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 .
Claim Status
Claims 13-14 and 16-33 are pending with claims 13-14 and 16-33 being examined. Claim 15 is canceled.
Response to Arguments
Applicant’s arguments, filed on 07/08/2026, along with the amendments have been fully considered and are not persuasive.
The previous 112(b) rejection is moot since applicant amended claims 13 and 14 to refer to the slots described in the specification.
Claims 13 and 14 no longer invoke interpretation under 35 USC 112(f) since the claims were amended such that no limitations currently meet the 3-prong analysis.
As to the arguments and remarks, the Examiner has found Applicants arguments not persuasive. The previous rejection has been modified in accord with the amendment..
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 13, 16-18 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Michaels (US 20080061064 A; hereinafter “Michaels” previous of record) in view of Chang (US 20200290762 A1; hereinafter “Chang”), Kern (US 5362642; hereinafter “Kern” previous of record), and Fisher et al. (US 20090290962 A1; hereinafter “Fisher” previous of record).
Regarding claim 13, Michaels teaches a method of manufacturing a cell culture solution container (Michaels; [0008] “invention related to a liner assembly) comprising:
providing a rigid first end (Michaels; fig. 1. 26);
providing a rigid second end (Michaels; fig. 1. 22);
providing a deformable middle portion (Michaels; fig. 1. 24);
attaching the deformable middle portion to the first end and second end (Michaels; fig. 1. 20), wherein the first end, second end, and middle portion enclose a region having a variable volume (Michaels; fig. 1. 28);
providing an inlet;
fluidly coupling the inlet to the region (Michaels; fig. 2. 56);
providing an outlet;
fluidly coupling the outlet to the region (Michaels; fig. 2. 54).
Michaels fails to teach the container is configured to be accepted by slots configured to move apart, the container is further configured to be secured to the slots after the slots accept the container, the slots are configured to move apart to cause the container to expanded.
However, Chang teaches the analogous art of a container (bag) (Chang; Title) wherein the container is configured to be accepted by slots (Chang; fig. 2. 101) configured to move apart (Chang; fig. 3. “arrows” moving apart),
the container is further configured to be secured to the slots after the slots accept the container (Chang; [0027]-[0028] “the bag is clamped by the clamping device” and fig. 2. 20),
the slots are configured to move apart to cause the container to expand (Chang; fig. 2 and 3. 101 and “arrows”).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Michaels container to be accepted by slots configured to move apart, the container is further configured to be secured to the slots after the slots accept the container, the slots are configured to move apart to cause the container to expand as taught by Chang because Chang teaches a container (bag) (Chang; Title) wherein the container is configured to be accepted by slots (Chang; fig. 2. 101) configured to move apart (Chang; fig. 3. “arrows” moving apart), the container is further configured to be secured to the slots after the slots accept the container (Chang; [0027]-[0028] “the bag is clamped by the clamping device” and fig. 2.20), the slots are configured to move apart to cause the container to expand (Chang; fig. 2 and 3. 101 and arrows).
The modification allows to expand the container to be filled (Chang; fig. 3. Arrows).
Michaels fails to teach loading cell culture solution powder in the region, and while the container is expanding or the container is in an expanded configuration: the container is configured to receive water.
However, Kern teaches the analogous art of a cell culture media (Kern; Title) that includes loading cell culture solution powder in the region (Kern; Abstract), and while the container is expanding or the container is in an expanded configuration: the container is configured to receive water (Kern; Col 5 lines 23-27). Kern teaches mixing the powdered cell culture solution (Kern; Abstract).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Michaels cell culture solution container to include loading cell culture solution powder in the region, and while the container is expanding or the container is in an expanded configuration: the container is configured to receive water as taught by Kern because Kern teaches a cell culture media (Kern; Title) that includes loading cell culture solution powder in the region (Kern; Abstract), and while the container is expanding or the container is in an expanded configuration: the container is configured to receive water (Kern; Col 5 lines 23-27). Kern teaches mixing the powdered cell culture solution (Kern; Abstract).
The modification allows to mix and reconstitute the cell culture powder (Kern; Abstract).
Michaels fails to teach the container includes a stirrer, and the stirrer is configured to be driven and to mix the cell culture solution powder and water to create a cell culture solution.
