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 § 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) 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shohat et al, US 2013/0116794 A1.
Regarding claims 1, 8, 11, 12, 13, 18, Shohat discloses a system and a prosthesis (200, Figs. 2A-B, 3A-D; also embodiment 700, 1000 in Figs. 7, 10A-D, which is the same as 200 and having two sections, para [0168]; paras [0190]-[0194]) for a location within an internal space (shoulder space, Figs. 3A, 7, 10A) that is at least one of a joint space located between a glenoid fossa and a humeral head and a subacromial space (Figs. 3A, 7, 10A), comprising: an inflatable implant (202, para [0111], Fig. 2A); and an augment (mesh or sponge-like structure, para [0110] and [0119]) disposed on the implant and mechanically or chemically coupled to the implant (para [0119]); the augment further comprises a fibrous material, the fibrous material comprising collagen, human collagen, bovine collagen, xenograph collagen, a synthetic material, a polyester material, an absorbable material, an organic material, silk, or combinations thereof (see PCTIL2008/000347 incorporated by reference, para [0110]; which teaches implant having two layers, one that can be mesh/sponge-like, where the sponge-like materials are fibrous such as methyl cellulose and absorbable, page 12, line 25 to page 13, line 20); wherein the prosthesis comprises an insertion configuration where the implant is deflated (para [0116], Figs. 3A-D), and wherein the prosthesis comprises an implanted configuration where the implant is inflated (para [0116], Figs. 3A-D); wherein the prosthesis is configured such that, when inserted into the location within the internal space, the augment is adjacent to a rotator cuff or an acromion (Figs. 3A, 7, 10A, para [0119]; see also paras [0124]-[0142] for method of implantation, para [0168]; para [0194]).
Regarding claim 2, Shohat discloses the prosthesis of claim 1, wherein in the implanted configuration, the implant is configured to simulate a bursa when inflated (para [1068]).
Regarding claims 3-4, Shohat discloses the prosthesis of claim 1, wherein the implant comprises an inflation port (206, para [0116]) configured to allow a fluid to enter an interior space of the implant and inflate the implant (para [0116]); wherein the fluid comprises at least one of saline, water, biomaterial, collagen, medicament, or tissue-growth promoter (para [0122]; inflation medium can be fluid such as lipid or oil which is biomaterial).
Regarding claims 5-7, Shohat discloses the prosthesis of claim 1, wherein in the insertion configuration, the augment is wrapped around the implant or coupled to at least a portion of the exterior surface of the implant (see PCTIL2008/000347 incorporated by reference, para [0110]; which teaches implant having two layers, one that can be mesh/sponge-like, where the sponge-like materials are fibrous such as methyl cellulose and absorbable, page 12, line 25 to page 13, line 20); wherein in the implanted configuration, the exterior surface of the implant includes at least one surface capable of overlaying a target area, wherein the augment is disposed on the at least one surface of the implant and capable of being positioned between the implant and the target area (Figs. 3A, 7, para [0119]; see also paras [0124]-[0142] for method of implantation, para [0168]).
Regarding claims 9 and 19, Shohat discloses the prosthesis of claim 1, wherein the prosthesis further comprises a plurality of intersecting filaments (mesh structure would have intersecting filaments or fibers of cellulose; or bridge 110 in Fig. 10B-D) configured to secure the prosthesis in the implanted configuration (para [0110]), and the system of claim 18, further comprising filaments for mechanically coupling the augment to the inflatable implant (mesh structure would have intersecting filaments or fibers of cellulose, (para [0110]); or bridge 110 in Figs. 10B-D).
Regarding claim 10, Shohat discloses the prosthesis of claim 1, wherein the prosthesis is disposed on an implant delivery tool in the insertion configuration (200, Fig. 2A, para [0116]).
Regarding claim 14, Shohat discloses a method (Figs. 3A, 7, 10A-D, para [0119]; see also paras [0124]-[0142] for method of implantation, para [0168]; para [0194]) comprising: providing a prosthesis (202) in an insertion configuration and disposed on an implant delivery tool (200, Fig. 3A), the prosthesis comprising an implant (202 inflatable portion) and an augment (mesh, see rejection for claim 1 above) disposed thereon; inserting the prosthesis in the insertion configuration into a location within an internal space (Figs. 3A, para [0124]); and inflating the prosthesis in the insertion configuration to provide the prosthesis in an implanted configuration (Figs. 3D, para [0131]).
Regarding claim 15, Shohat discloses the method of claim 14, wherein the implant delivery tool comprises: a handle (handle portion of 200, Fig. 2A) disposed at a proximal end of the implant delivery tool and configured to be grasped by a user (para [0111]; handle is capable of being held in a user’s hand); an implant rod (210) extending from the handle toward a distal end of the implant delivery tool, wherein in the step of inserting the prosthesis, the handle is positioned by the user such that the implant rod is positioned adjacent to the location within the internal space (Figs. 3A-D, para [0116]).
Regarding claim 16, Shohat discloses the method of claim 15, further comprising retracting the implant rod (210) from a position adjacent to the location within the internal space, wherein the prosthesis remains in the location within the internal space (para [0116]).
Regarding claim 17, Shohat discloses the method of claim 14, wherein the implant delivery tool comprises: a fluid path (inflation path, para [0122]) between the proximal end and the distal end; and a port (206) at the proximal end and in fluidic communication with the fluid path, wherein the step of inflating the prosthesis comprises injecting a fluid through the port and fluid path and into the implant (para [0122]).
Regarding claim 20, Shohat discloses the system of claim 18, further comprising: an implant delivery tool (Figs. 10A-D) comprising: a handle (handle portion of 1000, Fig. 10A) disposed at a proximal end of the implant delivery tool and configured to be grasped by a user (para [0111]; handle is capable of being held in a user’s hand); an implant rod (1032) extending from the handle toward a distal end of the implant delivery tool; a fluid path (inflation path, para [0122]; para [0194]) between the proximal end and the distal end; and a port (206 or valve 1036 at points 1038/1040, para [0194]) at the proximal end and in fluidic communication with the fluid path; and an augment delivery tool (1030) comprising: an augment sleeve (sleeve of 1030, Fig. 10B) configured to encapsulate the implant rod (para [0192]); and an augment rod (1034; tube that can inflate the second portion, which also has an augment disposed over balloon) disposed parallel to the augment sleeve and configured to secure the prosthesis proximate to the distal end of the implant delivery tool (para [0194], Fig. 10D).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATRINA M STRANSKY whose telephone number is (571)270-3843. The examiner can normally be reached Monday-Friday 8:30 am-5:00 pm EST.
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/KATRINA M STRANSKY/Primary Examiner, Art Unit 3700
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