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 .
Status of the Claims
Claims 1-20 are currently pending. Claims 1, 4-8, 10-11, 14-18, and 20 are currently amended. Claims 1-20 are currently rejected.
Response to Arguments
Applicant's arguments filed 05/07/2026 have been fully considered but they are not persuasive. Note that the rejections have been updated to address the amended claim language.
Applicant argues that Gray modified by Gray50 fail to teach the new limitation of “a fixed opening that physically translates along the fluid path so as to switch between an open state and a closed state”. Examiner disagrees with the characterization of Gray and Gray50 and notes that the “fixed opening that physically translates” presents several 112(b) issues, noted below in the rejections under 112.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., movement of a valve inlet/outlet) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Although claims 8 and 18 have been amended to include more detail regarding the “bourdon tube”, please note that the specification still does not clearly redefine the term.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 lines 5-6 “a fixed opening that physically translates along the fluid path so as to switch between an open state and a closed state”. It is unclear from the claim language how the opening is both “fixed” and “physically translates”. With respect to what is the opening “fixed”? With respect to what does the opening “physically translate”? It is unclear whether the opening is “fixed” open, “fixed” in space, or “fixed” relative to another structure. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 8 line 4 recites the limitation “an opening”. Claim 1, from which claim 8 depends, introduces “a fixed opening” on line 5. It is unclear whether the instance of this limitation in the dependent claim is meant to introduce a new structure (in which case the naming convention should be altered to better distinguish the structures) or refer back to the same structure earlier introduced (in which case the article should be changed to “the” and the naming convention altered to match). For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 11 lines 6-7 “a fixed opening that physically translates along the fluid path so as to switch between an open state and a closed state”. It is unclear from the claim language how the opening is both “fixed” and “physically translates”. With respect to what is the opening “fixed”? With respect to what does the opening “physically translate”? It is unclear whether the opening is “fixed” open, “fixed” in space, or “fixed” relative to another structure. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 18 line 4 recites the limitation “an opening”. Claim 11, from which claim 18 depends, introduces “a fixed opening” on line 6. It is unclear whether the instance of this limitation in the dependent claim is meant to introduce a new structure (in which case the naming convention should be altered to better distinguish the structures) or refer back to the same structure earlier introduced (in which case the article should be changed to “the” and the naming convention altered to match). For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999).
The term “bourdon tube” in claims 8, 9, 18, and 19 is used by the claim to mean “a tube with a first opening that is always open and a second opening which opens at a certain pressure to act as a valve,” while the accepted meaning is “a pressure indicating device…ben[t] into a C shape…One end is fixed and connected to the pressure to be measured. The other end is closed and left free.” (see included pdf of Chapter 12 of Industrial Instrumentation section 12.4.3) The term is indefinite because the specification does not clearly redefine the term.
For the purposes of examination, any of the meanings described has been interpreted to meet the claim limitation.
Claims 2-10 and 12-20 are rejected at least for depending, directly or indirectly, on a claim rejected under 112b, since claims inherit the deficiencies of those claims on which they depend.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-7 and 11-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gray (US 20120209183 A1; hereafter Gray) in view of a detailed embodiment of Gray, best shown in figs. 50 and 51 (hereafter Gray50).
Regarding claim 1, Gray discloses a fluid delivery device ([0196] Referring now to FIG. 3, a block diagram of a further embodiment employing fluidic principles is shown. A flow line 310 couples a reservoir 20, a pumping assembly 16, a dispensing assembly 120, and an exit assembly 17.), comprising:
a fluid path (flow line 310 in fig. 3);
a pressure source (pumping assembly 16, fig. 3, [0196]; also see pumping assembly noted in [0327]) fluidically coupled to a fluid source (reservoir 20, fig. 3, [0196]) storing a fluid ([0195] the pumping assembly 16 pumps fluid from a reservoir 20 to a dispensing assembly 120.).
