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 allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). 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, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 04/29/2026 has been entered.
Response to Arguments
There are apparently no remarks/arguments filed with the RCE submitted 04/29/2026 – only the IDS submitted 04/29/2026. It should however be noted the previously relied upon prior art of Fong et al. (U.S. Patent Application Publication 2017/0071780) in view of Weidenhagen et al. (U.S. Patent Application Publication 2004/0093026) do not make obvious the claimed invention with respect to the recited “the expandable sealing mechanism comprises a low-profile balloon.”
However, in view of the newly found and cited prior art, Edwards et al. (U.S. Patent 6,325,798), along with the previous prior art the claimed invention including “the expandable sealing mechanism comprises a low-profile balloon” is made obvious as shown in the rejections below.
Election/Restrictions
Due to the newly found and recited pieces of prior art there are no allowable and/or objected to claims and accordingly claims 36-37 and claims 66-67 are hereby withdrawn in a consistent manner with respect to initial election of species filed 07/03/2025 and the subsequent election filed 08/29/2025.
Due the RCE, this action is made non-final.
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 (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.
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 31 and the claims dependent on claim 31:
Claims 31-33, 35, 39-41, 44 are rejected under 35 U.S.C. 103 as being unpatentable over Fong et al. (U.S. Patent Application Publication 2017/0071780) in view of Weidenhagen et al. (U.S. Patent Application Publication 2004/0093026) in view of Edwards et al. (U.S. Patent 6,325,798).
Regarding claim 31, Fong et al. disclose a system comprising:
an electrically powered pump ("electric pump mechanism", see [0144]) comprising:
at least one pressure tube ("pressure tube 112", see [0144] and figure for example, and alternate/equivalent counterparts in other embodiments),
it should be noted the recitation that the at least one pressure tube is configured to connect to the sleeve of the anchoring device to thereby provide negative pressure to the sleeve of the anchoring device to create a frictional force that resists displacement of the sleeve of the anchoring device from the tissue cavity is a recitation of 1) intended use, 2) functional limitation, or 3) language directed to the manner in which an apparatus is intended to be employed. Please see the comments below regarding these recitations; and
a negative pressure indicator ("pressure gauge can be an indicator that demonstrates that sealing is maintained as suction force", see [0144]),
it should be noted the recitation that the negative pressure indicator is configured to detect when the negative pressure provided to the sleeve of the anchoring device drops below a pre-determined threshold value is a recitation of 1) intended use, 2) functional limitation, or 3) language directed to the manner in which an apparatus is intended to be employed. Please see the comments below regarding these recitations,
wherein the electrically powered negative pressure pump is configured to provide a continuous negative pressure to the sleeve of the anchoring device in a range of from -50 mmHg to -150 mmHg (see [0018], [0057]-[0058], [0086], [0087], and [0115] for example).
Fong et al. fail to recite a collection canister configured to collect fluid from an area around the tissue cavity in which the anchoring device is anchored.
Fong et al. also fail to recite the expandable sealing mechanism comprises a low-profile balloon.
Like Fong et al., Weidenhagen et al. disclose a system with an elongate device, a pump ("pump" 20, see abstract and figure 1) for suctioning (i.e., providing negative pressure) that is used in the intestine (large and small) and teach providing the system with a "collection canister 24 is provided between the negative pressure source 20 and the pressure distributor 40 for collecting any effluents", see abstract and figures 1-2.
Like Fong et al. (and Weidenhagen et al.), Edwards et al. disclose an elongate tubular element used in the gastrointestinal tract and expandable sealing mechanisms disposed on the tubular element and spaced apart by an roughened or uneven tubular surface and teach providing the expandable sealing mechanisms in the form of low-profile balloons (see a) balloons 246 and 248 figure 67, and/or b) balloons 290 and 300 figure 70) in order to provide a seal for the desired tract region.
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Fong et al., as taught by Weidenhagen et al., to provide the system with a "collection canister 24 is provided between the negative pressure source 20 and the pressure distributor 40 for collecting any effluents," and as further taught by Edwards et al., to provide the system with the expandable sealing mechanisms in the form of low-profile balloons in order to provide a seal for the desired tract region.
