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 .
Response to Preliminary Amendment
The amendment filed 08/02/23 has been entered. Claims 1-7, 9-13, 16, and 18-20 have been amended. Claims 8, 14-15, and 17 are in the original form. Thus, claims 1-20 remain pending in the application.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 11/02/23 and 05/09/24 were filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: “a compressible dimension” and “an active dimension” of at least claims 9 and 16 are not described in the specification.
Claim Objections
Claims 1, 2, 9, and 10 are objected to because of the following informalities:
Claim 1 lines 6-7 reads “one or more flow channel property” but should likely read “one or more flow channel [[property]] properties” for grammatical reasons. Each subsequent recitation of a “one or more property” of the flow channel should similarly be changed to “properties” for grammatical reasons
Claim 1 lines 11-12 reads “one or more resistance member property” but should likely read “one or more resistance member [[property]] properties” for grammatical reasons. Each subsequent recitation of a “one or more property” of the resistance member should similarly be changed to “properties” for grammatical reasons
Claim 2 lines 2-3 read “wherein the resistance member property” but should likely read “wherein the one or more resistance member [[property]] properties” to align with the language as originally presented in claim 1 from which claim 2 depends
Claim 9 lines 2-3 reads “wherein the resistance member property” but should likely read “wherein the one or more resistance member [[property]] properties” to align with the language as originally presented in claim 1 from which claim 9 depends
Claim 10 lines 8-9 reads “one or more flow channel property” but should likely read “one or more flow channel [[property]] properties” for grammatical reasons. Each subsequent recitation of a “one or more property” of the flow channel should similarly be changed to “properties” for grammatical reasons
Claim 10 lines 13-14 reads “one or more resistance member property” but should likely read “one or more resistance member [[property]] properties” for grammatical reasons. Each subsequent recitation of a “one or more property” of the resistance member should similarly be changed to “properties” for grammatical reasons
Appropriate correction is required.
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 2, 9, 11, and 16 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.
Regarding claim 2, lines 2-4 read “wherein the resistance member property the adjustment mechanism is configured to adjust comprises an elastic property”. It is unclear to the examiner if the claim is supposed to read “wherein the resistance member property [[the adjustment mechanism is configured to adjust]] comprises an elastic property” or “wherein [[the resistance member property]] the adjustment mechanism is configured to adjust [[comprises]] an elastic property”. Because claim 1, from which claim 2 depends, already recites “an adjustment mechanism configured to adjust a resistance member property”, the examiner will interpret that claim 2 reads “wherein the resistance member property [[the adjustment mechanism is configured to adjust]] comprises an elastic property” in order to ensure that claim 2 further limits the scope of claim 1.
Regarding claim 9, lines 2-5 read “wherein the resistance member property the adjustment mechanism is configured to adjust comprises at least one of a biasing constant, a compressible dimension of the resistance member, and an active dimension of the resistance member”. It is unclear to the examiner if the claim is supposed to read “wherein the resistance member property [[the adjustment mechanism]] is [[configured to adjust comprises]] at least one of a biasing constant, a compressible dimension of the resistance member, and an active dimension of the resistance member” or “wherein [[the resistance member property]] the adjustment mechanism is configured to adjust [[comprises]] at least one of a biasing constant, a compressible dimension of the resistance member, and an active dimension of the resistance member”. Because claim 1, from which claim 9 depends, already recites “an adjustment mechanism configured to adjust a resistance member property”, the examiner will interpret that claim 9 reads “wherein the resistance member property [[the adjustment mechanism]] is [[configured to adjust comprises]] at least one of a biasing constant, a compressible dimension of the resistance member, and an active dimension of the resistance member” in order to ensure that claim 9 further limits the scope of claim 1.
Regarding claim 11, lines 1-2 read “wherein the resistance member property the adjustment mechanism is configured to adjust comprises an elastic property”. It is unclear to the examiner if the claim is supposed to read “wherein the resistance member property [[the adjustment mechanism is configured to adjust]] comprises an elastic property” or “wherein [[the resistance member property]] the adjustment mechanism is configured to adjust [[comprises]] an elastic property”. Because claim 10, from which claim 11 depends, already recites “an adjustment mechanism configured to adjust a resistance member property”, the examiner will interpret that claim 11 reads “wherein the resistance member property [[the adjustment mechanism is configured to adjust]] comprises an elastic property” in order to ensure that claim 11 further limits the scope of claim 10.
