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 .
DETAILED ACTION
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-5, 7, 9-11, 14 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Hathorn US2015/0105699 and Rentschler et al. US2013/0172671.
For claim 1, Hathorn discloses “A method of applying pressure and support to a patient's abdomen during an enteroscopy procedure (0005, 0041; figs 2A-B), comprising:
applying a primary wrap (primary wrap 10; fig 4; 0044-0046) comprising a band of elastic material (0044) to an abdomen of a patient (0043);
maintaining tension in the band in order to apply constant pressure and the support to the patient's abdomen through a contraction of the primary wrap (0060, 0069-0071) in connection with an advancement or a withdrawal of an endoscope during an enteroscopy procedure (fig 26; 0073); and
adjusting at least one of the primary wrap or at least one secondary strap extending from the primary wrap to adjust compression to the abdomen of the patient (0044 describes the primary wrap 10 to be around the abdominal girth in patients) and support the advancement or the withdrawal of the endoscope through the contraction of the primary wrap and the at least one secondary strap (0060-0063)”.
Hathorn does not disclose the method specifically as an antegrade enteroscopy procedure, i.e.
“in connection with an antegrade enteroscopy procedure; introducing an endoscope through a mouth of the patient;
an advancement or a withdrawal of the endoscope through the mouth of the patient during the antegrade enteroscopy procedure;
support the advancement or the withdrawal of the endoscope during the antegrade enteroscopy procedure”.
Rentschler teaches in the same field of endeavor, an endoscopic procedure where the GI tract can be accessed through two natural orifices, the oral cavity or the anus, i.e. “in 2001 an enteroscopy procedure was introduced as a method of exploring a larger part of the small bowel in either antegrade or retrograde approach” (0158). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Rentschler into the invention of Hathorn in order to configure the method e.g. as claimed because it provides the advantage of applying tension via a wrap during an antegrade or retrograde enteroscopy procedure.
For claim 2, Hathorn discloses “The method of claim 1, wherein the enteroscopy procedure comprises at least one of: a sigmoidoscopy, an enteroscopy, a single balloon enteroscopy, a double balloon enteroscopy, a spiral enteroscopy, a push enteroscopy, or an examination of a small bowel (0041)”.
For claim 3, modified Hathorn discloses “The method of claim 1, wherein the primary wrap is applied prior to an introduction of the endoscope into the mouth (Rentschler: an endoscopic procedure where the GI tract can be accessed through two natural orifices, the oral cavity or the anus 0158) of the patient (Hathorn: 0073 discloses patients are provided with blankets after changing into hospital garments and the disclosed wrap performs this function which is considered to occur after the patient changes, i.e. before the enteroscopy procedure)”.
For claim 4 modified Hathorn discloses ”The method of claim 1, wherein the primary wrap is applied following an introduction of the endoscope into the mouth (Rentschler: an endoscopic procedure where the GI tract can be accessed through two natural orifices, the oral cavity or the anus 0158) of the patient (Hathorn: 0004; fig 3A-C discloses the endoscopy procedure applying manual pressure during a colonoscopy procedure. The reference does not specify when the wrap is applied, but based on the disclosure of when the manual pressure is being applied, i.e. during a procedure, it is considered to include the situation where the wrap takes the place of the manual pressure which is occurring during the procedure, i.e. after an introduction of the endoscope)”.
For claim 5, Hathorn discloses “The method of claim 1, wherein adjusting at least one of the primary wrap or the at least one secondary strap includes iteratively adjusting the at least one of the primary wrap or the at least one secondary strap in combination with iterative advancement of the endoscope (0041 describes an enteroscopy procedure which starts by negotiating the loop-prone sigmoid region and then proceeding to the small bowel, traversing additional sections of the bowel, each of which is considered to potentially require application of pressure and therefore adjustment and readjustment of the wrap, in an iterative fashion as the endoscope is advanced)”.
For claim 7, Hathorn discloses “The method of claim 1, wherein the adjusting at least one of the primary wrap or the at least one secondary strap includes iteratively adjusting the at least one of the primary wrap or the at least one secondary strap (0047 describes the fastening as a non-permanent mechanism, i.e. a hook strip which is detachable and therefore adjustable in an iterative manner as the user sees fit) that is performed in correlation with an iterative inflation or deflation of a balloon at the endoscope (0047 – inflatable plastic or composite air bladder)”.
For claim 9, Hathorn discloses “The method of claim 1, wherein the endoscope comprises an enteroscope, and the adjusting at least one of the primary wrap or the at least one secondary strap is performed in correlation with the advancement of the enteroscope to a cecum (0041)”.
For claim 10, Hathorn discloses “The method of claim 1, wherein the endoscope comprises an enteroscope, and the adjusting at least one of the primary wrap or the at least one secondary strap is performed in correlation with the advancement of the enteroscope across a terminal ileocecal valve into a terminal ileum (0041 describes retrograde enteroscopy into the small bowel, therefore having to traverse the terminal ileum)”.
