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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 4/27/26 and claims of 3/25/26 has been entered.
Claims 1-20 remain pending.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over IGARASHI (WO 2018/230155) in view of AMIOT (EP 0531631) both as supplied by applicant on the IDS dated 7/22/22 (previously cited) further in view of HADDAD (US 2009/0163858) and KLAUS (US 2006/0014274).
Regarding claim 1, 7 IGARASHI discloses a cassette 28 with a flow path 42, in which the cassette body is formed of an overlapping first and second sheet 40a,b of polyolefin (resin) with the flow path formed between the sheets (first set of flow paths formed between first pair of superimposed resin sheets)(0036-38, Fig 2); a rigid frame 84, 86 configured to support the cassette further comprising an attachment base 84 (plate shaped cover member) to cover the cassette body, wall shaped side portions that project from the outer periphery of the bottom cover member 84 to surround the outer edges of the cassette, wherein the cassette is disposed in an accommodation space defined in a recessed shape formed by the side wall portions the cover (0053-54, Fig 3-4) but does not explicitly disclose a second identical cassette main body co-located or superimposed in the accommodation space with the first.
However, AMIOT discloses a cell culture apparatus comprising a bioreactor envelope 1 with tubes (flow path cassette) in which a plurality of the envelopes are placed within an accommodation spaced defined in a recessed shape of the rigid frame 280 & 280’ with wall shaped side portions and a cover (Fig 8-9) (second cassette main body disposed in frame with first cassette body, first and second cassette superimposed in accommodation space).
It would have been obvious to one of ordinary skill in the art to modify the device of IGARASHI to include a second identical cassette body located in the frame space with the first as taught by AMIOT because it allows for industrial scale up (Page 1, lines 36-37).
IGARASHI discloses holes 94 (cut outs) that allow access to specific portions of the cassette (Fig 3-4) and AMIOT discloses when the culture envelopes are placed stacked within the frame the cassettes can have a cut out 370’ or 370 to allow fluid access to a lower envelope (second body includes a cut out configured to expose a portion of first cassette) (Fig 10-11) but do not explicitly disclose wherein the specified portion of the first cassette includes a part of the flow path in the first set that is separated from flat portions of the first pair of resin sheets on two sides of the part of the flow path.
However, HADDAD discloses a disposable cassette 5 with body 10 including tubing 15 (first cassette main body with first set of flow paths) that is located between the body 10 and a cover 50 (first pair of superimposed resin sheets) in which a portion of the first cassette main body is exposed via an opening (cut out), that portion includes a part of the flow path that is separated from the flat portions of the body and cover (first pair of superimposed sheets) on two sides of the flow path (Fig 1-4, 7, 0099-100, 0103).
It would have been obvious to one of ordinary skill in the art to modify the device of IGARASHI and AMIOT so that the cutout part of the second cassette is configured to expose the portion of the first cassette including a part of the flow path that is separated from the flat portions as taught by HADDAD because it allows for use of a pinch valve to selectively stop the flow of fluid (0037, 0103) through flexible tubing that meets the requirements of an IV fluid line (0101).
IGARASHI discloses the cassette has a connection tube 46 and 44 to connect the flow path to an outer side of the side walls (Fig 4) and AMIOT discloses the flow path tubes 20, 20’ of each envelope also connect through the side wall portions to an exterior (Fig 10) but neither explicitly disclose an interlayer connection tube at an outer side of the frame to connect the flow paths of the first and second cassette to carry liquid between the two cassettes.
However, KLAUS discloses a modularly designed cassette system in which at least two cassettes are connected by means of connecting channels 11, 12) by plug connections (first set of connectors, engaging portions) (interlayer connection tube in their circumferential surfaces at an outer side of the frame) by which the individual compartments 5, 6 of the individual cassettes are connected (connect a flow path in first set of flow paths of first cassette to flow path in second set of second cassette) which allows fluid to flow from one cassette to the other (0162-163, Fig 7, 12, 13).
