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 with respect to claims 1-10 have been considered but are moot in view of the current amendments. Thus, a new rejection follows below.
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Kusz et al. (hereinafter Kusz) US 2012/0284991 in view of Kini et al. (hereinafter Kini) US 2022/0243159.
Regarding claim 1, Kusz discloses a bag configured to carry out a bioprocessing operation; at least one port (adapter 14) welded to the single-use bag (vessel V may comprise a bag) [0012, 0043 and 0057], the at least one port including a channel (adapter 14 includes a tubular passage P capable of transmitting a fluid) for providing fluidic access to an interior volume of the single-use bag [0046], the at least one port having a barb (barb 16) formed thereon [0046]; and at least one mating ring (connector 12); wherein the at least one port includes a first feature configured to engage with a corresponding second feature of the at least one mating ring, such that the at least one mating ring can be locked to the at least one port (In one embodiment, as shown in FIG. 1b, the locking element for the adapter 14 includes a peripheral projection 14a in the form of a flange. As can be understood from the drawing, this flange forming the projection 14a in this embodiment is oversized relative to a recess 12b formed along the interior of an upstanding wall 12c at least partially defining the port T in the connector 12. The recess 12b forms a ledge, such as via an annular groove, and the projection 14a includes a corresponding mating edge. [0047]). See Figs. 1a, 1b.
Kusz does not expressly disclose that the bag is single-use. However, Kusz does disclose that a kit including different adapters may thus be provided, along with a supply of vessels (such as bags), each with a connector adapted to form a locking engagement with the different adapters [0079].
Assuming arguendo that one of ordinary skill in the art would not consider the bag of Kusz to be single-use.
Kini discloses a probe angle adjustment system (100) including a bioreactor vessel (110); and a disposable bag (113) having several openings for inserting sensing probes (114) is mounted within the volume of the bioreactor vessel (110) enclosure [0027].
Absent unexpected results, it would have been prima facie obvious to one of ordinary skill in the art to modify Kusz with a disposable bag as taught by Kini in order to reduce time and cost associated with cleaning and sterilizing vessel V after every use. Further, it would be advantageous to use a disposable bag to prevent cross contamination between reactions.
Regarding claim 2, Kusz discloses wherein the first feature comprises at least one groove and the second feature comprises at least one protrusion, and wherein the at least one mating ring is locked to the at least one port by inserting the at least one protrusion into the at least one groove and rotating the at least one mating ring relative to the at least one port (The connector 12 and adapter 14 are configured for threaded engagement. In FIGS. 11a and 11b, the adapter 14 includes a peripheral locking element in the nature of a male thread for engaging a female thread along the inner surface of wall 12c of connector. The converse arrangement is shown in FIGS. 11c and 11d. In FIG. 11d, it is noted that the inner wall 14c of the adapter 14 extends into the port T, and thus may be used to connect with a structure in the interior of the vessel, such as a dip tube or the like. [0066]).
Regarding claim 3, Kusz discloses wherein the first feature comprises at least one snap lock and the second feature comprises at least one protrusion, and wherein the at least one mating ring is locked to the at least one port by inserting the at least one protrusion into the at least one snap lock (Consequently, manually pressing the projection 14a serving as the locking element of the adapter 14 into engagement with e recess 12b and ledge together forming a matching locking element of the connector 12 forms a snap-fit engagement. [0008, 0014 and 0047]).
Regarding claim 4, Kusz discloses a port plate comprising at least one opening, the at least one opening corresponding to a location of the at least one port; wherein when the at least one opening is aligned with the at least one port and the at least one mating ring is locked to the at least one port, the port plate is secured to the single-use bag as shown in Figs. 13a and 13b reproduced below.
PNG
media_image1.png
666
632
media_image1.png
Greyscale
Regarding claim 5, Kusz does not disclose expressly disclose that the flexible bag is configured to be placed in an outer vessel and wherein the at least one mating ring includes an alignment feature, the alignment feature configured to align the port plate with the opening.
However, Kusz does disclose at least one port and at least one mating ring as discussed above in the rejection of claim 1.
Kini discloses wherein the single-use bag (disposable bag 113/913) is configured to be placed in an outer vessel (bioreactor vessel 110/910), the outer vessel having an opening corresponding to a location of at least one port (The bioreactor vessel (110) is provided with an opening in the form of a mounting bracket (111). A disposable bag (113) having several openings for inserting sensing probes (114) is mounted within the volume of the bioreactor vessel (110) enclosure.) [0027]. Also see [0044].
