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 .
Response to Amendment
The Amendment filed 12/15/2025 has been entered. Claims 2-11 remain pending in the application. New grounds of rejections necessitated by amendments are discussed below.
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 3-6 and 9-11 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 “the same” in line 11. There is insufficient antecedent basis for this limitation in the claim. It is unclear which element is being referred to. For examination purposes, “the same” is interpreted as “the at least one nutrient medium reservoir”. Claims 4-6 are rejected by virtue of their dependency on claim 3. It is suggested to recite “the same” as “the at least one nutrient medium reservoir”.
Regarding claim 9, claim 9 recites the limitation "the wall" in line 31. There is insufficient antecedent basis for this limitation in the claim. Claims 10-11 are rejected by virtue of their dependency on claim 9. It is suggested to recite “the wall” as “a wall”.
Regarding claim 9, claim 9 recites “the channel interior” in line 35. There is insufficient antecedent basis for this limitation in the claim. Claims 10-11 are rejected by virtue of their dependency on claim 9. It is suggested to recite “the channel interior” as “an interior of the at least one channel” or “a channel interior of the at least one channel”.
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 2-3 and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Baldwin et al. (US 20120040329 A1) in view of Holder et al. (US 20170298456 A1) and Wicks et al. (US 20040191892 A1), and Wales et al. (US 20190241856 A1).
Regarding claim 7, Baldwin teaches a phage culturing device (Fig. 2; abstract and paragraph [0027] teaches culturing and growth of bacteriophage), comprising a fluid line system (Fig. 2, interpreted as the fluidic elements, from 305, 304, 301, and 306) that is sealed off with respect to the outside environment (Fig. 2 shows elements from 305, 304, 301, and 306 are sealed off with respect to an outside environment), comprising:
a. an inlet port (Fig. 2, interpreted as a port of element 305 coupled to element 308) configured to have a sample vessel connected thereto in such a way that phages from a sample that is inserted into the sample vessel can be transferred via the inlet port into the fluid line system (interpreted as a functional limitation, see MPEP 2114; Fig. 2 and paragraph [0030] teaches element 305 is configured to have a sample vessel 308 connected thereto, that allows for a sample to be transferred to the fluid line system; note that the sample vessel is not positively recited structurally);
b. an outlet port (Fig. 2, interpreted as a port of element 306 coupled to element 320) configured to have a withdrawal vessel removably attached thereto so that the phages can be withdrawn from the fluid line system via the outlet port (interpreted as a functional limitation, see MPEP 2114; Fig. 2 and paragraph [0029] teaches tank 306 is coupled to conduit 320, therefore tank 306 has a port that is capable of having a withdrawal vessel removable attached, e.g. via the conduit 320, to withdraw phages as claimed at a later time; note that the withdrawal vessel is not positively recited structurally);
c. a filtration device (Fig. 2, tangential flow filter 301) disposed in a fluid line between the inlet port and the outlet port (Fig. 2 shows tangential flow filter 301 between the inlet port of element 305 and the outlet port of element 306) and comprises a filter membrane (Fig. 2, filter screen 302) configured to allow the phages to pass in a direction toward the outlet port, while not allowing bacteria to pass (paragraph [0029] teaches the filter screen is about 0.2 micron, therefore the filter screen is structurally capable of allowing phages having a size of less than 0.2 micron to pass while not allowing bacteria having a size of more than 0.2 micron to pass); and
e. at least one host bacteria reservoir including host bacteria in viable form (Fig. 2, storage vessel 308; paragraph [0030] teaches the vessel 308 comprises target bacteria),
wherein the filtration device is a tangential flow filtration device (Fig. 2, tangential flow filter 301) configured to cause the nutrient medium to flow tangentially across the filter membrane (paragraphs [0029],[0031] teach a tangential flow filter 301 having a filter screen; since Baldwin’s tangential flow filter is identical to that of the claimed “tangential flow filtration device”, the claimed function of being configured to cause the nutrient medium to flow tangentially across the filter membrane are presumed to be inherent, MPEP 2112.01(I)).
