NON-FINAL 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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6 January 2025 has been entered.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Response to Arguments
Applicant’s arguments with respect to claims 1, 5, 6, 11, and 16 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 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.
Claims 1, 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Drucker (U.S. Patent No. 3,743,174) as evidenced by Feix et al. (Feix, T., Bullock, I. M., & Dollar, A. M. (2014). Analysis of Human Grasping Behavior: Object Characteristics and Grasp Type. IEEE Transactions on Haptics, 7(3), 311–323. https://doi.org/10.1109/toh.2014.2326871, hereinafter Feix), and further in view of Goodwin et al. (U.S. Patent No. 9,073,650, hereinafter Goodwin).
Regarding claim 1, Drucker discloses a method for separating a suspension (Abstract), the method comprising: dispensing a liquid suspension into a compartment of a first bag assembly (plastic bag 16, Fig. 1); and rotating the first bag assembly using a centrifuge so as to at least partially separate the suspension, the first bag assembly being disposed within a first insert (cup 12, Fig. 1) that is housed within a first cavity (space between trunnion rings 14, Fig. 1) of a rotor (rotor 10, Fig. 1) of the centrifuge, the first insert having an open transverse cross section that is oval or elliptical (the cup has an oval cross section, see Fig. 4), and the first insert having an annular lip portion that freely projects out of the first cavity of the rotor (the cup is supported in the trunnion ring by a lip formed at the top of the cup”, col. 2 lines 21-29), but does not disclose dispensing a liquid suspension from a first container, through a manifold, and into a compartment of each of a plurality of bag assemblies that are each fluid coupled with the manifold; the lip projects out of the first cavity of the rotor by a distance of at least 1 cm.
While Drucker does not teach the specific length of the projection of the lip portion out of the cavity of the rotor, Drucker teaches that the lip projection “permits the cup to be removable from the ring, so that at the end of the centrifuge action, the cup 12 and the bag 16 may be removed together from the apparatus, and the bag later removed from the cup under circumstances wherein there is less chance of disturbing the precipitate in the bag” (col. 2 lines 21-30). Thus it would have been obvious to one of ordinary skill in the art to configure the lip portion with a dimension that would allow the user to grasp and lift the insert out of the cavity, such as at least 1 cm. For example, Feix et al. discloses dimensions of various objects that can be grasped by the human hand including 1 cm and 2 cm (Table 2). Given the teaching of Feix et al., it would have been obvious to determine the optimum dimension of the lip portion of Drucker needed for the user to install and remove the inserts from the cavity of the rotor, such as in the claimed ranges of at least 1 cm. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover optimum or workable ranges by routine experimentation. In re Aller, 220 F.20 454, 456, 105 USPO 233, 238 (CCPA 1955); In re Swain et al., 70 USPQ 412; Minnesota Mining and Mfg. Co. v. Coe, 38 USPQ 213; Allen et al. v. Coe, 57 USPQ 136; MPEP 2144.05(II)(A). Note that the specification contains no disclosure of either the critical nature of the claimed range or any unexpected results arising therefrom. Where patentability is said to be based upon particular chosen dimensions or upon another variable recited in a claim, the Applicant must show that the chosen dimensions are critical. In re Woodruff, 919 f.2d 1575, 1578, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990).
Goodwin discloses dispensing a liquid suspension from a first container (dispensing container 102, Fig. 1), through a manifold (108, Fig. 1), and into a compartment of each of a plurality of bag assemblies (receiving containers 110, Fig. 1) that are each fluid coupled with the manifold (Fig. 1-2, col. 1 lines 18-21). It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the method of Drucker with the manifold dispensing to each of multiple bags as taught by Goodwin for the purpose of simultaneously dispensing sterile liquid product from a storage container into a plurality of smaller containers, generally bags, that are then used for processing, testing or other purposes (col. 1 lines 18-21, Goodwin).
Regarding claim 4, the combination of Drucker, Feix, and Goodwin discloses wherein the first bag assembly (plastic bag 16, Fig. 1, Drucker) is positioned within the first cavity of the rotor by first inserting the first bag assembly within a cavity of the first insert (cup 12, Fig. 1, Drucker) and then placing the first insert within the first cavity (space between trunnion rings 14, Fig. 1, Drucker) of the rotor.
