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 .
Response to Arguments
Applicant's arguments filed 6/10/2026 have been fully considered but they are not persuasive because they are directed to the newly presented amendments which are presently examined. Therefore, a new ground(s) of rejection is made in view of Callcott, Patel, Richmond, and McCullen as necessitated by amendment.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Callcott et al. (WO 2019200235) "Callcott" in view of Patel et al. (US 20180360610) "Patel".
Regarding Claim 1, Callcott discloses a medical implant (artificial meniscus 2, par. [00107], Fig. 12A) for meniscus repair or replacement, wherein the medical implant extends along a plane (anterior and posterior horn axes, A— A and P— P, par. [00107], Fig. 12A) perpendicular to a first axis (vertical axis or z-axis, par. [00107], Fig. 13A);
characterized in that a density of said fibers varies along said plane, particularly resulting in a varying compressive strength along said first axis (pars. [00101], [00113]);
and/or a percentage of said fibers aligned in a circumferential direction (peripheral surface 12, par. [00111], Fig. 12B) in respect of said first axis differs along said plane, resulting in a varying tensile strength of the medical implant along said plane (par. [00111], but does not teach a plurality of fibers that are mechanically entangled with one another to form a felt material.
However, Patel, in the same field of art, teaches a medical implant (implant 100, par. [0030], See Annotated Fig. 1, below) wherein the medical implant comprises a plurality of fibers (fiber 122, par. [0033], See Annotated Fig. 1, below) that are mechanically entangled with one another (pars. [0005] and [0034], there are several intersecting fibers that may vary in their cross-sections and directional paths, creating a mechanically entangled formation, See Annotated Fig. 1, below) to form a felt material (pars. [0043] and [0044], implant 100 may be made of polymers such as polyethylene or PCL, which can form the felt material). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Callcott to include a plurality of fibers that are mechanically entangled with one another to form a felt material, as taught by Patel, in order to provide structural support including tensile and/or compressive support for the scaffold, which is designed to contribute to the formation of new functional tissues for medical purposes (Patel, par. [0030]).
Regarding Claim 2, Callcott further discloses the medical implant according to claim 1, characterized in that said medical implant comprises an outside surface (interior surfaces 12, pars. [00111], [00113], Fig. 12C), wherein said density of said fibers increases in a radial direction (direction of non-circumferential fiber bundles 28, pars. [00111], [00112], Figs. 12B and 12C) in respect of the first axis towards the outside surface;
such that said compressive strength increases in the radial direction towards the outside surface, and/or said percentage of said fibers aligned in said circumferential direction increases in the radial direction towards the outside surface (par. [00111], Fig. 12B);
such that said tensile strength of the medical implant increases in said radial direction towards said outside surface (par. [00111]- [00112], Fig. 12B).
Regarding Claim 3, Callcott does not disclose a medical implant with a plurality of zones arranged radially, with varying densities of fibers. However, Patel, in the same field of art, teaches a medical implant (implant 100, par. [0030], See Annotated Fig. 1, below) characterized in that said medical implant comprises a plurality of zones (scaffold 102 and reinforcing matrix 120, par. [0030], See Annotated Fig. 1, below);
wherein said density of said fibers (fiber 122, par. [0030], See Annotated Fig. 1, below) and/or said percentage of said fibers aligned in the circumferential direction (arrow A, par. [0033], Fig. 2) varies between the zones;
said zones are arranged along said radial direction (arrows B, par. [0035], Fig. 2). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Callcott to include a plurality of zones arranged radially, with varying densities of fibers as taught by Patel in order to provide structural support including tensile and/or compressive support for the scaffold, which is designed to contribute to the formation of new functional tissues for medical purposes (Patel, par. [0030]).
Regarding Claim 4, Callcott does not disclose a first end, central section, and second end along a curved line with a central recess. However, Patel, in the same field of art, teaches a medical implant characterized in that said medical implant extends from a first end (anterior end 110, par. [0033], See Annotated Fig. 1, below) via a central section (middle section 114, par. [0033], See Annotated Fig. 1, below) towards a second end (posterior end 112, par. [0033], See Annotated Fig. 1, below) along a curved line (circumferential direction 104, par. [0035], See Annotated Fig. 1, below) extending in the circumferential direction (arrow A, par. [0033]);
wherein the medical implant comprises a central recess (See Annotated Fig. 1, below), around which the curved line extends. It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Callcott to include a first end, central section, and second end along a curved line with a central recess as taught by Patel in order to provide a path for circumferential fibers and thus provide tensile and/or compressive support for the scaffold, which is designed to contribute to the formation of new functional tissues for medical purposes (Patel, pars. [0030], [0036]).
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Claim(s) 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Callcott and Patel as applied to claim 1 above, and further in view of Richmond (US 4919667 A) "Richmond".
Regarding Claim 5, Callcott as modified by Patel, does not disclose a medical implant with multiple layers of felt material stacked and connected by felting. However, Richmond, in the same field of art, teaches a medical implant (implant 10, col 3, lines 20-32, Fig. 1) characterized in that said medical implant is formed from a plurality of layers (woven cloth bottom layer 30, first felt intermediate layer 31, second felt intermediate layer 32, top cloth layer 33, col 3, lines 20-32, Figs. 3 and 6) of said felt material;
wherein the layers are stacked in a direction parallel to the first axis (line II, col 3, lines 20-32, Figs. 1 and 6);
and wherein said layers are connected by felting (col 3, lines 20-32, Fig. 6). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Callcott and Patel to include multiple layers of felt material stacked and connected by felting, as taught by Richmond, in order to provide a more accurate anatomical shape and reinforcement for strength and durability (Richmond, col 3, lines 46-54).
