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 .
Restriction/Election
Applicant’s election without traverse of claims 1-15 designated Species B in the reply filed on 05/29/2026 is acknowledged.
Examiner notes that claims 13-14 are drawn to non-elected species of figure 3 and includes features and arrangement of feature such as first/second piezoelectric pumps not requiring active valve as in elected species of figure 5 as also evidenced in instant application specification as-filed figure 3 and paras. [0058-0060].
Consequently, claim 13-14, 16-20 were withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/29/2026.
Currently, claims 1-12 and 15 will be examined on the merits as drawn to elected species B of figure 5.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: [6.1]figure 1 does not include reference sign “100” mentioned in the description in at least [0031] ;[6.2] figure 12A does not include reference sign “700A” mentioned in the description in at least [0085]; [6.3] figure 12B does not include reference sign “700B” mentioned in the description in at least [0086] ; [6.4] figures do not include Figure 1C mentioned in the description in at least [0076]; [6.5] figure 12 does not include “600”, “602” mentioned in the description in at least [0077];[6.6] figure 12A does not include “704” mentioned in the description in at least [0079].
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because [7.1] reference characters "12" (see instant application specification as-filed [0086]) and "712" (see instant application specification as-filed [0086]) have both been used to designate “closed bellows”.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “S2” has been used to designate both “first sensing device” (see instant application specification as-filed [0040]) and “second sensing device” (see instant application specification as-filed [0039]) .
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
“…For example, in some implementations, some modules of the electronic control system 108 are included in an external device (such as the external controller 120) that is in communication other modules of the electronic control system 108 included within the implantable device 100…” in para.[0031] needs to be corrected. A suggested correction is -- For example, in some implementations, some modules of the electronic control system 108 are included in an external device (such as the external controller 120) that is in communication with other modules of the electronic control system 108 included within the implantable device 100--.
“FIG. 3 is a schematic diagrams of an example fluidic architecture” in para. [0038] needs to be corrected. A suggested correction is -- FIG. 3 is a schematic diagram[[s]] of an example fluidic architecture--.
“…indicates that a desired state of deflation of the inflatable member 104 has been achieved (base on, for example, a fluid pressure sensed by the second sensing device S2)” in [0040] needs to be corrected. A suggested correction is -- indicates that a desired state of deflation of the inflatable member 104 has been achieved (based on, for example, a fluid pressure sensed by the second sensing device S2)--.
“In some examples, automatic control of the fluid operated inflatable device 100 can provide for the correction of internal device pressures based on atmospheric, or barometric, pressures detected by an external device, such as the external controller 120…” in [0075] needs to be corrected. A suggested correction is -- In some examples, automatic control of the fluid operated inflatable device 100 can provide for the correction of internal device pressures based on atmospheric, or barometric[[, ]]pressures detected by an external device, such as the external controller 120--.
Appropriate correction is required.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant's cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Following claims are objected to because of the following informalities:
Claim 5 lines 2-3 “wherein the closed bellows is filled with a compressible fluid, such that the closed bellows is configured to contract” needs to be corrected. A suggested correction is – a closed bellows within the housing, wherein the closed bellows is filled with a compressible fluid, [[such]] in a manner that the closed bellows is configured to contract —to avoid intended result/functional limitation interpretation (see MPEP 2111.04) which would raise question as to whether the limitation proceeding “such that” necessarily follows from preceding limitations and thus unclear as to whether this limitation is even required or not required.
