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 Amendment
The amendment filed on 9/10/2025 has been entered. Claims 1-23 are pending in the application. Claims 21-23 are new. The amendments to the claims overcome most of the objections and all of the 112(b) rejections previously set forth in the Non-Final Office Action mailed on 6/10/2025. The objections which have not been properly addressed are included again in this Office Action below. The amendments to the claims avoid the claims being interpreted under 35 U.S.C. 112(f) as described in the Non-Final Office Action mailed on 6/10/2025.
Claim Objections
Claims 1-2, 5, 9-11, 16-20, and 22-23 are objected to because of the following informalities:
-Claim 1, line 13: please correct “the elastomeric channel material” to “an elastomeric channel material”
-Claim 1, line 13: please delete “itself”
-Claim 1, line 13: please correct “a stressed” to “a stressed state”
-Claim 1, line 14: please correct “the predetermined” to “a predetermined”
-Claim 2, line 8: please correct “the camshaft” to “the rotatable camshaft”
-Claim 5, line 3: please correct “the camshaft” to “the rotatable camshaft”
-Claim 9, line 5: please correct “a collapsible bag” to “the collapsible bag”
-Claim 9, line 18: please correct “the elastomeric channel material” to “an elastomeric channel material”
-Claim 9, line 18: please delete “itself”
-Claim 9, line 19: please correct “a stressed” to “a stressed state”
-Claim 9, line 20: please correct “the predetermined” to “a predetermined”
-Claim 10, lines 3-4: please correct “ambient pressure” to “the ambient pressure”
-Claim 10, line 5: please correct “a predetermined pressure profile” to “the predetermined pressure profile”
-Claim 11, line 6: please correct “the fluid medicament” to “the liquid medicament”
-Claim 16, lines 14-15: please correct “the elastomeric channel material” to “an elastomeric channel material”
-Claim 16, line 15: please delete “itself”
-Claim 16, line 15: please correct “a stressed” to “a stressed state”
-Claim 16, line 16: please correct “the predetermined” to “a predetermined”
-Claim 17, line 1: please correct “a motor with” to “a motor engaged with”
-Claim 17, line 4: please correct “the shaft” to “the rotatable shaft”
-Claim 18, line 3: please correct “rotation of the camshaft” to “the rotation of the rotatable shaft”
-Claim 18, line 4: please correct “liquid medicament” to “the liquid medicament”
-Claim 19, line 4: please correct “camshaft” to “rotatable shaft”
-Claim 20, line 1: please correct “the time duration” to “a time duration”
-Claim 20, line 2: please correct “the camshaft” to “the rotatable shaft”
-Claim 22, line 2: please correct “a dispense phase” to “the dispense phase”
-Claim 22, line 3: please correct “downstream valve” to “the downstream valve”
-Claim 22, line 3: please correct “a draw phase” to “the draw phase”
-Claim 22, line 4: please correct “downstream valve” to “the downstream valve”
-Claim 23, line 2: please correct “a dispense phase” to “the dispense phase”
-Claim 23, line 3: please correct “downstream valve” to “the downstream valve”
-Claim 23, line 3: please correct “a draw phase” to “the draw phase”
-Claim 23, line 4: please correct “downstream valve” to “the downstream valve”
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.
Claim 21 is 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 21 recites “the upstream valve” twice in lines 2-4 and “downstream valve” twice in lines 3-4. There is insufficient antecedent basis for the upstream valve and the downstream valve. It is unclear whether Applicant intends to introduce an upstream valve and a downstream valve in claim 21, or whether Applicant intends for claim 21 to instead depend from claim 2 which is dependent from claim 1 and introduces an upstream valve and a downstream valve. For examination purposes, the Examiner interprets “when the upstream valve is closed and downstream valve is open” in lines 2-3 of claim 21 as “when the pinch/squeeze mechanism is open” and the Examiner interprets “when the upstream valve is open and downstream valve is closed” in lines 3-4 of claim 21 as “when the pinch/squeeze mechanism is closed”.
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.
Claims 1, 6-7, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sipin (US 6,280,408 B1).
