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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3/5/2026 has been entered.
Status of Claims
Claims 1-20 are pending and currently under consideration for patentability.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 03/19/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Response to Arguments
Applicant's arguments filed 12/18/2025 have been fully considered but they are not persuasive.
In response to the applicant’s argument that Holmes provides a loop connection that is fixed. The examiner disagrees. The fact that the loop is flexible as cited by the applicant is not fixed and is configured to be able to move. The claim language should specify where the loop is moving and the exact pivot point.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-7, 9-14, and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Chapman (US 5,484,239) in view of Holmes (US 20180304004 A1).
Regarding Claim 1, Chapman teaches an apheresis system (10)(whole blood separation system, column 1, lines 11-20)(figure 50) comprising: a chamber (232) configured to receive a centrifuge assembly (230) (fig. 21) (column 20, lines 8-10); and
a moving loop holder (392)(figs, 21 and 49) disposed in the chamber (232), the moving loop holder including a loop holder (400) defining a loop connection configured to interact with a flexible loop received by the centrifuge assembly (first and second clamp members 412 and 414 of clamp 400 receive an end of body 200, fig. 60) , the moving loop holder configured to move axially between a first position and a second position (umbilicus mount 392 moves between two shown positions) (Fig. 49) (col. 29, Ines 41-48),
, wherein in the first position, the moving loop holder is a first distance from the centrifuge assembly (fig. 49), and in the second position, the moving loop holder is a second distance from the centrifuge assembly, wherein the second distance is greater than the first distance (fig. 49).
Chapman fails to teach the moving loop holder including a loop holder defining a loop connection configured to interact with a flexible loop received by the centrifuge assembly, the moving loop holder configured to move axially between a first position and a second position. Holmes teaches the moving loop holder including a loop holder defining a loop connection configured to interact with a flexible loop received by the centrifuge assembly ([0185] In FIG. 6B), the moving loop holder configured to move axially between a first position and a second position ([0185] In FIG. 6B). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system of Chapman to have the moving loop holder including a loop holder defining a loop connection configured to interact with a flexible loop received by the centrifuge assembly, the moving loop holder configured to move axially between a first position and a second position similar to Holmes so that the position may be altered without impacting the centrifuge.
Regarding Claim 2, Chapman in view of Holmes teaches an apheresis system of claim 1. Chapman further teaches wherein the centrifuge assembly is prevented from moving from an operating state to a loading state when the moving loop holder is in the first position (fig. 49)(col. 29 Lines 41-56 and col. 28 lines 41-56) and the centrifuge assembly is allowed to move from the operating state to the loading state when the moving loop holder is in the second position (fig. 50-51) (col. 29, lines 45-53)(col 28, lines 15-19).
Regarding Claim 3, Chapman in view of Holmes teaches an apheresis system of claim 2. Chapman further teaches wherein the centrifuge assembly (centrifuge 230) (fig. 21) includes a first portion (348) and a second portion (350) , the second portion being movable relative to the first portion between an open position and a closed position (figs. 49-51), wherein in the loading state, the second portion is in the open position (fig. 50-51)(col. 29, lines 51-53), and in the operating state, the second portion is in the closed position (fig. 49 and 59)(col. 29, lines 45-51),.
Regarding Claim 4, Chapman in view of Holmes teaches an apheresis system of claim 3. Chapman further teaches, wherein in the second position (loading position shown by mount 392 shown in phantom lines of Fig. 49), a clearance exists between the moving loop holder and the centrifuge assembly to allow movement of the second portion between the open position and the closed position (mount 392 does not block centrifuge 230 and thus centrifuge chamber assembly 350 can move between the open and closed positions) (Fig. 49).
Regarding Claim 5, Chapman in view of Holmes teaches an apheresis system of claim 4. Chapman further teaches wherein the second portion is connected to the first portion via a hinge (centrifuge chamber assembly 350 connected by pivot hinge 368, Fig. 51), and moving the second portion between the open position and the closed position defines an arc (centrifuge chamber assembly 350 moves in an arc, Figures 49-51 ).
Regarding Claim 6, Chapman in view of Holmes teaches an apheresis system of claim 1. Chapman further teaches wherein in the first position (operating position shown in solid lines of umbilicus mount 392 in Fig. 49), the moving loop holder is nearer to a first side of a housing defining the chamber than in the second position (interior wall of compartment 232, disposed beneath front panel 238, Figures 21 and 50), and in the second position, the moving loop is nearer to a second side of the housing than in the first position (vertical wall including door 234, Figures 21 and 50).
Regarding Claim 7, Chapman in view of Holmes teaches an apheresis system of claim 1. Chapman further teaches wherein the loop connection includes a connector lock configured to engage a connector of the flexible loop (over-center latch 418 locks members 412 and 414 closed, Figures 60-62) (col. 29, In. 60-col. 30, In. 4).
Regarding Claim 9, Chapman in view of Holmes teaches an apheresis system of claim 1. Chapman further teaches wherein in the first position (operating position shown in solid lines of umbilicus mount 392 in Fig. 49), the flexible loop is locked in position relative to the loop holder (Fig. 49; see also col. 29, In. 53-col. 30, In. 4).
