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 .
Drawings
The drawings were received on 4/30/26. These drawings are acceptable.
Claim Objections
Claim 6 is objected to because of the following informalities: Claim 6 contains the status identifier “Currently amended” however no amendments appear to exist in the claim. Based on the lack of amendments in the claim, the examiner understands this claim to have the status of “Original”. Appropriate correction is required.
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 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.
Claim(s) 1-4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by He et al. (CN 103860297 A).
Regarding Claim 1, He discloses a prosthetic device (“bionic artificial atlanto-odontiod of the invention tooth joint”, [0038], Fig. 1) fully capable of supporting an atlantoaxial joint between a C1 vertebra and a C2 vertebra after an endoscopic endonasal odontoidectomy procedure resulting in a C1 vertebra without an anterior arch and a C2 vertebra without a dens, the device comprising:
a. a prosthetic dens replacement (“epistropheus part” see figure below, [0038]) which is capable of being fixed to the C2 vertebra via at least two screws (screws can extend through holes 2 shown in Fig. 1 [0040]); and;
b. a bracket (“atlas part”, see figure below, [0038]) to replace the anterior arch of the C1 vertebra, wherein the bracket is capable of being affixed to lateral masses of the C1 vertebra via at least two screws (screws can extend through holes 2 shown in Fig. 1 [0040]); wherein the bracket, when affixed to the C1 vertebra, is engageable with the dens replacement that is affixed to the C2 vertebra (shown engaged in Fig. 1-2, 5).
Both the a prosthetic dens replacement (“epistropheus part”) and the bracket (“atlas part”) have a small enough profile to pass through a patient’s endonasal corridor (see small sizes described in [0043-0048]) and both the parts are capable of being affixed without a posterior arthrodesis procedure (Fig 8 of He shows the anterior view of the installed device, there is no posterior component and the fasteners extending through the dens and bracket parts to engage the vertebral bone have the tool-engagement ends facing anteriorly as shown in Fig 8 below).
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Regarding Claim 2, the prosthetic dens replacement is capable of being fixed to the C2 vertebra via at least two cantilevered screws (at least two cantilevered screws can be fixed within holes 2 of epistropheus part shown in Fig. 1, [0040]).
Regarding Claim 3, the prosthetic dens replacement comprises titanium (“the atlas part, epistropheus part and bolt 8 is made of medical titanium alloy material”, [0039]).
Regarding Claim 4, the bracket comprises titanium (“the atlas part, epistropheus part and bolt 8 is made of medical titanium alloy material”, [0039]).
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.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over He et al. (CN 103860297 A) in view of Faulhaber (US Publication No. 2016/0051373 A1).
Regarding Claim 5, He discloses the device of claim 1 as described in the rejection above. He discloses that the surface of the joint and the arc plate are provided with a hydroxyapatite coating but is silent to the prosthetic dens replacement and the bracket comprise an antibiotic coating.
Faulhaber teaches providing an implant with a therapeutic coating such as antibiotic agents in the analogous art of vertebral implants [0026].
It would have been obvious to one having ordinary skill in the art before the effective filing date to apply an antibiotic agent coating to the device of He in order to provide a therapeutic effect as taught by Faulhaber.
Claim(s) 6-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over He et al. (CN 103860297 A) in view of Laufer et al. (“Endonasal endoscopic resection of the odontoid process in a nonachondroplastic dwarf with juvenile rheumatoid arthritis: feasibility of the approach and utility of the intraoperative Iso-C three-dimensional navigation.”, JNeurosurg Spine 2008)
Regarding Claim 6, He discloses the device of claim 1 as described in the rejection above. In Fig. 8, He shows the device implanted on the anterior side of the C1 and C2 vertebrae which shows c. positioning and fixing the prosthetic dens replacement to the patient's C2 vertebra where the dens was previously; e. positioning and fixing the bracket to the patient's C1 vertebra where the anterior arch of C1 was previously; and f. engaging the bracket with the prosthetic dens replacement.
However, He is silent to the approach of removing the parts of the C1 and C2 vertebrae and installing the prosthetic device including:
a. performing an endoscopic endonasal odontoidectomy procedure wherein the patient's anterior arch is removed from the patient's C1 vertebra and the patient's dens is removed from the patient's C2 vertebra;
b. placing the prosthetic dens replacement of claim 1 through a patient's endonasal corridor;
d. placing the bracket of claim 1 through a patient's endonasal corridor.
Laufer discloses an endoscopic endonasal odontoidectomy procedure in the same field of endeavor wherein the patient's anterior arch is removed from the patient's C1 vertebra and the patient's dens is removed from the patient's C2 vertebra. Laufer discloses the benefits of using a transnasal approach includes decrease of the risk of tongue and tracheal swelling, hypernasal and nasal speech and wound infection (page 378).
It would have been obvious to one having ordinary skill in the art to remove the C1 and C2 areas to be replaced with an endoscopic endonasal odontoidectomy in order to use an approach which decreases of the risk of tongue and tracheal swelling, hypernasal and nasal speech and wound infection. In using an endoscopic endonasal approach to remove the bone, it would have also been obvious to utilize the same approach pathway to insert the prosthetic components for the surgery in order to reduce the number of incisions in the patient.
