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 Objections
Claim 1 is objected to because of the following informalities: Applicant uses the phrase “the at least covering” in line 17. This should read “the at least one covering”. Appropriate correction is required.
Claim 2 is objected to because of the following informalities: Applicant uses the phrase “a a plurality” in lines 1-2. This should read “a plurality”. Appropriate correction is required.
Claim 37 is objected to because of the following informalities: Claim 37 ends with two periods at the end instead of a single period. 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 32 and 34 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.
Regarding claim 32, Applicant recites “the deployed configuration in which the plurality of protrusions are positioned close to the body of the implant and the deployed configuration in which the plurality of protrusions extend outward from the body to facilitate prevention of leakage of biological material and/or to resist displacement of the implant from its deployed position within the portion of the biological anatomy.” However, these limitations are found in lines 5-8 of independent claim 1, from which claim 32 depends. The examiner suggests amending the claim to recite “wherein the plurality of protrusions are configurable between an insertion configuration in which the plurality of protrusions are positioned close to the body of the implant and the deployed configuration
Amending the claim in this manner would overcome the rejection of record and remove the redundancy/duplicity of the claim.
Regarding claim 34, Applicant recites: “the deployed configuration in which the plurality of protrusions extend outward from the body to facilitate prevention of leakage of nucleus pulpous material from the intervertebral disc and/or to resist displacement of the implant from its deployed position within the annulus.” However, these limitations are found in lines 5-8 of independent claim 1, from which claim 34 depends. The examiner suggests amending the claim to recite “wherein the plurality of protrusions are configurable between an insertion configuration in which the plurality of protrusions are positioned close to the body of the implant and the deployed configuration
Amending the claim in this manner would overcome the rejection of record and remove the redundancy/duplicity of the claim.
Claim Rejections - 35 USC § 102
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.
Claims 1-2, 25-26, 32-34 and 37 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Drori et al. (US 2013/0338778).
Regarding claim 1, Drori et al. disclose an implant (figures 1-4B) configured for insertion into a defect in an annulus of an intervertebral disc (figures 1C-1D, 5A-5D, the implant comprising a body (see figure below) having a proximal end (see figure below) and a distal end (see figure below), the body extending along a longitudinal axis (80) from the proximal end to the distal end; and a plurality of protrusions (70) configured to extend outward from the body in a deployed configuration (figures 1A-3B) when inserted into the defect in the annulus to resist leakage of nucleus pulpous material and/or to improve resistance to displacement of the implant (¶85, ¶87, ¶92); and a plurality of ribs (30) each having a first end (150, figure 1A) coupled to the proximal end of the body, the plurality of ribs having at least one covering coupled thereto, wherein each of the plurality of ribs extend from the proximal end of the body in a direction towards the distal end of the body to a second end (160, figure 1A) of each respective rib in a closed configuration (figure 4A-4B) so that the second end of each respective rib has a first distance from the body, and wherein each of the plurality ribs extends outwards from the body in an open position (figure 1A, 3A) such that the second end of each respective rib has a second distance from the body that is greater than the respective first distance to expand the at least covering is positioned when the implant is deployed in the annulus (figures 1C-1D, 3A-3B).
Regarding claim 2, Drori et al. disclose wherein the at least one covering comprises a a plurality of sheets (¶93 “additionally deployed on the proximal portion”), each of the plurality of sheets coupled to a first and a second of the plurality of ribs (via 440’s openings, figures 3C-3D, ¶92).
Regarding claim 25, Drori et al. disclose the at least one covering comprises a one or more sheets of fabric composed of a polymer, synthetic material, a biological substance and/or is based on human tissue (¶92).
Regarding claim 26, Drori et al. disclose the at least one covering comprises flexible and/or conformable fabric material (¶92).
Regarding claim 30, Drori et al. disclose the at least one covering is configurable between an insertion configuration (figures 4A-4B) suitable for insertion into the portion of the biological anatomy and a deployed configuration (figures 1C-1d, 3A-3B) configured to facilitate prevention of leakage of biological nucleus pulpous material and/or to resist displacement of the implant (¶92).
Regarding claim 32, Drori et al. disclose the plurality of protrusions are configurable between an insertion configuration in which the plurality of protrusions are positioned close to the body of the implant (figures 4A-4B) and the deployed configuration in which the plurality of protrusions extend outward from the body to facilitate prevention of leakage of biological material and/or to resist displacement of the implant from its deployed position within the portion of the biological anatomy (figures 1C-1D, 3A-3B, ¶92).
Regarding claim 33, Drori et al. disclose the at least one covering is coupled to the plurality of protrusions such that transitioning the plurality of protrusions from the insertion configuration to the deployed configuration causes the at least one covering to transition from the insertion configuration to the deployed configuration (figures 3A-3B).
Regarding claim 34, Drori et al. disclose the plurality of protrusions (70) are configurable between an insertion configuration (figures 4A-4B) in which the plurality of protrusions are positioned close to the body of the implant (figures 4A-4B) and the deployed configuration (figures 1C-1D, 3A-3B) in which the plurality of protrusions extend outward from the body to facilitate prevention of leakage of nucleus pulpous material from the intervertebral disc and/or to resist displacement of the implant from its deployed position within the annulus (figures 1C-1D, 3A-3B, ¶92).
Regarding claim 37, Drori et al. disclose an implant configured for insertion into a defect in an annulus of an intervertebral disc, the implant comprising a body (see figure below) having a proximal end (see figure below) and a distal end (see figure below), the body extending along a longitudinal axis (80) from the proximal end to the distal end; and a plurality of protrusions (70) configured to extend outward from the body in a deployed configuration (figures 1C-1D, 3A-3B) when inserted into the defect in the annulus to resist leakage of nucleus pulpous material and/or to improve resistance to displacement of the implant (¶85, ¶87, ¶92); and a plurality of ribs (30) each having a first end (150, figure 1A) coupled to the distal end of the body, the plurality of ribs having at least one covering (410, figures 3A-3D) coupled thereto, wherein each of the plurality of ribs extend from the distal end of the body in a direction towards the proximal end of the body to a second end (160, figure 1A) of each respective rib in a closed configuration (figures 4A-4B) so that the second end of each respective rib has a first distance (figures 4A-4B) from the body, and wherein each of the plurality ribs extends outwards from the body in an open position (figures 1C-1D, 3A-3B) such that the second end of each respective rib has a second distance (figures 1C-1D, 3A-3B) from the body that is greater than the respective first distance to expand the at least covering when the implant is deployed in the annulus (figures 1C-1D, 3A-3B).
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW JAMES LAWSON whose telephone number is (571)270-7375. The examiner can normally be reached Mon - Fri 6:30-3:00.
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/MATTHEW J LAWSON/ Primary Examiner, Art Unit 3619