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, claims 8-9, in the reply filed on 02/24/2026, is acknowledged.
Claims 13-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/24/2026.
Claim Objections
Claim 8 is objected to because of the following informalities: In the last line, it is suggested to recite “Previously Presented” as “previously presented” since Previously Presented does not appear to be a proper noun. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: In line 1, it is suggested to recite “the two” as “the at least two” to improve consistency of terminology. Appropriate correction is required.
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.
In this case, “means for manual and automatic control of liquid flow rates…” in claim 8 is interpreted as a program (page 11, second paragraph) and equivalents thereof.
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 8-9 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.
Regarding claim 8, claim 8 recites the limitation "the cassette" in line 5. There is insufficient antecedent basis for this limitation in the claim. It is suggested to recite “the cassette” as “a cassette”. Claim 9 is rejected by virtue of its dependency on claim 8.
Regarding claim 8, claim 9 recites “the system comprises:…the cassette for growth and treatment of cells comprising at least one cuvette for cell culture growth, a cell culture media reservoir…” in lines 5-7; where “at least one cuvette…” is indented after “the cassette for growth and treatment of cells comprising”. It is unclear if the limitations following “the cassette for growth and treatment of cells comprising” are part of the cassette or part of the overall system. Is the cell culture media reservoir, reagent reservoir, waste container, and interconnecting tubes part of the “cassette” or the “system”? For examination purposes, the cell culture media reservoir, reagent reservoir, waste container, and interconnecting tubes are interpreted as part of “system”. Claim 9 is rejected by virtue of its dependency on claim 8.
Regarding claim 8, claim 8 recites “the independent liquid reservoirs” in lines 15-16. There is insufficient antecedent basis for this limitation in the claim. Additionally, it is unclear if the independent liquid reservoirs is the same or different from “cell culture media reservoir” and/or “reagent reservoir” established previously. It is suggested to recite “the independent liquid reservoirs” as “the cell culture media reservoir and the reagent reservoir”. For examination purposes, “the independent liquid reservoirs” is interpreted as the cell culture media reservoir and the reagent reservoir. Claim 9 is rejected by virtue of its dependency on claim 8.
Regarding claim 9, claim 9 recites “a culture media input tubing” and “a reagent tubing” in lines 4-6. It is unclear if these tubings are the same or different from “interconnecting tubes” established in claim 8. Do the interconnecting tubes comprise the culture media input tubing and the reagent tubing? Or are the interconnecting tubes different from the culture media input tubing and the reagent tubing?
Regarding claim 9, claim 9 recites “a cell culture media pump” and “a reagent pump” in lines 5-7. It is unclear if the cell culture media pump and reagent pump of lines 5-7 are the same or different from the “cell culture media pump” and “reagent pump” established in lines 2-3. It is suggested to recite “a cell culture media pump” and “a reagent pump” in lines 5-7 as “the cell culture media pump” and “the reagent pump”. Additionally, the last line recites “both pumps”. It is unclear if “both pumps” is referring to the “a cell culture media pump” and “a reagent pump” of lines 2-3 or of lines 5-7. It is suggested to recite “both pumps” as “both of the cell culture media pump and the reagent pump”.
Claim Rejections - 35 USC § 103
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 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Griffin et al. (US 20210102157 A1; effectively filed 02/09/2018; cited in the OA filed 11/26/2025) in view of Johnson et al. (US 20020179544 A1).
Regarding claim 8, Griffin teaches an automated reagent delivery system (abstract; Figs. 3-4, 20-24, 33-34) for growth and treatment of cells ([0102]-[0104] teaches a bioprocessing system with automated control for automated processing within each module; [0136] teaches treatment and growth of cells; [0155] teaches connection of reagent to the system), wherein the system comprises:
at least one slide out drawer (Figs. 20-24,33-34, drawer 712; [0157]-[0158]),
at least two peristaltic pumps attached to the drawer (Figs. 3,34 and [0159], teach pump assembly 738 including pumps 454, 456, 492 that is attached to the drawer 712 via at least a pump shoe 742; [0156],[0159] teaches apparatus 700 with a drawer comprises pumps that provide peristaltic motive forces, therefore the pumps are interpreted as at least two peristaltic pumps attached to the drawer; [0264] teaches two or more peristaltic pump tubes),
the cassette (Figs. 24,34, bioreactor vessel 410) for growth and treatment of cells (interpreted as an intended use, see MPEP 2114; [0136] teaches cell culture and treatment of growing cell culture with fresh media supply) comprising at least one cuvette for cell culture growth ([0136] teaches the bioreactor vessel, i.e. cuvette, for growing cell culture; [0126]-[0127] teaches the bioreactor vessel has a body that is transparent; therefore, the bioreactor vessel is interpreted as a cuvette),
a cell culture media reservoir ([0136], "culture medium reservoir"),
a reagent reservoir ([0155] teaches tubing to connect to reagent bags, i.e. reagent reservoir; [0157] teaches the drawer 712 includes an auxiliary compartment for housing reservoirs containing reagents),
a waste container (Fig. 33 and [0160], waste reservoir 472a), and
interconnecting tubes enabling connection with peristaltic pumps (Figs. 33-39 and [0170] teaches a tubing module with tubes, and pump tubes; therefore, the system includes interconnecting tubes that enable connections with the peristaltic pumps), wherein the cassette is detachable and movable as an entity ([0178] teaches the bioreactor vessel can be lifted off bed plates; [0181] teaches an operator can reseat the bioreactor vessel, therefore the bioreactor is detachable and movable as an entity),
wherein the cassette (Figs. 3, 24,33-34, bioreactor vessel 410) is attached to the drawer (Figs. 24,33-34) and connected with the peristaltic pumps (Figs. 33-34 and [0170] teaches the bioreactor vessel is attached to the drawer and fluidly connected with the pumps), and
a computer controller ([0269] teaches controllers 110, 210, and 310) and computer program product ([0269]-[0270] teaches software applications and instructions in a software application to carry out all of the methods, protocols, and workflows of the system) comprising means for manual and automatic control of liquid flow rates, output composition between the independent liquid reservoirs, pump control and execution of pre-set liquid flow programs ( [0124] teaches operation of these valves and pumps are automatically directed according to a programmed protocol so as to enable proper operation of module; [0222] teaches flow rate can be increased or decreased or maintained at a setpoint; [0271] teaches software of a controller to allow for fully autonomous, semi-autonomous, or gated control by a user or operator; therefore, the software and computer allows for manual and automatic control of liquid flow rates, output composition between the independent liquid reservoirs, and pump control and execution of pre-set liquid flow programs as claimed via pumps and valves).
