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 .
Election/Restrictions
Applicant’s election without traverse of Group I drawn to claims 1-29 for a fluidic device in the reply filed on 8 June 2026 is acknowledged.
Claims 30-45 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups II, III, IV, V, VI, and VII, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8 June 2026.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, following limitations must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Claim 10. The fluid device of claim 8, wherein the one or more sterilization process ports are valved.
Claim 11. The fluid device of claim 8, wherein the one or more sterilization process ports are coupled to one or more passive valves.
Notice that the drawings fail to show valves/passive-valves as claimed.
Claim 29. The fluid device of claim 1, wherein the sterile liquid transfer port further comprises a mechanical seal and the collar further comprises one or more sterilization ports in fluid communication with the plurality of conduits, the mechanical seal providing a first mechanism to achieve sterile sterilization and sterilant provided via the one or more sterilization ports providing a second mechanism to achieve sterilization.
Due to clarity issues (see the 112b rejection below) it is unclear if the mechanical seal and the one or more sterilization ports are providing some sort of additional structure (a first and second mechanism) or if the mechanical seal and the one or more sterilization ports by themselves are the “mechanisms” as claimed. It is noted that the drawings do not show any additional structure that could be considered as first and second mechanisms.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to because:
Figures 2B-2B, 4A-5L and 10-12B are in gray-scale making it difficult to see the components within the Figures.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because:
The abstract repeats information given in the title and includes phrases which can be implied “The present disclosure relates to system, devices and methods for automated fluid transfer. In an embodiment, the present disclosure relates to a system…”. The Office suggests that such phrases are deleted.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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 3-4 and 29 are 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.
In re claim 3, line 1, the phrase “can be”, or “can”, or “could be” renders the scope of the claim unclear because “can” is susceptible to more than one plausible construction. The verb form of the word “can” carries multiple meanings in the English language. It can be used to indicate a physical ability or some other specified capability, or it can be used to indicate a possibility or a probability. Therefore, it is not clear whether the limitation refers to a capability that is required to be present in the invention, or whether it refers to a capability that is a mere possibility that is not required. The Office recommends amending the claim to remove “can be”. For purposes of examination, the limitation will be considered as required for the robot to engage the robot engagement feature.
Claim 4 recites the limitation "the robot engagement feature" in line 1. There is insufficient antecedent basis for this limitation in the claim. It is unclear if the claim is intended to depend from claim 1 or there was a typographical error in which the claim should depend from claims 2 or 3 where the robot engagement feature is mentioned. The Office recommends amending the claim to depend from claim 3. For purposes of examination, the limitation will be considered as dependent from claim 3.
Claim 29 recites the limitation "a first mechanism" in lines 3-4 and “a second mechanism” in line 4. The limitations are unclear as there appears to be no correlating structures associated with the first and second mechanism. Paragraphs [0004] and [0085] of the specification submitted 28 March 2026 does not provide any additional structure to what the first and second mechanism entails nor the drawings show such a feature (see the Drawing Objection above). Due to the way the claim is written, it is unclear and indefinite if the mechanical seal and the one or more sterilization ports are providing some sort of additional structure (a first and second mechanism) or if the mechanical seal and the one or more sterilization ports by themselves are the “mechanisms” as claimed. The Office recommends amending the claim to better recite the first and second mechanism. Based on the disclosure and for the purposes of examination, the limitation of “first and second mechanisms” will be considered as benefits of the mechanical seal and sterilant rather than additional structures.
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.
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 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Parietti (US 20210324318 A1) in view of Nelson (US 20130189120 A1).
Regarding Claim 1:
Parietti discloses in Figures 3 and 13-23 a fluid device (1100 and 300, the rigid cartridge and instrument are the fluid device) for use in automated fluid transfer (Paragraph [0233], the fluid transfer is automated), comprising: a container for a volume of fluid (Paragraph [0306], the container is the soft-body bioreactor (1220) that stores a volume of fluid); and a universal collar (1100, the rigid container is the universal collar) couplable to the container (1220), the collar (1100) comprising: a plurality of conduits (Figure 13 as well as Paragraphs [0307] and [0309], the plurality of conduits are the tubes connecting between the connectors and the container), a sterile liquid transfer port (1190, the connectors are the ports) in fluid communication with the plurality of conduits (Paragraphs [0307] and [0309]), and a fluid pump module (300 and Paragraph [0342]) comprising compressible fluidic tubing (Paragraph [0306], the flexible elements are the compressible fluidic tubing) coupled between an inlet port (Paragraph [0316], the end of the channel submerged is the inlet port) and an outlet port (Paragraph [0339], the end of the channel connected to the reservoir is the outlet port), each of the inlet port and the outlet port being in fluid communication with the plurality of conduits (Figure 23, the inlet and outlet ports are in communication with the conduits), the compressible fluidic tubing being configured to be compressed by a fluid pump to control movement of fluids out of the container (Paragraph [0342], the flow of each liquid in each channel is controlled by a peristaltic pump).
