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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/12/2025 and 09/24/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
The amendments filed on 11/11/2025 has been entered. Claims 1 and 8 have been amended; claim 24 has been added; claims 15-20 have been cancelled. Accordingly, claims 1-14 and 21-24 are pending and under consideration.
Response to Arguments
Applicant’s arguments field on 05/14/2025 with respect to claims 1 and 8 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 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Skelley et al. US 2021/0261907 A1 (previously cited) in view of Kopp et al. US 4,412,553 A (previously cited), Davis et al. US 2014/0276415 A1 (newly cited), and Aurich et al. WO 2017035262 A1 (previously cited). 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 and claim 8 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, 6, 7, 8, 21, 22, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Skelley et al. US 2021/0261907 A1 (previously cited, hereinafter Skelley) in view of Kopp et al. US 4,412,553 A (previously cited, cited, hereinafter Kopp), Davis et al. US 2014/0276415 A1 (newly cited, hereinafter Davis), and Aurich et al. WO 2017035262 A1 (previously cited, hereinafter Aurich).
Regarding claim 1, Skelley discloses a system “S” (see annotated Fig. 3 below, second panel – a separation system “S” comprising many comprising various components) for using an in-line processing device “I” (Fig. 1D and see annotated Fig. 3 below – DLD chip being the in-line processing device “I”), the system “S” (see annotated Fig. 3 below) comprising:
a pressure system “P” (see annotated Fig. 3 below – pressure system “P”) including a first compartment (Fig. 3 – “sample reservoir”) configured to receive cells collected using the apheresis device (Par. 19 – “Samples containing these cells may be blood, compositions obtained by performing apheresis,…”, and Par. 53-54 – sample cells to be further isolated are collected by apheresis; thus, Examiner contends the “sample reservoir” is fully capable of receiving cell samples prepared by apheresis) and a second compartment (Fig. 3 – “buffer reservoir”) that is distinct from and not in fluid communication with the first compartment (Fig. 3 – the buffer reservoir is distinct and not fluidly coupled to the sample reservoir) and that is configured to receive a buffer solution (Fig. 3 – the “buffer reservoir” contains buffer), the pressure system “P” configured to direct the cells collected using the apheresis device (as established above in Par. 19, the sample containing cells are obtained by performing apheresis) to the in-line processing device “I” (see annotated Fig. 3 below – “in-line processing device “I”, sample in the “sample reservoir” is pumped towards the next device by means of the “sample pump”, as indicated by the downward arrow).
However, Skelley does not disclose a system for using an in-line processing device with an apheresis device, a container having a first compartment and second compartment, the container consisting essentially of the first and second compartments, the pressure system configured to change a pressure of the container to between 0.48 MPa and 0.69 MPa; and a fluid line that fluidly connects the apheresis device and the container.
Kopp, in the same field of endeavor of plasmapheresis system (Title), teaches a system 10 (Fig. 5 – plasmapheresis apparatus 10) for using an in-line processing device 86 (Fig. 5 – auxiliary equipment 86) with an apheresis device 14 (Fig. 5 – module 14 with microporous membranes, and Col. 2, line 3-11 – “plasmapheresis apparatus utilizing… microporous membranes”), and a fluid line 80 (Fig. 5 – set 80) that fluidly connects the apheresis device 14 (Fig. 5) and the container 12 (Fig. 5 – fluid flow control device 12).
Davis, in the same field endeavor of chambered reservoir (Par. 32), teaches a container 215 (Fig. 4 – assembly 215) having a first compartment 235 (Fig. 4 – drive chamber 235) and second compartment 245 (Fig. 4 – infusate chamber 245), the container 215 (Fig. 4) consisting essentially of the first and second compartments 235, 245 (Fig. 4).
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 (Par. 454 – “Place stopper on blood syringe and pressurize… the sample channel to 8.70 psi)”).
Examiner notes that while “an apheresis device” is not explicitly mentioned in the disclosure of Skelley, the sample which goes under further processing in the disclosure of Skelley is in fact obtained from performing apheresis. Therefore, Skelley suggests that an apheresis device is reasonably appropriate within the system given said teaching in Par. 19 and Par. 53. Therefore, given the teachings of Kopp, 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 system of Skelley to incorporate an apheresis device and its fluid line as taught by Kopp, in order to provide operational purposes of removing, harvesting the plasma from whole blood for exchange, transfusion, or fractionation (Col. 5, last paragraph, and Col. 6, line 1-2 of Kopp).