Regarding Claim 10, Chapman teaches an apheresis system (whole blood separation performed, col. 1, Ins. 11-20; fluid processing assembly 14, Fig. 21) comprising:
a chamber (compartment 232, Fig. 21 );
a centrifuge assembly disposed in the chamber (centrifuge 230, Fig. 21) and including a lower housing portion (centrifuge yoke assembly 348, Fig. 49) and a upper housing portion (centrifuge chamber assembly 350, Fig. 49), the upper housing portion being movable relative to the lower housing portion between (Figures 49-51); and
a moving loop holder also disposed in the chamber (mount 392, Figures 21 and 49; see also col. 29, lines. 41-48), the moving loop holder including a loop holder (clamp 400, Figures 49-50) and a loop connection disposed at an end of the loop holder (first and second clamp members 412 and 414, Fig. 60), the loop connection configured to interact with a loop extending from the centrifuge assembly (umbilicus 24, Fig. 49; se/:l also col. 12, In. 62-col. 13, In. 2), and the moving loop holder configured to move axially between an extended position and a retracted position (umbilicus mount 392 moves between two shown positions) (Fig. 49) (col. 29, Ines 41-48),
wherein in the extended position (operating position shown in solid lines of umbilicus mount 392 in Fig. 49), the moving loop holder is a first distance from the centrifuge assembly (position of mount 392 in solid lines, Fig. 49) and the upper housing portion is prevented from moving relative to the lower housing portion (Fig. 49; see also col. 29, Ins. 41-56; see also col. 28, Ins. 2-14), and in the retracted position, the moving loop holder is a second distance from the centrifuge assembly and the upper housing is allowed to move relative to the lower housing portion (Figures 50-51) (col. 29, Ins. 45-53) (col. 28, Ins. 15-19)
Chapman fails to teach the moving loop holder including a loop holder defining a loop connection configured to interact with a flexible loop received by the centrifuge assembly, the moving loop holder configured to move axially between a first position and a second position. Holmes teaches the moving loop holder including a loop holder defining a loop connection configured to interact with a flexible loop received by the centrifuge assembly ([0185] In FIG. 6B), the moving loop holder configured to move axially between a first position and a second position ([0185] In FIG. 6B). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system of Chapman to have the moving loop holder including a loop holder defining a loop connection configured to interact with a flexible loop received by the centrifuge assembly, the moving loop holder configured to move axially between a first position and a second position similar to Holmes so that the position may be altered without impacting the centrifuge.
Regarding Claim 11, Chapman in view of Holmes teaches the apheresis system of claim 10. Chapman further teaches wherein in the retracted position (loading position shown in phantom lines of Fig. 49), a clearance exists between the moving loop holder and the centrifuge assembly to allow movement of the upper housing portion between an open position and a closed position relative to the lower housing portion (392 does not block centrifuge 230 and thus centrifuge chamber assembly 350 can move between the open and closed positions, Fig. 49).
Regarding Claim 12, Chapman in view of Holmes teaches the apheresis system of claim 11. Chapman further teaches wherein the upper housing portion is connected to the lower housing portion via a hinge (centrifuge chamber assembly 350 connected by pivot hinge 368, Fig. 51), and moving the upper housing portion between the open position and the closed position defines an arc (centrifuge chamber assembly 350 moves in an arc) (Figures 49-51 )
Regarding Claim 13, Chapman in view of Holmes teaches the apheresis system of claim 10. Chapman further teaches in the extended position (operating position shown in solid lines, Fig. 49), the moving loop holder is nearer to a first side of a housing defining the chamber than in the retracted position (interior wall of compartment 232, disposed beneath front panel 238) (figures 21 and 50), and in the retracted position, the moving loop is nearer to a second side of the housing than in the extended position (vertical wall including door 234, Figures 21 and 50).
Regarding Claim 14, Chapman in view of Holmes teaches the apheresis system of claim 10. Chapman further teaches wherein the loop connection includes a connector lock configured to engage a connector of the flexible loop (over-center latch 418 locks members 412 and 414 closed) (Figures 60-62) (col. 29, In. 60-col. 30, In. 4).
Regarding Claim 16, Chapman in view of Holmes teaches the apheresis system of claim 10. Chapman further teaches, wherein in the first position (operating position shown in solid lines in Fig. 49), the flexible loop is locked in position relative to the loop holder (Fig. 49) (col. 29, In. 53-col. 30, In. 4).
