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 .
Claim Objections
Claims 8, 13, 15 and 16 are objected to because of the following informalities:
Claim 8 recites the limitation “one or the other or both”. To avoid confusion about the limits of claim 8, it will read as “further comprising teeth or ridges or both teeth and ridges on the superior face or inferior face or both the superior and inferior face”
Claim 13 recites “the anterior aspect”. For purposes of consistency this will be read as “an anterior aspect” where “aspect” is interpreted as a view.
Claim 15, “wherein a portion of said fixator port” should read “wherein a portion of one of the one or more fixator ports”.
Claim 16, “further comprising two fixator ports” should read “further comprises two fixator ports of the one or more fixator ports”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7, 9, 12 – 14, 18 – 20 and 22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 7 recites “wherein entire said blocking cams are inset”. Claim 7 is dependent upon claim 1 which recites “a blocking cam”. Emphasis is made on a single blocking cam, however claim 7 recites a plural recitation of the blocking cam(s). Therefore, it is unclear if claim 7 is meant to introduce a plurality of blocking cams or if it is directed towards the single blocking cam. For purposes of examination a single blocking cam is assumed. In addition, there appears to be a typographical error in the language. Claim 7 will be read as “wherein the entire blocking cam is inset from the external face”.
Claim 9 recites “wherein at least one cam port” and “two fixator ports”. It is unclear if these are meant to be the same as or different than “the cam port” and “the one or more fixator ports” of claim 1. For purposes of examination, they are assumed to be the same and claim 9 will be read as “wherein the cam port is at least one cam port and is positioned between two fixator ports of the at least one fixator port”.
Claim 12 recites “the blocking cams”, in plural forms. However, claim 1 only recites a single blocking cam. Therefor it is unclear if claim 12 is meant to introduce a plurality of blocking cams or the single blocking cam. In addition, it is unclear if the bone anchor, which was functionally recited in claim 1, is meant to be added to the claimed fixation device in a positive recitation. For purposes of examination claim 12 will read as “wherein said blocking cam and said bone anchor are distanced internally from the said external face…” where the bone anchor is not assumed to be part of the claimed invention.
Claim 13 recites plural cam ports, but is dependent upon claim 1 which only recites a single cam port. Therefore, it is unclear if claim 13 is meant to change the single cam port to a plurality of cam ports or maintain the single cam port. For purposes of examination only a single cam port is assumed.
Claim 14 recites “from a single blocking cam”. It is unclear if the this is the same as the blocking cam from claim 1, or if claim 14 is trying to introduce more than one blocking cam. For purpose of examination, only a single blocking cam is assumed. In addition, claim 14 will be read as “wherein in a locked mode, tabs from the blocking cam extend into two separate fixator ports of the one or more fixator ports”.
Claim 18, there is a lack of antecedent basis for the term “said head face”. In addition, it is unclear to which component the head face belongs. For purposes of examination claim 18 will be read as “wherein a head face of the blocking cam and said capture face of the cam port are configured to ….”.
Claim 19, there is a lack of antecedent basis for the term “said head face”. For purposes of examination claim 19 will be read as “a detent on a head face of the blocking cam”.
Claim 20 recites “a plurality of bone anchors”. It is unclear if these bone anchors are the same as or different from the functionally recited bone anchor of claim 1. For purposes of examination, they are assumed to be the same.
Claim 22 discloses “a plurality of bone anchors”. It is unclear if these are meant to be the same as or different from the functionally recited bone anchor of claim 21. For purposes of examination, they are assumed to be the same.
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.
Claim(s) 1, 3, 4, 7-10, 12-15, 17, 18 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Robinson et al. (US 2022/0087819 A1).
