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.
Claims 8-10 & 18 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 8 at Lines 1-2 recites “further comprising an elongated tissue closure device disposed within the segments of the elongated channel” which renders the claim indefinite as it is unclear if the recited elongated tissue closure device is the same as the elongated tissue closure device previously recited in Line 12 of independent Claim 1 (from which this claim depends), or a second elongated tissue closure device. For purposes of examination, the limitation is being interpreted as “further comprising the elongated tissue closure device disposed within the segments of the elongated channel”. Appropriate correction is required.
Claim 18 at Lines 1-2 recites “further comprising an elongated tissue closure device being secured over the top surface of the second flexible body by the second anchors,” which renders the claim indefinite as it is unclear if the recited elongated tissue closure device is the same as the elongated tissue closure device previously recited in Line 14 of independent Claim 12 (from which this claim depends), or a second elongated tissue closure device. For purposes of examination, the limitation is being interpreted as “further comprising the elongated tissue closure device secured over the top surface of the second flexible body by the second anchors,”. Appropriate correction is required.
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.
Claim(s) 1-5, 12-18, 21-22 & 24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Garcia et al. (US PG Pub No. 2015/0038969).
Regarding Claim 1, Garcia et al. discloses an implant for sternal closure (10, Figs. 1-10, Paragraphs [0286-0294]) comprising: an elongated body (bracket 16, Fig. ) having a first end, a second end, and a longitudinal axis that extends from the first end to the second end (See examiner annotated Fig. 4 below); the elongated body having top and bottom surfaces (See examiner annotated Fig. 5 below) that extend along the longitudinal axis; and a plurality of anchors (tabs 36, See examiner annotated Fig. 4 below) projecting from the top surface of the elongated body and being spaced from one another between the first and second ends of the elongated body (Fig. 4), each anchor including a segment of an elongated channel extending therethrough that is aligned with the longitudinal axis of the elongated body (See examiner annotated Fig. 3 below), wherein each anchor has an opening that is in communication with the segment of the elongated channel associated therewith (See examiner annotate Fig. 2 below); and wherein the bottom surface of the elongated body is configured to engage a sternum for distributing pressure forces from an elongated tissue closure device (band 14, Fig. 1 & 4, Paragraph [0287]) over the bottom surface to prevent the elongated tissue closure device from cutting into bone of the sternum (sternum 12, Fig. 1, Paragraph [00286]).
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Regarding Claim 2, Garcia et al. discloses wherein the plurality of anchors define gaps therebetween that overlie the top surface of the elongated body (See examiner annotated Fig. 3 above).
Regarding Claim 3, Garcia et al. discloses wherein the plurality of anchors are evenly spaced from one another between the first and second ends of the elongated body, and wherein each anchor has a constant length that extends along the longitudinal axis of the elongated body (See examiner annotated Fig. 4 above).
Regarding Claim 4, Garcia et al. discloses wherein the elongated body comprises a flexible body (body portion 30, Fig. 3, Paragraph [0288], “The bracket 16 may be a plate formed from a metallic and/or polymeric material and may include a body portion 30 and a plurality of legs 32 extending outward from the body portion 30. The bracket 16 may be relatively flexible to enable the bracket 16 to conform to the contours of the sternum 12 when the bracket 16 is fastened thereto (as shown in FIG. 1)”, Paragraph [0288]) that is more flexible at the location of the gaps and less flexible at the location of the anchors (As seen in Fig. 3, the body portion 30 is thinner at the gap locations than it is at the anchor locations, and thus the gap locations would be more flexible than at the anchors).
Regarding Claim 5, Garcia et al. discloses wherein the segments of the elongated channel define an elongated channel diameter (See examiner annotated Fig. 3 above), and wherein each opening associated with one of the segments of the elongated channel has a width that is less than the elongated channel diameter (Fig. 3).
Regarding Claim 12, Garcia et al. discloses an implant for sternal closure (10, Figs. 1-10, Paragraphs [0286-0294]) comprising: an flexible body (half of bracket 16, See examiner annotated Fig. 3 directly below, Paragraph [0288], “The bracket 16 may be a plate formed from a metallic and/or polymeric material and may include a body portion 30 and a plurality of legs 32 extending outward from the body portion 30. The bracket 16 may be relatively flexible to enable the bracket 16 to conform to the contours of the sternum 12 when the bracket 16 is fastened thereto (as shown in FIG. 1)”, Paragraph [0288]) having top and bottom surfaces (See examiner annotated Fig. 5 above) that extend along a longitudinal axis of the flexible body (See examiner annotated Fig. 4 above); and a plurality of anchors (See examiner annotated Fig. 4 above) projecting from the top surface of the flexible body, the anchors being spaced from one another along the longitudinal axis of the flexible body (Fig. 4), the anchors defining a series of gaps therebetween that are located between the anchors, the gaps overlying the top surface of the flexible body and being in alignment with the longitudinal axis of the flexible body (See examiner annotated Fig. 4 above); each anchor having a segment of an elongated channel extending therethrough, the elongated channel being in alignment with the longitudinal axis of the flexible body (See examiner annotated Fig. 3 above), and each anchor having an outer wall with an opening formed therein that is in communication with the respective segment of the elongated channel associated therewith (See examiner annotate Fig. 3 directly below); and wherein the bottom surface of the flexible body is configured to engage a sternum for distributing pressure forces from an elongated tissue closure device (band 14, Fig. 1 & 4, Paragraph [0287]) over the bottom surface to prevent the elongated tissue closure device from cutting into bone of the sternum (sternum 12, Fig. 1, Paragraph [0286]).
