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 .
DETAILED ACTION
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(s) is/are:
1. One or more circuit control devices configured to supply…and to collect… as in cl. 1.
2. Tank device configured to cool…as in cl. 7.
3. Holding device that holds…in a meandering state…as in cl. 9.
4. Temperature raising mechanism for raising a temperature…as in cl. 10.
5. One or more reaction installation devices configured to receive…as in cl. 14.
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.
1. One or more controller-affected pumps and optionally a casing, plurality of clamps, and a holding unit, and equivalents thereof (pars.[0063,0069,0096] of Applicant’s pre-grant publication US 2023/0357699).
2. A tank or equivalents thereof (pars.[0117,0145]; wherein Examiner notes that the specification does not provide any active means for cooling to the tank (i.e. Peltier cooler, fan, etc…) )
3. A frame or support, and equivalents thereof, as discussed in pars.[0072,0082], fig. 6.
4. Those structures as seen in pars.[0064,0079,0121,0139,0148], and equivalents thereof.
5. An enclosure and/or one or more supports and equivalents thereof as disclosed in pars.[0079], fig. 3.
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 1-20 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.
Claims 1 and 19 recites the limitation "the cells". There is insufficient antecedent basis for this limitation in the claim. It appears that Applicant intends to recite “cells.”
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.
Claim(s) 1-5, 7, 8, and 10-16, is/are rejected under 35 U.S.C. 102a1 as being anticipated by Wang et al. (US 2019/0002815), hereafter Wang.
With regard to claim 1, Wang discloses a cell culture system comprising one or more processing units, each processing unit including a plurality of bioreactors (i.e. culture chambers 100) figs. 1A, 2A, 4D, for example), and one or more circuit control devices (controller-linked, automated pump, and including the fluid flow circuit that includes the external flow paths and internal flow paths within the overall incubator 300 housing; pars.[0013,0037,0043,0053], fig. 4A, 4Dfor example), each circuit control device configured to supply the cells and the culture medium to at least one of the one or more processing unit and to collect cultures cells as claimed (“recovered cells” as disclosed herein), wherein a number of bioreactors being greater than a number of circuit control devices as in there are shown more culture chambers/bioreactors than control circuits, wherein a singular pump (see fig. 4A, for example) affects a plurality of culture chambers (pars.[0026,0035,0037,0039,0063, 0080, figs. 3B,4A, 4D, for example; and wherein Examiner notes that the claimed one more or control devices for their recited functionalities is provided by the art of Wang as discussed and separately noting herein that the claims do not require the physical infrastructure of sources/reservoirs, outputs/collection means coincident with providing positively being able to affect these elements to carry out such functions).
With regard to claim 2, Wang discloses a connection unit connected to the one or more processing units and removably coupled to the one or more control device as given by the fluidic pathways of the liquid flow circuit and electrical connections that provide such fluidic communication to supply culture media and collect cultured cells along with the operative electrical connections to do so in an automated-sensed-control fashion (pars.[0039,0045,0090,0119], figs.3B-3D, for example).
With regard to claims 3 and 7, Wang discloses the cell culture system further comprises a tank device including a culture medium accommodation unit (i.e. structural confines about the reservoir, ‘media container’), and the connection circuit connecting the culture medium accommodation unit and the one or more circuit control devices pars.[0038,0039,0090] figs. 3B, 4A, 4B, for example), and wherein the tank device is configured to cool the culture medium in the culture medium accommodation unit as in cl. 7 as it is commensurately structured and allows for such medium to reside over time and relatively cool from a starting temperature above room temp. (Examiner further notes, as discussed above in the ‘Claim Interpretation’ section, that the tank device configured for this functionality as disclosed by Applicant is not provided with active means of cooling as in a Peltier cooling element, fan, etc…).
