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 are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: Actuator 8 is not labeled only fiber 81. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: Number 82 is not in the specification only in the claims. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 17 is objected to because of the following informalities: In line 1 of the claim the claim states “at at” one “at” should be cancelled. 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 2, 10 and 19 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 2, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 10 and 19 include a broad range or limitation followed by linking terms (e.g., preferably, maybe, for instance, especially) and a narrow range or limitation within the broad range or limitation is considered indefinite since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired.
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, 5-12 and 15-22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stout Medical Group (WO 2007/084239)(provided by the applicant).
With respect to claim 1, Stout Medical Group discloses a method of injecting a foldable implant (See figures 78-81 below) into a body cavity of a patient (abstract device for vertebral disc repair), wherein the method comprises the steps of: a. providing the foldable implant (figs 78-81, 2); b. injecting the provided implant in an unfolded state into the body cavity (fig 80, and paragraph 109 inserted into the site), wherein in the unfolded state the implant is essentially straight (fig 80) extending along a longitudinal axis (L); and c. folding the injected implant from the unfolded state into a folded state (fig 81), wherein in the folded state the implant has a plurality of loops (see fig 81 below) each extending radially from a fold center (see fig 81 below).
With respect to claim 2, Stout Medical Group discloses wherein the body cavity is the intervertebral disc space, such as the intervertebral disc nucleus pulposus (abstract).
With respect to claim 3, Stout Medical Group discloses further comprising connecting the injected implant to a vertebral endplate (paragraph 111, support device anchored to the site).
With respect to claim 5, Stout Medical Group discloses wherein in the folded state the plurality of loops extend in a substantially fan-shaped manner (fig 81) between an upper plane (see fig 80 below) and a lower plane (see fig 80 below), wherein the upper plane and the lower plane are parallel to each other (fig 80) and have a distance from each other of less than 20 mm (paragraph 113 inserted through an 8mm port).
With respect to claim 6, Stout Medical Group discloses wherein the implant comprises a plurality of fold initiating elements (fig 78, 302) and a main body (fig 80, 2) having a plurality of fold positions (fig 80, 308) interspaced in the longitudinal direction (L) by loop sections (52), wherein each fold position (fig 81) is connected to a fold initiating element, wherein a. in the unfolded state the fold initiating elements are interspaced from each other in the longitudinal direction (L) and b. in the folded state the fold initiating elements are arranged in proximity of each other to define the fold center (fig 81 all the holes for the fiber are located near the fold center), such that for each loop section (see fig 81 below) a corresponding loop (is formed.
With respect to claim 7, Stout Medical Group discloses wherein the fold initiating elements (4) are arranged peripherally on a cross-section (fig 81 shows the holes all located on the side of the implant) of the main body of the implant.
With respect to claim 8, Stout Medical Group discloses wherein in the unfolded state the fold initiating elements are arranged on the same face of the main body (fig 78 all visible in the figure), such that in the folded state the plurality of loops extend between an upper plane and a lower plane (see fig 80 below), wherein the upper plane and the lower plane are parallel (fig 80) to each other and have a distance from each other of less than 20 mm (paragraph 113 inserted into a 8mm port).
With respect to claim 9, Stout Medical Group discloses wherein step c) includes actuating a fold actuator (fig 81, x or fig 78, 300) operatively coupled to the fold initiating elements, wherein the fold actuator is configured on actuation (paragraph 141) to bring the fold initiating elements into proximity of each other (fig 81), such that the plurality of loops are formed from the loop sections.
With respect to claim 10, Stout Medical Group discloses wherein the fold actuator comprises a fiber (fig 78, 300) connected to the fold initiating elements, wherein actuating the fold actuator comprises moving the fiber, preferably pulling the fiber (paragraph 141 pull cord).
With respect to claim 11, Stout Medical Group discloses, wherein the fold actuator comprises a retention structure (paragraph 142, a lock or knock) configured for engaging with the fold initiating elements such that, when the main body of the implant is ejected from an outlet opening (end of 38 in fig 54)) of an injection device (fig 54, 38), the fold initiating elements are retained by the retention structure, such that the loop sections interspacing the fold initiating elements fold up (fig 81).