Gray fig. 3 does not explicitly include a pressure-based control valve, though [0327] notes that “In some of the embodiments of the pumping mechanism described above, one or more aspects of the following valving operation description is relevant”.
Gray50, a detailed embodiment of Gray, best shown in figs. 50 and 51, teaches a pressure-based control valve (valve assembly 4000, fig. 50, [0327]) arranged in the fluid path (inlet 4030, inlet chamber 4050, and valve outlet 4040 shown in fig. 51, note fig. 50 shows the valve arranged in the fluid path) and including a fixed opening (see opening indicated in Modified Figs. 50 and 51 below) that physically translates (see 112b interpretation above) along the fluid path so as to switch between an open state (see fig. 51) and a closed state (see fig. 50) (see Modified Figs. 50 and 51 which show that the opening translates along the fluid path portion inlet chamber 4050) in response to a fluid delivery pressure applied by the pressure source in an upstream portion of the fluid path against the pressure-based control valve ([0327] As shown in FIG. 51, when the pumping assembly is actuated, sufficient pressure should be generated to unseat the membrane 4060 and the poppet 4020 from the valve seat 4070 thereby allowing fluid to flow from the valve inlet 4030, through an inlet chamber 4050 and to the valve outlet 4040.),
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wherein the pressure-based control valve is in the open state (see open state in fig. 51) responsive to the fluid delivery pressure being equal to or greater than a cracking pressure ([0329] pressure necessary to open the valve, i.e., "cracking pressure"; note that [0327] describes sufficient pressure needs to be generated to open the valve).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the pumping mechanism of fig. 3 to include the pressure-based control valve of figs. 50 and 51, since Gray [0327] notes that “In some of the embodiments of the pumping mechanism described above, one or more aspects of the following valving operation description is relevant” and both figures appear as aspects of linked fluid delivery systems. One would have been motivated to make the modification because, as noted by Gray [0327] “back pressure created by the action of a resilient dispensing assembly should be insufficient to cause retrograde flow through the flow biasing valve 4000”. Thus, the valve ensures fluid moves through the system in the correct direction.
Regarding claim 2, Gray modified by Gray50 discloses the fluid delivery device of claim 1, as described above. Gray further discloses the fluid delivery device comprising a wearable insulin pump ([0193] FIG. 1 shows a patient 12 wearing a fluid-delivery device 10; [0190] An exemplary use of embodiments of the device is for the delivery of insulin to diabetic patients).
Regarding claim 3, Gray modified by Gray50 discloses the fluid delivery device of claim 1, as described above, including the pressure source comprising a fluid delivery pump (pumping assembly 16, fig. 3, [0196]) having a form of at least one of a positive displacement pump, a syringe-style pump, a reciprocating pump, a MEMS pump, or a piezoelectric pump ([0202] As discussed above, the sensor 550 repeatedly measures a parameter, such as a displacement, or a thermodynamic variable or capacitance, that can be related to the volume of the resilient dispensing chamber 122. The volume measurements produced by the sensor 550 may be used to control, through a feedback loop, the timing and rate at which the pumping assembly pumps fluid to the dispensing chamber 122 so that the proper flow of fluid is delivered to exit assembly 17 and to a subsequent line, and thence, for example, to the patient.)
Regarding claim 5, Gray modified by Gray50 discloses the fluid delivery device of claim 1, as described above, including the pressure-based control valve (valve assembly 4000, fig. 50, [0327]) comprising a stop element (mounting of valve spring 4010 shown in figs. 50 and 51) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to prevent translation of the pressure-based control valve along the fluid path beyond a specified distance (see figs. 50 and 51, note that the valve cannot move farther than the base of the biasing spring which is fixed to the housing).
