Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Interpretation
Claims 1, 16, and 19 contain preambles that claim a “container and tube set…for use in an endoscopic procedure”. As such, the feature of “for use in an endoscopic procedure” merely describe a recited purpose or intended use, rather than any structural limitations, and therefor is not considered a limitation and is of no significance to claim construction for examination purposes. MPEP 2111.02(II).
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a flow control member configured to selectively occlude the second end of the second water supply tube” found in lines 2-3 of Claim 14. This feature is interpreted as the flow control member 1116 found in FIG. 11C and described in paragraph [0139] of the present patent application.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claim 1 is objected to because of the following informalities: line 14 includes the feature “fluid outlet in selective fluid communication first fluid inlet of the first container”. This appears to contain a typographical error, and should read “fluid outlet in selective fluid communication with the first fluid inlet of the first container”. Appropriate correction by Applicant is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The present rejection(s) reference specific passages from cited prior art. However, Applicant is advised that the rejections are based on the entirety of each cited prior art. That is, each cited prior art reference “must be considered in its entirety”. Therefore, Applicant is advised to review all portions of the cited prior art if traversing a rejection based on the cited prior art.
Claims 1-3 and 16-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Higuchi et al. (US PGPUB 2020/0114401 – “Higuchi”).
Regarding Claim 1, Higuchi discloses:
A container and tube set (Higuchi FIG. 1, unit 17 combined with tank 13 and gas cylinder 15) arranged and configured to couple to an endoscope (Higuchi FIG. 1, endoscope 19) for use in an endoscopic procedure (intended use that provides no structural limitations), the container and tube set comprising:
a first container (Higuchi FIG. 1, reservoir 11) configured to contain a fluid (Higuchi paragraph [0023], “a tubular solution reservoir 11 in which a pH-adjusted solution whose pH is adjusted is reserved”), the first container having a first fluid inlet (Higuchi FIG. 1, fluid inlet for liquid pipe P4) and a port (Higuchi FIG. 1, fluid outlet for liquid pipe P6) in fluid communication with a bottom portion (Higuchi FIG. 1, bottom of reservoir 11) thereof;
a first water supply tube including a first end (Higuchi FIG. 1, pipe P1), a second end (Higuchi FIG. 1, pipe P3), and a first lumen (Higuchi FIG. 1, interior of pipes P1-P3) extending therethrough, wherein the first lumen is in selective fluid communication (Higuchi FIG. 1, valve 31, selectively controlling fluid flowing into the interior lumen of pipes P1-P3; Higuchi paragraph [0024], “an entrance valve 31 connected to an upper side of the solution reservoir 11 and a sending pump 21 connected to the entrance valve 31”) with the first container (Higuchi FIG. 1, reservoir 11) and the second end of the first water supply tube is positioned external to the container (Higuchi FIG. 1, showing pipe P3 external to reservoir 11);
a first gas supply tube (Higuchi FIG. 1, pipe P5 from valve 33 to supply carbon dioxide gas in the E-direction to the top of reservoir 11; see Higuchi paragraph [0033]) including a first end (Higuchi FIG. 1, first end of pipe P5 entering reservoir 11), a second end (Higuchi FIG. 1, second end of pipe P5 attached to valve 33), and a second lumen (Higuchi FIG. 1, interior of pipe P5) extending therethrough, wherein the second lumen is in operative fluid communication with the first container (Higuchi FIG. 1, reservoir 11) and the second end of the first gas supply tube is positioned external to the first container (Higuchi FIG. 1, showing second end of pipe P5 attached to valve 33 external to reservoir 11);
a second container (Higuchi FIG. 1, tank 13) configured to contain a fluid (Higuchi paragraph [0024], “solution within the stock-solution tank 13”), the second container having a fluid outlet (Higuchi FIG. 1, outlet for pipe S1) in selective fluid communication (Higuchi FIG. 1, valve 31; Higuchi paragraph [0042], “the entrance valve 31 is opened and the sending pump 21 is operated. When the water level of the original cleaning solution arrives at the upper limit-sensor (65a and 65b), the entrance valve 31 is closed and the top valve 33 is switched to the gas-filling path.”) with the first fluid inlet of the first container (Higuchi FIG. 1, fluid inlet for liquid pipe P4 leading into reservoir 11);
a second water supply tube (Higuchi FIG. 1, pipe P4) including a first end (Higuchi FIG. 1, first end of pipe P4 coupled to valve 51), a second end (Higuchi FIG. 1, second end of pipe P4 coupled to inlet of reservoir 11), and a third lumen (Higuchi FIG. 1, interior lumen of pipe P4) extending therethrough, wherein the third lumen is in fluid communication with the second container (Higuchi FIG. 1, showing lumen within pipe P4 in fluid communication with tank 13 via pipes S1 and P1-P3) and the second end of the second water supply tube is coupled to the first fluid inlet of the first container (Higuchi FIG. 1, showing pipe P4 coupled to fluid inlet of reservoir 11); and
a fluid flow control mechanism (Higuchi FIG. 1, valves 31 and 51, and pump 21) positioned in-line with the second water supply tube (Higuchi FIG. 1, valves 31 and 51 positioned in-line with pipe P4), the fluid flow control mechanism configured to selectively fluidly couple the second container with the first container (Higuchi paragraph [0042], “ the entrance valve 31 is opened…When the water level of the original cleaning solution arrives at the upper limit-sensor (65a and 65b), the entrance valve 31 is closed.”).