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Regarding Claim 13, Garcia et al. discloses wherein the openings of the respective anchors are aligned with the longitudinal axis of the flexible body (See examiner annotated Fig. 3 above).
Regarding Claim 14, Garcia et al. discloses wherein the segments of the elongated channel each have a cross-sectional diameter (See examiner annotated Fig. 2 above), and wherein the openings each have a width that is smaller than the cross-sectional diameter of the respective segments of the elongated channel (Fig. 2).
Regarding Claim 15, Garcia et al. discloses further comprising the elongated tissue closure device (band 14, Fig. 1 & 4, Paragraph [0287]) being secured over the top surface of the flexible body by the spaced anchors (Figs. 2, 4, 5), the elongated tissue closure device extending through the segments of the elongated channel of the respective anchors for being aligned with the longitudinal axis of the flexible body (Paragraphs [0291-0293]).
Regarding Claim 16, Garcia et al. discloses wherein the flexible body has first and second flexible ends that are configured to be bent for conforming to the shape of an outer surface of a sternum (Fig. 1, Paragraph [0288], “The bracket 16 may be relatively flexible to enable the bracket 16 to conform to the contours of the sternum 12 when the bracket 16 is fastened thereto (as shown in FIG. 1).”).
Regarding Claim 17, Garcia et al. discloses a second flexible body (See examiner annotated Fig. 3 directly above, underneath Claim 12) having top and bottom surfaces (Fig. 5) that extend along a second longitudinal axis (dashed axis line extending through groove of plate between first and second flexible bodies) that intersects with the first longitudinal axis of the first flexible body; and a plurality of second anchors (tabs 36 of second flexible body) projecting from the top surface of the second flexible body, the second anchors being spaced from one another along the second longitudinal axis of the second flexible body; the second anchors defining a series of second gaps located between the respective second anchors and that are in alignment with the second longitudinal axis of the second flexible body; each second anchor having a segment of a second elongated channel extending therethrough that is in alignment with the second longitudinal axis of the second flexible body; and each second anchor having an outer wall with a second opening formed therein that is in communication with one of the segments of the second elongated channel extending therethrough (See examiner annotated Fig. 3 directly above).
Regarding Claim 18 as best understood, Garcia et al. discloses the elongated tissue closure device (14, Figs. 1, 2, 5) being secured over the top surface of the second flexible body by the second spaced anchors (Fig. 4), the elongated tissue closure device extending through the segments of the second elongated channel and being aligned with the second longitudinal axis of the second flexible body (See examiner annotated Fig. 3 directly above).
Regarding Claim 21, Garcia et al. discloses an implant for sternal closure (10, Figs. 1-10, Paragraphs [0286-0294]) comprising: an flexible body (bracket 16, Fig. 3, Paragraph [0288], “The bracket 16 may be a plate formed from a metallic and/or polymeric material and may include a body portion 30 and a plurality of legs 32 extending outward from the body portion 30. The bracket 16 may be relatively flexible to enable the bracket 16 to conform to the contours of the sternum 12 when the bracket 16 is fastened thereto (as shown in FIG. 1)”, Paragraph [0288]) having a first end, a second end, a longitudinal axis that extends from the first end to the second end (See examiner annotated Fig. 4 above), and top and bottom surfaces (See examiner annotated Fig. 5 above) that extend along the longitudinal axis of the flexible body (See examiner annotated Fig. 4 above); a plurality of anchors (See examiner annotated Fig. 4 above) projecting from the top surface of the flexible body and being spaced from one another between the first and second ends of the flexible body (Fig. 4), each anchor including a segment of an elongated channel that is aligned with the longitudinal axis of the flexible body (See examiner annotated Fig. 2 above), each anchor having an opening that is in communication with the segment of the elongated channel associated therewith (See examiner annotate Fig. 3 above under Claim 1); and an elongated tissue closure device (band 14, Fig. 1 & 4, Paragraph [0287]) secured over the top surface of the flexible body by the anchors, the elongated tissue closure device extending through the segments of the elongated channel, wherein the elongated tissue closure device has a cross-sectional diameter that is greater than a width of each opening of the respective anchors (Figs. 1, 2, 4, 5); and wherein the bottom surface of the flexible body is configured to engage a sternum for distributing pressure forces from an elongated tissue closure device (band 14, Fig. 1 & 4, Paragraph [0287]) over the bottom surface to prevent the elongated tissue closure device from cutting into bone of the sternum (sternum 12, Fig. 1, Paragraph [0286]).
