor for the purpose of replacing a disc and providing natural spinal movement to a patient.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to form the first and second articulating components to be identical, as taught by Yu et al., in order to ensure symmetrical load distribution and motion characteristics. The vertebrae above and below the implant experience similar contact stresses and wear patterns which is important for long-term implant performance and preventing asymmetric subsidence or wear.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of pre-AIA 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 –
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claim(s) 1-20 is/are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Yu et al. (U.S. 2008/0027547 A1).
The applied reference has a common inventor with the instant application. Based upon the pre-AIA 35 U.S.C. 102(e) date of the reference, it constitutes prior art. This rejection under pre-AIA 35 U.S.C. 102(e) might be overcome either by a showing under 37 CFR 1.132 that any invention disclosed but not claimed in the reference was derived from the inventor or joint inventors (i.e., the inventive entity) of this application and is thus not the invention “by another,” or if the same invention is not being claimed, by an appropriate showing under 37 CFR 1.131(a).
Concerning claim 1, Yu et al. disclose a prosthetic system for implantation between upper and lower vertebrae, the system comprising: an upper joint component (see Fig. 21, element 622) comprising an upper contact surface for engaging a resected lower surface of the upper vertebrae and a generally concave upper articulation surface (see par. 0053); a lower joint component (624) comprising a first lower contact surface for engaging a resected upper surface of the lower vertebrae and a generally convex lower articulation surface (see Fig. 24, element 681) configured to movably engage the generally concave upper articulation surface to form an articulating joint (see par. 0120), wherein the articulating joint is adapted for implantation within a disc space between the upper and lower vertebrae, allowing the upper and lower vertebrae to move relative to one another; and a bridge component (see Fig. 21, element 636) extending posteriorly from the lower joint component and from the disc space, the bridge component having a second lower contact surface configured for engaging a resected bone surface of a pedicle of the lower vertebrae (see Fig. 5), wherein the distal end of the bridge component comprises a connection component (see Fig. 22, element 640) adapted to receive a first fastener (74).
[AltContent: textbox (Upper Posterior Limiter Surface)][AltContent: arrow][AltContent: textbox (Second Lower Contact Surface)][AltContent: arrow][AltContent: textbox (First Lower Contact Surface)][AltContent: arrow]
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Concerning claim 2, wherein at least a portion of the second lower contact surface comprises a textured surface (see par. 0055).
Concerning claim 3, wherein at least a portion of the second lower contact surface comprises an osteoconductive material (see par. 0055).
Concerning claim 4, wherein at least a portion of the second lower contact surface comprises an osteoinductive material (see par. 0055).
Concerning claim 5, wherein the first lower contact surface is substantially parallel to the second lower contact surface (see Fig. 21 above).
Concerning claim 7, wherein the upper joint component further comprises an upper anterior limiter surface (see Fig. 5 below) and the lower joint component further comprises a lower anterior limiter surface (see Fig. 5 below), wherein the generally convex lower articulation surface is positioned between the lower anterior limiter surface and the bridge component.
[AltContent: textbox (Lower anterior limiter surface)][AltContent: arrow][AltContent: textbox (Upper anterior limiter surface)][AltContent: arrow]
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Concerning claim 8, wherein the first fastener comprises a bone screw (74).
Concerning claims 9 and 10, wherein the upper joint component further comprises an upper posterior limiter surfaced (see Fig. 22 above) and the lower joint component further comprises a lower posterior limiter surface (see Fig. 22, element 682), wherein the lower posterior limiter surface is positioned between the generally convex lower articulation surface and the distal end of the bridge component.
Concerning claim 11, wherein the upper and lower posterior limiter surfaces are spaced apart when the upper and lower anterior limiter surfaces are engaged together (articulation of device forward – away from bridge).
Concerning claim 12, wherein the upper and lower anterior limiter surfaces are spaced apart when the upper and lower posterior limiter surfaces are engaged together (articulation of the device backward – toward bridge).