Regarding claim 6, Gray modified by Gray50 discloses the fluid delivery device of claim 1, as described above, wherein the pressure-based control valve is in the closed state (see fig. 50) when the fluid delivery pressure is below the cracking pressure (see fig. 50, [0327], and [0329] previously noted in the 103 rejection of claim 1 above) (valve must be closed when fluid delivery pressure is below the cracking pressure because of the following definition: [0329] pressure necessary to open the valve, i.e., "cracking pressure").
Regarding claim 7, Gray modified by Gray50 discloses the fluid delivery device of claim 1, as described above. Gray further discloses comprising a control system ([0198] The controller 501 may include a processor and control circuitry for actuating a pumping assembly 16 to pump fluid to the dispensing assembly 120.) to control the fluid delivery pressure to cause the pressure-based control valve to inject a dosage of the fluid into a patient ([0196] the controller 501 can adjust the timing or extent of actuation of the pumping assembly 16 to achieve a desired basal or bolus flow rate and/or to deliver a desired basal or bolus cumulative dose) (Note that since the controller controls flow rate, and the valve is actuated by fluid pressure, the controller controls movement of the valve by modulating the flow conditions.).
Regarding claim 11, Gray discloses a fluid delivery method, comprising:
providing a fluid delivery device ([0196] Referring now to FIG. 3, a block diagram of a further embodiment employing fluidic principles is shown. A flow line 310 couples a reservoir 20, a pumping assembly 16, a dispensing assembly 120, and an exit assembly 17.), comprising:
a fluid path (flow line 310 in fig. 3);
a pressure source (pumping assembly 16, fig. 3, [0196]; also see pumping assembly noted in [0327]) fluidically coupled to a fluid source (reservoir 20, fig. 3, [0196]) storing a fluid ([0195] the pumping assembly 16 pumps fluid from a reservoir 20 to a dispensing assembly 120.), and
controlling the fluid delivery pressure via the pressure source ([0196] the controller 501 can adjust the timing or extent of actuation of the pumping assembly 16 to achieve a desired basal or bolus flow rate and/or to deliver a desired basal or bolus cumulative dose).
Gray fig. 3 does not explicitly include a pressure-based control valve, though [0327] notes that “In some of the embodiments of the pumping mechanism described above, one or more aspects of the following valving operation description is relevant”.
Gray50, a detailed embodiment of Gray, best shown in figs. 50 and 51, teaches a pressure-based control valve (valve assembly 4000, fig. 50, [0327]) arranged in the fluid path (inlet 4030, inlet chamber 4050, and valve outlet 4040 shown in fig. 51, note fig. 50 shows the valve arranged in the fluid path) and including a fixed opening (see opening indicated in Modified Figs. 50 and 51, included again below) that physically translates (see 112b interpretation above) along the fluid path so as to switch between an open state (see fig. 51) and a closed state (see fig. 50) (see Modified Figs. 50 and 51 which show that the opening translates along the fluid path portion inlet chamber 4050) in response to a fluid delivery pressure applied by the pressure source in an upstream portion of the fluid path against the pressure-based control valve ([0327] As shown in FIG. 51, when the pumping assembly is actuated, sufficient pressure should be generated to unseat the membrane 4060 and the poppet 4020 from the valve seat 4070 thereby allowing fluid to flow from the valve inlet 4030, through an inlet chamber 4050 and to the valve outlet 4040.),
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controlling the fluid delivery pressure via the pressure source to place ([0327] when the pumping assembly is actuated, sufficient pressure should be generated to unseat the membrane 4060 and the poppet 4020 from the valve seat 4070) the pressure-based control valve in the open state (see open state in fig. 51) responsive to the fluid delivery pressure being equal to or greater than a cracking pressure ([0329] pressure necessary to open the valve, i.e., "cracking pressure"; note that [0327] describes sufficient pressure needs to be generated to open the valve).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the pumping mechanism of fig. 3 to include the pressure-based control valve of figs. 50 and 51, since Gray [0327] notes that “In some of the embodiments of the pumping mechanism described above, one or more aspects of the following valving operation description is relevant” and both figures appear as aspects of linked fluid delivery systems. One would have been motivated to make the modification because, as noted by Gray [0327] “back pressure created by the action of a resilient dispensing assembly should be insufficient to cause retrograde flow through the flow biasing valve 4000”. Thus, the valve ensures fluid moves through the system in the correct direction.
