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 .
Response to Arguments
Applicant's arguments filed 09/18/2025 have been fully considered but they are not persuasive. Applicant argues that Tabatadze does not teach the claimed infusion line assembly comprising a vascular access device. However, as previously cited, Tabatadze does envision returning the treated blood to a patient. Thus the examiner maintains that Tabatadze includes a generic teaching of an infusion line assembly, but does not explicitly disclose the component parts. Newly cited reference Murata explicitly teaches the component parts of the infusion line assembly as set forth in the rejections of claims 56 and 88 as set forth below.
Applicant argues that the combination of Tabatadze/Mufti/Codisco is improper because the displacement device of Codisco is a pump rather than a part of a conduit. However, the examiner is not modifying the device of Tabatadze/Mufti to include the specific type of pump taught by Codisco but rather the teaching of an additional displacement device separate from the PIC and quencher containers, as set forth in the rejection below. In combination, said displacement device would be the type of device used in Mufti, such as a syringe, which is fully capable of displacing air and liquid.
Applicant further argues that the combination of Tabatadze/Mufti/Codisco/DelGiacco is improper because DelGiacco does not cure the alleged deficiencies of Tabatadze/Mufti. However, the Examiner maintains that the rejection is proper over the cited references as set forth above, and thus the simple substitution taught by DelGiacco is also proper, as set forth in the rejection below.
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 56-57, 59, 62-63, 65, 69, 76-79, 88, 93, 97, 99-100, 109-111, 112-114, 115-117, 118-127, and 134-135 are rejected under 35 U.S.C. 103 as being unpatentable over Tabatadze (US 20210227827 A1) in view of Mufti (US 20110286987 A1), further in view of Codisco (US 20160199831 A1), further in view of Murata (US 20200197588 A1).
Regarding Claim 56, Tabatadze discloses a kit for preparing a pathogen-inactivated whole blood composition (Figure 6, analogous to kit shown in provisional application 62/711241 shown in appendix to the specification, page 36), comprising:
(a) a vascular access device for drawing whole blood from a donor (phlebotomy needle, Fig 6);
(b) a first container suitable for mixing the whole blood and a pathogen inactivation compound (PIC), wherein the first container comprises at least a first inlet and a first outlet (Bag with anticoagulant comprises an inlet for the phlebotomy needle line, and an outlet connected to the line for transferring to the purified blood bag, Fig 6);
(c) a first conduit extending between the vascular access device and the first container and providing a fluid communication path for transferring the whole blood from the donor into the first container (line disposed between phlebotomy needle and bag with anticoagulant, Fig 6); and
(d) a container containing a pathogen inactivation compound (PIC container) (container with formulation of compound of structure 1, Fig 6. Compound of structure 1 inactivates pathogens [abstract][0032]);
(f) an infusion line assembly for infusing a pathogen-inactivated whole blood composition into a subject (Tabatadze envisions transfusion or return of the treated blood to a patient, thus implying an infusion line assembly for infusing the treated blood to a patient. ¶[0332]).
Tabatadze is silent regarding a second conduit, wherein the second conduit is coupled or configured to be coupled at one end to the PIC container, wherein the second conduit is coupled to the first container, configured to be coupled to the first container, or configured to be coupled to the first conduit, thereby providing a fluid communication path between the PIC container and the first container; and wherein the second conduit further comprises a displacement device suitable for increasing transfer of the PIC into the first container; wherein the displacement device displaces air from the displacement device to facilitate the transfer of the PIC; wherein the infusion line assembly comprises a second vascular access device and an infusion line conduit that is coupled or configured to be coupled to a container of the kit.
