DETAILED ACTION
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2 and 17 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. In claim 2, line 5 and claim 17, line 5 “the plurality” is recited and it is not clear what the plurality refers to, loops or posts or another structure? It is not clear that the claims 2 and 17 are claiming an actual method step that further limits claim 1 or are claiming a final configuration of an embolic device.
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) 1,3 and 6-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Strauss et al. (8,801,747). Strauss discloses a method of manufacturing an embolic device (col. 2, lines 1-5) comprising providing a mandrel (10; Fig. 2) having a plurality of extending posts (1,2,3) and providing an elongate flat member (60, square wire; col. 7, lines 45-46) having a longitudinal axis, a first side comprising a first side surface, and a second side comprising a second side surface, the first and second sides being reverse to each other with the first side surface and second side surface facing in opposite directions (Fig. 7C) wherein Fig. 7C shows first and second reverse sides in a loop configuration when the flat member is wound in a winding pathway (74). The elongate flat member (60) has an elongated constrained configuration (embolic device, 190) for being deployed through a delivery catheter (112,114; Fig. 1A) to targeted vascular site (116; Fig. 1B). Strauss discloses winding the flat member (60) at least partially around a first extending post (1; Fig. 6) of the plurality of extending posts (1,2,3) along the winding pathway (74) such that the second side surface of the flat member is in contact with the first extending post (1) wherein Fig. 6 shows that the second wire side is contacting the post (1) and the first side surface faces away from the first extending post (not contacting the first post; at reference 84; Fig. 6), partially twisting the flat member in a mobius loop (col. 4, lines 44-46) by looping and twisting the wire along the winding pattern (74) about its longitudinal axis (Fig. 7C) as it extends from the first extending post (1) to a second extending post (3; Fig. 6) of the plurality of extending posts (1,2,3) and winding the flat member at least partially around the second extending post (3) such that the second side surface of the flat member is in contact with the first extending post, wherein Fig. 6 shows that the second wire side is contacting the post (1) and the first side surface faces away from the first extending post (not contacting the first post; at reference 84; Fig. 6). Strauss discloses heat treating (col. 2, lines 59-60, col. 6, lines 55-60 and col. 7, lines 55-58) the elongate flat member (60) while wound on the mandrel (10) to provide a three-dimensional unconstrained configuration to the flat member comprising a plurality of successive loops (loop 1, loop 2, loop 3; Figs. 7A and 7B) in which the elongate flat member is at least partially twisted about its longitudinal axis between each loop of the plurality of loops (Fig. 7A). Regarding claim 3, Strauss discloses clockwise and anticlockwise winding along the winding pathway (74) on the successive posts (1,3; Fig. 6). Regarding claim 6, the flat member (60) is laid against a center post (4) of a handle (30) of the mandrel (10; Fig. 6). Regarding claims 7 and 8, Strauss discloses a platinum group (col. 7, lines 62-64) including platinum, rhodium, rhenium and silver.
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.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Strauss et al. (8,801,747) in view of Wallace et al. (6,322,576). Regarding claim 2, it is not clear what “the plurality” is referring to in line 5 and it is not clear that claim 2 is claiming an active method step or what a final embolic device configuration may look like but the Examiner is reading that the loops are formed on mandrel which are located 90 degrees from one another. Strauss discloses that the mandrel posts (1,2,3) are 120° from one another but does not disclose a mandrel configuration with 90° winding posts. Wallace teaches in Figs. 8A and 8B a mandrel (450) including a center post (460), three posts (pins; 451,452,453) positioned at about 120° from each other and Wallace teaches a 90° post orientation (500; Figs. 9A and 9B). It would have been obvious to the skilled artisan prior to the effective filing date of the present invention to position the winding posts on the mandrel of Strauss 90° from each other as taught by Wallace in order to form a plurality of winding loops in the embolic device that are angled by 65-95 degrees from each other.
