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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Puckett (WO2013151778).
With regards to claim 1, Puckett discloses a tubular electrospun graft implant (90), comprising: an electrospun tubular layer (70), wherein the electrospun tubular layer has a longitudinal axis (Pg 35, Line 3; “wrapped, e.g., around a hypotube,” a tube will inherently have a longitudinal axis) and an outer surface (Refer to figure below); one or more polymer layers of an electrospun sheet (76) rolled over the outer surface (Pg 35, Line 4; “An unsintered mat of espun PTFE 76 is wrapped around the structural frame”; wherein the term “wrapped” is synonymous with “rolled”) of the electrospun tubular layer (70) and around the longitudinal axis of the electrospun tubular layer (FIG 1); and a polymer layer (78) electrospun over the rolled one or more polymer layers of the electrospun sheet (76).
It is noted that the term “electrospun” in step (c) is treated as a product-by-process limitation that is not given patentable weight, wherein the prior art is not required to disclose that the polymer layer is applied by electrospinning. As set forth in MPEP 2113, “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product in the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695,698,227 USPQ 964,966 (Fed. Cir. 1985). In this case, the Puckett 2013 device has all the required structures of the claimed invention.
With regards to claim 2, Puckett discloses the tubular electrospun graft implant as set forth in claim 1, wherein there are between 10 to 20 layers (pg 10, line 29, “the composite devices described herein can have… 10-layered, or having even more layers”).
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With regards to claim 3, Puckett discloses the tubular electrospun graft implant as set forth in claim 1, wherein each of the one or more layers has a thickness between 30 micrometers to 50 micrometers or a thickness between 20 micrometers to 100 micrometers (pg 9, line 16; “each layer can have an average thickness ranging from about 0.0001 inches to about 0.25 inches”).
With regards to claim 4, Puckett discloses the tubular electrospun graft implant as set forth in claim 1, wherein there are two or more layers wherein the layers have different fiber directions relative to each other (pg 8, line 25; “electrospun layers… are in random orientation with respect to one another”).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Puckett (WO2013151778), in view of Lyons (WO2011139564A1).
With regards to claim 5, Puckett discloses a tubular graft implant, comprising two or more layers of an electrospun polymer sheet (Pg 7, line 2; “one or more layers of electrospun fibers”) rolled around a longitudinal axis defining the inner diameter of the tubular graft implant (Pg 35, Line 3; “wrapped, e.g., around a hypotube,” a tube will inherently have a longitudinal axis), but does not disclose wherein the two or more layers of the electrospun polymer sheet are moving independent from each other when the tubular graft implant is bending.
Lyons also discloses a tubular electrospun graft implant (20) comprising two or more layers of electrospun polymer sheet (40, 50). Lyons teaches two or more layers of the electrospun polymer sheet are moving independent from each other when the tubular graft implant is bending ([29], “can allow the inner line and outer layer the freedom to move coaxially independent from each other”).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Puckett so that the two or more layers of the electrospun polymer sheet are moveable independent from each other when the tubular graft implant is bending, as taught by Lyons, in order to enhance kink resistance ([29]), as is the goal of Puckett’s invention (pg 14, line 28).
The phrase “are moving independent from each other when the tubular graft implant is bending” is a functional limitation that is not given patentable weight, in that the prior art is not required to explicitly disclose that the layers move relative to one another during bending of the implant, but merely have the capability of performing in this manner to meet the claim requirement. In this case, the layers of the modified Puckett device are capable of moving relative to one another during bending of the implant.
With regards to claim 6, Puckett discloses the tubular graft has between 10 to 20 layers (pg 10, line 29, “the composite devices described herein can have… 10-layered, or having even more layers”).
With regards to claim 7, Puckett and Lyons disclose the tubular graft implant as set forth in claim 5, and Puckett discloses wherein each of the two or more layers has a thickness between 30 micrometers to 50 micrometers or a thickness between 20 micrometers to 100 micrometers (pg 9, line 16; “each layer can have an average thickness ranging from about 0.0001 inches to about 0.25 inches”).
With regards to claim 8, Puckett and Lyons disclose the tubular graft implant as set forth in claim 5, and Puckett discloses wherein the layers have different fiber directions relative to each other (pg 8, line 25; “electrospun layers… are in random orientation with respect to one another”).
Conclusion
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/R.F.N./Patent Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774