Regarding Claim 2, Higuchi discloses the features of Claim 1, as described above.
Higuchi further discloses a pressure relief mechanism (Higuchi FIG. 1, valve 33; Higuchi paragraph [0033], “top valve 33 is a 3-way solenoid valve…plays the roles of…the release of the gas and the like in the solution reservoir 11 to atmosphere in an I-direction (the pressure-reducing adjustment-path))idHi in fluid communication with an interior of the first container (Higuchi FIG. 1, showing valve 33 in fluid communication with an interior of reservoir 11 via pipe P5).
Regarding Claim 3, Higuchi discloses the features of Claim 1, as described above.
Higuchi further discloses a one-way valve positioned in-line with the second water supply tube (Higuchi paragraph [0025], “a connected state means a situation in which liquid or gas or gas-liquid mixture or the like can be passed between the respective devices in one-direction”).
Regarding Claim 16, Higuchi discloses:
A container and tube set (Higuchi FIG. 1, unit 17 combined with tank 13 and gas cylinder 15) arranged and configured to couple to an endoscope (Higuchi FIG. 1, endoscope 19) for use in an endoscopic procedure (intended use that provides no structural limitations), the container and tube set comprising:
a first container (Higuchi FIG. 1, reservoir 11) configured to contain a fluid (Higuchi paragraph [0023], “a tubular solution reservoir 11 in which a pH-adjusted solution whose pH is adjusted is reserved”), the first container having a first fluid inlet (Higuchi FIG. 1, fluid inlet for liquid pipe P4) and a port (Higuchi FIG. 1, fluid outlet for liquid pipe P6) in fluid communication with a bottom portion (Higuchi FIG. 1, bottom of reservoir 11) thereof;
a pressure relief mechanism (Higuchi FIG. 1, valve 33; Higuchi paragraph [0033], “top valve 33 is a 3-way solenoid valve…plays the roles of…the release of the gas and the like in the solution reservoir 11 to atmosphere in an I-direction (the pressure-reducing adjustment-path))idHi in fluid communication with an interior of the first container (Higuchi FIG. 1, showing valve 33 in fluid communication with an interior of reservoir 11 via pipe P5).