Regarding recitations of 1) intended use, 2) functional limitation, or 3) language directed to the manner in which an apparatus is intended to be employed the following should be noted. A recitation of intended use of the claimed invention must be evaluated to determine whether the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim. However, if a prior art structure is capable of performing the intended use as recited in the preamble, then it meets the claim. It is well established that a recitation with respect to the manner in which an apparatus is intended to be employed, i.e., a functional limitation, does not impose any structural limitation upon the claimed apparatus which differentiates it from a prior art reference disclosing the structural limitations of the claim. In re Pearson, 494 F.2d 1399, 181 USPQ 641 (CCPA 1974); In re Casey, 370 F.2d 576, 152 USPQ 235 (CCPA 1967); In re Otto, 312 F.2d 937, 136 USPQ 458 (CCPA 1963). Where the prior art reference is inherently capable of performing the function described in a functional limitation, such functional limitation does not define the claimed apparatus over such prior art reference, regardless of whether the prior art reference explicitly discusses such capacity for performing the recited function. In re Ludtke, 441 F.2d 660, 169 USPQ 563 (CCPA 1971 ). In addition, where there is reason to believe that such functional limitation may be an inherent characteristic of the prior art reference, Applicant is required to prove that the subject matter shown in the prior art reference does not possess the characteristic relied upon. In re Spada, 911 F.2d 705, 15 USPQ2d 1655 (Fed. Cir. 1990); In re King, 801 F.2d 1324, 1327, 231 USPQ 136, 138 (Fed. Cir. 1986); In re Ludtke, 441 F.2d at 664, 169 USPQ at 566 (CCPA 1971). A recitation with respect to the manner in which an apparatus is intended to be employed does not impose any structural limitation upon the claimed apparatus which differentiates it from a prior art reference disclosing the structural limitations of the claim. In re Pearson, 494 F.2d 1399, 181 USPQ 641 (CCPA 1974); In re Yanush, 477 F.2d 958, 177 USPQ 705 (CCPA 1973); In re Finsterwalder, 436 F.2d 1028, 168 USPQ 530 (CCPA 1971); In re Casey, 370 F.2d 576, 152 USPQ 235 (CCPA 1967); In re Otto, 312 F.2d 937, 136 USPQ 458 (CCPA 1963); Ex parte Masham, 2 USPQ2d 1647 (BdPatApp & Inter 1987).
Regarding claim 32, Fong et al. disclose the claimed invention. Claim 32 is a recitation
of 1) intended use, 2) functional limitation, or 3) language directed to the manner in
which an apparatus is intended to be employed and has been treated accordingly as noted
in the rejection to claim 31 above.
Regarding claim 33, Fong et al. disclose the claimed invention including a controller
configured to maintain the continuous negative pressure to the sleeve of the
anchoring device. This corresponds to the portion of the pump responsible for providing
"constant negative pressure at a level of pressure that allows for adequate anchoring so
that the sleeve does not become dislodged, but does not harm the bowel", see [0135].
Regarding claim 35, Fong et al. disclose the claimed invention since the pressure gauge
indicates pressure below -70 mmHg.
Regarding claims 39-40, Fong et al. in view of Weidenhagen et al. disclose or make
obvious the claimed invention including the collection canister comprises a housing
(housing denoted by the boundary lines of element 24 in figure 1 of Weidenhagen et al.)
and the inlet of the housing (the inlet/opening coupled line 22 in figure 1 of
Weidenhagen et al.).
Regarding claim 41, Fong et al. disclose the claimed housing (the exterior surface of the
pump which is "an electric pump mechanism", see [0144]).
Regarding claim 44, Fong et al. disclose the claimed invention. Claim 44 is a recitation
of 1) intended use, 2) functional limitation, or 3) language directed to the manner in
which an apparatus is intended to be employed and has been treated accordingly as noted
in the rejection to claim 31 above.
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Fong et al. (U.S. Patent Application Publication 2017/0071780) in view of Weidenhagen et al. (U.S. Patent Application Publication 2004/0093026) in view of Edwards et al. (U.S. Patent 6,325,798) as applied to claim 31 above, and further in view of Switzer (WO 2020/087129).
Regarding claim 34, Fong et al. in view of Weidenhagen et al. in view of Edwards et al. show the invention above,
but fail to explicitly recite (or make obvious) a leak alarm.
Like Fong et al. and Weidenhagen et al., Switzer discloses a system with an elongate device for suctioning that is used in the intestine and teach providing an "output sensor signals to actuator controller 325, such as a "low pressure" or "no pressure" signal, to indicate a fault, such as a fluid leak", (see [0196]) in order to provide a known and workable manner in warning of a leak.