The device of Parietti does not disclose a fluid pump module comprising compressible fluidic tubing coupled between an inlet port and an outlet port and the compressible fluidic tubing being configured to be compressed by a fluid pump to control movement of fluids out of the container.
Nelson teaches in Figure 1 a peristaltic pump, comprising: a fluid pump module (10, the pump assembly is the pump module and the fluid pump) comprising compressible fluidic tubing (12) coupled between an inlet port (20) and an outlet port (22) and the compressible fluidic tubing (12) being configured to be compressed by a fluid pump (10) to control movement of fluids (Paragraphs [0028] and [0034], the movement of the fluid is controlled).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Parietti to include a fluid pump module comprising compressible fluidic tubing coupled between an inlet port and an outlet port and the compressible fluidic tubing being configured to be compressed by a fluid pump to control movement of fluids as taught by Nelson with the motivation to control the rotation of the roller assembly to reduce the anomalies.
Regarding Claim 2:
Parietti discloses in Figures 3 and 13-23 the collar (1100) further comprises a robot engagement feature (Paragraph [0306], the edges formed by the walls are the robot engagement features).
Regarding Claim 3:
Parietti discloses in Figures 3 and 13-23 the robot engagement feature (Paragraph [0306]) can be engaged by a robot (202) to manipulate the fluid device (1100 and 300).
Regarding Claim 4:
Parietti discloses in Figures 3 and 13-23 the robot engagement feature comprises one or more depressions and/or protrusions within a surface of the collar (Paragraph [0306], the edges on the rounded corners are a protrusion that are grasped by the robot).
Claims 5-6, 17 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Perietti in view of Nelson in further view of Patrick (US 20220002652 A1).
Regarding Claim 5:
Parietti discloses in Figures 3 and 13-23 the collar (1100) and the container (1220).
The device of Parietti and Nelson do not teach the collar is releasably couplable to the container via corresponding features disposed on the collar and on the container.
Patrick teaches in Figures 1-2 a bioreactor vessel, comprising: the collar (101, the headplate is the collar) is releasably couplable to the container (103) via corresponding features disposed on the collar and on the container (Paragraph [0035], the collar and the container have a coupling interface).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Parietti and Nelson to include the collar is releasably couplable to the container via corresponding features disposed on the collar and on the container as taught by Patrick with the motivation to access the interior of the container to have access to the impeller.
Regarding Claim 6:
Parietti discloses in Figures 3 and 13-23 the container (1220).
The device of Parietti and Nelson do not teach a fluid capacity of the container ranges between about 1 milliliter to about 1 liter.
Patrick teaches in Figures 1-2 a bioreactor vessel, comprising: a fluid capacity of the container (103) ranges between about 1 milliliter to about 1 liter (Paragraph [0060], the fluid capacity of the container is between 5mL and 50,000L).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Parietti and Nelson to include a fluid capacity of the container ranges between about 1 milliliter to about 1 liter as taught by Patrick with the motivation to hold a desired volume within the container to meet the requirements.
Regarding Claim 17:
Parietti discloses in Figures 3 and 13-23 the collar (1100) further comprises a fluid access port (1190) for filling the container (1220) after coupling of the collar and the container (Paragraphs [0307], [0327], and [0329]).
The device of Parietti and Nelson do not expressly teach the collar further comprises a fluid access port for filling the container after coupling of the collar and the container.
Patrick teaches in Figures 1-2 a bioreactor vessel, comprising: the collar (101) further comprises a fluid access port (207) for filling the container (103) after coupling of the collar and the container (Paragraphs [0035] and [0095]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Parietti and Nelson to include the collar further comprises a fluid access port for filling the container after coupling of the collar and the container as taught by Patrick with the motivation to be able to add media additions at any point to the container without cross contamination.
