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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 23, 2026 has been reviewed and entered. Any previous objection/ rejection not repeated herein has been withdrawn.
All claims are patentably indistinct from, or lack unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). Specifically, the instant amendments do not overcome rejections under 35 USC 112 (a), (b) or 103(a) as set forth in the Final rejection filed September 22, 2025.
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.
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:
“gas distribution element” in claim 16; and
“electric current distribution element” in claim 18.
The following is a list of non-structural generic placeholders that may invoke 35 U.S.C. 112(f): “mechanism for,” “module for,” “device for,” “unit for,” “component for,” “element for,” “member for,” “apparatus for,” “machine for,” or “system for. ”Welker Bearing Co., v. PHD, Inc., 550 F.3d 1090, 1096, 89 USPQ2d 1289, 1293-94 (Fed. Cir. 2008); Mass. Inst. of Tech. v. Abacus Software, 462 F.3d 1344, 1354, 80 USPQ2d 1225, 1228 (Fed. Cir. 2006); Personalized Media, 161 F.3d at 704, 48 USPQ2d at 1886–87; Mas-Hamilton Group v. LaGard, Inc., 156 F.3d 1206, 1214-1215, 48 USPQ2d 1010, 1017 (Fed. Cir. 1998). Note that there is no fixed list of generic placeholders that always result in 35 U.S.C. 112(f) interpretation, and likewise there is no fixed list of words that always avoid 35 U.S.C. 112(f) interpretation. Every case will turn on its own unique set of facts. See MPEP 2181(I,A)
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.
As set forth in the previous Official action, the instant apparatus claims 1-4, 7-11, and 14-20 contain a large amount of functional/process and/or intended use language. Functional/process/intended use language usually does not add any further structure to an apparatus claim beyond a capability. It is highly recommend that any apparatus type claims distinguish over the prior art in terms of structure rather than function/process/use language. If the prior art structure is capable of performing the function/process/use language, then the prior art meets the limitation in the claims. The manner of operating an apparatus typically does not differentiate it claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim (see MPEP § 2114 & § 2173.05(g)).
The following types of claim language may raise a question as to its limiting effect (this list is not exhaustive):
i. preamble (see MPEP § 2111.02);
ii. functional/process/ intended use language associated with a claim limitation, (see MPEP § 2181);
iii. clauses such as "adapted to/for," “capable of/for”, “configured to/for”, "wherein," and "whereby" (see MPEP § 2111.04, subsection I);
iv. contingent limitations (MPEP § 2111.04, subsection II); and
v. printed matter (MPEP § 2111.05).
Of course, all recitations in claims 1-4, 7-11 and 14-20 have been considered by the examiner, including function/process/use language and no claim language has been ignored by the examiner. That is, every claimed element has been considered and given the appropriate amount patentable weight. Applicant can and should employ such language where appropriate and helpful. The examiner’s determination of whether the function/process/use recited language limits a claim is made on a case-by-case basis in light of the facts of the case. For example, sometimes functional/process/use language in apparatus type claims receive patentable weight when the language clearly defines a specific structural feature or mechanism that performs a function, rather than simply describing the intended use or result of the invention, and it is supported by the specification, providing a clear understanding of the claimed invention to someone skilled in the art; essentially, the claimed function/process/use language is tied to a defined structure or process, not just a general concept. However, this is not present in this case and the examiner must apply the broadest reasonable interpretation (BRI) consistent with the specification without reading disclosure form the specification into the claims. See MPEP §2111 and §2173.01 I.
As discussed below, the examiner’s patentability analysis has and again provides one or more interpretations and claim mappings of the claimed structures and/or limitations although other interpretations may be possible. The examiner considers “patentable weight” as language that limits the scope of the claim under the broadest reasonable claim interpretation. Furthermore, in most apparatus type claims only explicitly and positively recited elements are considered limiting the scope of the claim (see MPEP § 2115). This means, if a claim element is drafted such that it is not part of the invention, it cannot be used to narrow the scope of the claim. For example, claim 1 is directed to the disposable cartridge. Any recitations to the platform and elements included on the platform have not received patentable weight.
As instructed by the MPEP, the examiner is required to make the record as clear as possible with respect to the examiner’s interpretations. Again, the examiner makes clear that no patentable weight has been afforded to recitations following claim phrases, “configured to/for”, “adapted to/for”, “for”, “capable to/for”, etc. As with most of the examiner’s interpretations, they depend on the specific context and structure of the claims. After evaluating the context and structure of the apparatus claims in light of the specification, the examiner does not find these phrases limit the claims. At best, they only define the context in which the invention operates. In other words, these phrases are interchangeable and do not impart any patentable weight or require specific modification(s) for a particular purpose.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4, 7-11, and 14-20 remain rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 and 20 have been amended to recite the disposable cartridge includes “a single first prechamber and a single second prechamber in fluid communication with the bioreaction chamber”. This new recitation does not find support in the specification as filed.
