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 .
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.
Claim 12 is 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 12 recites the limitation “the first protrusion" in line 3. There is insufficient antecedent basis for this limitation in the claim. No first protrusion has been introduced in the claims prior to this recitation. In light of the specification, the office will interpret this to read “the inner member”.
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.
Claims 1-12 and 17-19 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Perryman et al. (US 11826082 B1) (hereon referred to as Perryman).
Regarding claim 1, Perryman teaches an implant (10, see Fig. 4) for connecting a lamina having an edge separated from a lateral mass of a vertebra during a laminoplasty procedure (see Fig. 3), the implant comprising:
a first portion (13) configured to engage with the lateral mass (note that this is a functional recitation; the device is capable of being oriented such that 13 is in contact with the lateral mass), the first portion (13) defining a surface (see labelled diagram of Fig. 4 below) for interfacing with the lateral mass (see the note on this functional recitation above), the first portion defining a transverse opening (see labelled diagram of Fig. 4 below) for receiving a fastener for fixing the first portion to the lateral mass (see Col. 3, ll. 12-17);
a second portion (11 and 12) configured to engage with the edge of the lamina separated from the lateral mass during the laminoplasty procedure (note that this is a functional recitation; the device is capable of being oriented such that 11 and 12 are in contact with the edge of the lamina), the second portion extending between a proximal end and a distal end (see labelled diagram of Fig. 4 below), the proximal end of the second portion (11 and 12) being connected to the first portion (13) so that the second portion is rotatable relative to the first portion (see Col. 3, ll. 33-40) about an axis of rotation (13b), wherein the second portion (11 and 12) defines a transverse opening (see labelled diagram of Fig. 4 below) for receiving a fastener for fixing the second portion to the lamina (see Col. 3, ll. 12-18).
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Regarding claim 2, Perryman teaches the implant of claim 1, wherein the second portion (11 and 12) comprises a receiving section (11a) configured to receive the edge of the separated lamina (see labelled diagram of Fig. 1 below).
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Regarding claim 3, Perryman teaches the implant of claim 2, wherein the receiving section (11a) is at the distal end of the second portion (11 and 12; see labelled diagrams of Figs. 1 and 4 above).
Regarding claim 4, Perryman teaches the implant of claim 3, the receiving section (11a) comprising:
an outer member extending distally from the second portion (see labelled diagram of Fig. 1 below);
an inner member extending distally from the second portion (see labelled diagram of Fig. 1 below);
the receiving section defining a space between the outer member and the inner member (see labelled diagram of Fig. 1 below).
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Regarding claim 5, Perryman teaches the implant of claim 4, wherein the receiving section (11a) is configured to receive the edge of the lateral mass between the outer member and the inner member (note that this is a functional recitation, and the receiving section is capable of such an orientation; also see Figs. 1 and 2, which demonstrate such an orientation).
Regarding claim 6, Perryman teaches the implant of claim 4, wherein the transverse opening (see labelled diagram of Fig. 3 above) for receiving a fastener for fixing the second portion to the lamina (see Col. 3, ll. 12-18) extends through the outer member (see labelled diagram of Fig. 4 below).
Regarding claim 7, Perryman teaches the implant of claim 6, wherein the receiving section (11a) defines a transition (see labelled diagram of Fig 4 below) between the outer member and the inner member, the transition extending along an axis parallel to a vertebral column when the first portion is fixed to the lateral mass (note that the axis of the vertebral column is interpreted to be perpendicular to the cross-section of the vertebrae, as it would align with the longitudinal axis of the entire spine. Also see labelled diagram of Fig. 4 below).
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Regarding claim 8, Perryman teaches the implant of claim 6, wherein a distance between the outer member and the inner member is greater than a width of the lamina at determined at the edge thereof (the distance between the two members is taken at their relative distal ends; see labelled diagram of Fig. 1 below).
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Regarding claim 9, Perryman teaches the implant of claim 8, wherein the inner member is configured to abut an inside surface of the lamina and the outer member is configured to abut an outside surface of the lamina when the edge of the lamina is received in the receiving section (first, note that this is a function recitation, requiring only that the device be capable of such a configuration; depending on the size or age of the human or animal being operated on, such a configuration is possible. Also see labelled diagram of Fig. 1 below).
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Regarding claim 10, Perryman teaches the implant of claim 9, wherein the inner member and the outer member define a U-shaped configuration for receiving the edge of the lamina (see labelled diagram of Fig. 1 below).
Regarding claim 11, Perryman teaches the implant of claim 9, wherein the outer member extends from the second portion further than the inner member (see labelled diagram of Fig. 1 below).
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Regarding claim 12, Perryman teaches the implant of claim 11, wherein the transverse opening is positioned in the outer member so that the fastener received through the opening and into the lamina does not interfere with the inner member (see labelled diagram of Fig. 1 below).
Regarding claim 16, Perryman teaches the implant of claim 6, wherein the first portion (13) and the axis of rotation (aligned with 13b) are configured so that the first portion (13) can be fixed to the lateral mass prior to cutting the lamina adjacent thereto (note that because of hinge 13b, first portion 13 may be angled such that it attaches to the lateral mass prior to cutting).