Regarding claim 5, Drucker discloses a method for separating a suspension (Abstract), the method comprising: dispensing a liquid suspension into a compartment of a first bag assembly (plastic bag 16, Fig. 1); and rotating the first bag assembly using a centrifuge so as to at least partially separate the suspension, the first bag assembly being disposed within a first insert (cup 12, Fig. 1) that is housed within a first cavity (space between trunnion rings 14, Fig. 1) of a rotor (rotor 10, Fig. 1) of the centrifuge, the first insert having an open transverse cross section that is oval or elliptical (the cup has an oval cross section, see Fig. 4), and the first insert having an annular lip portion that freely projects out of the first cavity of the rotor (the cup is supported in the trunnion ring by a lip formed at the top of the cup”, col. 2 lines 21-29), but does not disclose dispensing a liquid suspension from a first container, through a manifold, and into a compartment of each of a plurality of bag assemblies that are each fluid coupled with the manifold; the lip projects out of the first cavity of the rotor by a distance of at least 2 cm.
While Drucker does not teach the specific length of the projection of the lip portion out of the cavity of the rotor, Drucker teaches that the lip projection “permits the cup to be removable from the ring, so that at the end of the centrifuge action, the cup 12 and the bag 16 may be removed together from the apparatus, and the bag later removed from the cup under circumstances wherein there is less chance of disturbing the precipitate in the bag” (col. 2 lines 21-30). Thus it would have been obvious to one of ordinary skill in the art to configure the lip portion with a dimension that would allow the user to grasp and lift the insert out of the cavity, such as at least 1 cm. For example, Feix et al. discloses dimensions of various objects that can be grasped by the human hand including 1 cm and 2 cm (Table 2). Given the teaching of Feix et al., it would have been obvious to determine the optimum dimension of the lip portion of Drucker needed for the user to install and remove the inserts from the cavity of the rotor, such as in the claimed ranges of at least 2 cm. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover optimum or workable ranges by routine experimentation. In re Aller, 220 F.20 454, 456, 105 USPO 233, 238 (CCPA 1955); In re Swain et al., 70 USPQ 412; Minnesota Mining and Mfg. Co. v. Coe, 38 USPQ 213; Allen et al. v. Coe, 57 USPQ 136; MPEP 2144.05(II)(A). Note that the specification contains no disclosure of either the critical nature of the claimed range or any unexpected results arising therefrom. Where patentability is said to be based upon particular chosen dimensions or upon another variable recited in a claim, the Applicant must show that the chosen dimensions are critical. In re Woodruff, 919 f.2d 1575, 1578, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990).
Goodwin discloses dispensing a liquid suspension from a first container (dispensing container 102, Fig. 1), through a manifold (108, Fig. 1), and into a compartment of each of a plurality of bag assemblies (receiving containers 110, Fig. 1) that are each fluid coupled with the manifold (Fig. 1-2, col. 1 lines 18-21). It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the method of Drucker with the manifold dispensing to each of multiple bags as taught by Goodwin for the purpose of simultaneously dispensing sterile liquid product from a storage container into a plurality of smaller containers, generally bags, that are then used for processing, testing or other purposes (col. 1 lines 18-21, Goodwin).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Drucker as evidenced by Feix, and further in view of Goodwin, as applied to claim 1, and further in view of Cullis et al. (U.S. Patent No. 4,146,172, hereinafter Cullis).
Regarding claim 2, the combination of Drucker, Feix, and Goodwin does not disclose wherein the first bag assembly comprises a collapsible bag comprised of one or more sheets of flexible film.
Cullis discloses analogous art related to centrifugal separation of a liquid suspension, wherein the first bag assembly (red blood cell separation chamber 31, Fig. 4) comprises a collapsible bag comprised of one or more sheets of flexible film (col. 7 lines 4-10). It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the method of the combination of Drucker, Feix, and Goodwin with the type of bag as taught by Cullis for the purpose of providing a chamber for red blood cell separation that is made of hemo-compatible plastic material (col. 7 lines 4-10, Cullis).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Drucker as evidenced by Feix, and further in view of Goodwin, as applied to claim 1, and further in view of Persidsky (U.S. Patent No. 4,322,298).
