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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/23/2023, 11/18/2025 were filed after the mailing date of the FAOM. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Claim 1 lines 6: “a pressure unit” is interpreted as a pump or equivalent structure capable of providing positive and/or negative pressure (see Specification page 12 lines 30)
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 35-41, 47-49 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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.
Claim 35 lines 5-6 recites “the pressurized gas tank”. There is insufficient antecedent basis for this limitation in the claim. For prosecution, the limitation will be interpreted to mean a tank capable holding pressure. While claim 34 recites a pressurized tank, claim 35 depends from claim 32, not from claim 34. Claims 36-41 dependent on claim 35 are also rejected for said dependency.
Claim 47 line 1 recites the limitation “the controller”. There is insufficient antecedent basis for this limitation in the claim.
Claim 47 recites “wherein the controller controls a valve such that a positive pressure provided by a pressurized gas tank is applied via a lid in the receptacle or a negative pressure provided by a vacuum gas tank is applied via the lid in the receptacle” and is unclear how the action “the controller controls a valve” is correlated to “a positive pressure provided by a pressurized gas tank is applied via a lid in the receptacle or a negative pressure provided by a vacuum gas tank is applied via the lid in the receptacle”. For prosecution, the limitation will be interpreted to mean the controller controls a valve and there is a lid in the receptacle capable of holding positive pressure or negative pressure.
Claim 48 line 1 recites the limitation “the controller”. There is insufficient antecedent basis for this limitation in the claim.
Claim 49 line 1 recites the limitation “the controller”. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 32-39, 42-48, 50-51 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Griffith et al (US20180272346A1 published 09/27/2018; hereinafter Griffith).
Regarding claim 32, Griffith teaches a fluid control device (multi-well cell culture systems – paragraph 13) comprising:
at least one treatment device (a microfluidic device 4006 – Fig. 48) having a chamber (at least one channel 4005 in the microfluidic device 4006 – Fig. 48) for receiving a processing device;
at least one processing device which is arranged in the chamber of the treatment device (custom biomaterial scaffolds to support cells or organoids – paragraph 194); and
a control unit (bidirectional feedback controlled, closed-loop gravity-driven pump system – paragraph 227 and Fig. 48) comprising:
a pressure unit for providing positive and/or negative pressure (and/or is interpreted as or) (gravity-driven pump with a first driving reservoir 4001 and a second driving reservoir 4003 – paragraph 227);
at least one first control unit outlet fluidically connected to the processing device (an outlet 4004 – Fig. 48), comprising at least one receptacle for receiving a fluid sample (an outlet 4004 comprising tubing 04 that is capable of receiving a sample – annotated Fig. 48 and paragraph 513) (the pumping and recirculation circuits through 1/16″ ID polypropylene tubing – paragraph 513);
[AltContent: textbox (tubing 08)][AltContent: arrow]
at least one second control unit outlet fluidically connected to the treatment device (an outlet of the microfluidic device 4006 connecting to the second driving reservoir 4003 – Fig. 48); and
a connection unit (a connector comprising tubing 04 and tubing 08 between the supply reservoirs 4001, 4003 – paragraph 228) (polypropylene tubing connecting the feedback-controlled gravity-driven setup – paragraph 513) fluidically connecting the pressure unit with the first control unit outlet (the gravity-driven pump is connected to the outlet 4004 by the tubing 04 – annotated Fig. 48) and/or with the second control unit outlet (and/or is interpreted as or);
wherein the control unit is adapted to control the processing of the fluid sample in the processing device (Closed-loop feedback in the system is based on the results of this comparison, the computing unit 4010 implements a desired control scheme 4013 – paragraph 227) by applying a positive or negative pressure provided by the pressure unit to the first control unit outlet by means of the connection unit (the fluid to be added to or extracted from the driving reservoir is obtained, stored, and/or recirculated using an additional fluid reservoir 4015 – paragraph 227) and to control a physical state in the chamber of the treatment device (the volume of fluid in the driving reservoir determines in the pressure in the microfluidic device 4006; therefore, controlling a physical state in the scaffolds in the microfluidic device – paragraph 227).
Regarding claim 33, Griffith teaches the fluid control device according to claim 32, wherein the control unit is adapted to control the physical state in the chamber of the treatment device by fluidically connecting or disconnecting the pressure unit with the second control unit outlet by means of the connection unit (gravity-driven pump system is capable of controlling a hydrostatic pressure in the microfluidic device 4006 when connected to the microfluidic device 4006 by the tubing 04 – paragraph 227 and annotated Fig. 48).
Regarding claim 34, Griffith teaches the fluid control device according to claim 32, wherein the pressure unit comprises a pressurized gas tank having a positive pressure (the first driving reservoir 4001 contains a hydrostatic pressure – Fig. 48 and paragraph 82) (“pressurized gas tank” is interpreted as a tank or reservoir capable of holding pressure; see MPEP 2114 II), wherein the pressurized gas tank is fluidically connectable or connected to the first control unit outlet (the first driving reservoir 4001 is connected to the outlet 4004 – Fig. 48).