Regarding Claim 22:
Parietti discloses in Figures 3 and 13-23 the collar (1100) further comprises one or more ports (1190) in fluid communication with the plurality of conduits (Paragraphs [0307] and [0309]).
The device of Parietti and Nelson do not teach the container comprises an opening, and wherein the collar further comprises a fluid transport feature couplable to the opening and in fluid communication with the plurality of conduits.
Patrick teaches in Figures 1-3 a bioreactor vessel, comprising: the container (103) comprises an opening (Figure 4, the container has an opening), and wherein the collar (101) further comprises a fluid transport feature (Figure 2 and Paragraph [0041], the fluid transport feature are the set of components coupled to the top of the container) couplable to the opening and in fluid communication with the plurality of conduits (Figure 3, the plurality of conduits are located under the collar).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Parietti and Nelson to include in the collar of Parietti an opening and the collar further comprises a fluid transport feature couplable to the opening and in fluid communication with the plurality of conduits as taught by Patrick with the motivation to connect multiple components on the container to have the desired configuration for the bioreactor.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Perietti in view of Nelson in further view of Wang (WO 2019051486 A1).
Regarding Claim 7:
Parietti discloses in Figures 3 and 13-23 the pump (Paragraph [0342]).
The device of Parietti and Nelson do not teach the control of the movement of the fluids comprises bidirectional movement control.
Wang teaches in Figures 3A-3D a large-scale bioreactor, comprising: the control of the movement of the fluids comprises bidirectional movement control (Page 8, Lines 10-11, the pump is capable of bidirectional operation and is controlled by an automated control system).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Parietti and Nelson to include the control of the movement of the fluids comprises bidirectional movement control as taught by Wang with the motivation to fill or remove fluid or gas from a container with minimal human error.
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Perietti in view of Nelson in further view of Snow (US 20220081669 A1).
Regarding Claim 8:
Parietti discloses in Figures 3 and 13-23 the collar (1100) further comprises one or more ports (1190) in fluid communication with the plurality of conduits (Paragraphs [0307] and [0309]).
The device of Parietti and Nelson do not teach the collar further comprises one or more sterilization process ports in fluid communication with the plurality of conduits.
Snow teaches in Figure 1 a biological manufacturing system, comprising: one or more sterilization process ports in fluid communication with a conduit (Paragraph [0065], the at least one gas inlet is the sterilization process port that is in communication with the vessel).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Parietti and Nelson to include in the collar of Parietti one or more sterilization process ports in fluid communication with a conduit as taught by Snow with the motivation to create an ozone within the container in order to generate sterilizing gas.
Regarding Claim 9:
The above-discussed combination of Parietti, Nelson, and Snow accounts for this subject matter where Snow teaches in Figure 1 that the sterilant provided via the one or more sterilization process ports comprises one or more of vaporized hydrogen peroxide, ionized hydrogen peroxide, chlorine dioxide, and ethylene oxide (Paragraph [0065], the sterilant is the sterilizing gas that can be vaporized hydrogen peroxide).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Perietti in view of Nelson in further view of Snow and Donahue (US 20090120503 A1).
Regarding Claim 10:
Parietti discloses in Figures 3 and 13-23 the one or more ports comprises a valve (Paragraph [0327]).
The device of Parietti, Snow, and Nelson do not teach the one or more sterilization process ports are valved.
Donahue teaches in Figure 1 bioprocessing system, comprising: the one or more sterilization process ports are valved (Paragraphs [0041] and [0045-0046], steam is the sterilization fluid that has a port where a valve (82) is located).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Parietti, Snow, and Nelson to include in the collar of Parietti the one or more sterilization process ports are valved as taught by Donahue with the motivation to sterilize the interior of the bioreactor and the main channel to prevent contamination before the media is supplied.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Perietti in view of Nelson in further view of Snow and Mueller (US 20090320622 A1).
Regarding Claim 11:
Parietti discloses in Figures 3 and 13-23 the one or more ports comprises a valve (Paragraph [0327]).
The device of Parietti and Nelson do not teach the one or more sterilization process ports are coupled to one or more passive valves.
Snow teaches in Figure 1 one or more sterilization process ports in fluid communication with a conduit (Paragraph [0065]).
The device of Parietti, Snow, and Nelson do not teach the one or more sterilization process ports are coupled to one or more passive valves.
