DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/24/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/11/2025 has been entered.
Response to Amendment
The amendments filed on 11/11/2025 has been entered. Claim 1 has been amended; claims 11 has been added. Accordingly, claims 1-11 are pending and under consideration.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 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 is now rejected under 35 U.S.C. 103 as being unpatentable over Skelley et al. US 2021/0261907 A1 (previously cited), as cited in the IDS, in view of Davis et al. US 2014/0276415 A1 (newly cited). See rejection of claims below. Also, see claim interpretation below for application of prior art under 35 U.S.C. 102 and 103 regarding the newly amended limitation.
Claim Interpretation
The transitional phrase "consisting essentially of " limits the scope of a claim to the specified materials or steps" and those that do not materially affect the basic and novel characteristic(s)" of the claimed invention (See MPEP 2111.03.III). Since Par. 11, Par. 13, and Par. 40 of Applicant’s PG-Pub have yet to establish any component that would materially affect the basic and novel characteristic of the claimed invention, the limitation of “the container consisting essentially of the first and second compartments” of claim 1 is currently being construed as equivalent to “comprising”. (See MPEP 2111.03.III – For the purposes of searching for and applying prior art under 35 U.S.C. 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, "consisting essentially of" will be construed as equivalent to "comprising.")
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, 7, 8, 10, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Skelley et al. US 2021/0261907 A1 (previously cited, hereinafter Skelley), as cited in the IDS, in view of Davis et al. US 2014/0276415 A1 (newly cited, hereinafter Davis).
Regarding claim 1, Skelley discloses a method for processing cells collected (Par. 2 – “methods of simultaneously purifying and concentrating cells or other particles…”) using an apheresis device (Par. 19 – “Samples containing these cells may be blood, compositions obtained by performing apheresis,…”), the method (Par. 2) comprising:
receiving in a first distinct compartment (Fig. 3 – “sample reservoir”) the cells (see annotated Fig. 3 below – “sample reservoir” holds a sample) collected using the apheresis device (as established above in Par. 19, the sample containing cells are obtained by performing apheresis), a second distinct compartment (Fig. 3 – “buffer reservoir”) including a buffer solution (Fig. 3 – the “buffer reservoir” contains buffer)¸ the second distinct compartment is not in fluid communication with the first distinct compartment (Fig. 3 – the buffer reservoir is distinct and not fluidly coupled to the sample reservoir);
transferring at least a portion of the cells collected (Fig. 3 – sample in the “sample reservoir” is pumped towards the next device by means of the “sample pump”, as indicated by the downward arrow) using the apheresis device (as established above in Par. 19, the sample containing cells are obtained by performing apheresis) held by the container (see annotated Fig. 3 below – sample contained within the “sample reservoir” or container “C”) to a microfluidic device “I” (see annotated Fig. 3 below – microfluidic device “I”) for processing (Par. 53 – “Cells, particularly cells in compositions prepared by apheresis… may be isolated by performing DLD using microfluidic devices…”).
However, Skelley does not explicitly disclose a first distinct compartment and a second distinct compartment of a container and the container consisting essentially of the first and second distinct compartments; adjusting a pressure of the container; and at the adjusted pressure, transferring at least a portion of the cells.
Davis, in the same field endeavor of chambered reservoir (Par. 32), teaches a first distinct compartment 235 (Fig. 4 – drive chamber 235) and a second distinct compartment 245 (Fig. 4 – infusate chamber 245) of a container 215 (Fig. 4 – assembly 215) and the container 215 (Fig. 4) consisting essentially of the first 235 (Fig. 4) and second distinct compartments 245 (Fig. 4).
Examiner does note that the system of Skelley exists a “sample pump” (Fig. 3 of Skelley) and a “buffer pump” that is attached to the “sample reservoir” and “buffer reservoir”, respectively, and pumping means is well-known component within fluid systems that create pressurized fluid flow. Skelley also discusses that the containers can be pressurized to propel product stream (Par. 7 – “…the recycled product stream being propelled using, for example, pressurized containers, peristaltic pumps, or syringe pumps”). Therefore, 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 Skelley’s method and applied the known technique of pressurizing a container, also as taught by Skelley, since the application of this known technique yields no more than predictable results of driving the sample fluid by means of adjusting the pressure within the sample container. See MPEP 2143.I. Therefore, the limitation of “adjusting a pressure of the container; and at the adjusted pressure, transferring at least a portion of the cells” is met.