Regarding claim 1, Sipin discloses a system (see Fig. 6) for cyclically drawing a liquid medicament from a collapsible bag (flexible fluid container 160) under sub-ambient pressure conditions in a coordinated synchronization with operational pressures (see Fig. 6, col. 14 lines 12-64) which comprises:
the collapsible bag (flexible fluid container 160) for holding the liquid medicament, wherein the collapsible bag (flexible fluid container 160) is connected in fluid communication with an elastomeric fluid channel (transfer line 176) (see Fig. 6, col. 14 lines 12-64, transfer line 176 is able to be occluded by pinch valve 178 such that transfer line 176 is elastomeric; see also Fig. 3 and col. 9 lines 44-64);
a pressure shell (rigid housing 162) having an airtight chamber for holding the collapsible bag (flexible fluid container 160) therein with the elastomeric fluid channel (transfer line 176) extending outwardly from the pressure shell (rigid housing 162) (see Fig. 6, col. 14 lines 12-64);
a pressure sensor (transducer 174) mounted on the pressure shell (rigid housing 162) for sensing a sub-ambient pressure pc in the airtight chamber (see Fig. 6, col. 14 lines 12-64);
an equilibration valve (valve 170B/D) mounted on the pressure shell (rigid housing 162) (see Fig. 6, col. 14 lines 12-64);
a pinch/squeeze mechanism (pinch valve 178) for creating an operational under pressure pu in the elastomeric fluid channel (transfer line 176), wherein the operational under pressure pu is created by elastic rebound forces of the elastomeric channel material itself when transitioning from a stressed to an unstressed state, wherein the elastic rebound forces are generated by the predetermined modulus of elasticity of the elastomeric channel material (see Fig. 6, col. 14 lines 32-43, transfer line 176 is able to be occluded by pinch valve 178 such that transfer line 176 is elastomeric and thus able to undergo the claimed functions when stressed/unstressed by pinch valve 178; see also Fig. 3 and col. 9 line 51 – col. 10 line 65), wherein pu<pc to draw the liquid medicament from the collapsible bag (flexible fluid container 160) and into the elastomeric fluid channel (transfer line 176), and for alternately creating an operational over pressure po in the elastomeric fluid channel (transfer line 176), wherein po>pu to dispense the liquid medicament from the elastomeric fluid channel (transfer line 176) (see Fig. 6, col. 14 lines 32-43, transfer line 176 is able to be occluded by pinch valve 178 such that transfer line 176 is elastomeric and thus able to undergo the claimed functions when stressed/unstressed by pinch valve 178; see also Fig. 3 and col. 9 line 51 – col. 10 line 65); and
a controller (controller 182) connected to the pressure sensor (transducer 174) for determining a change of pressure Δpc in the pressure shell (rigid housing 162) during a duty cycle of the system (see Fig. 6, col. 14 lines 12-64), wherein the controller (controller 182) is connected to the equilibration valve (valve 170B/D) to reestablish ambient pressure pamb in the airtight chamber with a coordinated synchronization with po during the duty cycle (see Fig. 6, col. 14 lines 12-64), and further wherein the controller (controller 182) determines whether a change in Δpc/Δt is compliant with a predetermined pressure profile (see Fig. 6, col. 14 lines 12-64).
Regarding claim 6, Sipin discloses the system of claim 1 wherein the predetermined pressure profile is such that the duty cycle includes a plurality of successive pressure duty cycles measured in the airtight chamber of the pressure shell (rigid housing 162), wherein each of the plurality of successive pressure duty cycles has a same duration Δt and starts with the ambient pressure Pamb established by the equilibration valve (valve 170B/D), the predetermined pressure profile then proceeds through the duty cycle with a decreasing value of the sub-ambient pressure pc in the airtight chamber during Δt at a rate Δpc/Δt and ends at a time determined by the controller (controller 182) (see Fig. 6, col. 14 lines 12-64).
Regarding claim 7, Sipin discloses the system of claim 6 wherein an end time of the duty cycle is dependent on a rotational velocity ω of a camshaft (cam shaft 93) (see Fig. 6, col. 14 lines 12-64; pinch valve 178 is similar to pinch valve 90 of Fig. 3; see Fig. 3, col. 9 lines 51-63).
Regarding claim 21, Sipin discloses the system of claim 1 (see 112b rejection/interpretation of claim 21 above) wherein the equilibration valve (valve 170B/D) reestablishes the ambient pressure pamb specifically during a dispense phase when the pinch/squeeze mechanism (pinch valve 178) is open, while maintaining sub-ambient pressure during a draw phase when the pinch/squeeze mechanism (pinch valve 178) is closed (see Fig. 6, col. 14 lines 12-64).
