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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/04/2026 has been entered.
Response to Amendment
The Amendment filed 08/04/2026 has been entered. Claims 1-12 and 14-20 remain pending in the application. Claims 10-12, 14-15, and 20 are withdrawn. New grounds of rejections necessitated by amendments are discussed below.
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, “blocking means” of claim 16 is interpreted a non-transparent barrier (specification, page 25, last paragraph), a coating on a back part of containers (page 26, first paragraph), an integrated part of the cassette (page 26, second paragraph), and equivalents thereof. Note that claim 19 provides sufficient structure to the blocking means, therefore claim 19 is not interpreted under 35 U.S.C. 112(f).
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 3 and 7-8 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 3, claim 3 recites “a liquid composition” in line 2. It is unclear if “liquid composition” of claim 3 is the same or different from the “liquid composition” established in claim 1. It is suggested to delete claim 3 if the “liquid composition” of claim 3 is the same as claim 1.
Regarding claim 7, claim 7 recites “a sealing element” in lines 2 and 4. It is unclear if the sealing element of claim 7 is the same or different from the “pierceable and hermetically resealable membrane” established in claim 1. It is suggested to recite “a sealing element” as “the pierceable and hermetically resealable membrane” if referring to the same element.
Regarding claim 8, claim 8 recites “a plurality of piercing elements” in lines 1-2. It is unclear if the plurality of piercing elements of claim 8 is the same or different from the “one or more piercing elements” of claim 1. It is suggested to recite “a plurality of piercing elements” as “the one or more piercing elements” if referring to the same element.
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 1-4, 6-8, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Tashiro et al. (JPH 11123335 A; see machine translation) in view of Berthold et al. (US 5098663 A; cited in the IDS, filed 05/11/2023), Watson et al. (US 20090246085 A1), and Mann (US 20080156377 A1).
Regarding claim 1, Tashiro teaches an assembly (Figs. 1 and 12-15) comprising two or more frames (Figs. 1 and 12-15 teaches two or more frames of test tube stands), wherein each frame comprises a plurality of containers or is configured to hold a plurality of containers in a vertical direction (Figs. 1 and 12-15 teaches a plurality of test tubes or the frames are configured to hold test tubes in a vertical direction),
wherein each container is a bioreactor (Figs. 2 and 12-15 teaches test tubes, which are interpreted as a bioreactor since test tubes are structurally capable of functioning as a bioreactor, e.g. having a biological reaction occur within the test tube at a later time) configured to hold a liquid composition comprising a cultivation system or a fermentation system (interpreted as a functional limitation, see MPEP 2114; Figs. 2 and 12-15 teaches test tubes, which are structurally capable of holding a liquid composition comprising a cultivation system or a fermentation system at a later time; note that “a liquid composition comprising a cultivation system or a fermentation system” are not positively recited structurally),
wherein each frame is configured to receive at least one cassette (Figs. 1 and 12-15 teaches two or more frames of test tube stands having openings, therefore is configured to receive at least one cassette at a later time),
wherein each frame comprises an opening in an upper end (Figs. 1 and 12-15 teaches at least an opening, such as ports 5, in an upper end 7) and wherein:
a) each frame further comprises a hinge (Figs. 12-15 teaches each frame of test tube stand comprises hinge 14) or an internal slidable connection (Figs. 3-7, 9-11 teach each frame of the test tube stand have concave portions 16,16” and convex portions 15,15”), wherein the two or more frames are pivotably hinged to one another via said hinge (Figs. 12-15) or wherein the two or more frames are connected to one another via said internal slidable connection (Figs. 3-7, 9-11 teach each frame of the test tube stand have concave portions 16,16” and convex portions 15,15” which are connected to one another),
such that in a first configuration the two or more frames abut each other in a longitudinal direction (Fig. 15; alternatively, Fig. 9), and in a second configuration the two or more frames are in extension of each other (Figs. 12-14; alternatively Fig. 11), or
b) the assembly comprises a further slidable connection (Figs. 3-7, 9-11 teach each frame of the test tube stand have concave portions 16,16” and convex portions 15,15” that are slidably connected), wherein the two or more frames are releasably connected to one another via said further slidable connection (Figs. 3-7, 9-11), such that in a first configuration the two or more frames abut each other in a longitudinal direction (Fig. 9), and in a second configuration the two or more frames do not abut each other in a longitudinal direction while still connected to one another via said further slidable connection (Figs. 10-11),
and wherein each frame are configured to allow optical access to the containers from the side of said each frame at least when the assembly is in the second configuration (Figs. 12-14 teaches each frame have openings on the sides that allow for optical access; alternatively Fig. 11 teaches each frame have openings on the sides that allow for optical access).
