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 .
Status of Claims
Claims 1-3, 6- 9, 12, 21-24, 31, 36, 39, 43-45 and 47-53 are pending, of which claims 6-9, 12, 21-24, 31, 36, and 39 are withdrawn. Therefore, claims 1-3, 43-45, and 47-53 are examined below.
Response to Arguments
The remarks of 07/25/2025 have been fully considered but they are not persuasive.
Applicant argues that the prior art of record doesn't explicitly teach or disclose all of the elements of amended claim 1, in particular applicant argues that the prior art does not disclose a porous biocompatible scaffold forming an implant-tissue bridge in which tissue infiltrates and tissue fixation occurs.
This argument is moot in light of the new 103 rejection below.
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) 1-3, 48, and 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2011/0238094 (Thomas) in view of US 2010/0168808 (Citron) in view of US 2019/0380838 (Ghodbane)
Regarding claim 1, Thomas discloses a composite conformable cover (Fig. 1A, wherein 110 corresponds to a composite conformable cover) for an implantable medical device, comprising:
a porous biocompatible scaffold (Fig. 1a, 120, ¶0054, wherein 120 has a plurality of pores 140);
a plurality of biocompatible filaments (Fig. 2A, 230) embedded within and fixed to the biocompatible scaffold (see Fig 1A and 2A, wherein grip members are both embedded within and fixed to scaffold), each of the biocompatible filaments comprising:
a strain crystallized (¶0027, wherein deformation corresponds to strain crystallization) shape-memory polymer material (¶0026, wherein “shape memory polymers” corresponds to a shape-memory material) and configured to transform from an extended configuration (see 1B for extended configuration, see also ¶0043) to a reduced configuration (Fig. 1D, ¶0043 wherein the second, generally curled configuration corresponds to the reduce configuration) when the cover is heated to a predetermined temperature (¶0056, wherein above 20 deg Celsius corresponds to a predetermined temperature),
wherein, the plurality of biocompatible filaments is configured within the scaffold to cause the porous biocompatible scaffold of the conformable cover to transition from the porous biocompatible scaffold in the first condition (Fig. 1A, wherein filaments 130 are configured within scaffold 120) to cause the scaffold to conform in a second condition (Fig. 1C, wherein scaffold 120 conforms in the second condition shown) at the predetermined temperature (¶0056, wherein “specific temperatures corresponds to the predetermined temperature).
Thomas discloses a porous biocompatible scaffold (Fig. 1a, 120, ¶0054, wherein 120 has a plurality of pores 140) but doesn't explicitly teach or disclose that it is adapted to receive the medical device in a first condition or conform to a medical device in a second condition at the predetermined temperature
Citron discloses a porous biocompatible scaffold (abstract, “biodegradable poly-coated surgical meshes) adapted to receive the medical device (abstract, wherein “capable of encasing the cardiac rhythm management device” corresponds to receiving the medical device) in a first condition and conform to a medical device in a second condition (abstract, “capable of encasing the cardiac rhythm management device” corresponds to conforming to a medical device)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the porous biocompatible scaffold of Thomas to receive a medical device in a first condition, as taught by Citron, to in order to prevent or retard the formation of a biofilm and reduce post-op bacterial infection.
Thomas doesn't explicitly teach or disclose wherein in the second condition an implant-tissue bridge is formed between the tissue and the porous biocompatible scaffold enabling tissue infiltration into the porous biocompatible scaffold and tissue fixation of the porous biocompatible scaffold and medical device in-situ.
Citron doesn't explicitly teach or disclose wherein in the second condition an implant-tissue bridge is formed between the tissue and the porous biocompatible scaffold enabling tissue infiltration into the porous biocompatible scaffold and tissue fixation of the porous biocompatible scaffold and medical device in-situ.
Ghodbane discloses wherein in the second condition an implant-tissue bridge is formed between the tissue and the porous biocompatible scaffold (¶0013, wherein “tissue ingrowth corresponds to an implant tissue bridge) enabling tissue infiltration into the porous biocompatible scaffold and tissue fixation of the porous biocompatible scaffold and medical device in-situ (¶0013, wherein “tissue ingrowth corresponds to tissue infiltration and tissue fixation)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the porous biocompatible scaffold or Thomas in view of Citron to form an implant-tissue bridge, as taught by Ghodbane, in order to secure the scaffold after implantation
Regarding claim 2, Thomas discloses wherein the porous biocompatible scaffold (Fig. 1a, 120) comprises a coating (¶0046, “coated onto the sheet”) comprising a photoactive crosslinking agent (¶0044, “light activated shape memory polymers”) adapted to create a cross-link bonding between biological tissue and the porous biocompatible scaffold in-situ (¶0044, wherein “photo-crosslinking” corresponds to creating a cross-link bonding between tissue and the scaffold)
Regarding claim 3, Thomas discloses wherein at least one of the pluralities of biocompatible filaments (Fig. 2A, 230) comprises a photoactive crosslinking agent (¶0044, wherein “light activated shape memory polymers” corresponds to a photoactive crosslinking agent) for facilitating bonding of the cover to biological tissue when light is directed on the cover (¶0044, wherein “photo-crosslinking” corresponds to facilitating bonding of the cover to tissue when light is directed on the cover)
Regarding claim 48, Thomas discloses wherein the biocompatible filament (Fig. 2A, 230) comprises a light conductive, bioactive material (¶0044, wherein the light activated shape memory polymer corresponds to a light conductive, bioactive material)
Regarding claim 50, Thomas discloses at least one biocompatible fastener (Fig. 3B, 350) for fastening one part of the biocompatible scaffold to another part of the biocompatible scaffold or another biocompatible scaffold (¶0059, wherein seam 350 joins two parts of the same substrate 320). Thomas doesn’t explicitly teach or disclose forming an enclosure around a medical device.