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.
Claims 2-5 are rejected under 35 U.S.C. 103 as being unpatentable over Sipin (US 6,280,408 B1), as applied to claim 1 above, in view of Toman et al. (US 2006/0282040 A1).
Regarding claim 2, Sipin discloses the system of claim 1, wherein the pinch/squeeze mechanism (pinch valve 178) comprises: a fluid control unit including a rotatable camshaft (cam shaft 93) and a valve (cam 89) aligned along the rotatable camshaft (cam shaft 93) (see Fig. 6, col. 14 lines 32-36; pinch valve 178 is similar to pinch valve 90 of Fig. 3; see Fig. 3, col. 9 lines 51-63) to cyclically manipulate the elastomeric fluid channel (transfer line 176) through a plurality of configurations, in a predetermined sequence (degree of occlusion of pinch valve 178), for creating the operational under pressure pu in the elastomeric fluid channel (transfer line 176) during the duty cycle (see col. 14 lines 12-64); and a motor (motor 184) engaged with the rotatable camshaft (cam shaft 93) for cyclically rotating the camshaft (cam shaft 93) through 360˚ during the duty cycle at a controlled angular velocity ω (see col. 14 lines 12-64; see col. 9 line 51 – col. 10 line 60).
However, Sipin fails to expressly state wherein the fluid control unit includes an upstream valve, a piston, and a downstream valve aligned along the rotatable camshaft to cyclically manipulate the elastomeric fluid channel through the plurality of configurations, in the predetermined sequence.
Toman teaches a system (see Figs. 6A-D) wherein the fluid control unit includes an upstream valve (first pinch lever 38), a piston (piston 54), and a downstream valve (second pinch lever 40) aligned along the rotatable camshaft (cam 50) to cyclically manipulate the elastomeric fluid channel (tube 120/122) through the plurality of configurations, in the predetermined sequence (see Figs. 6A-D, par. [0086]-[0092]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Sipin to substitute the single valve with an upstream valve, a piston, and a downstream valve aligned along the rotatable camshaft to cyclically manipulate the elastomeric fluid channel through the plurality of configurations, in the predetermined sequence, as taught by Toman, in order selectively draw fluid into the pinch/squeeze mechanism and to ensure that fluid is not inadvertently delivered to the patient (see Toman par. [0088]-[0089]).
Regarding claim 3, modified Sipin teaches the system of claim 2 substantially as claimed. Modified Sipin further teaches wherein the elastomeric fluid channel (Sipin, transfer line 176) is configured to draw the liquid medicament from the collapsible bag (Sipin, flexible fluid container 160) and into the elastomeric fluid channel (Sipin, transfer line 176) when the upstream valve (Toman, first pinch lever 38) is open, the downstream valve (Toman, second pinch lever 40) is closed and the piston (Toman, piston 54) is being laterally withdrawn from the elastomeric fluid channel (Sipin, flexible fluid container 160), with a concomitant decrease in Δpc in the pressure shell (Sipin, rigid housing 162) until an end of the duty cycle when the upstream valve (Toman, first pinch lever 38) is closed and the downstream valve (Toman, second pinch lever 40) is open to dispense the liquid medicament from the elastomeric fluid channel (Sipin, transfer line 176) as the piston (Toman, piston 54) is laterally advanced against the elastomeric fluid channel (Toman, piston 54) (see Sipin col. 14 lines 12-64; see Toman par. [0086]-[0092]; see previous modifications in rejection of claim 2 above in which the valve of Sipin was substituted with the upstream valve, piston, and downstream valve of Toman).
Regarding claim 4, modified Sipin teaches the system of claim 3 substantially as claimed. Sipin further teaches wherein the controller (controller 182) is interconnected between the motor (motor 184) and the equilibration valve (valve 170B/D) to synchronously operate the equilibration valve (valve 170B/D) electronically with impulses from the controller (controller 182) corresponding with rotation of the rotatable camshaft (cam shaft 93) by the motor (motor 184) while the liquid medicament is being dispensed from the elastomeric fluid channel (transfer line 176) (see Fig. 6, col. 14 lines 12-64; see Fig. 3, col. 9 line 51 – col. 10 line 65).