However, Fisher teaches the analogous art of a collapsible bag (Fisher; Title) that includes a stirrer (Fisher; fig. 4. 51 and [0053]), and a liquid that may contain media that may be used in a biological reaction (Fisher; [0049]). Examiner will interpret Fisher’s liquid that may contain media as a cell culture solution, wherein the stirrer is configured to be driven and to mix the cell culture solution powder and water to create a cell culture solution (Fisher; [0053], and fig. 4. 11, 22, 51).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Michaels container to include a stirrer, and the stirrer is configured to be driven and to mix the cell culture solution powder and water to create a cell culture solution as taught by Fisher because Fisher teaches a collapsible bag (Fisher; Title) that includes a stirrer (Fisher; fig. 4. 51 and [0053]), and a liquid that may contain media that may be used in a biological reaction (Fisher; [0049]), wherein the stirrer is configured to be driven and to mix the cell culture solution powder and water to create a cell culture solution (Fisher; [0053], and fig. 4. 11, 22, 51).
The modification allows for mixing the cell culture solution (Fisher; [0085]).
Regarding claim 16, modified Michaels teaches the method of claim 13 (see above), wherein the providing the middle portion comprises providing a polyethylene bag or a polypropylene bag (Michaels; [0031] “materials for the bag include polyethylene”).
Regarding claim 17, modified Michaels teaches the method of claim 13, wherein one or more of the rigid first end, the rigid second end, and the middle portion comprise a recyclable material.
Modified Michaels teaches the one or more of the rigid first end, the rigid second end, and the middle portion can be made of polyethylene (see claim 16 above). It is known in the art that polyethylene is a recyclable material.
Regarding claim 18, modified Michaels teaches the method of claim 13 (see above), further comprising coupling a filter or a fitting configured to connect to a filter to the outlet (Michaels; fig. 5. 156). Examiner notes the port can be used to place a filter.
Regarding claim 21, modified Michaels teaches the method of claim 13 (see above), further comprising: configuring the container to be in a collapsed configuration (Michaels; fig. 1. 24 and [0032], and vacuum-sealing the middle portion of the container in the collapse configuration (Michaels; Abstract).
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Michaels (US 20080061064 A; hereinafter “Michaels”) in view of Chang (US 20200290762 A1; hereinafter “Chang”), Kern (US 5362642; hereinafter “Kern”), and Fisher et al. (US 20090290962 A1; hereinafter “Fisher” previous of record) as applied to claim 13 above, and in further view of Larsen et al. (US 20130081995 A1; hereinafter “Larsen”).
Regarding claim 19, modified Michaels teaches the method of claim 13 (see above) to include first and second ends (see above).
Modified Michaels fails to teach the rigid first and second ends comprise at least one of polyethylene, poly lactic acid (PLA), and poly carpolactone (PCL).
However, Larsen teaches the analogous art of a manufacturing a cell culture solution within a container (Larsen; fig. 2. 112, and [0043]) wherein the container has a body (Larsen; fig. 3. 120) that includes a rigid first end (Larsen; fig. 3. 134) and a second end (Larsen; fig. 3. 136) wherein the rigid first and second ends comprise at least one of polyethylene, poly lactic acid (PLA), and poly carpolactone (PCL) (Larsen; [0047] “body is comprised of polyethylene”).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Michaels first and second ends to be made of polyethylene, poly lactic acid (PLA), and poly carpolactone (PCL) as taught by Larsen because Larsen teaches manufacturing a cell culture solution within a container (Larsen; fig. 2. 112, and [0043]) wherein the container has a body (Larsen; fig. 3. 120) that includes a rigid first end (Larsen; fig. 3. 134) and a second end (Larsen; fig. 3. 136) wherein the rigid first and second ends comprise at least one of polyethylene, poly lactic acid (PLA), and poly carpolactone (PCL) (Larsen; [0047] “body is comprised of polyethylene”).
The modification allows to have an impermeable wall at each end (Larsen; [0047] ‘impermeable material such as polyethylene”).
Regarding claim 20, modified Michaels teaches the method of claim 13 (see above) to include a container (see above).
Modified Michaels fails to teach a volume of the container in an expanded configuration is 500L.
