DETAILED ACTION
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 .
Drawings
The drawings were received on 8 July 2025. These drawings are acceptable.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
Claim(s) 1-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toyama.
Regarding Claim 1, Toyama discloses a fecal diversion apparatus for a patient having a terminal ileum and ileocecal junction ([0015]-[0016]), the apparatus comprising:
an inflatable balloon ("balloon 33A"; [0125]; FIG. 15);
a fluid tube ("balloon pipeline 52"; [0126]; FIG. 19) connected to and in fluid communication with the balloon ([0126]; FIG. 16),
wherein the fluid tube is connected to the balloon at a distal end of the fluid tube ("disposed in the insertion-axis direction in the tube body 31"; [0127]; FIG. 19), and
wherein a proximal end of the fluid tube comprises a fluid port ("base 53"; [0127]; FIG. 15) configured to permit a fluid to flow into and out of the balloon via the fluid tube ([0128]); and
a fenestrated tube ("suction pipeline 36"; [0048]; FIGs. 16-18) alongside the fluid tube ("balloon pipeline 52 provided as a pipeline independent of the above suction pipeline 36"; [0126]; FIGs. 16-18), wherein a proximal end of the fenestrated tube comprises an egress port ("suction base 35"; [0048]; FIG. 15) configured to permit egress of gastrointestinal (GI) material via the fenestrated tube ([0048]-[0052]; FIG. 1),
further wherein the fenestrated tube comprises a plurality of longitudinally spaced apart ileal openings ("suction opening portion 37" [0079]; FIG. 13) along a fenestrated segment (see FIG. 13) configured to allow ingress of GI material in the terminal ileum into the fenestrated tube between a point of insertion into the terminal ileum and the ileocecal junction ("suctioning of fluid" [0081]); wherein the balloon is configured to be inflated and deflated through the fluid port ([0128]-[0129]).
Toyama fails to specify the balloon when inflated and pulled back, to occlude the ileocecal junction. However, Toyama discloses that the device may be inserted into various lumens of a patient, including the intestine ([0006]-[0011]). Furthermore, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this case, there is no structural difference between the claimed invention and Toyama’s device and Toyama’s device is capable of performing the intended steps of occluding the ileocecal junction when inflated and pulled back. Therefore, Toyama’s device meets the claim.
Regarding Claim 2, Toyama fails to specify the fenestrated segment is configured to be upstream from and proximal to the balloon located within the last 15-20cm of the terminal ileum after which the fenestrated tube exits the ileum through an enterostomy and an anterior abdominal wall to the exterior of the patient. However, Toyama discloses that the device may be inserted into various lumens of a patient, including the intestine ([0006]-[0011]). Furthermore, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this case, there is no structural difference between the claimed invention and Toyama’s device and Toyama’s device is capable of performing the intended steps of occluding an ileocecal junction of a patient and wherein the fenestrated tube is upstream from and proximal to the balloon located within the last 15-20cm of a terminal ileum after which the fenestrated tube exits the ileum through an enterostomy and an anterior abdominal wall to the exterior of the patient. Therefore, Toyama’s device meets the claim.
Regarding Claim 3, Toyama discloses the fluid port and egress port are configured to be located external to the patient ([0044]-[0048]; FIGs. 1-9).
Regarding Claim 4, Toyama discloses the egress port is configured to receive suction to extract GI material ([0048]-[0052]; FIG. 1).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toyama in view of Dono (US 20020173771 A1).
Regarding Claim 5, Toyama discloses A method of using a fecal diversion tube apparatus ([0015]-[0016]) in a patient ([0011]) having an abdominal wall, a terminal ileum, an ileocecal valve, and an ileocecal junction (inherent features of a human patient; FIG. ), the method comprising: providing a fecal diversion apparatus (see Abstract), the apparatus having:
an inflatable balloon ("balloon 33A"; [0125]; FIG. 15);
a fluid tube ("balloon pipeline 52"; [0126]; FIG. 19) connected to and in fluid communication with the balloon ([0126]; FIG. 16),
wherein the fluid tube is connected to the balloon at a distal end of the fluid tube ("disposed in the insertion-axis direction in the tube body 31"; [0127]; FIG. 19), and
wherein a proximal end of the fluid tube comprises a fluid port ("base 53"; [0127]; FIG. 15)configured to permit a fluid to flow into and out of the balloon via the fluid tube ([0128]); and
a fenestrated tube ("suction pipeline 36"; [0048]; FIGs. 16-18) alongside the fluid tube ("balloon pipeline 52 provided as a pipeline independent of the above suction pipeline 36"; [0126]; FIGs. 16-18), wherein a proximal end of the fenestrated tube comprises an egress port ("suction base 35"; [0048]; FIG. 15) configured to permit egress of gastrointestinal (GI) material via the fenestrated tube ([0048]-[0052]; FIG. 1), and,
at a distal end there is a fenestrated segment (see FIG. 13) comprising a plurality of longitudinally spaced apart ileal openings ("suction opening portion 37" [0079]; FIG. 13); and
connecting the egress port 35 to suction ("connected to the suctioning device 4" [0049]) to cause ingress of gastrointestinal (GI) material in the terminal ileum into the fenestrated tube ("suctioned fluid is mainly a fluid in the intestine 101" [0076]).
Toyama fails to specify inserting and advancing the apparatus through an insertion point in the terminal ileum until the balloon is through the ileocecal valve and the fenestrated segment is disposed within the terminal ileum between the insertion point and the ileocecal junction; inflating the balloon by flowing fluid into the fluid port; and pulling back on the tubes to cause the balloon to occlude the ileocecal junction. However, Dono teaches a method of using a device for removing waste from the small intestine (see Abstract) comprising inserting and advancing the apparatus through an insertion point in the terminal ileum until the balloon is through the ileocecal valve and the fenestrated segment is disposed within the terminal ileum between the insertion point and the ileocecal junction ([0034]); inflating the balloon by flowing fluid into the fluid port ([0035]); pulling back on the tubes to cause the balloon to occlude the ileocecal junction ([0035]). Therefore, Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Toyama to incorporate the teachings of Dono to suitably repair the colon ([0011]).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toyama in view of Dono and Johansson et al. (US 20060052759 A1).
Regarding Claim 7, Johansson teaches a method of continent ileostomy ([0006]) comprising securing a purse string suture around the insertion point ([0017]) and tacking the terminal ileum to the abdominal wall at the insertion point ([0006]-[0008]). Therefore, it would be obvious to modify the method of Toyama/Dono to suitably perform an ileostomy and treat the target disease ([0004]-[0005]).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toyama in view of Dono and Vazales et al. (US 20190336714 A1).
Regarding Claim 7, Vazales teaches “a pediatric and neonatal-sized airway management, or maintenance, system” ([0052]; FIG. 1) comprising a closed suction cleaning device module 12 and a manifold 13 ([0053]) further comprising a step of periodically flushing the egress port with saline ([0058] & [0075]). Therefore, it would be obvious to modify the method of Toyama/Dono to suitably clean the device before being disconnected ([0075]).
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 Cheng Fong "Ted" Yang whose telephone number is (571)272-8846. The examiner can normally be reached 10am - 6pm (EST) M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca E. Eisenberg can be reached on (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781
Cheng Fong "Ted" Yang
Examiner
Art Unit 3781