Citron discloses forming an enclosure around the medical device (see abstract, wherein the mesh is capable of encasing an implantable medical device).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the biocompatible scaffold of Thomas in view of Citron to form an enclosure around a medical device as taught by Citron, in order to prevent or retard the formation of a biofilm and reduce post-op bacterial infection.
Claim(s) 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2011/0238094 (Thomas) in view of US 2010/0168808 (Citron) in view of US 2019/0380838 (Ghodbane), as applied to claims above, and further in view of and further in view of US 2016/0067387 (Varanasi)
Regarding claim 43, Thomas discloses a biological scaffold (Fig. 1A, 120) made of polycaprolactone (¶0037, “polycaprolactone”). Thomas also discloses pores (Fig. 1A, 140) but doesn’t explicitly teach or discloses a hierarchal porous interconnective structure. Citron doesn’t explicitly teach or disclose a hierarchal porous interconnective structure. Ghodbane doesn't explicitly teach or disclose a hierarchal porous interconnective structure.
Varanasi discloses a biological scaffold (¶0188, wherein porous 3D polymer/composite networks correspond to a biological scaffold) with a hierarchal porous interconnective structure (¶0188, wherein porous networks with hierarchal patterns corresponds to a hierarchal porous interconnective structure).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the biological scaffold of Thomas in view of Citron in view of Ghodbane with a porous, hierarchal interconnective structure, as taught by Varanasi, in order to improve cell adhesion when implanted in biological tissue.
Claim(s) 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2011/0238094 (Thomas) in view of US 2010/0168808 (Citron) in view of US 2019/0380838 (Ghodbane), as applied to claims above, and further in view of US 2019/0360125 (Zhu)
Regarding claim 44, Thomas doesn’t explicitly teach or disclose a predetermined temperature within the range of 58 to 60 degrees Celsius. Citron doesn’t explicitly teach or disclose a predetermined temperature within the range of 58 to 60 degrees Celsius. Ghodbane doesn't explicitly teach or disclose a predetermined temperature within the range of 58 to 60 degrees Celsius.
Zhu discloses shape memory filaments wherein the predetermined temperature is with the range of 58 to 60 degrees Celsius (¶0008, wherein a selectively engineering shape recovery temperature between 25C and 90C overlaps the claimed range of 58 to 60 C).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the predetermined temperature of Thomas in view of Citron in view of Ghodbane to be between 58 to 60 degrees Celsius, as taught by Zhu, because in cases where the claim ranges overlap or lie inside ranges disclosed by the prior art a prima facie vase of obviousness exists (See MPEP 2144.05). Further, applicant appears to have placed no criticality on the claimed range.
Claim(s) 45 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2011/0238094 (Thomas) in view of US 2010/0168808 (Citron) in view of US 2019/0380838 (Ghodbane), as applied to claims above, and further in view of US 2006/0121609 (Yannas)
Regarding claim 45, Thomas discloses a biological scaffold (see rejection of claim 1) but doesn’t explicitly teach or discloses a density gradient. Citron doesn’t explicitly teach or discloses a density gradient. Ghodbane doesn’t explicitly teach or discloses a density gradient.
Yannas discloses a biological scaffold (¶0034, “biocompatible gradient scaffold”) with a density gradient (¶0034, wherein a gradient in crosslink density corresponds to a density gradient) to facilitate integration of soft tissue, a transition to hard tissue, and hard tissue within the scaffold (¶0034, wherein the biocompatible gradient scaffold is capable of the intended use).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the biological scaffold of Thomas in view of Citron in view of Ghodbane with a density gradient, as taught by Yannas, in order to facilitate cell adhesion (¶0055).
Claim(s) 47 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2011/0238094 (Thomas) in view of US 2010/0168808 (Citron) in view of US 2019/0380838 (Ghodbane), as applied to claims above, and further in view of US 2009/0024223 (Qin)
Regarding claim 47, Thomas discloses a biocompatible scaffold (see rejection of claim 1) but doesn’t explicitly teach or disclose a photoactive dye coating. Citron doesn’t explicitly teach or disclose a photoactive dye. Ghodbane doesn't explicitly teach or disclose a photoactive dye.
