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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5/18/26 has been entered.
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.
Claim(s) 1, 3, 5, 10, and 25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Simon et al. (5,669,933).
Simon discloses the following claimed limitations:
Claim 1: A vascular plug (Fig. 4), comprising: an outer layer (14) comprising a plurality of struts that (18) (Fig. 1 and 4), in an expanded configuration, are configured to contact a vessel wall in one or more locations (Fig. 2); a band (12) at a proximal end of the vascular plug (Fig. 1 and 4); and an inner layer (combination of 24 and 30) comprising a mesh (30) heat set into a shape (Col. 3 Lines 30-45), wherein the inner layer and the outer layer are being coupled to the band at the proximal end of the vascular plug (Fig. 4).
Claim 3: wherein the outer layer is composed of nitinol, stainless steel, cobalt-chromium, or combinations thereof (Col. 3 Lines 30-45).
Claim 5: wherein the inner layer is comprised of a wire braid (Fig. 4).
Claim 10: wherein the outer layer is comprised of between five and ten struts (Fig. 4).
Claim 25: wherein the inner layer and the outer layer are crimped together with the band (Fig. 4).
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.
Claim(s) 1, 3-7, 10-17, and 23-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barbut et al. (2002/0062134) in view of Zaver et al. (2007/0135826).
Claims 1, 13, and 16:
Barbut discloses a vascular plug, comprising: a layer (30) comprising a plurality of struts (32) that, in an expanded configuration, are configured to contact a vessel wall in one or more locations (Fig. 7 where it is capable of performing this function); a band (60) at a proximal end of the vascular plug (Fig. 1 and [0071]); and a layer comprising a mesh (40), wherein the two layers are being coupled to the band at the proximal end of the vascular plug (Fig. 1, [0071], and [0104]).
The claimed phrase “heat set into a shape” is being treated as a product by process limitation. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113.
It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987).
Barbut discloses all the limitations discussed above, however Barbut is silent to the struts being an outer layer and the mesh being the inner layer.
Zaver discloses another well-known medical device with a strut layer and a mesh layer as seen in Fig. 8-9, where in on embodiment the struts are the inner layer and the mesh is the outer layer (Fig. 8 and [0086]) while in another embodiment the struts are the outer layer and the mesh is the inner layer (Fig. 9 and [0086])
It would have been obvious to one of ordinary skill in the art to modify the device of Barbut to have the struts as the outer layer and the mesh as the inner layer, as taught by Zaver, since it has been held that a simple substitution of one known element for another will yield predictable results. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Claim 3: Barbut discloses that the outer layer is composed of nitinol, stainless steel, cobalt-chromium, or combinations thereof ([0070]).
Claim 5: 5 Barbut discloses that the inner layer is comprised of a wire braid (Fig. 1).
Claim 6: Barbut discloses that the wire braid comprises a 96 micron pore size ([0096]).
Claim 7: Barbut discloses that the wire braid comprises a 0.001 inch outer diameter wire ([0096]).
Claim 10: Barbut discloses that the outer layer is comprised of between five and ten struts (Fig. 1-2) .
Claim 11: Barbut in view of Zaver fails to teach that in the expanded configuration, the plurality of struts form a star-like shape when viewed from an end. One of ordinary skill in the art would have found it obvious to modify the shapes of the plurality of struts when expanded since it has been held that changing the shape of a working part involves only routine skill in the art. In re Dailey; 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Claim 12: Barbut discloses that in the expanded configuration, the plurality of struts define a plurality of cells (Fig. 1-2).
Claim 14: Barbut discloses that wherein the support structure is comprised of a plurality of struts (32) (Fig. 1-2).
Claim 15: Barbut discloses that wherein the mesh is affixed to the support structure ([0104]).
Claim 17: Barbut discloses that the mesh is comprised of a plurality of wires with a pore size sized to limit fluid flow through the vascular plug (Fig. 1 and [0096]).
Claim 23: Barbut discloses that the support structure comprises an elongated spherical shape formed from a plurality of struts (Fig. 1-3).
Claim 24: Barbut discloses that wherein the outer layer has approximately a spherical shape (Fig. 1-3).
Claim 25: The claimed phrase “the inner layer and the outer layer are crimped together with the band” is being treated as a product by process limitation. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barbut et al. (2002/0062134) in view of Zaver et al. (2007/0135826) and further in view of Hendriksen et al. (2011/0301630).
Barbut in view of Zaver discloses the claimed invention except for outer layer comprising a hypotube instead of multiple wires.
Hendriksen discloses a vascular plug (10) (Fig. 2), comprising: an outer layer (32, 30) comprising a plurality of struts (26) (Fig. 2 and [0023]) and an inner layer (40) (Fig. 2 and [0030]) comprising a mesh (Fig. 2) wherein the outer layer comprises a hypotube ([0029]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to make the outer layer of Barut in view of Zaver from a single material such as by cutting a hypotube, since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965).
Claim(s) 8, 9, 18, 21, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barbut et al. (2002/0062134) in view of Zaver et al. (2007/0135826) and further in view of Sepetka et al. (2008/0281350).
Claims 8, 9, 18, and 22
Barbut in view of Zaver teaches all the claimed limitations discussed above, however Barbut in view of Zaver is silent with regards to the inner layer having one or more radiopaque wires.
Sepetka discloses all the limitations discussed above including that the inner layer comprises one or more radiopaque wires ([0144]) and wherein the one or more radiopaque wires are composed of tantalum, platinum, or gold ([0144]).
It would have been obvious to a person having ordinary skill in the art at the time the invention was made to provide Barbut in view of Zaver with radiopaque wires in view of the teachings of Sepetka, in order to aid in visualizing the implant and to facilitate monitoring the deployment of the device and to aid in accurate placement within the target aneurysm ([0144])
Claim 21:
Barbut in view of Zaver discloses the claimed invention except for the plurality of wires are composed of at least one of nitinol, stainless steel, and cobalt-chromium.
Sepetka discloses all the limitations discussed above including that the plurality of wires are composed of at least one of nitinol, stainless steel, and cobalt-chromium ([0144]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to make the wires of at least one of nitinol, stainless steel, and cobalt-chromium, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Response to Arguments
Applicant’s arguments filed 5/18/26 have been considered but are moot in view of the new grounds of rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIANNE DORNBUSCH whose telephone number is (571)270-3515. The examiner can normally be reached Monday-Wednesday 9 am-3 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DIANNE DORNBUSCH/Primary Examiner, Art Unit 3771
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