Applicant’s outstanding Remarks/Arguments (beginning at the top of page 8) state the independent claims 1 (and presumably 20) have been amended to include the subject matter of cancelled claims 5 and 6. The examiner respectfully disagrees that the scope and patentable weight afforded to canceled claims 5 and 6 were included in independent claims 1 and 20. Specifically cancelled claim 5 recited “at least one bioreaction chamber is configured for receiving at least a first initial product coming from a first prechamber through the duct network”. Cancelled claim 6 recited “at least one bioreaction chamber is configured for receiving a second initial product coming from a second prechamber by means of the duct network, through the first prechamber”. The scope of previously examined claims 5 and 6 is directed to functional/ process/ use recitations and thus, have not been afforded patentable weight. For example, the previous recitation in claims 5 and 6, that the bioreaction chamber is “configured to” receive products coming from the first and second prechambers do not positively recite the products or the prechambers. Therefore, claims 5 and 6 do not provide support for the instant amendments to claims 1 and 20, which now positively recite both the first prechamber 13 and second prechamber 16 are part of the disposable cartridge.
For clarity the examiner refers to applicant’s corresponding US publication 2021/0355423 (hereinafter ‘423) to determine the structural relationship between the first, second, and bioreaction chambers. While, applicant’s figures 1A, 1B, and 7 do show a first prechamber 13 and a second prechamber 16 in fluid communication with the bioreaction chamber 4, the specification makes clear that the second prechamber 16 is located in a storage module 17 arranged on the platform 2, and thus not part of the disposable cartridge 3 (see ‘423 para [0086], [0097], [0102]). Accordingly, applicants instant amendments to claims 1 and 20 to the disposable cartridge including the first and second prechamber are considered new matter.
Furthermore, the specification as filed does not support the new recitations in claims 1 and 20 to a “single” first prechamber” and a “single” second prechamber. Again looking to applicant’s ‘423, the word “single” is only used 3 times in the specification as filed. The word single is used once with respect to the platform (see para [0006]) and twice with respect to the entire system, (see para [0026]). Nothing in the original specification clearly defines what applicant means by “a single” prechamber, much less the disposable cartridge includes both a “single first prechamber” and a “single second prechamber” in fluid communication with the bioreaction chamber therein.
In fact, all of applicant’s embodiments disclosed in the original specification show more than a “single” chamber in fluid communication with the bioreaction chamber. For example, Fig. 1A shows the bioreaction chamber 4 in the disposable cartridge is in fluid communication with a residue chamber/receptacle 10 (see para [0086] of ‘423). Likewise, Fig. 1B shows the bioreaction chamber 4 is in fluid communication with both a residue chamber/receptacle 10 and a cleaning chamber/receptacle 12. These are more than two single chambers in fluid communication with the bioreaction chamber. Thus, as best understood, the new recitations to “a single first prechamber” and “a single second prechamber” do not find support in the specification as filed. Note: the claims do not provide any structural differences between a first prechamber and a second prechamber, so it is confusing as to what the term “single chambers” even means, as discussed further below.
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 1-4, 7-11, and 14-20 remain 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.
The new recitations in claims 1 and 20 to “a single first prechamber and a single second prechamber in fluid communication with the bioreaction chamber” are confusing and indefinite. The term “single” is not defined in the claims or the disclosure. The recitation of a “single chamber” can be interpreted in multiple ways. It is not clear if applicant means a “single” type of chamber. The claimed recitations to a “first” and “second” prechamber are considered nominal. That is, one of ordinary skill in the art would reasonably interpret the terms chamber/reservoir/well as structural equivalents absent any special definition provided in the specification that structurally distinguishes the first and second prechambers from each other and/or any other chamber/reservoir/well. It is unclear from the claims how one would reasonably interpret a “single first prechamber” and a “single second prechamber” other than a plurality of prechambers. The claimed recitation include both a first and second single prechamber contradicts a single prechamber. As applicant appreciates, the definiteness of claim language is to ensure that the scope of the claims is clear so the public is informed of the boundaries to what constitutes infringement of any issued patent. In this case, the scope of the claims cannot be determined. The only difference between the prechambers is nominal.