With respect to claim 12, Stout Medical Group discloses wherein at least two loop sections have a different loop section length, such that in the folded state the corresponding loops have different sizes (Fig 81 shows end loops that are shorted than the middle loops).
With respect to claim 15, Stout Medical Group discloses wherein at the fold positions the main body has a smaller cross-section than in the loop sections (see fig 80 below).
With respect to claim 16, Stout Medical Group discloses wherein in the unfolded state the flexural modulus of the main body at the fold positions is lower (fig 80 grooves 208 allow for easier folding of the fold positions) than the average flexural modulus of the main body in the loop sections.
With respect to claim 17, Stout Medical Group discloses wherein at least one fold position in the unfolded state, the main body has a flexural modulus with respect to a target bend direction (T) that is smaller than a flexural modulus with respect to a bend direction that is either orthogonal to or opposite to the target bend direction (T), wherein the target bend direction (T) extends perpendicularly from the center of the longitudinal axis (L) of the main body towards the fold initiating element connected to the fold position (because the device is thinner and has smaller cross sections in the bending direction the modulus of bending is lower in that direct than the orthogonal direction).
With respect to claim 18, Stout Medical Group discloses wherein the implant comprises one of an allograft, a xenograft, an autograft, and a synthetic composite (paragraph 91, discloses each material).
With respect to claim 19, Stout Medical Group discloses wherein the implant (1) is made of at least 30 wt.-%, preferably at least 50 wt.-%, more preferably at least 70 wt.-%, collagen based on the dry weight of the implant (paragraph 91 claims the device can be collagen.
With respect to claim 20, Stout Medical Group discloses wherein the implant comprises a ligament or tendon (paragraph 91).
With respect to claim 21, Stout Medical Group discloses wherein in step c) the folding of the implant commences when the implant is either fully or partially injected in the body cavity (inserted through a port such that it would be straight until it was located in the disc.
With respect to claim 22, Stout Medical Group discloses method of intervertebral disc nucleus repair comprising: a. at least partially clearing an intervertebral disc space of a damaged or diseased intervertebral disc (paragraph 140 replaces the disc); b. injecting into the at least partially cleared intervertebral disc space a foldable implant in an unfolded state (fig 80), wherein in the unfolded state the implant is essentially straight extending along a longitudinal axis (L); c. folding (paragraph 141) the injected implant (from the unfolded state into a folded state (fig 81), wherein in the folded state the implant has a plurality of loops (see fig 81 below) each extending radially from a fold center (see fig 81 below)).
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Claim(s) 1-4, 6-7, 9-11, 13-14, 18 and 20-22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McKay et al. (US Pub 2004/0059418).
With respect to claim 1, McKay et al. discloses a method of injecting a foldable implant (See figures 8-10 below) into a body cavity of a patient (fig 8), wherein the method comprises the steps of: a. providing the foldable implant (figs 8, 71); b. injecting the provided implant in an unfolded state into the body cavity (fig 8), wherein in the unfolded state the implant is essentially straight (stars straight in the port 76) extending along a longitudinal axis; and c. folding the injected implant from the unfolded state into a folded state (fig 9-10), wherein in the folded state the implant has a plurality of loops (see fig 10 below) each extending radially from a fold center (see fig 10 below).
With respect to claim 2, McKay et al. discloses wherein the body cavity is the intervertebral disc space, such as the intervertebral disc nucleus pulposus (fig 8).
With respect to claim 3, McKay et al. discloses further comprising connecting the injected implant (1) to a vertebral endplate (fig 10, 73 and paragraph 77).
With respect to claim 4, McKay et al. discloses wherein the implant (1) is connected to the vertebral endplate by means of a suture anchor or bone anchor (paragraph 77, suture).