Mueller teaches in Figure 3bioprocessing system, comprising: the one or more passive valves (Paragraph [0033], passive valves can be implemented in the duct of the reactor).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Parietti, Snow, and Nelson to include in the collar of Parietti the one or more passive valves as taught by Mueller with the motivation to minimize the diffusion of the reaction media within the reactor back into the fluid ducts.
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Perietti in view of Nelson in further view of Sierad (US 11034928 B2).
Regarding Claim 12:
Parietti discloses in Figures 3 and 13-23 the collar (1100) further comprises one or more ports (1190) in fluid communication with the plurality of conduits (Paragraphs [0307] and [0309]).
The device of Parietti and Nelson do not teach the collar further comprises one or more air process ports in fluid communication with the plurality of conduits.
Sierad teaches in Figures 5 and 8 a bioreactor, comprising: one or more air process ports (450).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Parietti and Nelson to include in the collar of Parietti one or more air process ports as taught by Sierad with the motivation to create a pulsatile flow through the bioreactor to reproduce circulatory conditions.
Regarding Claim 13:
The above-discussed combination of Parietti, Nelson, and Sierad accounts for this subject matter where Sierad teaches in Figure 5 that the one or more air process ports (450) are compressed air process ports (Column 10, Lines 31-34, the port is connected to a pressurized gas source that uses air).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Perietti in view of Nelson in further view of Guinn (US 4918019 A).
Regarding Claim 14:
Parietti discloses in Figures 3 and 13-23 the collar (1100) further comprises one or more ports (1190) that comprises valves (Paragraph [0327]) to prevent the introduction of air into fluids during the fluid transfer (Paragraph [0340]).
The device of Parietti and Nelson do not expressly teach the collar further comprises valves to prevent the introduction of air into fluids during the fluid transfer.
Guinn teaches in Figures 1 a bioreactor system, comprising: valves (162 and 120) to prevent the introduction of air into fluids during the fluid transfer (Column 8, Lines 10-22, the introduction of air is prevented during fluid transfer).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Parietti and Nelson to include in the collar of Parietti valves to prevent the introduction of air into fluids during the fluid transfer as taught by Guinn with the motivation to prevent the fluid going to the fluid inlet leading to potential contamination or spillage.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Perietti in view of Nelson in further view of Sierad and Watkins (US 10059914 B2).
Regarding Claim 15:
Parietti discloses in Figures 3 and 13-23 the collar (1100) further comprises one or more ports (1190) in fluid communication with the plurality of conduits (Paragraphs [0307] and [0309]).
The device of Parietti and Nelson do not teach the one or more air process ports are air vents.
Sierad teaches in Figures 5 and 8 one or more air process ports (450).
The device of Parietti, Sierad, and Nelson do not teach the one or more air process ports are air vents.
Watkins teaches in Figure 1 a disposable bioreactor, comprising: the one or more air process ports are air vents (Column 5, Lines 18-25, the air vent is the exhaust port).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Parietti, Sierad, and Nelson to include in the collar of Parietti one or more air process ports are air vents as taught by Watkins with the motivation to reduce the potential pressure with the container.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Perietti in view of Nelson in further view of Sierad and Sosa (WO 2022132732 A1).
Regarding Claim 16:
Parietti discloses in Figures 3 and 13-23 the collar (1100) further comprises one or more ports (1190) in fluid communication with the plurality of conduits (Paragraphs [0307] and [0309]).
The device of Parietti and Nelson do not teach the collar further comprises hydrophobic filters couplable to the one or more air process ports.
Sierad teaches in Figures 5 and 8 one or more air process ports (450).
The device of Parietti, Sierad, and Nelson do not teach the collar further comprises hydrophobic filters couplable to the one or more air process ports.
Sosa teaches in Figure 39 a preparation kit for use with a processing apparatus, comprising: hydrophobic filters (549) couplable to the one or more air process ports (548).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Parietti, Sierad, and Nelson to include in the collar of Parietti hydrophobic filters couplable to the one or more air process ports as taught by Sosa with the motivation to prevent fluid from entering or exiting the apparatus that can lead to potential contamination or the kit not working.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Perietti in view of Nelson in further view of Van Wie (US 4939087 A).
Regarding Claim 18:
Parietti discloses in Figures 3 and 13-23 the collar (1100) further comprises one or more ports (1190) in fluid communication with the plurality of conduits (Paragraphs [0307] and [0309]).
The device of Parietti and Nelson do not teach the collar further comprises viewing windows that permit optical evaluation of fluid within a fluid conduit of the collar.