However, Larsen teaches the analogous art of a manufacturing a cell culture solution within a container (Larsen; fig. 2. 112, and [0043) wherein the container has an expanded configuration of 50 (Larsen; [0053] the body can hold from about 10L to 2000 L).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Michaels container to have an expanded volume configuration of 500L as taught by Larsen because Larsen teaches manufacturing a cell culture solution within a container (Larsen; fig. 2. 112, and [0043] wherein the container has an expanded configuration of 500L (Larsen; [0053] the body can hold from about 10L to 2000 L).
Overlapping ranges are prima facie evidence of obviousness. It would have been obvious to one having ordinary skill in the art to have selected the portion of 500L that corresponds to the claimed range because it is a standard range for cell culture media preparation in batches. In re Malagari, 184 USPQ 549 (CCPA 1974).
Claims 14, 22-27 and 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over Kern (US 5362642; hereinafter “Kern” previous of record) in view of Chang (US 20200290762 A1; hereinafter “Chang”), Fisher et al. (US 20090290962 A1; hereinafter “Fisher” previous of record), and Michaels (US 20080061064 A; hereinafter “Michaels” previous of record).
Regarding claim 14, Kern teaches a method of creating culture solution (Kern; Title), comprising: a first container in a collapsed configuration (Kern; fig. 1. 12), while the first container is expanding or the first container is in the expanded configuration: injecting water into the first container (Kern; Col. 5 lines 23-27), dispensing the culture solution into a second container (Kern; Col. 4 lines 55-57).
Kern fails to teach comprising: receiving, at slots of a dispenser, wherein: the slots are configured to move apart, and after receiving the first container, the slots are configured to secure the first container; moving the slots apart to expand the first container to an expanded configuration.
However, Chang teaches the analogous art of a container (bag) (Chang; Title) comprising; receiving, at slots of a dispenser, a first container in a collapsed configuration (Chang; fig. 2. 10, 101), wherein: the slots are configured to move apart (Chang; fig. 3. Arrows), and after receiving the first container, the slots are configured to secure the first container (Chang; fig. 5. 10) and [0029]); moving the slots apart to expand the first container to an expanded configuration (Chang; fig. 3. Arrows).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Kern’s first container to be received at slots of a dispenser, in a collapsed configuration, wherein:the slots are configured to move apart, and after receiving the first container, the slots are configured to secure the first container; moving the slots apart to expand the first container to an expanded configuration as taught by Chang because Chang teaches a container (bag) (Chang; Title) comprising; receiving, at slots of a dispenser, a first container in a collapsed configuration (Chang; fig. 2. 10, 101), wherein: the slots are configured to move apart (Chang; fig. 3. Arrows), and after receiving the first container, the slots are configured to secure the first container (Chang; fig. 5. 10) and [0029]); moving the slots apart to expand the first container to an expanded configuration (Chang; fig. 3. Arrows).
The modification allows to secure a container, expand the container and fill the container (Chang; fig. 3. 10. 101, fig. 5. 10 and [0027]).
Kern fails to teach driving a stirrer in the first container; and mixing, with the stirrer, a powder and the water in the first container to create the culture solution.
However, Fisher teaches the analogous art of a collapsible bag (Fisher; Title) that includes a stirrer (Fisher; fig. 4. 51 and [0053]), and a liquid that may contain media that may be used in a biological reaction (Fisher; [0049]). Examiner will interpret Fisher’s liquid that may contain media as a cell culture solution, driving a stirrer in the first container; and mixing, with the stirrer, a powder and the water in the first container to create the culture solution (Fisher; [0053], and fig. 4. 11, 22, 51), wherein a deformable middle portion (Fisher; fig. 4. 18) includes a powder is in the middle region (Fisher; fig. 4. 18. 22 and [0067]), an inlet fluidly coupled to the region (Fisher; fig. 4. 42); and an outlet fluidly coupled to the region (Fisher; fig. 4. 46).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Michael’s container to include a stirrer, and the stirrer is configured to be driven and to mix the cell culture solution powder and water to create a cell culture solution as taught by Fisher because Fisher teaches a collapsible bag (Fisher; Title) that includes a stirrer (Fisher; fig. 4. 51 and [0053]), and a liquid that may contain media that may be used in a biological reaction (Fisher; [0049]), wherein the stirrer is configured to be driven and to mix the cell culture solution powder and water to create a cell culture solution (Fisher; [0053], and fig. 4. 11, 22, 51), wherein a deformable middle portion (Fisher; fig. 4. 18) includes a powder is in the middle region (Fisher; fig. 4. 18. 22 and [0067]), an inlet fluidly coupled to the region (Fisher; fig. 4. 42); and an outlet fluidly coupled to the region (Fisher; fig. 4. 46).
