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: In Line 4, the word --and-- should be added at the end of the line after the semi-colon. In Line 8, the word “the” in front of “anchor” should be deleted. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: In Line 3, the word “the” in front of “anchor” should be deleted. Appropriate correction is required.
Claim 4 is objected to because of the following informalities: In Line 3, the word “spaced” in front of “anchors” should be deleted. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: In Line 2, the word “the” in front of “opening” should be deleted. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: In Line 2, the words “that pass through the spaced anchors” should be deleted. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: In Line 2, the word “spaced” in front of “anchors” should be deleted. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: In Lines 2-3, the words “of the spaced anchors” should be deleted. In Line 3, the word “spaced” in front of the second instance of the word “anchors” should be deleted. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: In Line 3, the word “spaced” in front of “anchors” should be deleted. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: In Line 1, the word “spaced” in front of “anchors” should be deleted. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: In Line 3, the word --and-- should be added at the end of the line after the semi-colon. In Line 6, the word “therebetween” should be deleted. In Lines 9 & 11, the word “the” in front of “anchor” should be deleted. In Line 10, the word --and-- should be added at the end of the line after the semi-colon. Appropriate correction is required.
Claim 14 is objected to because of the following informalities and should be amended as follows: “14. The pressure distribution implant as claimed in claim 13, wherein the segments of the elongated channel each have a cross-sectional diametereach have a widthis smaller than the cross-sectional diameter
Claim 15 is objected to because of the following informalities: In Lines 2-3, the word “spaced” in front of “anchors” should be deleted. In Line 4, the limitation “of the respective anchors” should be deleted. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: In Line 2, the words “for being” should be replaced with the words --to be--. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: In Line 3, the word --and-- should be added at the end of the line after the semi-colon. In Line 8, the words “that are” should be deleted. In Lines 10 & 12, the word “the” in front of “second” should be deleted. In Line 11, the word --and-- should be added at the end of the line after the semi-colon. Appropriate correction is required.
Claim 18 is objected to because of the following informalities: In Line 3, the word “spaced” in front of “anchors” should be deleted. Appropriate correction is required.
Claim 21 is objected to because of the following informalities: In Lines 6 & 8, the word “the” in front of “anchor” should be deleted. In Line 9, the word --and-- should be added at the end of the line after the semi-colon. In Line 12, the limitation “that is aligned with the longitudinal axis of the flexible body” should be deleted. In Line 13, the words “the openings” should be replaced with the words --each opening--. Appropriate correction is required.
Claim 22 is objected to because of the following informalities: In Lines 1-2, Line 3, and Line 4, the word “spaced” in front of “anchors” should be deleted. Appropriate correction is required.
Claim 23 is objected to because of the following informalities: In Line 2, the word “spaced” in front of “anchors” should be deleted. Appropriate correction is required.
Claim 24 is objected to because of the following informalities: In Line 2, the words “comprises devices” should be replaced with the word --is--. 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.
Claim 7 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 7 at Line 2 recites the limitation “the upper ends”. There is no antecedent basis for this limitation in the claim. For purposes of examination, the limitation is being interpreted as “upper ends”. Appropriate correction is required.
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) 1-16 & 21-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Madjarov (US PG Pub. No. 2015/0238237) in view of Bernstein et al. (US PG Pub No. 2013/0289564).
Regarding Claim 1, Madjarov discloses an implant (400, Figs. 19-20, Paragraphs [0075-0079]) capable of being used for sternal closure (Paragraph [0002]) comprising: an elongated body (body of 400, Fig. 19, Paragraph [0083] states that the embodiment of Fig. 19 is rectangular) 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. 19 below); the elongated body having top and bottom surfaces (420 & 410, Fig. 20) that extend along the longitudinal axis; and a plurality of anchors (440, Figs. 19-20, Paragraph [0078]) projecting from the top surface of the elongated body (Fig. 20) and being spaced from one another between the first and second ends of the elongated body (Fig. 19), each anchor including a segment of an elongated channel (each lumen 446, Fig. 20, Paragraph [0078]) extending therethrough.