Regarding claim 1, Robinson discloses an orthopedic fixation device operable for implantation in an intervertebral space in an implanted mode (Abstract) comprising:
an intervertebral spacer (paragraph [0079], ref. 140, Figs 14 – 15);
said intervertebral spacer comprising a boundary wall defining an external boundary of said intervertebral spacer (the “sidewalls” is considered to the boundary wall as disclosed in paragraph [0079]);
said intervertebral spacer comprising a superior face on said boundary wall facing superiorly for engaging an endplate of a vertebral body (see remarked Fig. 17 below);
said intervertebral spacer comprising an inferior face on said boundary wall facing inferiorly for engaging an endplate of a vertebral body (see remarked Fig. 17 below);
said intervertebral spacer comprising an external face facing away from said intervertebral spacer and extending between said superior face and said inferior face on said boundary wall (see remarked Fig. 17 below);
said intervertebral spacer comprising an internal face spaced inward from said external face on said boundary wall and extending between said superior face and said inferior face on said boundary wall (ref. 152);
at least a portion of said internal face defining a bone cavity extending between said superior face and said inferior face (ref. 52, Fig. 17);
one or more fixator ports (ref. 173) operable for housing at least a portion of a bone anchor (ref. 181) therein;
said one or more fixator ports extending through said external face and extending toward one or more of said superior face and said inferior face (Figs. 17 - 19);
a blocking cam (paragraph [0086], ref. 195);
said blocking cam comprising a round central body (see remarked Fig. 20 below);
said blocking cam having a central drive pocket extending through said central body operable for receiving a tool to impart rotation on said blocking cam (Fig. 20, ref. 220);
a pair of opposed tabs extending outward from said central body (Fig. 20, refs. 224, 227);
a cam port (paragraph [0085], ref. 200);
said cam port extending into said boundary wall through said external face (Fig. 14);
said cam port at least partially defined by a rounded head capture face operable for seating a portion of said round central body therein (see remarked Fig. 14)
a tab guide face (see remarked Fig. 14 below);
said tab guide face extending from said head capture face (Fig. 14);
said tab guide face defining a cam window extending between said cam port and adjacent said fixator port (see remarked Fig. 14 below);
one of said opposed tabs at least partially housed in said cam window (Fig. 17); and,
wherein said blocking cam is irremovable after manufacture from said intervertebral spacer without destruction of said blocking cam or said intervertebral spacer or both (paragraph [0087] discloses a pin ref. 218 which locks the blocking cam ref. 195 to the implant while still allowing it to rotate between positions to block the bone anchors).
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Regarding claim 3, Robinson discloses the orthopedic fixation device of claim 1 further comprising: a second cam window; said second cam window extending between said cam port and a second adjacent fixator port (as shown in Figs. 17 – 18, there are two cam windows to hold each of the tabs of the blocking cam).
Regarding claim 4, Robinson discloses the orthopedic fixation device of claim 1 further comprising: said fixator port comprising a reduced diameter neck face; a bone anchor; said bone anchor having an enlarged head; wherein in said implanted mode, said enlarged head is positioned between said neck face and one of said opposed tabs (as shown in Figs. 17 – 17, the fixator port narrows from a wide exterior opening to a narrower channel which is considered the reduced diameter neck face and the enlarged head, see FIG. 10, is situated between a respective tab and the neck face).
Regarding claim 7, Robinson discloses the orthopedic fixation device of claim 1 wherein entire said blocking cams are inset from said external face (Fig. 19).
Regarding claim 8, Robinson discloses the orthopedic fixation device of claim 1 further comprising a plurality of one or the other or both of teeth and ridges extending from one or the other or both of said superior face and said inferior face (Fig. 19 show ridges on both the superior and inferior faces).
Regarding claim 9, Robinson discloses the orthopedic fixation device of claim 1 wherein at least one cam port is positioned between two fixator ports (Fig. 18).
Regarding claim 10, Robinson discloses the orthopedic fixation device of claim 1 wherein said intervertebral spacer is manufactured from a non-porous material (paragraph [0008] discloses a metal alloy body which is considered to be non-porous).
Regarding claim 12, Robinson discloses the orthopedic fixation device of claim 1 wherein said blocking cams and said bone anchors are distanced internally from said external face in an implanted mode (Fig. 19).