Regarding Claim 17, Chapman in view of Holmes teaches a method of loading a centrifuge filler into an apheresis system (rotating outer bowl 374 and inner spool 376 are loaded into centrifugal processing assembly 10, Figures 49-52)(col. 1, Ins. 11-20), the method comprising:
Axially moving a moving loop holder (mount 392, Figures 21 and 49; see also col. 29, Ins. 41-48) disposed in a centrifuge chamber (mount 392 disposed in compartment 232, Fig. 21) from an extended position to a retracted position (mount 392 moves between extended and retracted positions, Fig. 49; see also col. 29, Ins. 41-48), wherein
a centrifuge assembly is also disposed in the centrifuge chamber, (centrifuge 230, Fig. 21 ), and
the moving loop holder includes a loop holder (clamp 400, Figures 49-50) and a loop connection disposed at an end of the loop holder (first and second clamp members 412 and 414, Fig. 60),
the loop connection is configured to interact with a flexible loop extending from the centrifuge assembly (24, Fig. 49; see also col. 12, In. 62-col. 13, In. 2),
in the extended position (operating position shown in solid lines of mount 392 in Fig. 49), the moving loop holder is a first distance from the centrifuge assembly, and in the retracted position (loading position shown in phantom lines of Fig. 49), the moving loop holder is a second distance from the centrifuge assembly, the second distance being greater than the first distance (position of mount 392 in phantom lines is further away from centrifuge 230 than in extended position, Fig. 49);
moving an upper housing portion of the centrifuge assembly (centrifuge chamber assembly 350, Fig. 49) from a closed position (fig. 49) to an open position relative to a lower housing portion, wherein in the retracted position, a clearance exists between the moving loop holder and the centrifuge assembly to allow movement of the upper housing portion between the open position and the closed position (figure. 49);
contacting a collection bladder including the flexible loop to an exposed portion of the centrifuge chamber (disposable processing chamber 16, col. 28, In. 54-col. 29, In. 5; see also Figures 20 and 49-52);
moving the upper housing portion from the open position to the closed position encasing at least a portion of the collection bladder (Figures 49-52; see also col. 28, In. 54-col. 29, In. 24); and
moving the moving loop holder from the retracted position to the extended position (Fig. 49)(col. 29, Ins. 51-56).
Regarding Claim 18, Chapman in view of Holmes teaches method of claim 17. Chapman further teaches wherein the moving loop holder further includes a release latch and the release latch is engaged to move the moving loop holder from the extended position to the retracted position or from the retracted position to the extended position (col. 29, Ins. 45-56, as upper mount 392 must be unlocked to pivot back into the loading position, as it is manually locked for use in the operating position, but is allowed to pivot between operating and loading positions).
Regarding Claim 19, Chapman in view of Holmes teaches method of claim 17. Chapman further teaches wherein the upper housing portion is connected to the lower housing portion via a hinge (pivot hinge 368, Fig. 51), and moving the upper housing portion between the open position and the closed position defines an arc (centrifuge chamber assembly 350 moves in an arc, Figures 49-51).
Regarding Claim 20, Chapman in view of Holmes teaches method of claim 17. Chapman further teaches wherein in the extended position (operating position shown in solid lines in Fig. 49, the moving loop holder is nearer to a first side of a housing defining the chamber than in the retracted position (interior wall of compartment 232, disposed beneath front panel 238, Figures 21 and 50), and in the retracted position, the moving loop is nearer to a second side of the housing than in the extended position (vertical wall including door 234, Figures 21 and 50).
Claims 8 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Chapman (US 5,484,239) in view of Holmes (US 20180304004 A1) in view of Lolachi (US 4,113,173).
Regarding Claim 8, Chapman in view of Holmes discloses the apheresis system of claim 7. Chapman fails to explicitly disclose that the connector lock includes a connector lock wheel configured to move relative to a flange to alter a size of the loop connection. Lolachi is in the field of centrifugal cell processing apparatuses (Abstract), and teaches a connector lock that comprises a connector lock wheel configured to move relati.ve to a flange to alter a size of a loop connection (bearing assembly 168 disposed within support hub 165 relative to guide sleeve 160, Fig. 14; see also col. 10, Ins. 33-42).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the apheresis system of Chapman to further include that the connector lock comprises a connector lock wheel configured to move relative to a flange to alter a size of the loop connection, as taught by Lolachi, the motivation being that such an arrangement provides additional support and eliminates gaps (Lolachi, col. 10, Ins. 33-42).
Regarding Claim 15, Chapman in view of Holmes discloses the apheresis system of claim 14. Chapman fails to explicitly disclose that the connector lock includes a connector lock wheel configured to move relative to a flange to alter a size of the loop connection. Lolachi is in the field of centrifugal cell processing apparatuses (Abstract), and teaches a connector lock that comprises a connector lock wheel configured to move relative to a flange to alter a size of a loop connection (bearing assembly 168 disposed within support hub 165 relative to guide sleeve 160, Fig. 14; see also col. 10, Ins. 33-42).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the apheresis system of Chapman to further include that the connector lock comprises a connector lock wheel configured to move relative to a flange to alter a size of the loop connection, as taught by Lolachi, the motivation being that such an arrangement provides additional support and eliminates gaps (Lolachi, col. 10, Ins. 33-42).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATE ELIZABETH STRACHAN whose telephone number is (571)272-7291. The examiner can normally be reached M-F: 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached on (571)-270-5879. The fax phone number for the organization where this application or proceeding is assigned is (571)-270-5879.
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/KATE ELIZABETH STRACHAN/Examiner, Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781
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