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 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) 37 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ho et al. (WO 2013/055293 A1; hereinafter “Ho”).
Ho discloses the following regarding claim 37: a method for production of a medical implant (paras. 0043, 0103, 0113), the method comprising: providing a carrier structure (e.g., 306, 430) having a compressible and expandable mesh structure (Figs. 3A, 4A-4B; para. 0083) with mesh elements (e.g., 308, 432) configured to delimit mesh openings (openings between the struts); applying a luminal functional layer (inner membrane layer) of a membrane of fibres (e.g., 302, 400) (para. 0040) to the carrier structure (para. 0043); perforating the functional layer by one of a laser cutting process or solvent spraying (paras. 0103, 0113); and applying an abluminal support layer of the membrane to the functional layer (para. 0043).
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) 19-30, 35, and 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ho in view of Shalev et al. (WO 2006/123340 A2; hereinafter “Shalev”).
Ho teaches the limitations the following regarding claim 19: a medical implant for treatment of an aneurysm comprising: a carrier structure (e.g., 306, 430) having a compressible and expandable mesh structure (Figs. 3A, 4A-4B; para. 0083) with mesh elements (e.g., 308, 432) configured to delimit mesh openings (openings between struts), wherein the mesh structure is covered, at least in one or more sections, with a membrane of fibres (e.g., 302, 400) (para. 0040, as polyurethanes are fibrous materials) including at least one luminal functional layer (inner membrane layer) (para. 0043) and at least one abluminal support layer (outer membrane layer) (para. 0043), each layer respectively having pores (e.g., 304, 408), and wherein the membrane is configured such that, as a consequence of a pressure gradient occurring between a first liquid pressure (blood flow pressure within elements 306, 430) in an inner through channel (central lumen of elements 306, 430) of the carrier structure and a second liquid pressure (blood flow pressure outside elements 306, 430) outside the support layer, at least the pores of the functional layer open to increase a flow of liquid through the membrane (Figs. 3B-3E, 5A-5B; paras. 0068, 0123-0124, 0135, 0145-0147).
Regarding claims 19, 21, and 25, Ho teaches the limitations of the claimed invention, as described above. While it states that the size and the density of the pores may be varied as needed (paras. 0049, 0053, 0058, 0129), it does not explicitly recite that a porosity of the functional layer is smaller than the porosity of the support layer. Shalev teaches that it is well known in the art that a medical implant comprises fibrous membranes, where the porosity of the inner, functional layer is smaller than the porosity of the outer, support layer (pgs. 14-17), for the purpose of providing the layers and the device with the desired mechanical properties. Shalev further teaches the fibres of the functional layer of the membrane have a fibre thickness of the claimed ranges, and the outer, support layers comprise thicker fibres (pgs. 12, 25). The support layer of the membrane of Shalev has a thickness of at least 3 µm (pg. 17). The fibres of the functional layer have a smaller fibre thickness than the fibres of the support layer, and wherein the functional layer has a higher ductility than the support layer or its fibres (pgs. 12, 25). It would have been an obvious matter of design choice to one having ordinary skill in the art to modify the membrane layers of Ho such that the porosity of the functional layer is smaller than the porosity of the support layer, as taught by Shalev, in order to provide the layers and the device with the desired mechanical properties. Such a modification would be made with a reasonable expectation of success.
In addition, regarding claims 22-27, the optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for one of ordinary skill to determine the optimal porosity values, the hardness, and the dimensions of the fibers and the membranes needed to achieve the desired results and to properly suit the implantation site. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the porosities, the hardness, and the dimensions of the fibers and the membranes, would have been obvious at the time of applicant's invention in view of the teachings of Ho and Shalev. It is well-established that merely selecting proportions and ranges is not patentable absent a showing of criticality. In re Becket, 33 USPQ 33; In re Russell, 169 USPQ 426.
Ho teaches the limitations the following regarding claim 20: the medical implant according to claim 19, wherein the fibres of the membrane are arranged loosely on top of one another at points of intersection (interpreted as the areas where the slit ends meet and/or the flaps meet the openings) (Figs. 3B-5B), so that intersecting fibres are movable with respect to each other at the points of intersection (paras. 0123-0124, 0135, 0145-0147), and wherein at least the fibres of the functional layer of the membrane are elastically or plastically deformable (paras. 068, 0101-0102, 0107, 0123-0124, 0145-0147).
Ho teaches the limitations the following regarding claim 28: the medical implant according to claim 19, wherein the membrane comprises a thermoplastic polyurethane (para. 0040).
Ho teaches the limitations the following regarding claim 29: the medical implant according to claim 19, wherein the membrane extends around an entire circumference of the carrier structure (para. 0043).
Ho teaches the limitations the following regarding claim 30: the medical implant according to claim 19, wherein the carrier structure is monolithic in configuration, and wherein the mesh elements of the mesh structure form webs configured to delimit the mesh openings of the mesh structure which are formed as cells (Figs. 3A, 4A-4B; para. 0036).
Ho teaches the limitations the following regarding claim 35: the medical implant according to claim 19, wherein the functional layer has a perforation (interpreted as one of the openings in the layer) in a region of the mesh openings (Figs. 3B-5B).
Ho teaches the limitations the following regarding claim 36: the medical implant according to claim 35, wherein the perforation is formed by one of holes, straight slits, curved slits, or T-shaped slits (Figs. 3B-5B).
Claim(s) 31-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ho in view of Shalev further in view of Richter et al. (Pub. No.: US 2003/0036792 A1; hereinafter “Richter”).
Ho, as modified by Shalev, teaches the limitations of the claimed invention, as described above. However, they do not recite the carrier structure having interwoven wires and the claimed thickness. Richter teaches that it is well known in the art that a carrier structure stent is made from a variety of means, including interwoven wires; and the wires form the mesh elements of the mesh structure and delimit the mesh openings of the mesh structure which are formed as interstices (Figs. 1A-3; para. 0018). Richter further teaches that a height of the mesh elements is between 40 µm and 160 µm (paras. 0030-0034). This construction provides the implant with the desired mechanical characteristics and dimensions best needed to properly fit the implantation site. It would have been an obvious matter of design choice to one having ordinary skill in the art to modify the implant of Ho and Shalev, to comprise the interwoven wires, as taught by Richter, in order to provide the implant with the desired mechanical characteristics and dimensions best needed to properly fit the implantation site. Such a modification would be made with a reasonable expectation of success.
In addition, regarding claims 32 and 34, the optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for one of ordinary skill to determine the optimal thicknesses of the mesh and the membrane needed to achieve the desired results and to properly suit the implantation site. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the thicknesses of the mesh and the membrane, would have been obvious at the time of applicant's invention in view of the teachings of Ho, Shalev, and Richter. It is well-established that merely selecting proportions and ranges is not patentable absent a showing of criticality. In re Becket, 33 USPQ 33; In re Russell, 169 USPQ 426.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ann Hu whose telephone number is (571) 272-6652. The examiner can normally be reached on Monday-Friday (9:00 am-5:30 pm EST).
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/ANN HU/Primary Examiner, Art Unit 3774
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