Baldwin fails to teach: d. at least one nutrient medium reservoir including a nutrient medium; the at least one host bacteria reservoir including the host bacteria in lyophilized, viable form and which is closed prior to use and which is configured to be connected to the at least one nutrient medium reservoir by a connecting line that is configured to be opened, the at least one nutrient medium reservoir being disposed upstream from the filtration device in the fluid line system, as viewed in a flow direction from the inlet port to the outlet port so that the phages that are transferred into the fluid line system can be replicated at least once by way of culturing upstream from the filtration device in the at least one nutrient medium reservoir including the host bacteria; the tangential flow filtration device configured to cause the nutrient medium to flow tangentially across the filter membrane in a reversing manner on one of two sides of the membrane.
Holder teaches a system for bacterial identification that can be used to detect foreign agents within samples, wherein the system can introduce bacteriophages into the system that can infect bacterial cells (abstract). Holder teaches various medium reservoirs coupled to a fluidic system (Fig. 1 shows reservoirs 116, 118, 120, 130, 128, 126 coupled to the fluidic system of cartridge 102). Holder teaches the system can include a growth medium reservoir and phage cocktail reservoir (paragraph [0080]). Holder teaches the system can supply sub-samples and bacteriophages with growth medium for the survival of the samples and bacteriophages (paragraph [0079]). Holder teaches a sample reservoir can be a collection tube that is pumped through the cartridge via tube connected to the cartridge at an inlet (paragraph [0074]). Holder teaches a controller can control valves leading to various reservoirs (paragraphs [0083],[0098]), wherein valves can be used to control the amount of fluid flowing into each reservoir (paragraph [0078]). Holder teaches detection chambers 114 can have a filter (paragraph [0081]; Fig. 2A), wherein the inlet for a buffer (204) is upstream of the filter (Fig. 2A).
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 device of Baldwin to incorporate the teachings of a growth medium reservoir, supplying samples with growth medium, valves, and a filter downstream of upstream inlets to reservoirs of Holder (Figs. 1-2; paragraphs [0078]-[0081], [0083],[0098]) to provide: d. at least one nutrient medium reservoir including a nutrient medium; the at least one host bacteria reservoir including host bacteria which is closed prior to use and which is configured to be connected to the at least one nutrient medium reservoir by a connecting line that is configured to be opened, the at least one nutrient medium reservoir being disposed upstream from the filtration device in the fluid line system, as viewed in a flow direction from the inlet port to the outlet port so that the phages that are transferred into the fluid line system can be replicated at least once by way of culturing upstream from the filtration device in the at least one nutrient medium reservoir including the host bacteria. Doing so would have a reasonable expectation of successfully improving supplying nutrient to the system to improve survival of the samples and improve control of fluid as discussed by Holder (paragraphs [0078]-[0081], [0083],[0098]).
Modified Baldwin fails to teach: the at least one host bacteria reservoir including the host bacteria in lyophilized, viable form; and the tangential flow filtration device configured to cause the nutrient medium to flow tangentially across the filter membrane in a reversing manner on one of two sides of the membrane.
Wicks teaches detection of microorganisms and assay devices for detection and enumeration of microorganisms (paragraph [0002]). Wicks teaches the devices use phage amplification for rapid and accurate results (paragraph [0005]). Wicks teaches the device comprises a pellet of lyophilized bacteria (paragraph [0036]), which was added to a chamber to serve as a helper cell, and the chamber was set to a closed position (paragraph [0036]). Wicks teaches bacteriophage are typically available in the form of lyophilized pellets (paragraph [0017]).
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 host bacteria of modified Baldwin to incorporate the teachings of the use of lyophilized bacteria for phage amplification of Wicks (paragraph [0036]) to provide: the at least one host bacteria reservoir including the host bacteria in lyophilized, viable form. Doing so would have a reasonable expectation of successfully improving addition of host bacteria into the reservoir by using bacteria in typically available forms as discussed by Wicks.
Modified Baldwin fails to teach: the tangential flow filtration device configured to cause the nutrient medium to flow tangentially across the filter membrane in a reversing manner on one of two sides of the membrane.
