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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/29/2026 has been entered.
Specification
The disclosure is objected to because of the following informalities: On page 2, lines 26-27, the specification refers to “claim 1”. Reference to any particular claim numbers should be removed because during prosecution, the referenced claim numbers can be changed/cancelled.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-8, and 11-19 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The limitation “other single-use components of the device assembly” in line 15 renders the claim indefinite because it is unclear which components are considered “other single-use components”.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-3, 8, 13, 14, 16, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Davis et al. (US 2013/0115588A1), in view of Kopf (US 6214221), and Friederichs et al. (US 2017/0290970).
Regarding claim 1, Davis teaches a device assembly (refer fig. 12) comprising:
a conjugation unit (fermenter) (“for performing a bioconjugation reaction in a medium” is reciting intended use of the conjugation unit without imparting additional structure);
a first filtration unit (microfiltration or centrifugation) (“for separating precipitates and/or agglomerates” is reciting intended use of the conjugation unit without imparting additional structure);
a second filtration unit (ultrafiltration) for performing an ultrafiltration,
the first filtration unit being arranged in a flow path between the conjugation unit and the second filtration unit (refer fig. 12); and
the device assembly further comprising a single control unit for controlling a transfer of the medium from the conjugation unit through the first filtration unit to the second filtration unit and for controlling the ultrafiltration and/or the diafiltration process (Refer [0012], [0036], [0042]),
wherein the second filtration unit comprises a preconfigured single-use loop- assembly for recirculating the medium in the ultrafiltration process which can be mounted to and/or dismounted from a basic structure of the device assembly as a whole (refer [0010] disclosing “the components of the systems are single use and disposable”; also refer [0029] disclosing “the bioreactor comprises a structural frame for holding a disposable container and the separation device is a disposable cross-flow filtration filter. In such a disposable system, other disposable units can include the following but not limited to pump head, flow meter, pressure transducer, process lines and connectors between the bioreactor and separation unit”).
Davis teaches that the single-use loop-assembly can be mounted to and/or dismounted from the basic structure of the device assembly as a whole, together with a single-use conjugation bag and a single-use recirculation bag (refer [0010] disclosing “the components of the systems are single use and disposable”; also refer [0029] disclosing “the bioreactor comprises a structural frame for holding a disposable container and the separation device is a disposable cross-flow filtration filter. In such a disposable system, other disposable units can include the following but not limited to pump head, flow meter, pressure transducer, process lines and connectors between the bioreactor and separation unit”).
Davis does not teach that the single loop assembly comprises a recirculation bag, a recirculation pump, sensor, tubing and connectors.
Kopf teaches an apparatus (fig. 5) for purifying a biological substance (Col. 1:Lines 7-15), the apparatus comprises a conjugation bag (34), a first filtration assembly (42), a second filtration assembly (82), a recirculation loop associated with the second filtration assembly (refer fig. 5), and recirculation bag (68) associated with the recirculation loop, sensors (refer fig. 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of invention to modify the single loop-assembly of Davis to include a recirculation bag, a recirculation pump, sensor, tubing and connectors to provide recirculation of fluid as taught by Kopf. Use of pumps to convey fluid through the tubing is well known in the art.
Regarding providing the single-loop assembly as a single-use/disposable, Freiederichs teaches a disposable unit that includes fluid circuit cartridge, containers, tubing, sensors, pump, and connectors (Refer [0088], fig. 9C). Selecting and combining disposable elements as a single-disposable unit would have been obvious to one of ordinary skill in the art because Freiederichs establishes that it is known in the art to provide multiple components as a single disposable unit.
Regarding claim 2, modified Davis teaches limitations of claim 1 as set forth above. Davis teaches LDPE as one of the materials suitable for bioreactor (refer [0066]), and filter made of polypropylene (refer [0098], [0106]).
Regarding claim 3, modified Davis teaches limitations of claim 1 as set forth above. Davis teaches that the conjugation unit comprises a flexible conjugation bag and a first bag holder holding the conjugation bag (refer [0058]).