Regarding claim 16, lines 1-4 read “wherein the resistance member property the adjustment mechanism is configured to adjust comprises at least one of a biasing constant, a compressible dimension of the resistance member, and an active dimension of the resistance member”. It is unclear to the examiner if the claim is supposed to read “wherein the resistance member property [[the adjustment mechanism]] is [[configured to adjust comprises]] at least one of a biasing constant, a compressible dimension of the resistance member, and an active dimension of the resistance member” or “wherein [[the resistance member property]] the adjustment mechanism is configured to adjust [[comprises]] at least one of a biasing constant, a compressible dimension of the resistance member, and an active dimension of the resistance member”. Because claim 10, from which claim 16 depends, already recites “an adjustment mechanism configured to adjust a resistance member property”, the examiner will interpret that claim 16 reads “wherein the resistance member property [[the adjustment mechanism]] is [[configured to adjust comprises]] at least one of a biasing constant, a compressible dimension of the resistance member, and an active dimension of the resistance member” in order to ensure that claim 16 further limits the scope of claim 10.
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.
Claims 1-6, 9, and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chappel et al. (U.S. PGPUB No. 2012/0048403), hereinafter Chappel.
Regarding claim 1, Chappel discloses an adjustable flow resistor comprising:
a housing (2, see FIGURE 7) having an inlet (1) to receive a fluid of an input flow (see [0047]);
a flow chamber (see ‘Modified FIGURE 7’ below) disposed in the housing (2);
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a flow modifier (5) disposed within (see ‘Modified FIGURE 7’ above) the flow chamber (see ‘Modified FIGURE 7’ above), the flow modifier (5) configured to define a flow channel (6) between the flow modifier (5) and an inner surface of the flow chamber (see [0060]: channel could be “between” surfaces as in FIGs 2/3, in spiral as in [0059] and Figure 7, or as in [0067]. Thus the flow modifier is “configured to” define a flow channel between the flow modifier and inner surface of chamber in all configurations), the flow channel (6) having one or more flow channel property (the flow channel length, aligning with Applicant disclosure in [0027]: flow channel properties include length), the flow modifier (5) configured to move within the flow chamber (see [0047-0057]: 5 axially movable in cylinder to displace the piston/ thus modifying the flow channel length to maintain a constant flow rate) and modify a flow channel property (the flow channel length, aligning with Applicant disclosure in [0027]: flow channel properties include length) in response to a pressure of the input flow acting on the flow modifier (5, see [0052-0057]: piston displaced to change length of flow channel to maintain a constant flow rate);
a resistance member (7) disposed within the housing (2) and configured to apply a force on the flow modifier (5 , see [0061]: 7 pushes on 5), the resistance member (7) having one or more resistance member property (length, see different lengths from figure 2 to figure 3. Resistance member property includes length according to applicant disclosure in [0039]: constant flow rate achieved by modifying length of spring) configured to affect movement of the flow modifier (5, see [0052]: 5 must move against force of spring and thus spring is “configured to affect movement” of the flow modifier because the spring force changes with length); and
an adjustment mechanism (see [0161-0162]: i.e.: a screw with preselected positions at the outlet) configured to adjust a resistance member property (see [0161-0162]: a preload on the spring is changed and thus a property of the spring is configured to adjust per calculations shown in [0069-0108] and the table following [0108]) and controllably modify a constant flow rate of the fluid moving out of the flow chamber (see [0048-0057]: piston 5 moves against force of spring 7 to increase channel 6 length and thus the spring length must change to compensate. For example, see length change of 7 from figure 2 to figure 3. Thus, when the adjustment mechanism changes the resistance member property, the modification of the flow rate will change as related to the spring pre-load & spring length).
