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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/5/26 has been entered.
Claims 8-15 remain pending, of which claim 15 was previously withdrawn.
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 8-14 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 8, the new limitation states “wherein pressurized air or gas is delivered to the first rigid container and the second rigid container when inverted via the one or more flexible vent tubing to cause the dry material to be transferred from the one or more rigid containers to the bioreactor”. This limitation renders the claim meets and bounds indefinite as the previous limitations state there are either a second rigid container connected to a first rigid container OR in the alternative, one or more rigid containers connected to a bioreactor. There is no positive recitation of both a first and second rigid container being connected to a bioreactor. Therefore, the amended limitation positively reciting a first and second rigid container AND bioreactor renders the claim indefinite as it is unclear whether the claimed system requires two rigid containers OR one or more rigid container and a bioreactor OR two rigid containers and a bioreactor.
Claims 9-14 are likewise rejected as they depend from claim 8 and fail to remedy the issues stated above.
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.
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 8, 11-14, are rejected under 35 U.S.C. 103 as being unpatentable over LEE (US 2014/0196791) as supplied by applicant on the IDS dated 12/13/21 in view of MILLER (US 5690450) and further in view of MAUCHLE (US 20120009046).
With respect to claim 8, LEE discloses a method and apparatus for the aseptic (sterile) transfer of micro-carriers (0002, 0005) in a disposable bioreactor system comprising dry micro-carriers (dry material) stored in a pouch 14 (second container) passing though an addition line, 16, e.g. a conduit (transfer tubing) for transferring dry material from second container) to a vessel 12 (to first container); the line capable of being reversibly blocked by a clamp (line must be flexible), with additional lines for other substances (more than one flexible transfer tubing) (0048, 50, Fig. 1), in which the pouch can be rigid (rigid container) (0049) in which the micro-carriers can be transferred by force of gravity (0050) or pushed by pumped liquid (0052) but does not explicitly disclose a flexible vent tubing including a dip tubing inserted in the container and connected to a source of pressurized gas.
However, MILLER discloses an apparatus for transporting powder material (dry material) from a box-shaped container 11 (rigid container holding dry material) (Col. 5, line 38-51, Fig 1), a feed line 58 (flexible transfer tubing) for transferring the dry material from the box container to a hopper (from second container to first container) (Col. 6, line 5-19), an air inlet 30 which is connected to a source of pressurized air, the pressurized air delivered through air lines 26, 28 (flexible vent tubing) to draw powder up a pick-up tube 54 (dip tubing connected to source of pressurized air) and transport it to a sprayer or hopper (transfer dry material from second container to first), the pick-up tube (dip tubing) having inlet openings and a vent hole through the walls of the tube near the lower inlet end (vent tubing) (Col 3, lines 64-Col 4, line 51, Col. 2, line 63-67 Fig. 1), in which the pick-up tube is inserted into the top of the box (container) and down through the powder until the lower inlet end is in position (Col. 5, lines 52-64). It would have been obvious to one of ordinary skill in the art to modify the force transferring the dry material of LEE to be the air lines (flexible vent tubing) including a pick-up tube (dip tubing) inserted in the container and connected to a source of pressurized air as taught by MILLER because it provides an apparatus for unloading all of the powder material from an original shipping container with a minimum of human operator attention which is easily transportable and simple and inexpensive to manufacture (Col. 1, lines 63- Col. 2, line 16).
It is noted the claim recites the orientation of the containers and tubing prior to use of the system. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The system disclosed by LEE utilizes flexible tubing connecting the containers and gravity to cause the solid material to flow into the bioreactor (Fig 1) and is capable of being used with the containers in an inverted position to prevent transfer of the material (see orientation in Fig 1 vs Fig 2). Additionally, MILLER discloses the tilt of the box can be at a variety of angles and at some angles the powder moves too slowly and the dip tube would be located above the level of the dry material (Col. 5, lines 11-27). Therefore, the above combination of LEE and MILLER are considered capable of being inverted prior to transferring such that the dip tubing is above the dry material.
LEE discloses a pumped fluid input to the pouch (pressurized fluid delivered to first or second rigid container) when the container is in an in-line position (inverted) to cause the microcarriers (dry material) to be transferred from the pouch (container) to the bioreactor (0052) and MILLER discloses the pick-up tube (dip tube) can be formed with concentric inner and outer tubes in which the outer tube can have vent holes to allow air to be drawn in between the tubes to flow down to the inlet opening located in the container (air is delivered to container via the one or more flexible vent tubing) to better fluidize compacted powder being extracted via the tube (to cause the dry material to be transferred from the rigid container) (Col 8, line 45-Col 9, line 57). Neither explicitly discloses that it is pressurized air that is delivered to the rigid container via the one or more flexible vent tunings.