Each of claim 5-8, 11, 12, 15 recite “in response to” encompassing limitations which need to be corrected to avoid intended result/functional limitation interpretation (see MPEP 2111.04) which would raise question as to whether the limitation proceeding “in response to” is even required or not required. Examiner suggests replacing “in response to” with “based on”, “based upon”, “triggered by”, “prompted by” or “activated by”, “upon” as appropriate. As an example amending claim 5 “the closed bellows is configured to contract in response to expansion of the reservoir, and to expand in response to contraction of the reservoir” to -- the closed bellows is configured to contract upon expansion of the reservoir, and to expand upon contraction of the reservoir--; claim 6 “control operation of the at least one pumping device in response to the received user input” to -- control operation of the at least one pumping device based upon the received user input--; claim 7 “wherein the electronic control system is configured to adjust operation of the at least one pumping device to reduce a pressure at the inflatable member and initiate deflation of the inflatable member in response to detection of a signal generated by interaction of a magnet with the electronic control system” to -- wherein the electronic control system is configured to adjust operation of the at least one pumping device to reduce a pressure at the inflatable member and initiate deflation of the inflatable member based on detection of a signal generated by interaction of a magnet with the electronic control system--; claim 8 “wherein the electronic control system is configured to control operation of the at least pumping device in response to user inputs including at least one of: a fluctuation in pressure detected by the at least one sensing device in response to a tapping input or a tugging input” to -- wherein the electronic control system is configured to control operation of the at least pumping device based upon user inputs including at least one of: a fluctuation in pressure detected by the at least one sensing device triggered by a tapping input or a tugging input--; claim 11 “control operation of the at least one pumping device in response to detected fluctuations in pressure, including: control the at least one pumping device to reduce a pressure at the inflatable member and deflate the inflatable member in response to detection of the inflatable member in an inflated state for greater than a preset period of time; control the at least one pumping device to maintain a current state of the fluid-controlled inflatable device in response to detection of a spike in pressure having a duration that is less than a preset period of time; and control the at least one pumping device to maintain the current state of the fluid-controlled inflatable device in response to detection of a change in atmospheric conditions” to -- control operation of the at least one pumping device prompted by detected fluctuations in pressure, including: control the at least one pumping device to reduce a pressure at the inflatable member and deflate the inflatable member based on detection of the inflatable member in an inflated state for greater than a preset period of time; control the at least one pumping device to maintain a current state of the fluid-controlled inflatable device based on detection of a spike in pressure having a duration that is less than a preset period of time; and control the at least one pumping device to maintain the current state of the fluid-controlled inflatable device based on detection of a change in atmospheric conditions--; claim 12 “wherein the electronic control system is configured to: detect a failure in the fluid-controlled inflatable device in response to detection of a time to reach a set pressure exceeding a set period of time” to -- wherein the electronic control system is configured to: detect a failure in the fluid-controlled inflatable device based on detection of a time to reach a set pressure exceeding a set period of time--; claim 15 “wherein, in a first mode, the active valve is configured to be closed by the electronic control system in response to detection of a pressure spike at the inflatable member to prevent deflation of the inflatable member; and in a second mode, the active valve is configured to be opened by the electronic control in response to detection of a power loss to the electronic fluid control system to allow deflation of the inflatable member” to -- wherein, in a first mode, the active valve is configured to be closed by the electronic control system based on detection of a pressure spike at the inflatable member to prevent deflation of the inflatable member; and in a second mode, the active valve is configured to be opened by the electronic control based on detection of a power loss to the electronic fluid control system to allow deflation of the inflatable member--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(B) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1-12 and 15 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claims 1 in lines 12-13 recites the limitation "the at least one pump". There is insufficient antecedent basis for this limitation in the claim. Additionally, it is unclear as to whether claim 1 lines 12-13 "the at least one pump" is the same as, different than or in addition to “pumping device” recited in claim 1 line 9 and if different in what way the two differ.
Each of claims 7, 11-12 recite “the fluid-controlled inflatable device”. There is insufficient antecedent basis for this limitation in the claim. Additionally, it is unclear as to whether claims 7, 11-12 " the fluid-controlled inflatable device " is the same as, different than or in addition to “fluid operated inflatable device” recited in claim 1.
Claim 12 recites “isolate fluid from an area of the detected failure” which renders this claim unclear in light of specification which is also silent as to how or in what structural means and functional manner fluid from an area of the detected failure is actually isolated.
Dependent claims 2-12 and 15 when analyzed as a whole are held to be patent ineligible under 35 U.S.C. 112(b) because the additional recited limitations fail to cure the 35 U.S.C. 112(b) issue in their respective base claims. Consequently, dependent claims 2-12 and 15 are also rejected under 35 U.S.C. 112(b) based on their direct/indirect dependency on their respective base claims.
Claim Rejections - 35 USC § 112 (d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 9-10 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph for the following reasons:
Please note that USPTO personnel are to give claims their broadest reasonable interpretation in light of the supporting disclosure. In re Morris, 127 F.3d 1048, 1054-55, 44 USPQ2d 1023, 1027-28 (Fed. Cir. 1997). Limitations appearing in the specification but not recited in the claim should not be read into the claim. E-Pass Techs., Inc. v. 3Com Corp., 343 F.3d 1364, 1369, 67 USPQ2d 1947, 1950 (Fed. Cir. 2003) (claims must be interpreted "in view of the specification" without importing limitations from the specification into the claims unnecessarily). In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550-551 (CCPA 1969). See also In re Zletz, 893 F.2d 319, 321-22, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989) ("During patent examination the pending claims must be interpreted as broadly as their terms reasonably allow.... The reason is simply that during patent prosecution when claims can be amended, ambiguities should be recognized, scope and breadth of language explored, and clarification imposed.... An essential purpose of patent examination is to fashion claims that are precise, clear, correct, and unambiguous. Only in this way can uncertainties of claim scope be removed, as much as possible, during the administrative process."). Consequently, a broad yet reasonable interpretation of claim 8 limitation “user inputs including at least one of: a fluctuation in pressure detected by the at least one sensing device in response to a tapping input or a tugging input; or a motion event detected by a motion detecting device of the fluid operated inflatable device or the external device” due to use of the term “at least one” encompasses the limitation that excludes tapping input. When so interpreted, claim 9 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim 8 upon which it depends, or for failing to include all the limitations of the claim upon which it depends as claim 9 is attempting to further limit “tapping input” which was not positively recited i.e. optionally recited in the base claim 8 in the first place. Examiner suggests amending claim 9 to – wherein the user inputs include the tapping input; and wherein the tapping input includes a series of taps in a preset sequence detected by a piezoelectric element of the at least one pumping device--.