It would have been obvious to one of ordinary skill in the art to modify the connection tubes of IGARASHI or AMIOT to be interlayer connection tubes that connect a flow path in the first cassette to a flow path in the second cassette to carry liquid from the first to the second or vice versa as taught by KLAUS because it allows for an increase in the volume of the system (0163) and allows for serial treatment steps (0099).
Regarding claim 2-3, IGARASHI discloses the holes 94 (cutouts) expose a portion of the cassette flow path to clamps (0056-57), and HADDAD discloses the opening has a one part sized to accommodate a non-moving member (sized to accommodate fixed body) of the pinch valve (clamp) and the other opening sized for the movable member (sized to accommodate rotating body) (0103, Fig 5, 7-8). It is noted the recitations of claim 3 further limit the parts of the clamp, however, the clamp is not a positively recited limitation of the cassette as claimed and therefore the features of the clamp do not further limit the claimed cassette
Regarding claim 4, IGARASHI discloses holes 92 to expose a portion of the cassette to a load detector 88 (pressure target detection unit) that enables pressure measurements inside the flow path (Fig 3-4, 0055).
Regarding claim 5, AMIOT discloses the culturing bioreactor can be an envelope (formed by folding back and superimposing single sheet) (Page 5, lines 19-20).
Regarding claim 6, IGARASHI in view of KLAUS does not explicitly disclose the point at which the interlayer connection tube connects to the first flow path is offset compared to the connection with the second flow path. However, it would have been obvious to one of ordinary skill in the art to provide the connection points to be offset to allow for ease of use when an operator is connecting the two cassettes. Additionally, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to place one connection offset, since it has been held that rearranging parts of an invention involved only routine skill in the art. MPEP 2144.04.
Regarding claim 8, IGARASHI discloses the cover member (frame) is formed in a rectangular shape (Fig 3) and is capable of being connected to a bag 21, 24 outside of the side portions (Fig 1).
Regarding claim 9, IGARASHI discloses the tube 46 (second set of connectors) to connect to an external device 18, which is capable of being a bioreactor as recited and that the cassette can have a third set of connectors to connect to the outside (Fig 14). It is noted that the bioreactor is not a positively recited limitation of the cassette as claimed and therefore the features of the bioreactor including the hollow fibers and intra/extra capillary loops do not further limit the claimed cassette.
Claims 10-20 are rejected under 35 U.S.C. 103 as being unpatentable over IGARASHI (WO 2018/230155) in view of AMIOT (EP 0531631) as applied above and further in view of ANTWILER (US 2008/0213894) (previously cited) further in view of HADDAD (US 2009/0163858) and KLAUS (US 2006/0014274).
Regarding claim 10, 15 IGARASHI discloses a cassette 28 with flow path 42a,b,c (flow path cassette in which flow paths are aggregated), a plurality of bags 21, 24 connected to the cassette (Fig 1), in which the cassette body is formed of an overlapping first and second sheet 40a,b of polyolefin (resin) with the flow path formed between the sheets (first set of flow paths formed between first pair of superimposed resin sheets)(0036-38, Fig 2); a rigid frame 84, 86 configured to support the cassette further comprising an attachment base 84 (plate shaped cover member) to cover the cassette body, wall shaped side portions that project from the outer periphery of the bottom cover member 84 to surround the outer edges of the cassette, wherein the cassette is disposed in an accommodation space defined in a recessed shape formed by the side wall portions the cover (0053-54, Fig 3-4) but does not explicitly disclose a second identical cassette main body co-located with the first.
However, AMIOT discloses a cell culture apparatus comprising a bioreactor envelope 1 with tubes (flow path cassette) in which a plurality of the envelopes are placed within an accommodation spaced defined in a recessed shape of the rigid frame 280 & 280’ with wall shaped side portions and a cover (Fig 8-9) (second cassette main body disposed in frame with first cassette body).
