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 Claims 1-8 in the reply filed on 3 June 2026 is acknowledged.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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. Such claim limitation is:
"A cell housing part" in claim 1 on line 4.
For examination purposes the “cell housing part” will be interpreted as a container which can hold cells in culture medium (Specification; pg. 23 lines 3-9).
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 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.
Claim 1 recites the limitation “”the culture medium housing part, the cell housing part, and the discharge path being connected to one of the holes in a switchable manner”. The scope of this limitation is unclear if it means they are connected directly to the hole and share a singular pathway or if it means a singular hole of the culture part receives media and cell input and output. Claims 2-8 are rejected by virtue of their dependence on a rejected base claim (claim 1).
Claims 2, 4, and 6 recite the limitation "the one hole" in:
Claim 2 on line 2 and on line 6.
Claim 4 on line 2
Claim 6 on line 3 and on lines 6-7
There was never a recitation of “a one hole” or of “a hole” in the independent claim. While there was antecedent basis for there being two holes, “holes provided at both ends”, in the culture part, there was not a singular hole established that could be referred to as “the one hole”. It is recommended to recite the hole that is connected to the housing parts and discharge path of which is being referred to as “the one hole” with an identifiable component name in the independent claim to be easily referred to in the dependent claims. There is insufficient antecedent basis for this limitation in the claim. Claims 5, 7, and 8 are rejected by virtue of their dependence on a rejected base claim (claims 4 and 6).
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.
Claims 1-3, 6, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Cattaruzzi (US20170037357A1) in view of Wrzesinski (US20220243162A1).
Regarding claim 1, Cattaruzzi teaches:
A cell culture apparatus (Cattaruzzi; Abstract, Para. [0050], Fig. 3) comprising:
a culture medium housing part configured to house a culture medium for culturing cells (Cattaruzzi; Para. [0045], Fig. 1, cell culture medium reservoir (2); Para. [0051], Fig. 3, cell culture medium (9));
a cell housing part configured to house the cells (Cattaruzzi; Para. [0057], Fig. 3, cell preparation chamber (19));
a discharge path for discharge (Cattaruzzi; Para. [0051], Fig. 3, culture chamber (2), valve (11), valve (11b), waste tank (13), "closing the normally-open valve 11 and opening the normally-closed valve 11b, the medium will flow from the cell culture chamber to the waste tank 13");
a culture part (Cattaruzzi; Paras. [0045, 0046], Fig. 1, cell culture chamber (5); Para. [0050], Fig. 3, cell culture chamber (2))
the culture medium housing part (Cattaruzzi; Para. [0045], Fig. 1, cell culture medium reservoir (2); Para. [0051], Fig. 3, cell culture medium (9)), the cell housing part (Cattaruzzi; Para. [0057], Fig. 3, cell preparation chamber (19)), and the discharge path (Cattaruzzi; Para. [0051], Fig. 3, culture chamber (2), valve (11), valve (11b), waste tank (13)) being connected to one of the holes in a switchable manner (Cattaruzzi; Paras. [0051-0061], Fig. 3, Description of the different flow paths for different phases during the cell culture process of the application. The valves of Fig. 3 allowing for the flow path changes listed here: 11, 11b, 10, 10b, 12, 12b. The switchable manner accomplished by which path or part has access to the culture part.)
Cattaruzzi does not teach:
a culture part having a hollow tubular shape with holes provided at both ends,
a movable wall inserted into the culture part from another hole of the culture part and arranged in a slidable manner along an inner peripheral face of the culture part,
wherein
the movable wall slides inside the culture part to perform sucking from at least either the culture medium housing part or the cell housing part into the culture part and discharge from inside the culture part to the discharge path.