However, Mufti teaches quenching methods for red blood cell pathogen inactivation, thus from the same field of endeavor, the second conduit is coupled or configured to be coupled at one end to the PIC container, wherein the second conduit is coupled to the first container, configured to be coupled to the first container, or configured to be coupled to the first conduit, thereby providing a fluid communication path between the PIC container and the first container; and wherein the second conduit further comprises a displacement device suitable for increasing transfer of the PIC into the first container; wherein the displacement device displaces air from the displacement device to facilitate the transfer of the PIC (Mufti teaches y-tubing comprising luer adaptors connected to a port of a blood mixing container. A syringe containing pathogen inactivation compound and a syringe containing quencher glutathione may be attached to each luer adaptor and the opposite end attached to the blood mixing container. The syringes containing the pathogen inactivation compound and the quencher are both displacement devices, which are both fully capable of displacing air ¶[0131-0134]) in order to mix the pathogen inactivating compound and the quencher with the blood at the same time, thereby facilitating adequate quenching of the undesired side reaction of the pathogen inactivating compound with the blood. (¶[0051]).
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 kit of Tabatadze so that the second conduit is coupled or configured to be coupled at one end to the PIC container, wherein the second conduit is coupled to the first container, configured to be coupled to the first container, or configured to be coupled to the first conduit, thereby providing a fluid communication path between the PIC container and the first container; and wherein the second conduit further comprises a displacement device suitable for increasing transfer of the PIC into the first container, in order to mix the pathogen inactivating compound and the quencher with the blood at the same time, thereby facilitating adequate quenching of the undesired side reaction of the pathogen inactivating compound with the blood. (as motivated by Mufti ¶[0051]).
Tabatadze/Mufti is silent whether the displacement device is separate from the PIC container; and wherein the infusion line assembly comprises a second vascular access device and an infusion line conduit that is coupled or configured to be coupled to a container of the kit.
However, Codisco teaches blood processing systems and methods, thus from the same field of endeavor, wherein the displacement device is separate from a first container (Fig 2 ¶[0098-0101] Codisco teaches a y type spike connection 232 comprising 3 IV bag spikes 236 that allow multiple products to be introduced into a single tubing line 204, with a pump acting as the displacement device (such as pump 909, Fig 9)) to allow for multiple products to be combined at a predetermined ratio into a common tubing line (¶[0101]).
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 kit of Tabatadze/Mufti so that the displacement device is separate from a first container, as taught by Codisco to allow for multiple products to be combined at a predetermined ratio into a common tubing line (as motivated by Codisco ¶[0101]) In combination, the kit of Tabatadze/Mufti/Codisco would have the PIC in a first container, with the displacement device configuration of Codisco wherein the displacement device is separate from said first container.
Tabatadze/Mufti/Codisco does not explicitly disclose that the infusion line assembly comprises a second vascular access device and an infusion line conduit that is coupled or configured to be coupled to a container of the kit.
However, Murata teaches a perfusion device, thus from the same field of endeavor, wherein the infusion line assembly comprises a second vascular access device and an infusion line conduit that is coupled or configured to be coupled to a container of the kit (Fig 1 ¶[0065] section of tube 30 extending from re-transfusion bag 37 to the vein of the patient, thus implying a second vascular access device) in order to return collected autologous blood to the patient (¶[0062]).
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 kit of Tabatadze/Mufti/Codisco so that the infusion line assembly comprises a second vascular access device and an infusion line conduit that is coupled or configured to be coupled to a container of the kit, as taught by Murata in order to return collected autologous blood to the patient (as motivated by Murata ¶[0062]).
Regarding Claim 57, Tabatadze discloses that the PIC container is configured to be coupled by a fluid communication path to the first container (container with compound of structure 1 is a liquid and is connected to the bag with anticoagulant, Fig 6 ¶[0148]).
Regarding Claim 59, Tabatadze discloses that the PIC container is coupled by a fluid communication path to the first container (container with compound of structure 1 is a liquid and is connected to the bag with anticoagulant, Fig 6 ¶[0148]).
Regarding Claim 62, Tabatadze discloses a container containing a quencher (quencher container) (neutralizer solution acts as a quencher to neutralize the residual compound of the compound of structure 1 ¶[0053]) neutralizer solution container is attached to the bag with anticoagulant, Fig 6 ¶[0150]).
Regarding Claim 63, Tabatadze discloses that the quencher container is configured to be coupled by a fluid communication path to the first container (neutralizer solution container is attached to the bag with anticoagulant, Fig 6 ¶[0150]).