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Madjarov does not disclose that segments of the elongated channel are aligned with the longitudinal axis of the elongated body. Madjarov does disclose segments positioned along the longitudinal axis which are not aligned with one another, and other segments which are aligned with one another such that an elongated channel extends therethrough across the body (See examiner annotated Fig. 19 above). Madjarov further discloses in Paragraph [0078] that “Accordingly, a number of enclosed channels 440 may be provided, as shown in FIG. 19, and they may be arranged at different angles with respect to one another as shown so as to provide the surgeon with the ability to select one or more enclosed channels based on their location and/or their orientation to match the particular application and surgeon's methods and preferences for the given procedure.” It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the segments along the longitudinal axis of the body of Madjarov to be aligned with each other and coaxial along the longitudinal axis as taught by Madjarov as an alternate and functionally equivalent anchor arrangement based on a surgeon’s preference and a patient’s particular needs.
Madjarov further fails to disclose wherein each anchor has an opening that is in communication with the segment of the elongated channel associated therewith.
Bernstein et al. discloses various embodiments of an implant for sternal closure (60, Figs. 1-13, Paragraphs [0048-0077]), wherein the implant comprises an elongate plate body (70), and an elongated tissue closure device (encircling member 68, Figs. 1-3), wherein the elongate plate body comprises a plurality of anchor portions (chamfer portions 172 & 168 with channels 124, 126, 128 & 130 therethrough, Figs. 4-5) spaced from one another along a longitudinal axis of the body, each anchor including a segment of an elongated channel (124-130, Fig. 5) extending therethrough, wherein Fig. 9 depicts another arrangement for the anchor portions which comprises a single opening (140, Paragraph [0067]) “that tapers upward to form a narrowed mouth or gap 142 disposed above and communicating with a body of the opening. The opening may be sized to receive the encircling member twice, with lips 144 of mouth 142 configured to retain the encircling member in the opening.” Bernstein et al. further discloses in Paragraph [0050] that “Each encircling member may be any elongate member that is of sufficient length and flexibility to be arranged in a loop, for example, a loop that encircles a portion of bone. The encircling member may be strong enough to be tensioned to compress bone. The encircling member may have a smooth surface to facilitate sliding the encircling member through openings of the fastening member, and/or may include surface structure, such as recesses and/or protrusions, to resist sliding after the encircling member has been attached to the fastening member. The encircling member may have any suitable cross-sectional shape including circular, oval, polygonal (e.g., rectangular), or any combination thereof, among others. Exemplary encircling members may include a wire, a cable, a strap, a suture, or the like.”
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify each anchor to include a narrowed mouth or gap disposed through the entirety of the uppermost surface thereof which is in communication with the lumen as taught by Bernstein et al. in order to allow a suture or other encircling member such as a cable or wire to be received in each anchor twice and retained within the anchor based on a patient’s particular needs and a surgeon’s preference.
Regarding Claim 2, the combination of Madjarov and Bernstein et al. discloses the claimed invention as stated above in Claim 1, and Madjarov further discloses wherein the plurality of anchors define gaps therebetween that overlie the top surface of the elongated body (See examiner annotated Fig. 19 above).
Regarding Claim 3, the combination of Madjarov and Bernstein et al. discloses the claimed invention as stated above in Claim 2, and Madjarov further discloses wherein the plurality of anchors are evenly spaced from one another between the first and second ends of the elongated body (Fig. 19), and wherein each the anchor has a constant length that extends along the longitudinal axis of the elongated body (the segments along the longitudinal axis of the body are aligned with each other and coaxial along the longitudinal axis as stated above in claim 1, Paragraph [0078]).