Regarding claim 3, the combination of Drucker, Feix, and Goodwin discloses wherein the rotor (rotor 10, Fig. 1, Drucker) comprises a swinging-bucket rotor (col. 2 lines 9-11, Drucker), but does not disclose the first cavity is formed on a bucket of the swinging-bucket rotor.
Persidsky discloses analogous art related to fractionation of a suspension, wherein the rotor comprises a swinging-bucket rotor and the first cavity is formed on a bucket of the swinging bucket rotor (col. 3 lines 57-60). It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the method of the combination of Drucker, Feix, and Goodwin with the bucket of Persidsky for the purpose of collecting platelets in a closed, sterile and disposable system (col. 1 lines 6-13, Persidsky).
Claims 6, 7, 8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Nelson (U.S. Patent No. 5,300,060) in view of Goodwin, and further in view of Drucker.
Regarding claim 6, Nelson discloses a method for separating a suspension, the method comprising: dispensing a liquid suspension from a first container 7, through a manifold (set of tubings and connectors, e.g., 35, 31, 37, 45, 40, and/or 42), and into a compartment of a bag 33 of a plurality of bag assemblies 33, 39, and/or 41 that are each fluid coupled with the manifold; separating the manifold from the first container 7 (col. 5 lines 26-28); placing each of the plurality of bag assemblies fluid coupled with the manifold into one or more cavities of a rotor of a centrifuge; and activating the centrifuge so as to at least partially separate the liquid suspension within the compartment of each of the plurality of bag assemblies fluid coupled with the manifold (col. 7 lines 1-44), but does not disclose dispensing a liquid suspension into a compartment of each of a plurality of bag assemblies.
Goodwin discloses a liquid suspension from a first container 102, through a manifold 108, and into a compartment of each of a plurality of bag assemblies 110 that are each fluid coupled with the manifold (Fig. 1 and 2). It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the method of Nelson with the dispensing of a liquid suspension through a manifold into a compartment of each of a plurality of bag assemblies taught by Goodwin for the purpose of simultaneously dispense sterile liquid product from a storage container into a plurality of smaller containers, generally bags, that are then used for processing, testing or other purposes (col. 1 lines 18-21).
The combination of Nelson and Goodwin does not explicitly disclose that the one or more cavities have an open transverse cross section that is oval or elliptical.
Drucker discloses a centrifuge with one or more cavities (cup 12, Fig. 1) having an open transverse cross section that is oval or elliptical (the cup has an oval cross section, see Fig. 4). It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the method of the combination of Nelson and Goodwin with the oval/elliptical open cross section as taught by Drucker for the purpose of allowing bags to be held in their more natural shape to reduce their tendency to rupture during high force spin time and permitting easy removal of the bags (col. 1 lines 16-30, Drucker).
Regarding claim 7, the combination of Nelson, Goodwin, and Drucker discloses wherein the first container comprises a fermenter or bioreactor (col. 3 lines 62 – 65, Goodwin).
Regarding claim 8, the combination of Nelson, Goodwin, and Drucker discloses wherein the liquid suspension is comprised of cells or microorganisms (col. 5 lines 21-28, red blood cells, Nelson).
Regarding claim 10, the combination of Nelson, Goodwin, and Drucker discloses dispensing at least a portion of the at least partially separated liquid suspension that is within one of the plurality of bag assemblies through the manifold and into a container connected to the manifold. (col. 7 lines 16-50, Goodwin).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Nelson in view of Goodwin, and further in view of Drucker, as applied to claim 6 above, and further in view of Eberle (U.S. Patent Application Pub. No. 2003/0176267).
Regarding claim 9, the combination of Nelson, Goodwin, and Drucker does not specifically disclose placing each of the plurality of bag assemblies into a cavity of a corresponding insert; and placing each insert into a corresponding cavity of the rotor.