Regarding Claim 65, Tabatadze discloses that the quencher container is coupled by a fluid communication path to the first container (neutralizer solution container is attached to the bag with anticoagulant, Fig 6 ¶[0150]).
Regarding Claim 69, Tabatadze is silent whether the second conduit comprises at one end at least one adaptor for coupling a PIC container to the second conduit.
However, Mufti teaches quenching methods for red blood cell pathogen inactivation, thus from the same field of endeavor, wherein the second conduit comprises at one end at least one adaptor for coupling the PIC container to the second conduit, , (Mufti teaches y-tubing comprising luer adaptors connected to a port of a blood mixing container. A syringe containing pathogen inactivation compound and a syringe containing quencher glutathione may be attached to each luer adaptor and the opposite end attached to the blood mixing container ¶[0131-0134]) in order to mix the pathogen inactivating compound and the quencher with the blood at the same time, thereby facilitating adequate quenching of the undesired side reaction of the pathogen inactivating compound with the blood. (¶[0051]).
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 kit of Tabatadze so that the second conduit comprises at one end at least one adaptor for coupling a PIC container to the second conduit, as taught by Mufti, in order to mix the pathogen inactivating compound and the quencher with the blood at the same time, thereby facilitating adequate quenching of the undesired side reaction of the pathogen inactivating compound with the blood. (as motivated by Mufti ¶[0051]).
Regarding Claim 76, Tabatadze discloses that the first container contains an anticoagulant (bag with anticoagulant, Fig 6).
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Regarding Claim 77, Tabatadze discloses a second container suitable for storing a pathogen-inactivated whole blood composition, wherein the second container comprises at least a first inlet and a first outlet (second container shown in the annotated figure has a first inlet and a first outlet).
Regarding Claim 78, Tabatadze discloses a third conduit extending between the first container and the second container and providing a fluid communication path for transferring a mixture comprising a whole blood composition and a PIC from the first container into the second container (line extending from the bag with anticoagulant to the purified blood container, Fig 6).
Regarding Claim 79, Tabatadze discloses a third container suitable for storing a pathogen-inactivated whole blood composition, wherein the third container comprises at least a first inlet and a first outlet, and wherein the kit further comprises a fourth conduit extending between the second container and the third container and providing a fluid communication path for transferring a mixture comprising a whole blood composition and a PIC from the second container into the third container (See annotated figure, third container 7 has at least one inlet and one outlet, and is coupled to second container 6 via a fluid conduit).
Regarding Claim 109, Tabatadze discloses that the PIC container is configured to be coupled to the first conduit (container for compound of structure 1 is coupled to the first conduit by virtue of its connection with the bag with anticoagulant, Fig 6).
Regarding Claim 110, Tabatadze discloses that the first container further comprises a second inlet and the PIC container is coupled or configured to be coupled by a fluid communication path to the second inlet of the first container (the container for compound of structure 1 is coupled to an inlet of the bag with anticoagulant, Fig 6).
Regarding Claim 111, Tabatadze discloses that the quencher container is configured to be coupled to the first conduit (container for neutralizer is coupled to the first conduit by virtue of its connection with the bag with anticoagulant, Fig 6).
Regarding Claim 115, Tabatadze discloses that the infusion line assembly is configured to be coupled to a first container, a second container or a third container (Tabatadze envisions transfusion or return of the treated blood to a patient, thus implying an infusion line assembly for infusing the treated blood to a patient. This infusion line would necessarily be coupled to one of the blood containers ¶[0332]).
Regarding Claim 116, Tabatadze discloses wherein the infusion line assembly is coupled to the second container (Tabatadze envisions transfusion or return of the treated blood to a patient, thus implying an infusion line assembly for infusing the treated blood to a patient. This infusion line would necessarily be coupled to one of the blood containers, preferably the second container, since the second container holds the purified blood intended for infusion, Fig 6 ¶[0332]).
Regarding Claim 117, Tabatadze/Mufti/Codisco does not explicitly disclose that the infusion line conduit extends between the first outlet of the second container and the second vascular access device, wherein the infusion line conduit provides a fluid communication path for sterilely transferring the pathogen-inactivated whole blood composition from the second container to the vascular access device.