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.
Furthermore, Examiner does note that the system of Skelley exists a “sample pump” (Fig. 3 of Skelley) that is attached to the “sample reservoir” container, 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 apparatus 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 changing the pressure within the sample container. Therefore, the limitation of “the pressure system configured to change a pressure of the container” is met.
Alternatively, 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 Skelley 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.
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Annotated Fig. 3, second panel of Skelley
Regarding claim 6, Skelley in view of Kopp in view of Davis in view of Aurich suggests the invention of claim 1. The combination further discloses wherein a size ratio of the first compartment 235 (Fig. 4 of Davis) to the second compartment 245 (Fig. 4 of Davis) is selected (Fig. 4 of Davis; Examiner further contends that a size for the first and chamber 235 and 245 has to be determined so that manufacture of the container can be achieved).
Regarding claim 7, Skelley in view of Kopp in view of Davis in view of Aurich suggests the invention of claim 1. The combination further discloses wherein the in-line processing device “I” (Fig. 3 of Skelley – DLD Chip) is a microfluidic device (Par. 53 of Skelley – “Cells, particularly cells in compositions prepared by apheresis… may be isolated… using microfluidic devices”).
Regarding claim 8, Skelley discloses a system “S” (see annotated Fig. 3’ below, second panel - a separation system “S” comprising many comprising various components) for using a microfluidic device “I” (Fig. 1D and see annotated Fig. 3’ below – DLD chip being the microfluidic device “I”; Par. 53 – “Cells, particularly cells in compositions prepared by apheresis… may be isolated… using microfluidic devices”), the system “S” (see annotated Fig. 3’ below) comprising:
a pressure system “P” (see annotated Fig. 3’ below – pressure system “P”) consisting essentially of two distinct compartments (Fig. 3 – “sample reservoir” and “buffer reservoir”), a first compartment (Fig. 3 – “sample reservoir”) of the two distinct compartments (Fig. 3 – two reservoirs) being configured to receive cells collected using the apheresis device (Par. 19 – “Samples containing these cells may be blood, compositions obtained by performing apheresis,…”, and Par. 53-54 – sample cells to be further isolated are collected by apheresis; thus, Examiner contends the “sample reservoir” is fully capable of receiving cell samples prepared by apheresis), a second compartment (Fig. 3 – “buffer reservoir”) of the two distinct compartments (Fig. 3 – two reservoirs) that is not in fluid communication with the first compartment (Fig. 3 – the buffer reservoir is distinct and not fluidly coupled to the sample reservoir) and that is configured to receive a buffer solution (Fig. 3 – the “buffer reservoir” contains buffer),
the pressure system P (see annotated Fig. 3’ below) configured to change a first pressure of the first compartment (Fig. 3 – “sample pump” is capable of pressurizing and moving fluid from the “sample reservoir”) and a second pressure of the second compartment (Fig. 3 – “buffer pump” is capable of pressurizing and moving fluid from the “buffer reservoir”) and to direct the cells collected using the apheresis device (Par. 19 – “Samples containing these cells may be blood, compositions obtained by performing apheresis,…”, and Par. 53-54 – sample cells to be further isolated are collected by apheresis) and the buffer solution to the microfluidic device I (see annotated Fig. 3’ below – see annotated Fig. 3’ below – “in-line processing device “I”, sample in the “sample reservoir” is pumped towards the next device by means of the “sample pump”, as indicated by the downward arrow; similarly, buffer is pumped towards the microfluidic device “I” by means of “buffer pump”).
However, Skelley does not disclose a system with an apheresis device, a container consisting essentially of two distinct compartments, 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; a first fluid line that fluidly connects the first compartment and the apheresis device.
Kopp, in the same field of endeavor of plasmapheresis system (Title), teaches a system 10 (Fig. 5 – plasmapheresis apparatus 10) with an apheresis device 14 (Fig. 5 – module 14 with microporous membranes, and Col. 2, line 3-11 – “plasmapheresis apparatus utilizing… microporous membranes”), and a fluid line 80 (Fig. 5 – set 80) that fluidly connects the first compartment 30 (Fig. 5 – fluid pathway 30) and the apheresis device 14 (Fig. 5).
