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
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.
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.
Claims 1-3, 5, 6, 13, 14, 23, 28, 29 and 32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cinquin et al US Patent Pub. 2004/0249399A1.
NOTE: see figure below for Examiner’s interpretation.
Regarding claims 1-3, 5, Cinquin et al discloses a prosthetic fixation device comprising: an inner support structure; an outer support structure positioned around the inner support structure and coupled to a prosthetic device; wherein the inner support structure comprises an expandable structure radially movable between an unexpanded to an expanded configuration, wherein in the expanded configuration, the inner support structure provides a radially outward force toward an inner surface of the outer support structure, wherein the inner and outer support structures are sized and configured to receive a portion of a biological conduit therebetween such that in the expanded configuration, the portion of the biological conduit is fixedly secured between the inner surface of the outer support structure and an outer surface of the inner support structure.
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Regarding claim 6, see paragraph 27.
Regarding claim 13, see figure above disclosing the outer support and the inner support fitting snuggly over and inside the blood vessel.
Regarding claim 14, see figure above showing that the length of the inner support in the expanded configuration corresponds to a length of the outer support.
Regarding claim 23, the prosthetic device is a vascular graft.
Regarding claims 28 and 29, all the claimed steps are inherently disclosed in this reference. Such as, the advancing step, the coupling step, the positioning step and the radial expansion step.
Regarding claim 32, the claimed steps, such as, the step of creating a liquid-tight seal, the testing of flowing liquid through the prosthetic device and the re-expansion of the stent if there is a leak in the joint are inherently addressed in every anastomosis surgery for the purpose of avoiding a leak and kill the patient.
Claim Rejections - 35 USC § 103
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.
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.
Claims 9, 15, 17, 18 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Cinquin et al US Patent Pub. 2004/0249399A1 in view of Harris et al WO2007/030892A1.
Regarding claims 9, 17, 18 and 26, Cinquin et al discloses the invention substantially as claimed. However, Cinquin et al is silent regarding the texture surfaces of the inner and outer support structures and a sealant.
Harris et al teaches an implant having a texture surface and a sealant for the purpose of having a tightly sealed connection. See page 5, lines 15-19 disclosing element 1 having a plurality of fibrous materials. Additionally, page 5, lines 20-23 discloses a sealant.
It would have been obvious to one having ordinary skill in the art to modify the surfaces of the inner and outer support structures with a textured surface and add a sealant material in order to create a tightly sealed connection.
Regarding claim 15, Cinquin et al discloses the claimed invention except for a length of the inner support is greater than or less than a length of the outer support. It would have been an obvious matter of design choice to modify the equal length of the inner and outer support structures with a length of the inner support is greater than or less than a length of the outer support, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Claims 11 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Cinquin et al US Patent Pub. 2004/0249399A1 in view of Kassab et al US Patent Pub. 2008/0300672A1.
Cinquin et al discloses the invention substantially as claimed. However, Cinquinet al does not disclose a magnetically connection between two parts.
Regarding claim 11, Kassab et al discloses an implant used for an anastomosis. The invention discloses a metallic stent and a magnet ring (external to the vessel) for the purpose of providing mechanical support to hold the implant in place and avoid accidental separation. See paragraph 19.
It would have been obvious to one having ordinary skill in the art to modify the connection in the Cinquin et al reference by using a magnetically attracted joint in order to provide a mechanical support to hold the implant in place and avoid accidental separation.
Regarding claim 31, at the time the invention was made, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the self-expandable stent with a stent made out of stainless-steel material and using a balloon expandable delivery catheter because Applicant has not disclosed that by having a balloon expandable stent provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the self-expandable stent because it would perform equally as well.
Therefore, it would have been an obvious matter of design choice to modify the Cinquin et al reference to obtain the invention as specified in claim 31.
Allowable Subject Matter
Claims 4 and 7 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALVIN J STEWART whose telephone number is (571)272-4760. The examiner can normally be reached Monday-Friday 8:30AM-6PM EST.
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/ALVIN J STEWART/Primary Examiner, Art Unit 3799 8/19/26
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