Regarding Claim 4, the combination of Madjarov and Bernstein et al. discloses the claimed invention as stated above in Claim 2, and Madjarov further discloses wherein the elongated body comprises a flexible body (“In other embodiments, however, such as in applications in which greater pliability is required, the bone fixation implant 400 may be made predominantly or solely of a polymer, such as PEEK.”, Paragraph [0077]). The combination does not disclose that the elongated body is more flexible at the location of the gaps and less flexible at the location of the anchors. However, Paragraph [0077] states 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 the combination to add a metal mesh grid therethrough which extends between each adjacent row and each adjacent column of fastener openings such that the body is more flexible at the fastener openings as taught by Madjarov in order to provide a thin profile implant which allows a degree of malleability and resiliency along the body to better shape and contour with the patient’s native anatomy.
Regarding Claim 5, the combination of Madjarov and Bernstein et al. discloses the claimed invention as stated above in Claim 1, and Madjarov further discloses wherein the segments of the elongated channel define an elongated channel diameter (diameter of lumen 446, Fig. 20, Paragraph [0078]), 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 (144, Fig. 9 of Bernstein).
Regarding Claim 6, the combination of Madjarov and Bernstein et al. discloses the claimed invention as stated above in Claim 5, and Madjarov further discloses wherein the segments of the elongated channel define tube-shaped hollows (lumen 446, Figs. 19-20, Paragraph [0078]) that are aligned with the longitudinal axis of the elongated body (the segments along the longitudinal axis of the body are aligned with each other and coaxial along the longitudinal axis as stated above in claim 1, Paragraph [0078]).
Regarding Claim 7 as best understood, the combination of Madjarov and Bernstein et al. discloses the claimed invention as stated above in Claim 6, and the combination further discloses wherein the openings are located at upper ends of the respective anchors (as taught by Bernstein, 144, Fig. 9), and wherein the openings are aligned with the longitudinal axis of the elongated body (the segments along the longitudinal axis of the body are aligned with each other and coaxial along the longitudinal axis as stated above in claim 1, Paragraph [0078]).
Regarding Claims 8-10, the combination of Madjarov and Bernstein et al. discloses the claimed invention as stated above in Claim 7, and Madjarov further discloses an elongated tissue closure device (450, Fig. 20, Paragraph [0078]) disposed within the segments of the elongated channel, wherein the elongated tissue closure device is a suture (450, Paragraph [0078]), wherein the elongated tissue closure device has a cross-sectional diameter that is less than an inner diameter of the elongated channel (lumen 446, Fig. 20), wherein the elongated tissue closure device extends through the anchors and along the longitudinal axis of the elongated body (“Thus, as shown in FIG. 20, a suturing needle may apply a suture stitch through the overlying tissue, then be passed through the enclosed channel 440, thereby threading a suture thread 450 (resorbable or permanent) through the enclosed channel. By selecting one or more of the enclosed channels 440 to receive the suture thread 450, the overlying tissue structure can be secured to the bone fixation implant using sutures that extend from the tissue structure through the selected enclosed channels.”) (the segments along the longitudinal axis of the body are aligned with each other and coaxial along the longitudinal axis as stated above in claim 1, Paragraph [0078]). The combination does not disclose wherein the elongated tissue closure device has a cross-sectional diameter that is greater than the width of the openings of the spaced anchors.
Bernstein et al. discloses in Paragraph [0067] that “FIGS. 7-10 show other embodiments of openings that may replace channels 124 and 126 (and/or channels 128 and 130 on only one side or opposite sides of collapsible aperture 134)… FIG. 9 shows a fastening member having a single opening 140 that tapers upward to form a narrowed mouth or gap 142 disposed above and communicating with a body of the opening. The opening may be sized to receive the encircling member twice, with lips 144 of mouth 142 configured to retain the encircling member in the opening.” And Paragraph [0050] discloses “Each encircling member may be any elongate member that is of sufficient length and flexibility to be arranged in a loop, for example, a loop that encircles a portion of bone. The encircling member may be strong enough to be tensioned to compress bone. The encircling member may have a smooth surface to facilitate sliding the encircling member through openings of the fastening member, and/or may include surface structure, such as recesses and/or protrusions, to resist sliding after the encircling member has been attached to the fastening member. The encircling member may have any suitable cross-sectional shape including circular, oval, polygonal (e.g., rectangular), or any combination thereof, among others. Exemplary encircling members may include a wire, a cable, a strap, a suture, or the like.”