Regarding claim 2, Chappel discloses the adjustable flow resistor of claim 1, and Chappel further discloses wherein the resistance member property [[the adjustment mechanism is configured to adjust]] comprises an elastic property (length, see different lengths from figure 2 to figure 3. See also Chappel [0069]-[0108] and the table following [0108] calculating spring stiffness for the design based on the preload, which affects the compression length of the spring during use. The elastic property comprising a length of the spring aligns with applicant disclosure in at least Applicant’s [0029]: an elastic property of the resistance member is that the member is a spring governed by Hooke’s law and see [0039] & [0041] of Applicant disclosure further explaining the relationship of length of the spring to maintaining the flow rate—length is part of Hooke’s law. )
Regarding claim 3, Chappel discloses the adjustable flow resistor of claim 1, and Chappel further discloses
wherein the adjustment mechanism (see [0161-0162]: i.e.: a screw with preselected positions at the outlet) includes a lumen (see outlet lumen in ‘Modified FIGURE 7’ above) extending along a length (length from the end of the flow chamber to the end of the outlet) of the adjustment mechanism (see [0161-0162]: i.e.: a screw with preselected positions at the outlet) such that the fluid exits the adjustable flow resistor through a distal end (rightward end in FIGURE 7 or see fluid flow exiting outlet 4 by fluid flow arrows shown in FIGURE 3) of the adjustment mechanism (see [0161-0162]: i.e.: a screw with preselected positions at the outlet), and
wherein the fluid flows through the lumen at the constant flow rate (see [0048-0052]).
Regarding claim 4, Chappel discloses the adjustable flow resistor of claim 1, and Chappel further discloses wherein the adjustment mechanism (see [0161-0162]: i.e.: a screw with preselected positions at the outlet) comprises a plurality of adjustment points (see [0161-0162]: preselected positions==more than 1== plurality), when activated an adjustment point is configured to modify the constant flow rate to a predefined flow rate associated with the adjustment point (see [0161-0162]: adjustment mechanism changes preload on spring which is “configured to modify the constant flow rate to a predefined flow rate” according to the calculations related to preload in [0069-0108] and the table in [0108]).
Regarding claim 5, Chappel discloses the adjustable flow resistor of claim 1, and Chappel further discloses wherein: the resistance member (7, see FIGURE 7) is a spring or a coil (see [0047]: spring 7); and the adjustment mechanism is configured to (configured to is functional language. Therefore the device need only be capable of performing the function. Outlet is positioned adjacent the spring and is therefore configured to constrain at least the end of the spring) constrain at least a portion of the spring or the coil (see [0161-0162] and FIGURE 7).
Regarding claim 6, Chappel discloses the adjustable flow resistor of claim 5, and Chappel further discloses wherein the adjustment mechanism is rotatable (see [0161-0162]: adjustment mechanism “screwed” manually or by external means such as a motor 22 as shaft of outlet connector. A motor or manual screw is rotatable) and configured to adjust a length of the spring or coil constrained by the adjustment mechanism (see [0161-0162] for adjustment mechanism changing preload on spring which is subsequently configured to adjust a length of the spring per calculations shown in [0069-0108] and the table following [0108]).
Regarding claim 9, Chappel discloses the adjustable flow resistor of claim 1, and Chappel further discloses wherein the resistance member property [[the adjustment mechanism]] is [[configured to adjust comprises]] at least one of a biasing constant, a compressible dimension of the resistance member, and an active dimension of the resistance member (length==compressible dimension of the resistance member, see different lengths from figure 2 to figure 3. Resistance member property includes length according to applicant disclosure in [0039]: constant flow rate achieved by modifying length of spring).
Regarding claim 18, Chappel discloses a method for adjusting a flow rate, the method comprising:
introducing a flow of fluid into a chamber (chamber formed within cylindrical device in FIGURE 3, see fluid flow arrows in FIGURE 3 and Pin as described in [0048-0059]) having a flow modifier (5) moveably situated (see [0047]: piston 5 axially movable) within the chamber (see FIGURE 3) and having a flow channel (6) defined by a gap between the flow modifier (5) and an inner surface of the chamber (see [0059-0060]: 6 between rod and inner surface of cylinder);
applying a first force from the fluid flow (Pin by fluid flow such as shown in FIGURE 3) against a proximal end (leftward side in FIGURE 2) of the flow modifier (5) to affect a length (see change in length from FIGURE 2 to FIGURE 3) of the flow channel (6) within the chamber (chamber within cylinder 2) to passively provide a constant rate of fluid flow (see [0048-0050]: fluid flow at constant rate regardless of the inlet side pressure/ force) through the chamber (chamber within cylinder 2);
setting an elastic property of a resistance member (7, see [0161-0162]: preload on spring is set and thus the elastic properties, including lengths are set as shown by the calculations in [0069-0108] and the table under [0108]) to apply a second force against (see [0061]: 7 pushes on 5 and thus provides a second force) a distal end (rightward end) of the flow modifier (5) to affect movement of the flow modifier (5) within the chamber (chamber within cylinder 2) and modify the constant rate of fluid flow through the chamber (see [0047-0057]: piston 5 displaced against the spring and thus achieves the constant flow rate).