It would have been obvious to one of ordinary skill in the art to modify the device of IGARASHI to include a second identical cassette body located in the frame space with the first as taught by AMIOT because it allows for industrial scale up (Page 1, lines 36-37).
IGARASHI discloses the air in the circuit is sent to the processing unit 16 (fig 6) but does not explicitly disclose the cassette is connected to a gas exchanger and a bioreactor that includes hollow fibers.
However, ANTWILER discloses a disposable tubing set for use with a cell expansion apparatus comprising a cassette with a set of tubing lines (flow path cassette) (0001, 0034) connected to an apparatus 10 that comprises a bioreactor 12 that may be made of hollow fibers enclosed in a housing, the bioreactor housing as at least four openings – two for the Intra-capillary space and two for the extra capillary space which are connected to the tubing set with connectors (0020-21, 0024-25, Fig 1); and an oxygenator 14 (gas exchanger) connected to the tubing lines of the cassette (0022-23).
It would have been obvious to one of ordinary skill in the art to modify the device of IGARASHI to include the flow path cassette being connected to a hollow fiber bioreactor and oxygenator as taught by ANTWILER because the cassette will aid in organizing tubes (0001) for the bioreactor and oxygenator which provide ideal conditions for the cells in the fluid such that they can be available for therapeutic and other purposes (0042).
IGARASHI discloses holes 94 (cut outs) that allow access to specific portions of the cassette (Fig 3-4) and AMIOT discloses when the culture envelopes are placed stacked within the frame the cassettes can have a cut out 370’ or 370 to allow fluid access to a lower envelope (second body includes a cut out configured to expose a portion of first cassette) (Fig 10-11) but do not explicitly disclose wherein the specified portion of the first cassette includes a part of the flow path in the first set that is separated from flat portions of the first pair of resin sheets on two sides of the part of the flow path.
However, HADDAD discloses a disposable cassette 5 with body 10 including tubing 15 (first cassette main body with first set of flow paths) that is located between the body 10 and a cover 50 (first pair of superimposed resin sheets) in which a portion of the first cassette main body is exposed via an opening (cut out), that portion includes a part of the flow path that is separated from the flat portions of the body and cover (first pair of superimposed sheets) on two sides of the flow path (Fig 1-4, 7, 0099-100, 0103).
It would have been obvious to one of ordinary skill in the art to modify the device of IGARASHI and AMIOT so that the cutout part of the second cassette is configured to expose the portion of the first cassette including a part of the flow path that is separated from the flat portions as taught by HADDAD because it allows for use of a pinch valve to selectively stop the flow of fluid (0037, 0103) through flexible tubing that meets the requirements of an IV fluid line (0101).
IGARASHI discloses the cassette has a connection tube 46 and 44 to connect the flow path to an outer side of the side walls (Fig 4) and AMIOT discloses the flow path tubes 20, 20’ of each envelope also connect through the side wall portions to an exterior (Fig 10) but neither explicitly disclose an interlayer connection tube at an outer side of the frame to connect the flow paths of the first and second cassette to carry liquid between the two cassettes.
However, KLAUS discloses a modularly designed cassette system in which at least two cassettes are connected by means of connecting channels 11, 12) by plug connections (first set of connectors, engaging portions) (interlayer connection tube in their circumferential surfaces (at an outer side of the frame) by which the individual compartments 5, 6 of the individual cassettes are connected (connect a flow path in first set of flow paths of first cassette to flow path in second set of second cassette) which allows fluid to flow from one cassette to the other (0162-163, Fig 7, 12, 13).
It would have been obvious to one of ordinary skill in the art to modify the connection tubes of IGARASHI or AMIOT to be interlayer connection tubes that connect a flow path in the first cassette to a flow path in the second cassette to carry liquid from the first to the second or vice versa as taught by KLAUS because it allows for an increase in the volume of the system (0163) and allows for serial treatment steps (0099).