Van Wie teaches in Figure 1 a bioprocessing, comprising: a viewing window (46) that permit optical evaluation of fluid within a fluid conduit (55-57) of the collar (Figure 1 and Column 10, Lines 30-34, the observation port allows for the optical evaluation of the fluid conduits from the collar (top of the housing)).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Parietti and Nelson to include in the collar of Parietti a viewing window that permit optical evaluation of fluid within a fluid conduit of the collar as taught by Van Wie with the motivation to view the tubes within the reactor to ensure the tubes do not become damaged with use of the bioreactor.
Parietti, Nelson, and Van Wie discloses the claimed invention except for multiple viewing windows. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the collar container multiple viewing windows, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Perietti in view of Nelson in further view of Murthy (US 20210047600 A1).
Regarding Claim 19:
Parietti discloses in Figures 3 and 13-23 the collar (1100) comprising the sterile liquid transfer port (1190).
The device of Parietti and Nelson do not teach the sterile liquid transfer port further comprises a mechanical seal.
Murthy teaches in Figure 1 a cell culture system, comprising: the sterile liquid transfer port further comprises a mechanical seal (Paragraph [0031], the ports can contain gaskets (mechanical seal)).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Parietti and Nelson to include the sterile liquid transfer port further comprises a mechanical seal as taught by Murthy with the motivation to prevent leaks around the ports that could cause contamination for objects around the chambers.
Claims 23, 26, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Perietti in view of Nelson in further view of Patrick (US20220002652 A1) and Guinn (US 4918019 A).
Regarding Claim 23:
Parietti discloses in Figures 3 and 13-23 the collar (1100) further comprises one or more ports (1190) in fluid communication with the plurality of conduits (Paragraphs [0307] and [0309]).
The device of Parietti, Patrick, and Nelson do not teach the fluid transport feature of the collar comprises a venting tube configured to extend through the opening of the container and to be disposed within the container.
Guinn teaches in Figure 1 a bioreactor system, comprising: the fluid transport feature of the collar (Figure 1, the lid of the container (102) is the collar which includes the fluid transport feature being the set of pipes connected to it) comprises a venting tube (108) configured to extend through the opening of the container and to be disposed within the container (Figure 1, the venting tube extends into the opening of the container and is disposed within it).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Parietti, Patrick, and Nelson to include in the collar of Parietti the fluid transport feature of the collar comprises a venting tube configured to extend through the opening of the container and to be disposed within the container as taught by Guinn with the motivation to release the gas from the container to prevent the container from becoming over pressurized.
Regarding Claim 26:
Parietti discloses in Figures 3 and 13-23 the collar (1100) further comprises one or more ports (1190) in fluid communication with the plurality of conduits (Paragraphs [0307] and [0309]).
The device of Parietti, Guinn and Nelson do not teach the fluid transport feature further comprises a liquid flow tube configured to extend through the opening of the container and to be disposed within the container.
Patrick teaches in Figures 1-3 the fluid transport feature (Paragraph [0041]) further comprises a liquid flow tube (207) configured to extend through the opening of the container (103) and to be disposed within the container (Figure 1, the liquid flow tube goes through the collar and into the container).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Parietti, Guinn, and Nelson to include in the collar of Parietti the fluid transport feature further comprises a liquid flow tube configured to extend through the opening of the container and to be disposed within the container as taught by Patrick with the motivation to add various fluids into the container for the desired end product.
Regarding Claim 28:
Parietti discloses in Figures 3 and 13-23 the collar (1100) further comprises one or more sterile liquid transfer ports (1190) in fluid communication with the plurality of conduits (Paragraphs [0307] and [0309]).
The device of Parietti, Guinn and Nelson do not teach the fluid transport feature further comprises a flow port in fluid communication with the container and the port.
Patrick teaches in Figures 1-3 the fluid transport feature further (Paragraph [0041]) comprises a flow port (207) in fluid communication with the container (103) and the port (Figures 2 and 4, the port where the tube goes through the collar).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Parietti, Guinn, and Nelson to include in the collar of Parietti the fluid transport feature further comprises a flow port in fluid communication with the container and the port as taught by Patrick with the motivation to add various fluids into the container for the desired end product.
Allowable Subject Matter
Claims 20-21, 24-25, and 27 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 29 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The closest pieces of prior art are Parietti (US 20210324318 A1) in view of Nelson (US 20130189120 A1).
