DETAILED CORRESPONDENCE
Note: This office action is in response to communication filed on 08/28/2025.
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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/28/2025 has been entered.
Status of Claims
Claims 1, 3-11, and 15-21 are pending in the application.
Claims 1, 3-11, and 15-21 are examined on the merits.
Response to Arguments
Applicant’s arguments filed on 08/28/2025 have been fully considered but are moot because the independent claim(s) has/have been amended and the new ground of rejection does not rely on the same combination references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 1, 3-11, and 15-21 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites the limitation “subsequently terminate the fecal removal cycle based on sensor data indicating a condition within the patient rectum” which was not described in the specification. There is no mention in the specification of terminating the fecal removal cycle based on sensor data indicating a condition within the patient rectum. Instead, the specification only discloses when the vacuum source exceeds a pre-determined threshold, the pump may be programmed to shut off temporarily and or reset to the programmed parameters (¶0214).
Claim(s) 3-11 and 15-21 is/are rejected as being dependent from claim 1 and therefor including all the limitation thereof.
Claim Rejections - 35 USC § 103
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 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 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, 3-9, 11, 15, and 21 is/are rejected under 35 U.S.C 103 as being unpatentable over Hassidov (US PGPUB 20160206805) in view of Shelton (US PGPUB 20200187768).
Regarding claim 1, Hassidov discloses a system configured for removal of fecal material from a patient's rectum (a colon cleaning system for cleaning a colon or other portion of an intestine to remove fecal material from the body: Abstract), wherein the system comprising:
a receptacle (a tip 14: ¶0117 and Fig. 7A),
a connecting tube (an insertion tube 13: ¶0219 and Fig. 7A) comprising at least a suction conduit (a suction channel 15A or 15B: ¶0220 and Fig. 7A), the connecting tube configured to couple the suction conduit to a suction port of the receptacle (¶0220 and Fig. 7A),
one or more sensors in communication with the receptacle (sensors 204 near/at the receptacle 14: ¶0125, 0133-0138, and Figs. 2A-D); and
a controller (a controller 213: ¶0125 and Figs. 2A-D), wherein the controller is configured to:
commence a fecal removal cycle by initiating application of suction through the suction port (step 1010: ¶0206 and Fig. 6); and
subsequently terminate the fecal removal cycle based on sensor data indicating a condition within the patient rectum (¶0100, 0130 and 0137), wherein termination of the fecal removal cycle comprises turning off operation of the source of negative pressure (¶0129-0130, 0137, and 0211);
wherein the suction conduit is couplable to a stool collection chamber to enable the stool collection chamber to receive fecal material from the suction conduit (the suction channel 15A/15B is couplable to a container 8: ¶0120 and Fig. 7A).
Hassidov does not disclose the controller is configured to control a source of negative pressure to deliver between 15 mmHg and 500 mmHg of suction through the suction port.
In an analogous art for being directed to solve the same problem, providing a safety negative pressure range of the anatomical environment during procedure, Shelton discloses systems and methods or in situ unclogging of a working channel of an endoscope (Abstract, ¶0007, and Fig. 1). Shelton further discloses/suggests a desired negative pressure for the anatomical environment is 34.5 kPa (34.5 kPa = 258.8 mmHg; thus, the taught negative pressure is within the claimed negative pressure range) for the benefit of keeping the pressure the anatomical environment within a safety range (¶0104).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of Hassidov in view of Shelton by having pressure through the suction port between 15 mmHg and 500 mmHg of suction, in order to keep the negative pressure the anatomical environment within a safety range, as suggested in ¶0104 of Shelton and as it has been held that a prima facie case of obviousness exists when the claimed ranges overlap with ranges disclosed by the prior art. See MPEP § 2144.05 (I). In addition, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the system of Hassidov to have suction through the suction port between 15 mmHg and 500 mmHg, motivated by the desires to optimize the cleaning abilities of the device to achieve the most efficient fecal removal cycle and as it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation (See MPEP § 2144.05 (II) (A & B)).
Regarding claim 3, Hassidov in view of Shelton discloses all the limitations as discussed above for claim 1.