Regarding claim 13, Robinson discloses the orthopedic fixation device of claim 1 wherein said cam ports and said fixator ports extend through said external face on the anterior aspect (Fig. 18).
Regarding claim 14, Robinson discloses the orthopedic fixation device of claim 1 wherein in a locked mode, tabs from a single blocking cam extend into two separate fixator ports (Fig. 18).
Regarding claim 15, Robinson discloses the orthopedic fixation device of claim 1 wherein a portion of said fixator port extends through an internal face and at least one of said superior face and said inferior face (Fig. 19 shows one of the at least one fixator ports extending through the internal face and the inferior face).
Regarding claim 17, Robinson discloses the orthopedic fixation device of claim 1 wherein said drive pocket is partially defined by a plurality of inset drive faces for receiving torque from a tool (Fig. 20 shows a plurality of concave and convex faces which are fully capable of receiving a tool and being torqued).
Regarding claim 18, Robinson discloses the orthopedic fixation device of claim 1 wherein said head face and said head capture face are configured to have increased friction therebetween as said blocking cam approaches a locked mode (as the blocking cam is rotated, the pin ref. 218 will slide into slot ref. 225 thus increasing friction and ultimately stopping rotation after a point).
Regarding claim 20, Robinson discloses the orthopedic fixation device of claim 1 further comprising: a plurality of bone anchors (Fig. 16, refs. 181, 179); said bone anchors seated in said fixator ports (Fig. 16); one or more of said bone anchors extending through said superior face (Fig. 16); and, wherein said one or more of said bone anchors extend through said inferior face in an implanted mode (Fig. 16).
Claim(s) 21 – 25 and 27 - 29 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Flickinger et al. (US 11/298,159 B1).
Regarding claim 21, Flickinger discloses an orthopedic fixation device in an implanted mode operable for fixation on a surface of a bone (Abstract) comprising:
a fixation plate (Fig. 1, refs. 100, 200);
said fixation plate comprising an internal face configured to face bone (bottom face ref. 104);
said fixation plate comprising an external face configured to face away from bone (top face ref. 102);
a bounding face encircling said fixation plate and extending between said internal face and said external face (this is considered to be the circumferential wall or side wall of the plate);
a plurality of fixator ports (Fig. 1, ref. 116);
said fixator ports extending between said external face and said internal face and operable for seating a bone anchor therein (Fig. 5A shows bone anchors seated within the ports);
said fixation plate having an integrated blocking mechanism (Fig. 3, ref. 300);
said integrated blocking mechanism comprising a blocking cam (see remarked Fig. 3 below) positioned adjacent at least one fixator port (Fig. 5A);
said blocking cam comprising a circular central body (Fig. 3, ref. 308);
one or more tabs (ref. 310, Fig. 3) extending outward from said central body (Fig. 3);
a pivot flange (ref. 306) on one end of said blocking cam encircling said central body (see remarked Fig. 3 below); and,
wherein said blocking cam is irremovable from said fixation plate without destruction of said blocking cam or said bone plate or both (Col. 7, lines 15 – 25 discloses a permanent connection between the integrated blocking mechanisms and the plate, for example via welding the cam to the plate via ref. 312).
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Regarding claim 22, Flickinger discloses the orthopedic fixation device of claim 21 further comprising a plurality of bone anchors operable for seating within said fixation ports to secure said fixation plate to bone (Figs. 5A – 5B).
Regarding claim 23, Flickinger discloses the orthopedic fixation device of claim 21 wherein said fixator ports are aligned in pairs along said fixation plate (Fig. 5A shows two pairs).
Regarding claim 24, Flickinger discloses the orthopedic fixation device of claim 21 wherein said blocking cam is positioned between a pair of said fixator ports (Fig. 5A).