Eberle discloses placing each of the plurality of bag assemblies into a cavity of a corresponding insert 5 (Fig. 5 and 8); and placing each insert into a corresponding cavity of the rotor (Fig. 1 and 2). It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the method of the combination of Nelson, Goodwin, and Drucker with the bag and insert configuration of Eberle for the purpose of using conventional blood bags in the centrifuge for the recovery of individual blood constituents (Abstract, Eberle).
Claims 11-13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Nelson in view of Roos et al. (Roos, D., de Boer M. (2004). [8] Purification and cryopreservation of phagocytes from human blood (Vol. 132, pp. 225-243). Academic Press. https://doi.org/10.1016/S0076-6879(86)32010-X), and further in view of Drucker.
Regarding claim 11, Nelson discloses a method for separating a suspension, the method comprising: rotating a first bag assembly 33 using a centrifuge so that a liquid suspension disposed within a compartment of the first bag assembly separates into a pellet and a liquid supernatant while the first bag assembly is disposed within a cavity of the centrifuge, which cavity orbits during centrifuge operation (col. 7 lines 3-6); transferring a sufficient amount of the liquid supernatant out of the compartment of the first bag assembly while the pellet is retained within the compartment of the first bag assembly so as to permit attachment of a clamp to the first bag assembly (col. 7 lines 36-44); dispensing, through a tube in fluid communication with the compartment of the first bag assembly, a liquid into the compartment of the first bag assembly after transferring the at least a portion of the liquid supernatant out of the compartment; and mixing the liquid with the pellet in the compartment of the first bag assembly to form a secondary suspension (col. 7 lines 44-48), but does not disclose removing the first bag assembly from the cavity and attaching the clamp to the first bag assembly and forming a seal across the first bag assembly so as to separate the compartment of the first bag assembly into an upper compartment that houses at least a portion of the supernatant and a lower compartment that houses the pellet, the upper compartment being sealed closed from the lower compartment.
Roos discloses removing the first bag assembly from the cavity and attaching the clamp to the first bag assembly and forming a seal across the first bag assembly so as to separate the compartment of the first bag assembly into an upper compartment that houses at least a portion of the supernatant and a lower compartment that houses the pellet, the upper compartment being sealed closed from the lower compartment (page 236 lines 21-31). It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the method of Nelson with the bag clamp as taught by Roos for the purpose of transferring leukocytes to another container before the majority of the red blood cells (page 236 lines 21-31).
The combination of Nelson and Roos does not explicitly disclose that the one or more cavities have an open transverse cross section that is oval or elliptical.
Drucker discloses a centrifuge with one or more cavities (cup 12, Fig. 1) having an open transverse cross section that is oval or elliptical (the cup has an oval cross section, see Fig. 4). It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the method of the combination of Nelson and Roos with the oval/elliptical open cross section as taught by Drucker for the purpose of allowing bags to be held in their more natural shape to reduce their tendency to rupture during high force spin time and permitting easy removal of the bags (col. 1 lines 16-30, Drucker).
Regarding claim 12, the combination of Nelson, Roos, and Drucker discloses wherein the liquid suspension is comprised of cells or microorganisms (col. 5 lines 21-28, red blood cells, Nelson).
Regarding claim 13, the combination of Nelson, Roos, and Drucker discloses wherein forming the seal across the first bag assembly is accomplished manually (page 236 lines 23-25, Roos).
Regarding claim 15, the combination of Nelson, Roos, and Drucker discloses wherein the cavity of the centrifuge is located in a bucket (“centrifuge cup”) of the centrifuge (col. 7 lines 3-6, Nelson).
Claims 16, 17, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Schroendorfer (U.S. Patent No. 4,445,883) in view of Drucker, ad further in view of Goodwin.