a first water supply tube including a first end (Higuchi FIG. 1, pipe P1), a second end (Higuchi FIG. 1, pipe P3), and a first lumen (Higuchi FIG. 1, interior of pipes P1-P3) extending therethrough, wherein the first lumen is in selective fluid communication (Higuchi FIG. 1, valve 31, selectively controlling fluid flowing into the interior lumen of pipes P1-P3; Higuchi paragraph [0024], “an entrance valve 31 connected to an upper side of the solution reservoir 11 and a sending pump 21 connected to the entrance valve 31”) with the first container (Higuchi FIG. 1, reservoir 11) and the second end of the first water supply tube is positioned external to the container (Higuchi FIG. 1, showing pipe P3 external to reservoir 11);
a first gas supply tube (Higuchi FIG. 1, pipe P5 from valve 33 to supply carbon dioxide gas in the E-direction to the top of reservoir 11; see Higuchi paragraph [0033]) including a first end (Higuchi FIG. 1, first end of pipe P5 entering reservoir 11), a second end (Higuchi FIG. 1, second end of pipe P5 attached to valve 33), and a second lumen (Higuchi FIG. 1, interior of pipe P5) extending therethrough, wherein the second lumen is in operative fluid communication with the first container (Higuchi FIG. 1, reservoir 11) and the second end of the first gas supply tube is positioned external to the first container (Higuchi FIG. 1, showing second end of pipe P5 attached to valve 33 external to reservoir 11);
a second container (Higuchi FIG. 1, tank 13) configured to contain a fluid (Higuchi paragraph [0024], “solution within the stock-solution tank 13”), the second container having a fluid outlet (Higuchi FIG. 1, outlet for pipe S1) in selective fluid communication (Higuchi FIG. 1, valve 31; Higuchi paragraph [0042], “the entrance valve 31 is opened and the sending pump 21 is operated. When the water level of the original cleaning solution arrives at the upper limit-sensor (65a and 65b), the entrance valve 31 is closed and the top valve 33 is switched to the gas-filling path.”) with the first fluid inlet of the first container (Higuchi FIG. 1, fluid inlet for liquid pipe P4 leading into reservoir 11);
a second water supply tube (Higuchi FIG. 1, pipe P4) including a first end (Higuchi FIG. 1, first end of pipe P4 coupled to valve 51), a second end (Higuchi FIG. 1, second end of pipe P4 coupled to inlet of reservoir 11), and a third lumen (Higuchi FIG. 1, interior lumen of pipe P4) extending therethrough, wherein the third lumen is in fluid communication with the second container (Higuchi FIG. 1, showing lumen within pipe P4 in fluid communication with tank 13 via pipes S1 and P1-P3) and the second end of the second water supply tube is coupled to the first fluid inlet of the first container (Higuchi FIG. 1, showing pipe P4 coupled to fluid inlet of reservoir 11);
a one-way valve positioned in-line with the second water supply tube (Higuchi paragraph [0025], “a connected state means a situation in which liquid or gas or gas-liquid mixture or the like can be passed between the respective devices in one-direction”); and
a fluid flow control mechanism (Higuchi FIG. 1, valves 31 and 51, and pump 21) positioned in-line with the second water supply tube (Higuchi FIG. 1, valves 31 and 51 positioned in-line with pipe P4), the fluid flow control mechanism configured to selectively fluidly couple the second container with the first container (Higuchi paragraph [0042], “ the entrance valve 31 is opened…When the water level of the original cleaning solution arrives at the upper limit-sensor (65a and 65b), the entrance valve 31 is closed.”).
Regarding Claim 17, Higuchi discloses the features of Claim 16, as described above. Higuchi further discloses wherein the fluid flow control mechanism (Higuchi FIG. 1, valves 31 and 51, and pump 21) is configured to increase a pressure of a fluid within the second water supply tube (Higuchi FIG. 1, pipe P4) to a pressure greater than a pressure within the interior of the first container (Higuchi FIG. 1, reservoir 11; see also fluid flow arrow B in Higuchi pipe P4 going from pump 21 to reservoir 11, causing a pressure-reducing adjustment path in an I-direction as shown for pressure relieve pipe P5).
Regarding Claim 18, Higuchi discloses the features of Claim 16, as described above. Higuchi further discloses wherein the fluid flow control mechanism is configured to supply a flow of fluid to the first container while the first container is pressurized (Higuchi FIG. 1, showing fluid from tank 13 entering reservoir 11, which is pressurized, as evidenced by the pressure-reducing adjustment path in an I-direction as shown for pressure relieve pipe P5).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Higuchi et al. (US PGPUB 2020/0114401 – “Higuchi”) in view of Shimon (US Patent 3,398,743 – “Shimon”).
Regarding Claim 4, Higuchi discloses the features of Claim 1, as described above.
Higuchi does not explicitly disclose wherein the fluid flow control mechanism comprises a squeeze bulb.
