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 Amendment
Applicant amended claims 1-2, 4-6, and 8-11, and canceled claims 12-21. Claims 1-11 are currently pending.
Response to Arguments
Applicant’s arguments, see pages 5-7 of Applicant’s Remarks, filed 04/01/26, with respect to the rejections of claims 12-13 and 17-20 as anticipated by Keaney, of claim 14 as unpatentable over Keaney in view of Nierich, of claims 15-16 as unpatentable over Keaney, and of claim 21 as unpatentable over Keaney in view of Unger have been fully considered and are persuasive in light of the cancelation of claims 12-21. Accordingly, the rejections have been withdrawn.
Applicant’s arguments, see page 5-6, with respect to the rejections of claims 1-2, 4-6, and 8-11 as being unpatentable over Guigan in view of Schlutz, of claim 3 in further view of Leach, and of claim 7 in further view of Unger have been fully considered. In light of the amendments to the claims, new grounds of rejection have been made as indicated below.
Applicant argues that neither Guigan nor Schlutz discloses or teaches the limitations of the amended claims. However, as indicated below Schlutz discloses most of the limitations of at least independent claims 1 and 6, and the limitations of claims 1 and 6 which Schlutz does not disclose are rendered obvious under a consideration of an obvious rearrangement of parts.
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 1-11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the supernatant compartment" in line 15. There is insufficient antecedent basis for this limitation in the claim. Applicant amended claim 1 to recite “a supernatant removal region” instead of “a supernatant compartment” in line 11. Additionally, applicant amended claims 4-5 to recite “the supernatant removal region” instead of “the supernatant compartment”. Therefore, for the purpose of examination, the “supernatant compartment” was interpreted to be the same as the “supernatant removal region”. Claims 2-5 are rejected as indefinite by virtue of their dependence on claim 1, and if the indefiniteness rejection of claim 1 is overcome, then so will those of claims 2-5.
Claim 6 recites the limitation “the wash compartment” in lines 9 and 14-15. There is insufficient antecedent basis for this limitation in the claim. Applicant amended claim 1 to recite “a wash reservoir” instead of “a wash compartment” in line 3. Additionally, applicant amended claims 8 and 10-11 to recite “the wash reservoir”. Therefore, for the purpose examination, the “wash compartment” was interpreted to be the same as the “wash reservoir”. Claims 7-11 are rejected as indefinite by virtue of their dependence on claim 6, and if the indefiniteness rejection of claim 6 is overcome, then so will those of claims 7-11.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-2, 4-6, and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Schlutz (US 3,982,691 A).
Regarding claim 1, Schlutz discloses an apparatus for centrifuging a suspension of red blood cells (Figs. 5-10; Col. 9, line 21 – Col. 10, line 9), comprising: a wash reservoir (Figs. 5-6 and 9, feat. 51; Col. 9, line 38 – Col. 10, line 9) positioned within a housing (Fig. 5, feats. 54, 55, 56) and located along an axis of rotation (Col. 9, line 38 – Col. 10, line 9: housing 54-56 holds wash reservoir 51 and they are rotated together about a central axis by motor 62a), wherein the wash reservoir defines a port for receiving the suspension of red blood cells (Figs. 5 and 9, feat. 75; Col. 10, lines 27-40); a fluid lumen in fluid communication with the port and the wash reservoir from below the wash reservoir, the fluid lumen extending from a top portion of the wash reservoir and through the wash reservoir (Figs. 5 and 10, feat. 72; Col. 10, lines 27-40; Col. 12, line 37 – Col. 13, line 11; Col. 13, lines 41-61: blood and washing fluid is introduced via pipe 72, which is in fluid communication with port 75 and wash reservoir 51 via conduit 53 and entry port 73); a supernatant removal region (Figs. 5 and 9: spent wash fluid is removed from the radially inward portions of reservoir 51 adjacent exit ports 76) in fluid communication with the wash reservoir (51; Col. 10, lines 27-40; Col. 12, line 37 – Col. 13, line 11); and a waste reservoir (Fig. 10: the space in fluid communication with exit pipe 77, above divider plate 122) in fluid communication with the supernatant removal region (Figs. 5 and 9, feat. 76; Col. 12, lines 41-53: spent wash fluid is removed from the radially inward portions of reservoir 51 adjacent exit ports 76, and then passes into ports 124 and the space above divider plate 122, at which point it can be extracted via exit pipe 77).