Regarding Claim 7, Laufer further discloses the endoscopic endonasal odontoidectomy procedure comprises: a. exposing the patient's O-C1 joint through the endonasal corridor using an inferior U-shaped nasopharyngeal flap; and b. removing the anterior arch of the patient's C1 vertebra and the dens of the patient's C2 vertebra.(on page 378: “An inverted U-shaped incision was made in the basopharyngeal fascia with its superior extent just below the sphenoid sinus, passing down the clivus with its lateral limits just medial to the eustachian tube and its base at the level of the C-2 vertebral body (Fig. 4A). The flap was pushed inferiorly into the oropharynx and the longus colli and capitis muscles were pushed laterally with the bovie to expose the ring of C-1. The arch of C-1 was removed with a high-speed drill (Fig. 4B) to expose the lateral margins of the dens, which was transected across its base.”)
Regarding Claim 8, He shows the dens replacement is fixed to the C2 vertebra via at least two cantilevered screws (8, fig. 8, He).
Regarding Claim 9, He shows the bracket is fixed to the C1 vertebra via at least two screws (8, fig. 8, He).
Regarding Claim 10, Laufer discloses the use of neuronavigation (Laufer pg. 377, “The Iso-C system (Siremobil Iso-C Three-Dimensional, Siemens Medical Solutions) with 3D fluoroscopic reconstruction was used for frameless stereotactic navigation (BrainLAB)”). It would have been obvious to further include using neuronavigation guidance when operating on the C1 and C2 vertebra installing the device in order to ensure proper placement of surgical tools and devices to avoid injury to the patient.
Regarding Claims 11 and 12, He discloses the prosthetic dens replacement and bracket comprise titanium (“the atlas part, epistropheus part and bolt 8 is made of medical titanium alloy material”, [0039, He]).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over He et al. (CN 103860297 A) in view of Laufer et al. (“Endonasal endoscopic resection of the odontoid process in a nonachondroplastic dwarf with juvenile rheumatoid arthritis: feasibility of the approach and utility of the intraoperative Iso-C three-dimensional navigation.”, JNeurosurg Spine 2008) and in view of Faulhaber (US Publication No. 2016/0051373 A1).
Regarding Claim 13, He in view of Laufer discloses the method of claim 6 as described in the rejection above. He discloses that the surface of the joint and the arc plate are provided with a hydroxyapatite coating but is silent to the prosthetic dens replacement and the bracket comprise an antibiotic coating.
Faulhaber teaches providing an implant with a therapeutic coating such as antibiotic agents in the analogous art of vertebral implants [0026].
It would have been obvious to one having ordinary skill in the art before the effective filing date to apply an antibiotic agent coating to the device of He in order to provide a therapeutic effect as taught by Faulhaber.
Response to Arguments
Applicant's arguments filed 4/30/26 have been fully considered but they are not persuasive.
Applicant argues that the device of He is intended to be attached via a posterior arthrodesis procedure based on the screw arrangement shown in Fig 8 and therefore does not disclose a device capable of being affixed without a posterior arthrodesis procedure. This is not persuasive because the view shown in Fig. 8 of He is an anterior view of the joint with device attached. As can be seen below, the screws are engaged from an anterior direction and there is no posterior component to the fixation system. Therefore He teaches a device capable of being affixed without a posterior arthrodesis procedure.
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Applicant argues that the components of He do not have a profile small enough to pass through the a patient’s endonasal corridor. This is not found persuasive because He describes the small dimensions of the device:
[0043] the outer radius of the joint ball is 10.2 mm, the inner radius is 5.35 mm, the height is 2.5 mm, the cone height is 10.9 mm, included angle alpha of the outer side wall of the round table is 10 degrees, circular in side wall angle b is 20 degrees (see FIG. 6).
[0044] arc wing composed of middle parallel part and two sides of the downward arc-shaped parts, two side downward angle c of the arc part is 160 degrees (see FIG. 7), the inner edge diameter is 97.5 mm, outside diameter is 100 mm, the total width is 48 mm, the height is 10.9 mm, and the thickness is 2.5 mm.
[0045] circle centre of the screw hole on the arc-shaped side wing distance is 36 mm, the radius of the screw hole is 3.5 mm. arc wing coated with hydroxyapatite coating.
[0046] joint with the arc wing is integrally formed, two part joint to arc radius is 1.5 mm connection.
[0047] diameter of ball joint top hemisphere (ball) is 10.7 mm, cylinder total height below connection is 10.9 mm, the tooth height of the bottom cylinder is 0.3 mm, the width is 0.43 mm, the tooth angle is 60 degrees, forming jagged bone-contacting surface.
[0048] arc plate thickness is 2 mm, is 3 mm, the total height is 22.5 mm. angle between bone-contacting surface and the bottom of the column of the arc-shaped plate is 125 degrees. arc surface inner diameter is 61 mm. under the arc plate is semicircular, and the diameter is 18.3 mm, the arc width is 10.7 mm, and the cylinder is the same, connected by an inclined surface. arc plate inner face (the bone-contacting surface) coated with a hydroxyapatite coating.
The examiner contends that these small dimensions of the device are fully capable of being placed through a retracted endonasal corridor of an adult human.
Conclusion
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 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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/JACQUELINE T JOHANAS/ Primary Patent Examiner, Art Unit 3773
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