Regarding claim 8, modified Davis teaches limitations of claim 1 as set forth above. Davis teaches that the first filtration unit is microfiltration unit (Refer fig. 12). Microfiltration membranes are known to have pore size in a range of about 0.1 µm to about 10 µm. "[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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 13, modified Davis teaches limitations of claim 9 as set forth above. Davis further teaches that the system can further comprise sensors for monitor conditions within the system, the sensors include conductivity sensor (refer [0023]).
Regarding claim 14, modified Davis teaches limitations of claim 9 as set forth above. Davis further teaches that the system comprises controllable valves (refer [0068]-[0070]).
Regarding claim 16, modified Davis teaches limitations of claim 1 as set forth above. Davis teaches that the second filtration unit comprises at least one cross-flow filter cassette held in a filter press (refer fig. 11).
Regarding claim 19, modified Davis teaches limitations of claim 14 as set forth above. Limitations of claim 19 is reciting operational step of the device of claim 1. "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Claim(s) 4 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davis et al. (US 2013/0115588A1), in view of Kopf (US 6214221), and Friederichs et al. (US 2017/0290970) as applied to claim 3 above, and further in view of Barrett et al. (US 9228166).
Regarding claim 4, modified Davis teaches limitations of claim 3 as set forth above. Modified Davis does not teach that the conjugation bag has a bottom portion and an outlet formed therein, the first bag holder having a bottom surface and a draining opening formed at a lowest point of the bottom surface, the bottom portion of the conjugation bag resting on the bottom surface of the first bag holder such that the outlet of the conjugation bag is located at the draining opening of the first bag holder.
Barrett teaches a flexible biocontainer (refer col. 6:lines 1-7) having a flexible wall forming a fluid impermeable bottom wall (refer fig. 1A, 1B, Col. 5:L53-63 disclosing a closed container having a plurality of ports), wherein the bottom wall of the flexible bioreactor comprises a port (refer port 64 in fig. 1B). Barrett further teaches a holder (500) for holding the flexible bioreactor (refer fig. 3), wherein the holder comprises an opening at bottom surface thereof (refer opening in fig. 4 that aligns with port 64 of biocontainer-refer fig. 5), wherein the bottom portion of the biocontainer is resting on the bottom surface of the holder such that the outlet of the conjugation bag is located at the port (draining opening) of the holder (refer fig. 5 disclsing bottom port 64 of biocontainer aligning with opening of the holder 500).
It would have been obvious to one of ordinary skill in the art before the effective filing date of invention to modify the system of Davis to provide conjugation bag that is a flexible bag and a first bag holder holding the conjugation bag, wherein the conjugation bag has a bottom portion and an outlet formed therein, the first bag holder having a bottom surface and a draining opening formed at a lowest point of the bottom surface, the bottom portion of the conjugation bag resting on the bottom surface of the first bag holder such that the outlet of the conjugation bag is located at the draining opening of the first bag holder to enable supporting the conjugation bag while maintaining form and shape of the bag while also enabling providing a shaking/rocking movement to allow mixing of the contents of the bag as taught by Barrett (refer col. 2:lines 58 – Col. 3:line 6).
Regarding claim 6, modified Davis teaches limitations of claim 4 as set forth above. Davis further teaches that a pH sensor is arranged in the conjugation bag (Refer [0023], [0062]).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davis et al. (US 2013/0115588A1), in view of Kopf (US 6214221), and Friederichs et al. (US 2017/0290970) as applied to claim 3 above, and further in view of Broadley et al. (US 2010/0075405A1).
Regarding claim 5, modified Davis teaches limitations of claim 3 as set forth above. Modified Davis does not teach that the first bag holder includes a double-walled containment, the conjugation unit further comprising a temperature control system for controlling the temperature of the medium in the conjugation bag, the temperature control system including a heat transfer fluid flowing through the double-walled containment of the first bag holder.
Broadley teaches a bioreactor system (40 in fig. 4) comprising a bioreactor (402), placed in a holder (404), wherein the holder is a double-walled holder (refer [0033]) and a heating fluid is flowing through the double walled jacket (refer [0033]) for controlling temperature of bioreactor media.
