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.
Claims 1-3, and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wallace et al. (US 20030195553 A1).
Regarding claim 1 Wallace discloses (fig. 7 and 10a-10d) an apparatus for treating an aneurysm in a blood vessel (see [0053]), the apparatus comprising:
an occlusion device 310 disposed on an elongate pusher 565 (see fig. 10c and [0053]), the occlusion device comprising a cover 320 for covering a neck of an aneurysm (see fig. 7 and [0046]), an inner anchoring member 330 for contacting an interior surface of an aneurysm (see fig. 7 and [0046]), and a central stem 315 connecting the cover 320 and the inner anchoring member 330 (see fig. 7 and [0046]);
wherein the occlusion device 310 is coupled to the pusher 565 on an outer surface of the cover (indirectly coupled to the outer surface, see fig, 10b);
wherein the cover 320 and the inner anchoring member 330 are configured to expand from a compressed configuration (configuration of fig. 10a) while disposed in a tube 555 (see fig. 10a and [0053]) to an expanded configuration (configuration of fig, 10c) when advanced out of a distal end of the tube 555 to be positioned within the aneurysm (see fig. 10c and [0053]); and
wherein the cover 320 and the inner anchoring member 330 have a substantially similar diameter (see fig. 7) and wherein the central stem 315 has a diameter less than the diameter of the cover 320 and the inner anchoring member 330 (see fig. 7).
Regarding claim 2 Wallace further discloses (fig. 7 and 10a-10d) the cover 320 and the inner anchoring member 330 each comprise a disc (see fig. 7 and [0046]).
Regarding claim 3 Wallace further discloses (fig. 7 and 10a-10d) the cover 320 and the inner anchoring member 330 are each flat (flattened disks, see [0046]).
Regarding claim 1 Wallace discloses (fig. 3 and 9a-9c) an apparatus for treating an aneurysm in a blood vessel (see [0040]), the apparatus comprising:
an occlusion device 110 disposed on an elongate pusher 465 (see fig. 9a and [0049])*, the occlusion device comprising a cover 120 for covering a neck of an aneurysm (see fig. 3 and [0040], an inner anchoring member 130 for contacting an interior surface of an aneurysm (see fig. 3 and [0040]), and a central stem 115 connecting the cover 120 and the inner anchoring member 130 (see fig. 3 and [0040]);
wherein the occlusion device 110 is coupled to the pusher 465 on an outer surface of the cover (indirectly coupled on the outer surface, see fig, 9b and [0050]);
wherein the cover 120 and the inner anchoring member 130 are configured to expand from a compressed configuration while disposed in a tube 450 to an expanded configuration when advanced out of a distal end of the tube 450 to be positioned within the aneurysm (see fig. 9a-9c, [0050], and [0052]); and
wherein the cover 120 and the inner anchoring member 130 have a substantially similar diameter (see fig. 3) and wherein the central stem 115 has a diameter less than the diameter of the cover 120 and the inner anchoring member 130 (see fig. 3).
*The Office notes that the device 110 is delivered in the same manner as disclosed in fig. 9a-9c, see [0052].
Regarding claim 2 Wallace further discloses (fig. 3 and 9a-9c) the cover 120 and the inner anchoring member 130 each comprise a disc (see fig. 3 and [0040]).
Regarding claim 5 Wallace further discloses (fig. 3 and 9a-9c) the cover 120 is flat (flattened disk, see [0040]) and wherein the inner anchoring member 130 is concave (flared disk, see fig. 3 and [0040]).
Claims 1, 2, 4, 6, 8-10, and 13-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Amplatz et al. (US 5,944,738 A1).
