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 amendments filed on 11/11/2025 have been entered. Claims 1, 8, and 24 have been amended; claims 4-7 and 13-22 have been cancelled. Accordingly, claims 1-3, 8-12, and 23-24 are pending and under consideration.
Response to Arguments
Applicant’s arguments field on 05/14/2025 with respect to claims 1, 8, and 24 have been considered but are moot because the new ground of rejection does not rely on the same combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
In light of further search and consideration, claim 1, 8, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Bontinck US 2013/0234039 A1 (newly cited) in view of Keeley US 2007/0287966 A1 (newly cited) and Aurich et al. WO 2017035262 A1 (previously cited).
Applicant's arguments filed on 07/06/2026 have been fully considered but they are not persuasive.
Regarding Applicant’s remarks stating that “First, as detailed at paragraph [0040] of the as-filed specification, "the difference in chamber size may provide a means by which to assure a volumetric or flow rate ratio between the cellular fluids 102 and the buffer fluids 104 which may be required by the microfluidic device 150" That is, the ratio is not a random variable as suggested by the Office” on page 11 of Applicant’s remarks, Examiner acknowledged the remarks, but respectfully disagrees. Par. 40 in Applicant’s specification does not demonstrate strong criticality regarding the relative dimensions, i.e., “The first and second chambers 182, 184 may have that same or different sizes. A size ratio of the first chamber 182 to the second chamber 184 may be selected to cause a flow rate/volume ratio to be delivered to the microfluidic device 150. In certain variations, the second chamber 184 may be larger than the first chamber 182. For example, the second chamber 184 may be about three times larger than the first chamber 182. The difference in Chamber size may provide a means by which to assure a volumetric or flow rate ratio between the cellular fluids 102 and the buffer fluids 104 which may be required by the microfluidic device 150”. To demonstrate criticality and unexpected results of a claimed range, Applicant should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960). MPEP 716.02(d).II.
Regarding Applicant’s remarks regarding routine optimization regarding the volumetric rations of the compartments on page 11-12 of Applicant’s remarks, Examiner acknowledged the remarks, but considered them moot because routine optimization was not the thrust of the previous rejection established in the Office Action mailed on 04/06/2026 nor the current rejection. See rejection of claims below.
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 1, 8, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Bontinck US 2013/0234039 A1 (newly cited, hereinafter Bontinck) in view of Keeley US 2007/0287966 A1 (newly cited, hereinafter Keely) and Aurich et al. WO 2017035262 A1 (previously cited, hereinafter Aurich).
Regarding claim 1, Bontinck discloses a system (Fig. 2 shows a system) for using a microfluidic device 1 (Fig. 1 – chamber 1, and Par. 34-35 – chamber 1 formed by films with a channel of micrometric/millimetric thickness) with an apheresis device (Par. 25 – “suitable blood components may comprise products obtained by apheresis…”), the system (Fig. 2) comprising:
a pressure system 8+9+12 (Fig. 2) consisting of having a first compartment 8 (Fig. 2 – receptacle 8) and a second compartment 9 (Fig. 2 – receptacle 9),
the first compartment 8 (Fig. 2) configured to receive cells collected (Par. 51 – “a bag 8 containing the fluid which is to be irradiated”) using the apheresis device (Par. 25 – “the fluid which is to be irradiated is, for example, a biological fluid, such as whole blood or a blood component. Examples of suitable blood components may comprise products obtained by apheresis”) and in independent communication with the microfluidic device 1 (Fig. 1-2, and Par. 46 – “The fluid which is to be irradiated is forwarded in the chamber 1 through the central inlet 6b”),
the second compartment 9 (Fig. 2) being distinct from and not in fluid communication with the first compartment 8 (Fig. 2), the second compartment 9 (Fig. 2) being configured to receive a buffer solution from a buffer reserve (Par. 51 – “shared bag 9 containing a neutral fluid”, and Par. 26 – “a neutral fluid may include a phosphate buffer, a saline solution, an additive solution, and/or preservation solution of a blood component”) and in independent communication with the microfluidic device 1 (Fig. 1-2, and Par. 46 – “a neutral fluid from the point of view of irradiation is forwarded through the upper 6c and lower 6a inlets”),
the pressure system 8+9+12 (Fig. 2) configured to change a pressure to direct the cells collected using the apheresis device to the microfluidic device 1 (Fig. 1-2, and Par. 71-73 – “the supply of the flow of fluid is realized by a fluid circulation device intended to establish the flows of fluid in the irradiation chamber, comprising a fluid circulating means, such as pump…”).