Hassidov further discloses the controller is configured to determine parameters of a fecal removal cycle (¶0129) using pressure sensor data from one or more pressure sensors (pressure sensor 204: ¶0129).
Regarding claim 21, Hassidov in view of Shelton discloses all the limitations as discussed above for claim 1.
Hassidov further discloses the connecting tube (13) comprises an irrigation conduit (an irrigation pipe 201: ¶0126) and wherein the connecting tube is configured to couple the irrigation conduit to an irrigation outlet of the receptacle (¶0004), and wherein the controller is configured such that applying the one or more fecal removal cycles includes applying irrigation from the irrigation outlet to deliver irrigation fluid (¶0207-0209 and Fig. 6).
Hassidov/Shelton does not disclose delivering the irrigation fluid between 1 ml and 1000 ml.
It appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the system of Hassidov to deliver the irrigation fluid between 1 ml and 1000 ml, as it involves only adjusting the volume of irrigation fluid.
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have further modified the system of Hassidov by delivering the irrigation fluid between 1 ml and 1000 ml, motivated by the desires to optimize the cleaning abilities of the device to achieve the most efficient fecal removal cycle and as it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation (See MPEP § 2144.05 (II) (A & B)).
Regarding claim 4, Hassidov in view of Shelton discloses all the limitations as discussed above for claim 21.
Hassidov further discloses the controller is configured to alternate the application of suction and irrigation during each fecal removal cycle (¶0204-0213 and Fig. 6).
Regarding claim 5, Hassidov in view of Shelton discloses all the limitations as discussed above for claim 21.
Hassidov further discloses the controller is configured to apply a stream of irrigation fluid from the irrigation outlet of the receptacle ¶0204-0213 and Fig. 6).
Regarding claim 6, Hassidov in view of Shelton discloses all the limitations as discussed above for claim 21.
Hassidov further discloses the controller is configured to finish each fecal removal cycle by applying irrigation (¶0208-0209 and Fig. 6).
Regarding claim 7, Hassidov in view of Shelton discloses all the limitations as discussed above for claim 1.
Hassidov further discloses the controller is configured to automatically trigger the application of the one or more fecal removal cycles (¶0204-0213).
Regarding claim 8, Hassidov in view of Shelton discloses all the limitations as discussed above for claim 1.
Hassidov further discloses the controller is configured to automatically trigger the application of the one or more fecal removal cycles based on sensor data received from one or more sensors (¶0204-0213).
Regarding claim 9, Hassidov in view of Shelton discloses all the limitations as discussed above for claim 1.
Hassidov further discloses the connecting tube (13) further comprises an air channel (an irrigation/air pipe 201 for irrigation: ¶0093-0094 and 0126) configured to couple to an air outlet of the receptacle (¶0004 and Fig. 6).
Regarding claim 11, Hassidov in view of Shelton discloses all the limitations as discussed above for claim 1.
Hassidov further discloses a vacuum pump providing the source of negative pressure (a vacuum pump 214: ¶0125 and 0206).
Regarding claim 15, Hassidov in view of Shelton discloses all the limitations as discussed above for claim 21.
Hassidov further discloses discloses the connecting tube (13) further comprises an air channel (an irrigation/air pipe 201 for irrigation: ¶0093-0094 and 0126) configured to couple to an air outlet of the receptacle (¶0004 and Fig. 6); and wherein the controller is configured such that applying the one or more fecal removal cycles includes applying air from the air outlet (¶0204-0213).
Claim(s) 10 is/are rejected under 35 U.S.C 103 as being unpatentable over Hassidov (US PGPUB 20160206805) in view of Shelton (US PGPUB 20200187768), as applied to claim 9 above, and further in view of Vining (US PGPUB 20100268154).
Regarding claim 10, Hassidov in view of Shelton discloses all the limitations as discussed above for claim 9.
Hassidov/Shelton does not disclose the controller is configured to apply air through the air outlet when the controller detects a vacuum lock.