With regard to claim 4, Wang disclose that the culture medium accommodation unit is configured to accommodate an amount of the culture medium required for culturing the cells in each of the one or more processing units, wherein Wang provides to commensurately disclose a structured and sized accommodation unit in as much as claimed and is thus fully capable thereof for such prospective application, wherein it is further noted the claims, which are drawn to a device, do not require particular cell culture processing as with particular volumes of medium.
With regard to claim 5, Wang discloses that the culture medium accommodation unit includes a culture medium tank (i.e. ‘media container’ that holds the culture media) in which the culture medium is accommodated and a culture medium installing member in which the culture medium tank is installed as seen by the spring-mounted platform for the media container as in fig. 4A (pars.[0038,0060,0064,0066], for example).
With regard to claim 8, Wang discloses that the connection circuit includes a culture medium intermediate flow path that connects the culture medium accommodation unit and at least one of the one or more processing units, wherein such culture medium intermediate flow path is seen as a section of the connection circuit defined by the flow path leading from the reservoir/sub-reservoir/media container to the pump and into respective culture chambers/bioreactors (see fig. 4A such as in the fluid line segment that connects of the processing unit of culture chamber 1 to the media container/culture medium accommodation unit) (and also as in figs.3D, 3E, 4A-4C, for example).
With regards to claims 10-12, Wang discloses a temperature raising mechanism for raising a temperature of the culture medium intermediate flow path as seen by the incubator 300 that is provided surrounding the culture medium intermediate flow path as discussed above as in cl. 8, and wherein the incubator as the temperature raising mechanism is provided in the circuit control device as in cl. 11. Further to this, as in cls. 12/20, each of the one or more circuit control devices includes a casing defining an internal space that is maintained at a selected temperature as claimed, wherein the incubator provides a casing serving at the temperature raising mechanism. Additionally, as in cl.12, the recitation “…a temperature of the culture medium intermediate flow path…when the culture medium intermediate flow path is arranged…” is drawn to a conditional recitation in which such condition is not positively necessitated by the claim; and further noting that Wang provides such an arrangement as the incubator casing is provided surrounding the culture medium intermediate flow path and is thus fully capable of raising the temperature thereof.
With regard to claims 13, Wang discloses a culture medium intermediate flow path, as discussed above, wherein such meandering flow path is provided so that the culture media therein spends sufficient time in the warming area to reach a target select temperature (and additionally noting that the recitation itself is predicated on a conditional process recitation of “…when the culture medium flows through…” that is not necessitated nor attributed patentable weight in the device claim) and such length in Wang is attributed equivocally to the claimed ‘flow path length’ for likewise functionality in as much as claimed and required herein, in which such flow path length is fully capable of providing a fluid at a given temperature and to a selected temperature as the given temperature afforded thereto by the equivocally provided temperature raising mechanism.
With regard to claim 14, Wang discloses one or more reactor installation devices configured to receive at least one of the one or more processing units, wherein the culture chambers are mounted above each subreservoir, and as seen in fig. 4A, for example, with the lowermost rectangular support structures therefor the culture chambers (par.[0010], 4A, for example).
With regard to claim 15, Wang discloses that the culturing system further includes a controller that is configured to control operations of at least one of the one or more circuit control devices (pars.[0013,0037,0038,0053], figs. 3B-D, for example).
With regard to claim 16, Wang discloses the cell culturing system further includes a sensor device 700 for measuring a component of the cell culture medium as guided to at least one of the one or more processing units (abstract, pars.[0013,0044,0048,0049,0090]).
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.
Claim(s) 6 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Castillo (US 2018/0030398).
Wang has been discussed above.
With regard to claim 6, Wang does not specifically disclose that the culture medium accommodation unit further includes a roller disposed on a bottom surface of the culture medium installing member.
With regard to claim 18, Wang does not specifically disclose that each of the plurality of bioreactors includes a plurality of hollow fibers.
Castillo discloses a system for the production of cells and/or cell products (abstract). Castillo discloses that the culture medium reservoir is provided with wheels for easy transport of the reservoir (par.[0037]). Castillo further discloses that the bioreactor for growing cell is provided with carries such as in hollow microfibers wherein such carrier provides an excellent substrate for the cells to grow on (par.[0087]).