The modification allows for mixing the cell culture solution (Fisher; [0085]), and introduction of liquid or gas from the container (Fisher; [0050]).
Kern fails to teach wherein the first container comprises: a rigid first end; a rigid second end; a deformable middle portion attached to the first end and second end and enclosing, with the first and second ends, a region having a variable volume; the powder in the region;an inlet fluidly coupled to the region; and an outlet fluidly coupled to the region.
However, Michaels teaches the analogous art of a cell culture container (Michaels; [0008]) that includes a rigid first end (Michaels; fig. 1. 26); a rigid second end (Michaels; fig. 22); a deformable middle portion attached to the first end and second end and enclosing with the first and second ends (Michaels; fig. 8. 58, 62, 64), a region having a variable volume (Michaels; fig. 8. 58 and [0032] “bag is collapsible”).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Kern’s first container to include a rigid first end; a rigid second end; a deformable middle portion attached to the first end and second end and enclosing with the first and second ends, a region having a variable volume as taught by Michaels because Michaels teaches a cell culture container (Michaels; [0008]) that includes a rigid first end (Michaels; fig. 1. 26); a rigid second end (Michaels; fig. 22); a deformable middle portion attached to the first end and second end and enclosing with the first and second ends (Michaels; fig. 8. 58, 62, 64), a region having a variable volume (Michaels; fig. 8. 58 and [0032] “bag is collapsible”).
The modification allows to the flexible container to be subjected to a vacuum (Michael’s Abstract).
Regarding claim 22, modified Kern teaches the method of claim 14 (see above) to include a first container that includes a rigid second end (see above).
Modified Kern fails to teach wherein the rigid second end comprises a tapered surface on an interior to the first container, the tapered surface tapering down and toward a center of the rigid second end.
However, Michaels teaches the analogous art of a cell culture solution container (Michaels; [0008] “invention related to a liner assembly) wherein the container comprises a rigid second end (Michaels; fig. 5. 112); wherein the rigid second end comprises a tapered surface on an interior to the first container, the tapered surface tapering down and toward a center of the rigid second end (Michaels; fig. 5. 102, 112).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Kern’s first container’s second end to a tapered surface on an interior to the first container, the tapered surface tapering down and toward a center of the rigid second end as taught by Michaels because Michaels teaches a cell culture solution container (Michaels; [0008] “invention related to a liner assembly) wherein the container comprises a rigid second end (Michaels; fig. 5. 112); wherein the rigid second end comprises a tapered surface on an interior to the first container, the tapered surface tapering down and toward a center of the rigid second end (Michaels; fig. 5. 102, 112).
The modification allows the stirrer to efficiently mix the solution.
Regarding claim 23, modified Kern teaches the method of claim 14 (see above) wherein the middle portion is a polyethylene bag or a polypropylene bag (Kern; Col. 8 lines 1-10).
Regarding claim 24, modified Kern teaches the method of claim 14 (see above)
wherein the one or more of the rigid first end, the rigid second end, and the middle portion can be made of polyethylene (see claim 23 above). It is known in the art that polyethylene is a recyclable material.
Regarding claim 25, modified Kern teaches the method of claim 14 (see above) to include rigid first and second ends (see above).
Modified Kern fails to teach wherein the rigid first and second ends comprise a tongue or a groove configured to, during insertion of the first container into a dispenser, couple the first container and the dispenser.
However, Michaels teaches the analogous art of a cell culture solution container (Michaels; [0008] “invention related to a liner assembly) that includes rigid first and second ends (see claim 14 above) wherein the rigid first end comprises a tongue or a groove (Michaels; [0022] “flange sized to receive collapsible liner”).
Michaels teaches a rigid first end with a flange, what the rigid flanged first end is used for is a matter of intended use.
It would have been obvious to include a groove or tongue on the second end to complimentary attach to the rigid first end flange.
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Kern’s rigid first end to comprise a tongue or a groove configured to, during insertion of the first container into a dispenser, couple the first container and the dispenser as taught by Michaels because Michaels teaches a cell culture solution container (Michaels; [0008] “invention related to a liner assembly) that includes rigid first and second ends (see claim 14 above) wherein the rigid first end comprises a tongue or a groove (Michaels; [0022] “flange sized to receive collapsible liner”).