In the same field of endeavor, system for removal of fecal material from a patient's rectum, Vining discloses a system for removal of fecal material from a patient's rectum (an apparatus 10: Abstract and ¶0020) comprising a connecting tube (a catheter 30 comprising multiple lumens 40, 70, or 82: ¶0020 and Fig. 2) comprising a suction conduit (a conduit connected to a valve 86: ¶0020, 0023, and Fig. 2), and a controller (a processor 90: ¶0023 and Fig. 2), wherein the controller is configured to apply one or more fecal removal cycles (¶0023-0028). Vining further discloses the controller is configured to apply air through the air outlet when the controller detects a vacuum lock (the processor 90 may control the gas insufflator 120 and the patient may be insufflated with gas, such as carbon dioxide, from the gas insufflator 120 at the same time as waste is suctioned by the vacuum 80; This simultaneous action may counter the formation of a "vacuum lock”: ¶0047-0048).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have further modified the system of Hassidov in view of Vining by having the controller configured to apply air through the air outlet when the controller detects a vacuum lock, in order to hinder the patient's rectum from collapsing, as suggested in ¶0048 of Vining.
Claim(s) 16-20 is/are rejected under 35 U.S.C 103 as being unpatentable over Vining (US PGPUB 20100268154 – of record) in view of Shelton (US PGPUB 20200187768 – of record), Burnett et al. (US PGPUB 20190343445 – of record), and Kazuhiko (JP 08117329 with English machine translation - attached).
Regarding claim 16, Vining discloses system for removal of fecal material from a patient's rectum (an apparatus 10: Abstract and ¶0020), the system comprising:
a receptacle (a retention balloon 32: ¶0021 and Fig. 2) configured for insertion into the patient's anal canal (¶0020: through the patient's anus and into the rectum);
a connecting tube (a catheter 30 comprising multiple lumens 40, 70, or 82: ¶0020 and Fig. 2) comprising a suction conduit (a conduit connected to a valve 86: ¶0020, 0023, and Fig. 2) and an irrigation channel (a conduit/channel connected to a valve 86: ¶0020, 0023, and Fig. 2), the connecting tube configured to couple the suction conduit to a suction port of the receptacle and the irrigation channel to an irrigation outlet of the receptacle (¶0023, 0030, and Fig. 2);
a canister housing 14 (¶0020 and Fig. 2);
a fluid pump (a roller pump: ¶0027) within the canister housing configured to couple to an irrigation fluid reservoir ("delivery mechanism 50 may utilize a roller pump that squeezes flexible plastic tubing connected to the enema container": ¶0027);
a suction pump (a vacuum 80: ¶0023 and Fig. 2) within the canister housing 14 (Fig. 2);
a controller (a processor 90: ¶0023 and Fig. 2) configured to apply one or more fecal removal cycles (¶0023-0028) including applying suction through the suction port by controlling a source of negative pressure to deliver suction (a vacuum 80: ¶0030 and Fig. 2) and applying irrigation from the irrigation outlet by controlling the fluid pump (the processor 90 controls operation of the delivery mechanism 50: ¶0028) to deliver between 1 ml and 1000 ml of irrigation fluid (¶0037);
Vining does not disclose controlling the suction pump to deliver between 15 mmHg and 500 mmHg of suction.
In an analogous art for being directed to solve the same problem, providing a safety negative pressure range of the anatomical environment during procedure, Shelton discloses systems and methods or in situ unclogging of a working channel of an endoscope (Abstract, ¶0007, and Fig. 1). Shelton further discloses/suggests a desired negative pressure for the anatomical environment is 34.5 kPa (34.5 kPa = 258.8 mmHg; thus, the taught negative pressure is within the claimed negative pressure range) for the benefit of keeping the pressure the anatomical environment within a safety range (¶0104).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of Vining in view of Shelton by selecting the source of negative pressure between 15 mmHg and 500 mmHg of suction, in order to keep the negative pressure the anatomical environment within a safety range, as suggested in ¶0104 of Shelton and as it has been held that a prima facie case of obviousness exists when the claimed ranges overlap with ranges disclosed by the prior art. See MPEP § 2144.05 (I).
Vining/Shelton does not disclose the canister housing enclosing an intermediate stool collection chamber having rigid walls and a stool collection bag coupled to the canister housing and a valve between the stool collection bag and the intermediate stool collection chamber.