Wales teaches a reversible liquid filtration system for cell culture perfusion (abstract). Wales teaches tangential flow filtration systems are known, and it is known to be advantageous to reconfigure the components of a TFF system to reverse the flow over a longer period in order to extend the life of the filter (paragraph [0006]). Wales teaches alternating tangential flow filtration systems, wherein reversal of the liquid flow along the filter helps to dislodge deposits from the filter and thereby prevent blockage (paragraph [0007]). Wales teaches provision of bi-directional valves means that the claimed system may be operated in a TFF perfusion mode, wherein the direction of a loop flow may be easily and conveniently reversed, which can advantageously prolong filter life (paragraph [0011]). Wales teaches the claimed system is highly flexible and offers the advantages of both TFF and ATF perfusion (paragraph [0014]). Wales teaches a pump is controllable to reverse the flow through the membrane to partially or fully clear the retentate side of the membrane of permeate material (paragraph [0017]).
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 tangential flow filtration device of modified Baldwin to incorporate the teachings of alternating tangential flow filtration systems that utilize reverse flow of Wales (paragraphs [0006],[0007],[0011],[0014],[0017]) to provide: the tangential flow filtration device configured to cause the nutrient medium to flow tangentially across the filter membrane in a reversing manner on one of two sides of the membrane. Doing so would have a reasonable expectation of successfully improving flexibility and lifespan of the tangential flow filtration device by helping to dislodge deposits from the filter and thereby prevent blockage, therefore prolonging the life of the filter membrane as taught by Wales.
Regarding claim 2, modified Baldwin fails to teach: the device according to claim 7, further comprising a valve disposed in the fluid line system between the inlet port and the nutrient medium reservoir and wherein the sample vessel connected to the inlet port is configured to be at least temporarily brought into fluid connection with the at least one nutrient medium reservoir by way of the valve.
Baldwin teaches various control valves to adjust flow and achieve predetermined ratios and concentrations of flow streams (paragraphs [0033]-[0035]).
Holder teaches various medium reservoirs coupled to a fluidic system (Fig. 1 shows reservoirs 116, 118, 120, 130, 128, 126 coupled to the fluidic system of cartridge 102). Holder teaches the system can include a growth medium reservoir and phage cocktail reservoir (paragraph [0080]). Holder teaches the system can supply sub-samples and bacteriophages with growth medium for the survival of the samples and bacteriophages (paragraph [0079]). Holder teaches a sample reservoir can be a collection tube that is pumped through the cartridge via tube connected to the cartridge at an inlet (paragraph [0074]). Holder teaches a controller can control valves leading to various reservoirs (paragraphs [0083],[0098]), wherein valves can be used to control the amount of fluid flowing into each reservoir (paragraph [0078]). Holder teaches detection chambers 114 can have a filter (paragraph [0081]; Fig. 2A), wherein the inlet for a buffer (204) is upstream of the filter (Fig. 2A).
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 device of modified Baldwin to incorporate the teachings of valves of Baldwin (paragraphs [0033]-[0035]) and the teachings of a growth medium reservoir, supplying samples with growth medium, valves, and a filter downstream of upstream inlets to reservoirs of Holder (Figs. 1-2; paragraphs [0078]-[0081], [0083],[0098]) to provide: the device according to claim 7, further comprising a valve disposed in the fluid line system between the inlet port and the nutrient medium reservoir and wherein the sample vessel connected to the inlet port is configured to be at least temporarily brought into fluid connection with the at least one nutrient medium reservoir by way of the valve. Doing so would have a reasonable expectation of successfully improving control of fluid flow and concentrations as discussed by Baldwin (paragraphs [0033]-[0035]) and improving supplying nutrient to the sample to improve survival of the samples and improving control of fluid as discussed by Holder (paragraphs [0078]-[0081], [0083],[0098]).
Regarding claim 3, modified Baldwin further teaches wherein the sample vessel and the at least one nutrient medium reservoir are each configured to be of variable volume (see above claim 7, modified Baldwin teaches the structures of the sample vessel and nutrient medium reservoir, which are structurally configured to be of variable volume since they have an internal space that can hold various amounts of volume).