Regarding claim 19, Chappel discloses the method of claim 18, and Chappel discloses further comprising outputting the fluid at a predetermined constant flow rate that is independent of a flow rate of the introduced flow of fluid (see [0048-0050]: fluid flow at constant rate regardless of the inlet side pressure/ force).
Regarding claim 20, Chappel discloses the method of claim 18, and Chappel further discloses wherein the setting step comprises using an adjustment mechanism (see [0161-0162]: i.e.: a manual screw or motor provided at shaft outlet with preselected positions) to adjust the elastic property of the resistance member (7, see [0161-0162]: preload on spring is set and thus the elastic properties, including lengths are set as shown by the calculations in [0069-0108] and the table under [0108]).
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.
Claims 7 is rejected under 35 U.S.C. 103 as being unpatentable over Chappel (U.S. PGPUB No. 2012/0048403).
Regarding claim 7, Chappel discloses the adjustable flow resistor of claim 1, but in the embodiment of FIGURE 7, Chappel is silent to “further comprising a stopper situated between the flow chamber and a distal end of the adjustment mechanism.”
However, in FIGURE 5, Chappel teaches an embodiment of the device further comprising a stopper (21, see FIGURE 5 with 21 disposed leftward of 19 and [0128]: plug 21) situated between the flow chamber (see 19 in FIGURE3. Therefore, the plug 21 as shown in the embodiment of FIGURE 5 would be seated to the left of 19 and thus between the flow chamber and distal end) and a distal end (rightward outlet of device) of the adjustment mechanism (adjustment mechanism on outlet 4).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the piston flow modifier disclosed in Chappel FIGURE 7 to be a gas filled chamber closed by a stopper as taught by Chappel FIGURE 5 for the purpose of reducing the device sensitivity to shocks (see [0128]), thus achieving “further comprising a stopper situated between the flow chamber and a distal end of the adjustment mechanism”.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Chappel as applied to claim 1 above, and further in view of Aklog et al. (U.S. PGPUB No. 2011/0251579), hereinafter Aklog.
Regarding claim 8, Chappel discloses the adjustable flow resistor of claim 1, but Chappel is silent to “wherein the resistance member is a pressurized gas chamber.”
However, Aklog teaches an adjustable flow system (see FIG. 5C-D with resistance member formed of compressible gas 28 constant flow rate achieved by adjusting a length of a gas space 27 as shown by length of space 27 in Fig. 5C to 5D and described in [0043]) comprising a resistance member (gas vessel 29 with compressible gas 28, see further explanation of compressible gas 28 in [0036-0038]), wherein the resistance member is a pressurized gas chamber (29, vessel 29 filled with compressible gas 28, see [0042-0043]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the resistance member disclosed in Chappel with the resistance member of a pressurized gas chamber as taught by Aklog for the purpose of forming a drive mechanism for infusion without the need for any outside power source, pump, or gravity (see [0035]) which facilitates delivery of different fluid volume percentages form the fluid chamber (see [0043]), thus achieving “wherein the resistance member is a pressurized gas chamber.”
Claims 10-17 are rejected under 35 U.S.C. 103 as being unpatentable over Chappel (U.S. PGPUB No. 2012/0048403) in view of Aklog (U.S. PGPUB No. 2011/0251579).