Shimon is analogous art in the field of tubular fluid control that teaches wherein the fluid flow control mechanism comprises a squeeze bulb (Shimon, FIG. 1, showing hand bulb 10 connecting container 62 to viscus tube 60; Shimon col. 3 lines 25-33,” A container or receptacle 62 containing the irrigating fluid is provided with a flexible conduit 64 having at its free end a hollow needle 66 which is inserted through the plug 56 at the end of tube 48…Thus, connected to viscus tube 60 and irrigating fluid container 62, the irrigating of the empty viscus organ is effected by first squeezing the hand bulb 10”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute Shimon’s hand bulb for the pump 21 shown in Higuchi FIG. 1. A person having ordinary skill in the art would be motivated to make this simple substitution of one known element for another to obtain the predictable result of a fluid flow control mechanism that is not dependent on a powered pump (see Higuchi paragraph [0039]), such that the system is functional even if power is interrupted.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Higuchi et al. (US PGPUB 2020/0114401 – “Higuchi”) in view of Vining (US PGPUB 2010/0268154 – “Vining”).
Regarding Claim 5, Higuchi discloses the features of Claim 1, as described above.
Although Higuchi discloses that the pump in the fluid flow control mechanism can be various types of pumps (e.g., centrifugal, van, gear, etc. – see Higuchi paragraph [0039]) Higuchi does not explicitly disclose wherein the fluid flow control mechanism comprises a peristaltic pump.
Vining is analogous art in the field of fluid control for an endoscope that teaches wherein the fluid flow control mechanism comprises a peristaltic pump (Vining FIG. 2, enema delivery mechanism 50; Vining paragraph [0027], “delivery mechanism 50 may utilize a roller pump that squeezes flexible plastic tubing connected to the enema container in a repetitive and controlled manner to force the enema fluid in the tube to move forward in a direction towards the patient”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to utilize Vining’s roller pump as the pump 21 shown in Higuchi FIG. 1. A person having ordinary skill in the art would be motivated to make this simple substitution of one known element for another to obtain the predictable result of a fluid flow control mechanism having a roller pump that directly squeezes a fluid line, thus reducing the need for line connectors to the pump that can be prone to leakage.
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Higuchi et al. (US PGPUB 2020/0114401 – “Higuchi”) in view of Bonanno et al. (US Patent 11,266,815 – “Bonanno”).
Regarding Claim 6, Higuchi discloses the features of Claim 1, as described above.
Higuchi does not explicitly disclose wherein the fluid flow control mechanism comprises a third container, a three-way port, and a pressure control device.
Bonanno teaches wherein the fluid flow control mechanism (Bonanno FIG. 2, system 1) comprises a third container (Bonanno FIG. 2, pressure reservoir 80), a three-way port (Bonanno FIG. 2, three-way stopcock 40), and a pressure control device (Bonanno FIG. 2, syringe 70; Bonanno FIG. 8, plenum 44, first connector 46, and second connector 48 of three-way stopcock 40; Bonanno col. 14 lines 23-26, “fluid (e.g., medicament 74) provided from the medicament injector 70 into the plenum 44 will enter through the second connector 48 and exit through the first connector 46.” Because of syringe 70’s coupling with pressure reservoir 80 and connection thereto via three-way stopcock 40, Examiner interprets this injection of fluid/medicament 74 as effecting/controlling the pressure within system 1, including three-way stopcock 40).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Bonanno’s pressure reservoir 80, stopcock 40, and syringe 70 with the container and tube set disclosed by Higuchi. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a syringe system that uses a combination of pressure from both a pressure reservoir as well as a syringe to control a delivery of a medicament to a catheter, such that the static pressure of the pressure reservoir 80 can be selectively augmented by the syringe for delivering the medicament.
Regarding Claim 7, Higuchi in view of Bonanno teaches the features of Claim 6, as described above.
Bonanno further teaches wherein the pressure control device comprises a syringe (Bonanno FIG. 2, syringe 70).
Claims 8-9 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Higuchi et al. (US PGPUB 2020/0114401 – “Higuchi”) in view of Ma et al. (US PGPUB 2021/0186394 – “Ma”).
Regarding Claim 8, Higuchi discloses the features of Claim 1, as described above.
Higuchi does not explicitly disclose wherein the fluid flow control mechanism comprises a slide clamp.
Ma is analogous art in the field of fluid control that teaches wherein the fluid flow control mechanism comprises a slide clamp (Ma FIG. 2C, clamp 54 partially pinching off tube 32).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Ma’s slide clamp with the container and tube set disclosed by Higuchi . A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a fluid flow control mechanism that is able to quickly and visibly control fluid flow through a supply tube, in order to ensure that the supply tube is open or closed, according to the need of the user.
Regarding Claim 9, Higuchi in view of Ma teaches the features of Claim 8, as described above.