For claim 11, Hathorn discloses “The method of claim 1, wherein the endoscope comprises an enteroscope, and the adjusting at least one of the primary wrap or the at least one secondary strap is performed in correlation with the advancement of the enteroscope into a small bowel of the patient (0041 – small bowel)”.
For claim 14, Hathorn discloses “The method of claim 1, further comprising: maintaining the compression with the primary wrap for a period of time following the withdrawal of the endoscope (0082)”.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hathorn and Rentschler as applied to claim 1 above, and further in view of Hathorn US2017/0042752 herein as Hathorn B.
For claim 6, Hathorn does not disclose “The method of claim 1, wherein adjusting at least one of the primary wrap or the at least one secondary strap includes iteratively adjusting the at least one of the primary wrap or the at least one secondary strap in combination with iterative withdrawal of the endoscope”. Hathorn B teaches in the same field of endeavor, an endoscopic procedure with application of compression during withdrawal (0022). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Hathorn B into the invention of Hathorn in order to configure the method e.g. as claimed because it allows the application of compression force during a withdrawal endoscopic procedure.
Claim(s) 8, 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hathorn and Rentschler as applied to claim 1 above, and further in view of Wang et al. US2019/0274687.
For claim 8, Hathorn does not disclose “The method of claim 1, wherein the endoscope comprises an enteroscope, and the adjusting at least one of the primary wrap or the at least one secondary strap includes iteratively adjusting the at least one of the primary wrap or the at least one secondary strap (0047 describes the fastening as a non-permanent mechanism, i.e. a hook strip which is detachable and therefore adjustable in an iterative manner as the user sees fit) that is performed in correlation with an iterative advancement or an iterative retraction of an overtube for the enteroscope (0040 describes an endoscopic procedure which includes advancement which can be reversed as the user sees fit, i.e. the advancement is not a permanent single motion)”.
Wang teaches in the same field of endeavor, endoscopic procedures utilizing an overtube (0078). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Wang into the invention of Hathorn in order to configure the method e.g. as claimed because it allows applying tension via the wrap during an endoscopic procedure using an overtube.
For claim 13, Hathorn does not disclose “The method of claim 1, wherein the endoscope comprises an enteroscope and the enteroscopy procedure comprises a spiral enteroscopy, and the adjusting at least one of the primary wrap or at least one elastic secondary strap includes iteratively adjusting the at least one of the primary wrap or the at least one secondary strap (0047 describes the fastening as a non-permanent mechanism, i.e. a hook strip which is detachable and therefore adjustable in an iterative manner as the user sees fit) that is performed in correlation with an iterative spiral rotation of the enteroscope”.
Wang teaches in the same field of endeavor, an endoscopic procedure using spiral enteroscopy (0113). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Wang into the invention of Hathorn in order to configure the method e.g. as claimed because it provides the advantage of applying tension via a wrap during a spiral endoscopy procedure.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hathorn and Rentschler as applied to claim 1 above, and further in view of Schembre US2012/0178994.
For claim 12 Hathorn does not disclose “The method of claim 1, wherein the endoscope comprises an enteroscope and the enteroscopy procedure comprises a spiral enteroscopy, and the adjusting at least one of the primary wrap or the at least one secondary strap includes iteratively adjusting the at least one of the primary wrap or the at least one secondary strap (0047 describes the fastening as a non-permanent mechanism, i.e. a hook strip which is detachable and therefore adjustable in an iterative manner as the user sees fit) that is performed in correlation with an iterative passive pleating or unpleating of a bowel of the patient”.
Schembre teaches in the same field of endeavor, an endoscopic procedure involving pleating or unpleating of a bowel (0052-0053). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Schembre into the invention of Hathorn in order to configure the method e.g. as claimed because it provides the advantage of applying tension via a wrap during a pleating or unpleating enteroscopy step.
Response to Arguments
Applicant's arguments filed 8/18/2025 have been fully considered but they are not persuasive.
Applicant’s argument is not persuasive. Claim 1 was previously rejected in view of only Hathorn while claim 15 was rejected in view of Rentschler. Applicant incorporated the previously rejected subject matter of claim 15 by Rentschler into claim 1 then provided arguments to that amended subject matter only toward Hathorn. Hathorn was never relied upon for the rejection of claim 15 subject matter. Applicant’s arguments should be directed toward the relied upon reference, i.e. Rentschler. Since no argument has been provided against the actual prior art used to reject the subject matter, applicant’s arguments amounts to piecemeal analysis of references:
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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 JAE K WOO whose telephone number is (571)272-0837. The examiner can normally be reached M-F 8:30-2:30p, 6p-9p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at (571) 272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jae Woo/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
9/22/25