Regarding claim 10, Chappel discloses an adjustable flow system (see FIGURE 7 and [0063]: Figure 7 incorporates previously disclosed element of FIGURES 2/3. Thus, paragraphs related to description of figures 2/3 are referenced for description of overlapping structures/ features) comprising:
a first pathway (pathway at inlet connector 1, see ‘Modified FIGURE 7’ below) for directing fluid (see [0047]);
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an adjustable flow resistor (2) having its input end (see ‘Modified FIGURE 7’ above) in communication with the first pathway (see ‘Modified FIGURE 7’ above and [0047]) for receiving a flow of fluid (see [0047]), the adjustable flow resistor (2) including:
a flow chamber (chamber within cylinder 2);
a flow modifier (5) disposed within (see ‘Modified FIGURE 7’ above) the flow chamber (see ‘Modified FIGURE 7’ above), the flow modifier (5) configured to define a flow channel (6) between the flow modifier (5) and an inner surface of the flow chamber (see [0060]: channel could be “between” surfaces as in FIGs 2/3, in spiral as in [0059] and Figure 7, or as in [0067]. Thus the flow modifier is “configured to” define a flow channel between the flow modifier and inner surface of chamber in all configurations), the flow channel (6) having one or more flow channel property (the flow channel length, aligning with Applicant disclosure in [0027]: flow channel properties include length), the flow modifier (5) configured to move within the flow chamber (see [0047-0057]: 5 axially movable in cylinder to displace the piston/ thus modifying the flow channel length to maintain a constant flow rate) and modify a flow channel property (the flow channel length, aligning with Applicant disclosure in [0027]: flow channel properties include length) in response to a pressure of the flow of fluid acting on the flow modifier (see [0052-0057]: piston displaced to change length of flow channel to maintain a constant flow rate);
a resistance member (7) disposed within (see ‘Modified FIGURE 7’ above) the adjustable flow resistor (2) and configured to apply a force on the flow modifier (5, see [0061]: 7 pushes on 5), the resistance member (7) having one or more resistance member property (length, see different lengths from figure 2 to figure 3. Resistance member property includes length according to applicant disclosure in [0039]: constant flow rate achieved by modifying length of spring) configured to affect movement of the flow modifier (5, see [0052]: 5 must move against force of spring and thus spring is “configured to affect movement” of the flow modifier because the spring force changes with length); and
an adjustment mechanism (see [0161-0162]: i.e.: a screw with preselected positions at the outlet) configured to adjust a resistance member property (see [0161-0162]: a preload on the spring is changed and thus a property of the spring is changed) and controllably modify a constant flow rate of the fluid flow exiting the adjustable flow resistor (see [0048-0057]: piston 5 moves against force of spring 7 to increase channel 6 length and thus the spring length must change to compensate. For example, see length change of 7 from figure 2 to figure 3. Thus, when the adjustment mechanism changes the resistance member property, the modification of the flow rate will change as related to the spring pre-load & spring length); and
a second pathway (see ‘Modified FIGURE 7’ above) in communication with an output end (see ‘Modified FIGURE 7’ above, or numeral 9 in FIGURE 2 & [0047]) of the adjustable flow resistor (2) to direct fluid exiting the adjustable flow resistor (as seen by fluid flow arrows in FIGURE 3).
Chappel is silent to a first pathway for directing fluid, specifically, “from a fluid reservoir;” and an adjustable flow resistor having its input end in communication with the first pathway for receiving a flow of fluid, specifically “from the fluid reservoir”
However, Aklog teaches an adjustable flow system (see FIGs. 8A-C with constant flow rate achieved by adjusting a length of a spring as shown by length of spring 86 in Fig. 8B to 8C and described in [0071-0074]) comprising a first pathway (97) for directing fluid from a fluid reservoir (81) and an adjustable flow resistor (see ‘Modified FIG. 8A’ below)
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having its input end (91) in communication with the first pathway (97) for receiving a flow of fluid from (see [0061-0067]) the fluid reservoir (81).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first pathway for directing fluid flow disclosed in Chappel to direct fluid flow specifically from a reservoir such that the input end of the flow resistor receives flow of fluid from the reservoir as taught by Aklog for the purpose of allowing the fluid to accumulate in a designated area prior to introduction into the inlet of the flow resistor such that the inlet fluid of the reservoir has a known pressure (see [0061-0063]), thus achieving a first pathway for directing fluid, specifically, “from a fluid reservoir;” and an adjustable flow resistor having its input end in communication with the first pathway for receiving a flow of fluid, specifically “from the fluid reservoir”.
Regarding claim 11, the modified system of Chappel teaches the system of claim 10, and Chappel further discloses wherein the resistance member property [[the adjustment mechanism is configured to adjust]] comprises an elastic property (length, see different lengths from figure 2 to figure 3. See also Chappel [0069]-[0108] and the table following [0108] calculating spring stiffness for the design based on the preload, which affects the compression length of the spring during use. The elastic property comprising a length of the spring aligns with applicant disclosure in at least Applicant’s [0029]: an elastic property of the resistance member is that the member is a spring governed by Hooke’s law and see [0039] & [0041] of Applicant disclosure further explaining the relationship of length of the spring to maintaining the flow rate—length is part of Hooke’s law. )
Regarding claim 12, the modified system of Chappel teaches the system of claim 10, and Chappell further discloses wherein: the resistance member (7, see FIGURE 7) is a spring or a coil (see [0047]: spring 7); and the adjustment mechanism is configured to (configured to is functional language. Therefore the device need only be capable of performing the function. Outlet is positioned adjacent the spring and is therefore configured to constrain at least the end of the spring) constrain at least a portion of the spring or the coil (see [0161-0162] and FIGURE 7).