Tashiro fails to teach:
the assembly comprising two or more cassettes; wherein each cassette comprises a plurality of containers or is configured to hold a plurality of containers in a vertical direction;
wherein the containers are provided with a pierceable and hermetically resealable membrane at least in their lower end, wherein said pierceable and hermetically resealable membrane allows introduction of one or more piercing elements, and wherein the one or more piercing elements comprise a needle; and
wherein each cassette are configured to allow optical access to the containers from the side of said each cassette at least when the assembly is in the second configuration.
Berthold teaches a specimen rack for specimen containers such as test tubes (abstract; Figs. 1-3). Berthold teaches individually removing test tubes and replacing them in a rack is labor intensive (column 1, lines 46-51). Berthold teaches the invention provides an improved specimen rack offering maximum safety in handling and enabling an entire process sequence to be simplified (column 2, lines 5-8). Berthold teaches the specimen rack comprises: a frame (stand 40) and cassettes (holders 20), wherein each cassette comprises a plurality of containers or is configured to hold a plurality of containers in a vertical direction (Figs. 1-3, 4F); wherein each cassette are configured to allow optical access to the containers from the side of said each cassette (Figs. 1-3). Berthold teaches the frame is configured to receive the cassettes (Fig. 1). Berthold teaches as a function of the particular detection method used and the equipment with which the user works, it may be necessary to remove the holders 20 from the stand 40 and reinsert them a number of times for the various procedures to be performed, this double safety system is of particular significance (column 4, lines 37-42). Berthold teaches specimen containers are capable of being moved and handled together without having to remove individual containers (column 6, lines 10-33).
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 assembly and frames of Tashiro to incorporate the teachings of improving specimen racks for test tubes by including a frame and removable cassettes of Berthold (Figs. 1-4; column 2, lines 5-8; column 4, lines 37-42; column 6, lines 10-33) to provide: the assembly comprising two or more cassettes; wherein each cassette comprises a plurality of containers or is configured to hold a plurality of containers in a vertical direction; wherein each cassette are configured to allow optical access to the containers from the side of said each cassette at least when the assembly is in the second configuration. Doing so would have a reasonable expectation of successfully improving safety in handling of the containers of each frame and enabling simplification of removing or replacing multiple containers for each frame as taught by Berthold (column 2, lines 5-8; column 4, lines 37-42; column 6, lines 10-33).
Modified Tashiro fails to teach: wherein the containers are provided with a pierceable and hermetically resealable membrane at least in their lower end, wherein said pierceable and hermetically resealable membrane allows introduction of one or more piercing elements, and wherein the one or more piercing elements comprise a needle.
Watson teaches a liquid storage apparatus for providing a safe and easy to use device for efficiently managing liquid reagents used in a variety of laboratory equipment, which helps reduce likelihood of accidents, allows for flexibility of experimental design, and helps maximize use of reagents to prevent waste (abstract). Watson teaches a plurality of a plurality of needles is provided in the lower part of a frame (Fig. 1, needles 60 of frame 40), each of said needles being configured to penetrate one container in its lower end when the apparatus holds a cassette holding the containers (Figs. 1-2; paragraph [0043]-[0045]). Watson teaches each container includes a top and bottom pierceable septum, which can be made from any pliable material that allows penetration by a needle and then seals the outside periphery of the needle to prevent leakage ([0043]). Watson teaches the piercing elements pierce the containers to allow liquid to flow out to a liquid mixing and handling system (paragraph [0045]). Watson teaches in certain diagnostic equipment and systems, reagents are stored in containers with a needle pierceable septum at one end (paragraph [0003]). Watson teaches the invention is useful in automated systems (paragraph [0011]).
