DETAILED ACTION
Response to Amendment
This action is in response to the amendment after non-final filed 20 May 2026. Claims 1-20 are pending, wherein claims 2-20 are new.
Response to Arguments
Applicant’s argument filed with respect to the 35 USC 102 rejection of claim 1 as being anticipated by Rajagopalan et al. (US Publication no. 2017/0333122) have been fully considered and are persuasive. The prior art is deficient in teach reduction in villous height. Additionally, the prior art is deficient in the teaching of reducing crypt density. Therefore, the rejection of claim 1 has been withdrawn.
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.
Claim(s) 15-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rajagopalan et al. (US Publication no. 2017/0333122 – previously cited).
In regard to claim 15, Rajagopalan et al. discloses a method of treating duodenal mucosal dysfunction in a patient (para 10), the method comprising:
performing a tissue treatment procedure comprising treating one or more segments of the patient's duodenal mucosal tissue (para 19);
wherein the tissue treatment reduces a mucosal volume of the one or more segments of the patient's duodenal mucosal tissue by at least 7% (para 42, teaches treating an axial length of at least 6 cm of duodenal tissue by ablation, which supports treating one or more segments of duodenal tissue; para 53-54, teach that the treatment includes ablating, removing or necrosing of target tissue, reducing surface area of target tissue which is considered to teach destruction or removal of tissue; para 354, discusses techniques for treating target tissue and expressly teach the device may reset selected tissue from the mucosal tissue; para 238, teaches that the treatment (as in para 42, 53-54, and 354) treats at least 10% of tissue).
Under the broadest reasonable interpretation of the claim, the claimed feature of reducing mucosal volume encompasses reducing the amount of mucosal tissue by ablating or removing tissue. Accordingly, as Rajagopalan et al. teaches ablating, which includes removing or resecting tissue, of at least 10% of the tissue is considered reasonably anticipate reducing the mucosal volume by at least 7%.
In regard to claim 16, in Rajagopalan et al., the tissue treatment procedure comprises ablating the one or more segments of the patient's duodenal mucosal tissue (para 19, 42, 53, 54, 238, and 354).
In regard to claim 17, in Rajagopalan et al., the tissue treatment procedure comprises a tissue treatment selected from the group consisting of: thermal coagulation; desiccation; non- desiccating tissue ablation; heat ablation; cryoablation; radiofrequency ablation; electroporation; ultrasound and/or other sound-based ablation; sonoporation; laser and/or other light-based ablation; mechanical abrasion; chemical abrasion and/or chemical ablation; and combinations thereof (para 353-354).
Allowable Subject Matter
Claims 1-14 and 18-20 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: the prior art fails to teach providing treatment to result in the claimed reduction in villous height or reduction in crypt density.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
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 BRIAN T GEDEON whose telephone number is (571)272-3447. The examiner can normally be reached M-F 8:00 am to 5:30 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David E. Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN T GEDEON/Primary Examiner, Art Unit 3796 6 August 2026
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