Ma further teaches wherein the slide clamp includes a slot (Ma Fig. 2C slot in slide clamp 54) extending through a thickness of the slide clamp, the slot including a first end region having a first width and a second end region having a second width, the second width may be greater than the first width (Ma paragraph [0088], “clamp 54 may include a slide clamp, which may include a slot that becomes progressively narrower”).
Regarding Claim 14, Higuchi discloses the features of Claim 1, as described above.
Higuchi does not explicitly disclose wherein the fluid flow control mechanism comprises a flow control member configured to selectively occlude the second end of the second water supply tube.
Ma is analogous art in the field of fluid control that teaches wherein the fluid flow control mechanism comprises a flow control member (Ma FIG. 2C, clamp 54) configured to selectively occlude the second end of the second water supply tube (Ma FIG. 2C, clamp 54 partially pinching off tube 32, which Examiner interprets as structurally analogous to pipe P4 in Higuchi FIG. 1).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Ma’s slide clamp with the container and tube set disclosed by Higuchi . A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a fluid flow control mechanism that is able to quickly and visibly control fluid flow through a supply tube, in order to ensure that the supply tube is open or closed, according to the need of the user.
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Higuchi et al. (US PGPUB 2020/0114401 – “Higuchi”) in view of Chen (US Patent 6,261,267 – “Chen”).
Regarding Claim 10, Higuchi discloses the features of Claim 1, as described above.
Higuchi does not explicitly disclose wherein the fluid flow control mechanism comprises a roller clamp.
Chen is analogous art in the field of tubular fluid control that teaches wherein the fluid flow control mechanism comprises a roller clamp (Chen FIG. 1, showing roller clamp 400 controlling tubular fluid flow of fluid from fluid container 200 to catheter 600).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Chen’s roller clamp with the container and tube set disclosed by Higuchi. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a container and tube set that is able to quickly and visibly control fluid flow through a supply tube, in order to ensure that the supply tube is open or closed, according to the need of the user.
Regarding Claim 11, Higuchi in view of Chen teaches discloses the features of Claim 10, as described above.
Chen further teaches wherein the roller clamp (Examiner-annotated Chen FIG. 1 shown below, roller clamp 400) comprises a housing (Chen FIG. 1, housing) having a profiled bottom surface (Chen FIG. 1, profiled bottom surface) and a roller (Chen FIG. 1, roller).
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Higuchi et al. (US PGPUB 2020/0114401 – “Higuchi”) in view of Yan et al. (US PGPUB 2021/0068732 – “Yan”).
Regarding Claim 12, Higuchi discloses the features of Claim 1, as described above.
Higuchi does not explicitly disclosed wherein the fluid flow control mechanism comprises a pinch clamp.
Yan is analogous art in the field of fluid control in a tube that teaches the fluid flow control mechanism comprises a pinch clamp (Yan FIG. 1C, showing pinch clamp device 10 pinching off tube 42).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Yan’s roller clamp with the container and tube set disclosed by Higuchi. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a container and tube set that is able to quickly and visibly control fluid flow through a supply tube, in order to ensure that the supply tube is open or closed, according to the need of the user.
Regarding Claim 13, Higuchi in view of Yan teaches discloses the features of Claim 12, as described above.
Yan further teaches wherein the pinch clamp comprises a first plate (Examiner-annotated Yan FIG. 1A shown below, first plate), a second plate (Yan FIG. 1A, second plate), and a hinge member (Yan FIG. 1A, hinge 32) interconnecting the first and second plates, the second plate including a first clamping feature (Yan FIG. 1A, first clamping surface 22) and a second clamping feature (Yan FIG. 1A, gap 34 that engages with first end 26 of second arm 24 in order to secure the position of clamping surface 30 relative to clamping surface 22).
PNG
media_image1.png
634
576
media_image1.png
Greyscale
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Higuchi et al. (US PGPUB 2020/0114401 – “Higuchi”) in view of Yan et al. (US PGPUB 2021/0068732 – “Yan”) and Gustafson et al. (US PGPUB 2001/0011555 – “Gustafson”).
Regarding Claim 15, Higuchi in view of Yan teaches the features of Claim 13, as described above.
Higuchi in view of Yan does not explicitly teach wherein the fluid flow control mechanism further comprises a floating stopper configured to selectively occlude a vent tube, the vent tube in fluid communication with an interior of the first container.
