Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The 112b rejection are withdrawn in view of amendments.
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 structures capable of providing positive and/or negative pressure (see Specification page 12 lines 30)
Claim 1 lines 7: “a control unit” is interpreted as a fluid control device capable of controlling fluid flow (see Specification page 2 lines 15-16)
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 § 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 32-37, 42-46, and 50 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al (US20100200402A1 published 08/12/2010; hereinafter Li) in view of Yerden (US20030092178A1 published 05/15/2003).
Regarding claim 32, Li teaches a fluid control device comprising:
at least one processing device arranged in the chamber of a treatment device (a microfluidic device 100 capable of being arranged in the chamber of a treatment device – Fig. 1-2 and paragraph 25), wherein the processing device comprises a receptacle configured to receive a fluid sample (wells 510 holding samples – Fig. 2A-B and paragraph 27) and a lid covering the receptacle (a manifold block 400 covering the wells 510 of a PCR-CE chip 500 – Fig. 2A-B and paragraph 25); and
a control unit (a measurement of a control system – paragraph 13 and Fig. 3B) comprising:
a pressure unit (an external pressure source – paragraph 25 and Fig. 1) for providing positive (an external pressure source applies pressure to the external port 420 – paragraph 25) and/or negative pressure (and/or is interpreted as or);
at least one first control unit outlet fluidically connected to the receptacle through the lid (an O-ring 515 connecting the manifold block 400 to the PCR-CE chip 500 – Fig. 2A-B);
at least one second control unit outlet (an outlet hose of the external pressure source connected to the external port 420 – paragraph 22); and
a connection unit (interconnecting channels 410 – paragraph 25 and Fig. 2A-B) fluidically connecting the pressure unit with the first control unit outlet (the interconnecting channels 410 connecting the external pressure source to the O-rings 515 – paragraph 25 and Fig. 2A-B) and/or with the second control unit outlet (and/or is interpreted as or);
wherein the control unit is configured to:
control the processing of the fluid sample in the receptacle by applying a positive or negative pressure (Pressure of 100 psi or less and 10 psi or above – paragraph 23) provided by the pressure unit to the first control unit outlet by means of the connection unit (external pressure source is connected to the O-rings 515 by means of the interconnecting channels 410 – paragraph 25 and Fig. 2A-B).
However, Li does not teach at least one treatment device having a chamber surrounded by a housing; and at least one processing device arranged in the chamber of the treatment device, at least one second control unit outlet fluidically connected to the chamber through the housing; and control a physical state in the chamber of the treatment device.
Yerden teaches a system for creating dynamic atmospheric conditions comprising at least one treatment device (a controlled atmosphere chamber for open dish cultures – paragraph 14) having a chamber surrounded by a housing (a culture chamber 36 surrounded by a host chambers 360 – Fig. 1); and
at least one processing device arranged in the chamber of the treatment device (open culture vessel 32 – Fig. 1),
a control unit (a controller 16 – Figs. 1-2) with at least one second control unit outlet (a gas infusion 26 from a continuous supplies gases 20 – Figs. 1-2) fluidically connected to the chamber through the housing (the gas infusion 26 connected to the culture chamber 36 through the host chambers 360 – Figs. 1-2); and
control a physical state in the chamber of the treatment device (the controller 16 and an oxygen control loop 160 for controlling or monitoring functions in addition to dynamic oxygen control, such as the control of temperature, humidity, CO2, or other gases – paragraphs 19, 41 and Figs. 1-4). Yerden teaches to create dynamic instead of static atmospheric conditions inside cell culture incubators to better simulation in vitro (in the dish) of those natural conditions that occur in vivo (in the body) (paragraph 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system, as taught by Li, by placing the system into the incubator, taught by Yerden, to gain dynamic instead of static atmospheric conditions. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because this modifications is a simple substitution of one known element for another to obtain predictable results.
Regarding claim 33, Li, modified by Yerden, 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 (the controller 16 – Yerden Fig. 1-2) by fluidically connecting or disconnecting the pressure unit with the second control unit outlet by means of the connection unit (the controller 16 comprising a switch 17 that will allow the operator to select which sensor is to provide the feedback to the oxygen control loop 160 – Yerden Figs. 1-2 and paragraph 38).
Regarding claim 34, Li, modified by Yerden, teaches the fluid control device according to claim 32, wherein the pressure unit comprises a pressurized gas tank having a positive pressure (CO2, or other gases – Yerden paragraphs 19, 41 and Figs. 1-4), wherein the pressurized gas tank is fluidically connectable or connected to the first control unit outlet and/or (and/or is interpreted as or) the second control unit outlet (a gas infusion 26 from a continuous supplies gases 20 – Yerden Figs. 1-2).