Regarding claim 1 Amplatz discloses (fig. 1-7) an apparatus capable of treating an aneurysm in a blood vessel (see note below), the apparatus comprising:
an occlusion device disposed on an elongate pusher (elongate metal shaft, see col. 8 ln. 51-63), the occlusion device comprising a cover 14 for covering a neck of an aneurysm (see note below), an inner anchoring member 12 for contacting an interior surface of an aneurysm (see note below), and a central stem 16 connecting the cover 14 and the inner anchoring member 12 (see col. 10 ln. 6-20 and fig. 4-6);
wherein the occlusion device is coupled to the pusher on an outer surface of the cover (via 32, see fig. 5 and col. 8 ln. 51-63);
wherein the cover 14 and the inner anchoring member 12 are configured to expand from a compressed configuration (configuration of fig. 5) while disposed in a tube (catheter, see col. 9 ln. 16-30) to an expanded configuration (configuration of fig. 7) when advanced out of a distal end of the tube (catheter) to be positioned within the aneurysm (see col. 8 ln. 51-63); and
wherein the cover 14 and the inner anchoring member 12 have a substantially similar diameter (see fig. 5 and 7) and wherein the central stem 16 has a diameter less than the diameter of the cover 14 and the inner anchoring member 12 (see fig. 7).
Note:
The preamble, "for treating an aneurysm in a blood vessel" merely recites intended uses of the apparatus. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Amplatz meets the structural limitations of the claim, and is capable of treating an aneurysm in a blood vessel as it is shaped and of the correct material to treat an aneurysm if delivered thereto.
The language “cover for covering a neck of an aneurysm… inner anchoring member for contacting an interior surface of an aneurysm” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Amplatz meets the structural limitations of the claim, and the cover is capable of covering a neck of an aneurysm and the inner anchoring member is capable of contacting an interior surface of an aneurysm. The device of Amplatz is shaped co that the cover would cover the neck of an aneurysm and the inner anchoring member would contact an interior surface of the aneurysm if places therein.
Regarding claim 2 Amplatz further discloses (fig. 1-7) the cover 14 and the inner anchoring member 12 each comprise a disc (see fig. 7).
Regarding claim 4 Amplatz further discloses (fig. 1-7) the cover 14 and the inner anchoring member 12 are each concave in shape with concavities facing toward the central stem 16 such that the central stem extends between an inner surface of the cover 14 and an inner surface of the inner anchoring member 12 (see fig. 7).
Regarding claim 6 Amplatz further discloses (fig. 1-7) the cover 14, the inner anchoring member 12, and the central stem 16 are formed by a unitary piece of mesh material (see col. 4 ln. 61 – col. 5 ln. 4).
Regarding claim 8 Amplatz further discloses (fig. 1-7) at least one of the cover 14 and the inner anchoring member 12 comprises two layers of mesh material (see fig. 5, 7).
Regarding claim 9 Amplatz further discloses (fig. 1-7) the at least one of the cover 14 and the inner anchoring member 12 comprising two layers of mesh material is formed by folding a top portion of a sphere of mesh into a bottom portion of the sphere of mesh, to form a two-layer hemisphere (see fig. 5, 7, and col. 8 ln. 51 – col. 9 ln. 15).
Regarding claim 10 Amplatz further discloses (fig. 1-7) the central stem comprises a cylindrical body.
Regarding claim 13 Amplatz discloses (fig. 1-7) an apparatus capable of treating an aneurysm in a blood vessel (see note below), the apparatus comprising:
an occlusion device disposed on an elongate pusher (elongate metal shaft, see col. 8 ln. 51-63), the occlusion device comprising a cover 14 for covering a neck of an aneurysm (see note below), an inner anchoring member 12 for contacting an interior surface of an aneurysm (see note below),
wherein the cover 14 and the inner anchoring member 12 are configured to expand from a compressed configuration (configuration of fig. 5) while disposed in a tube (catheter, see col. 9 ln. 16-30) to an expanded configuration (configuration of fig. 7) when advanced out of a distal end of the tube (catheter, see col. 8 ln. 51-63); and
wherein the cover 14 comprises two layers of mesh material formed by folding a top portion mesh into a bottom portion of the mesh (see fig. 5, 7, and col. 8 ln. 51 – col. 9 ln. 15).