Regarding claim 12, Gray modified by Gray50 discloses the method of claim 11, as described above. Gray further discloses the fluid delivery device comprising a wearable insulin pump ([0193] FIG. 1 shows a patient 12 wearing a fluid-delivery device 10; [0190] An exemplary use of embodiments of the device is for the delivery of insulin to diabetic patients).
Regarding claim 13, Gray modified by Gray50 discloses the method of claim 11, as described above, including the pressure source comprising a fluid delivery pump (pumping assembly 16, fig. 3, [0196]) having a form of at least one of a positive displacement pump, a syringe-style pump, a reciprocating pump, a MEMS pump, or a piezoelectric pump ([0202] As discussed above, the sensor 550 repeatedly measures a parameter, such as a displacement, or a thermodynamic variable or capacitance, that can be related to the volume of the resilient dispensing chamber 122. The volume measurements produced by the sensor 550 may be used to control, through a feedback loop, the timing and rate at which the pumping assembly pumps fluid to the dispensing chamber 122 so that the proper flow of fluid is delivered to exit assembly 17 and to a subsequent line, and thence, for example, to the patient.)
Regarding claim 15, Gray modified by Gray50 discloses the method of claim 11, as described above, including the pressure-based control valve (valve assembly 4000, fig. 50, [0327]) comprising a stop element (mounting of valve spring 4010 shown in figs. 50 and 51) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to prevent translation of the pressure-based control valve along the fluid path beyond a specified distance (see figs. 50 and 51, note that the valve cannot move farther than the base of the biasing spring which is fixed to the housing).
Regarding claim 16, Gray modified by Gray50 discloses the method of claim 11, as described above, wherein the pressure-based control valve is in the closed state (see fig. 50) when the fluid delivery pressure is below the cracking pressure (see fig. 50, [0327], and [0329] previously noted in the 103 rejection of claim 1 above) (valve must be closed when fluid delivery pressure is below the cracking pressure because of the following definition: [0329] pressure necessary to open the valve, i.e., "cracking pressure").
Regarding claim 17, Gray modified by Gray50 discloses the method of claim 11, as described above. Gray further discloses comprising providing a control system ([0198] The controller 501 may include a processor and control circuitry for actuating a pumping assembly 16 to pump fluid to the dispensing assembly 120.) to control the fluid delivery pressure to cause the pressure-based control valve to inject a dosage of the fluid into a patient ([0196] the controller 501 can adjust the timing or extent of actuation of the pumping assembly 16 to achieve a desired basal or bolus flow rate and/or to deliver a desired basal or bolus cumulative dose) (Note that since the controller controls flow rate, and the valve is actuated by fluid pressure, the controller controls movement of the valve by modulating the flow conditions.).
Claim(s) 4 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gray modified by Gray50 as applied to claim 1 or 11 above, and further in view of Schneeberger (US 20100028170 A1; hereafter Schneeberger).
Regarding claim 4, Gray modified by Gray50 discloses the fluid delivery device of claim 1, as described above, including comprising a sealing element (see 112f interpretation above) (valve seat 4070, [0327], fig. 50) to seal the fixed opening (fixed opening cannot move farther than sealing element/valve seat 4070, as shown in fig. 50, and is thus sealed in the closed state) in the pressure-based control valve when the fluid delivery pressure is below the cracking pressure ([0327] A valve spring 4010 exerts force on a poppet 4020 to sealingly press a valve membrane 4060 against a valve seat 4070 surrounding a terminal aperture of a valve outlet 4040.) (valve must be closed when fluid delivery pressure is below the cracking pressure because of the following definition: [0329] pressure necessary to open the valve, i.e., "cracking pressure").
