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, 5-7, 23, 27 and 30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Towler (US 2008/0086083).
Regarding claim 1, Towler discloses an occlusion device (Figure 7 or 10), comprising: a catheter (15) comprising a catheter lumen (¶[0032]); and a first toroidal balloon coupled to the catheter, wherein the first toroidal balloon (1 or 19; ¶[0030]) comprises: an outer surface having an outer diameter configured to seal against an inner portion of a vessel wall (evident from ¶[0046]); and a center lumen (7) configured to allow blood to flow therethrough and comprising: an adjustable center lumen diameter adapted to be varied by a user from at least a first center lumen diameter enabling a first blood flow rate to a second center lumen diameter enabling a second blood flow rate (¶[0046], [0048]).
Regarding claim 2, the first toroidal balloon is inflatable via the catheter lumen to dynamically decrease the center lumen diameter from the first center lumen diameter to the second center lumen diameter to decrease the blood flow rate through the center lumen from a first blood flow rate to a second blood flow rate less than the first blood flow rate (¶[0046]).
Regarding claim 3, the first toroidal balloon is deflatable via the catheter lumen to dynamically increase the center lumen diameter from the first center lumen diameter to the second center lumen diameter to increase the blood flow rate through the center lumen (¶[0046]).
Regarding claim 5, the catheter is coupled to the first toroidal balloon (19) such that the catheter passes through a body of the first toroidal balloon (Figure 10).
Regarding claim 6, the catheter is coupled to the first toroidal balloon such that the catheter is tangent to the center lumen (Figure 10; inasmuch as Applicant’s catheter is tangent to the balloon in Figures 4A and 4B).
Regarding claim 7, at least a portion of the first toroidal balloon is comprised of at least one of a silicone material, a polyurethane material, a latex material, a polyether block amide (PEBA) material, a nylon material, or a polyethylene terephthalate (PET) material (¶[0033], [0037]).
Regarding claim 23, Towler discloses an occlusion device (Figures 7 or 10), comprising: a catheter (15) comprising a catheter lumen (¶[0032]); a first toroidal balloon (1 or 19) coupled to the catheter, wherein the first toroidal balloon comprises: an outer surface having an outer diameter configured to seal against an inner portion of a vessel wall (evident from ¶[0046]); a volume (at “5” in Figure 1) adapted to be inflated or deflated by a fluid via the catheter lumen; and a center lumen (7) configured to allow blood to flow therethrough and comprising an adjustable center lumen diameter adapted to be varied by a user, wherein the adjustable center lumen diameter is adapted to be varied by a user by inflation or deflation of the volume via the catheter lumen to establish one of a desired blood pressure proximal to the balloon and a desired blood pressure distal to the balloon (¶[0046], [0048]).
Regarding claim 27, the adjustable center lumen diameter is adapted to be varied by a user to control one of a blood pressure proximal to the first toroidal balloon and a blood pressure distal to the first toroidal balloon (¶[0046], capable of this via controlling the lumen 7 diameter).
Regarding claim 30, the balloon could seal against an aorta wall as claimed (¶[0035]).
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.
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Towler (US 2008/0086083) in view of Tillman et al. (US 2016/0157868).
Regarding claim 4, Towler fails to disclose that the outer surface includes one or more traction elements to reduce migration of the occlusion device. Towler et al. disclose that the balloon is intended to allow perfusion flow therethrough (¶[0011]).
Tillman et al. disclose a balloon (18) for allowing perfusion flow therethrough (Abstract) and further disclose providing an outer surface of the balloon with one or more traction elements (30; Figure 4) to reduce migration of the balloon (¶[0067]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the outer surface of Towler with the traction elements of Tillman et al. in order to reduce migration of the balloon at an intended implantation site.
Claims 15, 16, 21, 22 and 24-26 are rejected under 35 U.S.C. 103 as being unpatentable over Towler (US 2008/0086083) in view of Barbut (US 6,595,980).
Regarding claims 15, 16, 21 and 24, Towler discloses the occlusion device substantially as claimed, including the limitations already addressed above, but fails to disclose a blood pressure measurement element disposed proximal and distal to the balloon as claimed. Towler intends to controllably reduce blood flow within a vessel via the balloon (¶[0002]; claims 48-50).
Barbut discloses a toroidal balloon (20) for restricting blood flow and further teaches providing a blood pressure measurement element proximal and distal to the balloon (col. 2, lines 38-47).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention and in view of Barbut to have provided a blood pressure measurement element proximal and distal to the balloon of Towler as claimed in order to better determine the amount of blood flow reduction achieved.
Further regarding claims 15 and 16, Towler in view of Barbut fail to disclose one of the claimed types of blood pressure measurement elements.
However, it is well-known in the art to use a MEMS sensor as a blood pressure sensor in/on catheter devices (see for example col. 1, lines 12-26 of US 9,624,092 as evidence). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used a MEMS sensor as the blood pressure measurement element of Towler in order to take advantage of this well-known means for incorporating a blood pressure sensor with a catheter.
Regarding claims 22 and 25, the center lumen could be varied as claimed depending on the incoming blood pressure, diameter of the vessel proximal to the balloon and diameter of the vessel distal to the balloon.
Regarding claim 26, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided some form of inflation device or controller as Towler indents to control the center lumen diameter via controlled inflation pressure (¶[0048]). With this modification, a flow rate within the claimed range would be achievable depending upon the blood flow rate proximal to the balloon and the center lumen diameter.
Claims 28, 29 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Towler (US 2008/0086083).
Regarding claims 28, 29 and 31, Towler fails to disclose that the center lumen can be completely closed as claimed.
However, Towler discloses closing of the lumen via inflation to at least reduce flow (¶[0046], [0048]) and completely obstructing the center lumen to prevent flow therethrough in numerous other embodiments (Figures 6 and 12-15).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the lumen in Figures 7 or 10 to completely close via inflation as claimed in order to provide these embodiments with the additional function of completely occluding flow which is a stated goal of Towler.
Response to Arguments
Applicant’s arguments with respect to the pending claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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 Thomas McEvoy whose telephone number is (571) 270-5034 and direct fax number is (571) 270-6034. The examiner can normally be reached on Monday-Friday, 9:00 am – 6:00 pm.
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/THOMAS MCEVOY/Primary Examiner, Art Unit 3771
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