However, Bontinck does not disclose including a container, the container consisting of having a first compartment and a second compartment, the second compartment being three times larger than the first compartment, change a pressure of the container to between 0.48 MPa and 0.69 MPa.
Keeley, in the same field of endeavor of systems for storing and controlling the constituent components of a solution (Par. 6), teaches including a container 28 (Fig. 2 – dual chamber container 28), the container 28 (Fig. 2) consisting of having a first compartment 46 (Fig. 2 – first chamber 46) and a second compartment 48 (Fig. 2 – second chamber 48).
Aurich, in the same field of endeavor of methods and devices of multi-step cell purification and concentration (Title), teaches to change a pressure of the container to 8.70 psi (Fig. 24 – sample syringe; Par. 454 – “Place stopper on blood syringe and pressurize… the sample channel to 8.70 psi)”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first compartment and the second compartment of Bontinck to be within a container such that they become a dual chamber container as taught by Keeley, since Keeley teaches that it is well-known in the art that many medical solutions must be separated into their constituent components for storage in order to maintain stability, viability, or to satisfy other medical concerns (Par. 1 of Keeley). The dual chamber container provides a simpler, more efficient and/or more flexible system of storing and controlling the constituent components of a solution (Par. 6 of Keeley).
It also would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the second compartment of the combined device be three times larger than the first compartment, in order to fit the particular procedure being done since this claimed dimension of the compartments does not change the container ability to hold medical products. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (Par. 40 of Applicant’s Pg-Pub), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pressure system of Bontinck to change a pressure of the container as taught by Aurich, in order to allow the blood to enter the chip/microfluidic device (Par. 456 of Aurich).
In addition, according to the discussion of Aurich in Par. 417 reciting “Pressure (e.g., about 10 psi) is needed to push the waste out of the array”, the adjusted/increased pressure would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention, because said increased pressure directly affects the flow of sample/particles within the microfluidic channel. Therefore, a sufficient pressure is desired to avoid clogging and settling of blood/particles/cells within the microfluidic device (Par. 417 of Aurich discusses prevention of channel clogging). As such, without showing unexpected results, the claimed pressure between 0.48 MPa and 0.69 MPa cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, the pressure change of container to be between 0.48 MPa and 0.69 MPa in the apparatus of Skelley in view of Aurich to obtain the desired non-clogging effect as the sample traverses through the microfluidic device, as taught by Aurich (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.). Thus, the limitation of “to change a pressure of the container to between 0.48 MPa and 0.69 MPa” is met.
Regarding claim 8, Bontinck discloses a system (Fig. 2 shows a system) for using a microfluidic device 1 (Fig. 1 – chamber 1, and Par. 34-35 – chamber 1 formed by films with a channel of micrometric/millimetric thickness) with an apheresis device (Par. 25 – “suitable blood components may comprise products obtained by apheresis…”), the system (Fig. 2) comprising:
a pressure system 8+9+12 (Fig. 2) consisting of two distinct compartments 8, 9 (Fig. 2 – receptacle 8 and receptacle 9),
a first compartment 8 (Fig. 2) of the two distinct compartments 8, 9 (Fig. 2) being configured to receive cells collected (Par. 51 – “a bag 8 containing the fluid which is to be irradiated”) using the apheresis device (Par. 25 – “the fluid which is to be irradiated is, for example, a biological fluid, such as whole blood or a blood component. Examples of suitable blood components may comprise products obtained by apheresis”) and in independent communication with the microfluidic device 1 (Fig. 1-2, and Par. 46 – “The fluid which is to be irradiated is forwarded in the chamber 1 through the central inlet 6b”),
a second compartment 9 (Fig. 2) of the two distinct compartments 8, 9 (Fig. 2) that is not in fluid communication with the first compartment 8 (Fig. 2), the second compartment 9 (Fig. 2) being configured to receive a buffer solution from a buffer reserve (Par. 51 – “shared bag 9 containing a neutral fluid”, and Par. 26 – “a neutral fluid may include a phosphate buffer, a saline solution, an additive solution, and/or preservation solution of a blood component”) and in independent communication with the microfluidic device 1 (Fig. 1-2, and Par. 46 – “a neutral fluid from the point of view of irradiation is forwarded through the upper 6c and lower 6a inlets”),
the pressure system 8+9+12 (Fig. 2) configured to independently change a first pressure of the first compartment 8 (Fig. 2) and a second pressure of the second compartment 9 (Fig. 2) and to direct the cells collected using the apheresis device and the buffer solution to the microfluidic device 1 (Fig. 1-2, Par. 46 – “the irradiation chamber has three inlets 6a, 6b, 6c and three outlets 7a, 7b, 7c for the fluids. The fluid which is to be irradiated is forwarded in the chamber 1 through the central inlet 6b, and a neutral fluid from the point of view of irradiation is forwarded through the upper 6c and lower 6a inlets”, and Par. 71-73 – “the supply of the flow of fluid is realized by a fluid circulation device intended to establish the flows of fluid in the irradiation chamber, comprising a fluid circulating means, such as pump…”).