Gray modified by Gray50 is silent to the sealing element being “formed of a sealing material, including, without limitation, an elastomer, rubber, silicon, a polymer, and/or the like” (see 112f interpretation above).
Schneeberger, in the art of pressure responsive valves ([0083]), teaches wherein a sealing element (valve seat 11a, fig. 4, [0073]) is formed of a sealing material in accordance with the 112f interpretation above ([0073] notes that that the valve seat 11a is made of soft material, [0075] notes that the soft material may be an elastomer polymer such as silicone).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the sealing element to be made of an elastomer as taught by Schneeberger since Schneeberger also teaches a pressure-responsive valve. Additionally, it has been held that the selection of a known material based on its suitability for its intended use is only a matter of ordinary skill in the art (See MPEP 2144.07). One would have been motivated to make the modification by Schneeberger [0034] which notes that soft, flexible materials, such as elastomers as silicone note in [0033], provide a decrease in the risk of leaks compared to closure contact zones made out of hard materials.
Regarding claim 14, Gray modified by Gray50 discloses the method of claim 11, as described above, including comprising providing a sealing element (see 112f interpretation above) (valve seat 4070, [0327], fig. 50) to seal the fixed opening (fixed opening cannot move farther than sealing element/valve seat 4070, as shown in fig. 50, and is thus sealed in the closed state) in the pressure-based control valve when the fluid delivery pressure is below the cracking pressure ([0327] A valve spring 4010 exerts force on a poppet 4020 to sealingly press a valve membrane 4060 against a valve seat 4070 surrounding a terminal aperture of a valve outlet 4040.) (valve must be closed when fluid delivery pressure is below the cracking pressure because of the following definition: [0329] pressure necessary to open the valve, i.e., "cracking pressure").
Gray modified by Gray50 is silent to the sealing element being “formed of a sealing material, including, without limitation, an elastomer, rubber, silicon, a polymer, and/or the like” (see 112f interpretation above).
Schneeberger, in the art of pressure responsive valves ([0083]), teaches wherein a sealing element (valve seat 11a, fig. 4, [0073]) is formed of a sealing material in accordance with the 112f interpretation above ([0073] notes that that the valve seat 11a is made of soft material, [0075] notes that the soft material may be an elastomer polymer such as silicone).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the sealing element to be made of an elastomer as taught by Schneeberger since Schneeberger also teaches a pressure-responsive valve. Additionally, it has been held that the selection of a known material based on its suitability for its intended use is only a matter of ordinary skill in the art (See MPEP 2144.07). One would have been motivated to make the modification by Schneeberger [0034] which notes that soft, flexible materials, such as elastomers as silicone note in [0033], provide a decrease in the risk of leaks compared to closure contact zones made out of hard materials.
Claim(s) 8-9 and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gray modified by Gray50 as applied to claim 1 or 11 above, and further in view of Zeisloft (US 3125118 A; hereafter Zeisloft).
Regarding claim 8, Gray modified by Gray50 discloses the fluid delivery device of claim 1, as described above.
Gray is silent to the pressure-based control valve comprising a bourdon tube (see 112b interpretation above).