Regarding Claim 21:
Claim 21 depends from claim 1 where Parietti and Nelson teach the fluid device. Claim 21 includes the limitation “the collar further comprises a pressure relief valve at the outlet port of the compressible fluidic tubing of the fluid pump module, and wherein the outlet port is further in fluid communication with the container such that, when there is excessive pressure at the outlet port, liquid is flowed into the container” in lines 1-4 of the claim. The limitation in view of all other limitations of claims 1 and 21 are not taught by the prior art of record. Additional references are needed to teach the limitation where it would lead to hindsight.
The closest pieces of prior art are Parietti (US 20210324318 A1) in view of Nelson (US 20130189120 A1) in further view of Murthy (US 20210047600 A1).
Regarding Claim 20:
Claim 20 depends from claims 1 and 19 where Parietti, Murthy, and Nelson teach the fluid device. Claim 20 includes the limitation “one or more sterilization process ports in fluid communication with the plurality of conduits, and wherein the mechanical seal of the sterile liquid transfer port and a sterilant provided via the one or more sterilization process ports ensure sterility of the collar” in lines 1-4 of the claim. The limitation in view of all other limitations of claims 1 and 19-20 are not taught by the prior art of record. Additional references are needed to teach the limitation where it would lead to hindsight.
The closest pieces of prior art are Parietti (US 20210324318 A1) in view of Nelson (US 20130189120 A1) in further view of Patrick (US20220002652 A1) and Guinn (US 4918019 A).
Regarding Claim 24:
Claim 24 depends from claims 1 and 22-23 where Parietti, Patrick, Guinn, and Nelson teach the fluid device. Claim 24 includes the limitation “a liquid vent reservoir configured to capture, upon inversion of the fluid device, fluid trapped within the venting tube” in lines 1-3 of the claim. The limitation in view of all other limitations of claims 1 and 22-23 are not taught by the prior art of record. Additional references are needed to teach the limitation where it would lead to hindsight.
Claim 25 is found to be allowable as it depends from claim 24.
The closest pieces of prior art are Parietti (US 20210324318 A1) in view of Nelson (US 20130189120 A1) in further view of Patrick (US20220002652 A1), Guinn (US 4918019 A), and Sierad (US 11034928 B2).
Regarding Claim 27:
Claim 27 depends from claims 1, 22-23, and 26 where Parietti, Patrick, Guinn, and Nelson teach the fluid device. Sierad teaches in Figures 5 and 8 a bioreactor comprising one or more air process ports (450). Claim 27 includes the limitation “the one or more air process ports are in fluid communication with the liquid flow tube” in lines 2-3 of the claim. The limitation in view of all other limitations of claims 1, 22-23, and 26 are not taught by the prior art of record. Additional references are needed to teach the limitation where it would lead to hindsight.
The closest pieces of prior art are Parietti (US 20210324318 A1) in view of Nelson (US 20130189120 A1) in further view of Murthy (US 20210047600 A1) and Snow (WO 20220081669 A1).
Regarding Claim 29:
Claim 29 depends from claims 1 and 22-23 where Parietti and Nelson teach the fluid device. Murthy teaches a cell culture system comprising a mechanical seal (Paragraph [0031]). Snow teaches in Figure 1 a biological manufacturing system comprising one or more sterilization process ports in fluid communication with a conduit (Paragraph [0065]). Claim 29 includes the limitation “the sterile liquid transfer port further comprises a mechanical seal and the collar further comprises one or more sterilization ports in fluid communication with the plurality of conduits, the mechanical seal providing a first mechanism to achieve sterile sterilization and sterilant provided via the one or more sterilization ports providing a second mechanism to achieve sterilization” in lines 1-5 of the claim. The limitation in view of all other limitations of claims 1 and 29 are not taught by the prior art of record. Additional references are needed to teach the limitation where it would lead to hindsight.
However, a full determination of allowability for the application will be done once all rejections and objections are overcome.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Cannon (US 7270996 B2) teaches a bioculture platform comprising conduits, a gas valve, and a reservoir.
Ludwig (US 8690129 B2) teaches a disposable mixing valve comprising conduits, a container, and a collar.
Feder (US 4201845 A) teaches a cell culture reactor comprising conduits, a container, and a collar.
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/STEPHANIE A SHRIEVES/Examiner, Art Unit 3753
/DAVID COLON-MORALES/Primary Examiner, Art Unit 3753
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