Note:
The preamble, "for treating an aneurysm in a blood vessel" merely recites intended uses of the apparatus. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Amplatz meets the structural limitations of the claim, and is capable of treating an aneurysm in a blood vessel as it is shaped and of the correct material to treat an aneurysm if delivered thereto.
The language “cover for covering a neck of an aneurysm… inner anchoring member for contacting an interior surface of an aneurysm” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Amplatz meets the structural limitations of the claim, and the cover is capable of covering a neck of an aneurysm and the inner anchoring member is capable of contacting an interior surface of an aneurysm. The device of Amplatz is shaped co that the cover would cover the neck of an aneurysm and the inner anchoring member would contact an interior surface of the aneurysm if places therein.
Regarding claim 14 Amplatz further discloses (fig. 1-7) the cover 14 and the inner anchoring member 12 have a substantially similar diameter (see fig. 7).
Regarding claim 15 Amplatz further discloses (fig. 1-7) the mesh comprises a sphere of mesh (see fig. 5), and wherein the cover 14 comprises two-layer hemisphere (see fig. 7).
Regarding claim 16 Amplatz further discloses (fig. 1-7) the cover 14 is concave in shape (see fig. 7).
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.
Claims 11 and 12, are rejected under 35 U.S.C. 103 as being unpatentable over Wallace in view of Aboytes et al. (US 20120239074 A1).
Regarding claims 11 and 12, Amplatz discloses the claimed invention substantially as claimed, as set forth above for claim 1. Amplatz is silent regarding the cover is made of a mesh material having a first density and the inner anchoring member is made from a mesh material having a second density, different from the first density; the second density is less than the first density.
However Aboytes, in the same filed of endeavor, teaches (fig. 8) a cover 520 is made of a mesh material having a first density and an inner anchoring member 530 is made from a mesh material having a second density, different from the first density; the second density is less than the first density (see [0068]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Amplatz to have the cover is made of a mesh material having a first density and the inner anchoring member is made from a mesh material having a second density, the second density is less than the first density as taught by Aboytes, for the purpose of promoting attachment to the higher density portion to improve healing (see Aboytes [0068]).
Claims 13 and 19 is rejected under 35 U.S.C. 103 as being unpatentable over Wallace in view of Amplatz.
Regarding claim 13, Wallace discloses (fig. 1-2b and 9a-9c) an apparatus for treating an aneurysm in a blood vessel (see [0030]), comprising:
an occlusion device 10 disposed on an elongate pusher 465 (see fig. 9a and [0049]), the occlusion device comprising a cover 20 for covering a neck of an aneurysm (see fig. 1 and [0030], an inner anchoring member 30 for contacting an interior surface of an aneurysm (see fig. 1 and [0031]);
wherein the cover 20 and the inner anchoring member 30 are configured to expand from a compressed configuration while disposed in a tube 450 to an expanded configuration when advanced out of a distal end of the tube 450 (see fig. 9a-9c, [0050], and [0052]).
Wallace is silent regarding the cover comprises two layers of mesh material formed by folding a top portion mesh into a bottom portion of the mesh.
However Amplatz, in the analogous art of occlusion devices, teaches (fig. 1-7) an occlusion device disposed on an elongate pusher (elongate metal shaft, see col. 8 ln. 51-63), the occlusion device comprising a cover 14 and inner anchoring member 12, wherein the cover 14 comprises two layers of mesh material formed by folding a top portion mesh into a bottom portion of the mesh (see fig. 5, 7, and col. 8 ln. 51 – col. 9 ln. 15).
