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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/11/2024, 04/30/2024 and 11/07/2023 in the 18/504077 application were considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group I, and Species 5 in the reply filed on 02/17/2026 is acknowledged. Claims 1-10, 12-18 and 20-22 are pending. Claims 8-10, 12-18 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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 6 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 6 includes the recitation of an instrument engagement member disposed on the second side of the exterior shield. The specifications and drawings lack a precise identification of the claimed instrument engagement member. Fig. 13 identifies a bore 416 which is adapted to receive the spraying end 212 of insertion instrument 200. For purposes of examination, the claimed “instrument engagement member” will be interpreted as the bore opening.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 4 is rejected under 35 U.S.C. 101 because applicant positively recites part of a human, i.e. "the amine groups interact and bind with a protein crosslinking reagent disposed on the exterior wall of the spinal disc.” Thus claim 14 includes a human within its scope and is non-statutory.
A claim directed to or including a human within its scope is not considered patentable subject matter under 35 U.S.C. 101. The grant of a limited, but exclusive property right in a human being is prohibited by the Constitution. In re Wakefield, 422 F.2d 897, 164 USPQ 636 (CCPA 1970).
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, 21 and 22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lambrecht et al. (U.S. 8,361,155 B2).
Concerning claim 1, Lambrecht et al. disclose an exterior shield (see Fig. 65B, element 822) for placement on a spinal disc having a spinal defect, the exterior shield comprising: a first side configured to face a central region of the spinal disc; a second side, opposite the first side, the second side configured to face outwardly from the central region; and a vertebral engagement member (824) configured to engage a vertebra adjacent the spinal disc, wherein the vertebral engagement member comprises at least one protrusion (826A and see col. 43, lines 13-17) and the at least one protrusion is configured to engage a vertebral body of the vertebra adjacent the spinal disc to mechanically stabilize the exterior shield, wherein the first side is configured to cover the spinal defect on the spinal disc to thereby stabilize an exterior wall of the spinal disc (see col. 43, lines 18-22).
Concerning claim 3, wherein the exterior shield attaches to the exterior wall of the spinal disc via at least one of sutures, barbed tacks, or adhesive material (see col. 43, lines 10-12; col. 36, lines 21-23) and Fig. 60C, element 810).
Concerning claim 7, wherein at least one of the first side, the sutures, the barbed tacks, or the adhesive material is coated in a degradable polymer containing a protein crosslinking reagent (see col. 11, lines 3-13).
Concerning claim 21, wherein the at least one protrusion (see Fig. 65B, element 826A) includes at least one of a barb or a pin (see col. 43, lines 15-17 which states that the structure 826A can be an anchor), wherein engaging the vertebral body of the vertebra adjacent the spinal disc includes at least partially embedding at least one of the barb or the pin within the vertebral body of the vertebra adjacent the spinal disc. It is noted that both barbs and pins are structures considered to be anchors. Applicant’s attention is directed to Fig. 3 which discloses a barb anchor element.
Concerning claim 22, wherein the vertebral engagement member (see Fig. 65B, element 824) is coupled to the second side.
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.
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(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lambrecht et al. (U.S. 8,361,155 B2) in view of Cauthen, III et al. (U.S. 7,922,768 B2) and Sansur et al. (U.S. 2020/0268522 A1).
Lambrecht et al. disclose the invention substantially as described above. However, Lambrecht et al. do not explicitly disclose a bore extending through the first side and the second side, wherein the bore is configured to transition between an open configuration and a closed configuration, wherein, in the open configuration, the bore provides an opening for spraying a liquid therethrough, wherein the bore biases into the closed configuration.
Cauthen teaches a bore extending through a first side and a second side of an annular shield, wherein the bore is configured to transition between an open configuration and a closed configuration, wherein, in the open configuration, the bore provides an opening for spraying a liquid therethrough (see Fig. 12A, element 10) in the same field of endeavor for the purpose of repairing and reconstructing an annulus.
Sansur et al. teach a spinal device having a valvular pore (see Fig. 9B, element 34) configured to provide one-way fluid flow for filling a spinal space (see par. 0048) in the same field of endeavor.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Lambrecht’s shield to include a closed biased bore configured to transition between an open configuration and a closed configuration, as taught by Cauthen and Sansur, in order to permit injection of material within the annular space. There are multiple motivations for injecting material into the annular space not limited to restoration of disc height due to loss of nucleus pulposus volume, collapse of the disc space under axial spinal loading, and restoring foraminal height thereby directly relieving nerve root compression and radicular pain.
Claim(s) 5 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lambrecht et al. (U.S. 8,361,155 B2) in view of Cauthen, III et al. (U.S. 7,922,768 B2) and Sansur et al. (U.S. 2020/0268522 A1), further in view of Trieu (U.S. 2007/0150060 A1).
Lambrecht in view of Cauthen and Sansur disclose the invention substantially as described above. However, Lambrecht in view of Cauthen and Sansur do not explicitly disclose that the liquid comprises a protein crosslinking reagent.
Trieu teaches the introduction of a protein crosslinking reagent (see claim 13; pars. 0020, 0071) into an intervertebral disc in the same field of endeavor for the purpose of maintaining and or increasing disc height, disc volume, or intra-discal pressure (see pars. 0010).
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 shield of Lambrecht, Cauthen, and Sansur by including a protein crosslinking reagent, as disclosed by Trieu, in order to bulk up the intervertebral disc thereby restoring normal function and mobility to the patient.
It is noted that Sansur discloses an instrument engagement member (bore opening 34 – see Fig. 9B) disposed on a second side of a spinal shield (20) wherein a bore extends through the instrument engagement member, wherein the bore is configured to transition into an open configuration upon interaction with an insertion instrument (50), wherein, in the open configuration, the bore receives liquid to thereby release the liquid into a spinal region (see Figs. 8B-9B). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the same delivery means.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lambrecht et al. (U.S. 8,361,155 B2) in view of Trieu (U.S. 2007/0150060 A1).
Lambrecht et al. disclose the invention substantially as described above. However, Lambrecht et al. do not explicitly disclose that the first side of the exterior shield is coated with a first coating comprising amine groups.
Trieu teaches the use of amines (see par. 0073) to support a nucleus pulposus in the same field of endeavor.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Lambrecht’s shield by coating it with amines, the concept of which is disclosed by Trieu, as amines are known for surface modification of implantable devices to improve cell adhesion and tissue integration.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The art relates to annular repair devices.
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