Regarding claim 16, Schroendorfer discloses a method for separating a suspension, the method comprising: dispensing a liquid suspension into a compartment of a first bag assembly 8, the first bag assembly comprising a first sheet of polymeric film overlying a second sheet of polymeric film so that the compartment is bound between the first sheet and the second sheet, the first sheet being sealed to the second sheet by a seam line that at least partially encircles the compartment (col. 4 lines 51-60), a first port 46 being mounted on the first sheet at a location spaced apart from the seam line and communicating with the compartment; and rotating the first bag assembly using a centrifuge so as to at least partially separate the liquid suspension within the compartment, the first bag assembly 8 being disposed within a first insert 10 that is housed within a first cavity of a rotor of a centrifuge so that the first port 46 is facing an interior surface of the first insert (Fig. 1, 4, and 5; col. 6 lines 22-29), but does not disclose a second port being mounted on the first sheet at a location spaced apart from the seam line and communicating with the compartment, the first insert having an open transverse cross section that is oval or elliptical, and dispensing a liquid suspension from a first container, through a manifold, and into a compartment of each of a plurality of bag assemblies that are each fluid coupled with the manifold.
However, it has been held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). See MPEP 2144.04. Therefore, it would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the first bag assembly of Schroendorfer with a second port on the first sheet at a location spaced apart from the seam line for the purpose of transferring additional amounts of a separated blood component out of the bag assembly (col. 5 lines 19-26; col. 6 line 30 – col. 7 line 13).
Drucker discloses the first insert (cup 12, Fig. 1) having an open transverse cross section that is oval or elliptical (the cup has an oval cross section, see Fig. 4). It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the method of Schroendorfer with the oval insert as taught by Drucker for the purpose of allowing bags to be held in their more natural shape to reduce their tendency to rupture during high force spin time and permitting easy removal of the bags (col. 1 lines 16-30, Drucker), and for completely encircling the blood processing bag and minimize the tearing and shearing forces on the relatively weak weld of the bag (col. 3 lines 6-32, Schroendorfer).
The combination of Shroendorfer and Drucker does not disclose dispensing a liquid suspension from a first container, through a manifold, and into a compartment of each of a plurality of bag assemblies that are each fluid coupled with the manifold.
Goodwin discloses dispensing a liquid suspension from a first container (dispensing container 102, Fig. 1), through a manifold (108, Fig. 1), and into a compartment of each of a plurality of bag assemblies (receiving containers 110, Fig. 1) that are each fluid coupled with the manifold (Fig. 1-2, col. 1 lines 18-21). It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the method of the combination of Shroendorfer and Drucker with the manifold dispensing to each of multiple bags as taught by Goodwin for the purpose of simultaneously dispensing sterile liquid product from a storage container into a plurality of smaller containers, generally bags, that are then used for processing, testing or other purposes (col. 1 lines 18-21, Goodwin).
Regarding claim 17, the combination of Schroendorfer, Drucker, Goodwin discloses wherein the first insert 56 has an annular lip portion that encircles an opening to a cavity of the first insert (Fig. 4, Schroendorfer), the first bag assembly 8 being disposed within the cavity of the first insert so that the first port 46 is disposed within the cavity of the first insert at an elevation lower than the annular lip portion (Fig. 4, Schroendorfer).
Regarding claim 19, the combination of Schroendorfer, Drucker, Goodwin does not disclose wherein the second port is disposed lateral to the first port when the first bag assembly is disposed within the first cavity of the rotor. However, it has been held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. In re Harza, supra. See MPEP 2144.04. In this case, it would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the first bag assembly of modified Schroendorfer with a second port on the first sheet and to have positioned it lateral to the first port for the purpose of transferring additional amounts of a separated blood component out of the bag assembly (col. 5 lines 19-26; col. 6 line 30 – col. 7 line 13, Schroendorfer).
Regarding claim 20, the combination of Schroendorfer, Drucker, Goodwin does not disclose wherein the second port is disposed lower than the first port when the first bag assembly is disposed within the first cavity of the rotor. However, it has been held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. In re Harza, supra. See MPEP 2144.04. In this case, it would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the first bag assembly of modified Schroendorfer with a second port on the first sheet and to have positioned it lower than the first port for the purpose of transferring additional amounts of a separated blood component out of the bag assembly (col. 5 lines 19-26; col. 6 line 30 – col. 7 line 13, Schroendorfer), such as, in a case where the volume content in the bag is smaller and therefore at a lower level.
Conclusion
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/Shuyi S. Liu/Examiner, Art Unit 1774