Dependent claim 10 when analyzed as a whole are held to be patent ineligible under 35 U.S.C. 112(b) because the additional recited limitations fail to cure the 35 U.S.C. 112(d) issue in their respective base claims. Consequently, dependent claims 10 are also rejected under 35 U.S.C. 112(d) based on their direct/indirect dependency on their respective base claims.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Interpretation
Claims terms where relevant are being interpreted in light of definitions enumerated in instant application specification as-filed para. [0029-0030], [0088].
Please note that USPTO personnel are to give claims their broadest reasonable interpretation in light of the supporting disclosure. In re Morris, 127 F.3d 1048, 1054-55, 44 USPQ2d 1023, 1027-28 (Fed. Cir. 1997). Limitations appearing in the specification but not recited in the claim should not be read into the claim. E-Pass Techs., Inc. v. 3Com Corp., 343 F.3d 1364, 1369, 67 USPQ2d 1947, 1950 (Fed. Cir. 2003) (claims must be interpreted "in view of the specification" without importing limitations from the specification into the claims unnecessarily). In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550-551 (CCPA 1969). See also In re Zletz, 893 F.2d 319, 321-22, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989) ("During patent examination the pending claims must be interpreted as broadly as their terms reasonably allow.... The reason is simply that during patent prosecution when claims can be amended, ambiguities should be recognized, scope and breadth of language explored, and clarification imposed.... An essential purpose of patent examination is to fashion claims that are precise, clear, correct, and unambiguous. Only in this way can uncertainties of claim scope be removed, as much as possible, during the administrative process.").
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 of this title, 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3, 4, 6, 8, 11, 12 are rejected under 35 U.S.C. 103 as being unpatentable over Hohlrieder et al. (Pub. No.: US 20190133737 A1, hereinafter referred to as "Hohlrieder") in view of Birk et al. (Pub. No.: US 20090270904 A1, hereinafter referred to as “Birk”).
As per independent Claim 1, Hohlrieder discloses an implantable fluid operated inflatable device (Hohlrieder in at least abstract, fig. 1-2, [0001], [0009-0014], [0016-0018], [0020], [0022-0023], [0038], [0040-0041], [0043-0047], [0050-0052], [0057], [0063-0065] for example discloses relevant subject-matter. More specifically, Hohlrieder in at least abstract, fig. 1-2, [0001] discloses implantable fluid operated inflatable device), comprising:
a fluid reservoir (Hohlrieder fig. 1-2, [0040], a receiving space 12 filled with fluid);
an inflatable member (Hohlrieder fig. 1-2, [0038], band part 1);
an electronic fluid control system (Hohlrieder fig. 1-2, [0043], 15, 17. see at least Hohlrieder [0043]"electric drive 15 is controlled by a pump electronics unit 17”) coupled between the fluid reservoir and the inflatable member and configured to control fluid between the fluid reservoir and the inflatable member (Hohlrieder fig. 1-2, [0040-0041], [0043]), the electronic fluid control system including:
a housing (Hohlrieder fig. 1-2, [0044], “a housing 26”);
a fluid control system (Hohlrieder fig. 1-2, [0040] “pump part 11”) received in the housing Hohlrieder fig. 1-2, [0040] “are arranged in a housing 26”), including fluidic architecture including pumping device positioned in a fluid passageway within in the housing (Hohlrieder fig. 1-2, [0040-0041], [0044]);
an electronic control system received in the housing (Hohlrieder [0046-0047], “pump electronics unit 17”. see Hohlrieder [0046] “pump electronics unit 17 and the operating electronics unit 20 together form the electrical control system of the medical device”),
the electronic control system including: electronics configured to control operation of the at least one pump (Hohlrieder [0043-0044] “pump unit 10 moreover has an electric drive 15 for the pump part 11. The electric drive 15 is controlled by a pump electronics unit 17 of the pump unit 10… components of the pump unit 10 are arranged in a housing 26”;); and
a communication module configured to communicate with at least one external device (Hohlrieder fig. 1, [0045] “operating electronics unit 20 of the operating unit 19 in this case communicates with the pump electronics unit 17 via a radio link”; [0047] “operating unit 19 can be arranged outside the body”); and
at least one pressure sensing device (Hohlrieder fig. 1-2, 17, 23, [0050-0051]. See at least Hohlrieder [0050-0051] “the pump electronics unit 17 is a pressure sensor 22 …air pressure sensor 23”) configured to sense a fluid pressure in the implantable fluid operated inflatable device, and to transmit the sensed pressure to the electronic control system (Hohlrieder fig. 1-2, 17, 23, [0050-0051], [0065]. See Hohlrieder [0050] “Using the pressure sensor 22, the pressure of the fluid in the receiving space 12 can thus be detected, which pressure corresponds to the pressure of the fluid in the hollow chamber 3”; [0051] “By use of this air pressure sensor 23, the electronic control system 17 is able to detect the ambient pressure, which corresponds to the atmospheric pressure. The air pressure sensor 23 could also be arranged in the operating unit 19, and the value detected by it could be transmitted to the pump electronics unit 17 via the radio link… If the air pressure sensor 23 is not arranged in the operating unit 19, the air pressure value could also in this case be transmitted from the pump electronics unit 17 to the operating electronics unit 20.”).