Regarding claim 35, Griffith teaches the fluid control device according to claim 32, wherein
b. the pressure unit comprises a gas mixer (the additional fluid reservoir 4015 capable of mixing gases – Fig. 48) that is arranged upstream of the pressurized gas tank (the first driving reservoir 4001 contains a hydrostatic pressure – Fig. 48 and paragraph 82) (“pressurized gas tank” is interpreted as a tank or reservoir capable of holding pressure; see MPEP 2114 II and 112b rejection) (the additional fluid reservoir 4015 arranged upstream of the first driving reservoir 4001 – Fig. 48) (and/or is interpreted as or).
Regarding claim 36, Griffith teaches the fluid control device according to claim 35, wherein the pressure unit comprises:
b. a gas filter arranged upstream of the pressurized gas tank for filtering gas (an open driving reservoir for fluid includes a mechanical barrier 4018 (i.e. air filter) – paragraph 227 and Fig. 48) (and/or is interpreted as or).
Regarding claim 37, Griffith teaches the fluid control device according to claim 35, wherein:
a. the pressure unit comprises a check valve that is arranged fluidically between the pressurized gas tank and the second control unit outlet (an auxiliary reservoir is generally connected to the supply reservoir and a valve or a pump that is operated by a CPU – paragraph 241) (the valve is deemed to be between the first driving reservoir 4001 and the outlet of the microfluidic device 4006 because the flow path is a loop – Fig. 48);
Regarding claim 38, Griffith teaches the fluid control device according to claim 35, wherein:
a. the connection unit comprises at least one valve for selectively fluidically connecting the pressurized gas tank or the vacuum gas tank with the first control unit outlet (an auxiliary reservoir is generally connected to the supply reservoir and a valve or a pump that is operated by a CPU – paragraph 241) (the connector comprises the valve because the valve is connected the tubing 04 and the outlet 4004 because the flow path is a loop – annotated Fig. 48 and Fig. 48); and/or (and/or is interpreted as or).
Regarding claim 39, Griffith teaches the fluid control device according to claim 38,
wherein the control unit comprises at least one controller for controlling the valve and/or the further valve (an auxiliary reservoir is generally connected to the supply reservoir and a valve or a pump that is operated by a CPU – paragraph 241), wherein the controller controls the valve based on a physical state in the treatment device and on a physical state of the processing device (for replenishing the fluid supply reservoir, an auxiliary reservoir is generally connected to the supply reservoir and a valve or a pump that is operated by a CPU – paragraph 241 and 266) (replenishing fluid to the supply reservoirs 4001, 4003 changes the hydrostatic pressure in the microfluidic chip 4006; therefore, the CPU is deemed to control the valve based on a physical state, in this case hydrostatic pressure, in the microfluidic device 4006 – Fig. 48 and paragraph 227) (and/or is interpreted as or).
Regarding claim 42, Griffith teaches the fluid control device according to claim 32, wherein the control unit comprises a housing (an incubator – paragraph 546) having at least one through hole for receiving a fluid connector of the treatment device (Temperature is controlled by placing these platforms in an incubator, which maintains the global temperature within to 37±0.5 deg – paragraph 291) (the hydrostatic chamber was monitored over a period of 48 hours inside an incubator; therefore, incubator is deemed to one through hole for receiving the microfluidic device in order to place the hydrostatic chamber into the incubator – paragraph 546) and wherein the housing is mechanically connectable with the treatment device (the microfluidic device is placed in the incubator; therefore, the incubator is deemed mechanically connectable with the microfluidic device) (and/or is interpreted as or).
Regarding claim 43, Griffith teaches the fluid control device according to claim 32, wherein the control unit comprises:
a. a plurality of first control unit outlets (the outlet 4004 and an outlet of the second driving reservoir 4003 – Fig. 48) wherein each of the plurality of first control unit outlets is fluidically connectable to one processing device (the outlet 4004 and an outlet of the second driving reservoir 4003 are connected to the custom biomaterial scaffold in the microfluidic device 4006 – Fig. 48) (and/or is interpreted as or).
Regarding claim 44, Griffith teaches the fluid control device according to claim 43, wherein:
a. the control unit comprises only one pressure unit (the multi-well cell culture system on comprises only one gravity-driven pump system – Fig. 48) (and/or is interpreted as or).
Regarding claim 45, Griffith teaches the fluid control device according to claim 32, wherein the control unit comprises an acquisition unit (non-contact fluid-level sensor – Fig. 48) configured to acquire information about the fluid sample in the processing device (The fluid height of each of the reservoirs is monitored by a non-contact fluid-level sensor – paragraph 227), and wherein the acquisition unit determines a physical state of the fluid sample located in the processing device based on the acquired information (Acquired fluid height signal is fed to a computing unit 4010, and the computing unit 4010 implements a desired control scheme 4013 to drive a fluid input and/or output into or out of either one of the driving reservoirs to control fluid heights H1 and/or H0 – paragraph 227).