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Fong et al. in view of Weidenhagen et al. in view of Edwards et al., as taught by Switzer, to provide an "output sensor signals to actuator controller 325, such as a "low pressure" or "no pressure" signal, to indicate a fault, such as a fluid leak" in order to provide a known and workable manner in warning of a leak of a suctioning system used in the intestines.
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Fong et al. (U.S. Patent Application Publication 2017/0071780) in view of Weidenhagen et al. (U.S. Patent Application Publication 2004/0093026) in view of Edwards et al. (U.S. Patent 6,325,798) as applied to claim 31 above, and further in view of Ueda (CN 103120578).
Regarding claim 38, Fong et al. in view of Weidenhagen et al. in view of Edwards et al. show the invention above,
but fail to explicitly recite the negative pressure indicator comprises a display screen.
Like Fong et al. and Weidenhagen et al. and Edwards et al., Ueda discloses a system with an elongate device for suctioning that is used in the intestine and teach providing the system with a display panel 64 on which to display pressure levels (see [0057]) as a known and workable manner of providing pressure information feedback regarding the suctioning procedure in the intestines.
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Fong et al. in view of Weidenhagen et al. in view of Edwards et al., as taught by Ueda, to provide the system with a display panel 64 on which to display pressure levels as a known and workable manner of providing pressure information feedback regarding the suctioning procedure in the intestines.
Claim 43 is rejected under 35 U.S.C. 103 as being unpatentable over Fong et al. (U.S. Patent Application Publication 2017/0071780) in view of Weidenhagen et al. (U.S. Patent Application Publication 2004/0093026) in view of Edwards et al. (U.S. Patent 6,325,798) as applied to claim 31 above, and further in view of Rhee et al. (U.S. Patent Application Publication 2014/0005668).
Regarding claim 43, Fong et al. in view of Weidenhagen et al. in view of Edwards et al. show the invention above,
but fail to explicitly recite the electrically powered negative pressure pump includes a long-lasting battery.
Like Fong et al. and Weidenhagen et al. and Edwards et al., Rhee et al. disclose a system with an elongate device and a pump used to treat the gastrointestinal tract and teach providing the system with a battery 437 and “a step-down regulator (e.g., LT3502 by Linear Technologies) may be employed by the power save circuit to reduce the supply voltage of the rail-to-rail amplifiers and thus extend the life of the battery 437,” thus providing a long-lasting battery (see [0146]).
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Fong et al. in view of Weidenhagen et al. in view of Edwards et al., as taught by Rhee et al., to provide the system with a battery and “a step-down regulator (e.g., LT3502 by Linear Technologies) may be employed by the power save circuit to reduce the supply voltage of the rail-to-rail amplifiers and thus extend the life of the battery 437,” thus providing a long-lasting battery.
Claim 61 and the claims dependent on claim 61:
Claims 61-63, 65, 69-71, and 73 are rejected under 35 U.S.C. 103 as being unpatentable over Fong et al. (U.S. Patent Application Publication 2017/0071780) in view of Weidenhagen et al. (U.S. Patent Application Publication 2004/0093026) in view of Rhee et al. (U.S. Patent Application Publication 2014/0005668).
Regarding claim 61, Fong et al. disclose a system comprising:
an electrically powered pump ("electric pump mechanism", see [0144]) comprising:
at least one pressure tube ("pressure tube 112", see [0144] and figure for example, and alternate/equivalent counterparts in other embodiments),
it should be noted the recitation that the at least one pressure tube is configured to connect to the sleeve of the anchoring device to thereby provide negative pressure to the sleeve of the anchoring device to create a frictional force that resists displacement of the sleeve of the anchoring device from the tissue cavity is a recitation of 1) intended use, 2) functional limitation, or 3) language directed to the manner in which an apparatus is intended to be employed. Please see the comments below regarding these recitations; and
a negative pressure indicator ("pressure gauge can be an indicator that demonstrates that sealing is maintained as suction force", see [0144]),
it should be noted the recitation that the negative pressure indicator is configured to detect when the negative pressure provided to the sleeve of the anchoring device drops below a pre-determined threshold value is a recitation of 1) intended use, 2) functional limitation, or 3) language directed to the manner in which an apparatus is intended to be employed. Please see the comments below regarding these recitations,
wherein the electrically powered negative pressure pump is configured to provide a continuous negative pressure to the sleeve of the anchoring device in a range of from -50 mmHg to -150 mmHg (see [0018], [0057]-[0058], [0086], [0087], and [0115] for example).