Hohlrieder makes obvious (see para. [0003] “valve”) but does not explicitly disclose the electronic control system including: at least one processor configured to control operation of the at least one pump and at least one valve
However, in an analogous implantable fluid operated inflatable device field of endeavor, Birk discloses an implantable fluid operated inflatable device (Birk in at least abstract, fig. 1-7, [0008-0010], [0013], [0015], [0017], [0028-0033], [0040-0045], [0047-0050], [0052-0053], [0055-0056], [0067], [0077-0081] for example discloses relevant subject-matter. More specifically, Birk in at last fig. 6-7, abstract, [0028]. See Birk abstract “banding device including … an implantable pump unit in communication with the fluid reservoir for controlling pressure within the inflatable member” ), comprising:
the electronic control system including: at least one processor configured to control operation of the at least one pump and at least one valve (Birk in at least fig. 2, 6-7, [0009-0010], [0015-0017], [0055-0056], [0067] for example discloses electronic control system 210 including: at least one processor configured to control operation of the at least one pump 206 and at least one valve 202/204. Birk [0015] “pump unit comprises a first fluid line including a one-way pump for passing fluid in a first direction and a second fluid line in parallel with the first line including a valve”; [0016] “pump unit generally comprises a inductively powered, piezoelectric pump, a first valve in line with the pump, a second valve in parallel with the pump; electronics in communication with the pump and first and second valves”; [0017] “high precision pump unit is controlled by an external remote control unit”; [0067] “high precision pump unit 106 includes a first fluid line including a first pump for passing fluid in a first direction and a second fluid line in parallel with the first fluid line including a first valve and a second pump for passing fluid in an opposing direction”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the implantable fluid operated inflatable device as taught by Hohlrieder, in a manner that the device further includes a valve that is controlled by the electronic control system, as taught by Birk. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage of electronically controlling implantable fluid operated inflatable device components such as valves and fluid flow within the fluidic circuit via controlling the valves (Birk, [0056]).
As per dependent Claim 3, the combination of Hohlrieder and Birk as a whole further discloses implantable fluid operated inflatable device wherein the reservoir includes a bellows structure configured to contract as fluid is expelled from the reservoir, and to expand as fluid flows into the reservoir (Hohlrieder in at least fig. 1-2, [0016], [0040]. See at least Hohlrieder [0016] “pump unit has a pump part having a receiving space which is filled with the fluid and of which the volume is variable by the drive… pump part can be a bellows closed by a bottom part and a cover part.”; [0040] “pump part 11 is formed by a bellows”).
As per dependent Claim 4, the combination of Hohlrieder and Birk as a whole further discloses implantable fluid operated inflatable device wherein the reservoir is received within the housing (reservoir 12 is received within the housing 26 as seen in fig. 1-2 of Hohlrieder).
As per dependent Claim 6, the combination of Hohlrieder and Birk as a whole further discloses implantable fluid operated inflatable device wherein the electronic control system is configured to receive a user input from the external device, and to control operation of the at least one pumping device in response to the received user input (Hohlrieder [0045] “adjust the band part 1 between the shut-off state and the release state, use is made of an operating unit 19 which is arranged spatially separate from the pump unit 10 and which has at least one operating element 21, for example a key, that can be activated by the user…operating electronics unit 20 of the operating unit 19 in this case communicates with the pump electronics unit 17 via a radio link”).