Regarding claim 46, Griffith teaches the fluid control device according to claim 32, wherein:
a. the processing device comprises at least one receptacle for receiving the fluid sample (the first driving reservoir 4001 is capable of receiving a fluid sample – Fig. 48) and a lid covering the receptacle (a mechanical barrier 4018 covering the first driving reservoir 4001 – Fig. 48) (and/or is interpreted as or).
Regarding claim 47, Griffith teaches the fluid control device according to claim 32, wherein the controller controls a valve (a valve or a pump that is operated by a CPU or microcontroller unit – paragraph 241) such that a positive pressure provided by a pressurized gas tank is applied via a lid in the receptacle (“a positive pressure provided by a pressurized gas tank is applied via a lid” is an intended use of the lid and deemed to read on a lid capable of holding pressure seem MPEP 2114II) (a mechanical barrier 4018 is capable of holding pressure – Fig. 48) or a negative pressure provided by a vacuum gas tank is applied via the lid in the receptacle.
Regarding claim 48, Griffith teaches the fluid control device according to claim 32, wherein the controller controls a further valve (a valve or a pump that is operated by a CPU or microcontroller unit – paragraph 241) such that a predetermined physical state is achieved in the chamber of the treatment device (A first driving reservoir 4001 contains fluid 4002 to a desired height (H1), and a second driving reservoir 4003 maintains fluid at another fluid height (H0) – paragraph 227).
Regarding claim 50, Griffith teaches the fluid control device according to claim 32, wherein:
a. the treatment device comprises a heating unit for heating the processing device (Temperature is controlled by placing these platforms in an incubator, which maintains the global temperature within to 37±0.5 deg – paragraph 291) (and/or is interpreted as or).
Regarding claim 51, Griffith teaches the fluid control device according to claim 32, wherein:
a. the treatment device comprises a housing surrounding the chamber, in which the processing device is arranged (Temperature is controlled by placing these platforms in an incubator, which maintains the global temperature within to 37±0.5 deg – paragraph 291) (and/or is interpreted as or).
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 40-41, 49 are rejected under 35 U.S.C. 103 as being unpatentable over Griffith in view of Yerden (US20030092178A1 published 05/15/2003).
Regarding claim 40, Griffith teaches the fluid control device according to claim 39.
However, Griffith does not teach the controller controls the further valve based on a physical state, in particular a gas composition, of the chamber of the treatment device and/or of a physical state of the fluid sample located in the processing device (and/or is interpreted as or).
Yerden teaches an incubator and oxygen controller wherein the controller controls the further valve based on a physical state, in particular a gas composition, of the chamber of the treatment device (An oxygen profile controller 16 controls gas oxygen tension inside each of one or more culture chambers 36 – paragraph 37) (and/or is interpreted as or). Yerden teaches to use an oxygen profile controller 16 to maintain specific gas oxygen profiles for the purpose of achieving better growth over longer periods of time (paragraphs 17 and 37).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the CPU, as taught by Griffith, with a controller and oxygen control loop, taught by Yerden, to have the ability to respond to changes in oxygen demand. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Griffith and Yerden teach cell culture devices.
Regarding claim 41, Griffith teaches the fluid control device according to claim 39, wherein the controller comprises: a third subcontroller (the computing unit implements a desired control scheme via a controller to drive a mechanism – paragraph 229).
However, Griffith does not teach a third subcontroller for controlling the further valve and/or a gas mixer (and/or is interpreted as or).
Yerden teaches an incubator and oxygen controller comprising a third subcontroller for controlling a gas mixer (and/or is interpreted as or) (the oxygen control loop may be designed to control oxygen directly in the culture chamber, or indirectly in a secondary gas mixing apparatus and then circulate oxygen controlled gas to the culture chamber – paragraph 19). Yerden teaches to use an oxygen profile controller 16 to maintain specific gas oxygen profiles for the purpose of achieving better growth over longer periods of time (paragraphs 17 and 37).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the CPU, as taught by Griffith, with a controller and oxygen control loop, taught by Yerden, to achieve better growth over longer periods of time. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Griffith and Yerden teach cell culture devices.
Regarding claim 49, Griffith teaches the fluid control device according to claim 32, wherein the treatment device comprises a humidifier (This experiment was also conducted in triplicate within an incubator (37° C. at 95% humidity) – paragraph 547)
However, Griffith does not teach the humidifier is controlled by the controller of the control unit.
Yerden teaches an incubator and oxygen controller wherein the humidifier is controlled by the controller of the control unit (the controller 16 controls oxygen and oxygen profiles and any other pertinent variables (e.g. CO.sub.2, temperature, humidity) – paragraph 42). Yerden teaches to use an oxygen profile controller 16 to maintain specific gas oxygen profiles for the purpose of achieving better growth over longer periods of time (paragraphs 17 and 37).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the CPU, as taught by Griffith, with a controller and oxygen control loop, taught by Yerden, to achieve better growth over longer periods of time. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Griffith and Yerden teach cell culture devices.
Conclusion
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/T.C.S./Examiner, Art Unit 1796
/ELIZABETH A ROBINSON/Supervisory Patent Examiner, Art Unit 1796