Claim(s) 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Strauss et al. (8,801,747) in view of Wallace et al. (6,322,576). Strauss does not disclose six winding posts on the mandrel. Wallace teaches mandrels comprising three 120° winding posts (450; Figs. 8A and 8B), six 90° winding posts (500; Figs. 9A and 9B) and eight winding posts (Fig. 11A) and winding a wire (520) in loops around each of the six posts (510,510,511,512,513,514) to form an embolic device (Fig. 10A). It would have been obvious to the skilled artisan prior to the effective filing date of the present invention to include additional winding posts on the mandrel of Strauss as taught by Wallace in order to form a selectable plurality of winding loops in the embolic device.
Claim(s) 9,10,14 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Strauss et al. (8,801,747) in view of Aboytes et al. (2012/0239074). Strauss does not disclose that the flat member is a braided wire member. Regarding claims 9,10 and 14, Aboytes teaches a braided wire mesh ([0026], lines 7-8; [0098]) comprising a flat member ribbon (210, Fig. 3; [0053], lines 1-4) that is constructed as an implant (Fig. 4). The braided wire ribbon (210) is connected at a distal end (224; Fig. 5A) and a proximal end (222; Fig. 5A) to securing elements comprising connection bands (240,242) and the proximal end is connected to an insertion portion (202) of a catheter (204). Regarding claim 15, the braided wire mesh ribbon (210) comprises radiopaque caps (240,242). It would have been obvious to the skilled artisan prior to the effective filing date of the present invention to connect the wound embolic device of Strauss to securing elements and catheter as taught by Aboytes in order to insert the embolic device for placement in the patient body.
Claim(s) 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Strauss et al. (8,801,747) in view of Aboytes et al. (2012/0239074) and further in view of Mazzocchi et al. (6,712,835). Strauss in view of Aboytes does not disclose that the proximal or distal end of the braided wire flat member ends is connected by adhesive. Regarding claim 11, Mazzocchi teaches end caps comprising clamps (15) to hold distal and proximal ends of a braided wire implant (10) and teaches that the distal and proximal ends of the implant are adhered with adhesive by soldering, brazing or welding to prevent unraveling of the ends (col. 6, lines 30-35) and that at least one end is secured to a connector (90; Fig. 9A; col. 13, lines 22-25). Regarding claim 12, Mazzocchi teaches that the braided wire implant is connected to a coil (266) of a catheter (C, Fig. 12A; col. 22, lines 15-18) It would have been obvious to the skilled artisan prior to the effective filing date of the present invention to adhere at least one of the proximal or distal end of the braided flat member of Strauss in view of Aboytes as taught by Mazzocchi so as to keep the ends of the braided flat member from unraveling when the braided flat member is connected to a catheter. Regarding claim 13, Strauss (col. 7, lines 65-67) teaches shape memory material and successive loops (190; Fig. 1D) and Aboytes [0098] teaches super elastic nitinol material for the flat member.
