DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1-17, 19, & 20 are rejected under pre-AIA 35 U.S.C. 102(a)(1) as being anticipated by Khairkhahan et al. (US Pat. No. 7,152,605 B2).
Regarding claim 1, Khairkhahan et al. disclose a fistula device 10 (occlusion device for a tubular anatomical structure – column 7, lines 20-22; Fig. 6), comprising: an elongate conduit 16 (Fig. 6) including: a first end with a first flow frame 11 (Fig. 6) configured to be positioned in a first vessel and span at least a portion of a lumen of the first vessel (intended use statements are indicated by italicizing the limitation; 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)); and a second end with a second flow frame 194 (Fig. 6) configured to be positioned in a second vessel and span at least a portion of a lumen of the second vessel); wherein at least one of the first flow frame 11 and the second flow frame 194 is comprised of a whisk (both frames 11 & 194 resemble whisk structures).
Regarding claim 2, Khairkhahan et al. further disclose a film covering (barrier 15 – column 5, line 11-15; Fig. 6) at least a portion the whisk 11.
Regarding claim 3, Khairkhahan et al. further disclose wherein the whisk 11 includes a cap 222 (Fig. 6); configured to seal a puncture site on a vessel wall.
Regarding claim 4, the limitation ‘wherein the first vessel is an artery and the second vessel is a vein’ is merely further defining the intended us of the device, this is not considered to further define the structure or device as it pertains to the positively recited claim language already recited. Khairkhahan et al.’s device is considered to be capable of being used for the intended purpose since it is already intended to be used within the human body and it meets all of the structural requirements of the claim.
Regarding claim 5, Khairkhahan et al. further disclose wherein the whisk 11 (whisk comprises spokes 17, 218) is comprised of nitinol (column 5, lines 3-5).
Regarding claim 6, Khairkhahan et al. further disclose wherein the whisk 11 comprises a ribbed frame having a plurality of ribs 17, 218 (Fig. 6).
Regarding claim 7, Khairkhahan et al. further disclose wherein at least one rib of the plurality of ribs 17, 218 comprises a bladed profile (Fig. 6).
Regarding claim 8, Khairkhahan et al. further disclose wherein the whisk comprises a lattice structure (provided by covering/barrier 15 – disclosed as having a porosity which is exemplary of a lattice structure - column 5, lines 11-26).
Regarding claim 9, Khairkhahan et al. further disclose wherein the conduit 16 comprises a continuous wall (solid conduit wall – Fig. 6).
Regarding claim 10, Khairkhahan et al. further disclose wherein the whisk 11 is integral with the elongate conduit 16 (fixedly attached to one another, thereby ‘integral’ – Fig. 6).
Regarding claim 11, Khairkhahan et al. further disclose wherein the whisk 11 is fixedly secured to the elongate conduit 16 (seen in Fig. 6 as fixedly attached).
Regarding claim 12, Khairkhahan et al. further disclose wherein the whisk 11 is configured to automatically fluctuate diametrically consistent with the corresponding first vessel or second vessel (whisk spokes are able to collapse for pre-deployment configuration and expand upon deployment; the collapsibility and expandability of the whisk changes the diameter of the whisk and thereby qualifies the structure to be ‘configured to automatically fluctuate diametrically’).
Regarding claim 13, Khairkhahan et al. further disclose wherein each of the first flow frame 11 and the second flow frame 194 comprise a whisk (Fig. 6 – spokes assemble to form a whisk like shape).
Regarding claim 14, Khairkhahan et al. further disclose wherein the elongate conduit is continuous (solid conduit wall – Fig. 6).
Regarding claim 15, Khairkhahan et al. disclose a fistula device comprising: a conduit 16 (Fig. 6) having a first end and a second end; a first whisk 11 (Fig. 6) extending from the first end of the conduit 16, the first whisk 11 configured to at least partially span a first lumen of a first vessel (intended use statements are indicated by italicizing the limitation; 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)); a second whisk 194 (Fig. 6) extending from the second end of the conduit 16, the second whisk 194 configured to at least partially span a second lumen of a second vessel; and a cap 222 (Fig. 6) on a distal end of the conduit 16 (via the whisk 11), the cap 222 configured to seal a puncture site of a wall of at least one of the first vessel and the second vessel when deployed.
Regarding claim 16, Khairkhahan et al. further disclose wherein the cap 222 is included on at least one of the first whisk 11 and the second whisk (Fig. 6).
Regarding claim 17, Khairkhahan et al. further disclose wherein each of the first whisk 11 and the second whisk 194 includes a cap 222, 191 (respectively).
Regarding claim 19, Khairkhahan et al. further disclose wherein the cap 222, 191 is configured to seal a puncture site created during percutaneous deployment (since caps 222, 191 provide proximal and distal seals to the device, they would be capable of sealing at the intended location).
Regarding claim 20 , Khairkhahan et al. further disclose wherein the fistula device is self-expandable (‘nitinol’ - column 5, lines 3-5).
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 18 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Khairkhahan et al. (US Pat. No. 7,152,605 B2) in view of Dubrul et al. (US Pub. No. 2010/0030256 A1).
Regarding claim 18, Khairkhahan et al. fail to explicitly disclose wherein the cap is imbibed with a therapeutic agent. However, Dubrul et al. teaches a similarly designed device to be used in the vasculature, wherein it is suggested and taught that therapeutic agents may be used to further treat the target site for any other concerns while the device is implanted (paragraph [0238]). It is considered well known in the art to utilized therapeutic agents with implanted medical devices, as evidenced by the suggestions and teachings of Dubrul et al., since providing such an agent can allow for quicker healing/treatment of the target site.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEY LAUREN FISHBACK whose telephone number is (571)270-7899. The examiner can normally be reached M-F 7:30a-3:30p.
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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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ASHLEY LAUREN FISHBACK
Primary Examiner
Art Unit 3771
/ASHLEY L FISHBACK/Primary Examiner, Art Unit 3771 September 19, 2026
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