Thus it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to replace the tissue closure device of Madjarov with an suture that has a cross-sectional diameter greater than the width of the opening of each anchor as taught by Bernstein et al. as an alternate and functionally equivalent securing means for attaching the implant to the patient as necessary based on a particular procedure.
Regarding Claim 11, the combination of Madjarov and Bernstein et al. discloses the claimed invention as stated above in Claim 1, and Madjarov further discloses wherein the anchors are made of a first flexible material “In other embodiments, however, such as in applications in which greater pliability is required, the bone fixation implant 400 may be made predominantly or solely of a polymer, such as PEEK.”, Paragraph [0077]). Madjarov does not disclose wherein the anchors first material is relatively softer and more flexible than a second material that covers the bottom surface of the flexible body. Paragraph [0077] states 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 the combination to add a metal mesh grid therethrough which extends between each adjacent row and each adjacent column of fastener openings such that the body is less flexible than the anchors as taught by Madjarov in order to provide a thin profile implant which allows a degree of malleability and resiliency along the body to better shape and contour with the patient’s native anatomy.
Regarding Claim 12, Madjarov discloses an implant (400, Figs. 19-20, Paragraphs [0075-0079]) capable of being used for sternal closure (Paragraph [0002]) comprising: a flexible body (body of 400, Fig. 19, Paragraph [0083]; “In other embodiments, however, such as in applications in which greater pliability is required, the bone fixation implant 400 may be made predominantly or solely of a polymer, such as PEEK.”, Paragraph [0077]) having top and bottom surfaces (420 & 410, Fig. 20) that extend along a longitudinal axis of the flexible body (See examiner annotated Fig. 19 above); a plurality of anchors (440, Figs. 19-20, Paragraph [0078]) 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. 19); the anchors defining a series of gaps therebetween that are located between the anchors, the gaps overlying the top surface of the flexible body (See examiner annotated Fig. 19 above); each anchor having a segment of an elongated channel extending therethrough (Fig.19), and each anchor having an outer wall (cylindrical outer wall forming each 440, Figs. 19-20).
Madjarov does not disclose the gaps or the elongated channel being in alignment with the longitudinal axis of the flexible body. Madjarov does disclose segments positioned along the longitudinal axis which are not aligned with one another, and other segments which are aligned with one another such that an elongated channel extends therethrough across the body (See examiner annotated Fig. 19 above). Madjarov further discloses in Paragraph [0078] that “Accordingly, a number of enclosed channels 440 may be provided, as shown in FIG. 19, and they may be arranged at different angles with respect to one another as shown so as to provide the surgeon with the ability to select one or more enclosed channels based on their location and/or their orientation to match the particular application and surgeon's methods and preferences for the given procedure.” It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the segments along the longitudinal axis of the body of Madjarov to be aligned with each other and coaxial along the longitudinal axis as taught by Madjarov as an alternate and functionally equivalent anchor arrangement based on a surgeon’s preference and a patient’s particular needs.
Madjarov further fails to disclose each anchor’s outer wall comprising an opening formed therein that is in communication with the respective segment of the elongated channel associated therewith.
Bernstein et al. discloses various embodiments of an implant for sternal closure (60, Figs. 1-13, Paragraphs [0048-0077]), wherein the implant comprises an elongate plate body (70), and an elongated tissue closure device (encircling member 68, Figs. 1-3), wherein the elongate plate body comprises a plurality of anchor portions (chamfer portions 172 & 168 with channels 124, 126, 128 & 130 therethrough, Figs. 4-5) spaced from one another along a longitudinal axis of the body, each anchor including a segment of an elongated channel (124-130, Fig. 5) extending therethrough, wherein Fig. 9 depicts another arrangement for the anchor portions which comprises a single opening (140, Paragraph [0067]) “that tapers upward to form a narrowed mouth or gap 142 disposed above and communicating with a body of the opening. The opening may be sized to receive the encircling member twice, with lips 144 of mouth 142 configured to retain the encircling member in the opening.” Bernstein et al. further discloses in Paragraph [0050] that “Each encircling member may be any elongate member that is of sufficient length and flexibility to be arranged in a loop, for example, a loop that encircles a portion of bone. The encircling member may be strong enough to be tensioned to compress bone. The encircling member may have a smooth surface to facilitate sliding the encircling member through openings of the fastening member, and/or may include surface structure, such as recesses and/or protrusions, to resist sliding after the encircling member has been attached to the fastening member. The encircling member may have any suitable cross-sectional shape including circular, oval, polygonal (e.g., rectangular), or any combination thereof, among others. Exemplary encircling members may include a wire, a cable, a strap, a suture, or the like.”