Regarding claim 17, Perryman teaches the implant of claim 6, wherein the axis of rotation extends along an axis parallel to a vertebral column when the first portion is fixed to the lateral mass (note that the axis of the vertebral column is interpreted to be perpendicular to the cross-section of the vertebrae, as it would align with the longitudinal axis of the entire spine. See labelled diagram of Fig. 2 below).
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Regarding claim 18, Perryman teaches the implant of claim 17, wherein the implant (10) comprises a hinge (12c and 13b) between the first portion (13) and the second portion (consisting of 11 and 12), thereby facilitating rotation of the first portion and the second portion (see Col. 3, ll. 33-40).
Regarding claim 19, Perryman teaches the implant of claim 6, wherein the receiving (11a) section is U-shaped (see labelled diagram of Fig. 5 below).
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Claims 1-4, 6, and 13-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Suh et al. (US 20130060283) (hereon referred to as Suh).
Regarding claim 1, Suh teaches an implant (10, see Fig. 2A) for connecting a lamina having an edge separated from a lateral mass of a vertebra during a laminoplasty procedure (see Fig. 1B), the implant comprising:
a first portion (14) configured to engage with the lateral mass (see Para. [0034] and [0037], reciting the ability for this device to satisfy the requirements of this functional limitation), the first portion (14) defining a surface (see labelled diagram of Fig. 2A below) for interfacing with the lateral mass (see Para. [0034] and [0037], reciting the ability for this device to satisfy the requirements of this functional limitation), the first portion defining a transverse opening (22) for receiving a fastener for fixing the first portion to the lateral mass (see Para. [0035]);
a second portion (12 and 16) configured to engage with the edge of the lamina separated from the lateral mass during the laminoplasty procedure (see Paras. [0006-0008]), the second portion extending between a proximal end and a distal end (see labelled diagram of Fig. 2A below), the proximal end of the second portion (see labelled diagram of Fig. 2A below) being connected to the first portion (14) so that the second portion is rotatable relative to the first portion (via hings system, see Para. [0034]) about an axis of rotation (20, see Para. [0034]), wherein the second portion (12 and 16) defines a transverse opening (22) for receiving a fastener for fixing the second portion to the lamina (see Para. [0035]).
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Regarding claim 2, Suh teaches the implant of claim 1, wherein the second portion (12 and 16) comprises a receiving section (see labelled diagram of Fig. 2A below) configured to receive the edge of the separated lamina (see Para. [0034] and [0037], reciting the ability for this device to satisfy the requirements of this functional limitation).
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Regarding claim 3, Suh teaches the implant of claim 2, wherein the receiving section (see labelled diagram of Fig. 2A above) is at the distal end of the second portion (see labelled diagram of Fig. 2A above).
Regarding claim 4, Suh teaches the implant of claim 3, the receiving section (see labelled diagram of Fig. 2A above) comprising:
an outer member extending distally from the second portion (see labelled diagram of Fig. 2A below);
an inner member extending distally from the second portion (see labelled diagram of Fig. 2A below);
the receiving section defining a space between the outer member and the inner member (see labelled diagram of Fig. 2A below).
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Regarding claim 6, Suh teaches the implant of claim 4, wherein the transverse opening (22) for receiving a fastener for fixing the second portion to the lamina (see Para. [0035]) extends through the outer member (see Fig. 2A, showing the opening extending fully through member 16).
Regarding claim 13, Suh teaches the implant of claim 6, wherein the outer member comprises a flexible portion (malleable material described in Para. [0048]) extending in the direction of the vertebral column (note that the vertebral column aligns with the longitudinal axis of the spine; see labelled diagram of Fig. 2A below), the flexible portion positioned between the transverse opening (22) in the second portion (at section 16) and the proximal end of the second portion (see labelled diagram of Fig. 2A below).
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Regarding claim 14, Suh teaches the implant of claim 6, further comprising a bone fusion material (bone graft insertion described in Para. [0057]) disposed on one or more surfaces of the implant that interface with the bone (note that the material is inside the hollow central region, therefore contacting multiple surfaces), the bone fusion material selected to encourage osteointegration between the bone and the bone fusion material (see Para. [0065], noting that the bone graft housing is configured to receive bone graft which is known in the art to improve osteointegration).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Perryman in the rejection of claim 6 above, and further in view of Lyons et al. (US 20110172709 A1) (hereon referred to as Lyons).
Perryman teaches an implant (10, see Fig. 4) for connecting a lamina as outlined in the rejection of claim 6 above, however fails to teach wherein the first portion comprises a plurality of positioning pins extending from the interface surface, the positioning pins configured to engage with the bone an inhibit movement between the first portion relative to the lateral mass while the fastener is installed.
Lyons teaches a vertebral implant (100), consisting of plates 20a and 20b, as well as plates 30a and 30b, wherein the plates consist of pins (50, described in the specification of Lyons as spikes, see Para. [0031]) protruding out of the device, which improve contact with the bone (see Para. [0036]).
It would be obvious to one of ordinary skill int eh art before the effective filing date of the claimed invention to modify the plates of Perryman to include sharp pins as taught by Lyons, as these would improve connection with the vertebrae by driving into bone and holding the device in place (see Para. [0037]).
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 HOLLY J LANE whose telephone number is (703)756-4702. The examiner can normally be reached Monday-Friday 9:00am-5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached on 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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/H.J.L./Examiner, Art Unit 3773
/ELLEN C HAMMOND/Primary Examiner, Art Unit 3773