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 3 is objected to because of the following informalities: “tesseletion” should be changed to “tessellation”. 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.
Claims 1, 4-5 and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Jarvinen (2002/0040241) in view of Nukavarapu et al. (2014/0178455) “Nukavarapu”.
Regarding claim 1, Jarvinen discloses a device 1 (Figs. 1A-1C) for interfacing at least one filamentous structure 11 (tendon graft; Fig. 3A and par. 0082), with real or simulated biological tissue (the device is fully capable of performing this intended use), comprising at least one body for anchoring the filamentous structure (protrusions 5 and 5 anchor the tendon graft 11; Fig.5), and said device comprising: at least one capstan (slot 8; Fig. 4C) configured for the wrapping of the filamentous structure (Fig. 4C discloses the filamentous structure looped/wrapped over the slot 8); and at least one porous portion including at least a first porous zone (par. 0102 discloses the implant comprises porosity to facilitate bone/tissue growth).
Jarvinen is silent regarding at least one porous portion having a trabecular structure and including at least a first porous zone having a porosity comprised between 1% and 98% and a pore size comprised between 0.1 pm and 800 um and a second porous zone having a pore size comprised between 1 um and 980 um, wherein the difference between the first porous zone and the second porous zone being comprised between 1% and 98% and being such as to ensure a gradient of deformability at least between the first porous zone and the second porous zone.
However, Nukavarapu teaches a similar porous implant (abstract) comprising at least one porous portion having a trabecular structure (par. 0103) and including at least a first porous zone having a porosity comprised between 1% and 98% and a pore size comprised between 0.1 pm and 800 um and a second porous zone having a pore size comprised between 1 um and 980 um, wherein the difference between the first porous zone and the second porous zone being comprised between 1% and 98% and being such as to ensure a gradient of deformability at least between the first porous zone and the second porous zone (pars. 0045-0048 disclose the porous implant has different porous zones with varying porosity where the porosity difference between the zones ranges from 1-98%; par. 0086 discloses a pore size of 200-600 um). Therefore, 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 device in Jarvinen to include at least one porous portion having a trabecular structure and including at least a first porous zone having a porosity comprised between 1% and 98% and a pore size comprised between 0.1 pm and 800 um and a second porous zone having a pore size comprised between 1 um and 980 um, wherein the difference between the first porous zone and the second porous zone being comprised between 1% and 98% and being such as to ensure a gradient of deformability at least between the first porous zone and the second porous zone, as taught and suggested by Nukavarapu, for allowing a gradient of porosity at different zones of the implant resulting in sufficient bioabsorbability (abstract of Nukavarapu).
Regarding claim 4, Jarvinen discloses wherein the body for the anchoring the filamentous structure is conformed as a tweezer comprising a first flat arm 5 and a second flat arm 6 (Fig. 4B discloses the arms move away and towards each other), wherein said arms are joined to one another by means of the capstan (as shown in Fig. 4B, the arms are joined at the slot 8).
Regarding claim 5, Jarvinen discloses wherein the body has the shape of a plate provided with a plurality of capstans (Fig. 1B discloses the flat plate shape of the arms 2 and 3 and par. 0090 and Figs. 1A-1B disclose a flat plate like extension 7; Fig. 8B discloses plurality of slots that allow for multiple filamentous structures to be looped/wrapped around the body).
Regarding claims 11-12, Jarvinen discloses wherein at least one part of the device is made of at least one material selected from the group consisting of bioreabsorbable material, biocompatible material, inert material, and conductive material; wherein said-the at least one material is selected from the group consisting of: polyesters, polyurethanes, polyanhydrides, polycarbonates, polyamides, polyolefins, fluorinated polymers, polvester copolymers, polyurethane copolymers, polyanhydrides copolymers, polycarbonates copolymers, polyamide copolymers, polyolefin copolymers, fluorinated polymer copolymers, polysaccharides, proteins, polyesters, polypeptides, polysaccharide copolymers, protein copolymers, polyester copolymers, polypeptide copolymers, and metal and ceramic material (par. 0098 discloses biocompatible and biodegradable polyanhydrides).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Jarvinen (2002/0040241) in view of Nukavarapu et al. (2014/0178455) “Nukavarapu” further in view of Drew et al. (2021/0298909) “Drew”.
Jarvinen in view of Nukavarapu disclosed the claimed invention of claim 1; except for wherein the structure of the at least one porous portion follows a Voronoi tesseletion that is projected onto the surface of the body for anchoring the filamentous structure. However, Drew teaches a similar porous implant comprising Voronoi tesseletion that is projected onto the surface of the body for anchoring the filamentous structure (par. 0041). Therefore, 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 device in Jarvinen in view of Nukavarapu to include at least one porous portion follows a Voronoi tesseletion that is projected onto the surface of the body for anchoring the filamentous structure, as taught and suggested by Drew, for providing a desired level of porosity to facilitate bioabsorbability (par. 0041 of Drew).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Jarvinen (2002/0040241) in view of Macossay-Torres (2009/0306775).
Jarvinen discloses a device 1 (Figs. 1A-1C) for interfacing at least one filamentous structure 11 (tendon graft; Fig. 3A and par. 0082), with real or simulated biological tissue (the device is fully capable of performing this intended use), comprising at least one body for anchoring the filamentous structure (protrusions 5 and 5 anchor the tendon graft 11; Fig.5), and said device comprising: at least one capstan (slot 8; Fig. 4C discloses the filamentous structure looped/wrapped over the slot 8); and at least one porous portion (par. 0102 discloses the implant comprises porosity to facilitate bone/tissue growth); and at least one filamentous structure 11 comprising a plurality of fibrous groups arranged to form a single bundle (par. 0004 discloses a fibrous braid) wrapped to the capstan (Fig. 4C discloses the filamentous structure which can be a braid, looped/wrapped over the slot 8).
Jarvinen is silent regarding at least one filamentous structure comprising a plurality of electrospun nanofiber groups; wherein said plurality electrospun nanofiber groups are arranged to form a single bundle. However, Macossay-Torres teaches a similar filamentous structure comprising a plurality of electrospun nanofiber groups arranged to form a single bundle (claim 17 and Fig. 10 disclose a tendon/bundle formed by multiple nanofibers). Therefore, 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 device in Jarvinen to include at least one filamentous structure comprising a plurality of electrospun nanofiber groups; wherein said plurality electrospun nanofiber groups are arranged to form a single bundle, as taught and suggested by Macossay-Torres, for using biocompatible materials with mechanical properties that closely resemble natural tissue (par. 0007 of Macossay-Torres).
Allowable Subject Matter
Claims 2 and 6 are allowed.
Claims 7-10 and 14-15 are 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.
The following is a statement of reasons for the indication of allowable subject matter: the closest prior art of record of Jarvinen (2002/0040241) and Nukavarapu et al. (2014/0178455) “Nukavarapu” fail to disclose the allowable subject matter of claim 7 also required in claim 2, which has not been found anticipated by or obvious over prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASHITA SHARMA whose telephone number is (571)270-5417. The examiner can normally be reached on 8am-5pm M-Th; 8am-4pm Fri.
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/YASHITA SHARMA/
Primary Examiner, Art Unit 3774