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 assembly of modified Tashiro to incorporate the teachings of a storage apparatus for containers comprising piercing elements and containers with pierceable septum of Watson (Figs. 1-2; paragraphs [0043]-[0045]) to provide: wherein the containers are provided with a pierceable membrane at least in their lower end, wherein said pierceable membrane allows introduction of one or more piercing elements, and wherein the one or more piercing elements comprise a needle. Doing so would have a reasonable expectation of successfully improving automation of processing and handling fluids within the containers for certain diagnostic systems as taught by Watson (paragraphs [0003],[0011],[0045]).
Modified Tashiro fails to teach: the pierceable membrane is a pierceable and hermetically resealable membrane.
Mann teaches a system that allows for the safe, rapid, efficient recovery of a drug solution from sealed vials (abstract). Mann teaches containers (Fig. 2, vials 120) provided with pierceable and hermetically resealable membrane at their lower end (Fig. 2 and paragraph [0015] teaches the lower ends of containers 120 includes caps or stoppers that re-seal after being punctured, i.e. pierceable and hermetically resealable membrane); wherein the system includes needles that pierce respective membranes (Fig. 2). Mann teaches the caps or stoppers prevent solution from leaking during normal storage and transportation, and allows for solution to be withdrawn without removing the stopper; and the stopper reduces risks of human contact with dangerous material, further contamination, and losing material during recovery process (paragraph [0015]).
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 pierceable membrane of modified Tashiro to incorporate Mann’s teachings of pierceable and hermetically resealable membranes for containers (Fig. 2; paragraph [0015]) to provide: the pierceable membrane is a pierceable and hermetically resealable membrane. Doing so would have a reasonable expectation of successfully preventing solution from leaking during normal storage and transportation, allowing for solution to be withdrawn without removing the membrane, reducing risks of human contact with dangerous material, further contamination, and losing material during recovery process as taught by Mann (paragraph [0015]).
Regarding claim 2, Tashiro further teaches wherein:
i. each frame (Figs. 1 and 12-15 teaches two or more frames of test tube stands) comprises an internal slidable connection (Figs. 3-7, 9-11 teach each frame of the test tube stand have concave portions 16,16” and convex portions 15,15”), or
ii. the assembly comprises a further slidable connection to which the two or more frames are attached (not required due to the “or” statement), or
iii. each frame comprises an internal slidable connection and the assembly comprises a further slidable connection to which the two or more frames are attached (not required due to the “or” statement).
Regarding claim 3, Tashiro further teaches wherein each container is configured to hold a liquid composition (Figs. 2, 12-15 and page 4, line 8 teaches liquid in the test tubes; therefore, each container is configured to hold a liquid composition as claimed).
Regarding claim 4, Tashiro further teaches wherein each container, or at least a part thereof, is made of a material allowing optical access to the inner part of the container at least from the side of the container (Figs. 2, 12-15 and page 4, lines 7-9 teach the state of the liquid in the test tubes can be seen well, therefore each container is implied to made of a material to allow optical access to inside of the container from the side of the container).
Regarding claim 6, modified Tashiro further teaches wherein the plurality of containers is provided in one or more rows (Tashiro, Figs. 12-15 teaches test tubes in one or more rows), and wherein each cassette is configured to receive and to hold said one or more rows (Tashiro in view of Berthold teaches each cassette configured to hold a plurality of containers in a vertical direction, wherein Tashiro, Figs. 12-15 teaches test tubes in one or more rows; therefore, modified Tashiro teaches each cassette configured to receive and hold one or more rows of the containers).
Regarding claim 7, modified Tashiro further teaches wherein:
i. the containers are provided with a sealing element in their lower end (not required due to the “or” statement; however, see above claim 1; modified Tashiro includes containers with pierceable and hermetically resealable membrane at their lower end), or
ii. the containers have an opening in their upper end (Tashiro, Figs. 12-15 teaches the test tubes having an opening in their upper end), or
iii. the containers are provided with a sealing element in their lower end (not required due to the “or” statement; however, see above claim 1; modified Tashiro includes containers with pierceable and hermetically resealable membrane at their lower end), and wherein the containers have an opening in their upper end (not required due to the “or” statement).
Regarding claim 8, modified Tashiro fails to teach wherein a plurality of piercing elements is provided in the lower part of the frames, each of said piercing elements being configured to penetrate one container in its lower end when the assembly holds the cassette holding the containers.