Claims 7, 8 and 9 now depend from canceled claim 5. Although not required, but in the interest of compact prosecution, the examiner has interpreted claim 7 as depending from claim 1. However, applicant must correct this deficiency in any future response. Furthermore, the examiner can make any subsequent action Final regardless of whether the examiner’s interpretation aligns with applicant’s intended and indefinite amendment.
Claim Rejections - 35 USC § 103
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 1-4, 7-11 and 14-20, as best understood, remain rejected under 35 U.S.C. 103 as being unpatentable over Hung et al., (US 2007/0275455; hereinafter “Hung”) in view of Gaige, (US 2016/0263572; hereinafter “Gaige”).
As to claims 1, 3, 11, 15, 16, 18, and 20, Hung teaches a system comprising a disposable cartridge 52 (microwell array device) cooperating with a platform 24, the device comprising:
at least one bioreaction chamber suitable for storing and/or handling fluids therein, (microwells, 58, 60, located in the microwell array device 52);
a duct network configured for circulating fluids there and include communication with the interior of the at least one bioreaction chamber (the microchannel connecting a station in the device, stations 1-18, with a microwell, or a station and a valve associated with the microwell 58, 60, the network has two sections 94, 96, each with eight microchannels, such as microchannel 98 in section 94, that are connected to one of eight passageways through a connecting microchannel, such as microchannel 87 in section 96 supplying passageway 62, see figures 3 and 5A-5B);
a flow control element through the duct network is represented by valves 78, 80, 82, (e.g. flow of medium from one of the three supply-reservoir stations to the well-distribution network is controlled by a pair of microvalves 106, 108 activated by fluid supply from station 18, and a pair of valves 104, 105 activated by fluid supply from station 17, microvalves and stations are thus in fluid communication wherein the valves are activated by pressurized fluid [see para 0051], the flow control element is configured for connecting with actuating element of the platform, namely stations 15 and 16, through a first multiconnector, namely inlet ports connecting to station ports of plate 24 and a second multiconnector, i.e. outlet ports of reservoirs 48, 50 of platform 2).
The device itself is placed on the plate so that its port stations are aligned to receive fluid from associated reservoirs on the plate, as shown in FIG. 2." see, paragraph [0068]. In addition, in fig 1, the microwell array system 20 (for conducting cell-culture assays, and assays involving particles such as cells, viruses, liposomes, etc. in a culture environment) includes a chamber 22 for holding a plurality of plates, such as plates 24, 26 (see fig 2). These plates are carried on a cell-culture tower 28 having a plurality of plate slots, such as slot 30, for releasably holding individual plates. Each slot provides a plurality of fluid pressure connections (not shown) between reservoirs in each plate and system solenoids, such as solenoids 31, 33, which can be activated to supplied pressurized fluid, such as air at 500 kPa pressure, to the respective reservoirs in the plates supported in each slot. In a system that contains 18 individually controllable solenoids, each solenoid will supply pressure to a 10-outlet manifold that connects that solenoid to a designated reservoir in each of the 10 plates. Hence, the first multiconnector are the reservoirs 48, 50 of plate 24 which are configured to be connected to a second multiconnector, i.e. the slot 30 of platform 22. Note the term “platform” is very broad and can read on the laboratory work bench.
Also note: the recitation “the first multiconnector is configured to be connected to a second multiconnector of the platform so that when the disposable cartridge cooperates with the platform a connection between the first multiconnector of the disposable cartridge and the second multiconnector of the platform is provided for connecting the flow control elements with the actuation element of the platform” has not received patentable weight since the platform and second multiconnector are not positively recited as part of the disposable cartridge and is therefore not given patentable weight, (see MPEP § 2114 & § 2173.05(g)).
Nevertheless, Hung does teach the disposable cartridge cooperates with the platform a connection between the first multiconnector of the disposable cartridge and the second multiconnector of the platform provides connection of the flow control elements with the actuation element of the platform (see para [0051] et seq.)
Hung does not explicitly teach the first multiconnector comprising a plurality of tubes or ducts or electrical connectors all of which are grouped together as a single integrated device, wherein the first mulitconnector being direct connected to the flow control elements through the plurality of tubes or ducts or electrical connectors.