It also would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the system with two distinct compartments of Skelley that contains blood product and buffer, for the two-compartmented container as taught by Davis, since these mechanisms perform the same function of holding medical/pharmaceutical products. Simply substituting one reservoir means for another would yield the predicable result of containing blood products and buffer solution within a medical setting. See MPEP 2143. Once the modification is made as discussed, blood/buffer solution are configured to be contained within the first and second compartment 235 and 245 of Davis, separated by the divider 240 so that they are distinct and not in fluid communication with each other. Once the modification is met as discussed, the first compartment 235 containing blood products/cells of Davis will be attached with the corresponding “sample pump” of Skelley, and the second compartment 245 containing buffer solution of Davis will be attached with the corresponding “buffer pump” of Skelley.
Regarding claim 7, Skelley in view of Davis suggests the invention of claim 1. The combination further discloses wherein the first compartment 235 (Fig. 4 of Davis has a first size (Fig. 4 of Davis – chamber 235 has a predetermined dimension) and the second compartment 245 (Fig. 4 of Davis) has a second size (Fig. 4 of Davis – chamber 245 has a predetermined dimension).
However, the combination does not disclose a second size that is larger than the first size.
It 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 combination be 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.
Regarding claim 8, Skelley in view of Davis suggests the invention of claim 7. However, the combination does not disclose wherein the second size is about three time larger than the first size.
It 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 combination 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.
Regarding claim 10, Skelley in view of Davis suggests the invention of claim 1. The combination further discloses wherein the adjusting of the pressure (Fig. 3 of Skelley – “sample pump” and “buffer pump”) of the container 215 (Fig. 4 of Davis) includes adjusting independently a first pressure of the first compartment 235 (Fig. 4 with the “sample pump” of Skelley in Fig. 3) and a second pressure of the second compartment 245 (Fig. 4 with the “buffer pump” of Skelley in Fig. 3).
Examiner notes that once the modification is made as discussed in claim 1, the first compartment 235 containing blood products/cells of Davis will be attached with the corresponding “sample pump” of Skelley, and the second compartment 245 containing buffer solution of Davis will be attached with the corresponding “buffer pump” of Skelley; thus, the limitation is met.
Regarding claim 11, Skelley discloses a method for processing cells collected (Par. 2 – “methods of simultaneously purifying and concentrating cells or other particles…”) using an apheresis device (Par. 19 – “Samples containing these cells may be blood, compositions obtained by performing apheresis,…”), the method (Par. 2) comprising:
receiving in a first distinct compartment (Fig. 3 – “sample reservoir”) the cells (see annotated Fig. 3 above – “sample reservoir” holds a sample) collected using the apheresis device (as established above in Par. 19, the sample containing cells are obtained by performing apheresis), a second distinct compartment (Fig. 3 – “buffer reservoir”) including a buffer solution (Fig. 3 – the “buffer reservoir” contains buffer), the second distinct compartment not being in fluid communication with the first distinct compartment (Fig. 3 – the buffer reservoir is distinct and not fluidly coupled to the sample reservoir);
transferring at least a portion of the cells collected (Fig. 3 – sample in the “sample reservoir” is pumped towards the next device by means of the “sample pump”, as indicated by the downward arrow) using the apheresis device (as established above in Par. 19, the sample containing cells are obtained by performing apheresis) held by the container (see annotated Fig. 3 below – sample contained within the “sample reservoir”) to a microfluidic device “I” (see annotated Fig. 3 below – microfluidic device “I”) for processing (Par. 53 – “Cells, particularly cells in compositions prepared by apheresis… may be isolated by performing DLD using microfluidic devices…”).
However, Skelley does not disclose a first distinct compartment and a second distinct compartment of a container, the second distinct compartment sharing a defining compartment wall with the first distinct compartment; adjusting a pressure of the container; and at the adjusted pressure, transferring at least a portion of the cells.
Davis, in the same field endeavor of chambered reservoir (Par. 32), teaches a first distinct compartment 235 (Fig. 4 – drive chamber 235) and a second distinct compartment 245 (Fig. 4 – infusate chamber 245) of a container 215 (Fig. 4 – assembly 215)¸ the second distinct compartment 245 (Fig. 4) sharing a defining compartment wall 240 (Fig. 4 – divider 240) with the first distinct compartment 235 (Fig. 4).