Schlutz does not disclose that the fluid lumen is positioned to align with the axis of rotation. Schlutz depicts the entry pipe (Figs. 5 and 10, feat. 72) defining the fluid lumen for introducing blood and washing fluid (Col. 12, lines 41-53) as off-center from the central axis of the injector (57), which is positioned at the axis of rotation of the wash reservoir (Fig. 5, feats. 51 and 57). Therefore, Schlutz depicts the fluid lumen as being off-center from the axis of rotation. However, the courts have held that that claims for a device which reads on the prior art except with regards to the position of a component of the device are unpatentable if shifting the position of the component would not modify the operation of the device. Please see MPEP §2144.04(VI) with respect to In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950). In this case, shifting the position of the entry pipe defining the fluid lumen of Schlutz, as well as the opening which puts it in fluid communication with the wash reservoir (Fig. 10, feat. 121; Col. 12, lines 41-53) so that it is aligned with the axis of rotation would not impact its ability to introduce blood and washing fluid into the fluid reservoir because it would still be in fluid communication with the reservoir. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the apparatus disclosed by Schlutz so that the fluid lumen is positioned to align with the axis of rotation.
Regarding claim 2, Schlutz suggests the apparatus of claim 1, and further discloses that the wash reservoir (Figs. 5 and 9, feat. 51) defines an excess red blood cell hold region (Figs. 5 and 9, feats. 53 and 73: If too much blood suspension is introduced, excess could be held in conduits 53 and ports 73). Regarding claim 4, Schlutz further discloses that the supernatant removal region comprises a wall having a surface angled relative to the axis of rotation (Figs. 5-6 and 9; Col. 10, lines 10-26: walls of wash reservoir 51 form a pinnacle 71 that the walls slope downwardly at an angle towards the exit ports 76 ). Regarding claim 5, Schlutz further discloses that the supernatant removal region is in fluid communication with the waste reservoir via a fluid lumen (Figs. 5 and 9, feat. 76; Col. 12, lines 41-53).
Regarding claim 6, Schlutz discloses a method for centrifuging a suspension of red blood cells (Col. 13, line 41 – Col. 14, line 48), comprising: introducing the suspension of red blood cells (Col. 13, lines 41-61) within a wash reservoir (Figs. 5-6 and 9, feat. 51; Col. 9, line 38 – Col. 10, line 9) through a fluid lumen (Figs. 5 and 10, feat. 72; Col. 10, line 27-40; Col. 12, line 37 – Col. 13, line 11), where the fluid lumen (72) is in fluid communication with a port (Figs. 5 and 9, feat. 75; Col. 10, lines 27-40) and the wash reservoir (51) from below the wash reservoir (Figs. 5 and 9, feat. 75), rotating the suspension within the wash reservoir such that a wash solution flows radially outward and up along a supernatant removal region (Figs. 5 and 9; Col. 13, line 62 – Col. 14, line 21: centrifugation drives plasma and wash fluid radially inward and upward towards the exit ports 76), and removing a supernatant from the supernatant removal region such that waste from the supernatant removal region remains in fluid communication with the wash reservoir (Col. 14, lines 9-21: spent wash fluid is removed via exit pipe 77, and therefore spent wash fluid is in fluid communication with wash reservoir 51 via exit pipe 77).
Schlutz does not disclose that the fluid lumen is positioned to align with the axis of rotation. Schlutz depicts the entry pipe (Figs. 5 and 10, feat. 72) defining the fluid lumen for introducing blood and washing fluid (Col. 12, lines 41-53) as off-center from the central axis of the injector (57), which is positioned at the axis of rotation of the wash reservoir (Fig. 5, feats. 51 and 57). Therefore, Schlutz depicts the fluid lumen as being off-center from the axis of rotation. However, the courts have held that that claims for a device which reads on the prior art except with regards to the position of a component of the device are unpatentable if shifting the position of the component would not modify the operation of the device. Please see MPEP §2144.04(VI) with respect to In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950). In this case, shifting the position of the entry pipe defining the fluid lumen of Schlutz, as well as the opening which puts it in fluid communication with the wash reservoir (Fig. 10, feat. 121; Col. 12, lines 41-53) so that it is aligned with the axis of rotation would not impact its ability to introduce blood and washing fluid into the fluid reservoir because it would still be in fluid communication with the reservoir. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method disclosed by Schlutz so that the fluid lumen is positioned to align with the axis of rotation.