Zeisloft, directed to a throttling valve comprising a pressure responsive Bourdon tube, teaches a pressure-based control valve (Bourdon tube 33’ and elastic tube 31’, fig. 8, col. 3 ln. 34-43 “FIGURE 8 is a fragmentary view of a modification of the structure of FIGURE 6”; see also fig. 6) comprising a bourdon tube (Bourdon tube 33’, fig. 8) (see 112b interpretation above), having a curved configuration in the closed state and transitioning to straighten in response to an internal fluid pressure reaching a cracking pressure (col. 3 ln. 23-25 “Increase in pressure in either of tubes 31 and 33 with respect to the pressure in chamber 20 tends to straighten both tubes”), wherein straightening of the tube moves an opening (distalmost slit 32, see figs. 6/8) at a distal end of the tube into fluid communication with a downstream conduit (col. 3 ln. 40-43, “an increase in pressure in either of tubes 31' or 33' tends to open the valve”).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Gray modified by Gray50 to, instead of having the valve open due to fluid pressure overcoming a spring force, have a pressure-sensitive Bourdon tube flex straight under pressure thus opening the slit to allow fluid through at the appropriate pressure, as taught by Zeisloft, since both references deal with pressure-responsive valve arrangements which open in response to increased pressure. Since both references employ pressure-responsive valves opening at a threshold pressure, it would have been an obvious matter of simple substitution of one known element (the Bourdon tube actuation mechanism of Zeisloft) for another (the spring actuated mechanism of Gray), and the results of the substitution would have been predictable due to the teachings of both references that the valve is actuated by pressure. (See MPEP 2143(I)(B).)
Regarding claim 9, Gray modified by Gray50 and Zeisloft discloses the fluid delivery device of claim 8, as described above, including the bourdon tube (Zeisloft: Bourdon tube 33/33’, fig. 6/8) comprising a C-shaped tube (see curved Bourdon tube 33/33’ in Zeisloft fig. 6/8) configured to straighten in response to the cracking pressure to enter the open state (col. 3 ln. 40-43, “an increase in pressure in either of tubes 31' or 33' tends to open the valve”).
Regarding claim 18, Gray modified by Gray50 discloses the method of claim 11, as described above.
Gray is silent to the pressure-based control valve comprising a bourdon tube (see 112b interpretation above).
Zeisloft, directed to a throttling valve comprising a pressure responsive Bourdon tube, teaches a pressure-based control valve (Bourdon tube 33’ and elastic tube 31’, fig. 8, col. 3 ln. 34-43 “FIGURE 8 is a fragmentary view of a modification of the structure of FIGURE 6”; see also fig. 6) comprising a bourdon tube (Bourdon tube 33’, fig. 8) (see 112b interpretation above), having a curved configuration in the closed state and transitioning to straighten in response to an internal fluid pressure reaching a cracking pressure (col. 3 ln. 23-25 “Increase in pressure in either of tubes 31 and 33 with respect to the pressure in chamber 20 tends to straighten both tubes”), wherein straightening of the tube moves an opening (distalmost slit 32, see figs. 6/8) at a distal end of the tube into fluid communication with a downstream conduit (col. 3 ln. 40-43, “an increase in pressure in either of tubes 31' or 33' tends to open the valve”).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Gray modified by Gray50 to, instead of having the valve open due to fluid pressure overcoming a spring force, have a pressure-sensitive Bourdon tube flex straight under pressure thus opening the slit to allow fluid through at the appropriate pressure, as taught by Zeisloft, since both references deal with pressure-responsive valve arrangements which open in response to increased pressure. Since both references employ pressure-responsive valves opening at a threshold pressure, it would have been an obvious matter of simple substitution of one known element (the Bourdon tube actuation mechanism of Zeisloft) for another (the spring actuated mechanism of Gray), and the results of the substitution would have been predictable due to the teachings of both references that the valve is actuated by pressure. (See MPEP 2143(I)(B).)
Regarding claim 19, Gray modified by Gray50 and Zeisloft discloses the fluid delivery device of claim 8, as described above, including the bourdon tube (Zeisloft: Bourdon tube 33/33’, fig. 6/8) comprising a C-shaped tube (see curved Bourdon tube 33/33’ in Zeisloft fig. 6/8) configured to straighten in response to the cracking pressure to enter the open state (col. 3 ln. 40-43, “an increase in pressure in either of tubes 31' or 33' tends to open the valve”).
Claim(s) 10 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gray modified by Gray50 and Zeisloft, or alternatively over Gray modified by Gray50, Zeisloft, and further in view of Darrah (US 20140228755 A1; hereafter Darrah).