Gustafson is analogous art in the field of fluid control (Gustafson FIG. 1, showing blood handling system that includes a chamber 10; see analogous cylinder 110 in Gustafson FIG. 4) that teaches wherein the fluid flow control mechanism further comprises a floating stopper (Gustafson FIG. 1, upper check ball 74) configured to selectively occlude a vent tube (Gustafson FIG. 4, gas vent 170, analogous to gas vent port 70 shown in Gustafson FIG. 1; Gustafson FIG. 3, valve seat 172 for gas vent 170 shown in Gustafson FIG. 4), the vent tube in fluid communication with an interior of the first container (Gustafson FIG. 3, upper check ball stopper 174 within cylinder 110, analogous to Gustafson chamber 10; Gustafson paragraph [0017], “gas vent ball is floated into place on the vent valve seat, closing the vent port”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Gustafson’s venting system with the container and tube set taught by Higuchi in view of Yan. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a container and tube set that is able to vent/purge bubbles that occur within tubing in the container and tube set taught by Higuchi in view of Yan (see Abstract of Gustafson).
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Higuchi et al. (US PGPUB 2020/0114401 – “Higuchi”) in view of Gustafson et al. (US PGPUB 2001/0011555 – “Gustafson”).
Regarding Claim 19, Higuchi discloses:
A container and tube set (Higuchi FIG. 1, unit 17 combined with tank 13 and gas cylinder 15) arranged and configured to couple to an endoscope (Higuchi FIG. 1, endoscope 19) for use in an endoscopic procedure (intended use that provides no structural limitations), the container and tube set comprising:
a first container (Higuchi FIG. 1, reservoir 11) configured to contain a fluid (Higuchi paragraph [0023], “a tubular solution reservoir 11 in which a pH-adjusted solution whose pH is adjusted is reserved”), the first container having a first fluid inlet (Higuchi FIG. 1, fluid inlet for liquid pipe P4) and a port (Higuchi FIG. 1, fluid outlet for liquid pipe P6) in fluid communication with a bottom portion (Higuchi FIG. 1, bottom of reservoir 11) thereof;
a first water supply tube including a first end (Higuchi FIG. 1, pipe P1), a second end (Higuchi FIG. 1, pipe P3), and a first lumen (Higuchi FIG. 1, interior of pipes P1-P3) extending therethrough, wherein the first lumen is in selective fluid communication (Higuchi FIG. 1, valve 31, selectively controlling fluid flowing into the interior lumen of pipes P1-P3; Higuchi paragraph [0024], “an entrance valve 31 connected to an upper side of the solution reservoir 11 and a sending pump 21 connected to the entrance valve 31”) with the first container (Higuchi FIG. 1, reservoir 11) and the second end of the first water supply tube is positioned external to the container (Higuchi FIG. 1, showing pipe P3 external to reservoir 11);
a first gas supply tube (Higuchi FIG. 1, pipe P5 from valve 33 to supply carbon dioxide gas in the E-direction to the top of reservoir 11; see Higuchi paragraph [0033]) including a first end (Higuchi FIG. 1, first end of pipe P5 entering reservoir 11), a second end (Higuchi FIG. 1, second end of pipe P5 attached to valve 33), and a second lumen (Higuchi FIG. 1, interior of pipe P5) extending therethrough, wherein the second lumen is in operative fluid communication with the first container (Higuchi FIG. 1, reservoir 11) and the second end of the first gas supply tube is positioned external to the first container (Higuchi FIG. 1, showing second end of pipe P5 attached to valve 33 external to reservoir 11);
a second container (Higuchi FIG. 1, tank 13) configured to contain a fluid (Higuchi paragraph [0024], “solution within the stock-solution tank 13”), the second container having a fluid outlet (Higuchi FIG. 1, outlet for pipe S1) in selective fluid communication (Higuchi FIG. 1, valve 31; Higuchi paragraph [0042], “the entrance valve 31 is opened and the sending pump 21 is operated. When the water level of the original cleaning solution arrives at the upper limit-sensor (65a and 65b), the entrance valve 31 is closed and the top valve 33 is switched to the gas-filling path.”) with the first fluid inlet of the first container (Higuchi FIG. 1, fluid inlet for liquid pipe P4 leading into reservoir 11);
a vent tube (Higuchi FIG. 1, tube P5 for venting reservoir 11 in the I-direction) including a first end (Higuchi FIG. 1, end of tube P5 connected to top valve 33), (Higuchi FIG. 1, end of tube P5 connected to top of reservoir 11), and a third lumen extending therethrough (Higuchi FIG. 1, lumen within tube P5 that accommodates venting in the depicted I-direction);