With respect to claim 6, McKay et al. discloses wherein the implant (1) comprises a plurality of fold initiating elements (see fig 8 and 9 below) and a main body (fig 8, 71) having a plurality of fold positions (see fig 10 below) interspaced in the longitudinal direction by loop sections (see fig 10 below), wherein each fold position is connected to a fold initiating element, wherein a. in the unfolded state the fold initiating elements are interspaced from each other in the longitudinal direction (L) and b. in the folded state the fold initiating elements are arranged in proximity (fig 10 shows the elements in proximity) of each other to define the fold center (fig 10), such that for each loop section (fig 10) a corresponding loop (fig 10) is formed.
With respect to claim 7, McKay et al. discloses wherein the fold initiating elements are arranged peripherally (openings on the surface of the implant) on a cross-section of the main body of the implant.
With respect to claim 9, McKay et al. discloses wherein step c) includes actuating a fold actuator (fig 8, 72) operatively coupled to the fold initiating elements (fig 8), wherein the fold actuator is configured on actuation to bring the fold initiating elements into proximity of each other, such that the plurality of loops are formed from the loop sections (fig 8 to fig 10).
With respect to claim 10, McKay et al. discloses wherein the fold actuator comprises a fiber (fig 8, 72) connected to the fold initiating elements, wherein actuating the fold actuator comprises moving the fiber, preferably pulling the fiber (paragraph 79).
With respect to claim 11, McKay et al. discloses wherein the fold actuator (8) comprises a retention structure (paragraph 90, securement mechanism) configured for engaging with the fold initiating elements such that, when the main body of the implant is ejected from an outlet opening (see fig 8 below) of an injection device (fig 8, 76), the fold initiating elements are retained by the retention structure, such that the loop sections interspacing the fold initiating elements fold up (paragraph 90).
With respect to claim 13, McKay et al. discloses wherein the main body comprises at least one loop section having a cross-sectional profile varying along the longitudinal direction (paragraph 62, tissue may vary in size and thickness).
With respect to claim 14, McKay et al. discloses wherein at least two loop sections have a different cross-sectional profile along the longitudinal direction (L), such that in the folded state the corresponding loops have different shapes (fig 10 the outer loops have a different shape than the inner loops).
With respect to claim 18, McKay et al. discloses wherein the implant comprises one of an allograft, a xenograft, an autograft (paragraph 60), and a synthetic composite (paragraph 74).
With respect to claim 20, McKay et al. discloses wherein the implant comprises a ligament or tendon (paragraph 59).
With respect to claim 21, McKay et al. discloses wherein in step c) the folding of the implant (1) commences when the implant is either fully or partially injected in the body cavity (inserted straight through 76 then folded).
With respect to claim 22, McKay et al. discloses a method of intervertebral disc nucleus repair comprising: a. at least partially clearing an intervertebral disc space of a damaged or diseased intervertebral disc (fig 8); b. injecting into the at least partially cleared intervertebral disc space a foldable implant (1) in an unfolded state (fig 8), wherein in the unfolded state the implant is essentially straight (straight in 76) extending along a longitudinal axis (L); c. folding the injected implant from the unfolded state into a folded state (fig 8-10), wherein in the folded state the implant has a plurality of loops (see fig 10 below) each extending radially from a fold center (see fig 10 below).
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Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 10828170 B2 discloses a folding implant for disc repair
US 20180116813 A1 discloses a folding implant for disc repair
US 9592132 B2 discloses a folding implant for disc repair
US 20160074174 A1 discloses a folding implant for disc repair
US 20140277481 A1 discloses a folding implant for disc repair
US 20110245926 A1 discloses a folding implant for disc repair
US 20110118789 A1 discloses a folding implant for disc repair
US 20100185290 A1 discloses a folding implant for disc repair
US 20090240335 A1 discloses a folding implant for disc repair
US 20080234687 A1 discloses a folding implant for disc repair
US 20080133012 A1 discloses a folding implant for disc repair
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEVEN J COTRONEO whose telephone number is (571)270-7388. The examiner can normally be reached Monday-Friday 9am-5pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached 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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/S.J.C/Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773
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