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 .
Election/Restrictions
Applicant’s election of Species A (system 100 of Figs. 2-11), claims 1-9 & 18, in the reply filed on 8/5/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 10-17 & 19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/5/2026.
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 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 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lashinski et al. (US Pub. No. 2003/0167083 A1).
Regarding claim 1, Lashinski et al. disclose a system (Figs. 1-4) for minimally invasive creation of an anastomosis to a duct in a body of a patient, wherein the anastomosis is created in a target region of the duct at an anastomosis site (at side port 19 - Figs. 1-4), wherein the duct comprises a duct wall, and wherein said duct wall is punctured at the anastomosis site (all italicized limitations indicate limitations that are intended use of the structure to be/being claimed; applicant is reminded that 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).), the system comprising: a delivery catheter 20 (Figs. 1-4) configured for percutaneous transluminal insertion through the duct to the target region, wherein the delivery catheter 20 is configured to be guided to the target region via a first guidewire 40 (Figs. 1-4); and a stent graft 10, 114 (Figs. 1-4) arranged within the delivery catheter 20, the stent graft 10, 114 comprising a main tube 10 and at least one branch tube 114, wherein the branch tube 114 is configured to be guided to the anastomosis site via a second guidewire 50 (Figs. 1-4); wherein the main tube 10 is configured to be expanded in the duct; and wherein the branch tube 114 extends from a first end to a second end, the first end being coupled to the main tube 10 and the second end being configured for insertion through the punctured duct wall at the anastomosis site (Figs. 1-4).
Regarding claim 2, Lashinski et al. further disclose wherein, the branch tube 114 is configured for insertion through the punctured duct wall from within the duct towards outside the duct (Figs. 1-4).
Regarding claim 3, Lashinski et al. further disclose a primary sheath 280 (Fig. 7; paragraphs [0089]-[0090]) extending around the main tube and the branch tube.
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 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 4-9 & 18 are rejected under 35 U.S.C. 103 as being unpatentable over Lashinski et al. (US Pub. No. 2003/0167083 A1) in view of Beane et al. (US Pub. No. 2011/0118763 A1).
Regarding claim 4, Lashinkski et al. fail to further disclose wherein the stent graft is arranged within the delivery catheter with the branch tube in an inverted position, wherein the second end of the branch tube is located in the main tube in said inverted position. However, Beane et al. teach a similar branched stent graft system wherein the construction of the branch tube involves an inverted branch tube 55 within a main tube 15 (paragraph [0061]) which is suggested and taught as an alternative configuration to ease insertion of the branch tube through the puncture of the vessel wall (paragraph [0061]). It is considered that one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious in view of the suggestion and teaching of Beane et al.’s disclosure to utilize an inverted branch configuration as a substitution for the branch configuration in Lashinkski et al.’s stent graft, in order to provide the benefit of easing the insertion of the tube through the puncture/opening.
Regarding claim 5, Beane et al. further teach wherein the system is configured for everting the branch tube 55 from the inverted position to an everted position (Fig. 17 & paragraph [0061]), wherein the second end of the branch tube is located outside the main tube 15 in said everted position (paragraph [0061]).
Regarding claim 6, Beane et al. further teach wherein the system is configured for inserting the branch tube 55 through the duct wall by everting the branch tube 55 from the inverted position to the everted position (paragraph [0061]).
Regarding claim 7, Beane et al. further teach a flexible wire 70, 105 or thread coupled to the branch tube 55 (Fig. 17; paragraphs [0060]-[0061]), preferably to the second end of the branch tube (NOTE: the use of the term ‘preferably’ allows for the limitation that follows to be interpreted as not required by the prior art).
Regarding claim 8, Beane et al. further teach wherein the flexible wire 70, 105 or thread is configured to be coupled with the second guidewire 70 (Fig. 17; paragraphs [0060]-[0061]).
Regarding claim 9, Beane et al. further teach wherein the branch tube 55 is everted by pulling the flexible wire or thread through the duct wall at the anastomosis site (this limitation is recited as an intended method step of everting the branch tube within a product claim; however, although the flexible wire 70, 105 in Beane et al. is disclosed to be pushed, it is also capable of being pulled via access from the distal opening of the branch tube, so the capability of this step is met by the structure).
Regarding claim 18, Beane et al. further teach wherein the flexible wire or thread is coupled to the second end of the branch tube (paragraph [0060] - ‘for example, positioning sheaths 105 could be used with each of the balloon catheter 75 and guidewire 70, thereby allowing precise positioning of each arm of the T-stent. When the T-stent is positioned in the desired location, the positioning sheaths 105 are detached from the T-stent, such as by detaching a connection. The detachable connection could be a suture, a wire, or other attachment means’).
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 August 22, 2026
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