DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendments filed on 07/06/2026 have been entered. Claims 1, 9, 11 have been amended; claims 6-8 and 10 have been cancelled. Accordingly, claims 1-5, 9, and 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, claims 1 and 11 are now rejected under 35 U.S.C. 103 as being unpatentable over Bontinck US 2013/0234039 A1 (newly cited) in view of Keeley US 2007/0287966 A1 (newly cited).
Applicant's arguments filed on 07/06/2026 have been fully considered but they are not persuasive.
Regarding Applicant’s remarks stating that “First, as detailed at paragraph [0040] of the as-filed specification, "the difference in chamber size may provide a means by which to assure a volumetric or flow rate ratio between the cellular fluids 102 and the buffer fluids 104 which may be required by the microfluidic device 150" That is, the ratio is not a random variable as suggested by the Office” on page 8 of Applicant’s remarks, Examiner acknowledged the remarks, but respectfully disagrees. Par. 40 in Applicant’s specification does not demonstrate strong criticality regarding the relative dimensions, i.e., “The first and second chambers 182, 184 may have that same or different sizes. A size ratio of the first chamber 182 to the second chamber 184 may be selected to cause a flow rate/volume ratio to be delivered to the microfluidic device 150. In certain variations, the second chamber 184 may be larger than the first chamber 182. For example, the second chamber 184 may be about three times larger than the first chamber 182. The difference in Chamber size may provide a means by which to assure a volumetric or flow rate ratio between the cellular fluids 102 and the buffer fluids 104 which may be required by the microfluidic device 150”. To demonstrate criticality and unexpected results of a claimed range, Applicant should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960). MPEP 716.02(d).II.
Regarding Applicant’s remarks regarding routine optimization regarding the volumetric rations of the compartments on page 9 of Applicant’s remarks, Examiner acknowledged the remarks, but considered them moot because routine optimization was not the thrust of the previous rejection established in the Office Action mailed on 04/06/2026 nor the current rejection. See rejection of claims below.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Bontinck US 2013/0234039 A1 (newly cited, hereinafter Bontinck) in view of Keeley US 2007/0287966 A1 (newly cited, hereinafter Keeley).
Regarding claim 1, Bontinck discloses a method for processing cells collected (Par. 2 – “methods for modifying the physical, chemical and/or biological properties of a fluid”) using an apheresis device (Par. 25 – “suitable blood components may comprise products obtained by apheresis…”), the method comprising:
receiving in a first distinct compartment 8 (Fig. 2 – receptacle 8) the cells collected (Par. 51 – “a bag 8 containing the fluid which is to be irradiated”) using the apheresis device (Par. 25 – “the fluid which is to be irradiated is, for example, a biological fluid, such as whole blood or a blood component. Examples of suitable blood components may comprise products obtained by apheresis”), a second distinct compartment 9 (Fig. 2 – receptacle 9) including a buffer solution (Par. 51 – “shared bag 9 containing a neutral fluid”, and Par. 26 – “a neutral fluid may include a phosphate buffer, a saline solution, an additive solution, and/or preservation solution of a blood component”), the first distinct compartment 8 (Fig. 2) being in independent communication with an microfluidic device 1 (Fig. 1-2 – chamber 1, Par. 34-35 – chamber 1 formed by films with a channel of micrometric/millimetric thickness, and Par. 46 – “The fluid which is to be irradiated is forwarded in the chamber 1 through the central inlet 6b”), the second distinct compartment 9 (Fig. 2) not being in fluid communication with the first distinct compartment 8 (Fig. 2), the second distinct compartment 9 (Fig. 2) being in independent communication with an microfluidic device 1 (Fig. 1-2, and Par. 46 – “a neutral fluid from the point of view of irradiation is forwarded through the upper 6c and lower 6a inlets”);
adjusting a pressure (Fig. 1-2, and Par. 71-73 – “the supply of the flow of fluid is realized by a fluid circulation device intended to establish the flows of fluid in the irradiation chamber, comprising a fluid circulating means, such as pump…”), the adjusting of the pressure includes adjusting independently a first pressure of the first distinct compartment 8 (Fig. 2, and Par. 46) and a second pressure of the second distinct compartment 9 (Fig. 2, and Par. 46); and at the adjusted pressure, transferring at least a portion of the cells collected using the apheresis device held by the container to the microfluidic device 1 for processing (Fig. 1-2, Par. 46 – “the irradiation chamber has three inlets 6a, 6b, 6c and three outlets 7a, 7b, 7c for the fluids. The fluid which is to be irradiated is forwarded in the chamber 1 through the central inlet 6b, and a neutral fluid from the point of view of irradiation is forwarded through the upper 6c and lower 6a inlets”, and Par. 71-73 – “the supply of the flow of fluid is realized by a fluid circulation device intended to establish the flows of fluid in the irradiation chamber, comprising a fluid circulating means, such as pump…”).
