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 .
Response to Arguments
The claim amendment filed 27 May 2026 adding the limitation that “the dispensing being while the first bag assembly is disposed within a first insert that is housed within a first cavity of a rotor of a centrifuge” (claim 1), or the corresponding language of claims 6 and 16, is supported in the specification as filed, e.g., at para. [0242] (“bag assemblies 48 can be received within cavities 142 or 200 either prior to or after filling bag assemblies 48 with suspension 18”). No new matter has been entered.
Upon consideration of the claim amendments and Applicant arguments with respect to claims 6-10, 16, 17, 19, and 20, the rejections under 35 U.S.C. 103 has been withdrawn.
Applicant’s arguments filed 27 May 2026 with respect to the rejections of claims 1 and 11 under 35 U.S.C. 103 have been fully considered but are not persuasive.
Applicant argues that the Office does not identify disclosure in the cited art that teaches or suggests every feature of claim 1, in particular, that dispensing occurs while the first bag assembly is disposed within a first insert that is housed within a first cavity of a rotor of a centrifuge (page 7, Remarks).
The amendments to claim 1 does not introduce new structural limitations, only recites a change in the sequence of two steps already disclosed (the step of placing a bag assembly within an insert/cavity, and the step of filling that bag assembly with a liquid suspension). It is well established that selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results. In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946). See MPEP 2144.04 (IV)(C). Applicant’s own specification does not identify any benefit or unexpected result from performing the dispensing step while the bag assembly is already disposed within the insert/cavity of the rotor, as opposed to before.
Moreover, Goodwin teaches positioning a receiving container onto its holding equipment (table 370) before filling, which means the loading and then filling sequence is a well known approach for the type of manifold filling of a plurality of containers as the claimed invention.
Regarding claim 11, Applicant argues that “Nelson describes returning a previously removed liquid to a first bag and does not suggest introducing to the first bag a liquid that differs from a previously-obtained supernatant” (page 10, Remarks). The examiner respectfully disagrees. Claim 11 recites “dispensing…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,” without reciting that the dispensed liquid must differ from the previously removed supernatant. Under BRI, “a liquid” reads on the previously removed supernatant itself. “Applicant also notes that the office does not identify disclosure in Nelson that teaches or suggests centrifugation to form a pellet or suggest that use of a clamp is needed” (page 10, Remarks). The examiner respectfully disagrees. Nelson discloses that after centrifugation, “[a] dense gerocyte layer remains in main bag 33” (col. 7 lines 36-44). The cell layer collected at the bottom of the bag reads on the claimed pellet. Applicant has not explained why the density-based, centrifugally formed cell layer disclosed by nelson is structurally or functionally distinguishable from the claimed pellet. Further, the rejection does not rely on Nelson for the clamp limitation. Roos was relied upon for the bag clamp step, and provides the benefit of preventing the pellet from being disturbed or resuspended during supernatant removal.
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.
Claim Rejections - 35 USC § 112
.The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6-10, 16, 17, 19, and 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 6, it is unclear whether “a cavity” in line 9 refers to the same “respective cavity” previously recited, or introduces an additional, unrelated cavity. Claims 7-10, which depend from claim 6, are rejected for the same reason.
Regarding claim 9, said claim recites “wherein the step of placing each of the plurality of bag assemblies comprises”. Claim 6, from which claim 9 depends, does not recite any “step of placing”. Accordingly, claim 9 lacks antecedent basis for “the step of placing”, and it is unclear what step or limitation of claim 6 is claim 9 further limiting.
Claim 16 recites the limitation "the centrifuge" in line 5. There is insufficient antecedent basis for this limitation in the claim. Claims 17, 19 and 20, which depend from claim 6, are rejected for the same reason.
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; “whole blood from a donor to be placed in a flat plastic bag”, col. 1 lines 6-8); and rotating the first bag assembly using a centrifuge so as to at least partially separate the suspension (col. 2 lines 14-16), 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 dispensing being while the first bag assembly is disposed within a first insert that is housed within a first cavity of a rotor of a centrifuge; 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).