Watson teaches a liquid storage apparatus for providing a safe and easy to use device for efficiently managing liquid reagents used in a variety of laboratory equipment, which helps reduce likelihood of accidents, allows for flexibility of experimental design, and helps maximize use of reagents to prevent waste (abstract). Watson teaches a plurality of a plurality of piercing elements is provided in the lower part of a frame (Fig. 1, needles 60 of frame 40), each of said piercing elements being configured to penetrate one container in its lower end when the apparatus holds a cassette holding the containers (Figs. 1-2; paragraph [0043]-[0045]). Watson teaches the piercing elements pierce the containers to allow liquid to flow out to a liquid mixing and handling system (paragraph [0045]). Watson teaches in certain diagnostic equipment and systems, reagents are stored in containers with a needle pierceable septum at one end (paragraph [0003]). Watson teaches the invention is useful in automated systems (paragraph [0011]).
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 assembly of modified Tashiro to incorporate the teachings of a storage apparatus for containers comprising piercing elements of Watson (Figs. 1-2; paragraphs [0043]-[0045]) to provide: wherein a plurality of piercing elements is provided in the lower part of the frames, each of said piercing elements being configured to penetrate one container in its lower end when the assembly holds the cassette holding the containers. Doing so would have a reasonable expectation of successfully improving automation of processing and handing fluids within the containers for certain diagnostic systems as taught by Watson (paragraphs [0003],[0011],[0045]).
Regarding claim 18, note that “said sealing element” is interpreted as not required due to the “or” statement (see claim 7), therefore, the limitations of “wherein said sealing element comprises a female part of a connecting pair consisting of a female part and a male part, said female part being configured to receive said male part to establish a fluid-tight connection via the connecting pair”, which further define the “sealing element” are interpreted as not required.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Tashiro in view of Berthold, Watson, and Mann as applied to claim 1 above, and further in view of Woods (US 20070017306 A1).
Regarding claim 5, modified Tashiro fails to teach wherein each cassette, frame, or each cassette and each frame is configured to match a standard Society for Biomolecular Screening (SBS) format, a Society for Laboratory Automation and Screening (SLAS) standard, or a standard SBS format and a SLAS standard when the assembly is in the first configuration.
Woods teaches a sample tube which engages in a supporting rack (abstract). Woods teaches conventionally, SBS format standard plates are well known in the industry (paragraph [0005]) and SBS format racks allows for processing with robots and systems that maintain high storage densities and throughput rate (paragraph [0005]). Woods teaches sample tubes can be operated on or stored within a standard 384-SBS format rack and may be accessed by automated sampling equipment by either piercing a seal or removing the seal (paragraph [0012]). Woods teaches a sample tube for use in a 384 SBS format rack (paragraph [0019]).
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 each cassette, frame, or each cassette and each frame of modified Tashiro to incorporate the teachings of SBS formats for sample tubes of Woods (paragraphs [0005],[0012],[0019]) to provide: wherein each cassette, frame, or each cassette and each frame is configured to match a standard Society for Biomolecular Screening (SBS) format, a Society for Laboratory Automation and Screening (SLAS) standard, or a standard SBS format and a SLAS standard when the assembly is in the first configuration. Doing so would have a reasonable expectation of successfully utilizing known standardized formats of laboratory equipment to improve automated processing, throughput, and storage of containers.
Claims 9 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Tashiro in view of Berthold, Watson, and Mann as applied to claim 1 above, and further in view of Verhoef et al. (US 20200319217 A1; filed 04/08/2019).
Regarding claim 9, modified Tashiro fails to teach wherein the containers comprise one or more optical sensor on their front side, said optical sensor being configured to allow measurement of one or more parameters of the liquid composition held in the containers.
Verhoef teaches a system for automated cell culture and testing, including a rack defining storage positions to support an array of sample holders (abstract). Verhoef teaches the system includes additional detection assembly or chemical sensor to monitor pH, oxygen, and/or carbon dioxide level within each well (paragraph [0061]), wherein each chemical sensor may be mounted on a side wall of a well (paragraph [0061]). Verhoef teaches sensing fluorescence (paragraph [0061]). Verhoef teaches the chemical sensor may detect light from a side wall of a well (paragraph [0065]). Verhoef teaches sensors and automation can include one or more of image sensors, pH sensors, O2 sensors, temperature sensors, and CO2 sensors, wherein all of these sensors are remotely operated by a user and results can be monitored (paragraph [0049]).