Regarding claim 25, Flickinger discloses the orthopedic fixation device of claim 21 wherein said blocking cam is switchable between a locked mode wherein said one or more tabs block removal of at least one of said bone anchors and an unlocked mode wherein said one or more tabs are clear from blocking removal of at least one of said bone anchors (Fig. 5A shows an unlocking mode and Fig. 5B shows the locked mode).
Regarding claim 27, Flickinger discloses the orthopedic fixation device of claim 21 further comprising a plate window spaced from a peripheral edge of said fixation plate and extending through said fixation plate (Fig. 1, ref. 108).
Regarding claim 28, Flickinger discloses the orthopedic fixation device of claim 21 further comprising: a retainer groove (refs. 216, 216’) formed in said fixation plate; and wherein said pivot flange is seated in said retainer groove (Co. 7, lines 15 – 25).
Regarding claim 29, Flickinger discloses the orthopedic fixation device of claim 21 wherein said blocking cam comprises a drive pocket extending through said central body operable for driving said blocking cam between a locked mode and an unlocked mode (Figs. 5A and 5B show a driving pocket, in a hexagon shape on a top surface of the device).
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) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Robinson et al. (US 2022/0087819 A1) in view of MacMillan et al. (US 2021/0085483 A1).
Regarding claim 11, Robinson discloses the orthopedic fixation device of claim 1 except wherein said intervertebral spacer comprises an open lattice structure. It is noted that Robinson does disclose a porous material (paragraph [0008]), but it not clear if the porous material is an open lattice structure.
MacMillan teaches an analogous orthopedic fixation device (Abstract) comprising an opening lattice structure (paragraph [0036]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the porous material of Robinson, to be an open lattice structure, as taught by MacMillan for the purpose of better holding graft material and thus enhanced osseointegration and bone ingrowth.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Robinson et al. (US 2022/0087819 A1) in view of Hapstack (US 2021/0251769 A1).
Regarding claim 16, Robinson discloses the orthopedic fixation device of claim 1 except for further comprising two fixator ports that extend through said superior face.
Hapstack teaches an analogous orthopedic fixation device (Abstract) comprising a plurality of fixator ports (Fig. 2) that extend through a superior face (Fig. 2, paragraph [0047]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the fixator ports such that two fixator ports extend through the superior face, as taught by Hapstack, for the purpose of better anchoring into the vertebrae.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Robinson et al. (US 2022/0087819 A1) in view of McLuen et al. (US 2021/0068973 A1).
Regarding claim 19, Robinson discloses the orthopedic fixation device of claim 1 except for further comprising: a detent on said head face of said blocking cam; a head dimple extending from said head capture face; wherein interaction between said detent and said head dimple provide tactile feedback to the user to indicate one or the other or both of a locked mode and unlocked mode.
McLuen teaches an orthopedic fixation device (Abstract) comprising a detent (ref. 306) on a head face of a locking mechanism (Fig. 3B, refs. 302); a head dimple (ref. 310) on a head capture face (ref. 308, Fig. 3B); wherein interaction between said detent and said head dimple provide tactile feedback to the user to indicate a rotational alignment. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the head face and head capture face of the fixation device of Robinson to include a detent on said head face of said blocking cam; a head dimple extending from said head capture face, as taught by McLuen, for the purpose of providing an anti-slipping or position locking function (paragraph [0067]). Please note that the tactile feed back is fully capable of indicating the unlocked or locked position.
Allowable Subject Matter
Claims 2, 5, 6 and 26 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Claims 2, 5, 6 and 26 in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found to disclose, or suggest a an orthopedic fixation device wherein the cam port face is of smaller diameter than said head capture face (claim 2), a threaded control face extending between the head capture face and the internal face (claim 5 – 6) and a threaded anchor hole being aligned with the central body of the blocking mechanisms (claim 26).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 which lists the prior art used in the current rejection.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TESSA M MATTHEWS whose telephone number is (571)272-8817. The examiner can normally be reached M - F 8am - 1pm.
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/TESSA M MATTHEWS/Examiner, Art Unit 3773