DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the heating element disposed between the proximal and distal occluding portions in claim 10 must be shown or the feature canceled from the claim.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 10 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 10 recites a heating element being disposed at least partially between the proximal and distal occluding portions. Assuming the embodiment of Fig. 2, which demonstrates proximal and distal occluding portions, the specification does not specifically show in the drawings or support in the disclosure a heating element being disposed between the proximal and distal occluding portions.
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.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 2-4, 8, 9, and 12-20 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. 2008/0311086 to Popowski.
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, heated ablative vapor passes through one or more openings and into direct contact with the mucosal tissue ([0194], circumferential treatment & [0187], steam 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 the radially expandable element through which to pass the heated ablative vapor.
Popowski teaches one or more openings in a radially expandable element having a proximal and distal occluding portion ([0051]). 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 Popowski 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 Popowski 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 Popowski 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 Popowski 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 Popowski teach the method of claim 8 as shown above, Rajagopalan further teaching the heated ablative fluid comprises steam ([0187]).
Regarding claim 12, Rajagopalan and Popowski 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 Popowski 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 Popowski teach the method of claim 13 as shown above, Rajagopalan further teaching the ablating comprises a non-desiccating ablation ([0187], the provision of steam is non-desiccating because it provides water).
Regarding claim 15, Rajagopalan and Popowski 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 Popowski 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 Popowski 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 duodenal mucosa ([0202]-[0203]).
Regarding claim 18, Rajagopalan and Popowski 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 Popowski 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 Popowski 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]).
Claims 5-7 are rejected under pre-AIA 35 U.S.C. 103(a) as being obvious over Rajagopalan and Popowski 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 Popowski 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, Popowski, 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, Popowski, and Hoey teach the method of claim 5 as shown above, Hoey further teaching the electrode comprises a bipolar electrode ([0104]).
Claim 10 is rejected under pre-AIA 35 U.S.C. 103(a) as being obvious over Rajagopalan and Popowski as applied to claim 2 above, and further in view of U.S. Patent No. 5,938,660 to Swartz et al. (“Swartz”).
Regarding claim 10, Rajagopalan teaches the method of claim 2 as shown above, but does not teach the position of the heating element.
Swartz teaches a heating element (30, Fig. 5) being disposed at least partially between a proximal (22) and a distal (20) occluding element. It would be obvious to one of ordinary skill in the art at the time the invention was made to have positioned the heating element of Rajagopalan between the proximal and distal occluding elements of Rajagopalan and Popowski as taught by Swartz to yield the predictable result of providing heat (or energy) to a fluid (conductive media) (column 14, lines 64 to column 15, line 1).
Response to Arguments
Applicant’s arguments and amendments with respect to drawings objections have been fully considered and are not persuasive. Although Applicant’s arguments have demonstrated support in the specification of such a limitation at least as an option, such a limitation has still not been shown in the drawings in combination with embodiment having proximal and distal occluding portions. The drawing objection has been maintained.
Applicant’s arguments and amendments with respect to 112 rejections have been fully considered and are persuasive in-part. The 112 rejections of claims 2 and 11 have been withdrawn. Regarding the 112 rejection of claim 10, Applicant argues that support for the limitation may be found, for example, in paragraph [0038]. However, paragraph [0038] only mentions that the heat generator can be positioned “on a radially expandable element,” and does not specify being positioned between the proximal and distal portions of that expandable element. It is noted that the drawings also do not show this limitation. The rejection stands.
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 Popowski as shown above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN KOO whose telephone number is (703)756-1749. The examiner can normally be reached M-F 8am-5pm EST.
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/B.K./Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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