However, Bontinck does not disclose including a container, the container consisting of two distinct compartments, the second compartment being three times larger than the first compartment, the pressure system configured to change at least one of the first pressure and the second pressure to between 0.48 MPa and 0.69 MPa.
Keeley, in the same field of endeavor of systems for storing and controlling the constituent components of a solution (Par. 6), teaches including a container 28 (Fig. 2 – dual chamber container 28), the container 28 (Fig. 2) consisting of having a first compartment 46 (Fig. 2 – first chamber 46) and a second compartment 48 (Fig. 2 – second chamber 48).
Aurich, in the same field of endeavor of methods and devices of multi-step cell purification and concentration (Title), teaches to change a first pressure of the first compartment (Fig. 24 – sample syringe, and Par. 456 – “Put the stopper on blood sample syringe and turn on pumps to… 8.7 psi (blood)”) and a second pressure of the second compartment (Fig. 24 – buffer syringe, and Par. 456 – “…turn on pumps to 10 psi (buffer)…”), the pressure system configured to change the pressure to 10 psi or 8.70 psi (Par. 454 and Par. 456 – “Place stopper on blood syringe and pressurize… the sample channel to 8.70 psi)”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first compartment and the second compartment of Bontinck to be within a container such that they become a dual chamber container as taught by Keeley, since Keeley teaches that it is well-known in the art that many medical solutions must be separated into their constituent components for storage in order to maintain stability, viability, or to satisfy other medical concerns (Par. 1 of Keeley). The dual chamber container provides a simpler, more efficient and/or more flexible system of storing and controlling the constituent components of a solution (Par. 6 of Keeley).
It also would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the second compartment of the combined device be three times larger than the first compartment, in order to fit the particular procedure being done since this claimed dimension of the compartments does not change the container ability to hold medical products. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (Par. 40 of Applicant’s Pg-Pub), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pressure system of the combination to change a pressure of the compartments as taught by Aurich, in order to allow the blood to enter the chip/microfluidic device (Par. 456 of Aurich).
In addition, according to the discussion of Aurich in Par. 417 reciting “Pressure (e.g., about 10 psi) is needed to push the waste out of the array”, the adjusted/increased pressure would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention, because said increased pressure directly affects the flow of sample/particles within the microfluidic channel. Therefore, a sufficient pressure is desired to avoid clogging and settling of blood/particles/cells within the microfluidic device (Par. 417 of Aurich discusses prevention of channel clogging). As such, without showing unexpected results, the claimed pressure between 0.48 MPa and 0.69 MPa cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, the pressure change of at least one of the first pressure and the second pressure to be between 0.48 MPa and 0.69 MPa in the apparatus of the combination to obtain the desired non-clogging effect as the sample traverses through the microfluidic device, as taught by Aurich (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.). Thus, the limitation of “to change a pressure at least one of the first pressure and the second pressure to between 0.48 MPa and 0.69 MPa” is met.