However, Murata teaches a perfusion device, thus from the same field of endeavor, wherein the infusion line conduit extends between the first outlet of the second container and the second vascular access device, wherein the infusion line conduit provides a fluid communication path for sterilely transferring the pathogen-inactivated whole blood composition from the second container to the vascular access device (Fig 1 ¶[0065] section of tube 30 extending from an outlet of re-transfusion bag 37 to the vein of the patient, thus implying a second vascular access device) in order to return collected autologous blood to the patient (¶[0062]).
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 kit of Tabatadze/Mufti/Codisco so that the infusion line conduit extends between the first outlet of the second container and the second vascular access device, wherein the infusion line conduit provides a fluid communication path for sterilely transferring the pathogen-inactivated whole blood composition from the second container to the vascular access device, as taught by Murata in order to return collected autologous blood to the patient (as motivated by Murata ¶[0062]). In combination, the infusion conduit taught by Murata would extend from the second container taught by Tabatadze because the infusion conduit would necessarily be coupled to one of the blood containers, preferably the second container, since the second container holds the purified blood intended for infusion.
Regarding Claim 132, Tabatadze is silent whether the second conduit comprises at one end at least one adaptor for coupling the quencher container to the second conduit.
However, Mufti teaches quenching methods for red blood cell pathogen inactivation, thus from the same field of endeavor, wherein the second conduit comprises at one end at least one adaptor for coupling the quencher to the second conduit (Mufti teaches y-tubing comprising luer adaptors connected to a port of a blood mixing container. A syringe containing pathogen inactivation compound and a syringe containing quencher glutathione may be attached to each luer adaptor and the opposite end attached to the blood mixing container ¶[0131-0134]) in order to mix the pathogen inactivating compound and the quencher with the blood at the same time, thereby facilitating adequate quenching of the undesired side reaction of the pathogen inactivating compound with the blood. (¶[0051]).
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 kit of Tabatadze so that the second conduit comprises at one end at least one adaptor for coupling the quencher container to the second conduit, as taught by Mufti, in order to mix the pathogen inactivating compound and the quencher with the blood at the same time, thereby facilitating adequate quenching of the undesired side reaction of the pathogen inactivating compound with the blood. (as motivated by Mufti ¶[0051]).
Regarding Claims 88 and 93, Tabatadze discloses a kit for preparing a pathogen-inactivated whole blood composition (Figure 6, analogous to kit shown in provisional application 62/711241 shown in appendix to the specification, page 36), comprising:
(a) a first container suitable for mixing a whole blood composition, a pathogen inactivation compound (PIC) and a quencher, wherein the first container comprises at least a first inlet and a first outlet (Bag with anticoagulant comprises an inlet for the phlebotomy needle line, and an outlet connected to the line for transferring to the purified blood bag, Fig 6);
(b) a second container suitable for storing a pathogen-inactivated whole blood composition, wherein the second container comprises at least a first inlet and a first outlet (See annotated figure, third container 7 has at least one inlet and one outlet, and is coupled to second container 6 via a fluid conduit);
(c) a container containing a pathogen inactivation compound (PIC container) (container with formulation of compound of structure 1, Fig 6. Compound of structure 1 inactivates pathogens [abstract][0032]);
(d) a container containing a quencher (quencher container) (neutralizer solution acts as a quencher to neutralize the residual compound of the compound of structure 1 ¶[0053]) neutralizer solution container is attached to the bag with anticoagulant, Fig 6 ¶[0150]) and;
(f) a second conduit extending between the first container and the second container and providing a fluid communication path for transferring the whole blood composition from the first container to the second container (line extending from the bag with anticoagulant to the purified blood container, Fig 6); and
(g) an infusion line assembly for infusing a pathogen-inactivated whole blood composition into a subject (Tabatadze envisions transfusion or return of the treated blood to a patient, thus implying an infusion line assembly for infusing the treated blood to a patient. ¶[0332]).