Davis, in the same field endeavor of chambered reservoir (Par. 32), teaches a container 215 (Fig. 4 – assembly 215) consisting essentially two distinct compartments 235, 245 (Fig. 4 – drive chamber 235 and infusate chamber 245).
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)”).
Examiner notes that while “an apheresis device” is not explicitly mentioned in the disclosure of Skelley, the sample which goes under further processing in the disclosure of Skelley is in fact obtained from performing apheresis. Therefore, Skelley suggests that an apheresis device is reasonably appropriate within the system given said teaching in Par. 19 and Par. 53. Therefore, given the teachings of Kopp, 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 system of Skelley to incorporate an apheresis device and its fluid line as taught by Kopp, in order to provide operational purposes of removing, havesting the plasma from whole blood for exchange, transfusion, or fractionation (Col. 5, last paragraph, and Col. 6, line 1-2 of Kopp).
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 in view of Kopp 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.
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.
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Annotated Fig. 3’ of Skelley
Regarding claim 21, Skelley in view of Kopp in view of Davis in view of Aurich 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 the second compartment 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 combined device 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 22, Skelley in view of Kopp in view of Davis in view of Aurich suggests the invention of claim 21. 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 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.
Regarding claim 24, Skelley discloses a system S” (see annotated Fig. 3’ above, second panel – a separation system “S” comprising many comprising various components) for using a microfluidic device “I” (Fig. 1D and see annotated Fig. 3’ below – DLD chip being the microfluidic device “I”; Par. 53 – “Cells, particularly cells in compositions prepared by apheresis… may be isolated… using microfluidic devices”) with an apheresis device, the system “S” (see annotated Fig. 3’ above) comprising:
a pressure system “P” (see annotated Fig. 3’ above – pressure system “P”) including two or more distinct compartments (Fig. 3 – “sample reservoir” and “buffer reservoir”), a first compartment (Fig. 3 – “sample reservoir”) of the two or more distinct compartments (Fig. 3 – “sample reservoir” and “buffer reservoir”) being configured to receive cells collected using the apheresis device (Par. 19 – “Samples containing these cells may be blood, compositions obtained by performing apheresis,…”, and Par. 53-54 – sample cells to be further isolated are collected by apheresis; thus, Examiner contends the “sample reservoir” is fully capable of receiving cell samples prepared by apheresis), a second compartment (Fig. 3 – “buffer reservoir”) of the two or more distinct compartments (Fig. 3 – “sample reservoir” and “buffer reservoir”) not being in fluid communication with the first compartment (Fig. 3 – the buffer reservoir is distinct and not fluidly coupled to the sample reservoir) and that is configured to receive a buffer solution (Fig. 3 – the “buffer reservoir” contains buffer),
the pressure system P (see annotated Fig. 3’ below) configured to change a first pressure of the first compartment (Fig. 3 – “sample pump” is capable of pressurizing and moving fluid from the “sample reservoir”) and a second pressure of the second compartment (Fig. 3 – “buffer pump” is capable of pressurizing and moving fluid from the “buffer reservoir”) and to direct the cells collected using the apheresis device (Par. 19 – “Samples containing these cells may be blood, compositions obtained by performing apheresis,…”, and Par. 53-54 – sample cells to be further isolated are collected by apheresis) and the buffer solution to the microfluidic device I (see annotated Fig. 3’ below – see annotated Fig. 3’ below – “in-line processing device “I”, sample in the “sample reservoir” is pumped towards the next device by means of the “sample pump”, as indicated by the downward arrow; similarly, buffer is pumped towards the microfluidic device “I” by means of “buffer pump”).
However, Skelley does not disclose a system with an apheresis device, a container having two or more distinct compartments, 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 MPa; and a first fluid line that fluidly connects the first compartment and the apheresis device.