Regarding Claim 6, Callcott as modified by Patel does not disclose a medical implant with stacked layers with varying thickness and arc lengths and cover layers. However, Richmond, in the same field of art, teaches a medical implant wherein said medical implant is formed from a plurality of layers of said felt material (col 3, lines 20-32);
wherein the layers are stacked in a direction parallel to the first axis (col 3, lines 20-32, Figs. 1 and 6);
and wherein said layers are connected by felting, and is characterized in that said layers comprise a bottom layer (woven cloth bottom layer 30, col 3, lines 20-32, Figs. 3 and 6) and a top layer (top cloth layer 33, col 3, lines 20-32, Figs. 3 and 6);
wherein an arc length of the bottom layer extending along the curved line (perimeter edge 22 and 23, col 2, lines 65-68, col 3, lines 1-19, Figs. 1 and 6) is greater than an arc length of the top layer extending along the curved line, such that a thickness of the medical implant measured parallel to the first axis increases from the first end (end 63, col 5, lines 49-68, Fig. 7) towards the central section (central portion 61, col 5, lines 49-68, Fig. 7) and/or from the second end (end 63, col 5, lines 49-68, Fig. 7) towards the central section (col 2, lines 65-68, col 3, lines 1-19 and 33-45, Figs. 3 and 6);
wherein said layers comprise at least one intermediate layer (first felt intermediate layer 31, second felt intermediate layer 32) between the bottom layer and the top layer (col 3, lines 20-32, Figs. 3 and 6);
wherein an arc length of the at least one intermediate layer is between the arc length of the bottom layer and the arc length of the top layer (col 3, lines 33-45, Figs. 1 and 3);
wherein the medical implant further comprises a first cover layer (bottom face 24, col 2, lines 65-68, col 3, lines 1-19, Fig. 6) covering the bottom layer, the intermediate layers and the top layer on a top surface (top surface 25, col 2, lines 65-68, col 3, lines 1-19, Fig. 6) from the first end towards the second end and/or the medical implant further comprises a second cover layer covering said bottom layer, said intermediate layers and said top layer on a rim surface (col 2, lines 65-68, col 3, lines 1-19, Fig. 6). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Callcott and Patel to include stacked layers with varying thickness and arc lengths and cover layers as taught by Richmond in order to provide a more accurate anatomical shape and reinforcement for strength and durability (Richmond, col 3, lines 46-54).
Regarding Claim 7, Callcott as modified by Patel does not disclose, a medical implant with a strip arranged around the outside surface. However, Richmond, in the same field of art, teaches the medical implant characterized in that said medical implant comprises a strip (porous tube 40, col 3, lines 60-68, Fig. 9) comprising said felt material (col 3, lines 60-68, Fig. 9);
wherein said strip is arranged in said circumferential direction in respect of the first axis along an outside surface (perimeter edge 23, col 4, lines 5-17, Fig. 11) of the medical implant between the bottom layer and the top layer (col 3, lines 60-68, col 4, lines 5-17, Figs. 9 and 11);
wherein said strip extends along said curved line (col 3, lines 60-68, col 4, lines 5-17, Figs. 9 and 11);
wherein said strip has an arc length along the curved line which is shorter than the arc length of the bottom layer and shorter than the arc length of the top layer (col 3, lines 60-68, col 4, lines 5-17, Figs. 9 and 11). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Callcott to include a strip arranged around the outside surface as taught by Richmond in order to promote natural fibrous tissue growth (Richmond, col 3, lines 60-68, col 6, lines 52-64).
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over Callcott et al. (WO 2019200235) "Callcott" and Patel as applied to claim 4 above, and further in view of McCullen et al. (WO 2018204440 A2) "McCullen".
Regarding Claim 8, Callcott as modified by Patel discloses claim 4, but does not disclose a
replacement member and supporting body. However, McCullen, in the same field of art, teaches a medical implant (joint implant 100, page 22, par. [82], See Annotated Fig. 1, below) characterized in that said medical implant comprises a replacement member (bottom lip 105, page 22, par. [82], See Annotated Fig. 1, below) configured to replace a part of a soft biological tissue (page 22, par. [82]), comprising a meniscus, and a supporting body (ligature 103, page 22, par. [82], See Annotated Fig. 1, below) connected to the replacement member (page 22, par. [82], See Annotated Fig. 1, below);
wherein the supporting body extends from the first end (anterior end 106, page 22, par. [82], See Annotated Fig. 1, below) via the central section (area of ligature 103 between top lip 104 and bottom lip 105, page 22, par. [82], See Annotated Fig. 1, below) to the second end (posterior end 107, page 22, par. [82], See Annotated Fig. 1, below) along the curved line (internal edge 108, See Annotated Fig. 1, below) in the circumferential direction (direction of internal edge 108, See Annotated Fig. 1, below);
and wherein the replacement member is arranged on a bottom surface (bottom of ligature 103, See Annotated Fig. 1, below) of the supporting body (page 22, par. [82], See Annotated Fig. 1, below);
wherein the replacement member covers a partial segment of said bottom surface (page 22, par. [82], See Annotated Fig. 1, below);
wherein said replacement member has a thickness measured parallel to the first axis (See Annotated Fig. 1, below) which is greater than a thickness of the supporting body measured parallel to the first axis (pages 8 and 9, par. [27], See Annotated Fig. 1, below). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure of Callcott to include a replacement member and supporting body as taught by McCullen in order to more closely reference the structure and organization of the meniscus tissue (McCullen, page 22, par. [82]).
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Conclusion
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 NATALIE NICOLE THOMAS whose telephone number is (571)272-0004. The examiner can normally be reached Monday - Friday 8:30am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached at (408)918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NATALIE N THOMAS/Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
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