Modified Baldwin fails to teach: wherein the at least one nutrient medium reservoir is a plurality of the nutrient medium reservoirs and the plurality of nutrient medium reservoirs are configured to be of variable volume, the sample vessel being configured as a syringe or as a blood collection tube operating by aspiration or vacuum principle and/or the nutrient medium reservoir being configured as a flexible pouch, so that as a result of a change in volume the nutrient medium that has been mixed with host bacteria can be at least partially delivered from the at least one nutrient medium reservoir into the sample vessel and back into the same or a different one of the nutrient medium reservoirs.
Holder teaches various medium reservoirs coupled to a fluidic system (Fig. 1 shows reservoirs 116, 118, 120, 130, 128, 126 coupled to the fluidic system of cartridge 102). Holder teaches the system can include a plurality of reservoirs, and in addition to growth medium reservoirs, the system can include a phage cocktail reservoir (paragraph [0080]). Holder teaches the system can supply sub-samples and bacteriophages with growth medium for the survival of the samples and bacteriophages (paragraph [0079]).
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 at least one nutrient medium reservoir of modified Baldwin to incorporate the teachings of various medium reservoirs, such as growth medium reservoirs and a phage cocktail reservoir of Holder (Figs. 1-2; paragraphs [0079]-[0080]) to provide: wherein the at least one nutrient medium reservoir is a plurality of the nutrient medium reservoirs and the plurality of nutrient medium reservoirs are configured to be of variable volume. Doing so would have a reasonable expectation of successfully improving control of supply desired nutrient or growth medium to the system to improve survival of the samples as discussed by Holder (paragraphs [0078]-[0081], [0083],[0098]).
Modified Baldwin fails to teach: the sample vessel being configured as a syringe or as a blood collection tube operating by aspiration or vacuum principle and/or the nutrient medium reservoir being configured as a flexible pouch, so that as a result of a change in volume the nutrient medium that has been mixed with host bacteria can be at least partially delivered from the at least one nutrient medium reservoir into the sample vessel and back into the same or a different one of the nutrient medium reservoirs.
Baldwin teaches an analytical unit is fed sample streams (paragraph [0035]). Baldwin teaches return lines to concentrate the size of samples (paragraph [0031]).
Holder teaches the sample can be contained in a blood collection tube and is pumped through the microfluidic cartridge via a tube connected to the microfluidic cartridge at the inlet (paragraph [0074]). Holder teaches various medium reservoirs coupled to a fluidic system (Fig. 1 shows reservoirs 116, 118, 120, 130, 128, 126 coupled to the fluidic system of cartridge 102). Holder teaches the system can include a growth medium reservoir and phage cocktail reservoir (paragraph [0080]). Holder teaches the system can supply sub-samples and bacteriophages with growth medium for the survival of the samples and bacteriophages (paragraph [0079]). Holder teaches a sample reservoir can be a collection tube that is pumped through the cartridge via tube connected to the cartridge at an inlet (paragraph [0074]). Holder teaches a controller can control valves leading to various reservoirs (paragraphs [0083],[0098]), wherein valves can be used to control the amount of fluid flowing into each reservoir (paragraph [0078]).
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 sample vessel of modified Baldwin to incorporate the teachings of sample streams and returning lines for samples of Baldwin (paragraphs [0031],[0035]) and the teachings of a collection tube and pumping a sample of Holder (paragraph [0074]) to provide: the sample vessel being configured as a blood collection tube operating by aspiration or vacuum principle, so that as a result of a change in volume the nutrient medium that has been mixed with host bacteria can be at least partially delivered from the at least one nutrient medium reservoir into the sample vessel and back into the same or a different one of the nutrient medium reservoirs. Doing so would have a reasonable expectation of successfully improving supplying a sample and nutrient to the device to improve survival of the samples and improve control of fluid as discussed by Holder (paragraphs [0078]-[0081], [0083],[0098]).