The modification allows to have a tight connection between the rigid first and second ends and the first container.
Regarding claim 26, modified Kern teaches the method of claim 14 (see above), wherein the first container further comprises a filter (Kern; fig. 1. 40) and a fitting configured to connect to a filter (Kern; fig. 4. 40, 66 illustrates what appears to be tube 66 fitted to the filter 40).
Regarding claim 27, modified Kern teaches the method of claim 14 (see above) to include a rigid first and second end (see above).
Modified Kern fails to teach wherein: the inlet is located on the rigid first end, and the outlet is located on the rigid second end.
However, Michaels teaches the analogous art of a cell culture solution container (Michaels; [0008] “invention related to a liner assembly) that includes a rigid first and second end (see claim 14 above) wherein the inlet is located on the rigid first end (Michaels; fig. fig. 2. 56), and the outlet is located on the rigid second end (Michaels; fig. 1. 52 and [0025] “vacuum source port for evacuation”).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Kern’s first and second end wherein: the inlet is located on the rigid first end, and the outlet is located on the rigid second end as taught by Michaels because Michaels teaches a cell culture solution container (Michaels; [0008] “invention related to a liner assembly) that includes a rigid first and second end (see claim 14 above) wherein the inlet is located on the rigid first end (Michaels; fig. fig. 2. 56), and the outlet is located on the rigid second end (Michaels; fig. 1. 52 and [0025] “vacuum source port for evacuation”).
The modification allows the fluid to flow from the rigid first and to the rigid second end.
Regarding claim 29, modified Kern teaches the method of claim 14 (see above), wherein when the first container is in the expanded configuration, the middle portion is flexible (Kern; fig. 1. 12 illustrates a first container in the expanded configuration, wherein the container is a bag). It is well known in the art that when bads are in an expanded configuration the middle portion is flexible.
Regarding claim 30, modified Kern teaches the method of claim 14 (see above) to include a middle portion (see above).
Modified Kern fails to teach wherein, in the collapsed configuration, the middle portion is configured to be vacuum-sealed.
However, Michaels teaches the analogous art of a cell culture solution container (Michaels; [0008] “invention related to a liner assembly) that includes a middle portion (see claim 14 above) wherein, in the collapsed configuration, the middle portion is configured to be vacuum-sealed (Michaels; Abstract).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Kern’s middle portion to be vacuum sealed when in a collapsed configuration as taught by Michaels because Michaels teaches a cell culture solution container (Michaels; [0008] “invention related to a liner assembly) that includes a middle portion (see claim 14 above) wherein, in the collapsed configuration, the middle portion is configured to be vacuum-sealed (Michaels; Abstract).
The modification allows to have a compact packaging.
Claims 28 and 31-32 are rejected under 35 U.S.C. 103 as being unpatentable over Kern (US 5362642; hereinafter “Kern” previous of record) in view of Chang (US 20200290762 A1; hereinafter “Chang”), Fisher et al. (US 20090290962 A1; hereinafter “Fisher” previous of record), and Michaels (US 20080061064 A; hereinafter “Michaels” previous of record) as applied to claim 14 above, and further in view of Larsen et al. (US 20130081995 A1; hereinafter “Larsen” previous of record).
Regarding claim 28, modified Kern teaches the method of claim 14 (see above) to include a rigid first and second end (see above).
Modified Kern fails to teach wherein the rigid first and second ends comprise at least one of polyethylene, poly lactic acid (PLA), and poly carpolactone (PCL).
However, Larsen teaches the analogous art of a manufacturing a cell culture solution within a container (Larsen; fig. 2. 112, and [0043]) wherein the container has a body (Larsen; fig. 3. 120) that includes a rigid first end (Larsen; fig. 3. 134) and a second end (Larsen; fig. 3. 136) wherein the rigid first and second ends comprise at least one of polyethylene, poly lactic acid (PLA), and poly carpolactone (PCL) (Larsen; [0047] “body is comprised of polyethylene”).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Kern’s first and second ends to be made of polyethylene, poly lactic acid (PLA), and poly carpolactone (PCL) as taught by Larsen because Larsen teaches manufacturing a cell culture solution within a container (Larsen; fig. 2. 112, and [0043]) wherein the container has a body (Larsen; fig. 3. 120) that includes a rigid first end (Larsen; fig. 3. 134) and a second end (Larsen; fig. 3. 136) wherein the rigid first and second ends comprise at least one of polyethylene, poly lactic acid (PLA), and poly carpolactone (PCL) (Larsen; [0047] “body is comprised of polyethylene”).
