DETAILED ACTION
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.
Claims 1-17, 24 and 25 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Independent claims 1 and 24 require “a plurality of cultivation compartments” and “one or more ports”, such that “each of the plurality of cultivation compartments include one of the one or more ports”. It is unclear how many ports are required by the claims. The term “one or more ports” reads on configurations where the bag comprises only a single port, while the term “each of the plurality of cultivation compartments include one of the one or more ports” requires that there must be more than one port (i.e., at least one port for each of the multiple compartments). Figure 1, for example, shows that each compartment is serviced by a different collection of ports, and so it is unclear how a single port (“one or more ports”) would fulfill the limitation “each of the plurality of cultivation compartments include one of the one or more ports”.
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.
Claims 1-13, 24 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Gebauer (US 20170044477) in view of Riese (US 4637061).
With respect to claims 1, 3, 9 and 10, Gebauer teaches a flexible plastic bag (Figure 3:42) for the cultivation of cells. Paragraph [0023] states that a top wall film and a bottom wall film are sealed to each other by durable weld seams to form the inner volume of the bag. A plurality of ports (Figure 3:54,55)are provided to introduce and withdraw fluids to and from the inner volume. A plurality of frangible weld seams (Figure 3:52) join the insides of the top and bottom wall films and divide the inner volume into a plurality of cultivation compartments (Figure 3:45,46,47), which allows transfer of a cell culture from one cultivation compartment to another. This is described in paragraph [0029]. Figs. 1-3 show that each of the plurality of cultivation compartments include one or more of the plurality of ports. Gebauer, however, states that the frangible weld seams are ruptured by mechanical action from the outside of the bag, but does not expressly state that a plurality of gripping means are provided adjacent to each frangible weld seam.
Riese discloses a flexible plastic bag comprising a top wall film (Figure 2:19) and a bottom wall film (Figure 2:21) sealed to each other inside-to-inside by durable weld seams (Figure 1:35) to form a bag with an inner volume delimited by the durable weld seams. One or more ports (Figure 5:55) are provided for introducing and withdrawing fluids to or from the inner volume. A plurality of frangible seals (Figure 1:23) join the insides of the top and bottom wall films and divide the inner volume into a plurality of compartments (Figure 5:13,15). A plurality of gripping means (Figure 2:29) are affixed to the top and bottom wall films. Each of the plurality of gripping means is adjacent to a specific frangible seal and is adapted to break that specific frangible seal by pulling apart the gripping means. Fig. 2, for example, shows that the gripping means may be positioned above the frangible seal so that the gripping means are directly attached to a single compartment. This is described in column 4, line 64 to column 6, line 2. Riese further contemplates embodiments in which multiple chambers, frangible seals and gripping means are provided (“The drawings show a container having two chambers but it is to be understood that a container may have three chambers or more. Each chamber should be selectively sealed by a reclosable interior fastener with gripper flaps associated with each fastener”).
Before the effective filing date of the claimed invention, it would have been obvious to provide the Gebauer plastic bag with a plurality of gripping means that are each paired to and configured to break a specific frangible seal. Riese teaches that gripping means, such as flaps, “facilitate the opening” of the frangible seal and are readily added to the exterior of a plastic bag using known techniques. Riese shows how the incorporation of gripping means coupled to specific frangible seals offers greater control over the selective opening and closing of multiple compartments within a bag.
With respect to claim 2, Gebauer and Riese disclose the combination as described above. The gripping means 29 of Riese are described as “flaps”, which is understood to read on “a tab of film”, “a handle” and “a fold”.
With respect to claim 4, Gebauer and Riese disclose the combination as described above. As previously discussed, both Gebauer and Riese teach bags in which the top and bottom wall films are directly sealed to each other along their edges by durable weld seams.
With respect to claim 5, Gebauer and Riese disclose the combination as described above. Gebauer teaches the cultivation compartments may also comprise one more sensors for temperature, which reads on the instant claim limitation of one or more sensors adapted to measure at least one property in at least one cultivation compartment.
With respect to claim 6, Gebauer and Riese disclose the combination as described above. Gebauer additionally teaches that many other sensors, such as cell density sensors, are used to measure cell viability. See paragraph [0030].
With respect to claim 7, Gebauer and Riese disclose the combination as described above. Gebauer additionally teaches in paragraph [0024] that the bag assembly of the invention can be arranged on a rocking tray (Figure 1:13), which reads on the instant claim limitation of a bag adapted to be attached to a moving table platform for agitation.
With respect to claim 8, Gebauer and Riese disclose the combination as described above. Gebauer teaches the bag assemblies can be presterilized such as by radiation sterilization. See paragraph [0031].