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify each anchor to include a narrowed mouth or gap disposed through the entirety of the uppermost surface thereof which is in communication with the lumen as taught by Bernstein et al. in order to allow a suture or other encircling member such as a cable or wire to be received in each anchor twice and retained within the anchor based on a patient’s particular needs and a surgeon’s preference.
Regarding Claim 13, the combination of Madjarov and Bernstein et al. discloses the claimed invention as stated above in Claim 12, and Madjarov further discloses wherein the openings of the respective anchors are aligned with the longitudinal axis of the flexible body (the segments, including the openings 144 in Fig. 9 as taught by Berstein as stated above, along the longitudinal axis of the body are aligned with each other and coaxial along the longitudinal axis as stated above in claim 1, Paragraph [0078]).
Regarding Claim 14, the combination of Madjarov and Bernstein et al. discloses the claimed invention as stated above in Claim 13, and Madjarov further discloses wherein the segments of the elongated channel each have a cross-sectional diameter (diameter of lumen 446, Fig. 20, Paragraph [0078]), and wherein the openings each have a width that is smaller than the cross-sectional diameter of each respective segment of the elongated channel (width of 144, Fig. 9 of Bernstein which is smaller than the width of the channel 140 in Fig. 9).
Regarding Claim 15, the combination of Madjarov and Bernstein et al. discloses the claimed invention as stated above in Claim 14, and Madjarov further discloses an elongated tissue closure device (450, Fig. 20, Paragraph [0078]) being secured over the top surface of the flexible body by the anchors (Fig. 20), the elongated tissue closure device extending through the segments of the elongated channel for being aligned with the longitudinal axis of the flexible body (“Thus, as shown in FIG. 20, a suturing needle may apply a suture stitch through the overlying tissue, then be passed through the enclosed channel 440, thereby threading a suture thread 450 (resorbable or permanent) through the enclosed channel. By selecting one or more of the enclosed channels 440 to receive the suture thread 450, the overlying tissue structure can be secured to the bone fixation implant using sutures that extend from the tissue structure through the selected enclosed channels.”) (the segments along the longitudinal axis of the body are aligned with each other and coaxial along the longitudinal axis as stated above in claim 1, Paragraph [0078]).
Regarding Claim 16, the combination of Madjarov and Bernstein et al. discloses the claimed invention as stated above in Claim 12, and Madjarov further discloses wherein the flexible body has first and second flexible ends (1st and 2nd ends, See examiner annotated Fig. 19 above) that are capable of being bent for conforming to the shape of an outer surface of a sternum (“In other embodiments, however, such as in applications in which greater pliability is required, the bone fixation implant 400 may be made predominantly or solely of a polymer, such as PEEK.”, Paragraphs [0077, 0099]).