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 containers of modified Tashiro to incorporate the teachings of sensors for containers and optically measuring containers from a side of the container of Verhoef (paragraphs [0049],[0061],[0065]) to provide: wherein the containers comprise one or more optical sensor on their front side, said optical sensor being configured to allow measurement of one or more parameters of the liquid composition held in the containers. Doing so would have a reasonable expectation of successfully improving automation of monitoring and analyzing the containers.
Regarding claim 17, modified Tashiro fails to teach the assembly according to claim 9, wherein each container comprises at least one of a first optical sensor configured to measure CO2 content, a second optical sensor configured to measure O2 content, and a third optical sensor configured to measure pH.
Verhoef teaches a system for automated cell culture and testing, including a rack defining storage positions to support an array of sample holders (abstract). Verhoef teaches the system includes additional detection assembly or chemical sensor to monitor pH, oxygen, and/or carbon dioxide level within each well (paragraph [0061]), wherein each chemical sensor may be mounted on a side wall of a well (paragraph [0061]). Verhoef teaches sensing fluorescence (paragraph [0061]). Verhoef teaches the chemical sensor may detect light from a side wall of a well (paragraph [0065]). Verhoef teaches sensors and automation can include one or more of image sensors, pH sensors, O2 sensors, temperature sensors, and CO2 sensors, wherein all of these sensors are remotely operated by a user and results can be monitored (paragraph [0049]).
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 containers of modified Tashiro to incorporate the teachings of sensors for containers and optically measuring containers from a side of the container of Verhoef (paragraphs [0049],[0061],[0065]) to provide: the assembly according to claim 9, wherein each container comprises at least one of a first optical sensor configured to measure CO2 content, a second optical sensor configured to measure O2 content, and a third optical sensor configured to measure pH. Doing so would have a reasonable expectation of successfully improving automation of monitoring and analyzing the containers according to known parameters such as CO2, O2, and pH.
Claims 16 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Tashiro in view of Berthold, Watson, and Mann as applied to claim 6 above, and further in view of Du et al. (US 20160327585 A1).
Regarding claim 16, modified Tashiro fails to teach the assembly according to claim 6, wherein the assembly further comprises blocking means separating said first and second row of containers.
Du teaches a test tube rack of an analyzer pipeline including multiple test tube holders for holding test tubes (abstract). Du teaches the test tube rack includes a light blocker configured at a side wall of the test tube rack and across multiple test tube holders (paragraphs [0008],[0028]). Du teaches the light blocker is configured at a portion of a side wall of a test tube to strengthen the stability of the test tube rack (paragraph [0032]).
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 assembly of modified Tashiro to incorporate the teachings of a test tube rack including a light blocker of Du (paragraphs [0008],[0028],[0032]) to provide: the assembly according to claim 6, wherein the assembly further comprises blocking means separating said first and second row of containers. Doing so would have a reasonable expectation of successfully improving light separation between the rows of containers and strength the stability of the assembly, therefore improving optical analysis of individual containers or rows of containers.
Regarding claim 19, modified Tashiro fails to teach the assembly according to claim 16, wherein:
i. the blocking means comprise or consist of a non-transparent barrier separating said first and second row of containers, or
ii. the blocking means comprise or consist of a coating on the back part of the containers, wherein said coating is configured to prevent optical access to one of said rows,
wherein the non-transparent barrier, the coating, or the non-transparent barrier and the coating, is of dimensions such that optical access to one of said first and second row of containers is enabled from one side of said one row while optical access to the other of said first and second row of containers from said one side of said one row is prevented.
Du teaches a test tube rack of an analyzer pipeline including multiple test tube holders for holding test tubes (abstract). Du teaches the test tube rack includes a light blocker configured at a side wall of the test tube rack and across multiple test tube holders (paragraphs [0008],[0028]). Du teaches the light blocker is configured at a portion of a side wall of a test tube to strengthen the stability of the test tube rack (paragraph [0032]).