Tabatadze is silent regarding a first conduit, wherein the first conduit at one end is coupled to or configured to be coupled to the PIC container and the quencher container, and wherein the first conduit further comprises a displacement device suitable for increasing the transfer of the PIC and the quencher into the first container, wherein the first conduit is coupled or configured to be coupled to the first container, providing a fluid communication path between the PIC container and the quencher container and the first container; and wherein the infusion line assembly comprises a vascular access device and an infusion line conduit that is coupled or configured to be coupled to a container of the kit.
However, Mufti teaches quenching methods for red blood cell pathogen inactivation, thus from the same field of endeavor, including a first conduit, wherein the first conduit at one end is coupled to or configured to be coupled to the PIC container and the quencher container, and wherein the first conduit further comprises a displacement device suitable for increasing the transfer of the PIC and the quencher into the first container; wherein the displacement device displaces air from the displacement device to facilitate the transfer of the PIC and the quencher; wherein the first conduit is coupled or configured to be coupled to the first container, providing a fluid communication path between the PIC container and the quencher container and the first container (Mufti teaches y-tubing comprising luer adaptors connected to a port of a blood mixing container. A syringe containing pathogen inactivation compound and a syringe containing quencher glutathione may be attached to each luer adaptor and the opposite end attached to the blood mixing container. The syringes containing the pathogen inactivation compound and the quencher are both displacement devices, which are both fully capable of displacing air ¶[0131-0134]) in order to mix the pathogen inactivating compound and the quencher with the blood at the same time, thereby facilitating adequate quenching of the undesired side reaction of the pathogen inactivating compound with the blood. (¶[0051]).
Therefore, it would have been obvious to modify the kit of Tabatadze to include a first conduit, wherein the first conduit at one end is coupled to or configured to be coupled to the PIC container and the quencher container, and wherein the first conduit further comprises a displacement device suitable for increasing the transfer of the PIC and the quencher into the first container, wherein the first conduit is coupled or configured to be coupled to the first container, providing a fluid communication path between the PIC container and the quencher container and the first container, as taught by Mufti, in order to mix the pathogen inactivating compound and the quencher with the blood at the same time, thereby facilitating adequate quenching of the undesired side reaction of the pathogen inactivating compound with the blood. (as motivated by Mufti ¶[0051]).
Tabatadze/Mufti is silent whether the displacement device is separate from the PIC container and the quencher container; and wherein the infusion line assembly comprises a vascular access device and an infusion line conduit that is coupled or configured to be coupled to a container of the kit.
However, Codisco teaches blood processing systems and methods, thus from the same field of endeavor, wherein the displacement device is separate from a first container and a second container (Fig 2 ¶[0098-0101] Codisco teaches a y type spike connection 232 comprising 3 IV bag spikes 236 that allow multiple products to be introduced into a single tubing line 204, with a pump acting as the displacement device (such as pump 909 in Fig 9)).) to allow for multiple products to be combined at a predetermined ratio into a common tubing line (¶[0101]).
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 kit of Tabatadze/Mufti so that the displacement device is separate from a first container and a second container, as taught by Codisco to allow for multiple products to be combined at a predetermined ratio into a common tubing line (as motivated by Codisco ¶[0101]). In combination, the kit of Tabatadze/Mufti/Codisco would have the PIC in a first container and the quencher in a second container, with the displacement device configuration of Codisco wherein the displacement device is separate from said first container.
Tabatadze/Mufti/Codisco does not explicitly disclose that the infusion line assembly comprises a vascular access device and an infusion line conduit that is coupled or configured to be coupled to a container of the kit.
However, Murata teaches a perfusion device, thus from the same field of endeavor, wherein the infusion line assembly comprises a vascular access device and an infusion line conduit that is coupled or configured to be coupled to a container of the kit (Fig 1 ¶[0065] section of tube 30 extending from re-transfusion bag 37 to the vein of the patient, thus implying a second vascular access device) in order to return collected autologous blood to the patient (¶[0062]).
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 kit of Tabatadze/Mufti/Codisco so that the infusion line assembly comprises a vascular access device and an infusion line conduit that is coupled or configured to be coupled to a container of the kit, as taught by Murata in order to return collected autologous blood to the patient (as motivated by Murata ¶[0062]).
