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 .
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 newly recites the word “interative” which is not a word. It is interpreted as “iterative”.
Appropriate correction is required.
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);
iteratively advancing the endoscope (0040 describes advancing the endoscope forward); and
iteratively 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 describes adjusting the straps during the procedure, which involves advancing the endoscope and therefore “iteratively” adjusting)”.
Hathorn does disclose enteroscopy procedures (0005) but does not explicitly disclose the method specifically as an antegrade enteroscopy procedure, i.e.:
“during an antegrade enteroscopy procedure”
“in connection with the antegrade enteroscopy procedure that includes at least one of an antegrade balloon enteroscopy or an antegrade spiral enteroscopy;
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;”
iteratively advancing the endoscope “through the mouth of the patient with iterative inflation and deflation of at least one balloon or rotation of an overtube at the endoscope
in correlation with the iterative inflation or deflation of the at least one balloon or rotation of the overtube at the endoscope, wherein iterative adjustment of the at least one of the primary wrap or the at least one secondary wrap
support the advancement or the withdrawal of the endoscope during the antegrade enteroscopy procedure”.
Rentschler teaches in the same field of endeavor, a balloon 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 double-balloon enteroscopy was introduced as a method of exploring a larger part of the small bowel in either antegrade or retrograde approach). 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 since the tensioning advantage is provided based on the anatomy and not the entry orifice.
For claim 2, modified Hathorn discloses “The method of claim 1, wherein the antegrade enteroscopy procedure comprises at least one of: a single balloon enteroscopy, a double balloon enteroscopy, or an examination of a small bowel (Rentschler: 0158 double-balloon enteroscopy was introduced as a method of exploring a larger part of the small bowel in either antegrade or retrograde approach)”.
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 iteratively 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 iteratively 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 the iterative inflation or deflation of at least one balloon at the endoscope (Rentschler: 0158 double-balloon enteroscopy was introduced as a method of exploring a larger part of the small bowel in either antegrade or retrograde approach)”.
For claim 9, Hathorn discloses “The method of claim 1, wherein the endoscope comprises an enteroscope, and the iteratively 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 iteratively 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 iteratively 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 iteratively 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 iteratively 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 the 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 antegrade enteroscopy procedure comprises a spiral enteroscopy, and the iteratively 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 antegrade enteroscopy procedure comprises a spiral enteroscopy, and the iteratively 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 3/23/2026 have been fully considered but they are not persuasive.
Rentschler has been proven to disclose a double balloon enteroscopy procedure, both retro and antegrade as shown above along with the requisite motivation. Additionally, Hathorn discloses advancing the endoscope and adjusting the straps during the procedure. This is considered “iterative”.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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/Jae Woo/Examiner, Art Unit 3795
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
09/28/26