Regarding claim 11-12, IGARASHI discloses the holes 94 (cutouts) expose a portion of the cassette flow path to clamps (0056-57), and HADDAD discloses the opening has a one part sized to accommodate a non-moving member (sized to accommodate fixed body) of the pinch valve (clamp) and the other opening sized for the movable member (sized to accommodate rotating body) (0103, Fig 5, 7-8). It is noted the recitations of claim 3 further limit the parts of the clamp, however, the clamp is not a positively recited limitation of the cassette as claimed and therefore the features of the clamp do not further limit the claimed cassette.
Regarding claim 13, IGARASHI discloses holes 92 to expose a portion of the cassette to a load detector 88 (pressure target detection unit) to enable pressure measurements inside the flow path (Fig 3-4, 0055).
Regarding claim 14, AMIOT discloses the culturing bioreactor can be an envelope (formed by folded single sheet) (Page 5, lines 19-20).
Regarding claim 16, IGARASHI in view of KLAUS does not explicitly disclose the point at which the interlayer connection tube connects to the first flow path is offset compared to the connection with the second flow path. However, it would have been obvious to one of ordinary skill in the art to provide the connection points to be offset to allow for ease of use when an operator is connecting the two cassettes. Additionally, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to place one connection offset, since it has been held that rearranging parts of an invention involved only routine skill in the art. MPEP 2144.04.
Regarding claim 17, IGARASHI discloses a kit (0030) with cassette 28 with flow path 42a,b,c (flow path cassette in which flow paths are aggregated), a plurality of bags 21, 24 connected to the cassette (Fig 1), in which the cassette body is formed of an overlapping first and second sheet 40a,b of polyolefin (resin) with the flow path formed between the sheets (first set of flow paths formed between first pair of superimposed resin sheets)(0036-38, Fig 2); a rigid frame 84, 86 configured to support the cassette further comprising an attachment base 84 (plate shaped cover member) to cover the cassette body, wall shaped side portions that project from the outer periphery of the bottom cover member 84 to surround the outer edges of the cassette, wherein the cassette is disposed in an accommodation space defined in a recessed shape formed by the side wall portions the cover (0053-54, Fig 3-4) but does not explicitly disclose a second identical cassette main body co-located with the first.
However, AMIOT discloses a cell culture apparatus comprising a bioreactor envelope 1 with tubes (flow path cassette) in which a plurality of the envelopes are placed within an accommodation spaced defined in a recessed shape of the rigid frame 280 & 280’ with wall shaped side portions and a cover (Fig 8-9) (second cassette main body disposed in frame with first cassette body).
It would have been obvious to one of ordinary skill in the art to modify the device of IGARASHI to include a second identical cassette body located in the frame space with the first as taught by AMIOT because it allows for industrial scale up (Page 1, lines 36-37).
IGARASHI discloses the air in the circuit is sent to the processing unit 16 (fig 6) but does not explicitly disclose the cassette is connected to a gas exchanger and a bioreactor that includes hollow fibers.
However, ANTWILER discloses a disposable tubing set comprising a cassette with a set of tubing lines (flow path cassette) (0001, 0034) connected to an apparatus 10 that comprises a bioreactor 12 that may be made of hollow fibers enclosed in a housing, the bioreactor housing as at least four openings – two for the Intra-capillary space and two for the extra capillary space which are connected to the tubing set with connectors (0020-21, 0024-25, Fig 1); and an oxygenator 14 (gas exchanger) connected to the tubing lines of the cassette (0022-23).
It would have been obvious to one of ordinary skill in the art to modify the device of IGARASHI to include the flow path cassette being connected to a hollow fiber bioreactor and oxygenator and the kit placed in a cell culturing device as taught by ANTWILER because the cassette will aid in organizing tubes (0001) for the bioreactor and oxygenator which in conjunction with the cell expansion apparatus provide ideal conditions for the cells in the fluid such that they can be available for therapeutic and other purposes (0042).