In the related art of systems for culturing cells, Gaige teaches a system, microfluidic plate, platform and control and analysis system 10 which comprises a microfluidic plate 100 positioned on the stage of an inverted microscope 20, hence the microfluidic plate 100 (disposable cartridge) cooperates with the microscope 20 (platform). the disposable cartridge 100 comprises:
at least one bioreaction chamber reads on culture chamber 104, see fig 2.
a duct network teaches the fluidic channels 102, see figure 2, to control cell loading, perfusion of media, and solution exposure by providing variable pressure to each of the wells of the microfluidic plate 100,
flow control element (reads on a valves, see para [0030] et seq. and pneumatic manifold 120, as shown in figs. 4A-B) for controlling the flow of fluid circulating through the duct network, the flow control element for controlling the flow of fluid being configured for connecting with actuation element, the actuation element (the controller 40 is a CellASIC® ONIX Microfluidic Control System (commercially available from EMD Millipore Corporation), which is able to supply positive pressure up to 10 PSI and negative pressure of −8.2 PSI. However, any suitable controller that is able to provide any of variable pressure, a desired gas environment, or temperature control for a microfluidic device may be used, see paragraph [0030] et seq.);
a first multiconnector comprising a plurality of tubes or ducts or electrical connectors all of which are grouped together as a first integrated single device (body 152), wherein the first mulitconnector is directly connected to the flow control elements (i.e., valves/ pumps) through the plurality of tubes or ducts or electrical connectors (reads on the pneumatic connector 150 which places each gas line of the tubing 30 in communication with a respective channel inlet 124, see fig 9A, 9B, 11A, 11B, 12A, 12B, 13A and 13B and paragraph [0038] et seq.)
Gaige also teaches a second multiconnector (reads on the pneumatic interface 170 for use with a pneumatic connector 150 between the manifold 120 and tubing 30 (see para [0032] et seq.), or between the controller 40 and tubing 30, see figs 11 A, 11 B, paragraph [0042]), provided for connecting the flow control elements directly with the actuation element (controller 40) of the platform. FIG. 6 illustrates an embodiment of a pneumatic connector 150. The pneumatic connector 150 may be used as an attachment mechanism for removably securing the tubing 30 to a pneumatic manifold, such as the pneumatic manifold 120 of FIG. 5. While in this embodiment, the pneumatic connector 150 is positioned between the tubing 30 and manifold 120, in certain embodiments the pneumatic connector 150 may be positioned between the tubing 30 and the controller 40. In still further embodiments, pneumatic connectors 150 may be situated at both positions. Thus, the first and second multiconnector are directly connected as shown in in Fig. 9B.
Gaige also teaches the flow control element for controlling the flow of fluid is configured for connecting, in electrical communication, with the actuation element of the platform through the first multiconnector (see para [0027] et seq.)
As best understood, the disposable cartridges in both references include a “single” first prechamber and a “single” second prechamber in fluid communication with the bioreaction chamber. That is, these chambers are discrete and not considered connected to each other beyond the duct network linking them to the bioreaction chamber. However, if not, it would have been an obvious matter of design choice to provide only the necessary number of chambers for the needs of the end user for the expected benefit of reducing materials. Furthermore, such a modification would have involved a mere change in the size of a component (less chambers?). A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Accordingly, it would have been obvious to one of ordinary skill in the art at the time the claimed invention was filed to have included in the system of Hung, the first multiconnector providing a plurality of tubes, ducts and electrical communication all grouped together as first single device to provide fluid and heating of the wells, like that taught in Gaige since it is expected that using one single grouped multiconnector for interconnecting gas and electrical connections would reduce the required number of separate connectors and make for a fast installation.
Note that both Hung and Gaige teach the disposable cartridge configured to transfer product in any chamber though the channels to the bioreactor chamber. For the reasons delineated above, this wherein clause does not structurally limit the disposable cartridge.
As to claim 2, Hung teaches the flow control element for controlling the flow of fluid are configured for connecting, in fluid communication, with the actuation element of the platform through the first multiconnector (see para [0027] et seq.)
As to claims 3 and 18, Hung does not explicitly teach the flow control elements is configured to connecting in electrical communication with the actuation element of the platform through the first multiconnector.
As to claim 4, Hung teaches the disposable cartridge comprises a plurality of receptacles (reads on wells) connected to the duct network suitable for storing fluids therein and configured for being in fluid communication with one another and/or with the interior of the at least one bioreaction chamber (see para [0009] et seq.)
As to claim 7, Gaige teaches the disposable cartridge comprises the at least a first prechamber 106 suitable for storing at least a first initial product, wherein this first prechamber comprises a first inlet for introducing therein the first initial product (see para [0036] et seq.)
As to claim 8, Gaige teaches the first prechamber 106 comprises a second inlet 110 for introducing a second initial product coming from the second prechamber 108 (see Fig. 2).
As to claim 9, Gaige teaches the disposable cartridge comprises conditioning element (reads on heater) configured for conditioning at least one of the initial products before being introduced into the interior of the at least one bioreaction chamber (see para [0029] et seq., the tubing 30 may further comprise a connection (e.g., an electrical connection) in communication with a heating element).
