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 .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: See table.
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.
Claim
Generic Placeholder
Functional Language
Corresponding Structure
11
device
convection
Stirring mechanism in the interior; a tilting mechanism to which the container is coupled (Spec page 11, last paragraph)
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.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: See table.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
Claim
Generic Placeholder
Functional Language
Corresponding Structure
7
device
exchange
Inlet line and outlet line; cannula; pump (in claim)
12
device
convection
Stirring or tilting mechanism (in claim)
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
Response to Arguments
Applicant's arguments filed 09/02/2025 have been fully considered but they are not persuasive. Applicant argues that the cited references do not teach that the biological cell material comprises a composition of cell material which contains different cell types which carry characteristic HL antigens from a predetermined reference group of subjects. However, Zhao teaches the use of human leukocyte antigens as possible biological cell material (Zhao ¶[0061] stem cells may express leukocyte common antigen CD45), and Lunyak teaches the importance of incorporating different cell types from a predetermined reference group of subjects (Lunyak ¶[0055] input cells may comprise a heterogenous mixture of cells from more than one individual) to customize the input cells in order to control the subsequent factor production (as motivated by Lunyak ¶[0055]). Thus, in combination one of ordinary skill would arrive at the claimed invention in light of Zhao/Akers/Lunyak as set forth in the rejection below.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5, 7, 15, 17-18, 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Zhao (US 20120277652 A1) in view of Akers (US 20040110273 A1), further in view of Lunyak (US 20180161373 A1).
Regarding Claim 1, Zhao discloses a treatment apparatus which is designed for extracorporeal blood treatment of blood from a subject for an immunotolerance enhancement of the subject (stem cell reactor 16, 30, Figs 1 and 3), comprising: - at least one container (chamber 32, Fig 3 ¶[0102]) which has an interior for receiving a blood sample of blood from the subject (fluid pathway between fluid conduits 31 and 39, Fig 3) and an exchange device which is designed to supply and/or discharge the blood sample into or out of an interior of the at least one container (fluid conduits 31 and 39, Fig 3), and - a cell exposure device which is positioned in the at least one container and has biological cell material with surface molecules (stem cells 36 on the outer surface of tubular membrane 37, Fig 3), wherein the biologicalthe blood sample (stem cells 36 may be anywhere in the chamber 32, Fig 3 ¶[0102]), comprising a reaction of endogenous immune cells in the blood with the surface molecules of the biological cell material (lymphocytes flowing from conduit 31 and out of conduit 39 react with the stem cells 36 in the chamber 32 to activate Treg cells ¶[0102]), wherein the exchange device comprises an inlet line and an outlet line which are in fluidic connection with the interior (fluid lines 31 and 39, Fig 3), and the biological cell material comprises characteristic HL antigens (¶[0061] stem cells may express leukocyte common antigen CD45).
Zhao is silent whether the at least one container is at least one vessel capable of being closed to its surroundings during the extracorporeal treatment, and the inlet line and the outlet line each contain a closable valve for separating the interior of the at least one container from the surroundings during the treatment of the blood sample, and whether the biological cell material comprises a composition of cell material which contains different cell types from a predetermined reference group of subjects.
However, Akers teaches a biologic culture chamber, thus from the same field of endeavor, wherein the at least one container is at least one vessel capable of being closed to its surroundings during the cell culture process (culture chamber 10 is sealed by two end pieces 11, creating an enclosed space, Fig 1 ¶[0038]), and the inlet line (inlet tubing 72, Fig 1) and the outlet line (outlet tubing 71, Fig 1) each contain a closable valve (each of the inlet tubing 72 and outlet tubing 71 include a valve 60, Fig 1) for separating the interior of the at least one container from the surroundings (valves 60 may control fluid flow into and out of chamber 10, Fig 1 ¶[0039]) during the treatment of the blood sample so that the entry and exit of media is controlled, allowing controlled delivery of nutrient fluid and removal of waste fluid (¶[0039][0050]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Zhao so that the at least one container is at least one vessel capable of being closed to its surroundings during the cell culture process, and the inlet line and the outlet line each contain a closable valve for separating the interior of the at least one container from the surroundings during the treatment of the blood sample, as taught by Akers so that the entry and exit of media is controlled, allowing controlled delivery of nutrient fluid and removal of waste fluid (as motivated by Akers ¶[0039][0050]). In combination, the valves taught by Akers would be fully capable of being used during the extracorporeal blood treatment of Zhao.