Neither Drucker nor Goodwin expressly discloses that the dispensing step occurs while the first bag assembly is disposed within the first insert that is housed within the first cavity of the rotor. However, this amounts to no more than a change in the sequence of two steps individually taught by the combination, the step of positioning a bag assembly within an insert or cavity, and the step of dispensing a liquid suspension into the bag assembly. Both steps are disclosed by the combination of Drucker and Goodwin as discussed above. It is well established that selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results. In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946). See MPEP 2144.04 (IV)(C). Goodwin discloses that its own manifold system 300 can be first positioned on table 370 and then a fluid is passed into chambers 330 of flexible bags 304 (col. 16, line 60 – col. 17 line 23). Goodwin thus demonstrates positioning a receiving container onto the cavity of its supporting structure (table 370, Fig. 20A, corresponding to the claimed cavity of the rotor rotor) before dispensing fluid into it is a known approach for using a manifold to fill a plurality of containers. 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 modified Drucker, with the bag assembly positioned within the insert and cavity of the rotor before dispensing, and to have dispensed the suspension into the bag assembly while it is positioned within the insert and cavity of the rotor, in view of Goodwin’s own disclosed sequence, and further because one of ordinary skill in the art would have recognized the obvious advantage of loading an empty, more easily handled bag assembly into the insert before it is filled.
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; “whole blood from a donor to be placed in a flat plastic bag”, col. 1 lines 6-8); and rotating the first bag assembly using a centrifuge so as to at least partially separate the suspension (col. 2 lines 14-16), 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 analogous art related to a manifold dispensing method, comprising 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 11-13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Nelson (U.S. Patent No. 5,300,060) 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 the cavity having an open transverse cross section that is oval or elliptical; 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 analogous art related to a method for separating a suspension, comprising 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 step as taught by Roos for the purpose of transferring one centrifugally separated fraction (leukocytes) to another container before the majority of another fraction (red blood cells) (page 236 lines 21-31, Roos). The clamp across the bag assembly would seal the supernatant fraction away from the pelleted cellular material so that the pellet is not disturbed or resuspended during supernatant removal.
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).
Allowable Subject Matter
Claims 6-10 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action, since the prior art does not teach or suggest a method for separating a suspension comprising 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 while each bag assembly is disposed in a respective cavity of a rotor of a centrifuge; separating the manifold from the first container; and activating the centrifuge so as to give rise to an at least partially separated liquid suspension within the compartment of each of the plurality of bag assemblies fluid coupled with the manifold. In particular, Nelson does not teach dispensing into a compartment of each of a plurality of bag assemblies that are each fluid coupled with the manifold while each bag assembly is disposed in a respective cavity of a rotor of a centrifuge, and activating the centrifuge with the compartment of each of the plurality of bag assemblies fluid coupled with the manifold.
Claims 16, 17, 19 and 20 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action, since the prior art does not teach or suggest a method for separating a suspension comprising dispensing a liquid suspension from a first container, through a manifold, and into a compartment of a first bag assembly of a plurality of bag assemblies that are each fluid coupled with the manifold while the first bag assembly is disposed within a first insert that is housed within a first cavity of a rotor of the centrifuge, in combination with the first bag assembly comprising a first sheet of polymeric film overlaying a second sheet of polymeric film, a first port and a second port each mounted on the first sheet, and the first insert having an open transverse cross section that is oval or elliptical. In particular, Schroendorfer’s support/insert 10 is a deformable structure mounted on a wall of a centrifuge cassette or a pressure plate. There is no motivation for combining Drucker’s oval insert and rotor cavity structure with Schroendorfer’s pressure plate support structure.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHUYI S LIU whose telephone number is (571)272-0496. The examiner can normally be reached MON - FRI 9:30AM - 2:30PM EST.
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/Shuyi S. Liu/Examiner, Art Unit 1774