Fong et al. fail to recite a collection canister configured to collect fluid from an area around the tissue cavity in which the anchoring device is anchored.
Fong et al. also fail to recite a long-lasting battery.
Like Fong et al., Weidenhagen et al. disclose a system with an elongate device, a pump ("pump" 20, see abstract and figure 1) for suctioning (i.e., providing negative pressure) that is used in the intestine (large and small) and teach providing the system with a "collection canister 24 is provided between the negative pressure source 20 and the pressure distributor 40 for collecting any effluents", see abstract and figures 1-2.
Like Fong et al. (and Weidenhagen et al.), Rhee et al. disclose a system with an elongate device and a pump used to treat the gastrointestinal tract and teach providing the system with a battery 437 and “a step-down regulator (e.g., LT3502 by Linear Technologies) may be employed by the power save circuit to reduce the supply voltage of the rail-to-rail amplifiers and thus extend the life of the battery 437,” thus providing a long-lasting battery (see [0146]).
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Fong et al., as taught by Weidenhagen et al., to provide the system with a "collection canister 24 is provided between the negative pressure source 20 and the pressure distributor 40 for collecting any effluents," and as further taught by Rhee et al., to provide the system with a battery and “a step-down regulator (e.g., LT3502 by Linear Technologies) may be employed by the power save circuit to reduce the supply voltage of the rail-to-rail amplifiers and thus extend the life of the battery 437,” thus providing a long-lasting battery.
Regarding recitations of 1) intended use, 2) functional limitation, or 3) language directed to the manner in which an apparatus is intended to be employed the following should be noted. A recitation of intended use of the claimed invention must be evaluated to determine whether the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim. However, if a prior art structure is capable of performing the intended use as recited in the preamble, then it meets the claim. It is well established that a recitation with respect to the manner in which an apparatus is intended to be employed, i.e., a functional limitation, does not impose any structural limitation upon the claimed apparatus which differentiates it from a prior art reference disclosing the structural limitations of the claim. In re Pearson, 494 F.2d 1399, 181 USPQ 641 (CCPA 1974); In re Casey, 370 F.2d 576, 152 USPQ 235 (CCPA 1967); In re Otto, 312 F.2d 937, 136 USPQ 458 (CCPA 1963). Where the prior art reference is inherently capable of performing the function described in a functional limitation, such functional limitation does not define the claimed apparatus over such prior art reference, regardless of whether the prior art reference explicitly discusses such capacity for performing the recited function. In re Ludtke, 441 F.2d 660, 169 USPQ 563 (CCPA 1971 ). In addition, where there is reason to believe that such functional limitation may be an inherent characteristic of the prior art reference, Applicant is required to prove that the subject matter shown in the prior art reference does not possess the characteristic relied upon. In re Spada, 911 F.2d 705, 15 USPQ2d 1655 (Fed. Cir. 1990); In re King, 801 F.2d 1324, 1327, 231 USPQ 136, 138 (Fed. Cir. 1986); In re Ludtke, 441 F.2d at 664, 169 USPQ at 566 (CCPA 1971). A recitation with respect to the manner in which an apparatus is intended to be employed does not impose any structural limitation upon the claimed apparatus which differentiates it from a prior art reference disclosing the structural limitations of the claim. In re Pearson, 494 F.2d 1399, 181 USPQ 641 (CCPA 1974); In re Yanush, 477 F.2d 958, 177 USPQ 705 (CCPA 1973); In re Finsterwalder, 436 F.2d 1028, 168 USPQ 530 (CCPA 1971); In re Casey, 370 F.2d 576, 152 USPQ 235 (CCPA 1967); In re Otto, 312 F.2d 937, 136 USPQ 458 (CCPA 1963); Ex parte Masham, 2 USPQ2d 1647 (BdPatApp & Inter 1987).
Regarding claim 62, Fong et al. disclose the claimed invention. Claim 32 is a recitation
of 1) intended use, 2) functional limitation, or 3) language directed to the manner in
which an apparatus is intended to be employed and has been treated accordingly as noted
in the rejection to claim 31 above.
Regarding claim 63, Fong et al. disclose the claimed invention including a controller
configured to maintain the continuous negative pressure to the sleeve of the
anchoring device. This corresponds to the portion of the pump responsible for providing
"constant negative pressure at a level of pressure that allows for adequate anchoring so
that the sleeve does not become dislodged, but does not harm the bowel", see [0135].
Regarding claim 65, Fong et al. disclose the claimed invention since the pressure gauge
indicates pressure below -70 mmHg.
