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 Objections
Claim 1 is objected to because of the following informalities: on line 6, “band at a proximal end of the vascular plug” should be -- band at the proximal end of the vascular plug--. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: on line 5, “band at a proximal end of the vascular plug” should be -- band at the proximal end of the vascular plug--. Appropriate correction is required.
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) 13-15, 17, 18, and 23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hendriksen et al. (2011/0301630).
Hendriksen discloses the following claimed limitations:
Claim 13: A vascular plug (10) (Fig. 2), comprising: an outer layer (30, 32) comprising a support structure (Fig. 1-2 and [0023]); a band (22) (Fig. 2 and [0023]) at a proximal end of the vascular plug (Fig. 2); and an inner layer (40) comprising a mesh (Fig. 2) positioned within the support structure (Fig. 2 and [0030]), the inner layer being coupled to the band at a proximal end of the vascular plug (Fig. 2 and [0023]); and, wherein, in an expanded configuration, the support structure is configured to contact a vessel wall in one or more locations (Fig. 3c).
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).
Claim 14: wherein the support structure is comprised of a plurality of struts (26) (Fig. 1-2 and [0023]).
Claim 15: wherein the mesh is affixed to the support structure (Fig. 2 and [0030]).
Claim 17: wherein the mesh is comprised of a plurality of wires with a pore size sized to limit fluid flow through the vascular plug (Fig. 2 and [0030]).
Claim 18: further comprising one or more radiopaque markers (46) mounted on the support structure (Fig. 1-2 and [0036])
Claim 23: wherein the support structure comprises an elongated spherical shape (part 30) formed from a plurality of struts (26) (Fig. 1).
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, 10-12, 16, and 24 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Hendriksen et al. (2011/0301630).
Hendriksen discloses the following claimed limitations:
Claim 1: A vascular plug (10) (Fig. 2), comprising: an outer layer (32, 30) comprising a plurality of struts (26) (Fig. 2 and [0023]) that, wherein in an expanded configuration, the plurality of struts are configured to contact a vessel wall in one or more locations (Fig. 3c); a band (22) (Fig. 2 and [0023]) at a proximal end of the vascular plug (Fig. 2); and an inner layer (40) (Fig. 2 and [0030]) comprising a mesh (Fig. 2), the inner layer being coupled to the band at a proximal end of the vascular plug (Fig. 2 and [0023]).
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).
Claim 2: wherein the outer layer comprises a hypotube ([0029] and [0043]).
Claim 3: wherein the outer layer is composed of nitinol, stainless steel, cobalt-chromium, or combinations thereof ([0029]).
Claim 10: wherein the outer layer is comprised of between five and ten struts (Fig. 1-2).
Claim 11: wherein, in the expanded configuration, the plurality of struts form a star-like shape when viewed from an end (Fig. 1).
Claim 12: wherein, in the expanded configuration, the plurality of struts define a plurality of cells (Fig. 1-2).
Claim 16: The claimed phrase “heat set under the support structure” 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 24: wherein the outer layer has approximately a spherical shape (part 30 as seen in Fig. 1).
Claim(s) 5, 6, 8, 9, 21, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hendriksen et al. (2011/0301630) in view of Sepetka et al. (2008/0281350).
Claims 5 and 6:
Hendriksen teaches all the claimed limitations discussed above, however Hendriksen is silent with regards to the inner layer being a wire braid of 96 micron pore size.
Sepetka discloses a vascular plug (Fig. 2a-e) with an inner layer (the matrix 165) (Fig. 2a-e and [0177]) comprising a mesh (Fig. 2e and [0177]); wherein the inner layer comprised of a wire braid ([0144]) with a 96 micron pore size ([0119]).
It would have been obvious to one of ordinary skill in the art to modify the inner layer of Hendriksen to have a wire braid with 96 micorn pore size, as taught by Sepetka, 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).
Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to have a braid with 96 micron pore size, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Claims 8, 9, and 22:
Hendriksen teaches all the claimed limitations discussed above, however Hendriksen 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 Hendriksen 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:
Hendriksen 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.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hendriksen et al. (2011/0301630) in view of Sepetka et al. (2008/0281350) and further in view of of Clubb et al. (2004/0153117).
Hendriksen in view of Sepetka teaches all the claimed limitations discussed above however, Hendriksen in view of Sepetka does not disclose that the wire braid comprises a 0.001 inch outer diameter wire.
Clubb discloses a mesh made from a plurality of wires that are braided ([0056]) where the wire braid comprises a 0.001 inch outer diameter wire ([0056]).
It would have been obvious to a person having ordinary skill in the art at the time the invention was filed to provide Hendriksen in view of Sepetka with a wire diameter of .001 inches in view of the teachings of Clubb, in order to control the pore size and pore distribution in a filter as well as being easier to handle than unbraided wire of this diameter ([0056]).
Response to Arguments
Applicant’s arguments filed on 2/17/26 have been considered but are moot in view of the new grounds of rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The cited prior art appears to teach the claimed limitations when considered alone or in combination.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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