Kopp, in the same field of endeavor of plasmapheresis system (Title), teaches a system 10 (Fig. 5 – plasmapheresis apparatus 10) with an apheresis device 14 (Fig. 5 – module 14 with microporous membranes, and Col. 2, line 3-11 – “plasmapheresis apparatus utilizing… microporous membranes”), and a fluid line 80 (Fig. 5 – set 80) that fluidly connects the first compartment 30 (Fig. 5 – fluid pathway 30) and the apheresis device 14 (Fig. 5).
Davis, in the same field endeavor of chambered reservoir (Par. 32), teaches a container 215 (Fig. 4 – assembly 215) having two or more distinct compartments 235, 245 (Fig. 4 – drive chamber 235 and infusate chamber 245), the second compartment 245 (Fig. 4) sharing a defining compartment wall 240 (Fig. 4 – divider 240) with the first compartment 235 (Fig. 4).
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 (Fig. 24 – buffer syringe, and Par. 456 – “…turn on pumps to 10 psi (buffer)…”) 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)”).
Examiner notes that while “an apheresis device” is not explicitly mentioned in the disclosure of Skelley, the sample which goes under further processing in the disclosure of Skelley is in fact obtained from performing apheresis. Therefore, Skelley suggests that an apheresis device is reasonably appropriate within the system given said teaching in Par. 19 and Par. 53. Therefore, given the teachings of Kopp, 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 system of Skelley to incorporate an apheresis device and its fluid line as taught by Kopp, in order to provide operational purposes of removing, harvesting the plasma from whole blood for exchange, transfusion, or fractionation (Col. 5, last paragraph, and Col. 6, line 1-2 of Kopp).
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 implemented 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.
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 Skelley in view of Kopp in view of Davis 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, Skelley in view of Kopp in view of Davis 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 “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.
Regarding claim 3, Skelley in view of Kopp in view of Davis in view of Aurich in view of Misumi suggests the invention of claim 2. The combination of further discloses wherein the pressure system “P” (see annotated Fig. 3 above of Skelley) 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, Skelley in view of Kopp in view of Davis 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 “P” of Skelley will have a stationary plate and movable plates, instead of a sample pump and a buffer pump, with the container of Davis in the middle as taught by Misumi.
Examiner notes that once the modification is made as discussed above, given the multi-compartment container of Davis, movement of pressing members 22 and 23 as taught by Misumi can individually apply pressure onto the walls of first compartment 235 and the second compartment 245 of Davis, respectively. 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, Skelley in view of Kopp in view of Davis in view of Aurich in view of Misumi suggests the invention of claim 9. The combination further discloses wherein the pressure system “P” (see annotated Fig. 3’ above of Skelley) 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, Skelley in view of Kopp in view of Davis 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 235 (Fig. 4 of Davis) and a second plate 23 (Fig. 4 of Misumi) aligned with the second compartment 245 (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 two-compartment container as established in claim 9. Therefore, the movable plate 22 and 23 of Misumi will align with compartment 235 and 245 of Davis, respectively. Thus, the limitation is met.
Regarding claim 12, Skelley in view of Kopp in view of Davis in view of Aurich in view of Misumi suggests the invention of claim 11. The combination further discloses wherein the pressure system “P” (see annotated Fig. 3’ above of Skelley) 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, Skelley in view of Kopp in view of Davis 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 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 2 and 3, 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 2. Therefore, the movable plate 22 and 23 of Misumi will align with compartment 235 and 245 of Davis, respectively. Thus, the limitation is met.
Claims 4, 5, 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Skelley in view Kopp in view of Davis in view of Aurich as applied to claim 1 and claim 8 above, and further in view of Wells et al. US 2024/0110152 A1 (previously cited, hereinafter Wells).
Regarding claim 4, Skelley in view of Kopp in view of Davis in view of Aurich suggests the invention of claim 1. However, the combination does not explicitly disclose wherein the fluid line further includes a valve.
Wells, in the same field of endeavor of cell processing of apheresis product (Par. 949), teaches wherein the fluid line 324 (Fig. 130B – inlet port 324) further includes a 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.”).
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 fluid line of the combination to further incorporate a valve 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).