However, Wrzesinski teaches:
a culture part having a hollow tubular shape (Wrzesinski; Abstract; Paras. [0057-0059], described as a cylindrical vessel; Para. [0164], Fig. 1, annular compartment (22)) with holes provided at both ends (Wrzesinski; Paras. [0175, 0209], Fig. 1 and 5a, planar access port (76); Paras. [0169], Fig. 2b, orifice (44)),
a movable wall (Wrzesinski; Abstract, Paras. [0049, 0059, 0096], Fig. 1, movable wall (38)) inserted into the culture part from another hole of the culture part (Wrzesinski; Abstract, Paras. [0049, 0059, 0096], Fig. 1, movable wall (38); Fig. 2b, orifice (44)) and arranged in a slidable manner along an inner peripheral face of the culture part (Wrzesinski; Abstract, Paras. [0049, 0059, 0096], Fig. 1, movable wall (38)),
wherein
the movable wall slides inside the culture part to perform sucking (A moveable wall moving within an airtight cylindrical volume creates a pressure change that allows for either sucking or discharging depending on the direction it moves; Wrzesinski; Abstract, Paras. [0049, 0059, 0096], Fig. 1, movable wall (38); Paras. [0175, 0209], Fig. 1 and 5a, planar access port (76); Paras. [0169], Fig. 2b, orifice (44)) from at least either the culture medium housing part or the cell housing part into the culture part and discharge from inside the culture part to the discharge path (Stated previously in the claim that Cattaruzzi contains parts that read on all of the locations that are connected to the culture part as claimed. The recitation of the intended direction, source, or destination are understood as intended use limitations. MPEP 2114(II)).
Therefore, it would be obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the cell culture container/bioreactor of Cattaruzzi by including the syringe like construction of the bioreactor as taught by Wrzesinski because both Cattaruzzi and Wrzesinski are directed to the culture of cells within a reaction vessel. Wrzesinski teaches that the syringe like construction components of the reaction vessel allows for time and environmental control of the reaction or cell growth due to easier media exchange (Wrzesinski; Para. [0042]), and this involves applying a known teaching (syringe like construction of Wrzesinski) to a similar device (a reaction vessel for cell culture applications) to yield predictable results (a cell culture vessel involving a syringe like media exchange mechanism for easier control).
Regarding claim 2, Modified Cattaruzzi (Cattaruzzi in view of Wrzesinski) teaches all of the elements of the current invention as stated with respect to claim 1. Modified Cattaruzzi (Cattaruzzi in view of Wrzesinski) teaches:
The cell culture apparatus according to claim 1, wherein the movable wall
slides inside the culture part in a direction moving away from the one hole (Wrzesinski; Abstract, Paras. [0049, 0059, 0096], Fig. 1, movable wall (38); Paras. [0175, 0209], Fig. 1 and 5a, planar access port (76); Paras. [0169], Fig. 2b, orifice (44)) to perform sucking from at least either the culture medium housing part or the cell housing part into the culture part (This movement causes a pressure change that creates a vacuum which a liquid (in this case) will fill if provided. The source from where said liquid will come from uses intended use claim language MPEP 2114(II)) and
slides inside the culture part in a direction moving close to the one hole to perform discharge (Wrzesinski; Abstract, Paras. [0049, 0059, 0096], Fig. 1, movable wall (38); Paras. [0175, 0209], Fig. 1 and 5a, planar access port (76); Paras. [0169], Fig. 2b, orifice (44)) from inside the culture part to the discharge path (This movement discharges the contents of the space, a liquid (in this case). The destination of which said liquid will go to uses intended use claim language MPEP 2114(II)).
Regarding claim 3, Modified Cattaruzzi (Cattaruzzi in view of Wrzesinski) teaches all of the elements of the current invention as stated with respect to claim 1. Modified Cattaruzzi (Cattaruzzi in view of Wrzesinski) teaches:
The cell culture apparatus according to claim 1, wherein the culture part is provided in a rotatable manner (Cattaruzzi; Para. [0049], rotation gear (9); Wrzesinski; Para. [0159], Fig. 7) about an axis of the tubular shape (Wrzesinski; Abstract; Paras. [0057-0059], described as a cylindrical vessel; Para. [0164], Fig. 1, annular compartment (22)).
Regarding claim 6, Modified Cattaruzzi (Cattaruzzi in view of Wrzesinski) teaches all of the elements of the current invention as stated with respect to claim 1.
Modified Cattaruzzi teaches:
Processing circuitry (Cattaruzzi; Paras. [0041, 0045], parameter acquisition system (9), parameters monitoring system (10); Para. [0032] an example of a control system being used based on cell culture data and the control system enacting a response).
Cattaruzzi also teaches that sensors are used to collect parameter data in order to activate automatic control of the system (Cattaruzzi; Para. [0053]) and that the use of automatic actuators (which are control/processing circuitry) prevent possible human errors (Cattaruzzi; Para. [0037]).
Modified Cattaruzzi does not teach:
processing circuitry causing
the movable wall to slide in a direction moving away from the one hole to perform sucking from at least either the culture medium housing part or the cell housing part into the culture part and
causing the movable wall to slide in a direction moving close to the one hole to perform discharge from inside the culture part to the discharge path.