Claim(s) 16 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Strauss et al. (8,801,747). Strauss discloses a method of manufacturing an embolic device (col. 2, lines 1-5) comprising providing a mandrel (10; Fig. 2) having a plurality of extending posts (1,2,3) and providing an elongate flat member (60, square wire; col. 7, lines 45-46) having a longitudinal axis, a first side comprising a first side surface, and a second side comprising a second side surface, the first and second sides being reverse to each other with the first side surface and second side surface facing in opposite directions (Fig. 7C) wherein Fig. 7C shows first and second reverse sides in a loop configuration when the flat member is wound in a winding pathway (74). The elongate flat member (60) has an elongated constrained configuration (implant, 190) for being deployed through a delivery catheter (112,114; Fig. 1A) to targeted vascular site (116; Fig. 1B). Strauss discloses winding the flat member (60) at least partially around a first extending post (1; Fig. 6) of the plurality of extending posts (1,2,3) along the winding pathway (74) such that the second side surface of the flat member is in contact with the first extending post (1) wherein Fig. 6 shows that the second member side is contacting the post (1) and the first side surface faces away from the first extending post (not contacting the first post; at reference 84; Fig. 6), partially twisting the flat member in a mobius loop (col. 4, lines 44-46) by looping and twisting the wire along the winding pattern (74) about its longitudinal axis (Fig. 7C) as it extends from the first extending post (1) to a second extending post (3; Fig. 6) of the plurality of extending posts (1,2,3) and winding the flat member at least partially around the second extending post (3) such that the second side surface of the flat member is in contact with the first extending post, wherein Fig. 6 shows that the second wire side is contacting the post (1) and the first side surface faces away from the first extending post (not contacting the first post; at reference 84; Fig. 6). Strauss discloses heat treating (col. 2, lines 59-60, col. 6, lines 55-60 and col. 7, lines 55-58) the elongate flat member (60) while wound on the mandrel (10) to provide a three-dimensional unconstrained configuration to the flat member comprising a plurality of successive loops (loop 1, loop 2, loop 3; Figs. 7A and 7B) in which the elongate flat member is at least partially twisted about its longitudinal axis between each loop of the plurality of loops (Fig. 7A). Strauss discloses that the twisting between posts is a mobius loop (Fig. 7C) which is about a 180° twist between loops and Applicants’ claim 16 uses the terminology “about 120 degrees” for partially twisting, with Applicants’ Fig. 1 illustrating what appears to be a twist between the bottom loop portion (16, shaded in Fig. 1) and right twisted portion (14; not shaded in Fig. 1) which is illustrated by Strauss (Fig. 7A). The twist of Strauss is definitively greater than 90° as Fig. 7C shows the first and second side facing away from each other on either side of the twist and the Examiner considers that the Strauss mobius loop twist is about 120 degrees as claimed. It would have been obvious to the skilled artisan prior to the effective filing date of the present invention to conduct routine experimentation of a twist angle in the winding method of Strauss so as to from a loop between unconnected ends of the flat member between winding posts.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Strauss et al. (8,801,747) in view of Wallace et al. (6,322,576). Regarding claim 17, it is not clear what “the plurality” is referring to in line 5 and it is not clear that claim 2 is claiming an active method step or what a final embolic device configuration may look like but the Examiner is reading that the loops are formed on mandrel which are located 90 degrees from one another. Strauss discloses that the mandrel posts (1,2,3) are 120° from one another but does not disclose a mandrel configuration with 90° winding posts. Wallace teaches in Figs. 8A and 8B a mandrel (450) including a center post (460), three posts (pins; 451,452,453) positioned at about 120° from each other and Wallace teaches a 90° post orientation (500; Figs. 9A and 9B). It would have been obvious to the skilled artisan prior to the effective filing date of the present invention to position the winding posts on the mandrel of Strauss 90° from each other as taught by Wallace in order to form a plurality of winding loops in the embolic device that are angled by 65-95 degrees from each other.
Claim(s) 19 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Strauss et al. (8,801,747) in view of Wallace et al. (6,322,576). Strauss does not disclose six winding posts on the mandrel. Wallace teaches mandrels comprising three 120° winding posts (450; Figs. 8A and 8B), six 90° winding posts (500; Figs. 9A and 9B) and eight winding posts (Fig. 11A) and winding a wire (520) in loops around each of the six posts (510,510,511,512,513,514) to form an embolic device (Fig. 10A). It would have been obvious to the skilled artisan prior to the effective filing date of the present invention to include additional winding posts on the mandrel of Strauss as taught by Wallace in order to form a selectable plurality of winding loops in the embolic device.
Regarding claim 20, Strauss discloses clockwise and anticlockwise winding along the winding pathway (74) on the successive posts (1,3; Fig. 6).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDWARD THOMAS TOLAN whose telephone number is (571)272-4525. The examiner can normally be reached M-F 7:30-5.
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/EDWARD T TOLAN/Primary Examiner, Art Unit 3725