Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 2/7/24;4/15/24;7/30/24;11/14/24;3/14/25;9/3/25;1/8/26 are in compliance with the provisions of 37 CFR 1.97(b). Accordingly, the IDSs are being considered by the Examiner.
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 1-7, 10 rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Brucker et al. (US 2007/0168020) (“Brucker”).
(claim 1) Brucker discloses: A method for fabricating a delivery catheter for treating a bifurcated vessel having a mother vessel 22 and a daughter vessel 24, the method comprising (see Figs 6-14): positioning a daughter catheter including a daughter expandable member 82 to extend distally under a proximal portion of a mother stent 50 and out through a side hole (see Fig. 10) of the mother stent so that the daughter expandable member is disposed distal to the side hole; positioning a mother catheter including a mother expandable member 80 relative to the daughter catheter; and partially crimping 92 the mother stent to the mother expandable member included in the mother catheter so as to permit proximal and distal movement of the daughter catheter relative to the mother stent, wherein the partial crimping couples the daughter catheter and the mother catheter together such that when in use, advancement of the mother and daughter catheters into apposition with a carina 26 at a bifurcation of the bifurcated vessel results in a tension between the mother and daughter catheters that prevents further distal advancement thereof. [0067],[0061-0067]
(claim 2) A delivery system (Figs. 6-14) for treating a bifurcated vessel having a mother vessel 22 and a daughter vessel 24, the delivery system 100 comprising: a mother catheter comprising a mother elongate shaft and a mother expandable member 80 disposed adjacent a distal end of the mother elongate shaft, and a stent 50 with a side hole (see Fig. 10) disposed over the mother expandable member; and a daughter catheter comprising a daughter elongate shaft and a daughter expandable member 82 disposed adjacent a distal end of the daughter elongate shaft, wherein the daughter catheter is slidably disposed under the stent and passes through the side hole (see Figs. 9-10).
Claim 3: a cross sectional profile of the daughter catheter is smaller than a cross sectional profile of the mother catheter such that, when crimped or partially crimped together by a mother stent, the mother stent adopts a pear shaped or figure eight configuration in cross section. (Figs. 12-14)
Claim 4: the daughter catheter further comprises a daughter stent 54 disposed over the daughter expandable member 82.
Claim 5: the daughter stent is configured to expand simultaneously with the proximal portion of the mother stent. [0065]
Claim 6: a radiopaque marker 90 is provided on the daughter catheter to align, in use, with a radiopaque marker provided on the mother catheter.
Claim 7: the daughter expandable member is configured to expand independently of the mother expandable member. [0065]
Claim 10: the mother expandable member and the daughter expandable member are configured to expand the mother stent evenly adjacent the bifurcation when inflated simultaneously (Fig. 14).
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.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
Claims 8-9 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Brucker in view of Penn et al. (US 5,906,640) (“Penn”).
Brucker discloses the invention as substantially claimed but does not directly disclose a therapeutic coating on the stents. Penn, in the analogous art, teaches a coating material (anti-restenosis drug) on a bifurcated stent (C6L4-14). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was made to have modified the stent of Brucker to add the therapeutic coating as taught by Penn as this is common practice for safety and care to a patient.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEANNA K HALL whose telephone number is (571)272-2819. The examiner can normally be reached M-F 8:30am- 4:30pm EST.
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/DEANNA K HALL/Primary Examiner, Art Unit 3783
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