Zhao/Akers is silent whether the biological cell material comprises a composition of cell material which contains different cell types from a predetermined reference group of subjects.
However, Lunyak teaches the use of stem cell therapy in an extracorporeal device (¶[0272]), thus from the same field of endeavor, wherein the biological cell material comprises a composition of cell material which contains different cell types from a predetermined reference group of subjects (¶[0055] input cells may comprise a heterogenous mixture of cells from more than one individual) to produce strong suppression of inflammation and autoimmune response and provide immunomodulation to influence T-cell production, and to customize the input cells in order to control the subsequent factor production (¶[0002][0018][0055]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Zhao/Akers so that the biological cell material comprises a composition of cell material which contains different cell types from a predetermined reference group of subjects, as taught by Lunyak to produce strong suppression of inflammation and autoimmune response and provide immunomodulation to influence T-cell production and to customize the input cells in order to control the subsequent factor production (as motivated by Lunyak ¶[0002][0018][0055]). In combination, the biological cell material of Zhao/Akers/Lunyak would include a composition of cell material which contains different cell types which carry characteristic HL antigens from a predetermined reference group of subjects.
Regarding Claim 2, Zhao/Akers/Lunyak discloses that the cell exposure device has a separating layer, wherein the biological cell material is separated from the interior by the separating layer and the biological cell material is held on the cell exposure device and the separating layer is designed for a substance exchange between the biological cell material and the blood sample (one or more membranes 37 may isolate the lymphocytes from direct contact with the stem cells 36, thus the one or more membranes act as a separating layer. ¶[0102])
Regarding Claim 3, Zhao/Akers/Lunyak discloses that the cell exposure device has a support on which the biological cell material is arranged in an adherent state (a population of stem cells may be attached to a positively charged substrate surface ¶[0105]).
Regarding Claim 4, Zhao/Akers/Lunyak discloses that the support has a binding layer which is designed for an adherent binding of at least one of induced pluripotent stem cells (iPS cells), adult stem cells and cells differentiated therefrom (stem cells may be adhered to one surface on the porous membrane, thus implying a binding layer ¶[0112]).
Regarding Claim 5, Zhao/Akers/Lunyak discloses that the cell exposure device has a suspension space (chamber 32 houses cultured stem cells 36 in a circulating stem cell nutrient medium, Fig 3 ¶[0102]) in which the biological cell material is arranged in at least one of a suspended state and on carrier beads (stem cells 36 may be anywhere in the chamber 32, such as suspended in the nutrient medium, or within a plurality of microcarriers, Fig 3 ¶[0102][0105]).
Regarding Claim 7, Zhao/Akers/Lunyak discloses that the exchange device comprises at least one of a cannula which is designed for direct connection to the circulation of the subject (fluid conduit 12 is directly connected to the patient 2 to extract blood therefrom, Fig 1 ¶[0100]), and a pump which is arranged for blood transport into or out of the container (blood is extracted from the patient 2 with a pump ¶[0100]).
Regarding Claim 15, Zhao/Akers/Lunyak discloses at least one of - active substances which promote the development of immunotolerance, active substances which promote regulatory T cells (¶[0017] describes different active substances to activate Treg cells).
Regarding Claim 17, Zhao/Akers/Lunyak discloses a kit for extracorporeal blood treatment (system 10, Fig 1), comprising at least one treatment apparatus according to claim 1 (system 10 includes the treatment apparatus as set forth above for claim 1).
Regarding Claim 18, Zhao/Akers/Lunyak discloses a method ([abstract]) for operating a treatment apparatus according to claim 1 for extracorporeal blood treatment of blood from a subject for an immunotolerance enhancement of the subject (see above for claim 1), comprising the steps of - providing a blood sample to be treated of blood from the subject (blood may be drawn from a patient 2, Fig 1), - introducing the blood sample into the at least one container of the treatment apparatus (blood flows to stem cell reactor 16, 30, Fig 1), - treating the blood sample by an interaction, comprising a reaction of
Regarding Claim 20, Zhao/Akers/Lunyak discloses that the treatment apparatus is connected to the circulation of the subject, wherein - the blood to be treated flows as the blood sample into the treatment apparatus and back out therefrom into the circulation (Fig 1 shows blood flowing from patient 2 through the system 10 and returning via fluid return conduit 18).
