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 § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 2-4, 8, 9, and 12-21 are rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication No. 2013/0345670 to Rajagopalan et al. (“Rajagopalan”) in view of U.S. Patent Publication No. 5,611,775 to Machold et al. (“Machold”).
The applied reference has a common inventor with the instant application. Based upon the pre-AIA 35 U.S.C. 102(e) date of the reference, it constitutes prior art. This rejection under pre-AIA 35 U.S.C. 102(e) might be overcome either by a showing under 37 CFR 1.132 that any invention disclosed but not claimed in the reference was derived from the inventor or joint inventors (i.e., the inventive entity) of this application and is thus not the invention “by another,” or if the same invention is not being claimed, by an appropriate showing under 37 CFR 1.131(a).
Regarding claim 2, Rajagopalan teaches a method of treating mucosal tissue in a patient's duodenum ([0007]), the method comprising introducing a treatment device into the patient's gastrointestinal tract ([0095]), the treatment device comprising an elongate shaft (311, Fig. 12) having a fluid lumen ([0164]) and a radially expandable element (322b/322a) configured, when expanded, to form a proximal occluding portion (322b) and a distal occluding portion (322a) spaced apart along a distal portion of the elongate shaft (Fig. 12), a fluid delivery element positioned between the proximal and distal occluding portions of the radially expandable element ([0168]), and a heating element configured to heat fluid from the fluid lumen ([0187], steam requires heating by some heating element), treating mucosal tissue of the patient's duodenum by performing a sequence of steps comprising: (a) advancing the treatment device to an untreated location in the patient's duodenum ([0095]), (b) expanding the radially expandable element to at least partially isolate a circumferential portion of the mucosal tissue at the untreated location between the proximal and distal occluding portions ([0061], circumferential portion proximate the Ampulla of Vater, the first treatment would be considered “untreated”), and (c) delivering heated ablative fluid into direct contact with the circumferential portion of the mucosal tissue at the untreated location by causing a delivery of energy to the heating element and a delivery of fluid to the fluid lumen to generate the heated ablative fluid, wherein, in the expanded condition, the heated ablative fluid passes through one or more openings and into direct contact with the mucosal tissue ([0194], circumferential treatment & [0187], steam or heated water is used to removed tissue/ablate, a heating element is required in order to create steam), and (d) after delivering the heated ablative fluid, treating additional mucosal tissue in the patient's duodenum by repeating (a)-(c) ([0223]), but does not teach the one or more openings being in a radially expanded portion of the radially expandable element through which to pass the heated ablative fluid.
Machold teaches one or more openings (46, Fig. 6) in a radially expanded portion (middle portion of 45) of a radially expandable element (45) having a proximal (47) and distal (48) occluding portion. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have performed a simple substitution of the dual occluder balloon design of Rajagopalan with the dual occluder balloon design of Machold to obtain the predictable result of providing therapeutic fluid to a treatment area that is between two occluding elements which are used to isolate a treatment area and optimize therapy.
Regarding claim 3, Rajagopalan and Machold teach the method of claim 2 as shown above, Rajagopalan further teaching identifying an ampulla of Vater ([0015], non-target tissue is identified & [0028], the Ampulla of Vater is non-target tissue) of the patient and wherein treating mucosal tissue of the patient's duodenum is done after identifying the ampulla of Vater of the patient (Fig. 14, treatment 410 occurs after protective insertion into the Ampulla of Vater 408, which must be identified in order to be placed) and wherein the untreated location in the patient's duodenum is away from the ampulla of Vater ([0061], proximate the ampulla of Vater).
Regarding claim 4, Rajagopalan and Machold teach the method of claim 3 as shown above, Rajagopalan further teaching the treatment device is configured to identify the Ampulla of Vater ([0015], non-target tissue is identified & [0028], the Ampulla of Vater is non-target tissue).
Regarding claim 8, Rajagopalan and Machold teach the method of claim 2 as shown above, Rajagopalan further teaching, based on causing the delivery of energy to the heating element, converting fluid from the fluid lumen to vapor using the heating element, the vapor to be expelled by the fluid delivery element ([0187], the provision of steam).
Regarding claim 9, Rajagopalan and Machold teach the method of claim 8 as shown above, Rajagopalan further teaching the heated ablative fluid comprises steam ([0187]).
Regarding claim 12, Rajagopalan and Machold teach the method of claim 2 as shown above, Rajagopalan further teaching treating mucosal tissue at a plurality of locations in the patient's duodenum that together define at least 50% of a cumulative axial length of the patient's duodenum ([0018], a full length of the mucosal layer of the duodenum is at least 50%).