Qin discloses a biocompatible scaffold (Fig. 34, osteochondral plug 36) is coated with photoactive dye (¶0110, wherein plug is coated with photoactive dye)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the biological scaffold of Thomas in view of Citron in view of Ghodbane with a photoactive dye, as taught by Qin, to provide an improved sealing interface.
Claim(s) 49 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2011/0238094 (Thomas) in view of US 2010/0168808 (Citron) in view of US 2019/0380838 (Ghodbane), as applied to claims above, and further in view of US 2004/0267362 (Hwang)
Regarding claim 49, Thomas discloses a light conductive, bioactive material (¶0044, wherein the light activated shape memory polymer corresponds to a light conductive, bioactive material) but doesn’t explicitly teach or disclose that the filaments extend through an entire thickness of the cover. Citron doesn’t explicitly teach or disclose that the filaments extend through an entire thickness of the cover. Ghodbane doesn’t explicitly teach or disclose that the filaments extend through an entire thickness of the cover.
Hwang discloses filaments (Fig. 1, fibers 18) that extend through an entire thickness of the cover, between a first surface and an opposed surface of the cover (see Fig. 1, wherein traverse oriented fibers 18 extend through each side of scaffold 10).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the light conductive, bioactive filaments of Thomas in view of Citron in view in view of Ghodbane to extend though an entire thickness of the cover, as taught by Hwang, in order to improve the tensile strength of the cover in the transverse direction (i.e., in a direction normal to the surface of the cover).
Claim(s) 51 and 52 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2011/0238094 (Thomas) in view of US 2010/0168808 (Citron) in view of US 2019/0380838 (Ghodbane) in view of US 2016/0067387 (Varanasi), as applied to claims above, and further in view of US 2019/0314552 (Wadsworth)
Regarding claim 51, Thomas doesn’t explicitly teach or disclose a biocompatible anchor. Citron doesn’t explicitly teach or disclose a biocompatible anchor. Ghodbane doesn’t explicitly teach or disclose a biocompatible anchor. Varanasi doesn’t explicitly teach or disclose a biocompatible anchor.
Wadsworth discloses at least one biocompatible anchor (¶0021, “anchor regions”) for anchoring the biocompatible scaffold (¶0022, wherein solidified biocompatible matric corresponds to the biocompatible scaffold) to biological tissue of a subject.
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the biocompatible scaffold of Thomas in view of Citron in view of Ghodbane in view of Varanasi at least one biocompatible anchor, as taught by Wadsworth, in order to facilitate attachment and/or fixation (Wadsworth, ¶0072).
Regarding claim 52, Thomas discloses a photoactive crosslinking agent (¶0044, “light activated shape memory polymers”) but doesn’t explicitly teach or disclose a biocompatible anchor. Citron doesn’t explicitly teach or disclose a biocompatible anchor. Varanasi doesn’t explicitly teach or disclose a biocompatible anchor. Ghodbane doesn’t explicitly teach or disclose a biocompatible anchor. Varanasi doesn’t explicitly teach or disclose a biocompatible anchor.
Wadsworth discloses wherein the biocompatible anchor (¶0021, “anchor regions”) comprises biocompatible scaffold (¶0022, wherein solidified biocompatible matric corresponds to the biocompatible scaffold).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the conformable cover of Thomas in view of Citron in view of Ghodbane in view of Varanasi with biocompatible anchors, as taught by Wadsworth, in order to facilitate attachment and/or fixation (¶0072).
Claim(s) 53 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2011/0238094 (Thomas) in view of US 2010/0168808 (Citron), as applied to claims above and further in view of US 2017/0043052 (San Antonio)
Regarding claim 53, Thomas discloses a porous biocompatible scaffold (see rejection of claim 1) but doesn't explicitly teach or disclose bioactive glass in the form of microspheres of spherical glass particles either coated on or impregnated within the scaffold polymer component encouraging soft tissue infiltration into and adhesion to the biocompatible scaffold. Citron doesn't explicitly teach or disclose bioactive glass in the form of microspheres of spherical glass particles either coated on or impregnated within the scaffold polymer component encouraging soft tissue infiltration into and adhesion to the biocompatible scaffold.
San Antonio discloses bioactive glass in the form of microspheres of spherical glass particles (¶0157, wherein “PCT-bioglass scaffold corresponds to microspheres of spherical glass particles) either coated on or impregnated within the scaffold polymer component (¶0157, wherein HDPE sheet is coated) encouraging soft tissue infiltration into and adhesion to the biocompatible scaffold (¶0157, wherein the coated HDPE sheet is configured for this intended use)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the scaffold of Thomas in view of Citron with a coating of bioactive glass, as taught by San Antonio, in order to promote soft tissue infiltration after implantation.
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 extension fee 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 date of this final action.
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/MAXIMILIAN TOBIAS SPENCER/Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
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