With respect to claims 11-13, Gebauer and Riese disclose the combination as described above. Gebauer teaches the bag assembly of the invention can be arranged on a rocking tray, which reads on the instant claim limitation of a bag attached to a moving table platform for agitation of said bag.
With respect to claim 24, Gebauer and Riese disclose the combination as described above. The durable weld seams of Gebauer and Riese are each pulled apart without damaging top and bottom wall films using a force between 5N and 80N.
With respect to claim 25, Gebauer and Riese disclose the combination as described above. As previously discussed, Gebauer indicates that it is desirable to use a flexible plastic bag as a cultivation bag characterized by a cultivation chamber configured to receive cultivation medium. Gebauer shows in Figs. 1-3 how the second cultivation compartment is at least 120% the volume of the first cultivation compartment, and how the third cultivation compartment is at least 120% the volume of the second cultivation compartment. See paragraph [0022].
Claims 1-13, 24 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Barney (US 5462526) in view of Riese (US 4637061) and Gebauer (US 20170044477).
With respect to claims 1 and 3, Barney discloses a flexible plastic bag comprising a top wall film (Figure 2:12) and a bottom wall film (Figure 2:14) sealed to each other inside-to-inside by durable weld seams (Figure 1:16) to form a bag with an inner volume delimited by the durable weld seams. One or more ports (Figure 2:40) are provided for introducing and withdrawing fluids to or from the inner volume. A plurality of frangible weld seams (Figure 1:24,26) join the insides of the top and bottom wall films and divide the inner volume into a plurality of compartments (Figure 1:18,20,22). This is described in column 4, line 12 to column 5, line 14 and column 6, lines 49-64. The flexible bag and compartments are fully capable of holding a variety of different fluids, including fluid for the cultivation of cells. Apparatus claims cover what a device is, not what a device does. 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. Barney, however, states that the frangible weld seams are ruptured by squeezing the bag, and therefore does not teach that a plurality of gripping means are provided adjacent to each frangible weld seam.
Riese discloses a flexible plastic bag comprising a top wall film (Figure 2:19) and a bottom wall film (Figure 2:21) sealed to each other inside-to-inside by durable weld seams (Figure 1:35) to form a bag with an inner volume delimited by the durable weld seams. One or more ports (Figure 5:55) are provided for introducing and withdrawing fluids to or from the inner volume. A plurality of frangible seals (Figure 1:23) join the insides of the top and bottom wall films and divide the inner volume into a plurality of compartments (Figure 5:13,15). A plurality of gripping means (Figure 2:29) are affixed to the top and bottom wall films. Each of the plurality of gripping means is adjacent to a specific frangible seal and is adapted to break that specific frangible seal by pulling apart the gripping means. Fig. 2, for example, shows that the gripping means may be positioned above the frangible seal so that the gripping means are directly attached to a single compartment. This is described in column 4, line 64 to column 6, line 2. Riese further contemplates embodiments in which multiple chambers, frangible seals and gripping means are provided (“The drawings show a container having two chambers but it is to be understood that a container may have three chambers or more. Each chamber should be selectively sealed by a reclosable interior fastener with gripper flaps associated with each fastener”).
Before the effective filing date of the claimed invention, it would have been obvious to provide the Barney plastic bag with a plurality of gripping means that are each paired to and configured to break a specific frangible seal. Riese teaches that gripping means, such as flaps, “facilitate the opening” of the frangible seal and are readily added to the exterior of a plastic bag using known techniques. Riese shows how the incorporation of gripping means coupled to specific frangible seals offers greater control over the selective opening and closing of multiple compartments within a bag.
Barney and Riese still differ from Applicant’s claimed invention. Barney appears to show only a single port and therefore does not expressly teach that each of the plurality of compartments includes a port.
Gebauer teaches a flexible plastic bag (Figure 3:42) for the cultivation of cells. Paragraph [0023] states that a top wall film and a bottom wall film are sealed to each other by durable weld seams to form the inner volume of the bag. A plurality of ports (Figure 3:54,55) are provided to introduce and withdraw fluids to and from the inner volume. A plurality of frangible weld seams (Figure 3:52) join the insides of the top and bottom wall films and divide the inner volume into a plurality of cultivation compartments (Figure 3:45,46,47), which allows transfer of a cell culture from one cultivation compartment to another. This is described in paragraph [0029]. Figs. 1-3 show that each of the plurality of cultivation compartments include one or more of the plurality of ports.