Note that the limitation of “so that as a result of a change in volume the nutrient medium that has been mixed with host bacteria can be at least partially delivered from the at least one nutrient medium reservoir into the sample vessel and back into the same or a different one of the at least one nutrient medium reservoir” is interpreted as an intended use of the claimed device. Note that an intended use 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 intended use, then it meets the claim. See MPEP 2114. The apparatus of modified Baldwin is identical to the presently claimed structure. Modified Baldwin discloses the device comprising the sample vessel and nutrient medium reservoir as claimed and therefore, would have the ability to perform the use recited in the claim. See MPEP 2112.01 (I).
Regarding claim 8, modified Baldwin teaches a set comprising the device according to claim 7 (see above claim 7). Modified Baldwin fails to teach the set comprising a plurality of the devices according to claim 7, wherein each of the devices includes a different not antibiotic-resistant host bacteria of a type of an antibiotic-resistant bacterial strain.
Baldwin teaches applications where it will often be requires to prepare multiple bacteriophage, as for phage panels, phage cocktails and phage multi-panels (paragraph [0022]).
Holder teaches various medium reservoirs coupled to a fluidic system (Fig. 1 shows reservoirs 116, 118, 120, 130, 128, 126 coupled to the fluidic system of cartridge 102). Holder teaches the system can include a growth medium reservoir and phage cocktail reservoir (paragraph [0080]). Holder teaches the system can supply sub-samples and bacteriophages with growth medium for the survival of the samples and bacteriophages (paragraph [0079]). Holder teaches a controller can control valves leading to various reservoirs (paragraphs [0083],[0098]), wherein valves can be used to control the amount of fluid flowing into each reservoir (paragraph [0078]). Holder teaches a plurality of incubation reservoirs (Fig. 1, element 112), wherein each reservoir can be coupled to reservoirs of different compositions and different antibiotic solutions (paragraph [0080]). Holder teaches each of the plurality of incubation reservoirs configured to receive a different bacteriophage (claim 15). Holder teaches samples are tested in parallel to determine resistance or sensitivity to an antibiotic (paragraph [0117]).
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 set of modified Baldwin to incorporate the teachings of a need to prepare multiple bacteriophages and panels of Baldwin (paragraph [0022]) and the teachings of having a plurality of reservoirs configured to receive different bacteriophages and testing samples in parallel to determine resistance or sensitivity to an antibiotic of Holder (claim 15; paragraphs [0079]-[0080],[0117]) to provide: the set comprising a plurality of the devices according to claim 7, wherein each of the devices includes a different not antibiotic-resistant host bacteria of a type of an antibiotic-resistant bacterial strain. Doing so would have a reasonable expectation of successfully using multiple of the devices to improve throughput of analysis of different bacteria via parallel testing of bacteria that are have at least some sensitivity to an antibiotic, i.e. not antibiotic-resistant.
Claims 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Baldwin in view of Holder, Wicks, and Wales as applied to claim 3 above, and further in view of Summer et al. (US 20130149759 A1).
Regarding claim 4, modified Baldwin fails to teach: wherein the plurality of the nutrient medium reservoirs are disposed upstream from the filtration device, as viewed in the flow direction from the inlet port to the outlet port, and, in the flow direction, are consecutively connected each via a respective switchable 3-way valve to a connecting line leading to the filtration device in such a way that a change in volume of the sample vessel or of a nutrient medium reservoir allows the nutrient medium to be withdrawn from one of the nutrient medium reservoirs and transferred into another of the nutrient medium reservoir situated downstream in the flow direction.
Summer teaches a system and method for using bacteriophages to control unwanted bacteria in bacteria-mediated reaction processes (paragraph [0024]; Fig. 1). Summer teaches the system comprises a plurality of tangential flow filters (132, 133, 134) and a plurality of nutrient medium reservoirs (incubation tank 105 and tank 108; paragraph [0124] teach tank 105 comprises growth media from tank 108; paragraph [0072] teaches incubation 104 to allow phage adsorption to bacteria, which inherently comprises nutrients for the bacteria), wherein the plurality of nutrient medium reservoirs are connected to a connecting line (Fig. 1, interpreted as the fluidic lines from element 116 to 134) upstream and leading to filtration device (134) via switchable 3-way valves (Fig. 1 shows 3-way valves 116, 117). Summer teaches target bacteria from storage tank 105 is released and mixed with a phase solution in incubation tank 104 (paragraph [0072]).