However, Bontinck does not disclose the second distinct compartment being three times larger than the first distinct compartment, the container consisting of the first and second distinct compartments.
Keeley, in the same field of endeavor of systems for storing and controlling the constituent components of a solution (Par. 6), teaches the container 28 (Fig. 2) consisting of the first 46 (Fig. 2 – first chamber 46) and second distinct compartments 48 (Fig. 2 – second chamber 48).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first compartment and the second compartment of Bontinck to be within a container such that they become a dual chamber container as taught by Keeley, since Keeley teaches that it is well-known in the art that many medical solutions must be separated into their constituent components for storage in order to maintain stability, viability, or to satisfy other medical concerns (Par. 1 of Keeley). The dual chamber container provides a simpler, more efficient and/or more flexible system of storing and controlling the constituent components of a solution (Par. 6 of Keeley).
It also would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the second compartment of the combined device be three times larger than the first compartment, in order to fit the particular procedure being done since this claimed dimension of the compartments does not change the container ability to hold medical products. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (Par. 40 of Applicant’s Pg-Pub), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
Regarding claim 11, Bontinck discloses a method for processing cells collected (Par. 2 – “methods for modifying the physical, chemical and/or biological properties of a fluid”) using an apheresis device (Par. 25 – “suitable blood components may comprise products obtained by apheresis…”), the method comprising:
receiving in a first distinct compartment 8 (Fig. 2 – receptacle 8) the cells collected (Par. 51 – “a bag 8 containing the fluid which is to be irradiated”) using the apheresis device (Par. 25 – “the fluid which is to be irradiated is, for example, a biological fluid, such as whole blood or a blood component. Examples of suitable blood components may comprise products obtained by apheresis”), a second distinct compartment 9 (Fig. 2 – receptacle 9) including a buffer solution (Par. 51 – “shared bag 9 containing a neutral fluid”, and Par. 26 – “a neutral fluid may include a phosphate buffer, a saline solution, an additive solution, and/or preservation solution of a blood component”), the first distinct compartment 8 (Fig. 2) being in independent communication with a microfluidic device 1 (Fig. 1-2 – chamber 1, Par. 34-35 – chamber 1 formed by films with a channel of micrometric/millimetric thickness, and Par. 46 – “The fluid which is to be irradiated is forwarded in the chamber 1 through the central inlet 6b”), the second distinct compartment 9 (Fig. 2) not being in fluid communication with the first distinct compartment 8 (Fig. 2), the second distinct compartment 9 (Fig. 2) being in independent communication with the microfluidic device 1 (Fig. 1-2, and Par. 46 – “a neutral fluid from the point of view of irradiation is forwarded through the upper 6c and lower 6a inlets”),
adjusting a pressure (Fig. 1-2, and Par. 71-73 – “the supply of the flow of fluid is realized by a fluid circulation device intended to establish the flows of fluid in the irradiation chamber, comprising a fluid circulating means, such as pump…”), the adjusting of the pressure of the container includes adjusting independently a first pressure of the first distinct compartment 8 (Fig. 2, and Par. 46) and a second pressure of the second distinct compartment 9 (Fig. 2, and Par. 46); and at the adjusted pressure, transferring at least a portion of the cells collected using the apheresis device held by the container to the microfluidic device 1 for processing (Fig. 1-2, Par. 46 – “the irradiation chamber has three inlets 6a, 6b, 6c and three outlets 7a, 7b, 7c for the fluids. The fluid which is to be irradiated is forwarded in the chamber 1 through the central inlet 6b, and a neutral fluid from the point of view of irradiation is forwarded through the upper 6c and lower 6a inlets”, and Par. 71-73 – “the supply of the flow of fluid is realized by a fluid circulation device intended to establish the flows of fluid in the irradiation chamber, comprising a fluid circulating means, such as pump…”).