However, Wrzesinski teaches:
processing circuitry causing (Wrzesinski; Para. [0042], “A component-sensor which activates media exchange”).
the movable wall to slide in a direction moving away from the one hole to perform sucking (Wrzesinski; Para. [0042], "a component-sensor which activates media exchange"; Para. [0164], this media exchange means the piston can move in a motion that could suck in media, movable wall (38)) from at least either the culture medium housing part or the cell housing part into the culture part and
causing the movable wall to slide in a direction moving close to the one hole to perform discharge (Wrzesinski; Para. [0042], "a component-sensor which activates media exchange"; Para. [0164], this media exchange means the piston can move in a motion that could discharge media, movable wall (38)) from inside the culture part to the discharge path.
Therefore, it would be obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to combine the processing circuitry which uses sensor data for the automatic control of a bioreactor system of Modified Cattaruzzi with the component sensors used for automatic media exchange as taught by Wrzesinski because both Modified Cattaruzzi and Wrzesinski are directed to the culture of cells within a reaction vessel which use sensors for automatic control of system mechanisms. Modified Cattaruzzi teaches that the benefit of the use of automatic control is that it has the ability to eliminate human error affecting the system (Cattaruzzi; Paras. [0037, 0053]) and Wrzesinski teaches the use of set points to improve media and system control to ensure consistency of the system (Wrzesinski; Para. [0042]). This involves applying the known teaching (component sensors to activate media exchange) to a similar device (a control system that uses sensors for automatic control) to yield predictable results (an automatic control system with the addition of component sensors that activates a media change).
Regarding claim 7, Modified Cattaruzzi (Cattaruzzi in view of Wrzesinski) teaches all of the elements of the current invention as stated with respect to claim 6. Modified Cattaruzzi (Cattaruzzi in view of Wrzesinski) teaches:
The cell culture apparatus according to claim 6, wherein the culture part is provided in a rotatable manner about an axis of the tubular shape (Wrzesinski; Abstract; Paras. [0057-0059], describes as a cylindrical vessel adapted for rotation; Para. [0164], Fig. 1, annular compartment (22)), and
the processing circuitry performs control to rotate the culture part (Cattaruzzi; Paras. [0041, 0045], parameter acquisition system (9), parameters monitoring system (10); Para. [0032], example of a control system being used based on cell culture data and the control system enacting a response) about the axis of the tubular part.
Claim 4, 5, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Cattaruzzi (US20170037357A1) in view of Wrzesinski (US20220243162A1) as applied to claims 1 and 6 above, and further in view of Hong (US20110287529).
Regarding claim 4, Modified Cattaruzzi (Cattaruzzi in view of Wrzesinski) teaches all of the elements of the current invention as stated with respect to claim 1.
Modified Cattaruzzi (Cattaruzzi in view of Wrzesinski) teaches (from claim 1 for reference):
a discharge path for discharge (Cattaruzzi; Para. [0051], Fig. 3, culture chamber (2), valve (11), valve (11b), waste tank (13), "closing the normally-open valve 11 and opening the normally-closed valve 11b, the medium will flow from the cell culture chamber to the waste tank 13");
a culture part ((Cattaruzzi; Paras. [0045, 0046], Fig. 1, cell culture chamber (5); Para. [0050], Fig. 3, cell culture chamber (2))) having a hollow tubular shape (Wrzesinski; Abstract; Paras. [0057-0059], described as a cylindrical vessel; Para. [0164], Fig. 1, annular compartment (22)) with holes provided at both ends (Wrzesinski; Paras. [0175, 0209], Fig. 1 and 5a, planar access port (76); Paras. [0169], Fig. 2b, orifice (44))
Modified Cattaruzzi does not teach:
The cell culture apparatus according to claim 1, wherein an end provided with the one hole is formed in a tapered shape with a diameter of the tubular shape increasing as a distance from the hole increases.
Hong teaches:
The cell culture apparatus according to claim 1, wherein an end provided with the one hole is formed in a tapered shape (Hong; Abstract; [0011, 0030, 0032]; Fig. 1, culture tube (10), beveled portion (16)) with a diameter of the tubular shape increasing as a distance from the hole increases (Hong; Abstract; [0011, 0030, 0032]; Fig. 1, culture tube (10), beveled portion (16)).