Regarding claim 24, Bontinck discloses a system (Fig. 2 shows a system) for using a microfluidic device 1 (Fig. 1 – chamber 1, and Par. 34-35 – chamber 1 formed by films with a channel of micrometric/millimetric thickness) with an apheresis device (Par. 25 – “suitable blood components may comprise products obtained by apheresis…”), the system (Fig. 2) comprising:
a pressure system 8+9+12 (Fig. 2) consisting of having two or more distinct compartments 8, 9 (Fig. 2 – receptacle 8 and receptacle 9),
a first compartment 8 (Fig. 2) of the two or more distinct compartments 8, 9 (Fig. 2) being configured to receive cells collected (Par. 51 – “a bag 8 containing the fluid which is to be irradiated”) using the apheresis device (Par. 25 – “the fluid which is to be irradiated is, for example, a biological fluid, such as whole blood or a blood component. Examples of suitable blood components may comprise products obtained by apheresis”) and in independent communication with the microfluidic device 1 (Fig. 1-2, and Par. 46 – “The fluid which is to be irradiated is forwarded in the chamber 1 through the central inlet 6b”),
a second compartment 9 (Fig. 2) of the two or more distinct compartments 8, 9 (Fig. 2) not being in fluid communication with the first compartment 8 (Fig. 2), the second compartment 9 (Fig. 2) being configured to receive a buffer solution from a buffer reserve (Par. 51 – “shared bag 9 containing a neutral fluid”, and Par. 26 – “a neutral fluid may include a phosphate buffer, a saline solution, an additive solution, and/or preservation solution of a blood component”) and in independent communication with the microfluidic device 1 (Fig. 1-2, and Par. 46 – “a neutral fluid from the point of view of irradiation is forwarded through the upper 6c and lower 6a inlets”),
the pressure system 8+9+12 (Fig. 2) configured to independently change a first pressure of the first compartment 8 (Fig. 2) and a second pressure of the second compartment 9 (Fig. 2) and to direct the cells collected using the apheresis device and the buffer solution to the microfluidic device 1 (Fig. 1-2, Par. 46 – “the irradiation chamber has three inlets 6a, 6b, 6c and three outlets 7a, 7b, 7c for the fluids. The fluid which is to be irradiated is forwarded in the chamber 1 through the central inlet 6b, and a neutral fluid from the point of view of irradiation is forwarded through the upper 6c and lower 6a inlets”, and Par. 71-73 – “the supply of the flow of fluid is realized by a fluid circulation device intended to establish the flows of fluid in the irradiation chamber, comprising a fluid circulating means, such as pump…”)
However, Bontinck does not disclose including a container consisting of having two or more distinct compartments, the second compartment being three times larger than the first compartment, the second compartment sharing a defining compartment wall with the first compartment, the pressure system configured to change at least one of the first pressure and the second pressure to between 0.48 MPa and 0.69 MP.
Keeley, in the same field of endeavor of systems for storing and controlling the constituent components of a solution (Par. 6), teaches including a container 28 (Fig. 2 – dual chamber container 28), the container 28 (Fig. 2) consisting of having a first compartment 46 (Fig. 2 – first chamber 46) and a second compartment 48 (Fig. 2 – second chamber 48), the second compartment 48 (Fig. 2) sharing a defining compartment wall 44 (Fig. 2 – divider 44) with the first compartment 46 (Fig. 2).
Aurich, in the same field of endeavor of methods and devices of multi-step cell purification and concentration (Title), teaches to change a first pressure of the first compartment (Fig. 24 – sample syringe, and Par. 456 – “Put the stopper on blood sample syringe and turn on pumps to… 8.7 psi (blood)”) and a second pressure of the second compartment (Fig. 24 – buffer syringe, and Par. 456 – “…turn on pumps to 10 psi (buffer)…”), the pressure system configured to change the pressure to 10 psi or 8.70 psi (Par. 454 and Par. 456 – “Place stopper on blood syringe and pressurize… the sample channel to 8.70 psi)”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first compartment and the second compartment of Bontinck to be within a container such that they become a dual chamber container as taught by Keeley, since Keeley teaches that it is well-known in the art that many medical solutions must be separated into their constituent components for storage in order to maintain stability, viability, or to satisfy other medical concerns (Par. 1 of Keeley). The dual chamber container provides a simpler, more efficient and/or more flexible system of storing and controlling the constituent components of a solution (Par. 6 of Keeley), as peeleable container systems require a great deal of fluid force to separate the seal, which can be difficult for individuals having limited upper body strength such as infirmed or elderly patients (Par. 5 of Keeley).