IGARASHI discloses holes 94 (cut outs) that allow access to specific portions of the cassette (Fig 3-4) and AMIOT discloses when the culture envelopes are placed stacked within the frame the cassettes can have a cut out 370’ or 370 to allow fluid access to a lower envelope (second body includes a cut out configured to expose a portion of first cassette) (Fig 10-11) but do not explicitly disclose wherein the specified portion of the first cassette includes a part of the flow path in the first set that is separated from flat portions of the first pair of resin sheets on two sides of the part of the flow path.
However, HADDAD discloses a disposable cassette 5 with body 10 including tubing 15 (first cassette main body with first set of flow paths) that is located between the body 10 and a cover 50 (first pair of superimposed resin sheets) in which a portion of the first cassette main body is exposed via an opening (cut out), that portion includes a part of the flow path that is separated from the flat portions of the body and cover (first pair of superimposed sheets) on two sides of the flow path (Fig 1-4, 7, 0099-100, 0103).
It would have been obvious to one of ordinary skill in the art to modify the device of IGARASHI and AMIOT so that the cutout part of the second cassette is configured to expose the portion of the first cassette including a part of the flow path that is separated from the flat portions as taught by HADDAD because it allows for use of a pinch valve to selectively stop the flow of fluid (0037, 0103) through flexible tubing that meets the requirements of an IV fluid line (0101).
IGARASHI discloses the cassette has a connection tube 46 and 44 to connect the flow path to an outer side of the side walls (Fig 4) and AMIOT discloses the flow path tubes 20, 20’ of each envelope also connect through the side wall portions to an exterior (Fig 10) but neither explicitly disclose an interlayer connection tube at an outer side of the frame to connect the flow paths of the first and second cassette to carry liquid between the two cassettes.
However, KLAUS discloses a modularly designed cassette system in which at least two cassettes are connected by means of connecting channels 11, 12) by plug connections (interlayer connection tube in their circumferential surfaces (at an outer side of the frame) by which the individual compartments 5, 6 of the individual cassettes are connected (connect a flow path in first set of flow paths of first cassette to flow path in second set of second cassette) which allows fluid to flow from one cassette to the other (0162-163, Fig 7, 12, 13).
It would have been obvious to one of ordinary skill in the art to modify the connection tubes of IGARASHI or AMIOT to be interlayer connection tubes that connect a flow path in the first cassette to a flow path in the second cassette to carry liquid from the first to the second or vice versa as taught by KLAUS because it allows for an increase in the volume of the system (0163) and allows for serial treatment steps (0099).
Regarding claim 18-19, IGARASHI discloses the holes 94 (cutouts) expose a portion of the cassette flow path to clamps (0056-57), and HADDAD discloses the opening has a one part sized to accommodate a non-moving member (sized to accommodate fixed body) of the pinch valve (clamp) and the other opening sized for the movable member (sized to accommodate rotating body) (0103, Fig 5, 7-8). It is noted the recitations of claim 3 further limit the parts of the clamp, however, the clamp is not a positively recited limitation of the cassette as claimed and therefore the features of the clamp do not further limit the claimed cassette.
Regarding claim 20, IGARASHI discloses holes 92 to expose a portion of the cassette to a load detector 88 (pressure target detection unit) to enable pressure measurements inside the flow path (Fig 3-4, 0055).
Response to Arguments
Applicant’s arguments with respect to claims 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Specifically KLAUS is newly cited to address the amended limitations.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 10114010 also discloses exterior tubing (interlayer connection tubes) between two cassettes (Fig 3-4).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIELLE B HENKEL whose telephone number is (571)270-5505. The examiner can normally be reached M-Th 11-7 EST, Alt. Fridays.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIELLE B HENKEL/Examiner, Art Unit 1799
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799
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