Regarding claim 13, Rajagopalan and Machold teach the method of claim 12 as shown above, Rajagopalan further teaching the treatment device is an ablation device ([0009]) and wherein treating mucosal tissue at a plurality of locations comprises ablating the mucosal tissue at the plurality of locations ([0223]).
Regarding claim 14, Rajagopalan and Machold teach the method of claim 13 as shown above, Rajagopalan further teaching the ablating comprises performing a non-desiccating ablation ([0187], the provision of steam is non-desiccating because it provides water).
Regarding claim 15, Rajagopalan and Machold teach the method of claim 12 as shown above, Rajagopalan further teaching treating at least a portion of the patient's jejunum by: (e) advancing the treatment device to an untreated location in the patient's jejunum ([0035]), (f) at least partially isolating a circumferential portion of the mucosal tissue at the untreated location between the proximal and distal occluding portions ([0168]), and(g) delivering heated ablative fluid into direct contact with the circumferential portion of the mucosal tissue at the untreated location by causing a delivery of energy to the heating element and a delivery of fluid to the fluid lumen ([0194]).
Regarding claim 16, Rajagopalan and Machold teach the method of claim 2 as shown above, Rajagopalan further teaching at least one of the proximal and the distal occluding elements is configured to move between an expanded state and a contracted state ([0207]).
Regarding claim 17, Rajagopalan and Machold teach the method of claim 2 as shown above, Rajagopalan further teaching the method is confined to treatment in the patient's duodenum and/or the patient's duodenum and a portion of the patient's jejunum contiguous with the patient’s duodenal mucosa ([0202]-[0203]).
Regarding claim 18, Rajagopalan and Machold teach the method of claim 2 as shown above, Rajagopalan further teaching the patient has been diagnosed with diabetes, and the wherein method comprises performing steps (a)-(d) as part of a method of treating the patient's diabetes ([0014]).
Regarding claim 19, Rajagopalan and Machold teach the method of claim 2 as shown above, Rajagopalan further teaching the patient has been diagnosed with a metabolic disease, and wherein the method comprises performing steps (a)-(d) as part of a method of treating the patient's metabolic disease ([0018]).
Regarding claim 20, Rajagopalan and Machold teach the method of claim 2 as shown above, Rajagopalan further teaching introducing the treatment device to the patient's duodenum through a working channel of an endoscope ([0095]-[0096]).
Regarding claim 21, Rajagopalan and Machold teach the method of claim 2 as shown above, Machold further teaching the one or more openings (46) are disposed on a sidewall region of the radially expandable element (all of 40 is expandable) that extends longitudinally between the proximal occluding portion (47) and the distal occluding portion (48) and is configured to extend along the mucosal tissue (Fig. 6) when the radially expandable element is in the expanded condition.
Claims 5-7 are rejected under pre-AIA 35 U.S.C. 103(a) as being obvious over Rajagopalan and Machold as applied to claim 2 above, and further in view of U.S. Patent Publication No. 2011/0160648 to Hoey.
Regarding claim 5, Rajagopalan and Machold teach the method of claim 2 as shown above, and although Rajagopalan teaches various electrodes ([0029]) which can used with balloons containing heated fluid ([0031]), it does not explicitly mention electrodes being used to heat fluid for ablation.
Hoey teaches a heating element comprises an electrode ([0093]) used to heat fluid for ablation ([0100]). It would be obvious to one of ordinary skill in the art at the time the invention was made to have used electrodes to heat the heated fluid of Rajagopalan as taught by Hoey to yield the predictable result of providing a heated ablation fluid. Rajagopalan already teaches the use of a heated ablation fluid, Hoey merely shows an example of how the fluid is often heated in a similar type of ablation device.
Regarding claim 6, Rajagopalan, Machold, and Hoey teach the method of claim 5 as shown above, Hoey further teaching causing the delivery of energy to the heating element comprises delivering RF energy to the electrode in monopolar, bipolar and/or combined monopolar-bipolar energy delivery modes ([0104]).
Regarding claim 7, Rajagopalan, Machold, and Hoey teach the method of claim 5 as shown above, Hoey further teaching the electrode comprises a bipolar electrode ([0104]).
Response to Arguments
Applicant’s arguments and amendments with respect to drawings objections have been fully considered and are persuasive. The drawing objections have been withdrawn.
Applicant’s arguments and amendments with respect to 112 rejections have been fully considered and are persuasive. The 112 rejections have been withdrawn.
Applicant’s arguments and amendments with respect to art rejections have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Rajagopalan and Machold as shown above.
Conclusion
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/B.K./Examiner, Art Unit 3783 /THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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