Regarding claim 5, modified Sipin teaches the system of claim 3 substantially as claimed. Sipin further teaches wherein the motor (motor 184) is interconnected between the controller (controller 182) and the equilibration valve (valve 170B/D), wherein the equilibration valve (valve 170B/D) is engaged with the camshaft (cam shaft 93) to synchronously operate the equilibration valve (valve 170B/D) mechanically with rotation of the rotatable camshaft (cam shaft 93) by the motor (motor 184) while the liquid medicament is being dispensed from the elastomeric fluid channel (transfer line 176) (see Fig. 6, col. 14 lines 12-64; see Fig. 3, col. 9 line 51 – col. 10 line 65).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Sipin (US 6,280,408 B1), as applied to claim 6 above, in view of Adaniya et al. (US 2016/0030663 A1).
Regarding claim 8, Sipin discloses the system of claim 6. However, Sipin fails to expressly state wherein Δpc/Δt = 0 indicates an occlusion when an operation of the system is to be stopped.
Adaniya teaches a system (see Fig. 43) wherein Δpc/Δt = 0 indicates an occlusion when an operation of the system is to be stopped (see par. [0190] and [0234]-[0235]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Sipin to include wherein Δpc/Δt = 0 indicates an occlusion when an operation of the system is to be stopped, as taught by Adaniya, in order to stop the motor and indicate to an operator when there is an occlusion in the system (see Adaniya par. [0234]-[0235]).
Claims 9-14, 16-19, and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Sipin (US 6,280,408 B1) in view of Toman et al. (US 2006/0282040 A1).
Regarding claim 9, Sipin discloses a system (see Fig. 6) for cyclically drawing a liquid medicament from a collapsible bag (flexible fluid container 160) under sub-ambient pressure conditions in a coordinated synchronization with operational pressures (see Fig. 6, col. 14 lines 12-64) which comprises:
a pressure sensor (transducer 174) for measuring an air pressure pc inside an airtight chamber of a pressure shell (rigid housing 162) while a collapsible bag (flexible fluid container 160) filled with the liquid medicament is held in the airtight chamber (see Fig. 6, col. 14 lines 12-64);
an elastomeric fluid channel (transfer line 176) extending outwardly form the pressure shell (rigid housing 162), wherein the elastomeric fluid channel (transfer line 176) is connected in fluid communication with the collapsible bag (flexible fluid container 160) inside the airtight chamber (see Fig. 6, col. 14 lines 12-64, transfer line 176 is able to be occluded by pinch valve 178 such that transfer line 176 is elastomeric; see also Fig. 3 and col. 9 lines 44-64);
a fluid control unit engaged with the elastomeric fluid channel (transfer line 176) outside the pressure shell (rigid housing 162), wherein the fluid control unit includes a rotatable camshaft (cam shaft 93) on which a valve (cam 89) is aligned (see Fig. 6, col. 14 lines 32-36; pinch valve 178 is similar to pinch valve 90 of Fig. 3; see Fig. 3, col. 9 lines 51-63) to cyclically manipulate the elastomeric fluid channel (transfer line 176) through a plurality of configurations, in a predetermined sequence (degree of occlusion of pinch valve 178), to create a predetermined pressure profile in the airtight chamber during a duty cycle (see col. 14 lines 12-64);
a motor (motor 184) engaged with the rotatable camshaft (cam shaft 93) for cyclically rotating the camshaft (cam shaft 93) through 360˚ during the duty cycle at a controlled angular velocity ω to create an operational under pressure pu in the elastomeric fluid channel (transfer line 176) (see col. 14 lines 12-64; see col. 9 line 51 – col. 10 line 60), wherein the operational under pressure pu is created by elastic rebound forces of the elastomeric channel material itself when transitioning from a stressed to an unstressed state, wherein the elastic rebound forces are generated by the predetermined modulus of elasticity of the elastomeric channel material (see Fig. 6, col. 14 lines 32-43, transfer line 176 is able to be occluded by pinch valve 178 such that transfer line 176 is elastomeric and thus able to undergo the claimed functions when stressed/unstressed by pinch valve 178; see also Fig. 3 and col. 9 line 51 – col. 10 line 65), wherein pu is less than pc (pu < pc) to draw the liquid medicament from the collapsible bag (flexible fluid container 160) during a draw phase of the duty cycle and thereafter dispense the liquid medicament from the elastomeric fluid channel (transfer line 176), with an operational over pressure po during a dispense phase of the duty cycle (see Fig. 6, col. 14 lines 32-43, transfer line 176 is able to be occluded by pinch valve 178 such that transfer line 176 is elastomeric and thus able to undergo the claimed functions when stressed/unstressed by pinch valve 178; see also Fig. 3 and col. 9 line 51 – col. 10 line 65); and
an equilibration valve (valve 170B/D) to reestablish ambient pressure pamb in the pressure shell (rigid housing 162) during the dispense phase of the duty cycle (see Fig. 6, col. 14 lines 12-64).