Griffin fails to teach the computer program product comprising the means for customization and saving of Previously Presented automated liquid handling programs.
Johnson teaches an apparatus for automatically processing and transferring fluids (abstract), specifically a cell processing and fluid transfer device ([0040]). Johnson teaches the device includes program files and the system may be used to modify files, design new programs, or archive as records ([0041]). Johnson teaches operations and controlled modules that allow for editing command signals to control fluid flow rates and paths, and monitoring operation states of the device ([0043]). Johnson teaches pumping rate and fluid flow rate for each pump may be driven at different speeds and individually controlled, thereby providing increased fluid transfer flexibility to users of the device ([0045]). Johnson teaches the systems display the programs or procedures, and a user may select a saved procedure to delete, edit, or run ([0065]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the computer program product comprising the means of Griffin to incorporate the teachings of a cell processing and fluid transfer device with programs for editing a saved procedure of Johnson ([0041],[0043],[0065]) to provide: the computer program product comprising the means for customization and saving of Previously Presented automated liquid handling programs. Doing so would have a reasonable expectation of successfully improving flexibility and control of the system by allowing for a user to edit, modify, and save previous programs or procedures.
Regarding claim 9, Griffin further teaches wherein the two peristaltic pumps (Figs. 3,34 and [0159], teach pump assembly 738 including pumps 454, 456, 492 that is attached to the drawer 712 via at least pump shoe 742; [0156],[0159] teaches apparatus 700 with a drawer comprises pumps that provide peristaltic motive forces, therefore is interpreted as at least two peristaltic pumps attached to the drawer; [0264] teaches two or more peristaltic pump tubes) are a cell culture media pump for pumping cell culture media into the cuvette ([0194] teaches pump 456 to pump contents of the bioreactor vessel 410 along a circulation loop and back to the bioreactor vessel 410, therefore the pump 456 is capable of pumping cell culture media into the cuvette), and a reagent pump for pumping a reagent into the cuvette ([0190] teaches pump 454 pumps an antibody coating solution, i.e. reagent, into the bioreactor vessel 410),
wherein the cell culture media reservoir ([0136], "culture medium reservoir") is connected with the cuvette via a culture media input tubing and a cell culture media pump (Fig. 3-4,20,33-34 and [0136],[0194] teach culture medium reservoir 446b of first fluid assembly 440 is fluidly connected with bioreactor vessel 410 via bioreactor line 414, i.e. tubing, and pump 456; note that the culture medium reservoir 446b is fluidly connected with pump 456 since [0194] teaches pump 456 flows contents along a first circulation loop, out of port 416, through line 450, and back to bioreactor vessel 410 through line 414), and
the reagent reservoir is connected with the cuvette via a reagent tubing and a reagent pump (Figs. 3-4, 20,33-34 and [0190] teaches antibody solution from reservoir 466f of first fluid assembly 440 is fluidly connected with bioreactor vessel 410 via at least tubing 464f and pump 454), and
both pumps provide together constant or pulsating fluid flow ([0222] teaches flow rate of the pumps are adjusted to maintain a constant mass and volume and are maintained at a flow rate, therefore the pumps are capable of providing at least constant fluid flow).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Collins (US 20190358633 A1) teaches a system for automated cell culture (abstract; Figs. 1-2), including disposables including fresh media, reagent containers, waste container, cell culture flask, bioreactor, and pumping elements (abstract).
Murthy et al. (US 20210047600 A1; effectively filed 08/13/2019) teaches an automated cell culture system including pumps (abstract; Figs. 1A-1B).
Patil et al. (US 20190017011 A1) teaches an apparatus (Figs. 1-5) for biomanufacturing (abstract). Patil teaches a tray is removable by a sliding motion (Figs. 4-5). Patil teaches the apparatus includes pumps (Fig. 3, elements 48,49).
Peng (US 20170166865 A1) teaches a laboratory apparatus (abstract), wherein a program for the single-chip microcomputer can be modified and/or stored into a new program at any time and can be started and stopped at any time ([0104]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HENRY H NGUYEN whose telephone number is (571)272-2338. The examiner can normally be reached M-F 7:30A-5:00P.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571) 270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HENRY H NGUYEN/Primary Examiner, Art Unit 1758