Regarding Claim 97, Tabatadze discloses a second vascular access device for drawing whole blood from a donor and a third conduit extending between the second vascular access device and the first inlet of the first container and providing a fluid communication path for transferring the whole blood from the donor into the first container (phlebotomy needle and line coupling to bag with anticoagulant, Fig 6);
Regarding Claim 99, Tabatadze discloses that the first container contains an anticoagulant (bag with anticoagulant, Fig 6).
Regarding Claim 100, Tabatadze discloses a third container suitable for storing a pathogen-inactivated whole blood composition, wherein the third container comprises a first inlet and a first outlet, and wherein the kit further comprises a fourth conduit extending between the second container and the third container and providing a fluid communication path for transferring the whole blood composition from the second container into the third container (See annotated figure, third container 7 has at least one inlet and one outlet, and is coupled to second container 6 via a fluid conduit).
Regarding Claims 112-114, Tabatadze is silent whether the second conduit comprises at one end a first adaptor for coupling a PIC container to the second conduit and a second adaptor for coupling a quencher container to the second conduit, wherein the second conduit is coupled to the first container, wherein the second conduit is configured to be coupled to the first conduit, providing a fluid communication path between the PIC container and/or quencher container and the first container.
However, Mufti teaches quenching methods for red blood cell pathogen inactivation, thus from the same field of endeavor, wherein the second conduit comprises at one end a first adaptor for coupling a PIC container to the second conduit and a second adaptor for coupling a quencher container to the second conduit, wherein the second conduit is coupled to the first container, wherein the second conduit is configured to be coupled to the first conduit, providing a fluid communication path between the PIC container and/or quencher container and the first container. (Mufti teaches y-tubing comprising luer adaptors connected to a port of a blood mixing container. A syringe containing pathogen inactivation compound and a syringe containing quencher glutathione may be attached to each luer adaptor and the opposite end attached to the blood mixing container ¶[0131-0134]) in order to mix the pathogen inactivating compound and the quencher with the blood at the same time, thereby facilitating adequate quenching of the undesired side reaction of the pathogen inactivating compound with the blood (¶[0051]).
Therefore, it would have been obvious to modify the kit of Tabatadze so that the second conduit comprises at one end a first adaptor for coupling a PIC container to the second conduit and a second adaptor for coupling a quencher container to the second conduit, wherein the second conduit is coupled to the first container, wherein the second conduit is configured to be coupled to the first conduit, providing a fluid communication path between the PIC container and/or quencher container and the first container, as taught by Mufti, in order to mix the pathogen inactivating compound and the quencher with the blood at the same time, thereby facilitating adequate quenching of the undesired side reaction of the pathogen inactivating compound with the blood. (as motivated by Mufti ¶[0051]) In combination, the second conduit taught by Mufti would be coupled to the first conduit by virtue of its connection to the first container.
Regarding Claims 118-124, Tabatadze is silent whether the first conduit further comprises at least one adaptor for coupling the first conduit to the PIC container and the quencher container, wherein the first conduit comprises a first adaptor for coupling the PIC container to the first conduit and a second adaptor for coupling the quencher container to the first conduit, wherein the first conduit is coupled to the PIC container and the quencher container, wherein the first conduit is configured to be coupled to an inlet of the first container, wherein the first conduit is coupled to an inlet of the first container, the first container further comprises a second inlet, and wherein the first conduit is coupled or configured to be coupled to the second inlet of the first container, wherein the first conduit is configured to be coupled to the third conduit, providing a fluid communication path between the PIC container and the quencher container and the first container.
However, Mufti teaches quenching methods for red blood cell pathogen inactivation, thus from the same field of endeavor, the first conduit further comprises at least one adaptor for coupling the first conduit to the PIC container and the quencher container, wherein the first conduit comprises a first adaptor for coupling the PIC container to the first conduit and a second adaptor for coupling the quencher container to the first conduit, wherein the first conduit is coupled to the PIC container and the quencher container, wherein the first conduit is configured to be coupled to an inlet of the first container, wherein the first conduit is coupled to an inlet of the first container, the first container further comprises a second inlet, and wherein the first conduit is coupled or configured to be coupled to the second inlet of the first container, wherein the first conduit is configured to be coupled to the third conduit, providing a fluid communication path between the PIC container and the quencher container and the first container (Mufti teaches y-tubing comprising luer adaptors connected to a port of a blood mixing container. A syringe containing pathogen inactivation compound and a syringe containing quencher glutathione may be attached to each luer adaptor and the opposite end attached to an inlet of the blood mixing container ¶[0131-0134]) in order to mix the pathogen inactivating compound and the quencher with the blood at the same time, thereby facilitating adequate quenching of the undesired side reaction of the pathogen inactivating compound with the blood (¶[0051]).