However, Sipin fails to expressly state wherein the fluid control unit includes the rotatable camshaft on which an upstream valve, a piston, and a downstream valve are aligned to cyclically manipulate the elastomeric fluid channel through the plurality of configurations, in the predetermined sequence.
Toman teaches a system (see Figs. 6A-D) wherein the fluid control unit includes a rotatable camshaft (cam 50) on which an upstream valve (first pinch lever 38), a piston (piston 54), and a downstream valve (second pinch lever 40) are aligned to cyclically manipulate the elastomeric fluid channel (tube 120/122) through the plurality of configurations, in the predetermined sequence (see Figs. 6A-D, par. [0086]-[0092]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Sipin to substitute the single valve with an upstream valve, a piston, and a downstream valve aligned along the rotatable camshaft to cyclically manipulate the elastomeric fluid channel through the plurality of configurations, in the predetermined sequence, as taught by Toman, in order selectively draw fluid into the fluid control unit and to ensure that fluid is not inadvertently delivered to the patient (see Toman par. [0088]-[0089]).
Regarding claim 10, modified Sipin teaches the system of claim 9 substantially as claimed. Sipin further teaches a controller (controller 182) connected to the pressure sensor (transducer 174) for determining a change of pressure Δpc in the pressure shell (rigid housing 162) during the duty cycle (see Fig. 6, col. 14 lines 12-64), wherein the controller (controller 182) is connected to the equilibration valve (valve 170B/D) to reestablish ambient pressure pamb in the pressure shell (rigid housing 162) during the duty cycle (see Fig. 6, col. 14 lines 12-64), and further wherein the controller (controller 182) determines whether a change in Δpc/Δt is compliant with a predetermined pressure profile (see Fig. 6, col. 14 lines 12-64).
Regarding claim 11, modified Sipin teaches the system of claim 10 substantially as claimed. Modified Sipin further teaches wherein the elastomeric fluid channel (Sipin, transfer line 176) is configured to draw the liquid medicament from the collapsible bag (Sipin, flexible fluid container 160) and into the elastomeric fluid channel (Sipin, transfer line 176) when the upstream valve (Toman, first pinch lever 38) is open, the downstream valve (Toman, second pinch lever 40) is closed and the piston (Toman, piston 54) is being laterally withdrawn from the elastomeric fluid channel (Sipin, flexible fluid container 160), with a concomitant decrease in Δpc in the pressure shell (Sipin, rigid housing 162) until an end of the duty cycle when the upstream valve (Toman, first pinch lever 38) is closed and the downstream valve (Toman, second pinch lever 40) is open to dispense the liquid medicament from the elastomeric fluid channel (Sipin, transfer line 176) as the piston (Toman, piston 54) is laterally advanced against the elastomeric fluid channel (Toman, piston 54) (see Sipin col. 14 lines 12-64; see Toman par. [0086]-[0092]; see previous modifications in rejection of claim 9 above in which the valve of Sipin was substituted with the upstream valve, piston, and downstream valve of Toman).
Regarding claim 12, modified Sipin teaches the system of claim 11 substantially as claimed. Sipin further teaches wherein the controller (controller 182) is interconnected between the motor (motor 184) and the equilibration valve (valve 170B/D) to synchronously operate the equilibration valve (valve 170B/D) electronically with impulses from the controller (controller 182) corresponding with rotation of the rotatable camshaft (cam shaft 93) by the motor (motor 184) while the liquid medicament is being dispensed from the elastomeric fluid channel (transfer line 176) (see Fig. 6, col. 14 lines 12-64; see Fig. 3, col. 9 line 51 – col. 10 line 65).