The modification allows to have an impermeable wall at each end (Larsen; [0047] ‘impermeable material such as polyethylene”).
Regarding claim 31, modified Kern teaches the method of claim 14 (see above) to include a rigid first and second end (see above).
Modified Kern fails to teach wherein at least one of the rigid first end and the rigid second end is opaque to a sterilization light.
However, Larsen teaches the analogous art of a manufacturing a cell culture solution within a container (Larsen; fig. 2. 112, and [0043]) wherein the container has a body (Larsen; fig. 3. 120) that includes a rigid first end (Larsen; fig. 3. 134) and a second end (Larsen; fig. 3. 136) wherein at least one of the rigid first end and the rigid second end is opaque to a sterilization light (Larsen; [0052]).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Kern’s rigid first and second end wherein at least one of the rigid first end and the rigid second end is opaque to a sterilization light as taught by Larsen because Larsen teaches manufacturing a cell culture solution within a container (Larsen; fig. 2. 112, and [0043]) wherein the container has a body (Larsen; fig. 3. 120) that includes a rigid first end (Larsen; fig. 3. 134) and a second end (Larsen; fig. 3. 136) wherein at least one of the rigid first end and the rigid second end is opaque to a sterilization light (Larsen; [0052]).
The modification prevents the media from breakdown with light.
Regarding claim 32, modified Kern teaches the method of claim 14 (see above) to include a first container (see above).
Modified Kern fails to teach wherein a volume of the first container in the expanded configuration is 500L.
However, Larsen teaches the analogous art of a manufacturing a cell culture solution within a container (Larsen; fig. 2. 112, and [0043) wherein the container has an expanded configuration of 50 (Larsen; [0053] the body can hold from about 10L to 2000 L).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Kern’s container to have an expanded volume configuration of 500L as taught by Larsen because Larsen teaches manufacturing a cell culture solution within a container (Larsen; fig. 2. 112, and [0043) wherein the container has an expanded configuration of 50 (Larsen; [0053] the body can hold from about 10L to 2000 L).
Overlapping ranges are prima facie evidence of obviousness. It would have been obvious to one having ordinary skill in the art to have selected the portion of 500L that corresponds to the claimed range because it is a standard range for cell culture media preparation in batches. In re Malagari, 184 USPQ 549 (CCPA 1974).
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Kern (US 5362642; hereinafter “Kern” previous of record) in view of Chang (US 20200290762 A1; hereinafter “Chang”), Fisher et al. (US 20090290962 A1; hereinafter “Fisher” previous of record), and Michaels (US 20080061064 A; hereinafter “Michaels” previous of record) as applied to claim 14 above, and further in view of Hurst (US 20040245144 A1; hereinafter “Hurst”).
Regarding claim 33, modified Kern teaches the method of claim 14 (see above) to include two portions (receiving slots) (see above).
Modified Kern fails to teach receiving an input via a user interface of the dispenser, wherein the input causes the two portions to move apart to expand the first container.
However, Hurst teaches the analogous art of a mixing bag (Hurst; Title) and the use of a controller that is used to inject solution into the interior mixing chamber, the controller is further connected to a computer (Hurst; [0125]).
It would have been obvious to program the computer in Hurst to move Kern’s receiving slots to move the rigid first and second ends apart to expand the first container before injecting the solution into the interior mixing chamber.
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Kern’s two portions to include a computer that controls the method as taught by Hurst because Hurst teaches a mixing bag (Hurst; Title) and the use of a controller that is further connected to a computer (Hurst; [0125]) wherein the computer system controls the method (Hurst; [0117]).
The modification allows to control the method (Hurst; [0117]).
Response to Arguments
Applicant’s arguments with respect to claims 13 and 14 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
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 ALEX RAMIREZ whose telephone number is (571)272-9756. The examiner can normally be reached Monday - Friday 8:00 - 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, Charles Capozzi can be reached at (571) 270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/A.R./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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