Therefore, it would have been obvious to modify the kit of Tabatadze so that the first conduit further comprises at least one adaptor for coupling the first conduit to the PIC container and the quencher container, wherein the first conduit comprises a first adaptor for coupling the PIC container to the first conduit and a second adaptor for coupling the quencher container to the first conduit, wherein the first conduit is coupled to the PIC container and the quencher container, wherein the first conduit is configured to be coupled to an inlet of the first container, wherein the first conduit is coupled to an inlet of the first container, the first container further comprises a second inlet, and wherein the first conduit is coupled or configured to be coupled to the second inlet of the first container, wherein the first conduit is configured to be coupled to the third conduit, providing a fluid communication path between the PIC container and the quencher container and the first container, as taught by Mufti in order to mix the pathogen inactivating compound and the quencher with the blood at the same time, thereby facilitating adequate quenching of the undesired side reaction of the pathogen inactivating compound with the blood (as motivated by Mufti ¶[0051]). In combination, the first conduit taught by Mufti would be coupled to the third conduit of Tabatadze by virtue of its connection to the first container.
Regarding Claim 125, Tabatadze discloses that the infusion line assembly is configured to be coupled to a first container, a second container or a third container (Tabatadze envisions transfusion or return of the treated blood to a patient, thus implying an infusion line assembly for infusing the treated blood to a patient. This infusion line would necessarily be coupled to one of the blood containers ¶[0332]).
Regarding Claim 126, Tabatadze discloses wherein the infusion line assembly is coupled to the second container (Tabatadze envisions transfusion or return of the treated blood to a patient, thus implying an infusion line assembly for infusing the treated blood to a patient. This infusion line would necessarily be coupled to one of the blood containers, preferably the second container, since the second container holds the purified blood intended for infusion, Fig 6 ¶[0332]).
Regarding Claim 127, Tabatadze/Mufti/Codisco does not explicitly disclose that the infusion line conduit extends between the first outlet of the second container and the vascular access device of the infusion line assembly, wherein the infusion line conduit provides a fluid communication path for sterilely transferring the pathogen-inactivated whole blood composition from the second container to the vascular access device.
However, Murata teaches a perfusion device, thus from the same field of endeavor, wherein the infusion line conduit extends between the first outlet of the second container and the vascular access device of the infusion line assembly, wherein the infusion line conduit provides a fluid communication path for sterilely transferring the pathogen-inactivated whole blood composition from the second container to the vascular access device (Fig 1 ¶[0065] section of tube 30 extending from an outlet of re-transfusion bag 37 to the vein of the patient, thus implying a second vascular access device) in order to return collected autologous blood to the patient (¶[0062]).
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 kit of Tabatadze/Mufti/Codisco so that the infusion line conduit extends between the first outlet of the second container and the vascular access device of the infusion line assembly, wherein the infusion line conduit provides a fluid communication path for sterilely transferring the pathogen-inactivated whole blood composition from the second container to the vascular access device, as taught by Murata in order to return collected autologous blood to the patient (as motivated by Murata ¶[0062]). In combination, the infusion conduit taught by Murata would extend from the second container taught by Tabatadze because the infusion conduit would necessarily be coupled to one of the blood containers, preferably the second container, since the second container holds the purified blood intended for infusion.
Regarding Claim 133, Tabatadze/Mufti does not explicitly disclose that the PIC container and the quencher container are the same container.