Regarding claim 13, modified Sipin teaches the system of claim 12 substantially as claimed. Sipin further teaches wherein the motor (motor 184) is interconnected between the controller (controller 182) and the equilibration valve (valve 170B/D), wherein the equilibration valve (valve 170B/D) is engaged with the rotatable camshaft (cam shaft 93) to synchronously operate the equilibration valve (valve 170B/D) mechanically with rotation of the rotatable camshaft (cam shaft 93) by the motor (motor 184) while the liquid medicament is being dispensed from the elastomeric fluid channel (transfer line 176) (see Fig. 6, col. 14 lines 12-64; see Fig. 3, col. 9 line 51 – col. 10 line 65).
Regarding claim 14, modified Sipin teaches the system of claim 1 substantially as claimed. Sipin further teaches wherein the predetermined pressure profile is such that the duty cycle includes a plurality of successive pressure duty cycles measured in the airtight chamber of the pressure shell (rigid housing 162), wherein each of the plurality of successive pressure duty cycles has the dispense phase wherein the equilibration valve (valve 170B/D) is activated, and the draw phase wherein the equilibration valve (valve 170B/D) is deactivated (see Fig. 6, col. 14 lines 12-64).
Regarding claim 16, Sipin discloses a system (see Fig. 6) for following a pressure profile to cyclically draw a liquid medicament from a collapsible bag (flexible fluid container 160) under sub-ambient pressure conditions in a coordinated synchronization with operational pressures (see Fig. 6, col. 14 lines 12-64) which comprises:
a pressure shell (rigid housing 162) having an airtight chamber for holding the collapsible bag (flexible fluid container 160) therein under a sub-ambient pressure, pc, with an elastomeric fluid channel (transfer line 176) in fluid communication with the collapsible bag (flexible fluid container 160) extending outwardly from the pressure shell (rigid housing 162) (see Fig. 6, col. 14 lines 12-64, transfer line 176 is able to be occluded by pinch valve 178 such that transfer line 176 is elastomeric; see also Fig. 3 and col. 9 lines 44-64), and wherein a pressure sensor (transducer 174) and an equilibration valve (valve 170B/D) are mounted on the pressure shell (rigid housing 162) (see Fig. 6, col. 14 lines 12-64);
a fluid control unit, wherein the fluid control unit is engaged with the elastomeric fluid channel (transfer line 176) and includes a valve (cam 89) aligned along a camshaft (cam shaft 93) (see Fig. 6, col. 14 lines 32-36; pinch valve 178 is similar to pinch valve 90 of Fig. 3; see Fig. 3, col. 9 lines 51-63) to cyclically manipulate the elastomeric fluid channel (transfer line 176) through a plurality of configurations, in a predetermined sequence (degree of occlusion of pinch valve 178), to create an operational over pressure po in the elastomeric fluid channel (transfer line 176) during a dispense phase of a duty cycle, and an operational under pressure pu in the elastomeric fluid channel (transfer line 176) during a draw phase of the duty cycle (see col. 14 lines 12-64), wherein the operational under pressure pu is created by elastic rebound forces of the elastomeric channel material itself when transitioning from a stressed to an unstressed state, wherein the elastic rebound forces are generated by the predetermined modulus of elasticity of the elastomeric channel material (see Fig. 6, col. 14 lines 32-43, transfer line 176 is able to be occluded by pinch valve 178 such that transfer line 176 is elastomeric and thus able to undergo the claimed functions when stressed/unstressed by pinch valve 178; see also Fig. 3 and col. 9 line 51 – col. 10 line 65), wherein po > pc > pu (see Fig. 6, col. 14 lines 32-43, transfer line 176 is able to be occluded by pinch valve 178 such that transfer line 176 is elastomeric and thus able to undergo the claimed functions when stressed/unstressed by pinch valve 178; see also Fig. 3 and col. 9 line 51 – col. 10 line 65);
a controller (controller 182) connected to the fluid control unit engaged with the elastomeric fluid channel (transfer line 176), and to the pressure sensor (transducer 174) and the equilibration valve (valve 170B/D) mounted on the pressure shell (rigid housing 162), wherein the controller (controller 182) is preprogrammed with the pressure profile to configured the fluid control unit to open the valve (cam 89) during the dispense phase of the duty cycle to create po therein to dispense the liquid medicament therefrom, and to configure the fluid control unit to close the valve (cam 89) during the draw phase of the duty cycle to create pu in the elastomeric fluid channel (transfer line 176) to draw the liquid medicament from the collapsible bag (flexible fluid container 160) and into the elastomeric fluid channel (transfer line 176), and further wherein the equilibration valve (valve 170B/D) is activated during the dispense phase of the duty cycle to reset an ambient pressure pamb in the airtight chamber (see Fig. 6, col. 14 lines 12-64).