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 device of modified Baldwin to incorporate the teachings of a plurality of nutrient medium reservoirs upstream a tangential flow filters and controlled via 3-way valves of Summer (Fig. 1; paragraphs [0072],[0124]) to provide: wherein the plurality of the nutrient medium reservoirs are disposed upstream from the filtration device, as viewed in the flow direction from the inlet port to the outlet port, and, in the flow direction, are consecutively connected each via a respective switchable 3-way valve to a connecting line leading to the filtration device in such a way that a change in volume of the sample vessel or of a nutrient medium reservoir allows the nutrient medium to be withdrawn from one of the nutrient medium reservoirs and transferred into another of the nutrient medium reservoir situated downstream in the flow direction. Doing so would have a reasonable expectation of successfully improving successive processing of a sample prior to filtration.
Regarding claim 5, modified Baldwin fails to teach: wherein a respective dedicated host bacteria supply is assigned to each of the plurality of nutrient medium reservoirs and each of the dedicated host bacteria supplies is configured to only be brought in connection with the nutrient medium of the nutrient medium reservoir assigned to that dedicated host bacteria supply, the connection being directly at the assigned nutrient medium reservoir by a closed connecting line which is configured to be opened.
Holder teaches various medium reservoirs coupled to a fluidic system (Fig. 1 shows reservoirs 116, 118, 120, 130, 128, 126 coupled to the fluidic system of cartridge 102). Holder teaches the system can include a growth medium reservoir and phage cocktail reservoir (paragraph [0080]). Holder teaches the system can supply sub-samples and bacteriophages with growth medium for the survival of the samples and bacteriophages (paragraph [0079]). Holder teaches a controller can control valves leading to various reservoirs (paragraphs [0083],[0098]), wherein valves can be used to control the amount of fluid flowing into each reservoir (paragraph [0078]). Holder teaches a plurality of incubation reservoirs (Fig. 1, element 112), wherein each reservoir can be coupled to reservoirs of different compositions and different antibiotic solutions (paragraph [0080]). Holder teaches each of the plurality of incubation reservoirs configured to receive a different bacteriophage (claim 15).
Summer teaches initial bacteria is supplied from storage tank through a valve (paragraph [0124]).
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 device and the plurality of nutrient medium reservoirs of modified Baldwin to incorporate the teachings of control valves for reservoirs, and a plurality of incubation reservoirs each configured to receive different bacteriophages and each coupled to respective reservoirs for compositions and antibiotic solutions of Holder (claim 15; paragraphs [0078]-[0080],[0083],[0098]) and the teachings of supplying bacteria from a storage tank through a valve of Summer (paragraph [0124]) to provide: wherein a respective dedicated host bacteria supply is assigned to each of the plurality of nutrient medium reservoirs and each of the dedicated host bacteria supplies is configured to only be brought in connection with the nutrient medium of the nutrient medium reservoir assigned to that dedicated host bacteria supply, the connection being directly at the assigned nutrient medium reservoir by a closed connecting line which is configured to be opened. Doing so would have a reasonable expectation of successfully improving control of supplying desired components, such as respective host bacteria supply, to the respective nutrient medium reservoirs.
Regarding claim 6, modified Baldwin fails to teach the device according to claim 5, further comprising a sterile filter disposed between two of the nutrient medium reservoirs situated consecutively in the flow direction.
Baldwin teaches a filter to remove larger particles and trash (paragraph [0029]). Baldwin teaches filter sterilizing the fluid into the appropriate media for a three way combination to proliferate the desired phages of viruses (paragraph [0005]).
Summer teaches a biomass stream is passed through a filtration system to remove debris and trash followed by microfiltration by a tangential flow filter (paragraph [0089]).
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 device of modified Baldwin to incorporate the teachings of the use of filters within a fluidic system of Baldwin (paragraphs [0005],[0029]) and Summer (paragraph [0089]) to provide: the device according to claim 5, further comprising a sterile filter disposed between two of the nutrient medium reservoirs situated consecutively in the flow direction. Doing so would have a reasonable expectation of successfully improving sterility of the device and improving removal of undesired components, such as larger particles, debris, and trash, between various stages or fluidic components of the device.