Kusz in view of Kini does not expressly disclose wherein the at least one mating ring includes an alignment feature, the alignment feature configured to align the port plate with the opening. However, absent unexpected results, it would have been prima facie obvious to one of ordinary skill in the art to provide an alignment feature on the at least one mating ring of Kusz, the alignment feature configured to align the port plate with the opening of the bioreactor vessel of Kini, in order to secure the port of Kusz to the outer vessel as taught by Kini while ensuring a hermetic seal.
Regarding claim 6, Kusz does not disclose expressly disclose wherein the at least one mating ring further comprises a probe support or angle guide, the probe support configured to physically support a probe attached to the at least one port.
Kini discloses a probe support or angle guide (probe support bar 112 and/or support frame 912), the probe support configured to physically support a probe (sensing probe 114/914) attached to at least one port [0027, 0044 and 0046]. See Figs. 1 and 9.
Regarding claim 7, Kusz does not disclose expressly disclose wherein the probe support or angle guide is configured to maintain the probe at an angle relative to a longitudinal axis of the channel.
Kini discloses wherein the probe support or angle guide is configured to maintain the probe at an angle relative to a longitudinal axis of the channel as shown in at least Figs. 1 and 9.
Regarding claim 8, Kusz in view of Kini does not expressly disclose a protective cover, configured to cover the at least one port during shipping and when the cover is aligned with the at least one port and the at least one mating ring is locked to the at least one port, the cover is secured to the single-use bag.
However, absent unexpected results, it would have been prima facie obvious to one of ordinary skill in the art to provide a protective cover, in order to maintain an aseptic environment.
As to covering the at least one port during shipping and when the cover is aligned with the at least one port and the at least one mating ring is locked to the at least one port, the cover is secured to the single-use bag, the device disclosed by Kusz in view of Kini is structurally the same as the instantly claimed. Thus, in the absence of further positively recited structure the device of Kusz in view of Kini is capable of providing the operating condition.
Further, it is noted that apparatus claims cover what a device is, not what a device does or how it is to be used. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114.
Regarding claim 10, Kusz discloses wherein the at least one port comprising a plurality of ports and the at least one mating ring comprises a plurality of mating rings, and wherein each of the plurality of mating rings is configured to lock to a corresponding port of the plurality of ports (…the connector 12 may include multiple ports, each for receiving an adapter 14. Thus, in FIG. 13a, the ports T are arranged linearly along an oblong connector 12 including a flange 12a. As should be understood, the configurability allows for different adapters 14 to be used (note the size of the center adapter as opposed to the two adapters flanking it). [0068]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Kusz US 2012/0284991 in view of Kini US 2022/0243159 as applied to claims 1-8 and 10 above, and further in view of Erdenberger US 2014/0349385.
Regarding claim 9, Kusz in view of Kini does not expressly disclose wherein the at least one mating ring further comprises an attachment mechanism configured to be attached to a hook or clip.
However, Erdenberger does disclose a lift assembly 102 includes a lifting component 108 mounted on the assembly support structure 112 and movable relative to the assembly support structure 112. The lifting component 108 can be in the form of one or more lifting bars 116 including hooks 118 that can be used to support a flexible bag such as a collapsible bag in a collapsed or un-collapsed configuration [0073].
Therefore, it would have been obvious to one of ordinary skill in the art to modify the at least one mating ring Kusz in view of Kini with an attachment mechanism configured to be attached to a hook, and wherein when the hook or clip is attached, the hook or clip is configured to further attach to an external structure in order to provide an alternative support structure. Further, it appears that the invention would perform equally well with the support structure of Erdenberger.
As to wherein when the hook or clip is attached, the hook or clip is configured to further attach to an external structure, the device disclosed by Kusz in view of Kini and Erdenberger is structurally the same as the instantly claimed. Thus, in the absence of further positively recited structure the device of Kusz in view of Kini and Erdenberger is capable of providing the operating condition.
Further, it is noted that apparatus claims cover what a device is, not what a device does or how it is to be used. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYDIA EDWARDS whose telephone number is (571)270-3242. The examiner can normally be reached on Monday-Wednesday 08:00-18:00 EST.
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, Curtis Mayes can be reached on (571)272-1234. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LYDIA EDWARDS/Primary Examiner, Art Unit 1796