It also would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the second compartment of the combined device be three times larger than the first compartment, in order to fit the particular procedure being done since this claimed dimension of the compartments does not change the container ability to hold medical products. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (Par. 40 of Applicant’s Pg-Pub), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pressure system of the combination to change a pressure of the compartments as taught by Aurich, in order to allow the blood to enter the chip/microfluidic device (Par. 456 of Aurich).
In addition, according to the discussion of Aurich in Par. 417 reciting “Pressure (e.g., about 10 psi) is needed to push the waste out of the array”, the adjusted/increased pressure would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention, because said increased pressure directly affects the flow of sample/particles within the microfluidic channel. Therefore, a sufficient pressure is desired to avoid clogging and settling of blood/particles/cells within the microfluidic device (Par. 417 of Aurich discusses prevention of channel clogging). As such, without showing unexpected results, the claimed pressure between 0.48 MPa and 0.69 MPa cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, the pressure change of at least one of the first pressure and the second pressure to be between 0.48 MPa and 0.69 MPa in the apparatus of the combination to obtain the desired non-clogging effect as the sample traverses through the microfluidic device, as taught by Aurich (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.). Thus, the limitation of “to change a pressure at least one of the first pressure and the second pressure to between 0.48 MPa and 0.69 MPa” is met.
Claims 2, 3, 9, 10, 11, 12, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Bontinck in view of Keeley in view of Aurich as applied to claim 1 and claim 8 above, and further in view of Misumi et al. US 5,456,824 A (previously cited, hereinafter Misumi).
Regarding claim 2, Bontinck in view of Keeley in view of Aurich suggests the invention of claim 1. However, the combination does not disclose wherein the pressure system includes a stationary plate and one or more moveable plates that are configured to move relative to the stationary plate, wherein the container is disposed between the stationary plate and the one or more moveable plates and movement of the one or more moveable plates changes the pressure of the container.
Misumi, in the same field of endeavor of liquid separating apparatus (Title), teaches wherein the pressure system 15 (Fig. 3 – housing 15) includes a stationary plate 19 (Fig. 4 – supporting member 19) and one or more moveable plates 20 (Fig. 4 – pressing member 20 comprising first pressing member 21, auxiliary pressing member 22, and second pressing member 23) that are configured to move relative to the stationary plate 19 (Col. 7, line 16-18 – “…the supporting member 19 which fulfills the role of supporting and pressing the primary bag B1… is adapted to press on the primary bag B1 in cooperation with a pressing member 20 disposed inside the housing 15…”; Col. 7, line 49-50 – “the first pressing member 21 is moved toward or away from the primary bag B1…”; and Col. 8, line 1-3 – “The auxiliary pressing member 22… is moved toward or away from the primary bag B1, kept substantially parallel to the supporting member 19”), wherein the container B1 (Fig. 4 – primary bag B1) is disposed between the stationary plate 19 and the one or more moveable plates 20 (Fig. 4 – primary bag B1 is positioned between the supporting member 19 and the pressing member 20) and movement of the one or more moveable plates 20 changes the pressure of the container B1 (Col. 2, last line and Col. 3, line 1-3 – “…compressing the parent container with pressure externally exerted on the outer surfaces of the parent container by the use of a pressing member…”; Examiner contends that Figs. 6-8 show the pressing members 21 and 22 being moved to exert external pressure onto the primary bag B1).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substituted the pressure system using pumps of the combination that allows pressurization of a container for propelling fluid content, for a pressure system using mechanically moving plates as taught by Misumi, since these mechanisms perform the same function of producing pressurized liquid within a container so that enough driving force is induced for fluid to flow toward the next processing step. Simply substituting one pressuring means for another would yield the predicable result of pressurizing the fluid along with the container for fluid propulsion. See MPEP 2143. Once the combination is made as discussed, the pressure system 12 of the combination will have a stationary plate and movable plates with the container consisting of two distinct compartments in the middle as taught by Misumi.