Concerning claim 13, wherein a medial-lateral width of the upper joint component is substantially equal to a medial-lateral width of the lower joint component (see Figs. 21-22).
Concerning claim 14, wherein the upper contact surface further comprises an upwardly extending keel (see Fig. 21) extending along at least a portion of the upper contact surface.
Concerning claim 15, wherein the first lower contact surface further comprises a downwardly extending keel (see Fig. 5, element 52) extending along at least a portion of the first lower contact surface.
Concerning claim 16, Yu et al. disclose a prosthetic system (see Figs. 21-24 and 5-7) for implantation between upper and lower vertebrae, the system comprising a first articulating component and a second articulating component, the first articulating component being substantially identical in construction to the second articulating component, each of the first and second articulating components comprising: an upper joint component comprising an upper contact surface for engaging a resected lower surface of the upper vertebrae and a generally concave upper articulation surface; a lower joint component comprising a first lower contact surface for engaging a resected upper surface of the lower vertebrae and a generally convex lower articulation surface configured to movably engage the generally concave upper articulation surface to form an articulating joint, wherein the articulating joint is adapted for implantation within a disc space between the upper and lower vertebrae, allowing the upper and lower vertebrae to move relative to one another; and a bridge component extending posteriorly from the lower joint component and from the disc space, the bridge component having a second lower contact surface configured for engaging a resected bone surface of a pedicle of the lower vertebrae, wherein the distal end of the bridge component comprises a connection component adapted to receive a first fastener (see annotated Figs. 21, 22 and 5 above).
Concerning claim 17, wherein each of the first and second articulating components further comprises an upper anterior limiter surface on the upper joint component and a lower anterior limiter surface on the lower joint component, wherein the generally convex lower articulation surface is positioned between the lower anterior limiter surface and the bridge component (see Fig. 5 above).
Concerning claim 18, wherein each of the first and second articulating components further comprises an upper posterior limiter surface on the upper joint component (see Fig. 22 above) and a lower posterior limiter surface (see Fig. 22, element 682) on the lower joint component, wherein the lower posterior limiter surface is positioned between the generally convex lower articulation surface and the distal end of the bridge component.
Concerning claim 19, wherein the upper and lower posterior limiter surfaces of each of the first and second articulating components are spaced apart when the upper and lower anterior limiter surfaces are engaged together (articulation of device forward – away from bridge).
Concerning claim 20, wherein the upper and lower anterior limiter surfaces of each of the first and second articulating components are spaced apart when the upper and lower posterior limiter surfaces are engaged together (articulation of device backward – toward the bridge).
Concerning claim 6, Yu et al. disclose a prosthetic system for implantation between upper and lower vertebrae, the system comprising: an upper joint component (see Fig. 5, element22) comprising an upper contact surface for engaging a resected lower surface of the upper vertebrae and a generally concave upper articulation surface (see par. 0053); a lower joint component (24) comprising a first lower contact surface for engaging a resected upper surface of the lower vertebrae and a generally convex lower articulation surface configured to movably engage the generally concave upper articulation surface to form an articulating joint, wherein the articulating joint is adapted for implantation within a disc space between the upper and lower vertebrae, allowing the upper and lower vertebrae to move relative to one another; and a bridge component (see Fig. 5, element 36) extending posteriorly from the lower joint component and from the disc space, the bridge component having a second lower contact surface configured for engaging a resected bone surface of a pedicle of the lower vertebrae (see Fig. 5), wherein the distal end of the bridge component comprises a connection component (see Fig. 6, element 34) adapted to receive a first fastener (74), wherein the second lower contact surface includes a recessed portion (within element 66) that accommodates a portion of the first fastener.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Applicant’s attention is directed to Fig. 28 of U.S. 20050154461 which discloses the claimed invention at least of claims 1 and 16.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLEN HAMMOND whose telephone number is (571)270-3819. The examiner can normally be reached Monday-Friday 8 - 4 PM .
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo C. Robert, at 571 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ELLEN C HAMMOND/ Primary Examiner, Art Unit 3773