As per dependent Claim 8, the combination of Hohlrieder and Birk as a whole further discloses implantable fluid operated inflatable device wherein the electronic control system is configured to control operation of the at least pumping device in response to user inputs including at least one of: a fluctuation in pressure detected by the at least one sensing device in response to a tapping input or a tugging input; or a motion event detected by a motion detecting device of the fluid operated inflatable device or the external device (Hohlrieder [0045] “adjust the band part 1 between the shut-off state and the release state, use is made of an operating unit 19 which is arranged spatially separate from the pump unit 10 and which has at least one operating element 21, for example a key, that can be activated by the user…operating electronics unit 20 of the operating unit 19 in this case communicates with the pump electronics unit 17 via a radio link”. Here, prior art “key activation by the user” is representative of motion event that is detecting by key associated motion detecting element of operating unit/device of the fluid operated inflatable device or the external device. Also see Hohlrieder [0009], [0012-0014], [0016], [0046], [0051], [0065] discloses sensors arranged in pump part receiving space, in the hollow chamber of the band part or in the channel of a hose connecting the band part to the pump part, or a strain gauge affixed to a membrane which deforms due to pressure fluctuations that by means of device electronic control system detects motion event of the fluid operated inflatable device.).
As per dependent Claim 11, the combination of Hohlrieder and Birk as a whole further discloses implantable fluid operated inflatable device wherein the electronic control system is configured to monitor pressure levels in the fluid-controlled inflatable device, and to control operation of the at least one pumping device in response to detected fluctuations in pressure, including: control the at least one pumping device to reduce a pressure at the inflatable member and deflate the inflatable member in response to detection of the inflatable member in an inflated state for greater than a preset period of time; control the at least one pumping device to maintain a current state of the fluid-controlled inflatable device in response to detection of a spike in pressure having a duration that is less than a preset period of time; and control the at least one pumping device to maintain the current state of the fluid-controlled inflatable device in response to detection of a change in atmospheric conditions (Hohlrieder [0009], [0012-0014], [0016], [0046], [0051], [0065] discloses the electronic control system ([0046]) is configured to monitor pressure levels in the fluid-controlled inflatable device via sensors to control operation of the at least one pumping device 10 in response to pressure sensor detected fluctuations in pressure, including one of more of the recited operations. Also see Birk [0070] “systems … meet at least one safety specifications… in the event of any failure of the systems, either no change in gastric band 102 tightness or a loosening of gastric band 102 results”).
As per dependent Claim 12, the combination of Hohlrieder and Birk as a whole further discloses implantable fluid operated inflatable device wherein the electronic control system is configured to: detect a failure in the fluid-controlled inflatable device in response to detection of a time to reach a set pressure exceeding a set period of time or an inability to reach the set pressure (Birk in at least [0044] “sensing or measuring pressure in the system 100 can be useful in diagnosing system leaks or obstructions… if the pressure consistently drops over an …period of time, the clinician can diagnose a leak within the system and plan for an appropriate treatment to fix the problem…if there is an obstruction within the system with a sustained pressure rise over time, the clinician can diagnose an obstruction within the system and plan for an appropriate treatment to fix the problem.”); output an alert of the detected failure to the external device (Birk in at least [0044] discloses “sensing or measuring pressure in the system 100 can be useful in diagnosing system leaks or obstructions” which can be displayed on display as disclosed in [0048] “remote controller unit 108 has a user interface including at least one display 116 and at least one user input 118… Remote controller unit 108 permits a clinician or a patient to navigate through menu driven screens used for data entry, data collection, and high precision pump unit 106 control.”); and isolate fluid from an area of the detected failure (Birk in at least [0044], [0048] discloses diagnostically isolating i.e. enabling detection of fluid from an area of the detected failure).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Hohlrieder in view of Birk and further in view of Lamraoui (Pub. No.: US 20170325926 A1, hereinafter referred to as “Lamraoui-926”).
As per dependent Claim 5, combination of Hohlrieder and Birk as a whole disclose implantable fluid operated inflatable device further comprising a closed bellows within the housing, wherein the closed bellows is filled with a compressible fluid(Hohlrieder in at least fig. 1-2, [0016], [0040] for example discloses a closed bellows within the housing 26, wherein the closed bellows is filled with a compressible fluid. See at least Hohlrieder [0016] “pump unit has a pump part having a receiving space which is filled with the fluid and of which the volume is variable by the drive… pump part can be a bellows closed by a bottom part and a cover part.”; [0040] “pump part 11 is formed by a bellows which is closed by a bottom part 13 and a cover part”).
The combination of Hohlrieder and Birk as a whole does not explicitly disclose closed bellows is configured to contract in response to expansion of the reservoir, and to expand in response to contraction of the reservoir.