Examiner does note that the system of Skelley exists a “sample pump” (Fig. 3 of Skelley) and a “buffer pump” that is attached to the “sample reservoir” and “buffer reservoir”, respectively, and pumping means is well-known component within fluid systems that create pressurized fluid flow. Skelley also discusses that the containers can be pressurized to propel product stream (Par. 7 – “…the recycled product stream being propelled using, for example, pressurized containers, peristaltic pumps, or syringe pumps”). Therefore, 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 Skelley’s method and applied the known technique of pressurizing a container, also as taught by Skelley, since the application of this known technique yields no more than predictable results of driving the sample fluid by means of adjusting the pressure within the sample container. See MPEP 2143.I. Therefore, the limitation of “adjusting a pressure of the container; and at the adjusted pressure, transferring at least a portion of the cells” is met.
It also would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the system with two distinct compartments of Skelley that contains blood product and buffer, for the two-compartmented container as taught by Davis, since these mechanisms perform the same function of holding medical/pharmaceutical products. Simply substituting one reservoir means for another would yield the predicable result of containing blood products and buffer solution within a medical setting. See MPEP 2143. Furthermore, one of ordinary skill in the art would have been motivated to implement a two-compartmented container with a wall as taught by Davis, in order to aid in the delivery of liquid of the chamber (Par. 38 of Davis). Once the modification is made as discussed, blood/buffer solution are configured to be contained within the first and second compartment 235 and 245 of Davis, separated by the divider 240 so that they are distinct and not in fluid communication with each other.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Skelley in view of Davis as applied to claim 1 above, and further in view of Baxter et al. US 2014/0100518 A1 (previously cited, hereinafter Baxter).
Regarding claim 2, Skelley in view of Davis suggests the invention of claim 1. However, the combination does not disclose wherein the adjusting of the pressure comprises decreasing the pressure inside the container from a first pressure to a second pressure.
Baxter, considered to be analogous art to the instant application as both seek to provide a solution to pumping fluids via means of parallel plates and a container inbetween (Abstract of Baxter, and Par. 7 of Applicant’s PG-Pub), teaches wherein the adjusting of the pressure comprises decreasing the pressure inside the container from a first pressure to a second pressure (Par. 23 – “…to decrease pressure in the flexible container 103…”; Examiner contends that a decrease in pressure inherently has an initial pressure value and a final pressure value).
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 adjustment step of the combination to further have a decreasing step as taught by Baxter, in order to maintain a desired pressure within the container (Par. 23 of Baxter).
Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Skelley in view of Davis as applied to claim 1 above, and further in view of Aurich et al. WO 2017035262 A1 (previously cited, hereinafter Aurich).
Regarding claim 3, Skelley in view of Davis suggests the invention of claim 1. However, the combination does not disclose wherein the adjusting of the pressure comprises increasing the pressure inside the consider form a first pressure to a second pressure.
Aurich, in the same field of endeavor of methods and devices of multi-step cell purification and concentration (Title), teaches wherein the adjusting of the pressure comprises increasing the pressure inside the consider form a first pressure to a second pressure (Par. 454 – “Place stopper on blood syringe and pressurize… the sample channel to 8.70 psi)”; Examiner contends that an increase in pressure inherently has an initial pressure value and a final pressure value).
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 adjustment step of the combination to further have an increasing step as taught by Aurich, in order to allow the blood the enter the chip/microfluidic device (Par. 456 of Aurich).
Regarding claim 4, Skelley in view of Davis in view of Aurich suggests the invention of claim 3. The combination further discloses wherein the first pressure is atmospheric pressure (Par. 454 of Aurich – “blood syringe is not capped and is at atmospheric pressure”; in other words, the sample compartment is initially at atmospheric pressure; Examiner notes that once the modification is made as discussed in claim 3, the first and second pressure of Aurich is also incorporated into the method of Skelley; thus, the limitation is met).
However, the combination does not disclose the second pressure is about 70 pounds per square inch (psi).
Examiner notes that the combination currently discloses the second pressure at 8.7 psi. (Par. 454 of Aurich).