Allowable Subject Matter
Claims 9-11 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 9, the closest prior art of Baldwin et al. (US 20120040329 A1) fails to teach: the first and the second cavity being connected to one another by way of at least one channel at regions of the wall which are formed by the filter membrane and the at least one channel is configured so that across the at least one channel nutrient medium can be pumped back and forth between the first and second cavities and can flow tangentially at a first side of the wall pointing toward the channel interior and which at a second side of the wall facing away from the channel interior adjoins a third cavity, an inlet channel opening into the first cavity and an outlet channel opening into the third cavity.
None of the prior art teaches or fairly suggests, alone or in combination, all of the limitations of claim 9. Therefore, claim 9 is deemed allowable. Claims 10-11 are deemed allowable based on their dependency on claim 9.
Response to Arguments
Applicant’s arguments, see page 8, filed 12/15/2025, with respect to rejections under 35 U.S.C. 112 have been fully considered and are mostly persuasive. The amendments to the claims overcome most of the 112(b) rejections of 09/26/2025, however, the following are maintained:
Regarding claim 3, claim 3 recites “the same” in line 11. There is insufficient antecedent basis for this limitation in the claim. It is unclear which element is being referred to. For examination purposes, “the same” is interpreted as “the at least one nutrient medium reservoir”. Claims 4-6 are rejected by virtue of their dependency on claim 3. It is suggested to recite “the same” as “the at least one nutrient medium reservoir”.
Regarding claim 9, claim 9 recites the limitation "the wall" in line 31. There is insufficient antecedent basis for this limitation in the claim. Claims 10-11 are rejected by virtue of their dependency on claim 9. It is suggested to recite “the wall” as “a wall”.
Regarding claim 9, claim 9 recites “the channel interior” in line 35. There is insufficient antecedent basis for this limitation in the claim. Claims 10-11 are rejected by virtue of their dependency on claim 9. It is suggested to recite “the channel interior” as “an interior of the at least one channel” or “a channel interior of the at least one channel”.
Applicant’s arguments, see pages 8-9, filed 12/15/2025, with respect to the rejection(s) of claim 7 under 35 U.S.C. 103 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 Baldwin et al. (US 20120040329 A1) in view of Holder et al. (US 20170298456 A1) and Wicks et al. (US 20040191892 A1), and Wales et al. (US 20190241856 A1).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Zhou et al. (US 20150158907 A1) teaches open circuit filtration systems (abstract). Zhou teaches traditional unidirectional tangential flow filtration (TFF), with no reverse flow, causes filter fouling (paragraph [0004]). Zhou teaches open circuit filtration system providing reversible tangential fluid flow across a surface of a cross-flow filter, as opposed to conventional unidirectional open circuit or bidirectional closed circuit filtration systems, provides for increased viable cell density, increased percentage viable cells, increased specific and/or volumetric productivity, increased specific glucose consumption, and decreased filter fouling (paragraph [0005]).
Bhargav et al. (US 20210261900 A1; effectively filed 08/29/2018) teaches a system including a tangential flow filter (abstract), wherein a control unit directs at least one of further flow of a second quantity of the feed fluid from the bioreactor, a portion of the permeate fluid, and a portion of a nutrient fluid, along a second direction opposite to the first direction via the tangential flow filter (abstract). Bhargav teaches there is a need for an enhanced perfusion system having a tangential flow filter and a method for cleaning the tangential flow filter of the perfusion system (paragraph [0006]). Bhargav teaches: the reverse of the feed fluid or the permeate fluid or the nutrient fluid through the tangential flow filter creates a turbulence, thereby reducing clogging of the tangential flow filter; the exemplary techniques enable to extend a life of the single use tangential flow filter and also extend a duration for which the process can be run without interruption; and it is possible to achieve higher cell densities because the tangential flow filter can be cleaned in a sterile manner during the process (paragraph [0070]).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 HENRY H NGUYEN whose telephone number is (571)272-2338. The examiner can normally be reached M-F 7:30A-5:00P.
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/HENRY H NGUYEN/Primary Examiner, Art Unit 1758