As to claim 10, Hung teaches the disposable cartridge comprises element for driving the circulation of the fluid contained in the at least one bioreaction chamber through the duct network (via pressurized gas).
As to claims 14, 17, and 19, Gaige teaches the platform comprises a storage module (reads on channels 122 and heater configured for being in fluid communication with the disposable cartridge and for maintaining a pre-established temperature therein (see para [0027] et seq., The pneumatic controller 40 may be configured to interact with the microfluidic plate 100 by using the tubing 30 to supply a gas or liquid to the plate 100, control the temperature of the plate 100, or perform other desired functions.)
Citations to art
In the above citations to documents in the art, an effort has been made to specifically cite representative passages, however rejections are in reference to the entirety of each document relied upon. Other passages, not specifically cited, may apply as well.
Response to Arguments
Applicant's arguments filed March 23, 2026 have been fully considered but they are not persuasive.
Applicant argues that Hung and Gaige do not describe a disposable cartridge including “a single first prechamber” and a “single second prechamber” in fluid communication with the bioreaction chamber.
The examiner respectfully disagrees. As discussed above, these recitations are confusing and indefinite. However, as best understood, the disposable cartridges in both references include a “single” first prechamber and a “single” second prechamber in fluid communication with the bioreaction chamber. That is, these chambers are discrete and not considered connected to each other beyond the duct network linking them to the bioreaction chamber. However, if not then it would have been an obvious matter of design choice to provide only the necessary number of chambers based on considerations such as the needed throughput based on the expected benefit of reducing materials. Furthermore, such a modification would have involved a mere change in the size of a component (less chambers?). A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). Also, applicant’s arguments do not provide any advantage with respect to the instant amendments that limit the claimed disposable cartridge to include “a single first prechamber” and “a single second prechamber”. The Office maintains it would have been reasonable to a skilled artisan to determine the necessary number of chambers in the disposable cartridge based on desired throughput.
Also, MPEP 2106.04(a) details that the claims must reflect the disclosed improvement. Note specifically, the claims must include the components or steps of the invention that provide the improvement described in the specification. In this case, applicant’s improvement over the art is vague, but it appears to be directed to being less manual and requiring less connections between components in a cell culture system (see applicant’s background of the invention section). Applicant’s arguments have failed to explain how the addition of a “single first prechamber” and a “single second prechamber” in the disposable cartridge provides any inventive improvement beyond trying to “get around” the applied prior art. Absent any reasoning as to how the claim amendments provide an improvement over the prior art is strong evidence that such amendments would be obvious to a person having ordinary skill in the art (PHOSITA). Under U.S. patent law, 35 U.S.C. § 103 requires that a claimed invention be nonobvious to a PHOSITA at the relevant time. The statute and USPTO guidance make clear that the mere existence of differences between the prior art and the claims is not enough to establish nonobviousness. The USPTO and courts do not consider differences between the prior art and claims in isolation. Instead, they weigh whether those differences, in the context of the entire invention, would have been obvious to a PHOSITA at the relevant time. See MPEP 2141. In this case, applicant’s arguments fail to provide an evidence as to how the instant amendments are an improvement. Therefore, for the reasons delineated above, and in the previous Official action, the claims remain rejected under 35 USC 103.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure include:
Nozaki et al., (US 2013/0143307; hereinafter “Nozaki”).
Nozaki teaches a disposable cartridge 107/108 for cooperating with a platform 226 in a system for culturing cells, characterized in that the disposable cartridge comprises:
at least one bioreaction chamber 401 suitable for storing and/or handling fluids therein,
a duct network 302 configured for circulating fluids therein and for being in fluid communication with the interior of the at least one bioreaction chamber, and
a flow control means for controlling the flow of fluid circulating through the duct network (valve 312) the flow control means for controlling the flow of fluid being configured for connecting with actuation means (reads on syringe pump 311) of the platform through a first multiconnector (see ports connecting channels 302),
wherein the fluids to be circulated in the duct network and the fluids to be stored and/or handled in the bioreaction chamber are culture media, or a liquid medium, or cells, or any combination thereof.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 P. Kathryn Wright whose telephone number is (571)272-2374. The examiner can normally be reached on 9:30am-7:30 pm EST.
Examiner interviews are available via telephone and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
E-mail communication Authorization
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting the following statement via EFS Web (using PTO/SB/439) or Central Fax (571-273-8300):
Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached on (571) 270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/P. Kathryn Wright/Primary Examiner, Art Unit 1798
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