Regarding claim 35, Li, modified by Yerden, teaches the fluid control device according to claim 34, wherein:
b. the pressure unit comprises a gas mixer (the oxygen control loop may contain a secondary gas mixing apparatus – Yerden paragraph 19) that is arranged upstream of the pressurized gas tank and/or that comprises at least two inlets for gas inlet (the oxygen control loop 160 Yerden comprises at least two inlets – Yerden Figs. 1-2) and/or comprises an outlet for releasing the mixed gas (and/or is interpreted as or).
Regarding claim 36, Li, modified by Yerden, teaches the fluid control device according to claim 35, wherein the pressure unit comprises:
a. a pump that is arranged upstream of the pressurized gas tank (a pump 42 arranged upstream of the pressurized gas tank – Yerden Fig. 4) and/or (and/or is interpreted as or) that is adapted to increase pressure in the pressurized gas tank; and/or (and/or is interpreted as or)
Regarding claim 37, Li, modified by Yerden, teaches the fluid control device according to claim 35, wherein:
a. the pressure unit comprises a check valve (FIG. 2 has a hatched arrow for the CO2 tank – Yerden – Figs. 1-2 and paragraph 41) (the examiner points out that it is obvious to one of ordinary skill that the outlet of a compress gas tank must have valves) that is arranged fluidically between the pressurized gas tank and the first control unit outlet and/or second control unit outlet (the outlet of the CO2 tank is arranged between the CO2 tank and the gas infusion 26 – Yerden Figs. 1-2 and paragraph 41); and/or
b. the control unit is adapted to supply the same gas to the treatment device and to the processing device; and/or
c. the pressurized gas tank supplies the same gas to the first control unit outlet and the second control unit outlet.
Regarding claim 42, Li, modified by Yerden, teaches the fluid control device according to claim 32, wherein the control unit comprises a housing (the controller 16 having a housing – Yerden Fig. 2) having at least one through hole for receiving a fluid connector of the treatment device (the housing having at least one through hole for receiving a CO2 line from the CO2 tank – Yerden Fig. 2) and/or another through hole for receiving a further fluid connector of the processing device, and wherein the housing is mechanically connectable with the treatment device.
Regarding claim 43, Li, modified by Yerden, teaches the fluid control device according to claim 32, wherein the control unit comprises:
b. a plurality of second control unit outlets (additional control loops 140 – Yerden Fig. 1) wherein each of the plurality of second control unit outlets is fluidically connectable to one treatment device (the additional control loops 140 connectable to the microfluidic device – Li Fig. 1-2 and Yerden Fig. 1).
Regarding claim 44, Li, modified by Yerden, teaches the fluid control device according to claim 43, wherein:
b. the control unit comprises several connection units (the controller 16 having several connections to different gas tanks – Yerden Fig. 2 and paragraph 41); and/or
Regarding claim 45, Li, modified by Yerden, teaches the fluid control device according to claim 32, wherein the control unit comprises an acquisition unit configured to acquire information about the fluid sample in the processing device (a liquid oxygen sensor 28 configured to acquire information about the fluid sample – Yerden Fig. 1), and wherein the acquisition unit determines a physical state of the fluid sample located in the processing device based on the acquired information (a liquid oxygen sensor 28 determines dissolved oxygen tension 280 in the culture media – Yerden Fig. 1 and paragraph 38).
Regarding claim 46, Li, modified by Yerden, teaches the fluid control device according to claim 32, wherein the lid comprises at least one extension tube (holes sealed by an epoxy glue 450 – Li Fig. 2A-B) extending into the receptacle and being fluidically connected to the first control unit outlet (the holes extend to the wells 510 and being fluidically connected to the O-ring 515 – Li Fig. 2A-B).
Regarding claim 50, Li, modified by Yerden, teaches the fluid control device according to claim 32, wherein:
b. the control unit is adapted to control a physical state in the chamber of the treatment device by controlling the heating unit (a controller 16 and an oxygen control loop 160 for controlling of temperature, humidity, CO2, or other gases – Yerden paragraphs 19, 41 and Figs. 1-4).
Claims 38-41, 47-49, 51 are rejected under 35 U.S.C. 103 as being unpatentable over Li, modified by Yerden, in view of Hugh et al (US Pat No. 5,792,427 A published 08/11/1998; hereinafter Hugh).
Regarding claim 38, Li, modified by Yerden, teaches the fluid control device according to claim 35,
However, Li, modified by Yerden, does not teach the connection unit comprises at least one further valve that in a first position fluidically connects the pressurized gas tank with the treatment device and in a second position separates the fluidic connection between the pressurized gas tank and the treatment device.