Regarding Claim 21, Zhao/Akers/Lunyak discloses that the blood sample is moved during the treatment in the treatment apparatus (the sample moves as it flows into and out of the reactor 30 via fluid conduits 31 and 39, Fig 3 ¶[0102]).
Regarding Claim 22, Zhao/Akers/Lunyak discloses that adjusting at least one of an amount and a concentration of the biological cell material in the treatment apparatus depending on a given or achieved immunotolerance of the subject (Zhao envisions various concentrations of stem cells in the reactor chamber ¶[0108]).
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Zhao (US 20120277652 A1) in view of Akers (US 20040110273 A1), in view of Lunyak (US 20180161373 A1), further in view of Humes (US 20070269489 A1).
Regarding Claim 8, Zhao/Akers/Lunyak is silent regarding a retaining device which is arranged for retaining the biological cell material in the container.
However, Humes teaches an extracorporeal blood treatment system, thus from the same field of endeavor, with a retaining device which is arranged for retaining the biological cell material in the container (filter 44 assists in retaining cells within body 34, Fig 4) to prevent large blood constituents from causing an undesired immune response with the cells (¶[0041]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Zhao/Akers/Lunyak to include a retaining device which is arranged for retaining the biological cell material in the container, as taught by Humes to prevent large blood constituents from causing an undesired immune response with the cells (as motivated by Humes ¶[0041]).
Regarding Claim 9, Zhao/Akers/Lunyak is silent whether the retaining device has a mechanically- or chemically-acting filter.
However, Humes teaches an extracorporeal blood treatment system, thus from the same field of endeavor, wherein the retaining device has a mechanically- or chemically-acting filter (filter 44 is a mechanically acting porous filter, Fig 4 ¶[0017]) to prevent large blood constituents from causing an undesired immune response with the cells (¶[0041]).
Therefore, it would have been obvious to modify the device of Zhao/Akers/Lunyak so that the retaining device has a mechanically- or chemically-acting filter, as taught by Humes to prevent large blood constituents from causing an undesired immune response with the cells (as motivated by Humes ¶[0041]).
Regarding Claim 10¸ Zhao/Akers/Lunyak is silent whether the retaining device is part of the exchange device.
However, Humes teaches an extracorporeal blood treatment system, wherein the retaining device is part of the exchange device (filter 44 may be located upstream or at the downstream outlet of the device, and thus is part of the inlet or outlet of the device ¶[0041]) to prevent large blood constituents from causing an undesired immune response with the cells (¶[0041]).
Therefore, it would have been obvious to modify the device of Zhao/Akers/Lunyak so that the retaining device is part of the exchange device, as taught by Humes to prevent large blood constituents from causing an undesired immune response with the cells (as motivated by Humes ¶[0041]).
Claims 11, 12, 14, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Zhao (US 20120277652 A1) in view of Akers (US 20040110273 A1), in view of Lunyak (US 20180161373 A1), further in view of Gorsuch (US 20020188240 A1).
Regarding Claim 11, Zhao/Akers/Lunyak is silent regarding a convection device which is designed for moving the blood sample in the interior of the at least one container.
However, Gorsuch teaches a cell therapy bioreactor, thus from the same field of endeavor, with a convection device which is designed for moving the blood sample in the interior of the at least one container (fluid circulator may be used within the bioreactor which can be a stirrer, turbine, pump, etc. ¶[0019]) to ensure proper mixing of the culture media within the bioreactor (¶[0019]).
Therefore, it would have been obvious to modify the device of Zhao/Akers/Lunyak to include a convection device which is designed for moving the blood sample in the interior of the at least one container, as taught by Gorsuch to ensure proper mixing of the culture media within the bioreactor (as motivated by Gorsuch ¶[0019]).