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 second 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 second pressure of about 70 psi 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 second pressure during an increase of pressure inside the container to about 70 psi in the method 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 “the second pressure is about 70 pounds per square inch (psi)” is met.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Skelley in view of Davis as applied to claim 1 above, and further in view of Peritt et al. US 2021/0244871 A1 (previously cited, hereinafter Peritt) and Misumi et al. US 5,456,824 A (previously cited, hereinafter Misumi), as cited in the IDS.
Regarding claim 5, Skelley in view of Davis suggests the invention of claim 1. The combination further discloses wherein the pressure is adjusted using a pressure system “P” (see annotated Fig. 3 of Skelley below – pressure system “P”) that is fluidly coupled to the microfluidic device “I” (see annotated Fig. 3 of Skelley below – pressure system “P” is fluidly connected to microfluidic device “I”).
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Annotated Fig. 3, second panel of Skelley
However, Skelley does not disclose a pressure system that is fluidly coupled to the apheresis device, the pressure system comprising 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.
Peritt, in the same field of endeavor of methods and systems of real-time modification of cells (Title), teaches a pressure system (Par. 253-254 – pumps discussed: “means for forcing the cells through the channels under controlled conditions. Such means can include, for example, a pump, either within or connected to the cell customization module [400] or, alternatively, upstream of the cell customization module [400]”) that is fluidly coupled to the apheresis device 1200 (Fig. 2 – cell separation module 200; Par. 134 – “the cell separation module (200) comprises a cell separator (1200) such as an apheresis device”. Examiner notes that the sample fluid flows from the apheresis device 1200 in Fig. 2 to the microfluidic device 421 in Fig. 3 via the aforementioned pump means).
Misumi, in the same field of endeavor of liquid separating apparatus (Title), teaches wherein the pressure system 15 (Fig. 3 – housing 15) comprising 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 have modified the method of the combination to have the pressure system fluidly connected to the apheresis device as taught by Peritt, in order to force the suspended cells from the cell separation module/apheresis device through the plurality of microfluidic channels (Par. 39 of Peritt) and allow for transport of cells in and through the systems (Par. 124 of Peritt). Once the modification is made as discussed, the method of the combination will have the pressure system “P” fluidly connected to both the apheresis device and the microfluidic device.
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 modification is made as discussed, the pressure system “P” of the combination will have a stationary plate and movable plates, instead of a sample pump, with the container of Davis in the middle as taught by Misumi.
Claims 6 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Skelley in view of Davis in view of Peritt in view of Misumi as applied to claim 5 above, and further in view of Wells et al. US 2024/0110152 A1 (previously cited, hereinafter Wells), as cited in the IDS and Aurich.
Regarding claim 6, Skelley in view of Davis in view of Peritt in view of Misumi suggests the invention of claim 5. The combination further discloses the pressure system “P” (see annotated Fig. 3 of Skelley above) further comprises:
a second fluid line (see annotated Fig. 3 of Skelley above – “second fluid line”) that fluidly connects the second compartment 245 (Fig. 4 of Davis) and a buffer solution (Fig. 3 of Skelley – “buffer reservoir” having a fluid line that flows into the microfluidic device “I”; Examiner notes that once the modification is made as discussed in claim 1, the second compartment 245 of Davis contains a buffer solution, thus the annotated line provides a fluid channel for the buffer solution in the second compartment);
a third fluid line 285 (Fig. 4 of Davis) that fluidly connects the first compartment 235 (Fig. 4 of Davis) and the microfluidic device “I” (see annotated Fig. 3 of Skelley above, and Fig. 3 of Skelley – “Sample in” port of the microfluidic device);
a fourth line 255 (Fig. 4 of Davis) that fluidly connects the second compartment 245 (Fig. 4 of Davis) and the microfluidic device “I” (see annotated Fig. 3 of Skelley above, and Fig. 3 of Skelley – “Buffer in” port of the microfluidic device);
However, the combination does not disclose a first fluid line that fluidly connects the first compartment and the apheresis device, the first fluid line comprising a first valve; the second fluid line comprising a second valve; the third fluid line comprising a third valve; the fourth fluid line comprising a fourth valve, and wherein the method further comprises: closing the first and second valves and opening the third and fourth valves prior to the adjusting of the pressure.