Therefore, it would be obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the tubular shape of the reaction vessel of Modified Cattaruzzi (Cattaruzzi in view of Wrzesinski) by the tapered shape of the reaction vessel as taught by Hong because both Modified Cattaruzzi (Cattaruzzi in view of Wrzesinski) and Hong are directed to tubular bioreaction vessels that are rotated (Cattaruzzi; Para. [0049], rotation gear (9); Hong; Para. [0010]). Hong teaches that the tapered end of the vessel allows for smooth removal of all the culture media from the vessel (Hong; Para. [0032]), and this involves applying a known teaching (the tapered shape of the exit portion of the reaction vessel) to a similar device (a tubular/cylindrical bioreactor vessel) to yield predictable results (a tubular reaction vessel with a tapered exit portion).
Regarding claim 5, Dually Modified Cattaruzzi (Cattaruzzi in view of Wrzesinski and further in view of Hong) teaches all of the elements of the current invention as stated with respect to claim 4.
Dually Modified Cattaruzzi does not teach:
The cell culture apparatus according to claim 4, wherein discharge is performed from inside the culture part to the discharge path by tilting the culture part.
Hong teaches:
The cell culture apparatus according to claim 4, wherein discharge is performed from inside the culture part to the discharge path by tilting the culture part (Hong; Paras. [0057-0059], Fig. 4, angle adjustment unit (150)).
Therefore, it would be obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to combine the reaction vessel of Dually Modified Cattaruzzi (Cattaruzzi in view of Wrzesinski and further in view of Hong) with the reaction vessel tilting mechanism as taught by Hong because both Dually Modified Cattaruzzi (Cattaruzzi in view of Wrzesinski and further in view of Hong) and Hong are directed to tubular bioreaction vessels that are rotated (Cattaruzzi; Para. [0049], rotation gear (9); Hong; Para. [0010]). Hong teaches that the use of a tilting mechanism when discharging from the reaction vessel allows complete removal of all the culture media or liquid contents of the reaction vessel (Hong; Para. [0021]), and this involves applying a known teaching (the use of a tilting mechanism to empty a reaction vessel) to a similar device (a reaction vessel which requires emptying) to yield predictable results (a reaction vessel with tilting mechanism to ensure complete discharge of the vessel contents).
Regarding claim 8, Modified Cattaruzzi (Cattaruzzi in view of Wrzesinski) teaches all of the elements of the current invention as stated with respect to claim 6.
Modified Cattaruzzi (Cattaruzzi in view of Wrzesinski) teaches:
The cell culture apparatus according to claim 6, wherein the processing circuitry performs control to perform discharge from inside the culture part to the discharge path (Cattaruzzi; Paras. [0037, 0053], operations are totally controlled by automatic actuators; Wrzesinski; Para. [0042], "a component-sensor which activates media exchange"; Para. [0164], this media exchange means the piston can move in a motion that could discharge media, movable wall (38)).
Modified Cattaruzzi (Cattaruzzi in view of Wrzesinski) does not teach:
wherein the processing circuitry performs control to perform discharge from inside the culture part to the discharge path by tilting the culture part.
Hong teaches:
wherein discharge is performed from inside the culture part to the discharge path by tilting the culture part (Hong; Paras. [0057-0059], Fig. 4, angle adjustment unit (150))(As previously seen in the rejection of claim 5), and that the tilting mechanism includes an actuator (Hong; Paras. [0058-0059], in Para. [0059] it is mentioned that the tilting mechanism can have an actuator, which by definition converts control signals into physical motion or response)
Therefore, it would be obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to combine the control system/processing circuitry of Modified Cattaruzzi (Cattaruzzi in view of Wrzesinski) by including the actuator of a tilting mechanism as taught by Hong because both Modified Cattaruzzi (Cattaruzzi in view of Wrzesinski) and Hong are directed to bioreactors for cell culture. Modified Cattaruzzi teaches that the benefit of the use of automatic control is that it has the ability to eliminate human error affecting the system (Cattaruzzi; Paras. [0037, 0053]) and Wrzesinski teaches the use of set points to improve media and system control to ensure consistency of the system (Wrzesinski; Para. [0042]). This involves applying a known teaching (actuator used for a tilting mechanism) to a similar device (a control system/processing circuitry that uses actuators to control the system components) to yield predictable results (another actuator to be controlled which corresponds to a tilting mechanism which can decrease the human error affecting the system).
Conclusion
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/D.L.B./Examiner, Art Unit 1758
/MATTHEW D KRCHA/Primary Examiner, Art Unit 1796
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