It would have been obvious to one of ordinary skill in the art before the effective filing date of invention to modify the holder of modified Davis to include a double-walled holder having heat transfer fluid flowing through the double-walled holder for controlling temperature of media in the conjugation bag as taught by Broadley.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davis et al. (US 2013/0115588A1), in view of Kopf (US 6214221), and Friederichs et al. (US 2017/0290970) as applied to claim 3 above, and further in view of Lingen et al. (US 2020/0164338).
Regarding claim 7, modified Davis teaches limitations of claim 1 as set forth above. Modified Davis does not teach that the conjugation unit comprises a controllable draining valve and the first filtration unit comprises a transfer pump for transferring the medium from the conjugation unit through the first filtration unit to the second filtration unit.
Lingen teaches a device assembly (refer fig. 2, 3, 4) comprising: a conjugation unit (1 or 2); a first filtration unit (refer 25 in fig. 4); a second filtration unit (refer 22 in fig. 4), the first filtration unit being arranged in a flow path between the conjugation unit and the second filtration unit (Refer fig. 4 indicating first filter unit 25 being placed between conjugation unit and second filter unit 22); and the device assembly further comprising a control unit (refer [0087] , [0129]). Lingen further teaches that the conjugation unit comprises a controllable draining valve (7 or 8) and the first filtration unit comprises a transfer pump (28a) for transferring the medium from the conjugation unit through the first filtration unit to the second filtration unit.
It would have been obvious to one of ordinary skill in the art before the effective filing date of invention to modify the device of modified Davis to include controllable draining valve and the first filtration unit comprises a transfer pump for transferring the medium from the conjugation unit through the first filtration unit to the second filtration unit as taught by Lingen.
Claim(s) 11-12 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davis et al. (US 2013/0115588A1), in view of Kopf (US 6214221) and Friederichs et al. (US 2017/0290970) as applied to claim 1 above, and further in view of Barrett et al. (US 9228166).
Regarding claims 11 and 12, modified Davis teaches limitations of claim 1 as set forth above. Kopf teaches that the recirculation bag (68) has a bottom portion having an outlet formed therein (Refer fig. 5). Kopf also teaches that the recirculation bag includes a thermal jacket 35 (or other heat transfer means, such as for example a heating coil disposed in the liquid volume in the reservoir 34, a recirculation heater external of the reservoir, through which liquid is flowed from the reservoir, heated to suitable temperature in the heater unit, and returned to the liquid volume of the reservoir), to provide the liquid and resin mixture with a suitable temperature to preserve the target substance's activity (Refer C13/L25-35).
Modified Davis does not teach that recirculation bag being held in a second bag holder having a bottom surface and a draining opening formed at a lowest point of the bottom surface, the bottom portion of the single-use recirculation bag resting on the bottom surface of the second bag holder such that the outlet of the single-use recirculation bag is located at the draining opening of the second bag holder.
Barrett teaches a flexible biocontainer (refer col. 6:lines 1-7) having a flexible wall forming a fluid impermeable bottom wall (refer fig. 1A, 1B, Col. 5:L53-63 disclosing a closed container having a plurality of ports), wherein the bottom wall of the flexible bioreactor comprises a port (refer port 64 in fig. 1B). Barrett further teaches a holder (500) for holding the flexible bioreactor (refer fig. 3), wherein the holder comprises an opening at bottom surface thereof (refer opening in fig. 4 that aligns with port 64 of biocontainer-refer fig. 5), wherein the bottom portion of the biocontainer is resting on the bottom surface of the holder such that the outlet of the conjugation bag is located at the port (draining opening) of the holder (refer fig. 5 disclsing bottom port 64 of biocontainer aligning with opening of the holder 500).
It would have been obvious to one of ordinary skill in the art before the effective filing date of invention to modify the system of modified Davis to provide recirculation bag that is a flexible bag and a second bag holder holding the recirculation bag, wherein the recirculation bag has a bottom portion and an outlet formed therein, the second bag holder having a bottom surface and a draining opening formed at a lowest point of the bottom surface, the bottom portion of the recirculation bag resting on the bottom surface of the second bag holder such that the outlet of the recirculation bag is located at the draining opening of the second bag holder to enable supporting the recirculation bag while maintaining form and shape of the bag while also providing a shaking/rocking movement to allow mixing of the contents of the bag as taught by Barrett (refer col. 2:lines 58 – Col. 3:line 6).