However, in an analogous implantable fluid operated inflatable device field of endeavor, Lamraoui-926 discloses implantable fluid operated inflatable device (Lamraoui-926 in at least fig. 1-2, abstract, [0019-0025], [0027] ,[0075]. See at least Lamraoui-926 [0075] “system comprises an inflatable occlusive sleeve 3 containing a variable volume of a fluid, intended to surround at least one portion of a natural conduit (not shown) to be occluded, and a reservoir 5 with a variable volume (illustrated in FIGS. 2 to 5) filled with a fluid.” ) comprising a closed bellows within the housing, wherein the closed bellows is filled with a compressible fluid, such that the closed bellows is configured to contract in response to expansion of the reservoir, and to expand in response to contraction of the reservoir (Lamraoui-926 in at least fig. 2, [0077], [0094] for example discloses a closed bellows 9 within the housing 1, wherein the closed bellows is filled with a compressible fluid, such that the closed bellows is configured to contract in response to expansion of the reservoir, and to expand in response to contraction of the reservoir. See at least Lamraoui-926 [0077] “reservoir comprises a fixed portion and a movable portion, the displacement of the movable portion varying the volume of the reservoir”; [0094] “the reservoir with a variable volume comprises bellows assembled in the casing… reservoir with variable volume then consists of the bellows (acting as a movable portion), of a wall of the casing and of a hood acting with said wall of the casing, as a fixed portion. The reservoir further comprises an orifice allowing transfer of the fluid from and to the outside of the reservoir”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the operation of the closed bellows of the implantable fluid operated inflatable device of Hohlrieder, as modified with Birk, such that bellows is configured to contract in response to expansion of the reservoir, and to expand in response to contraction of the reservoir Lamraoui-926. A person of ordinary skill would have been motivated to do so as a matter of simple substitution of one know element/component with another known functional equivalent (see MPEP 2143), with a reasonable expectation of success, for the advantage of obtaining the predictable result of fluid management within the fluidic circuit to effectively adjust the diameter of the band thereby occluding the anatomical natural conduit (Lamraoui-926, abstract, [0020-0021], [0075]).
Claims 7, 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Hohlrieder in view of Birk and further in view of Lamraoui (Pub. No.: US 20220357783 A1, hereinafter referred to as “Lamraoui-783”).
As per dependent Claim 7, combination of Hohlrieder and Birk as a whole disclose implantable fluid operated inflatable device of claim 6 (see claim 6 analysis), wherein the electronic control system is configured to adjust operation of the at least one pumping device to reduce a pressure at the inflatable member and initiate deflation of the inflatable member (Hohlrieder compare fig. 1 inflatable member/band with reduced a pressure at the inflatable member/band ..deflated inflatable member/band and Birk in [0008] “high precision pump unit is configured and structured to enable tightening and/or loosening of a gastric band by moving a metered amount of fluid between an implantable reservoir and the at least one inflatable member of the gastric band.”).
The combination of Hohlrieder and Birk as a whole does not explicitly disclose interaction of a magnet with the electronic control system features i.e. the electronic control system is configured to adjust operation of the at least one pumping device to reduce a pressure at the inflatable member and initiate deflation of the inflatable member in response to detection of a signal generated by interaction of a magnet with the electronic control system, positioned corresponding to the fluid-controlled inflatable device for a preset period of time.
However, in an analogous implantable fluid operated inflatable device field of endeavor, Lamraoui-783 discloses implantable fluid operated inflatable device (Lamraoui-783 fig. 1-2, [0058-0061] for example discloses implantable fluid operated inflatable device 10.)