It would have been obvious to one of ordinary skill in the art to modify Wang so as to provide a roller disposed on a bottom surface of the culture medium installing member such as taught by the analogous art of Castillo to a system for the production of cells in order to provide added mobility to the system in aiding with the movement of cell culture media to the system that can be heavy, and to modify Wang so as to provide hollow fibers to the plurality of bioreactors such as taught by Castillo in order to provide an excellent substrate for the cells to grow on as would likewise be appreciated in Wang to likewise cell growth in the culture chamber bioreactors.
Claim(s) 9, 17, 19, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Jang et al. (US 2019/0352589), hereafter Jang.
Wang has been discussed above.
With regard to claim 9, Wang does not specifically disclose a holding unit that holds the culture medium intermediate flow path in a meandering state.
With regard to claim 17, Wang does not specifically disclose wherein the controller feedback-controls the operation of the least one of the one or more circuit control devices on the basis of a measurement result of the sensor device.
With regard to claim 19, Wang does not specifically disclose a temperature raising mechanism for raising a temperature of the culture medium intermediate flow path (and wherein the remainder of claim 19 coincides with the above discussion in Wang to claims 1-4 and 8).
With regard to claim 20, Examiner notes that Wang, as discussed above as likewise provided with respect to claims 12 and 13, discloses the circuit control device includes a casing defining an internal space that is maintained at a selected temperature and comprises the temperature raising mechanism and with a coincident flow path length to the culture medium intermediate flow path. Herein, cl. 20 is provided by way of this prior discussion as well as the above-discussed deficiencies to cl. 19 obviated by Jang below.
Jang discloses an automated cell culturing system (abstract). Wang discloses that the cell culture media from the fresh media source 206 can be warmed prior to introduction into the fluidic circuit of the system by providing a warming area (holding unit) including a cell culture intermediate flow path 674 therein that holds the intermediate flow path 674 in a meandering state (i.e. coiled or serpentine such that the media therein spends sufficient time in the warming area 676 to reach a target temperature), and wherein the warming fluid path provides a warming area 676 that is heated by waste heat from the temperature controlling module 658 and connected heat exchanger within the tank device 652 as a temperature raising mechanism (par.[0138], fig. 16; and further noting that while exemplified as ‘cooled air flow’ in fig. 16, it is disclosed in par.[0008,0137] that this temperature control module is also configured to warm the interior space of tank in a similar but opposite approach that generates a warming output to the space), wherein the temperature controlling module 658 is provided within the tank device 652 in which the tank/nutrient fill bag 206 is held (pars.[0136-0137], fig. 16).
Jang further discloses that the automated cell culture system 100 can provide real time adjustment of parameters in a closed loop feedback system, wherein the computer determines, based on sensed parameters, particular operation of one or more components of the automated cell culture system (par.[0076], for example).
It would have been obvious to one of ordinary skill in the art to modify Wang to provide a holding unit that holds the culture medium intermediate flow path in a meandering state and a temperature raising mechanism for raising a temperature of the culture medium intermediate flow path such as taught by the analogous subject matter of Jang to an automated cell culturing system in which such holding unit for holding the culture medium intermediate flow path in a meandering path and with a temperature raising mechanism in the tank device provides an obvious, alternative arrangement that affords both active heating and sufficient time for warming of the cell culture media before it is introduced into the fluidic circuit as would likewise be appreciated in the automated culturing system of Wang in providing to avoid thermal shock and affording stable growth conditions, in which Wang likewise contemplates temperature control in providing a temperature raising mechanism by that of an incubator.