Regarding Claim 22, Garcia et al. discloses wherein the plurality of anchors define gaps therebetween that overlie the top surface of the flexible body and that are located between the anchors (See examiner annotated Fig. 3 above, underneath Claim 1), wherein the flexible body is relatively more flexible at the location of the gaps and relatively less flexible at the location of the anchors (“The bracket 16 may be a plate formed from a metallic and/or polymeric material and may include a body portion 30 and a plurality of legs 32 extending outward from the body portion 30. The bracket 16 may be relatively flexible to enable the bracket 16 to conform to the contours of the sternum 12 when the bracket 16 is fastened thereto (as shown in FIG. 1)”, Paragraph [0288]) (As seen in Fig. 3, the body portion 30 is thinner at the gap locations than it is at the anchor locations, and thus the gap locations would be more flexible than at the anchors).
Regarding Claim 24, Garcia et al. discloses wherein the elongate tissue closure device is a polymer band (“The band 14 may be a flat, elongated and flexible member formed from a metallic material and/or a polymeric material, for example.”, Paragraph [0287]).
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.
Claim(s) 11 & 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Garcia et al. (US PG Pub No. 2015/0038969) in view of Madjarov (US PG Pub No. 2015/0238237).
Regarding Claim 11 & 23, Garcia et al. discloses the claimed invention as stated above in Claims 1 & 12, including wherein the flexible body includes a biocompatible polymer material (“The bracket 16 may be a plate formed from a metallic and/or polymeric material and may include a body portion 30 and a plurality of legs 32 extending outward from the body portion 30. The bracket 16 may be relatively flexible to enable the bracket 16 to conform to the contours of the sternum 12 when the bracket 16 is fastened thereto (as shown in FIG. 1)”, Paragraph [0288]), except wherein the anchors are made of a first material that is relatively softer and more flexible than a second material that covers the bottom surface of the flexible body.
Madjarov discloses in Paragraph [0077] that "the material of the bone fixation implant may be selected to match the range of motion and pliability of the chest wall, which may vary depending on the area of the chest wall being treated. For example, some embodiments of the bone fixation implant may include a structural portion 105 made of titanium, aluminum, stainless steel, Nitinol, or some other metal (e.g., in the form of a wire, a plate, or a mesh, as described above with respect to FIGS. 13 and 14) and may also include a polymer body, which may be made of PEEK."). As seen in Figs. 13-14, the mesh configuration of the metal structural portion which runs through the polymer body extends between each adjacent row and each adjacent column of fastener openings such that it defines a grid pattern where the areas of the fastener openings have no mesh and thus would be more flexible. Madjarov further teaches in Paragraph [0099] that "In addition to minimizing reactions between different metal components (e.g., the metal in the implant and the metal in the fasteners), the use of a structural portion comprising metal that is at least partially surrounded by a polymer body as described above may also impart a certain degree of malleability and resiliency to the bone fixation implant, which may allow the implant to be molded by a surgeon during surgery to the shape and contour of the patient's native bone or body structure to which the implant is being applied. Moreover, the use of PEEK or other shape memory polymers in the polymer body, where such materials have the ability to return from a (temporary) deformed state to a (permanent) original shape, may serve to relieve some of the stresses experienced by the installed implants that may otherwise be borne solely by the metal components of the bone fixation implant. Furthermore, use of a polymer body as described above may also provide for less metal to be used in the structural portion, thereby allowing bone fixation implants having a thinner profile to be created, which in turn may minimize the pain and discomfort experienced by the patient as the patient heals and resumes daily activities."
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the polymer body of Garcia et al. to add a metal mesh grid therethrough as taught by Madjarov in order to provide a thin profile implant which allows malleability and resiliency along the body to better shape and contour with the patient's native anatomy.
Allowable Subject Matter
Claims 6-7 & 19-20 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.
Claims 8-10 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant’s amendments, filed 06/24/26, have overcome the objections to claims 1, 3-9, 11-12, 14-18, & 21-24.
Applicant’s amendments, filed 06/24/26, have overcome the 112(b) rejection for claim 7.
In regards to Applicant’s arguments, filed 06/24/26, with respect to the Madjarov in view of Berstein et al. rejection and the the Madjarov in view of Berstein et al. and Matheny rejection: The Applicant’s arguments have been fully considered but are moot in view of the new grounds of rejection based on the newly amended claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a).
Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WEISS whose telephone number is (571) 270-5597. The examiner can normally be reached Monday through Friday, 8:00 am to 4:00 pm EST. If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, KEVIN T. TRUONG, at 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JESSICA WEISS/
Primary Examiner, Art Unit 3775
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