DETAILED ACTION
Claims 1 and 12 are currently amended. Claims 18-26 are canceled. A complete action on the merits of pending claims 1-17 appears below.
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 .
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/29/25 has been entered.
Claim Rejections - 35 USC § 103
Claims 1, 3-13, and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Sharma US 20190388133 in view of Zadno-Azizi US 20010049517.
Regarding claim 1, Sharma teaches method of performing a catheter-based medical procedure in a duodenum of a subject (Fig. 23B), comprising: providing a catheter (Fig. 23A catheter 2340) with at least a first expandable member at a distal end thereof; expanding the first expandable member (Fig. 23A 2342 for claim 5 or 2344 for claim 4) engages with a duodenal mucosa wherein the surface of the first expandable member covers a major duodenal papilla (par. [0419] insulating membrane of balloon covering ampulla of vater); and applying energy to the duodenal mucosa adjacent the first expandable member when expanded to ablate the duodenal mucosa (par. [0418]).
Sharma does not explicitly teach the first expandable member radially outward thereby increasing a volume of the first expandable member such that a surface of the first expandable member circumferentially. However, Sharma teaches a membrane that is expanded to cover sites in the duodenum (pars. [0418] and [0419]).
Zadno-Azizi, in an analogous device, teaches where the expandable member can be a balloon, coil, ribbon, or tube (par. [0167]).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to substitute the membrane ribbon of Sharma with the balloon of Zadno-Azizi. It is seen to preform equally as well and would yield the predictable result of expanding inside of the human body to cover tissue.
Regarding claim 3, Sharma teaches further comprising expanding a second expandable member (Fig. 23A 2342 for claim 4 or 2344 for claim 5) spaced apart from the first expandable member, and wherein applying energy ablates a selected length of duodenal mucosa between the first expandable member and the second expandable member (par. [0418]).
Regarding claim 4, Sharma teaches wherein the second expandable member is spaced apart proximally from the first expandable member (Fig. 23A 2342).
Regarding claim 5, Sharma teaches wherein the second expandable member is spaced apart distally from the first expandable member (Fig. 23A 2344).
Regarding claim 6, Sharma teaches wherein the selected length is from 5 cm to 25 cm (par. [0352]).
Regarding claims 7-9, Sharma teaches wherein the second expandable member is positioned in a first/third/fourth part of the duodenum (Fig. 23B the parts don’t depend from one another nor are they claimed to be different; therefore, they are just a spot in the duodenum).
Regarding claim 10, Sharma teaches wherein the catheter includes a second expandable member, wherein the first expandable member and the second expandable member comprise inflatable balloons (Fig. 23A).
Regarding claim 11, Sharma teaches wherein applying energy is provided by a flowable media introduced through the catheter to the duodenal mucosa adjacent the first expandable member when expanded (par. [0417] and Fig. 23B).
Regarding claim 12, Sharma teaches wherein the flowable media comprises a vapor that is adapted to undergo a vapor to liquid phase change to thereby apply energy to the duodenal mucosa (par. [0247] condensing of vapor to treat tissue).
Regarding claim 13, Sharma teaches wherein the vapor is water vapor (par. [0265]).
Regarding claims 15-17, Sharma teaches a broader range than the claimed wherein applying energy occurs at a rate of 15 cal/sec to 50 cal/sec, and wherein applying energy occurs for less than 20 seconds (par. [0352] 5-2500 cal/sec over 1-60 seconds).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to optimize the method of Sharma to have an energy rate of 15 cal/sec to 50 cal/sec for less than 20 seconds. Those of ordinary skill in the art know to manipulate parameters depending on the procedure being performed; therefore, they would use an energy rate of 15 cal/sec to 50 cal/sec for less than 20 seconds, or any appropriate parameter values, depending on the tissue being treated.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Sharma and Zadno-Azizi, as applied to claim 1 and further in view of Rajagopalan US 20200060942.
Regarding claim 2, Sharma and Zadno-Azizi do not explicitly teach wherein the surface of the first expandable member covers a minor duodenal papilla. However, as seen in claim 1 Sharma teaches protecting tissue with the expandable member
Rajagopalan, in an analogous method, teaches protecting different papilla, ducts, pylorus or a combination thereof in the duodenum (par. [0149]).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to modify the method of Sharma and Zadno-Azizi to cover the minor papilla. This presents the advantage of not damaging non-target tissue (Rajagopalan par. [0149]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Sharma and Zadno-Azizi, as applied to claim 1 and further in view of Lee US 20200253659.
Regarding claim 14, Sharma does not explicitly teach wherein the vapor is at least partly alcohol.
Lee, in an analogous method, teaches where the treatment fluid can be water, saline, or alcohol (par. [0011]).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to substitute the water in Sharma and Zadno-Azizi to be alcohol. It is seen to perform equally as well and would yield the result of treating the tissue region of interest.
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are moot because the new ground of rejection does not rely on the same combination of reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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/R.T.C./Examiner, Art Unit 3794
/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794