Regarding claim 13, the modified system of Chappel teaches the system of claim 12, and Chappell further discloses wherein the adjustment mechanism is rotatable (see [0161-0162]: adjustment mechanism “screwed” manually or by external means such as a motor 22 as shaft of outlet connector. A motor or manual screw is rotatable) to adjust a length of the spring or coil constrained by the adjustment mechanism (see [0161-0162] for adjustment mechanism changing preload on spring which is subsequently configured to adjust a length of the spring per calculations shown in [0069-0108] and the table following [0108] and the different lengths of the spring as shown from FIGURE 2 to FIGURE 3).
Regarding claim 14, the modified system of Chappel teaches the system of claim 10, but Chappel (FIGURE 7) is silent to “wherein the resistance member is a pressurized gas chamber.”
However, Aklog teaches an adjustable flow system (see FIG. 5C-D with resistance member formed of compressible gas 28 constant flow rate achieved by adjusting a length of a gas space 27 as shown by length of space 27 in Fig. 5C to 5D and described in [0043]) comprising a resistance member (gas vessel 29 with compressible gas 28, see further explanation of compressible gas 28 in [0036-0038]), wherein the resistance member is a pressurized gas chamber (29, vessel 29 filled with compressible gas 28, see [0042-0043]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the resistance member disclosed in Chappel with the resistance member of a pressurized gas chamber as taught by Aklog for the purpose of forming a drive mechanism for infusion without the need for any outside power source, pump, or gravity (see [0035]) which facilitates delivery of different fluid volume percentages form the fluid chamber (see [0043]), thus achieving “wherein the resistance member is a pressurized gas chamber.”
Regarding claim 15, the modified system of Chappel teaches the system of claim 10, but in the embodiment of FIGURE 7, Chappel is silent to “further comprising a stopper situated between the flow chamber and a distal end of the adjustment mechanism.”
However, in FIGURE 5, Chappel teaches an embodiment of the device further comprising a stopper (21, see FIGURE 5 with 21 disposed leftward of 19 and [0128]: plug 21) situated between the flow chamber (see 19 in FIGURE3. Therefore, the plug 21 as shown in the embodiment of FIGURE 5 would be seated to the left of 19 and thus between the flow chamber and distal end) and a distal end (rightward outlet of device) of the adjustment mechanism (adjustment mechanism on outlet 4).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the piston flow modifier disclosed in Chappel FIGURE 7 to be a gas filled chamber closed by a stopper as taught by Chappel FIGURE 5 for the purpose of reducing the device sensitivity to shocks (see [0128]), thus achieving “further comprising a stopper situated between the flow chamber and a distal end of the adjustment mechanism”.
Regarding claim 16, the modified system of Chappel teaches the system of claim 10, and Chappel further discloses wherein the resistance member property [[the adjustment mechanism]] is [[configured to adjust comprises]] at least one of a biasing constant, a compressible dimension of the resistance member, and an active dimension of the resistance member (length==compressible dimension of the resistance member, see different lengths from figure 2 to figure 3. Resistance member property includes length according to applicant disclosure in [0039]: constant flow rate achieved by modifying length of spring).
Regarding claim 17, the modified system of Chappel teaches the system of claim 10, and Chappel further discloses
wherein the adjustment mechanism (see [0161-0162]: i.e.: a screw with preselected positions at the outlet) includes a lumen (see lumen of second pathway in ‘Modified FIGURE 7’ above) extending along a length (length of second pathway lumen) of the adjustment mechanism to an outlet (outlet at rightward exit of device from second pathway), and
wherein the fluid flows through the lumen at the constant flow rate (see [0048-0052]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN PAIGE FARRELL whose telephone number is (571)272-0198. The examiner can normally be reached M-F: 730AM-330PM Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHLEEN PAIGE FARRELL/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783