However, MAUCHLE discloses a device for emptying powder bags comprising a powder container 12 with an inserted powder moving pipe 70 (vent tubing including dip tubing), in which the pipe is formed by two radially spaced pipes, with the powder moving pipe 70 inside a fluidizing air pipe 132 that supplies fluidizing compressed air from a compressed air source 6 to the lower pipe end (pressurized air is delivered to the container via vent tubing) where the fluidizing air 134 exits and there fluidizes the powder to allow it to pump through the powder feed pipe (to cause the dry material to be transferred from the container to a bioreactor) (0075).
It would have been obvious to one of ordinary skill in the art to modify the device of LEE and MILLER to include the pressurized air source being connected to the vent tubing to deliver pressurized air to the container to cause the transfer of material as taught by MAUCHLE because it causes the powder to float in the fluidizing compressed air to allow the powder pump to more easily move it pneumatically through the powder feed pipe (0075).
With respect to claim 11, LEE discloses the flexible lines/conduits (tubing) has clamps or other suitable reversible blocking means (valve) (0050) and aseptic connectors (0058).
With respect to claim 13, LEE discloses the system is sterilized by gamma radiation (0062).
With respect to claim 12, 14, LEE discloses the dry material is micro-carriers (0050).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over LEE (US 2014/0196791) as supplied by applicant on the IDS dated 12/13/21 in view of MILLER (US 5690450) and MAUCHLE (US 20120009046) as applied above, further in view of BEAR (US 2012/0248111).
With respect to claim 9, LEE discloses the pouch can be any discrete enclosed or enclosable container for holding a volume of micro-carriers within a region, that is separate from, but connected or connectable to the vessel (bioreactor) e.g., by one or more conduits and one or more associated ports, connectors, etc. (0049) but does not explicitly disclose the containers are bottle shaped and provided with an upper ported cap for attaching to the tubing. However, BEAR discloses a container cap for use in a laboratory vessel such as a bottle (Abs) and that it was known to use bottles in laboratory applications for sterile filling and transfer of components by way of a tubing set that passes through a vessel cap and the tubing can include dip tubes (0003), the cap having connectors, such as ports (upper ported cap) that couple with tubing to allow for the movement of substances into or out of the container (0017-18) the ports also connected with a dip tube inserted in the bottle (0032-33, Fig 6-7). It would have been obvious to one of ordinary skill in the art to modify the discrete enclosed or enclosable container with ports of LEE to be the bottle with cap having ports connected to a dip tube inside the bottle as taught by BEAR because the bottle apparatus supports the maintenance of an aseptic environment, allowing the bottle to remain connected to accessories such as tubing passing through the vessel cap (0003).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over LEE (US 2014/0196791) as supplied by applicant on the IDS dated 12/13/21 in view of MILLER (US 5690450) and MAUCHLE (US 20120009046) as applied above, further in view of BIVENS (US 2006/0013061) also supplied on the IDS.
With respect to claim 10, LEE discloses controlling flow of micro-carriers from the pouch to the vessel (0055), but does not explicitly disclose the pouch container is placed on a scale.
However, BIVENS discloses an automated control method for dry bulk material transfer comprising base/additive material tanks (rigid containers, second container) connected to a blending tank (bioreactor, first container) and a vacuum/suction (pressurized air) source to transfer dry materials between tanks (0023-24), in which the base/additive material tanks may employ an electronic scale (container is placed on a scale) which is used to measure the discharge of the bulk material from the tank (0027). It would have been obvious to one of ordinary skill in the art to modify the flow control of LEE to include the pouch container weight measured by a scale as taught by BIVENS because it provides an automated control method for efficiently transferring dry bulk materials in measured quantities (0007).
Response to Arguments
Applicant's arguments filed 5/5/26 have been fully considered but they are not persuasive.
In response to applicant’s argument that there is no teaching in the prior art of a first or second container being inverted and that the cited art are not capable of inversion because the proposed modification would render them unsuitable for their intended purpose, the examiner disagrees. LEE discloses multiple orientations of the pouch delivering the microcarriers (see Fig 1, 2) in which the orientation of Fig. 2 is vertically in-line with the receiving bioreactor (upside down/inverted) which provides explicit evidence that the intended purpose is not rendered unsuitable by changing the pouch orientation. It is noted that “the first rigid container and second rigid container are inverted prior to” and “when inverted” are recitations of intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. For the aforementioned reason, the prior art is considered capable of being inverted, absent any clear evidence to the contrary.
Applicant’s arguments with respect to claims 8-14 regarding the prior art not disclosing the newly claimed pressurized air or gas delivery to the rigid container have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2013/0136671 is cited as it relates to the amended limitations by teaching movement of a container contents via applying pneumatic pressure to the chamber through a pneumatic conduit (see Fig 1F).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIELLE B HENKEL whose telephone number is (571)270-5505. The examiner can normally be reached M-Th 11-7 EST, Alt. Fridays.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIELLE B HENKEL/Examiner, Art Unit 1799
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799
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