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 assembly of modified Tashiro to incorporate the teachings of a test tube rack including a light blocker of Du (paragraphs [0008],[0028],[0032]) to provide: the assembly according to claim 16, wherein: i. the blocking means comprise or consist of a non-transparent barrier separating said first and second row of containers, or ii. the blocking means comprise or consist of a coating on the back part of the containers, wherein said coating is configured to prevent optical access to one of said rows, wherein the non-transparent barrier, the coating, or the non-transparent barrier and the coating, is of dimensions such that optical access to one of said first and second row of containers is enabled from one side of said one row while optical access to the other of said first and second row of containers from said one side of said one row is prevented. Doing so would have a reasonable expectation of successfully improving light separation between the rows of containers and strength the stability of the assembly, therefore improving optical analysis of individual containers or rows of containers.
Response to Arguments
Applicant’s arguments, see pages 7-10, filed 08/04/2026, with respect to the rejection(s) of claims 1-4, 6-7, and 18 under 35 U.S.C. 103 over Tashiro and Berthold and dependent claims 5, 8, 9, 17, 16, 19 under 35 U.S.C. 103, specifically regarding the limitation of “wherein the containers are provided with a pierceable and hermetically resealable membrane at least in their lower end, wherein said pierceable and hermetically resealable membrane allows introduction of one or more piercing elements, and wherein the one or more piercing elements comprise a needle” of amended claim 1, have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Tashiro et al. (JPH 11123335 A; see machine translation) in view of Berthold et al. (US 5098663 A; cited in the IDS, filed 05/11/2023), Watson et al. (US 20090246085 A1), and Mann (US 20080156377 A1).
In response to applicant’s argument that Tashiro and Berthold fail to teach containers that are each a bioreactor configured to hold a liquid composition comprising a cultivation system or a fermentation system (Remarks, page 7), the examiner disagrees.
Tashiro teaches wherein each container is a bioreactor (Figs. 2 and 12-15 teaches test tubes, which are interpreted as a bioreactor since test tubes are structurally capable of functioning as a bioreactor, e.g. having a biological reaction occur within the test tube at a later time) configured to hold a liquid composition comprising a cultivation system or a fermentation system (interpreted as a functional limitation, see MPEP 2114; Figs. 2 and 12-15 teaches test tubes, which are structurally capable of holding a liquid composition comprising a cultivation system or a fermentation system at a later time).
Note that the “liquid composition comprising a cultivation system or a fermentation system” are not positively recited structurally and is interpreted as a functional limitation of the claimed assembly. A claim is only limited by positively recited elements; thus, inclusion of the material or article (“liquid composition comprising a cultivation system or a fermentation system”) worked upon by a structure (bioreactor) being claimed does not impart patentability to the claims (see MPEP 2115).
A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the functional limitations, then it meets the claim. See MPEP 2114. The apparatus of modified Tashiro is identical to the presently claimed structure. Modified Tashiro discloses the claimed container as claimed and therefore, would have the ability to perform the function of being a bioreactor configured to hold a liquid composition comprising a cultivation system or a fermentation system recited in the claim. See MPEP 2112.01 (I).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., Remarks, page 8, second full paragraph, “for active gas delivery”; Remarks, page 9, paragraph starting with “Claim 8”, “the present disclosure which introduces gas or medium into a live culture or fermentation”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ayres et al. (US 3887466 A) teaches a self-contained fluid separator assembly (abstract). Ayres teaches the container (Figs. 1-3, container 12) having closures (14,16) made of a self-sealing elastomeric material such as rubber which is capable of receiving cannula (18) penetrated therethrough for conducting blood into the container (column 2, lines 58-66); wherein when the cannula is removed the closure is resealed with no loss of blood (5) passing through the penetration portion (31) (column 2, lines 66-68).
Herchenbach et al. (US 20080075634 A1; cited in the IDS 05/11/2023) teaches a rack for a plurality of capped tubes, including a frame to vertically hold the tubes (Figs. 2-12; abstract). Herchenbach teaches the containers 24 may include covers over their top with pierceable membranes so that the pipettes may pierce the membranes to enter the containers 24 for access to the specimens contained therein, with the membranes substantially closing after the pipettes are removed, thereby both protecting the remaining specimens against external contamination and ensuring that nothing from the containers 24 escape to contaminate other specimens (paragraph [0008]).
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/HENRY H NGUYEN/Primary Examiner, Art Unit 1758
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