Regarding claim 8, Schlutz suggests the method of claim 6. As discussed above, Schlutz discloses that red blood cells and wash fluid are introduced via an entry pipe (Figs. 5 and 10, feat. 72; Col. 12, lines 41-53). As discussed above, rearranging the entry pipe, and therefore the fluid lumen for introducing the blood and wash fluid, to be along the axis of rotation of the wash reservoir would not change the operation of the apparatus and method, and is therefore obvious. Therefore, Schlutz further suggests that introducing the suspension comprises introducing the red blood cells within the reservoir located along the axis of rotation of the wash reservoir.
Regarding claim 9, Schlutz suggests the method of claim 6, and Schlutz further discloses that rotating the suspension comprises flowing a wash solution through one or more openings which flow into the waste (Col. 13, line 62 – Col. 14, line 21). Regarding claim 10, Schlutz further discloses that the supernatant removal region is located circumferentially and in fluid communication with the wash reservoir (Figs. 5 and 9: spent wash fluid is removed from the radially inward portions of reservoir 51 adjacent exit ports 76, and is located circumferentially around the exit ports 76).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Schlutz in view of Leach (US 2016/0288139 A1).
Regarding claim 3, Schlutz suggests the apparatus of claim 1, but does not disclose a valve positioned along the top portion of the wash reservoir.
Leach teaches a cell washing apparatus (Figs. 2-8, feat. 100; ¶0025-0029) comprising a valve (134; ¶0029) at the top portion of a wash reservoir (124; ¶0029 and 0035). The valve advantageously controls fluid outflow from the wash reservoir based on the speed of the centrifuge (¶0029). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the apparatus suggested by Schlutz so that it comprises a valve positioned along the top portion of the wash reservoir in order to control fluid outflow from the wash reservoir as taught by Leach.
Claims 7 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Schlutz in view of Unger et al. (US 5,114,396 A).
Regarding claim 7, Schlutz suggests the method of claim 6. Schlutz further discloses that red blood cell washing may continue until the red blood cells are free of contaminants (Col. 14, lines 17-21), but does not disclose that the method steps of claim 6 are each repeated from one to four times.
Unger teaches a red blood cell washing system (Figs. 1-3, feat. 1; Col. 2, line 65 – Col. 3, line 8) and method (Figs. 4a-4j; Col. 4, line 53 – Col. 5, line 42) in which the third to sixth steps, which comprise accelerating, decelerating, and stopping the centrifuge (Figs. 4c-4f; Col. 5, lines 6-38), are repeated as many times as required to make the red blood cells clinically acceptable (Col. 5, lines 39-42). Unger teaches that between 3 and 4 repetitions are typically required (Col. 5, lines 39-42). The 3 to 4 repetitions lies within the claimed range of 1 to 4 repetitions, and therefore a prima facie case of obviousness exists for the claimed range. Please see MPEP §2144.05(I). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method suggested by Schlutz so that it further comprises repeating each of the steps from one to four times in order to ensure that the red blood cells are clinically acceptable as taught by Unger.
Regarding claim 11, Schlutz suggests the method of claim 6, but does not disclose a waste reservoir located circumferentially below the wash reservoir.
As discussed above, Unger teaches a red blood cell washing system (Figs. 1-3, feat. 1; Col. 2, line 65 – Col. 3, line 8) and method (Figs. 4a-4j; Col. 4, line 53 – Col. 5, line 42) comprising a centrifugal container assembly (Fig. 1, feat. 1; Col. 2, line 65 – Col. 3, line 53) with an annular primary container for receiving a cell suspension (2), a circular wash container (3), and a circular waste container circumferentially below the wash container (4). Unger teaches that such a container configuration removes the need for additional containers outward from the primary container holding the cells, which advantageously allows substantially the full diameter of the centrifuge rotor to be used (Col. 5, lines 48-58). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method suggested by Schlutz so that a waste reservoir located circumferentially below the wash reservoir in order to allow substantially the full diameter of the centrifuge rotor to be used as taught by Unger.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Dorian (US 2018/0154374 A1) discloses a red blood cell washing system.
Guigan US 5,188,583 A) discloses a centrifuging apparatus.
Schlutz (US 4,091,989 A) discloses a continuous flow fractionation and separation device.
Leach et al. (US 2010/0314334 A1) discloses a centrifugation apparatus.
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 ARJUNA P CHATRATHI whose telephone number is (571)272-8063. The examiner can normally be reached M-F 8:30-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at 5712727159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARJUNA P CHATRATHI/Examiner, Art Unit 3781
/CATHARINE L ANDERSON/Primary Examiner, Art Unit 3781
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