DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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.
Continued Examination Under 37 CFR 1.114
3. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/23/2026 has been entered.
Claim Rejections - 35 USC § 112
4. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
5. Claims 1, 6, 10, 16, and 17, as well as claims 2-5, 7-9, 12-15, 18-29, and 31 due to their dependencies on the previous claims, are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
6. Claim 1 recites the limitation "the distal end of the catheter" in lines 7-8 and 12-13. There is insufficient antecedent basis for this limitation in the claim. While Claim 1 does recite “a catheter” in line 3 of the claim, there is no recitation of “a distal end” of the catheter. Therefore, the claim is indefinite. Proper correction is required.
7. Claims 6, 10, 16, and 17 all recite the limitation “the distal end of the catheter”. Since Claim 1 fails to recite “a distal end of the catheter”, this renders these claims indefinite. Proper correction is required.
Allowable Subject Matter
8. Claim 1 contains allowable subject matter. The following is a statement of reasons for the indication of allowable subject matter: a method of ablating tissue comprising inserting an endoscope, inserting a catheter through a channel of the endoscope, and expanding a structure to circumferentially surround an interior surface of the target tissue is well known in the art. This is supported by at least the references cited during the prosecution of this case, as well as other references in the general area that could be located with minimal effort. However, the prior art of record fails to specifically teach directing a first amount of energy to a first treatment zone, compressing the structure, directing a second amount of energy to a second treatment zone, and after directing the second amount of energy to the second treatment zone, repeatedly moving the catheter to different portions of the patient's duodenum, forming different treatment zones, and applying amounts of energy until a contiguous circumferential ablation region comprising of 25% to 90% of the patient's mucosa over a length of 2 cm to 25 cm of the duodenum is achieved, wherein said circumferential ablation region is defined by ablated tissue having an average thickness and a mean thickness and wherein a thickness of ablated tissue at any specific point in the circumferential ablation region is within 25% of said average thickness or mean thickness. The prior art also fails to provide sufficient motivation to make such specific modifications and would require improper use of hindsight to arrive at the claimed invention when considered along or in any proper combination.
9. As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Conclusion
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNIE L SHOULDERS whose telephone number is (571)272-3846. The examiner can normally be reached Monday-Friday (alternate Fridays) 8AM-5PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at 571-272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANNIE L SHOULDERS/Examiner, Art Unit 3794
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