Regarding claim 10, Gray modified by Gray50 and Zeisloft discloses the fluid delivery device of claim 8, as described above. Gray further teaches comprising a control system ([0198] The controller 501 may include a processor and control circuitry for actuating a pumping assembly 16 to pump fluid to the dispensing assembly 120.) to control the fluid delivery pressure to cause the pressure-based flow control valve to inject a dosage of the fluid into a patient ([0196] the controller 501 can adjust the timing or extent of actuation of the pumping assembly 16 to achieve a desired basal or bolus flow rate and/or to deliver a desired basal or bolus cumulative dose) (Note that since the controller controls flow rate, and the valve is actuated by fluid pressure, the controller controls movement of the valve by modulating the flow conditions.) based, at least in part, on a flow rate determined based on Poiseuille’s law (Examiner notes that since Poiseuille’s law is a law of fluid dynamics, the relationship between the fluid pressure and the flow rate is inherently based, at least in part, on Poiseuille’s law.).
Alternatively, Gray as modified is silent to the flow rate being based, at least in part, on a flow rate determined based on Poiseuille’s law.
Darrah, in the art of fluid delivery systems, teaches a control system (controller noted in [0077]) to control the fluid delivery pressure based, at least in part, on a flow rate ([0077] A processing unit or controller may be actuated to control the pressure exerted on the fluid container and thus, the fluid flow rate out of the fluid container.) determined based on Poiseuille’s law ([0126] It is well known that laminar fluid flow Q in a rigid cylindrical tube with radius r and length L can be described by Poiseuille's equation).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Gray modified by Gray50 and Zeisloft to have the controller 501 of Gray calculate the fluid delivery pressure based on Poiseuille’s law since, as taught by Darrah, Poiseuille’s equation is a well-known expression of fluid flow in a cylindrical tube. One would have been motivated to make the modification because Poiseuille’s law is well known and would provide a good estimate of the flow rate/fluid pressure under laminar conditions.
Regarding claim 20, Gray modified by Gray50 and Zeisloft discloses the method of claim 18, as described above. Gray further teaches comprising a control system ([0198] The controller 501 may include a processor and control circuitry for actuating a pumping assembly 16 to pump fluid to the dispensing assembly 120.) to control the fluid delivery pressure to cause the pressure-based flow control valve to inject a dosage of the fluid into a patient ([0196] the controller 501 can adjust the timing or extent of actuation of the pumping assembly 16 to achieve a desired basal or bolus flow rate and/or to deliver a desired basal or bolus cumulative dose) (Note that since the controller controls flow rate, and the valve is actuated by fluid pressure, the controller controls movement of the valve by modulating the flow conditions.) based, at least in part, on a flow rate determined based on Poiseuille’s law (Examiner notes that since Poiseuille’s law is a law of fluid dynamics, the relationship between the fluid pressure and the flow rate is inherently based, at least in part, on Poiseuille’s law.).
Alternatively, Gray as modified is silent to the flow rate being based, at least in part, on a flow rate determined based on Poiseuille’s law.
Darrah, in the art of fluid delivery systems, teaches a control system (controller noted in [0077]) to control the fluid delivery pressure based, at least in part, on a flow rate ([0077] A processing unit or controller may be actuated to control the pressure exerted on the fluid container and thus, the fluid flow rate out of the fluid container.) determined based on Poiseuille’s law ([0126] It is well known that laminar fluid flow Q in a rigid cylindrical tube with radius r and length L can be described by Poiseuille's equation).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Gray modified by Gray50 and Zeisloft to have the controller 501 of Gray calculate the fluid delivery pressure based on Poiseuille’s law since, as taught by Darrah, Poiseuille’s equation is a well-known expression of fluid flow in a cylindrical tube. One would have been motivated to make the modification because Poiseuille’s law is well known and would provide a good estimate of the flow rate/fluid pressure under laminar conditions.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 07/23/2026
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