Regarding Claim 12, Zhao/Akers/Lunyak is silent whether the convection device comprises at least one of a stirring mechanism in the interior and a tilting mechanism, to which the at least one container is coupled.
However, Gorsuch teaches a cell therapy bioreactor, thus from the same field of endeavor, wherein the convection device comprises at least one of a stirring mechanism in the interior and a tilting mechanism, to which the at least one container is coupled (fluid circulator may be used within the bioreactor which can be a stirrer, turbine, pump, etc. ¶[0019]) to ensure proper mixing of the culture media within the bioreactor (¶[0019]).
Therefore, it would have been obvious to modify the device of Zhao/Akers/Lunyak so that the convection device comprises at least one of a stirring mechanism in the interior and a tilting mechanism, to which the at least one container is coupled, as taught by Gorsuch to ensure proper mixing of the culture media within the bioreactor (as motivated by Gorsuch ¶[0019]).
Regarding Claim 14, Zhao/Akers/Lunyak is silent regarding a plurality of containers each with an exchange device and a cell exposure device, which has biological cell material, wherein - the containers contain different types of biological material.
However, Gorsuch teaches a cell therapy bioreactor, thus from the same field of endeavor, with a plurality of containers each with an exchange device and a cell exposure device, which has biological cell material, wherein - the containers contain different types of biological material (Gorsuch describes the use of a secondary bioreactor after the use of a first bioreactor, both of which would have cell colonies and cell products as well as a plasma return conduit ¶[0022]) in order to further expand the cell and tissue colonies for harvesting and later use (¶[0022]).
Therefore, it would have been obvious to modify the device of Zhao/Akers/Lunyak to include a plurality of containers each with an exchange device and a cell exposure device, which has biological cell material, wherein - the containers contain different types of biological material, as taught by Gorsuch in order to further expand the cell and tissue colonies for harvesting and later use (as motivated by Gorsuch ¶[0022]).
Regarding Claim 16, Zhao/Akers/Lunyak is silent regarding at least one of - a measuring device which is designed to detect substances from the blood sample which are bound to the biological cell material, and - a collecting device which is designed to collect substances from the blood sample which are bound to the biological cell material.
However, Gorsuch teaches a cell therapy bioreactor, thus from the same field of endeavor, with a collecting device which is designed to collect substances from the blood sample which are bound to the biological cell material (container 11 collects metabolites and other components separated within culture product refinement apparatus 9, Fig 1 ¶[0023]) in order to provide an optimum plasma mix for return to the patient in compliance with demands of the specific therapy desired (¶[0023]).
Therefore, it would have been obvious to modify the device of Zhao/Akers/Lunyak to include a collecting device which is designed to collect substances from the blood sample which are bound to the biological cell material, as taught by Gorsuch in order to provide an optimum plasma mix for return to the patient in compliance with demands of the specific therapy desired (as motivated by Gorsuch ¶[0023]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Zhao (US 20120277652 A1) in view of Akers (US 20040110273 A1), in view of Lunyak (US 20180161373 A1), further in view of Gorsuch (US 20020188240 A1), further in view of Ward (US 20110184377 A1).
Regarding Claim 13, Zhao/Akers/Lunyak/Gorsuch is silent whether the at least one container has a flexible container wall.
However, Ward teaches an extracorporeal blood treatment device, thus from the same field of endeavor, wherein the at least one container has a flexible container wall (Ward describes a convection device (pump) acting externally on a flexible container ¶[0002]) to provide adequate adsorptive capacity while also allowing high flow rates of blood (¶[0002]).
Therefore, it would have been obvious to modify the device of Zhao/Akers/Lunyak/Gorsuch so that the at least one container has a flexible container wall, as taught by Ward to provide adequate adsorptive capacity while also allowing high flow rates of blood by using an external pump (as motivated by Ward¶[0002]).
Claims 19 and 24 is rejected under 35 U.S.C. 103 as being unpatentable over Zhao (US 20120277652 A1) in view of Akers (US 20040110273 A1), in view of Lunyak (US 20180161373 A1), further in view of Robinson (US 6695803 B1).