However, Sipin fails to expressly state wherein the fluid control unit includes an upstream valve, a piston, and a downstream valve aligned along the camshaft to cyclically manipulate the elastomeric fluid channel through the plurality of configurations, in the predetermined sequence; wherein the controller is preprogrammed with the pressure profile to configure the fluid control unit to close the upstream valve and open the downstream valve during the dispense phase of the duty cycle as the piston is advanced against the elastomeric fluid channel to create po therein to dispense the liquid medicament therefrom, and to configure the fluid control unit to open the upstream valve and close the downstream valve during the draw phase of the duty cycle as the piston is withdrawn from the elastomeric fluid channel to create pu in the elastomeric fluid channel to draw the liquid medicament into the elastomeric fluid channel.
Toman teaches a system (see Figs. 6A-D) wherein the fluid control unit includes an upstream valve (first pinch lever 38), a piston (piston 54), and a downstream valve (second pinch lever 40) aligned along a camshaft (cam 50) to cyclically manipulate the elastomeric fluid channel (tube 120/122) through the plurality of configurations, in the predetermined sequence (see Figs. 6A-D, par. [0086]-[0092]); wherein the controller is preprogrammed with the pressure profile to configure the fluid control unit to close the upstream valve (first pinch lever 38) and open the downstream valve (second pinch lever 40) during the dispense phase of the duty cycle as the piston (piston 54) is advanced against the elastomeric fluid channel (tube 120/122) to create po therein to dispense the liquid medicament therefrom, and to configure the fluid control unit to open the upstream valve (first pinch lever 38) and close the downstream valve (second pinch lever 40) during the draw phase of the duty cycle as the piston (piston 54) is withdrawn from the elastomeric fluid channel (tube 120/122) to create pu in the elastomeric fluid channel (tube 120/122) to draw the liquid medicament into the elastomeric fluid channel (tube 120/122) (see Figs. 6A-D, par. [0086]-[0092]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Sipin to substitute the single valve with an upstream valve, a piston, and a downstream valve aligned along the camshaft to cyclically manipulate the elastomeric fluid channel through the plurality of configurations, in the predetermined sequence, and configure the control unit to operate the upstream valve, the piston, and the downstream valve accordingly, as taught by Toman, in order selectively draw fluid into the fluid control unit and to ensure that fluid is not inadvertently delivered to the patient (see Toman par. [0088]-[0089]).
Regarding claim 17, modified Sipin teaches the system of claim 16 substantially as claimed. Sipin further teaches a motor (motor 184) with the camshaft (cam shaft 93), wherein the camshaft (cam shaft 93) is a rotatable shaft, wherein the rotatable shaft is engaged with the fluid control unit and is rotated at an angular velocity ω to establish the duty cycle with a rotation of the shaft through 360˚ (see col. 14 lines 12-64; see col. 9 line 51 – col. 10 line 60).
Regarding claim 18, modified Sipin teaches the system of claim 17 substantially as claimed. Sipin further teaches wherein the controller (controller 182) is interconnected between the motor (motor 184) and the equilibration valve (valve 170B/D) to synchronously operate the equilibration valve (valve 170B/D) electronically with impulses from the controller (controller 182) corresponding with rotation of the camshaft (cam shaft 93) by the motor (motor 184) while the liquid medicament is being dispensed from the elastomeric fluid channel (transfer line 176) (see Fig. 6, col. 14 lines 12-64; see Fig. 3, col. 9 line 51 – col. 10 line 65).
Regarding claim 19, modified Sipin teaches the system of claim 17 substantially as claimed. Sipin further teaches wherein the motor (motor 184) is interconnected between the controller (controller 182) and the equilibration valve (valve 170B/D), wherein the equilibration valve (valve 170B/D) is engaged with the camshaft (cam shaft 93) to synchronously operate the equilibration valve (valve 170B/D) mechanically with rotation of the camshaft (cam shaft 93) by the motor (motor 184) while the liquid medicament is being dispensed from the elastomeric fluid channel (transfer line 176) (see Fig. 6, col. 14 lines 12-64; see Fig. 3, col. 9 line 51 – col. 10 line 65).
