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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/16/2026 has been entered.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/203,118, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Provisional Application No. 63/203,118 does not disclose a stabilizing plate as required by independent claims 1 and 13. Accordingly, the effective filing date of claims 1-2, 4-5, 13, 19, 26 is 8/24/2021 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 21-24 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 21, 22, 23 and 24 each depend from cancelled claim 6 and therefore are incomplete claims. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1, 2, 4, 5, 26 and 13, 19, 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Malek (US Publication No. 2010/0121378 A1) in view of Al-Jazaeri et al. (US Publication No. 2021/0106432 A1) and Robioneck et al. (US Patent No. 6296647 B1).
Regarding Claim 13, Malek discloses a system for facet joint fusion comprising:
a body (100) defining a cavity (interior space 110) [0026] for receiving a bone grafting material (“facet joint fusion cages 100, 200 include bone graft material or bone substitute material in the inner space 110, 223, 228”, [0039]), the body configured to be inserted between an inferior facet and a superior facet of a facet joint [0024];
a first fastener (152) for securing the body, at least indirectly, to the inferior facet; and
a second fastener (151) for securing the body, at least indirectly, to the superior facet [0027-0028].
Malek discloses “where the facet fusion cage used in the method includes one or more buttress plates, the methods include securing the one or more buttress plates to the vertebrae”, [0045], and “the buttress plates 370 have holes for receiving a bone screw … for engaging bone”, [0031]). However, Malek does not expressly describe a first fastener through the plate secured to the superior facet and a second fastener through the plate secured to an inferior facet. Malek also describes the buttress plate attached to the first part, the second part or both the first and second parts of the cage or connected to an exterior surface of the cage [0008, 0031], but Malek silent to the attachment between the plate and the body comprising a threaded stem extending from the body and a slot in the plate through which the stem is received with a nut secured on the stem for securing the plate to the body, the stem being adjustable relative to the plate along a length of the slot perpendicular to the stem axis.
Al-Jazaeri discloses a facet fusion method in the same field of endeavor wherein a stabilization plate (130) attached to an implant body (10) is stabilized with a first screw (146) through the plate secured to the superior facet (143) and a second screw (146) through the plate secured to an inferior facet (145) (Fig 28A-B, [0277, Al-Jazaeri]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use a first screw through the plate secured to the superior facet and a second screw through the plate secured to an inferior facet as taught by Al-Jazaeri in order to provide a fastener arrangement known in the art to stabilize a facet joint on both sides of the joint.
Robioneck teaches a connection between an intervertebral implant body (10/12) and a stabilization plate (32) in the analogous art of interspinous implants (Fig. 1-2). Robioneck teaches that the plate (32) is connected or attached to the body (10/12) via a threaded stem (46) extending from the body and an elongated slot (40) in the plate through which the stem is received with a nut (51) secured on the stem (46) for securing the plate to the body (col. 4; ln. 20-37) (Fig. 1-2).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to connect the body and plate of Malek with a threaded stem extending from the body and an elongate slot in the plate through which the stem is received with a nut secured on the stem for securing the plate to the body, as taught by Robioneck in order to use a connection known in the art to predictably secure a plate to an interspinous implant. This connection with the elongate slot in the plate as taught by Robioneck would allow the stem to be adjustable relative to the plate along a length of the slot perpendicular to the stem axis.
Regarding Claim 19, the stabilizing plate (370, Malek) comprises a wedge element (see figure below), wherein the wedge element is fully capable of engaging the superior facet and secures the superior facet between the body and the stabilizing plate.
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Regarding Claim 25, the wedge element (see figure above) is fully capable of engaging a back side of the superior facet (back side can be considered facing in cephalad direction).
Regarding Claim 1, Malek discloses a method for facet joint fusion comprising:
filling a cavity of a body (100) of a device with a bone grafting material (“facet joint fusion cages 100, 200 include bone graft material or bone substitute material in the inner space 110, 223, 228”, [0039]);
inserting the body (100) of the device between an inferior facet and a superior facet of a facet joint (“positioning a facet fusion cage in the facet joint of a patient in need of facet joint fusion” [0045]); and
attaching a stabilizing plate (“buttress plate”) to the body and securing the inferior facet to the superior facet (“Where the facet fusion cage used in the method includes one or more buttress plates, the methods include securing the one or more buttress plates to the vertebrae”, [0045]).
However, Malek does not expressly show a first fastener/ screw through the plate secured to the superior facet and a second fastener/ screw through the plate secured to an inferior facet but does disclose that the plate could have holes to receive bone screws [0031].
Al-Jazaeri discloses a facet fusion method in the same field of endeavor wherein a stabilization plate (130) attached to an implant body (10) is stabilized with a first screw (146) through the plate secured to the superior facet (143) and a second screw (146) through the plate secured to an inferior facet (145) (Fig 28A-B, [0277, Al-Jazaeri]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use a first screw through the plate secured to the superior facet and a second screw through the plate secured to an inferior facet as taught by Al-Jazaeri in order to provide a fastener arrangement known in the art to stabilize a facet joint on both sides of the joint.
Malek further discloses the buttress plates 370 are connected to an exterior surface of the fusion cage 100 [0008, 0031, Malek], but to the attachment between the plate and the body comprising a threaded stem extending from the body and a slot in the plate through which the stem is received with a nut secured on the stem for securing the plate to the body, the stem being adjustable relative to the plate along a length of the slot perpendicular to the stem axis.
Robioneck teaches a connection between an intervertebral implant body (10/12) and a stabilization plate (32) in the analogous art of interspinous implants (Fig. 1-2). Robioneck teaches that the plate (32) is connected or attached to the body (10/12) via a threaded stem (46) extending from the body and an elongated slot (40) in the plate through which the stem is received with a nut (51) secured on the stem (46) for securing the plate to the body (col. 4; ln. 20-37) (Fig. 1-2).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to connect the body and plate of Malek with a threaded stem extending from the body and an elongate slot in the plate through which the stem is received with a nut secured on the stem for securing the plate to the body, as taught by Robioneck in order to use a connection known in the art to predictably secure a plate to an interspinous implant. This connection with the elongate slot in the plate as taught by Robioneck would allow the stem to be adjustable relative to the plate along a length of the slot perpendicular to the stem axis.
Regarding Claim 2, Malek discloses decorticating a surface of the inferior facet forming a decorticated inferior facet surface; and decorticating a surface of the superior facet forming a decorticated superior facet surface (“decorticating an interior surface of a facet joint with the rasp”) , wherein the body of the device is inserted between the decorticated inferior facet surface and the decorticated superior facet surface [0050, 0051, 0053, Malek].
Regarding Claim 4, Malek discloses that the use of the plate clamps the implant body between the superior and inferior facets [0037, Malek].
Regarding Claim 5, Malek discloses the body comprises a tapered prism (Fusion cage 100 may have wedged profile, [0038, Malek]).
Regarding Claim 26, as modified with the connection of the threaded stem extending from the body and an elongate slot in the plate through which the stem is received with a nut secured on the stem for securing the plate to the body, as taught by Robioneck in the rejection of claim 1 above, the prism shaped body of Malek can be movable along the elongated slot of the plate to locate the body within the joint.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 13 have been considered but are moot because of the new grounds of rejection necessitated by amendment.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See Form PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE T JOHANAS whose telephone number is (571)270-5085. The examiner can normally be reached Mon. - Fri. 9:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached 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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/JACQUELINE T JOHANAS/ Primary Patent Examiner, Art Unit 3773