Therefore, the substitution of one known cover shape (two layers of mesh material formed by folding a top portion mesh into a bottom portion of the mesh as taught in Amplatz) for another (umbrella as taught in Wallace) would have been obvious to one of ordinary skill in the before the effective filing date of the claimed invention since the substitution of the cover shape as taught in Amplatz would have yielded predictable results, namely, a cover of Wallace that would occlude an aneurysm. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 19, Wallace discloses (fig. 1-2b and 9a-9c) a method for treating an aneurysm in a blood vessel (see [0030]), comprising:
providing an apparatus comprising an occlusion device 10 disposed on an elongate pusher 465 (see fig. 9a and [0049]), the occlusion device comprising a cover 20 for covering a neck of an aneurysm (see fig. 1 and [0030], an inner anchoring member 30 for contacting an interior surface of an aneurysm (see fig. 1 and [0031]);
wherein the cover 20 and the inner anchoring member 30 are configured to expand from a compressed configuration while disposed in a tube 450 to an expanded configuration when advanced out of a distal end of the tube 450 (see fig. 9a-9c, [0050], and [0052]); and
delivering the occlusion device through a tube 450 and into an aneurysm (see fig. 9a-9c, [0050], and [0052]); and detaching the occlusion device from the pusher (see fig. 9a-9c, [0050], and [0052]).
Wallace is silent regarding the cover comprises two layers of mesh material formed by folding a top portion mesh into a bottom portion of the mesh.
However Amplatz, in the analogous art of occlusion devices, teaches (fig. 1-7) an occlusion device disposed on an elongate pusher (elongate metal shaft, see col. 8 ln. 51-63), the occlusion device comprising a cover 14 and inner anchoring member 12, wherein the cover 14 comprises two layers of mesh material formed by folding a top portion mesh into a bottom portion of the mesh (see fig. 5, 7, and col. 8 ln. 51 – col. 9 ln. 15).
Therefore, the substitution of one known cover shape (two layers of mesh material formed by folding a top portion mesh into a bottom portion of the mesh as taught in Amplatz) for another (umbrella as taught in Wallace) would have been obvious to one of ordinary skill in the before the effective filing date of the claimed invention since the substitution of the cover shape as taught in Amplatz would have yielded predictable results, namely, a cover of Wallace that would occlude an aneurysm. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Wallace in view of Amplatz, as applied to claim 13 above, and further in view of Aboytes.
Regarding claim 18, Wallace as modified discloses the claimed invention substantially as claimed, as set forth above for claim 13. Wallace as modified is silent regarding the cover is made of a mesh material having a first density and the inner anchoring member is made from a mesh material having a second density, different from the first density.
However Aboytes, in the same filed of endeavor, teaches (fig. 8) a cover 520 is made of a mesh material having a first density and an inner anchoring member 530 is made from a mesh material having a second density, different from the first density (see [0068]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Wallace as modified to have the cover is made of a mesh material having a first density and the inner anchoring member is made from a mesh material having a second density, different from the first density as taught by Aboytes, for the purpose of promoting attachment to the higher density portion to improve healing (see Aboytes [0068]).
Claim Rejections - 35 USC § 102/103
Claims 7 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Amplatz or in the alternative as obvious under 35 U.S.C. 103 in view of Amplatz.
Regarding claims 7 and 17, Amplatz discloses the claimed invention substantially as claimed, as set forth above for claims 1 and 13.
Amplatz teaches that the cover, the inner anchoring member, and the central stem are formed of mesh but does not disclose the cover, the inner anchoring member, and the central stem are formed of separate pieces of mesh material and joined together to form the occlusion device. The claimed phrase “the cover, the inner anchoring member, and the central stem are formed of separate pieces of mesh material and joined together to form the occlusion device” is being treated as a product by process limitation. As set forth in MPEP 2113, product-by-process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 U.S.C. 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. See MPEP 2113.
Thus, even though Amplatz does not disclose the cover, the inner anchoring member, and the central stem are formed of separate pieces of mesh material and joined together to form the occlusion device, it appears that the product in Amplatz would be the same or similar as that claimed; especially since both applicant’s product and the prior art product is made of a mesh.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE H SCHWIKER whose telephone number is (571)272-9503. The examiner can normally be reached Monday - Friday 7:30 am-4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771