Regarding claims 69-70, Fong et al. in view of Weidenhagen et al. disclose or make
obvious the claimed invention including the collection canister comprises a housing
(housing denoted by the boundary lines of element 24 in figure 1 of Weidenhagen et al.)
and the inlet of the housing (the inlet/opening coupled line 22 in figure 1 of
Weidenhagen et al.).
Regarding claim 71, Fong et al. disclose the claimed housing (the exterior surface of the
pump which is "an electric pump mechanism", see [0144]).
Regarding claim 73, Fong et al. disclose the claimed invention. Claim 73 is a recitation
of 1) intended use, 2) functional limitation, or 3) language directed to the manner in
which an apparatus is intended to be employed and has been treated accordingly as noted
in the rejection to claim 31 above.
Claim 64 is rejected under 35 U.S.C. 103 as being unpatentable over Fong et al. (U.S. Patent Application Publication 2017/0071780) in view of Weidenhagen et al. (U.S. Patent Application Publication 2004/0093026) in view of Rhee et al. (U.S. Patent Application Publication 2014/0005668) as applied to claim 61 above, and further in view of Switzer (WO 2020/087129).
Regarding claim 64, Fong et al. in view of Weidenhagen et al. in view of Rhee et al. show the invention above,
but fail to explicitly recite (or make obvious) a leak alarm.
Like Fong et al. and Weidenhagen et al., Switzer discloses a system with an elongate device for suctioning that is used in the intestine and teach providing an "output sensor signals to actuator controller 325, such as a "low pressure" or "no pressure" signal, to indicate a fault, such as a fluid leak", (see [0196]) in order to provide a known and workable manner in warning of a leak.
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Fong et al. in view of Weidenhagen et al. in view of Rhee et al., as taught by Switzer, to provide an "output sensor signals to actuator controller 325, such as a "low pressure" or "no pressure" signal, to indicate a fault, such as a fluid leak" in order to provide a known and workable manner in warning of a leak of a suctioning system used in the intestines.
Claim 68 is rejected under 35 U.S.C. 103 as being unpatentable Fong et al. (U.S. Patent Application Publication 2017/0071780) in view of Weidenhagen et al. (U.S. Patent Application Publication 2004/0093026) in view of Rhee et al. (U.S. Patent Application Publication 2014/0005668) as applied to claim 31 above, and further in view of Ueda (CN 103120578).
Regarding claim 68, Fong et al. in view of Weidenhagen et al. in view of Edwards et al. show the invention above,
but fail to explicitly recite the negative pressure indicator comprises a display screen.
Like Fong et al. and Weidenhagen et al., Ueda discloses a system with an elongate device for suctioning that is used in the intestine and teach providing the system with a display panel 64 on which to display pressure levels (see [0057]) as a known and workable manner of providing pressure information feedback regarding the suctioning procedure in the intestines.
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Fong et al. in view of Weidenhagen et al. in view of Rhee et al., as taught by Ueda, to provide the system with a display panel 64 on which to display pressure levels as a known and workable manner of providing pressure information feedback regarding the suctioning procedure in the intestines.
Claim 73 is rejected under 35 U.S.C. 103 as being unpatentable over Fong et al. (U.S. Patent Application Publication 2017/0071780) in view of Weidenhagen et al. (U.S. Patent Application Publication 2004/0093026) in view of Rhee et al. (U.S. Patent Application Publication 2014/0005668) as applied to claim 31 above, and further in view of Edwards et al. (U.S. Patent 6,325,798).
Regarding claim 73, Fong et al. in view of Weidenhagen et al. in view of Edwards et al. show the invention above,
but fail to explicitly recite the expandable sealing mechanism comprises a low-profile balloon.
Like Fong et al. and Weidenhagen et al. and Rhee et al., Edwards et al. disclose an elongate tubular element used in the gastrointestinal tract and expandable sealing mechanisms disposed on the tubular element and spaced apart by an roughened or uneven tubular surface and teach providing the expandable sealing mechanisms in the form of low-profile balloons (see a) balloons 246 and 248 figure 67, and/or b) balloons 290 and 300 figure 70) in order to provide a seal for the desired tract region.
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Fong et al. in view of Weidenhagen et al. in view of Rhee et al., as taught by Edwards et al., to provide the expandable sealing mechanisms in the form of low-profile balloons in order to provide a seal for the desired tract region.
Conclusion
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/AARON F ROANE/Primary Examiner, Art Unit 3792
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