Regarding claim 3, Bontinck in view of Keeley in view of Aurich in view of Misumi suggests the invention of claim 2. The combination of further discloses wherein the pressure system (Fig. 2 of Bontinck modified by Fig. 4 of Misumi) further includes one or more motors 26, 34, 36 (Fig. 4 of Misumi – first drive motor 26, auxiliary drive motor 34, and second drive motor 37) configured to move the one or more moveable plates 20 (Fig. 4 of Misumi – each motor 26, 34, and 37 are connected to its corresponding pressing member 21, 22, and 23, respectively, to drive said pressing members) relative to the stationary plate 19 (Fig. 4, and 6-8 of Misumi – exemplary movement of pressing members 21 and 22 relative to supporting member 19).
Examiner notes that once the modification is made as discussed in claim 2, the pressure system comprising a stationary plate and movable plates as taught by Misumi will be incorporated in its entirety into the pressure system of the combination; therefore, the motor attached to each pressing member/movable plate of Misumi will also be incorporated into the pressure system of the combined device to produce the linear movement. Thus, the limitation is met.
Regarding claim 9, Bontinck in view of Keeley in view of Aurich suggests the invention of claim 8. However, the combination does not disclose wherein the pressure system includes a stationary plate and one or more moveable plates that are configured to move relative to the stationary plate, wherein the container is disposed between the stationary plate and the one or more moveable plates and movement of the one or more moveable plates changes the first pressure of the first compartment and the second pressure of the second compartment.
Misumi, in the same field of endeavor of liquid separating apparatus (Title), teaches wherein the pressure system 15 (Fig. 3 – housing 15) includes a stationary plate 19 (Fig. 4 – supporting member 19) and one or more moveable plates 20 (Fig. 4 – pressing member 20 comprising first pressing member 21, auxiliary pressing member 22, and second pressing member 23) that are configured to move relative to the stationary plate 19 (Col. 7, line 16-18 – “…the supporting member 19 which fulfills the role of supporting and pressing the primary bag B1… is adapted to press on the primary bag B1 in cooperation with a pressing member 20 disposed inside the housing 15…”; Col. 7, line 49-50 – “the first pressing member 21 is moved toward or away from the primary bag B1…”; and Col. 8, line 1-3 – “The auxiliary pressing member 22… is moved toward or away from the primary bag B1, kept substantially parallel to the supporting member 19”), wherein the container B1 (Fig. 4 – primary bag B1) is disposed between the stationary plate 19 and the one or more moveable plates 20 (Fig. 4 – primary bag B1 is positioned between the supporting member 19 and the pressing member 20) and movement of the one or more moveable plates 20 changes the pressure of the compartment (Col. 2, last line and Col. 3, line 1-3 – “…compressing the parent container with pressure externally exerted on the outer surfaces of the parent container by the use of a pressing member…”; Examiner contends that Figs. 6-8 show the pressing members 21 and 22 being moved to exert external pressure onto the internal compartment of the primary bag B1).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substituted the pressure system using pumps of the combination that allows pressurization of a container for propelling fluid content, for a pressure system using mechanically moving plates as taught by Misumi, since these mechanisms perform the same function of producing pressurized liquid within a container so that enough driving force is induced for fluid to flow toward the next processing step. Simply substituting one pressuring means for another would yield the predicable result of pressurizing the fluid along with the container for fluid propulsion. See MPEP 2143. Once the combination is made as discussed, the pressure system of the combination will have a stationary plate and movable plates, with the container consisting of two distinct compartments in the middle in the middle as taught by Misumi.
Examiner notes that once the modification is made as discussed above, given the dual chamber container of Keeley, movement of pressing members 22 and 23 as taught by Misumi can individually apply pressure onto the walls of first compartment 8 and the second compartment 9 of Bontinck. Therefore, the movable pressing members/plates can adjust the pressure of each compartment of the container. Thus, the limitation of “movement of the one or more moveable plates changes the first pressure of the first compartment and the second pressure of the second compartment” is met.
Regarding claim 10, Bontinck in view of Keeley in view of Aurich in view of Misumi suggests the invention of claim 9. The combination further discloses wherein the pressure system (Fig. 2 of Bontinck modified by Fig. 4 of Misumi) further includes one or more motors 26, 34, 36 (Fig. 4 of Misumi – first drive motor 26, auxiliary drive motor 34, and second drive motor 37) configured to move the one or more moveable plates 20 (Fig. 4 of Misumi – each motor 26, 34, and 37 are connected to its corresponding pressing member 21, 22, and 23, respectively, to drive said pressing members) relative to the stationary plate 19 (Fig. 4, and 6-8 of Misumi – exemplary movement of pressing members 21 and 22 relative to supporting member 19).