Further, it would have been obvious to one of ordinary skill in the art to modify Wang wherein the controller provides feedback control of the operation of the at least one of the one or more fluidic circuit control devices on the basis of a measurement result of the sensor device such as suggested by the analogous art of Jang in which Wang likewise discloses a control system that controls operation of the pump(s) according to a parameter measured by a sensor (abstract, par.[0013.0049]) and in which feedback control is a well-known control architecture that would provide to enhance stability and accuracy of the desired cell culturing assay to be accomplished in Wang.
Claim(s) 12 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Gebauer et al. (US 2019/0194589), hereafter Gebauer.
Wang has been discussed above.
If the discussion above to Wang with respect to claims 12 and 13 and the casing afforded by the incubator is not taken as providing the recited casing serving as a temperature raising mechanism as claimed than such a modification would have been obvious.
Gebauer discloses bioreactors designed as jacketed allowing for heat transfer to achieve temperature control for process liquids such as cell cultures or culture media by heating or cooling (par.[0003]).
It would have been obvious to one of ordinary skill in the art to modify Wang to provide each of the one or more circuit control devices including a casing defining an internal space that is maintained at a selected temperature and serving as the temperature raising mechanism as in cls. 12 and 13 such as suggested by the analogous art of Gebauer to cell culturing and temperature control therein, wherein providing a jacket allowing for heat transfer to controllably warm the process fluid as in the culture media/um provides an obvious, analogue arrangement to that of incubator casing arranged about the culture medium intermediate flow path and that would suitably provide desired temperature control for proper cell culturing and have a reasonable expectation of success therein.
Further, with regard to claims 13, Wang/Gebauer discloses a culture medium intermediate flow path, as discussed above, wherein such meandering flow path is provided so that the culture media therein spends sufficient time in the warming area to reach a target select temperature (and additionally noting that the recitation itself is predicated on a conditional process recitation of “as guided…when the culture medium flows through…” that is not necessitated nor attributed patentable weight in the device claim) and such length in Wang is attributed equivocally to the claimed ‘flow path length’ for likewise functionality in as much as claimed and required herein, in which such flow path length is fully capable of providing a fluid at a given temperature and to a selected temperature as the given temperature afforded thereto by the equivocally provided temperature raising mechanism.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Jang as applied to claims 9-11, 17, 19, and 20 above, and further in view of Gebauer.
If the discussion above to Wang/Jang with respect to claim 20 above to the casing afforded by the incubator is not taken as providing the recited casing serving as a temperature raising mechanism as claimed than such a modification would have been obvious.
Gebauer has been discussed above.
It would have been obvious to one of ordinary skill in the art to modify Wang to provide each of the one or more circuit control devices including a casing defining an internal space that is maintained at a selected temperature and serving as the temperature raising mechanism as in cls. 12 and 13 such as suggested by the analogous art of Gebauer to cell culturing and temperature control therein, wherein providing a jacket allowing for heat transfer to controllably warm the process fluid as in the culture media/um provides an obvious, analogue arrangement to that of incubator casing arranged about the culture medium intermediate flow path and that would suitably provide desired temperature control for proper cell culturing and have a reasonable expectation of success therein.
Further, with regard to claims 20, Wang/Jang/Gebauer discloses a culture medium intermediate flow path, as discussed above, wherein such meandering flow path is provided so that the culture media therein spends sufficient time in the warming area to reach a target select temperature (and additionally noting that the recitation itself is predicated on a conditional process recitation of “as guided…when the culture medium flows through…” that is not necessitated nor attributed patentable weight in the device claim) and such length in Wang is attributed equivocally to the claimed ‘flow path length’ for likewise functionality in as much as claimed and required herein, in which such flow path length is fully capable of providing a fluid at a given temperature and to a selected temperature as the given temperature afforded thereto by the equivocally provided temperature raising mechanism.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Gebauer et al. (US 2012/0258441) discloses methods for controlling culture parameters in a bioreactor that is relevant to Applicant’s field of endeavor.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NEIL N TURK whose telephone number is (571)272-8914. The examiner can normally be reached M-F 930-630.
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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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/NEIL N TURK/Primary Examiner, Art Unit 1798