However, Bontinck does not disclose the second distinct compartment being three times larger than the first distinct compartment, the second distinct compartment sharing a defining compartment wall with the first distinct compartment, the container consisting of the first and second distinct compartments.
Keeley, in the same field of endeavor of systems for storing and controlling the constituent components of a solution (Par. 6), teaches the second distinct compartment 48 (Fig. 2 – second chamber 48) sharing a defining compartment wall 44 (Fig. 2 – divider 44) with the first distinct compartment 46 (Fig. 2 – first chamber 46), the container 28 (Fig. 2 – dual chamber container 28) consisting of the first 46 (Fig. 2) and second distinct compartments 48 (Fig. 2).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first compartment and the second compartment of Bontinck to be within a container such that they become a dual chamber container as taught by Keeley, since Keeley teaches that it is well-known in the art that many medical solutions must be separated into their constituent components for storage in order to maintain stability, viability, or to satisfy other medical concerns (Par. 1 of Keeley). The dual chamber container provides a simpler, more efficient and/or more flexible system of storing and controlling the constituent components of a solution (Par. 6 of Keeley), as peeleable container systems require a great deal of fluid force to separate the seal, which can be difficult for individuals having limited upper body strength such as infirmed or elderly patients (Par. 5 of Keeley).
It also would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the second compartment of the combined device be three times larger than the first compartment, in order to fit the particular procedure being done since this claimed dimension of the compartments does not change the container ability to hold medical products. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (Par. 40 of Applicant’s Pg-Pub), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Bontinck in view of Keeley 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, Bontinck in view of Keeley 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 Bontinck in view of Keeley as applied to claim 1 above, and further in view of Aurich et al. WO 2017035262 A1 (previously cited, hereinafter Aurich).
Regarding claim 3, Bontinck in view of Keeley suggests the invention of claim 1. However, the combination does not disclose wherein the adjusting of the pressure comprises increasing the pressure inside the container 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 container 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, Bontinck in view of Keeley 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.
Claims 5 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Bontinck in view of Keeley 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, Bontinck in view of Keeley suggests the invention of claim 1. The combination further discloses wherein the pressure is adjusted using a pressure system 8+9+12 (Fig. 2 of Bontinck) that is fluidly coupled to the microfluidic device 1 (Fig. 1-2 of Bontinck – chamber 1).
However, the combination 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 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 of the combination will have a stationary plate and movable plates, instead of a sample pump, with the container of Bontinck in the middle as taught by Misumi. Examiner notes that once the modification is made as discussed above, given the dual chamber container of Bontinck modified by Keeley, movement of pressing members 22 and 23 as taught by Misumi can individually apply pressure onto the walls of first compartment 8 and the second compartment 9 of Bontinck.
Regarding claim 9, Bontinck in view of Keeley in view of Perritt in view of Misumi discloses the invention of claim 5. 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 distinct compartment 8 (Fig. 2 of Bontinck) and a second moveable plate 23 (Fig. 4 of Misumi) in alignment with the second distinct compartment 9 (Fig. 4 of Bontinck), and the first and second moveable plates 22, 23 (Fig. 4 of Misusmi) are moved independently to adjust the pressure of the respective first and second distinct compartments 8, 9 (Fig. 2 of Bontinck).
Examiner notes that once the modification is made as discussed above, given the dual chamber container of Bontinck modified by Keeley, movement of pressing members 22 and 23 as taught by Misumi can individually apply pressure onto the walls of first compartment 8 and the second compartment 9 of Bontinck. Examiner also notes that once the combination is made as discussed, the pressing system of multiple plates of Misumi will be incorporated into the combined system, specifically outside of the two-compartment container as established. Therefore, the movable plate 22 and 23 of Misumi will align with compartment 8 and 9 of Bontinck, respectively, as it would have been obvious for one of ordinary skill in the art to assign such a configuration given the size of each compartment as established. Thus, the limitation is met.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Wolff et al. US 10,058,091 B2 teaches a dual compartment container for cell processing.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH DAO LE whose telephone number is (571)272-7198. The examiner can normally be reached Monday - Friday 8:30 am - 5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/QUYNH DAO LE/Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781