wherein the electronic control system is configured to adjust operation of the at least one pumping device to reduce a pressure at the inflatable member and initiate deflation of the inflatable member in response to detection of a signal generated by interaction of a magnet with the electronic control system, positioned corresponding to the fluid-controlled inflatable device for a preset period of time (Lamraoui-783 in at least [0019-0020], [0033-0034], [0048-0049], [0058-0061] . See at least Lamraoui-783 [0019-0020] “the first activation element comprises a sensor selected from … magnetic … sensor… activation element is distinct from the command system and consists of … a stylus or a badge or chip, in particular magnetic or electro-magnetic.”; [0048-0049] “first activation element 4 comprises a proximity or contact sensor 7 selected from a group consisting of … magnetic … sensor…type of sensor 7 measures or detects the presence of an added activation element 6 when it is in proximity to or in physical contact with the sensor, thereby triggering the first activation element… activation element 6 … may also be in the form of a stylus or a badge, especially a magnetic or electro-magnetic badge or chip.”; [0058-0061] “artificial urinary sphincter… medical device 2 comprises at least one inflatable occlusive cuff 10 surrounding the natural duct 11… and a tubular fluid connection 12, one end of which is connected to the cuff 10 to create a fluid connection with the rest of the medical device 2…medical device 2 also includes a control unit and a pump (not shown for clarity), the pump itself including a variable volume reservoir. The pump reservoir is filled with fluid and connected to the other end of the tubular fluid connection 12. Thus the pump reservoir, the tubular fluid connection 12 and the occlusive cuff 10 form a single fluid circuit, whereby fluid can be transferred bidirectionally from the reservoir to the pump…In operation, the unit controls the pump so as to increase or decrease the volume of fluid in the reservoir and hence the amount of fluid in the cuff 10 via the fluid circuit. This arrangement has the effect of allowing the cuff to be inflated or deflated, increasing or decreasing the compression exerted and thus compressively sealing or releasing the urethra 11 thereby preventing urine leakage for patients suffering from incontinence…medical device 2 including the occlusive cuff 10, the tubular fluid connection 12, the command unit, the pump and the reservoir are therefore implanted in the human or animal body … to be remotely commanded by the command system 1 located outside the body” ).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electronic control system configured to adjust operation of the at least one pumping device to reduce a pressure at the inflatable member and initiate deflation of the inflatable member of the implantable fluid operated inflatable device of Hohlrieder, as modified with Birk, such that the electronic control system is configured to adjust operation of the at least one pumping device to reduce a pressure at the inflatable member and initiate deflation of the inflatable member in response to detection of a signal generated by interaction of a magnet with the electronic control system, positioned corresponding to the fluid-controlled inflatable device for a preset period of time as disclosed in Lamraoui-783. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage of deriving a fail-safe implant that prevents unintentional accidental activation or deactivation of implantable fluid operated inflatable device using an external magnet percutaneous actuator (Lamraoui-783, [0011]).
As per dependent Claim 9, combination of Hohlrieder and Birk as a whole disclose implantable fluid operated inflatable device of claim 8 (see claim 8 analysis)
The combination of Hohlrieder and Birk as a whole does not explicitly disclose tapping input features i.e. wherein the tapping input includes a series of taps in a preset sequence detected by a piezoelectric element of the at least one pumping device.
However, in an analogous implantable fluid operated inflatable device field of endeavor, Lamraoui-783 discloses implantable fluid operated inflatable device (Lamraoui-783 fig. 1-2, [0058-0061] for example discloses implantable fluid operated inflatable device 10.),
wherein the tapping input includes a series of taps in a preset sequence detected by a piezoelectric element of the at least one pumping device (Lamraoui-783 in at least [0019], [0033], [0050]. See at least Lamraoui-783 [0033] “activation element comprises …fingerprint recognition sensor is configured to recognise at least a first succession of fingerprints to activate a first command of the medical device and at least a second succession of fingerprints to activate a second command of the medical device, the first command being different from the second command”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify input type provided to the implantable fluid operated inflatable device of Hohlrieder, as modified with Birk, by further including tapping input that includes a series of taps in a preset sequence detected by a piezoelectric element of the at least one pumping device as disclosed in Lamraoui-783. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage of deriving a fail-safe implant that prevents unintentional accidental activation or deactivation of implantable fluid operated inflatable device using an external magnet percutaneous actuator (Lamraoui-783, [0011]).
As per dependent Claim 10, the combination of Hohlrieder, Birk and Lamraoui-783 as a whole further discloses implantable fluid operated inflatable device, wherein the preset sequence includes: a wake-up sequence to wake the fluid operated inflatable device, including a first tapping sequence defined by a first number of taps in a first pattern; and an activation sequence corresponding to a user input, including a second tapping sequence defined by a second number of taps in a second pattern (see at least Lamraoui-783 [0050] “a fingerprint recognition sensor 7, it is provided that the sensor is configured to recognise at least a first succession of fingerprints so as to activate a first command, for example opening of the urethra, and at least a second succession of fingerprints different from the first to activate a second command, for example a request for information on the pressure exerted by the medical device on the natural duct or on the open or sealed state of the duct.” ).
Contingently Allowable Subject-Matter
As per dependent claim 2, 15, dependent claim 2, 15 would be contingently allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims in addition to overcoming any other rejections/objections enumerated above.
Additionally, as per dependent claim 2, 15, dependent claim 2, 15 is being objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims in addition to overcoming any other rejections/objections enumerated above.
The following is a statement of reasons for the indication of allowable subject matter:
As per dependent Claim 2, none of the prior art discloses implantable fluid operated inflatable device wherein the reservoir is bonded to an outer surface of the housing including all of the limitations, features, combination and arrangement of features of their respective base claim and any intervening claims.