Regarding claim 17, modified Davis teaches limitations of claim 12 set forth above. Davis further teaches that the control unit controls controllable valves (refer [0068]-[0070]).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davis et al. (US 2013/0115588A1), in view of Kopf (US 6214221) and Friederichs et al. (US 2017/0290970) as applied to claim 1 above, and further in view of Husemann et al. (US 2018/0187140A1).
Regarding claim 15, Modified Davis teaches limitations of claim 1 set forth above. Modified Davis does not teach that a dip dray is arranged below the single use loop- assembly, the dip tray having a bottom surface and a draining means formed at a lowest point of the bottom surface.
Husemann teaches a bioreactor system (fig. 1) having a receiving container for receiving a disposable bag, in which a collecting tray for collecting a fluid exiting the receiving container is positioned below the receiving container (refer [0038]. Husemann further discloses that “Usually, no medium should exit the receiving container in an uncontrolled way. In case of a defect or leak in the disposable bag and/or in the receiving container, as well as in case of a defect or leak in the temperature regulating circuit, the collecting tray may collect the exiting liquid, before it flows on the ground. Thus the danger of contaminating the ground is reduced and the disposal of the exited liquid is simplified” (refer [0038]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device assembly of modified Davis to provide a dip tray arranged below the single use loop- assembly to collect any leakage and prevent contaminating the ground as taught by Husemann. Providing outlets/ports at bottom of tray would have been obvious to one of ordinary skill in the art for removal of the collected leakage.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davis et al. (US 2013/0115588A1), in view of Kopf (US 6214221) and Friederichs et al. (US 2017/0290970) as applied to claim 1 above, and further in view of Castillo (US 2018/0030398A1).
Regarding claim 18, modified Davis teaches limitations of claim 1 as set forth above. Modified Davis does not teach that all components of the device assembly, except for and operating panel coupled to the control unit, are mounted on a trolley, however, making a device assembly portable is not sufficient by itself to patentably distinguish over an otherwise old device unless there are new or unexpected results. In re Lindberg, 194 F.2d 732, 93 USPQ 23 (CCPA 1952). Additionally, Castillo teaches a device comprising production of cells and/or cell products. The system comprises at least one cell culture unit comprising at least one bioreactor for culturing cells, at least one technical control unit for controlling a cell growth parameters, said technical control unit is at least fluidly connected to the cell culture unit (refer abstract). The device is provided with wheels 17 for easy transport (refer [0037]). Providing the device on wheels or trolley would have been obvious to one of ordinary skill in the art to facilitate easy transport.
Response to Arguments
Applicant's arguments filed 06/29/2026 have been fully considered but they are not persuasive.
Regarding rejection of instant claim 1 (which includes limitations of claims 9 and 10), applicant argued: “Davis is directed to a general cell culture and separation system for biologicals and vaccine production. Davis does not address the acute operator safety concerns specific to cytotoxic ADC synthesis”. This is not found to be persuasive because the claim is directed to a device (i.e. an apparatus). "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Applicant further argued: “the prior art does not disclose or suggest: (a) a preconfigured assembly that arrives ready to install with components already interconnected, preventing false connections and reducing installation time and error; (b) a design in which the entire set of wetted single-use components is dismounted and disposed of as a single closed unit; or (c) an integrated loop-assembly that combines a recirculation pump, sensors, tubing, and connectors into one mountable/dismountable unit”. This is not found to be persuasive because the current rejection includes prior art, Freiederichs et al. (US 2017/0290970), teaching a disposable unit that includes fluid circuit cartridge, containers, tubing, sensors, pump, and connectors (Refer [0088], fig. 9C). Selecting and combining disposable elements as a single-disposable unit would have been obvious to one of ordinary skill in the art because Freiederichs establishes that it is known in the art to provide multiple components as a single disposable unit.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Levin et al. (US 2005/0197612A1) teaches a disposable blood cartridge comprising tubing, filter, bag, and sensors.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PRANAV PATEL whose telephone number is (571)272-5142. The examiner can normally be reached M-F 6AM-4PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bobby Ramdhanie can be reached at (571) 270-3240. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PRANAV N PATEL/Primary Examiner, Art Unit 1779
Prosecution Insights