Examiner notes that once the modification is made as discussed in claim 9, the pressure system comprising a stationary plate and movable plates as taught by Misumi will be incorporated in its entirety into the pressure system of the combination; therefore, the motor attached to each pressing member/movable plate of Misumi will also be incorporated into the pressure system of the combination to produce the linear movement. Thus, the limitation is met.
Regarding claim 11, Bontinck in view of Keeley in view of Aurich in view of Misumi suggests the invention of claim 9. The combination further discloses wherein the one or more moveable plates 20 (Fig. 4 of Misumi) includes a first plate 22 (Fig. 4 of Misumi) aligned with the first compartment 8 (Fig. 2 of Bontinck) and a second plate 23 (Fig. 4 of Misumi) aligned with the second compartment 9 (Fig. 4 of Davis).
Examiner notes that once the combination is made as discussed in claim 9, the pressing system of multiple plates of Misumi will be incorporated into the combined system, specifically outside of the dual compartment container as established in claim 9. Therefore, the movable plate 22 and 23 of Misumi will align with compartment 8 and 9 of Bontinck, respectively, as it would have been obvious for one of ordinary skill in the art to assign such a configuration given the size of each compartment as established in claim 9. Thus, the limitation is met.
Regarding claim 12, Bontinck in view of Keeley in view of Aurich in view of Misumi suggests the invention of claim 11. The combination further discloses wherein the pressure system (Fig. 2 of Bontinck modified by Fig. 4 of Misumi) further includes a first motor 34 (Fig. 4 of Misumi – drive motor 34) configured to move the first plate 22 (Fig. 4 of Misumi) relative to the stationary plate 19 (Fig. 4 and Col. 8, line 1-5 of Misumi – “The auxiliary pressing member 22… is moved toward or away from the primary bag B1, kept substantially parallel to the supporting member 19,… by an auxiliary drive motor 34…”) and a second motor 37 (Fig. 4 of Misumi) configured to move the second plate 23 (Fig. 4 of Misumi) relative to the stationary plate 19 (Fig. 4 and Col. 8, line 9-13 of Misumi – “The second pressing member 23… is moved toward or away from the primary bag B1, kept substantially parallel to the supporting member 19,… a second drive motor 37 of the second pressing member 23”).
Examiner notes that once the modification is made as discussed in claim 11, the pressure system comprising a stationary plate and movable plates as taught by Misumi will be incorporated in its entirety into the pressure system of the combination; therefore, the motor attached to each pressing member/movable plate of Misumi will also be incorporated into the pressure system of the combination to produce the linear movement. Thus, the limitation is met.
Regarding claim 23, Bontinck in view of Keeley in view of Aurich in view of Misumi suggests the invention of claim 2. The combination of further discloses wherein the one or more moveable plates 20 (Fig. 4 of Misumi) includes a first moveable plate 22 (Fig. 4 of Misumi) in alignment with the first compartment 8 (Fig. 2 of Bontinck) and a second moveable plate 23 (Fig. 4 of Misumi) in alignment with the second compartment 9 (Fig. 2 of Bontinck), and the first and second moveable plates 22, 23 (Fig. 6-8 of Misumi) are moved independently (Fig. 6-8 of Misumi demonstrates independent movement of plate 22 with respective plate 23, and Col. 7, line 37-39 of Misumi – “These pressing members 21, 22, and 23 are supported by independent supporting members respectively”) to adjust the pressure of the respective first 8 and second compartments 9 (Fig. 2 of Bontinck).
Examiner notes that once the combination is made as discussed in claim 2 and 3, the pressing system of multiple plates of Misumi will be incorporated into the combined system, specifically outside of the dual compartment container as established in claim 2. Therefore, the movable plate 22 and 23 of Misumi will align with compartment 8 and 9 of Bontinck, respectively, as it would have been obvious for one of ordinary skill in the art to assign such a configuration given the size of each compartment as established in claim 1. Thus, the limitation is met.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Wolff et al. US 10,058,091 B2 teaches a dual compartment container for cell processing.
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 QUYNH DAO LE whose telephone number is (571)272-7198. The examiner can normally be reached Monday - Friday 8:30 am - 5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/QUYNH DAO LE/Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781