Wells, in the same field of endeavor of cell processing of apheresis product (Par. 949), teaches
a first fluid line 324 (Fig. 130B – inlet port 324) that fluidly connects the first compartment 310 (Fig. 130B), the first fluid line 324 (Fig. 130B) comprising a first valve (Par. 714 – “inlet port 324… may each include a conduit having a closing mechanism, for example, a valve, stopcock, tube clamp, cap, stopper, etc.”);
the third fluid line 326 (Fig. 130B) comprising a third valve (Par. 714 – “outlet ports 326… may each include a conduit having a closing mechanism, for example, a valve, stopcock, tube clamp, cap, stopper, etc.”); and
the fourth fluid line 328 (Fig. 130B – outlet port 328) comprising a fourth valve (Par. 714 – “…outlet ports… 328 may each include a conduit having a closing mechanism, for example, a valve, stopcock, tube clamp, cap, stopper, etc.”).
Aurich, in the same field of endeavor of methods and devices of multi-step cell purification and concentration (Title), teaches wherein the method further comprises: closing the first and second valves (Par. 454 – “Place stopper into buffer syringe”, which corresponds to the second valve and “Place stopper on blood syringe”, which corresponds to the first valve) and opening the third and fourth valves after the adjusting of the pressure (Par. 454 – “Turn on pump A (Buffer pump) and release clamp”, which corresponds to the fourth valve, and “Par. 456 – “Put the stopper on blood sample syringe and turn on pumps to 8.7 psi (blood)… then remove clamp from blood sample”, which corresponds to the third valve).
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 method of combination to further incorporate valves as taught by Wells, in order to have an open and closed configuration to allow or prevent the passage of liquid or other materials (Par. 714 of Wells). It also would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have duplicated a valve to include another valve in the second fluid line of the combined device, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. Furthermore, the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). See MPEP 2144. In this instant case, the valve in the second fluid line would perform the same function of allowing or restricting flow through the second fluid line without new and unexpected result. Thus, the limitation “the second fluid line comprising a second valve” is met. It also 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 of the combination to further incorporate a first fluid line as taught by Wells, in order to allow liquid or other materials (e.g., cells) to pass through (Par. 714 of Wells).
Since the pressure system is fluidly coupled to the apheresis device as established in claim 5 as taught by Peritt, and now that it is further established that said fluid connection between the apheresis device and the pressure system is achieved via the first fluid line, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have recognized that Wells’ first fluid line 324 of the first compartment needs to fluidly couple with the apheresis device to form a cohesive connection from the apheresis device. Thus, the limitation “a first fluid line that fluidly connects the first compartment and the apheresis device” is met.
Lastly, one of ordinary skill in the art would have recognized that there are a finite number of orders for opening the third and fourth valves: prior to adjusting the pressure, during adjusting the pressure, and after adjusting the pressure while the first and second valves remain closed, in order to prime and purge air out of the fluid lines (Par. 454 of Aurich). Thus it would have been obvious to try the remaining two options, including prior to adjusting the pressure, because there is a finite number of identified, predictable solutions. Choosing from a finite number of identified, predictable solutions, with a reasonable expectation for success, is likely to be obvious to a person if ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, E.). Thus, the limitation of “prior to the adjusting of the pressure” is met.
Regarding claim 9, Skelley in view of Davis in view of Peritt in view of Misumi in view of Wells in view of Aurich suggests the invention of claim 6. The combination 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 235 (Fig. 4 of Davis) and a second moveable plate 23 (Fig. 4 of Misumi) in alignment with the second compartment 245 (Fig. 4 of Davis), 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 235 and second compartments 245 (Fig. 4 of Davis).
Examiner notes that once the modification is made as discussed in claim 5, the pressing system of multiple plates of Misumi will be incorporated into the combined system, specifically outside of the two-compartment container as established in claim 5. Therefore, the movable plate 22 and 23 of Misumi will align with compartment 235 and 245 of Davis, respectively. Thus, the limitation is met.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Park US 2016/0114960 A1 teaches a dual-compartment pouch
Schenk US 2010/0028215 A1 teaches a compartmented container
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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/QUYNH DAO LE/Examiner, Art Unit 3781
/ANDREW J MENSH/Primary Examiner, Art Unit 3781