Hugh teaches an interior controlled atmosphere chamber 14 wherein the connection unit (gas flow control circuit 348 – column 12 line 49) comprises at least one further valve (gas flow control circuit 348 is used to control a valve 350 – column 12 lines 49-50) that in a first position fluidically connects the pressurized gas tank with the treatment device (the valve is open in a first position to permit gas (such as carbon dioxide) from a gas source 352 to enter incubator 354 – column 12 lines 49-50) and in a second position separates the fluidic connection between the pressurized gas tank and the treatment device (the valve 350 is capable of being closed in a second position – column 12 lines 49-50 and Fig. 9). Hugh teaches to regulate carbon dioxide levels in the incubator to simulate a specific pH or acidity level.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system, as taught by Li as modified by Yerden, with the gas flow control circuit 348 and valve 350, taught by Hugh, to gain the ability to simulate a specific pH or acidity level. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Li, Hugh, and Yerden teach devices for controlling gas or vapor via pressure.
Regarding claim 39, Li, as modified by Yerden modified by Hugh, teaches the fluid control device according to claim 38, wherein the control unit comprises at least one controller for controlling the valve (the gas flow control circuit 348 is used to control a valve 350 – Hugh column 12 lines 49-50) and/or (“and/or” is interpreted as “or”) the further valve, wherein the controller controls the valve based on a gas flow flowing through the first control unit outlet, and/or (“and/or” is interpreted as “or”) the controller controls the valve based on a physical state in the treatment device and on a physical state of the processing device.
Regarding claim 40, Li, as modified by Yerden modified by Hugh, teaches the fluid control device according to claim 39, wherein:
e. the controller is adapted to control a humidifier arranged in the chamber of the treatment device (the controller 16 may control humidity – Yerden paragraph 41);
Regarding claim 41, Li, as modified by Yerden modified by Hugh, teaches the fluid control device according to claim 39, wherein the controller comprises:
d. a fourth subcontroller for controlling a humidifier (the controller 16 having other pertinent control loops 140 for controlling humidity – Yerden paragraphs 41 and 48).
Regarding claim 47, Li, as modified by Yerden modified by Hugh, teaches the fluid control device according to claim 39, wherein the controller controls the valve (the gas flow control circuit 348 is used to control a valve 350 – Hugh column 12 lines 49-50) such that the positive pressure provided by the pressurized gas tank is applied via the lid into the receptacle (the wells 510 are pressurized via the external pressure port 420 on the manifold block 400 – Li Figs. 1-2).
Regarding claim 48, Li, modified by Yerden, teaches the fluid control device according to claim 39, wherein the controller controls a further valve (FIG. 2 has a hatched arrow for the CO2 tank – Yerden – Figs. 1-2 and paragraph 41) (the examiner points out that it is obvious to one of ordinary skill that the outlet of a compress gas tank must have valves) such that a predetermined physical state is achieved in the chamber of the treatment device (the oxygen control loop moves the oxygen concentration to the desired setpoint set by the operator – Yerden paragraph 20 ).
Regarding claim 49, Li, modified by Yerden, teaches the fluid control device according to claim 39, wherein the treatment device comprises a humidifier that is controlled by the controller of the control unit (the controller 16 may control humidity – Yerden paragraph 41).
Regarding claim 51, Li, modified by Yerden, teaches the fluid control device according to claim 32.
However, Li, modified by Yerden, does not teach wherein the housing comprises a transparent housing part enabling an acquisition unit to acquire information about the fluid sample located in the processing device.
Hugh teaches an interior controlled atmosphere chamber 14 wherein the housing comprises a transparent housing part (a dual glass pane door - column 3 lines 33-34) enabling an acquisition unit to acquire information about the fluid sample located in the processing device (the glass door capable of enabling an acquisition unit to acquire information about the fluid sample located in the processing device; see MPEP2115). Hugh teaches to a dual glass pane configuration a heated inner pane to prevent or remove condensate on the inside surface of the glass (column 3 lines 35-38).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system, as taught by Li as modified by Yerden, with a dual glass pane door, taught by Hugh, to prevent or remove condensate on the inside surface. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Li, Hugh, and Yerden teach devices for controlling gas or vapor via pressure.
Response to Arguments
Applicant’s addition arguments with respect to the 102/103 rejections of the claims have been considered, and a new prior art rejection has been modified in order to address the amended claim language.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TINGCHEN SHI whose telephone number is (571)272-2538. The examiner can normally be reached M-F 9am-6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at (571) 270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/T.C.S./Examiner, Art Unit 1796
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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