DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments, see the amendment, filed 2/4/26, with respect to the rejection(s) of claim(s) 1-10 and 15-19 under Ostermayer et al. have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Zumbrum et al. (11691866).
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.
Claim(s) 1 - 4, 15 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ostermayer et al. (WO 2022/132544; cited prior art) in view of Zumbrum et al. (11691866).
Regarding claim 1, the Ostermayer et al. reference discloses an automatic drug
substance (DS) fill system (Figures 1 and 7), comprising: a plurality of pumps (124; i.e.,
peristaltic pumps; para. 0061), each pump configured to fill a respective DS container
(128, 728; Figs. 2C and 7) of a plurality of DS containers (Figs. 2B, 7); a plurality of
weighing scales (10T, 140; paragraph 0040; Figs. 2C, 7), each weighing scale configured to measure weights associated with each respective DS container of the plurality of DS containers (paragraphs 0038 - 0040); and a controller (800) configured to: cause each of the plurality of pumps to fill each respective DS container, of the plurality of DS containers; monitor the weights (paragraphs 0004 - 0005); paragraphs 0063 - 0068) associated with each respective DS container, of the plurality of DS containers measured by each of the plurality of weighing scales; compare the weights associated with each respective DS container, of the plurality of DS containers measured by each of the plurality of weighing scales, to a threshold weight (paragraphs 0004 - 0005; paragraphs 0063 - 0068); and cause each of the plurality of pumps to cease filling each respective DS container, of the plurality of DS containers, based on the weight associated with their respective DS container reaching the threshold weight. The Ostermayer et al. reference doesn’t disclose simultaneously filling each DS container. The Zumbrum et al. reference discloses another aseptic drug filling system having a controller (5200) which controls multiple containers being simultaneously filled to allow for reduction in filling time by a factor of 5, 10 or even 20 times (see col. 2, lines 10 – 15). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date to modify the Ostermayer et al. device to simultaneously fill the DS containers as, for example, taught by the Zumbrum et al. reference in order to allow for reduction in filling time by a factor of 5, 10 or even 20 times.
Regarding claim 2, further comprising a tubing manifold (104, 106) configured to connect a fill line from a DS source (1000) to each of the plurality of pumps (124) via a sealed, sterile connection. The system is aseptic.
Regarding claim 3, further comprising a user interface (610), and wherein the controller (800) is further configured to receive an indication of the threshold weight as an input via the user interface (paragraph 0039).
Regarding claim 4, wherein the controller (800) is further configured to separately control each of the plurality of pumps (124) to cease filling each respective DS container.
Regarding claims 15 and 18, the method would be inherent during normal use and operation of the device.
Claim(s) 5 - 10 and 15 -19 is/are rejected under 35 U.S.C. 103 as being
unpatentable over Ostermayer et al., as applied to claim 1, and further in view of DiGianfilippo et al. (7343224).
Regarding claim 5, modified Ostermayer et al. reference further discloses wherein the controller (800) is further configured to generate respective alerts (i.e., alarms) based on pressure sensors (758), but doesn't disclose having alarms based on the weight associated with each DS container reaching the threshold weight. However, the DiGianfilippo et al. reference discloses another automatic drug filling system (10)
having a control to deliver a mixture by volume and/or weight by controlling flow rate of
rotary pumps based on a target volume. Further, DiGianfilippo et al. generates an alarm when alarm conditions occur, which would include threshold volume not being
met (col. 19, line 62 - col. 20, line 7). Therefore, it would have been obvious to one of
ordinary skill in the art at the time of the effective filing date to modify the Ostermayer
et al. device to generate an alarm based on weight as, for example, taught by the
DiGianfilippo et al. reference since a weight-based alarm system is well known in the
art, conventional and would be obvious to try without unexpected results.
Regarding claim 6, the Ostermayer et al. reference discloses the invention as
claimed (discussed supra) including a plurality of sensors (i.e., weighing scales), but
doesn't disclose measuring a volume of DS from each pump to each container.
However, the DiGianfilippo et al. reference discloses another automatic drug filling
system (10) having a control to deliver a mixture by volume and/or weight by controlling
flow rate of rotary pumps based on a target volume (see col. 14, lines 5 - 22).
Therefore, it would have been obvious to one of ordinary skill in the art at the
time of the effective filing date to modify the Ostermayer et al. device to control filling of
the contains by volume as, for example, taught by the DiGianfilippo et al. reference,
since filling by volume is well known in the art, conventional and would be obvious to try
as an alternative without unexpected results.
Regarding claim 7, DiGianfilippo et al. further teaches rotor rotation sensors
(70) to control target volume via the peripheral processing unit (60) (see col. 14, lines 5
- 22).
Regarding claim 8, DiGianfilippo et al. further teaches an interactive user interface (76) to input threshold volume and control filling via controller (72).
Regarding claim 9, DiGianfilippo et al. further teaches separate control of each pump (col. 8, lines 18 - 40).
Regarding claim 10, DiGianfilippo et al. further teaches generates an alarm when alarm conditions occur, which would include threshold volume not being met. See col. 19, line 62 - col. 20, line 7.
Regarding claims 15 - 19, the method would be inherent during normal use and operation of the device.
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.
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/TIMOTHY L MAUST/ Primary Examiner, Art Unit 3753