Regarding Claims 21 & 24, Madjarov discloses an implant (400, Figs. 19-20, Paragraphs [0075-0079]) capable of being used for sternal closure (Paragraph [0002]) comprising: a flexible body (body of 400, Fig. 19, Paragraph [0083]; “In other embodiments, however, such as in applications in which greater pliability is required, the bone fixation implant 400 may be made predominantly or solely of a polymer, such as PEEK.”, Paragraph [0077]) having first and second ends and a longitudinal axis that extends from the first end to the second end (See examiner annotated Fig. 19 above), and top and bottom surfaces (420 & 410, Fig. 20) that extend along the longitudinal axis (See examiner annotated Fig. 19 above); a plurality of anchors (440, Figs. 19-20, Paragraph [0078]) projecting from the top surface of the flexible body and being spaced from one another between the first and second ends of the body (Fig. 19); each anchor having a segment of an elongated channel extending therethrough (Fig.19), and each anchor having an outer wall (cylindrical outer wall forming each 440, Figs. 19-20); and an elongated tissue closure device (450, Fig. 20, Paragraph [0078]) secured over the top surface of the flexible body by the anchors, wherein the elongated tissue closure device is a suture (450, Paragraph [0078]), the elongated tissue closure device extending through the segments of the elongated channel (“Thus, as shown in FIG. 20, a suturing needle may apply a suture stitch through the overlying tissue, then be passed through the enclosed channel 440, thereby threading a suture thread 450 (resorbable or permanent) through the enclosed channel. By selecting one or more of the enclosed channels 440 to receive the suture thread 450, the overlying tissue structure can be secured to the bone fixation implant using sutures that extend from the tissue structure through the selected enclosed channels.”).
Madjarov does not disclose the elongated channel being in alignment with the longitudinal axis of the flexible body. Madjarov does disclose segments positioned along the longitudinal axis which are not aligned with one another, and other segments which are aligned with one another such that an elongated channel extends therethrough across the body (See examiner annotated Fig. 19 above). Madjarov further discloses in Paragraph [0078] that “Accordingly, a number of enclosed channels 440 may be provided, as shown in FIG. 19, and they may be arranged at different angles with respect to one another as shown so as to provide the surgeon with the ability to select one or more enclosed channels based on their location and/or their orientation to match the particular application and surgeon's methods and preferences for the given procedure.” It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the segments along the longitudinal axis of the body of Madjarov to be aligned with each other and coaxial along the longitudinal axis as taught by Madjarov as an alternate and functionally equivalent anchor arrangement based on a surgeon’s preference and a patient’s particular needs.
Madjarov further fails to disclose each anchor’s outer wall comprising an opening formed therein that is in communication with the respective segment of the elongated channel associated therewith, wherein the elongated tissue closure device has a cross-sectional diameter that is greater than a width of the openings of the respective anchors.
Bernstein et al. discloses various embodiments of an implant for sternal closure (60, Figs. 1-13, Paragraphs [0048-0077]), wherein the implant comprises an elongate plate body (70), and an elongated tissue closure device (encircling member 68, Figs. 1-3), wherein the elongate plate body comprises a plurality of anchor portions (chamfer portions 172 & 168 with channels 124, 126, 128 & 130 therethrough, Figs. 4-5) spaced from one another along a longitudinal axis of the body, each anchor including a segment of an elongated channel (124-130, Fig. 5) extending therethrough, wherein Fig. 9 depicts another arrangement for the anchor portions which comprises a single opening (140, Paragraph [0067]) “that tapers upward to form a narrowed mouth or gap 142 disposed above and communicating with a body of the opening. The opening may be sized to receive the encircling member twice, with lips 144 of mouth 142 configured to retain the encircling member in the opening.” Bernstein et al. further discloses in Paragraph [0050] that “Each encircling member may be any elongate member that is of sufficient length and flexibility to be arranged in a loop, for example, a loop that encircles a portion of bone. The encircling member may be strong enough to be tensioned to compress bone. The encircling member may have a smooth surface to facilitate sliding the encircling member through openings of the fastening member, and/or may include surface structure, such as recesses and/or protrusions, to resist sliding after the encircling member has been attached to the fastening member. The encircling member may have any suitable cross-sectional shape including circular, oval, polygonal (e.g., rectangular), or any combination thereof, among others. Exemplary encircling members may include a wire, a cable, a strap, a suture, or the like.”