Regarding claim 5, Skelley in view of Kopp in view of Davis in view of Aurich in view of Wells suggets the invention of claim 4. The combination further discloses where the fluid line 80 (Fig. 5 of Kopp) is a first fluid line (Fig. 5 of Kopp, and Examiner notes that once the modification is made as discussed in claim 1, the fluid line of Kopp will be incorporated into the device of Skelley, becoming the fluid line that connects the apheresis device and the container “C” of the pressures system “P”), the valve 324 (Fig. 130B of Wells) is a first valve (Fig. 130B of Wells – valve of port 324 belongs to the first fluid line upon the modification of claim 4), and the system “S” (see annotated Fig. 3 above of Skelley) further includes:
a second fluid line (see annotated Fig. 3 of Skelley above – “second fluid line”) that fluidly connects the pressure system “P” and the in-line processing device “I” (see annotated Fig. 3 of Skelley above – the “second fluid line” is the dashed line with arrow that runs from the pressure system “P” to the chip/in-line processing device “I”).
However, the combination does not disclose the second fluid line having a second 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 duplicated the valve of the combination to include another similar valve in the second line of the combination, 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. 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 duplicated the valve of the combination onto the second fluid line, in order to yield the predictable result of safely restricting or allowing a flow to traverse through the second fluid line.
Regarding claim 13, Skelley in view of Kopp in view of Davis in view of Aurich suggests the invention of claim 8. The combination further discloses a second fluid line (see annotated Fig. 3’ above of Skelley) that fluidly connects a buffer source (Fig. 3 of Skelley – “buffer reservoir” having a fluid line that flows into the DLD chip).
However, the combination does not explicitly disclose the first fluid line comprising a first valve; and a second fluid line that fluidly connects the second compartment and a buffer source, the second fluid line comprising a second valve.
Wells, in the same field of endeavor of cell processing of apheresis product (Par. 949), teaches a first valve of the first fluid line 324 (Fig. 130A-B – inlet port 324, and Par. 714 – “inlet port 324… may each include a conduit having a closing mechanism, for example, a valve, stopcock, tube clamp, cap, stopper, etc.”).
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 fluid line of the 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).
While the second fluid line disclosed by Skelley is currently connected between the buffer source/reservoir and the microfluidic chip, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have rearranged the second fluid line so that the connection is between the buffer source and the second compartment of the container, which has been established in claim 9 that it is for receiving a buffer solution, since this claimed position of the second fluid line does not change the system ability to provide a suspension media for processing cells as all cells ultimately mix with the buffer solution and the mixed solution is fed into the microfluidic device. Since applicant has not given any criticality to why the position of the second fluid line disclosed has any importance to the function of the claimed device (Par. 25 of Applicant’s specification), the Federal Circuit held that, where the only difference between the prior art and the claims was the position of a claimed element and altering the position of that claimed element would not have modified the operation of the device, the claimed device was not patentably distinct from the prior art device because it merely involved the rearrangement of parts. See MPEP 2144. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Lastly, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have duplicated the valve of the combination to include another similar valve in the second line of the combined system, 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. 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 duplicated the valve of the combination onto the second fluid line, in order to yield the predictable result of safely restricting or allowing a flow to traverse through the second fluid line.
Regarding claim 14, Skelley in view of Kopp in view of Davis in view of Aurich suggests the invention of claim 13. The combination further teaches a third fluid line 285 (Fig. 4 of Davis) that fluidly connects the first compartment 235 (Fig. 4 of Davis) and a first port of the microfluidic device “I” (see annotated Fig. 3’ of Skelley above, and Fig. 3 of Skelley – “Sample in” port of the microfluidic device), and
a fourth line 255 (Fig. 4 of Davis) that fluidly connects the second compartment 245 (Fig. 4 of Davis) and a second port of 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 currently disclose further the third fluid line including a third valve; the fourth fluid line including a fourth valve.
Wells, in the same field of endeavor of cell processing of apheresis product (Par. 949), teaches further the third fluid line 326 (Fig. 130B of Wells – outlet port 326) including 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 of Wells – outlet port 328) including 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.”).
Examiner notes that once the modification is made as discussed in claim 8, the container of Davis is incorporated into the system of the combination, including the fluid lines. Thus, the limitation 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 system of the combination to further incorporate the third and fourth 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).
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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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
/PHILIP R WIEST/Primary Examiner, Art Unit 3781
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