a second water supply tube (Higuchi FIG. 1, pipe P4) including a first end (Higuchi FIG. 1, first end of pipe P4 coupled to valve 51), a second end (Higuchi FIG. 1, second end of pipe P4 coupled to inlet of reservoir 11), and a third lumen (Higuchi FIG. 1, interior lumen of pipe P4) extending therethrough, wherein the third lumen is in fluid communication with the second container (Higuchi FIG. 1, showing lumen within pipe P4 in fluid communication with tank 13 via pipes S1 and P1-P3) and the second end of the second water supply tube is coupled to the first fluid inlet of the first container (Higuchi FIG. 1, showing pipe P4 coupled to fluid inlet of reservoir 11); and
a fluid flow control mechanism (Higuchi FIG. 1, valves 31 and 51, and pump 21) positioned in-line with the second water supply tube (Higuchi FIG. 1, valves 31 and 51 positioned in-line with pipe P4), the fluid flow control mechanism configured to selectively fluidly couple the second container with the first container (Higuchi paragraph [0042], “ the entrance valve 31 is opened…When the water level of the original cleaning solution arrives at the upper limit-sensor (65a and 65b), the entrance valve 31 is closed.”).
Higuchi does not explicitly disclose a vent tube including a first end, a second end, and a third lumen extending therethrough, wherein the third lumen is in selective fluid communication with the first container.
Gustafson is analogous art in the field of tubular fluid control that teaches a vent tube (Gustafson FIG. 4, gas vent 170, analogous to gas vent port 70 shown in Gustafson FIG. 1; Gustafson FIG. 3, valve seat 172 for gas vent 170 shown in Gustafson FIG. 4) including a first end (Gustafson FIG. 1, top part of gas vent 70), a second end (Gustafson FIG. 1, bottom part of gas vent 70), and a third lumen extending therethrough (Gustafson paragraph [0053], “gas vent 170 for purging gas”, indicating the presence of a lumen within gas vent 170, wherein the third lumen is in selective fluid communication with the first container (Gustafson FIG. 3, upper check ball stopper 174 within cylinder 110, analogous to Gustafson chamber 10; Gustafson paragraph [0017], “gas vent ball is floated into place on the vent valve seat, closing the vent port”; Examiner interprets this as teaching that the upper check ball stopper 174 causes selective fluid communication between the interior of the cylinder 110 and the gas vent 170).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Gustafson’s venting system with the container and tube set disclosed by Higuchi A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a container and tube set that is able to vent/purge bubbles that occur within tubing in the container and tube set disclosed by Higuchi (see Abstract of Gustafson).
Regarding Claim 20, Higuchi in view of Gustafson teaches the features of Claim 19, as described above.
Higuchi further discloses wherein the fluid flow control mechanism is configured to fluidly couple the vent tube (Higuchi FIG. 1, tube P5) with atmosphere (Higuchi paragraph [0033], “release of the gas and the like in the solution reservoir 11 to atmosphere in an I-direction (the pressure-reducing adjustment-path).) prior to fluidly coupling the second container with the first container (intended use, providing not additional structural limitations).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure include, but are not limited to:
Massi et al. (US PGPUB 2013/0226114 – “Massi”), which teaches in Massi FIG. 2 a fluid drainage system 200 that includes a pump bulb 220 and a roller clamp 206 for controlling fluid movement through a tube 224; and
Pollock et al. (US PGPUB 2022/0192478 – “Pollock”), which teaches in Pollock FIG. 14B an integrated container and tube set 1400b that has a low-pressure chamber 1437-2 connected to a high-pressure chamber 1437-1 via a side channel 1433 that has an internal check valve 1499b to control fluid flow direction.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIM BOICE whose telephone number is (571)272-6565. The examiner can normally be reached Monday-Friday 9:00am - 5:00pm Eastern.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at (571)272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
JIM BOICE
Examiner
Art Unit 3795
/JAMES EDWARD BOICE/Examiner, Art Unit 3795
Prosecution Insights