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify each anchor to include a narrowed mouth or gap disposed through the entirety of the uppermost surface thereof which is in communication with the lumen and replace the tissue closure device with an suture that has a cross-sectional diameter greater than the width of the opening of each anchor as taught by Bernstein et al. as an alternate and functionally equivalent securing means for attaching the implant to the patient as necessary based on a particular procedure.
Regarding Claims 22-23, the combination of Madjarov and Bernstein et al. discloses the claimed invention as stated above in Claim 21, and Madjarov further discloses wherein the plurality of spaced anchors define gaps (See examiner annotated Fig. 19 above) therebetween that overlie the top surface of the flexible body and that are located between the anchors; and wherein the flexible body comprises a biocompatible polymer material (PEEK, Paragraph [0077]).
Madjarov does not disclose that the flexible body is relatively more flexible at the location of the gaps and relatively less flexible at the location of the spaced anchors, wherein the anchors are made of a first material that is softer and more flexible than a second material that covers the bottom surface of the flexible body. However, Paragraph [0077] states 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 the combination to add a metal mesh grid therethrough which extends between each adjacent row and each adjacent column of fastener openings such that the body is more flexible at the fastener openings and anchors as taught by Madjarov in order to provide a thin profile implant which allows a degree of malleability and resiliency along the body to better shape and contour with the patient’s native anatomy.
Claim(s) 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Madjarov (US PG Pub. No. 2015/0238237) in view of Bernstein et al. (US PG Pub No. 2013/0289564) as applied to Claim 12 above and further in view of Matheny (US PG Pub No. 2015/0265325).
Regarding Claims 17-20, the combination of Madjarov and Bernstein et al. discloses the claimed invention as stated above in claim 16, except a second flexible body having top and bottom surfaces that extend along a second longitudinal axis that intersects with the first longitudinal axis of the first flexible body; a plurality of second anchors 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 the 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; each the 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; an elongated tissue closure device being secured over the top surface of the second flexible body by the second spaced anchors, 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; wherein the first and second flexible bodies cross one another and define an implant structure having an X-shaped configuration; and a pin that pivotally interconnects the first and second flexible bodies for selectively changing the angle between the first longitudinal axis of the first flexible body and the second longitudinal axis of the second flexible body.
Madjarov does disclose an embodiment of the implant which is X-shaped in Fig. 12. Paragraph [0069] further states that “Moreover, in some embodiments, in addition to variations in the configuration (e.g., size, shape, material, etc.) of the structural portion 105, the configuration of the polymer body 110 may also vary depending on the intended use of the bone fixation implant 100.”
Matheny discloses various embodiments of sternal closure implants (Figs. 1, 3 & 4), wherein the Fig. 1 embodiment comprises a polymeric X-shaped body (10, Paragraphs [0138-0140, 0145, 0152]) comprising a plurality of apertures (16) for insertion of sutures therethrough for attaching the implant to the sternum of a patient (Paragraph [0140]), and wherein the Fig. 3 embodiment comprises a multi-link body (30, Paragraphs [0161-0162]) comprising a plurality of elongated rotatably connected or pivoting links (32, 34, 36) with pivoting points/pins (35) therebetween to allow for flexibility in the location where the apparatus is connected to a patient’s sternum, and comprising a plurality of apertures (holes, not labeled in Fig. 3) for insertion of sutures therethrough for attaching the implant to the sternum of a patient. Matheny further teaches in Paragraph [0169] that “Without departing from the spirit and scope of this invention, one of ordinary skill can make various changes and modifications to the invention to adapt it to various usages and conditions. As such, these changes and modifications are properly, equitably, and intended to be, within the full range of equivalence of the following claims.”
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the shape of the implant of Madjarov to be X-shaped comprising first and second flexible body portions pivotally coupled by a pivot pin for selectively changing the angle therebetween as taught by Matheny as an alternate and functionally equivalent shape for insertion over a patient’s sternum which supports healing of bone and surrounding tissue while providing the benefit of allowing the implant to be adjusted as necessary based on the patient’s particular anatomy.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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/JESSICA WEISS/Primary Examiner, Art Unit 3775