In the same field of endeavor, a medical device capable of sensing data based on sensors incorporated into a catheter adapted to reside in rectal location, Burnett discloses an intermediate stool collection chamber (a reservoir or cassette 1022: ¶0156 and Fig. 10A) having rigid walls (Fig. 10A; wherein rigidity is an inherent physical property of all materials); a stool collection bag (a drainage bag 1020: ¶0169 and Fig. 10A) coupled to the canister housing (Fig. 10A); and a valve (one way valves 1136: ¶0169 and Fig. 10A) between the stool collection bag 1020 and the intermediate stool collection chamber 1022 (Fig. 10A) for the benefit of controlling or eliminating airlocks (¶0155-0159).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of Vining and Shelton in view of Burnett by incorporating an intermediate stool collection chamber, a stool collection bag coupled to the canister housing, and a valve between the stool collection bag and the intermediate stool collection chamber, in order to control or eliminate airlocks, as suggested in ¶0155-0159 of Burnett.
Vining/Shelton/Burnett does not disclose the valve is configured to prevent backflow from the stool collection bag to the intermediate stool collection chamber, the valve prevents backflow from the stool collection bag to the intermediate stool collection chamber when suction is applied from the suction port of the receptable, and the valve is configured to be opened when suction is not being applied from the suction port of the receptacle, so that collected fecal material may be transferred from the intermediate stool collection chamber to the stool collection bag.
In the same field of endeavor, system/device for removing feces through an anus, Kazuhiko discloses an insertion tool 1 to be inserted into the anus, an irrigation pump 4, an irrigation chamber 6, a suction pipe 7, a suction pump 10, and a storage container 11 (¶0014-0015 and Fig. 1). Kazuhiko further discloses a safety valve 9 provided in the suction pipe 7 between the insertion tool 1 and the suction pump 10, wherein the valve is configured to prevents backflow and configured to be opened when suction is not being applied (¶0015) for the benefit of preventing intestinal damage due to excessive suction (¶0015).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have further modified the system of Vining in view of Kazuhiko by substituting the valve with a safety valve configured to prevent backflow from the stool collection bag to the intermediate stool collection chamber when suction is applied from the suction port of the receptable and configured to be opened when suction is not being applied from the suction port of the receptacle, in order to prevent intestinal damage due to excessive suction, as suggested in ¶0015 of Kazuhiko.
Regarding claim 17, Vining in view of Shelton, Burnett, and Kazuhiko discloses all the limitations as discussed above for claim 16.
Vining further discloses the controller 90 is configured to apply a stream of irrigation fluid from the irrigation outlet of the receptacle (the processor 90 controls the delivery mechanism 90 and "delivery mechanism 50 may propel the enema 200 through the catheter 30 into the patient": ¶0040).
Regarding claim 18, Vining in view of Shelton, Burnett, and Kazuhiko discloses all the limitations as discussed above for claim 16.
Vining further discloses the controller 90 is configured to finish each fecal removal cycle by applying irrigation ("vacuum 80 may be activated to remove waste from a patient and then deactivated so that the delivery mechanism 50 may resume administration of the enema 200 to the patient": ¶0046).
Regarding claim 19, Vining in view of Shelton, Burnett, and Kazuhiko discloses all the limitations as discussed above for claim 16.
Vining further discloses the connecting tube further comprises an air channel (a release valve 38: ¶0022) configured to couple to an air outlet of the receptacle (¶0022).
Regarding claim 20, Vining in view of Shelton, Burnett, and Kazuhiko discloses all the limitations as discussed above for claim 19.
Vining further discloses the controller is configured to apply air through the air outlet ("patient may be insufflated with gas, such as carbon dioxide, from the gas insufflator 120 at the same time as waste is suctioned by the vacuum 80": ¶0048) when the controller detects a vacuum lock (¶0048).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NHU Q TRAN whose telephone number is (571)272-2032. The examiner can normally be reached Monday-Thursday 8:00-5:00 (PST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, SARAH AL-HASHIMI can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NHU Q. TRAN/Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781
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