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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed 06/16/2023 has/have been considered by the Examiner.
The information disclosure statement filed 06/16/2023 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
Specifically, although a copy of “Schott web-page image from July 9, 2016” titled “Schott Cartridges - From Standardized to Customized Quality Options” was included, the copy is not legible.
Due to a long list of IDS submitted, examiner refers Applicant to MPEP 2004 and in particular to point 13 which states: It is desirable to avoid the submission of long lists of documents if it can be avoided. Eliminate clearly irrelevant and marginally pertinent cumulative information. If a long list is submitted, highlight those documents which have been specifically brought to applicant’s attention and/or are known to be of most significance. See Penn Yan Boats, Inc. v. Sea Lark Boats, Inc., 359 F. Supp. 948, 175 USPQ 260 (S.D. Fla. 1972), aff’d, 479 F.2d 1338, 178 USPQ 577 (5th Cir. 1973), cert. denied, 414 U.S. 874 (1974). But cf. Molins PLC v. Textron Inc., 48 F.3d 1172, 33 USPQ2d 1823 (Fed. Cir. 1995).
Note that consideration by the examiner of the information submitted in an IDS means nothing more than considering the documents in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.
Status of the Claims
Claims 1-20 are currently pending. Claims 1-20 are currently rejected.
Specification
The disclosure is objected to because of the following informalities:
“Poiuselle’s law”, which occurs twice in [0037], should read “Poiseuille’s law”
Appropriate correction is required.
Claim Objections
Claims 10 and 20 are objected to because of the following informalities:
Claim 10 line 3, “Poiuselle’s law” should read “Poiseuille’s law”
Claim 10 line 3, “Poiuselle’s law” should read “Poiseuille’s law”
Appropriate correction is required.
Claim Interpretation
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 sealing element” in claims 4 and 14. The limitation “a sealing element” in claims 4 and 14 is interpreted in light of US-20230233757-A1 to be [0025] “formed of a sealing material, including, without limitation, an elastomer, rubber, silicon, a polymer, and/or the like” and to engage with the control valve below the cracking pressure.
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 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.
Claim 8-20 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.
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.
Claim 11 line 2 reads “providing fluid delivery device comprising:”. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, this line has been interpreted to read “providing a fluid delivery device comprising:”.
Claims 9-10 and 12-20 are rejected for being dependent upon a claim rejected under 112b, since dependent claims inherit the deficiencies of the 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 configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to move in an opening direction 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.),
wherein the pressure control valve is in an 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 movement of the pressure-based control valve in the opening direction 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 a closed position (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 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.).
Regarding claim 11, Gray discloses a fluid delivery method, comprising:
providing 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 configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to move in an opening direction 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.),
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 control valve in an 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 movement of the pressure-based control valve in the opening direction 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 a closed position (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 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.).
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 an opening 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 an opening 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 Murakami (US 3042073 A; hereafter Murakami).
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).
Murakami, directed to an automatic regulating valve, teaches a pressure-based control valve (Bourdon tube 3, lever 70, rod 8, coil spring 6, and valve body 5; fig. 1; col. 3 ln. 45-56) comprising a bourdon tube (Bourdon tube 3, fig. 1) (see also claim 1) (col. 3 ln. 45-56 describes how when the inside pressure of the apparatus 25 reaches a maximum limit, the Bourdon tube 3 expands from its curved configuration and causes the valve body 5 to open).
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 actuate the valve at the desired pressure threshold as taught by Murakami, since both references deal with pressure-responsive valve arrangements which open at a high cracking pressure. One would have been motivated to make the modification because the Bourdon tube arrangement taught by Murakami allows for accurate and rapid actuation of the valve and micro-adjustment of pressure as noted in col. 4 ln. 2-14. Also, 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 Murakami) for another (the spring actuated mechanism of Gray), and the results of the substitution would have been predictable due to the teachings of Murakami. (See MPEP 2143(I)(B).)
Regarding claim 9, Gray modified by Gray50 and Murakami discloses the fluid delivery device of claim 8, as described above, including the bourdon tube (see 112b interpretation above) (Murakami: Bourdon tube 3, fig. 1) comprising a C-shaped tube (see curved Bourdon tube 3 in Murakami fig. 1) configured to straighten in response to the cracking pressure to enter the open state (col. 3 ln. 45-56 describes how when the inside pressure of the apparatus 25 reaches a maximum limit, the Bourdon tube 3 expands from its curved configuration and causes the valve body 5 to open).
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).
Murakami, directed to an automatic regulating valve, teaches a pressure-based control valve (Bourdon tube 3, lever 70, rod 8, coil spring 6, and valve body 5; fig. 1; col. 3 ln. 45-56) comprising a bourdon tube (Bourdon tube 3, fig. 1) (see also claim 1) (col. 3 ln. 45-56 describes how when the inside pressure of the apparatus 25 reaches a maximum limit, the Bourdon tube 3 expands from its curved configuration and causes the valve body 5 to open).
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 actuate the valve at the desired pressure threshold as taught by Murakami, since both references deal with pressure-responsive valve arrangements which open at a high cracking pressure. One would have been motivated to make the modification because the Bourdon tube arrangement taught by Murakami allows for accurate and rapid actuation of the valve and micro-adjustment of pressure as noted in col. 4 ln. 2-14. Also, 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 Murakami) for another (the spring actuated mechanism of Gray), and the results of the substitution would have been predictable due to the teachings of Murakami. (See MPEP 2143(I)(B).)
Regarding claim 19, Gray modified by Gray50 and Murakami discloses the method of claim 18, as described above, including the bourdon tube (see 112b interpretation above) (Murakami: Bourdon tube 3, fig. 1) comprising a C-shaped tube (see curved Bourdon tube 3 in Murakami fig. 1) configured to straighten in response to the cracking pressure to enter the open state (col. 3 ln. 45-56 describes how when the inside pressure of the apparatus 25 reaches a maximum limit, the Bourdon tube 3 expands from its curved configuration and causes the valve body 5 to open).
Claim(s) 10 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gray modified by Gray50 and Murakami, or alternatively over Gray modified by Gray50, Murakami, and further in view of Darrah (US 20140228755 A1; hereafter Darrah).
Regarding claim 10, Gray modified by Gray50 and Murakami 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 Poiuselle'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 Poiuselle'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 Poisuelle’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 Murakami 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 Murakami 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 Poiuselle'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 Poiuselle'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 Poisuelle’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 Murakami 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Zeisloft (US 3125118 A) - fig. 8, curved tube, either along with or because of a bourdon tube, straightens to allow flow at high pressures; col. 1 ln. 22-27 “the curvature of the elastic tube may be varied by forcible deformation of the tube by any mechanical connection to the tube; it may be varied by pressure within the tube or by pressure within a Bourdon tube connected to the elastic tube;”
Grover (US 3411705 A) - figs. 2-3 and 5 shows bourdon tube with slits on the outside pressed against housing (housing acts as a valve seat), slits open when pressure drops and bourdon tube contracts
Wang (US 5161629 A) - bourdon tube with venting valve at “closed” end, operated by opening a valve by unscrewing a nut
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/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 02/20/2026