Regarding claim 22, modified Sipin teaches the system of claim 9 substantially as claimed. Modified Sipin further teaches wherein the equilibration valve (Sipin, valve 170B/D) reestablishes the ambient pressure pamb specifically during a dispense phase when the upstream valve (Toman, first pinch lever 38) is closed and the downstream valve (Toman, second pinch lever 40) is open, while maintaining sub-ambient pressure during a draw phase when the upstream valve (Toman, first pinch lever 38) is open and the downstream valve (Toman, second pinch lever 40) is closed (see Sipin Fig. 6, Sipin col. 14 lines 12-64; see Toman Figs. 6A-D, Toman par. [0086]-[0092]; see previous modifications in rejection of claim 9 above in which the valve of Sipin was substituted with the upstream valve, piston, and downstream valve of Toman).
Regarding claim 23, modified Sipin teaches the system of claim 16 substantially as claimed. Modified Sipin further teaches wherein the equilibration valve (Sipin, valve 170B/D) reestablishes the ambient pressure pamb specifically during a dispense phase when the upstream valve (Toman, first pinch lever 38) is closed and the downstream valve (Toman, second pinch lever 40) is open, while maintaining sub-ambient pressure during a draw phase when the upstream valve (Toman, first pinch lever 38) is open and the downstream valve (Toman, second pinch lever 40) is closed (see Sipin Fig. 6, Sipin col. 14 lines 12-64; see Toman Figs. 6A-D, Toman par. [0086]-[0092]; see previous modifications in rejection of claim 16 above in which the valve of Sipin was substituted with the upstream valve, piston, and downstream valve of Toman).
Claims 15 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Sipin (US 6,280,408 B1) in view of Toman et al. (US 2006/0282040 A1), as applied to claims 14 and 17 above, further in view of Adaniya et al. (US 2016/0030663 A1).
Regarding claim 15, modified Sipin teaches the system of claim 14 substantially as claimed. Sipin further teaches wherein a time duration of the duty cycle is dependent on the controlled angular velocity ω of the rotatable camshaft (cam shaft 93) (see Fig. 6, col. 14 lines 12-64).
However, modified Sipin fails to expressly state when Δpc/Δt does not comply with the predetermined pressure profile during the draw phase of the duty cycle, an occlusion is indicated requiring a stop to an operation of the system.
Adaniya teaches a system (see Fig. 43) when Δpc/Δt does not comply with the predetermined pressure profile during the draw phase of the duty cycle, an occlusion is indicated requiring a stop to an operation of the system (see par. [0190] and [0234]-[0235]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of modified Sipin to include when Δpc/Δt does not comply with the predetermined pressure profile during the draw phase of the duty cycle, an occlusion is indicated requiring a stop to an operation of the system, as taught by Adaniya, in order to stop the motor and indicate to an operator when there is an occlusion in the system (see Adaniya par. [0234]-[0235]).
Regarding claim 20, modified Sipin teaches the system of claim 17 substantially as claimed. Sipin further teaches wherein the time duration of the duty cycle is dependent on the angular velocity ω of the camshaft (cam shaft 93) (see Fig. 6, col. 14 lines 12-64).
However, modified Sipin fails to expressly state when Δpc/Δt does not comply with the pressure profile during the draw phase of the duty cycle, an occlusion is indicated requiring a stop to an operation of the system.
Adaniya teaches a system (see Fig. 43) when Δpc/Δt does not comply with the pressure profile during the draw phase of the duty cycle, an occlusion is indicated requiring a stop to an operation of the system (see par. [0190] and [0234]-[0235]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of modified Sipin to include when Δpc/Δt does not comply with the pressure profile during the draw phase of the duty cycle, an occlusion is indicated requiring a stop to an operation of the system, as taught by Adaniya, in order to stop the motor and indicate to an operator when there is an occlusion in the system (see Adaniya par. [0234]-[0235]).
Response to Arguments
Applicant’s arguments with respect to claims 1, 9, and 16 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AVERY SMALE whose telephone number is (571)270-7172. The examiner can normally be reached Mon.-Fri. 8-4 ET.
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/AVERY SMALE/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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