Regarding Claim 19, Zhao/Akers/Lunyak is silent whether the blood sample to be treated, is at least one of provided in a supply reservoir, and discharged into a collection reservoir.
However, Robinson teaches a blood processing system, thus from the same field of endeavor, wherein the blood sample to be treated, is at least one of provided in a supply reservoir, and discharged into a collection reservoir (Blood treatment system 2A includes a blood bag 196 and blood reservoir 164, Fig 12) which allows for a greater variety of blood treatments, such as blood collection, autotransfusion, thawed blood processing, thus reducing costs (Col 5 ln 9-23).
Therefore, it would have been obvious to modify the method of Zhao/Akers/Lunyak so that the blood sample to be treated, is at least one of provided in a supply reservoir, and discharged into a collection reservoir, as taught by Robinson, which allows for a greater variety of blood treatments, such as blood collection, autotransfusion, thawed blood processing, thus reducing costs (as motivated by Robinson Col 5 ln 9-23).
Regarding Claim 24, Zhao/Akers/Lunyak is silent whether a blood donation from the subject is at least one of provided in a supply reservoir and discharged into a collection reservoir.
However, Robinson teaches a blood processing system, thus from the same field of endeavor, wherein - a blood donation from the subject is at least one of provided in a supply reservoir and discharged into a collection reservoir (Blood treatment system 2A includes a blood bag 196 and blood reservoir 164, Fig 12) which allows for a greater variety of blood treatments, such as blood collection, autotransfusion, thawed blood processing, thus reducing costs. (Col 5 ln 9-23).
Therefore, it would have been obvious to modify the method of Zhao/Akers/Lunyak so that a blood donation from the subject is at least one of provided in a supply reservoir and discharged into a collection reservoir, as taught by Robinson, which allows for a greater variety of blood treatments, such as blood collection, autotransfusion, thawed blood processing, thus reducing costs (as motivated by Robinson Col 5 ln 9-23).
Claims 23 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Zhao (US 20120277652 A1) in view of Akers (US 20040110273 A1), in view of Lunyak (US 20180161373 A1), further in view of Humes (US 20110190679 A1).
Regarding Claim 23, Zhao/Akers/Lunyak is silent whether the treatment apparatus is provided in a frozen state and is thawed before the blood sample is introduced into the container of the treatment apparatus.
However, Humes teaches an extracorporeal cell-based therapy device, thus from the same field of endeavor, wherein the treatment apparatus is provided in a frozen state and is thawed before the blood sample is introduced into the container of the treatment apparatus (extracorporeal cell-based therapeutic device 190 is frozen at manufacture and thawed prior to use by a medical professional ¶[0136][0144]) in order to maintain cell viability (¶[0136]).
Therefore, it would have been obvious to modify the method of Zhao/Akers/Lunyak so that the treatment apparatus is provided in a frozen state and is thawed before the blood sample is introduced into the container of the treatment apparatus, as taught by Humes in order to maintain cell viability (as motivated by Humes ¶[0136]).
Regarding Claim 25, Zhao/Akers/Lunyak is silent whether the cell exposure device with the biological cell material is provided in a frozen state and is thawed before the blood sample is introduced into the at least one container of the treatment apparatus.
However, Humes teaches an extracorporeal cell-based therapy device, thus from the same field of endeavor, wherein the cell exposure device with the biological cell material is provided in a frozen state and is thawed before the blood sample is introduced into the at least one container of the treatment apparatus (extracorporeal cell-based therapeutic device 190 along with cell material is frozen at manufacture and thawed prior to use by a medical professional ¶[0136][0144]) in order to maintain cell viability (¶[0136]).
Therefore, it would have been obvious to modify the method of Zhao/Akers/Lunyak so that the cell exposure device with the biological cell material is provided in a frozen state and is thawed before the blood sample is introduced into the at least one container of the treatment apparatus, as taught by Humes in order to maintain cell viability (as motivated by Humes ¶[0136]).
Conclusion
THIS ACTION IS MADE FINAL. 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 TIMOTHY LEE FLYNN whose telephone number is (571)272-8255. The examiner can normally be reached Monday-Friday 7:30-5 ET.
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/TIMOTHY L FLYNN/Examiner, Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781