However, Mufti teaches quenching methods for red blood cell pathogen inactivation, thus from the same field of endeavor, wherein it would be beneficial to add the quencher solution and the pathogen inactivation compound to the first container thereby facilitating adequate quenching of the undesired side reaction of the pathogen inactivating compound with the blood (Mufti ¶[0051]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the PIC container and the quencher container be the same container because it would have been obvious to try (as set forth in MPEP 2143 I.(E)) since there are a finite number of identified, predictable solutions to this problem (either using separate containers for PIC and quencher, or using one container containing both PIC and quencher), and one of ordinary skill would have a reasonable expectation of success based on the teachings of Mufti, wherein it is desirable to add the PIC and quencher at the same time (as motivated by Mufti ¶[0051]).
Regarding Claim 134, Tabatadze discloses wherein the infusion line assembly is configured to be coupled to the second container (Tabatadze envisions transfusion or return of the treated blood to a patient, thus implying an infusion line assembly for infusing the treated blood to a patient. This infusion line would necessarily be coupled to one of the blood containers, preferably the second container, since the second container holds the purified blood intended for infusion, Fig 6 ¶[0332]).
Regarding Claim 135, Tabatadze discloses wherein the infusion line assembly is configured to be coupled to the second container (Tabatadze envisions transfusion or return of the treated blood to a patient, thus implying an infusion line assembly for infusing the treated blood to a patient. This infusion line would necessarily be coupled to one of the blood containers, preferably the second container, since the second container holds the purified blood intended for infusion, Fig 6 ¶[0332]).
Claims 128-131 are rejected under 35 U.S.C. 103 as being unpatentable over Tabatadze (US 20210227827 A1) in view of Mufti (US 20110286987 A1), in view of Codisco (US 20160199831 A1), further in view of Murata (US 20200197588 A1), further in view of DelGiacco (US 20130327712 A1), with evidence from Hamman (US 20150111277 A1).
Regarding Claims 128-129, Tabatadze/Mufti/Codisco is silent whether the displacement device is a sample diversion pouch, an air pillow, or a sampling pouch.
However, DelGiaccio teaches a system for treating a blood sample (¶[0001]), thus from the same field of endeavor, wherein the displacement device is a sample diversion pouch or sampling pouch (sampling pouches 71 and 72, Fig 10 ¶[0096]), in order to obtain pre and post-cryoprotectant samples if desired (¶[0096]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to simply substitute the displacement device of Tabatadze/Mufti/Codisco with the sampling pouches as taught by DelGiacco, because both are well known in the art (DelGiacco lists both sampling pouches and syringes as structural equivalents in DelGiacco ¶[0075], and evidentiary reference Hamman lists peristaltic pumps, syringe pumps, rotary pumps, and pressure infusors as structural equivalents in Hamman ¶[0066]). Furthermore, Applicant’s specification ¶[0123] lists sample pouches, syringes, and flexible containers as suitable displacement devices) and would produce the predictable result of obtaining pre and post treatment samples if desired (as motivated by DelGiacco ¶[0096]).
Regarding Claims 130-131, Tabatadze/Mufti/Codisco is silent whether the displacement device is a sample diversion pouch, an air pillow, or a sampling pouch.
However, DelGiaccio teaches a system for treating a blood sample (¶[0001]), thus from the same field of endeavor, wherein the displacement device is a sample diversion pouch or sampling pouch (sampling pouches 71 and 72, Fig 10 ¶[0096]), in order to obtain pre and post-cryoprotectant samples if desired ¶[0096]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to simply substitute the displacement device of Tabatadze/Mufti/Codisco with the sampling pouches as taught by DelGiacco, because both are well known in the art (DelGiacco lists both sampling pouches and syringes as structural equivalents in DelGiacco ¶[0075], and evidentiary reference Hamman lists peristaltic pumps, syringe pumps, rotary pumps, and pressure infusors as structural equivalents in Hamman ¶[0066]). Furthermore, Applicant’s specification ¶[0123] lists sample pouches, syringes, and flexible containers as suitable displacement devices) and would produce the predictable result of obtaining pre and post treatment samples if desired (as motivated by DelGiacco ¶[0096]).
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.
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/TIMOTHY L FLYNN/Examiner, Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781