As per dependent Claim 15, none of the prior art discloses implantable fluid operated inflatable device wherein the fluidic architecture includes: a first uni-directional pump and a first passive valve positioned in a first fluid passageway to selectively generate and control fluid flow in a first direction, from the inflatable member toward the reservoir; a second uni-directional pump and a second passive valve positioned in a second fluid passageway to selectively generate and control fluid flow in a second direction, from the reservoir to the inflatable member; a first sensing device positioned to sense a fluid pressure at the reservoir; a second sensing device positioned to sense a fluid pressure at the inflatable member; and an active valve positioned in-line with the inflatable member, wherein, in a first mode, the active valve is configured to be closed by the electronic control system in response to detection of a pressure spike at the inflatable member to prevent deflation of the inflatable member; and in a second mode, the active valve is configured to be opened by the electronic control in response to detection of a power loss to the electronic fluid control system to allow deflation of the inflatable member including all of the limitations, features, combination and arrangement of features of their respective base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure and/or the claims.
Prior art US 20180064536 A to Brown et al. discloses inflatable implantable prosthesis that includes. an inflatable member, a reservoir configured to hold fluid, and a pump assembly configured to facilitate a transfer of the fluid from the reservoir to the inflatable member when the prosthesis is in an inflation mode and facilitate a transfer of the fluid from the inflatable member to the reservoir when the prosthesis is in a deflation mode similar to that disclosed.
Prior art US 20230404778 A1 to Lamraoui discloses a system that is implantable in the human or animal body, comprising a fluid circuit with a variable-volume reservoir similar to that disclosed. More specifically, Lamraoui discloses a system that is implantable in a human or animal body, comprising: a fluidic circuit comprising: an inflatable element containing a variable volume of a fluid; a variable-volume fluid reservoir comprising a fixed first part and a movable second part; and an actuator mechanically coupled to the second part; wherein the second part is also elastically deformable such that, when the second part is fixed with respect to the first part, the second part is designed to be mechanically deformed in response to a variation in pressure in the fluidic circuit, so as to alter the volume of the reservoir in order to compensate for said variation in pressure in the fluidic circuit.
Prior art US 20160030178 A1 to Forsell discloses treatment apparatus comprising an adjustable prosthesis device implanted in a patient similar to that disclosed. More specifically, prosthesis device engages the corpus cavernosum or penile tissue of the patient to provide flaccid or erect state of the penis. An implanted adjustment device is adapted to adjust the prosthesis such that the penis can be temporarily erected. The prosthesis is preferably controlled with a remote control and an implanted powered operation device, which may include servo means, operates the adjustment device.
Prior art US 5562598 A to Whalen et al. discloses magnetically operated artificial urethral sphincter for the treatment of total urinary incontinence similar to that disclosed. The artificial urethral sphincter employs an external magnet to achieve closure of the urethral cuff, a hydraulically operated silicone rubber sphincter cuff. The proposed invention consists of the urethral cuff, a connecting tube, and an elastomeric bellows assembly. The invention is closed by an external magnet placed on the skin over the implanted reservoir assembly. When the external magnet is in place the elastomeric bellows of the reservoir is compressed, and the prosthetic sphincter is closed. Removal of the external magnet from the skin over the implant allows the bellows to expand, thus opening the urethral cuff.
Prior art US 20210236317 A1 to Forsell discloses treatment apparatus comprising an adjustable prosthesis device implanted in a patient similar to that disclosed.
Prior art US 20230264020 A1 to Stefopoulos et al. discloses prosthesis configured to recognize sequences of pre-defined events (such as taps/swipes on the skin overlying a sensor or other input receiver) similar to that disclosed. In this regard, a predetermined pattern can correspond to a wake command, and the prosthesis can be configured to recognize such as an alert to the device that an incoming action command is about to be provided by the user. Then, the device can receive the incoming action command and respond accordingly.
Prior art US 20170199643 A1 to Schnyder et al. discloses method for controlling a device via touch gestures carried out by a wearer of the device similar to that disclosed. More specifically, as part of the gesture a finger is swiped across first and second sound inlets of the hearing device. A gesture is detected by determining if a first output signal from a first microphone at the first sound inlet contains a component caused by the finger touching the hearing device at the first sound inlet and if a second output signal from a second microphone at the second sound inlet contains a component caused by the finger touching the hearing device at the second sound inlet. Based on the detected gesture a control signal changes a processing parameter or setting of a signal processing unit of the hearing device. Additionally, a hearing device capable of performing the proposed method and a method of fitting such a hearing device are provided.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUNITA REDDY whose telephone number is (571)270-5151. The examiner can normally be reached on M-Thu 10-4 EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHARLES A MARMOR II can be reached on (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUNITA REDDY/Primary Examiner, Art Unit 3791
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