Before the effective filing date of the claimed invention, it would have been obvious to provide each of Barney’s compartments with at least one port. Gebauer teaches that this allows one to separately add and remove fluid from each compartment. Those of ordinary skill would have understood that this would allow the Barney bag to be used for a greater range of applications, such as cell culture. It is well established that a mere duplication of parts (here, the provision of multiple ports so that each compartment interfaces with a port) that produces an art-recognized benefit and/or a predictable cumulative result is prima facie obvious. See MPEP 2144.04.
With respect to claim 2, Barney, Riese and Gebauer disclose the combination as described above. The gripping means 29 of Riese are described as “flaps”, which is understood to read on “a tab of film”, “a handle” and “a fold”.
With respect to claim 4, Barney, Riese and Gebauer disclose the combination as described above. As previously discussed, both Barney and Riese teach bags in which the top and bottom wall films are directly sealed to each other along their edges by durable weld seams.
With respect to claims 5, 9 and 10, Barney, Riese and Gebauer disclose the combination discussed above in claim 1. Further, Riese teaches that the compartments are configured to receive a biological specimen. Gebauer additionally teaches the cultivation compartments may also comprises one more sensors for temperature, which reads on the instant claim limitation of one or more sensors adapted to measure at least one property in at least one cultivation compartment. This is taught in paragraphs [0022]-0030].
With respect to claim 6, Barney, Riese and Gebauer disclose the invention discussed above in claim 5. Gebauer further teaches a cell density sensor (see paragraph [0030]), which reads on the instant claim limitation of at least one of said sensors is a viable cell density sensor.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the invention of Barney to include at least one of said sensors is a viable cell density sensor as taught by Gebauer, in order to sufficiently allow for the monitoring of cells in the compartment of the apparatus. Further, Gebauer teaches the one or more sampling outlets, inlets for culture medium of the device provide for the measuring of cell density of a cultivation compartment.
With respect to claim 7, Barney, Riese and Gebauer disclose the combination discussed above in claim 1. Further, Barney teaches a bag (pouch) discussed above. However, Barney does not teach a bag adapted to be attached to a moving table platform, such as a rocking table platform, for agitation.
Gebauer teaches a flexible bag assembly which allows transfer of a cell culture from one cultivation compartment to another, and Gebauer teaches the bag assembly of the invention can be arranged on a rocking tray (Figure 1:13), which reads on the instant claim limitation of a bag adapted to be attached to a moving table platform, such as a rocking table platform, for agitation. See paragraph [0024].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the invention of Barney to include a bag adapted to be attached to a moving table platform, such as a rocking table platform, for agitation as taught by Gebauer, because Gebauer teaches the rocking tray platform of the invention can provide agitation during cultivation. Gebauer expressly mentions that such a rocking operation is safe and convenient, is accomplished automatically without user oversight, and “allows transfer of a cell culture from one cultivation compartment to another without risk of premature leakage between compartments or of bag damage”.
With respect to claim 8, Barney, Giese and Gebauer disclose the combination discussed above in claim 1. Further, Barney teaches a bag (pouch) discussed above. However, Barney does not explicitly teach that the bag is supplied presterilized, such as by radiation sterilization.
Gebauer teaches a flexible bag assembly which allows transfer of a cell culture from one cultivation compartment to another, and Gebauer teaches the bag assemblies can be presterilized such as by radiation sterilization (paragraph [0031]), which reads on the instant claim limitation of supplied presterilized, such as by radiation sterilization.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the invention of Barney to include supplied presterilized, such as by radiation sterilization as taught by Gebauer. Gebauer teaches that bag assemblies should be sterilized to prevent contamination, especially when used for cell culture, and that pre-sterilization is useful for end-users who may not be equipped to conduct a sterilization operation.
With respect to claims 11-13, Barney, Riese and Gebauer disclose the combination discussed above in claim 1. Further, Barney teaches a bag (pouch) comprised of polymeric sheets discussed above. However, Barney does not teach a bag attached to a moving table platform for agitation of said bag.
Gebauer teaches a flexible bag assembly which allows transfer of a cell culture from one cultivation compartment to another, and Gebauer teaches the bag assembly of the invention can be arranged on a rocking tray (Figure 1:13), which reads on the instant claim limitation of a bag attached to a moving table platform for agitation of said bag.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the invention of Barney to include a bag attached to a moving table platform for agitation of said bag as taught by Gebauer, because Gebauer teaches the rocking tray platform of the invention can provide agitation during cultivation. Gebauer expressly mentions that such a rocking operation is safe and convenient, is accomplished automatically without user oversight, and “allows transfer of a cell culture from one cultivation compartment to another without risk of premature leakage between compartments or of bag damage”.
With respect to claim 24, Barney, Riese and Gebauer disclose the combination as described above. The durable weld seams of Barney, Riese and Gebauer are each pulled apart without damaging top and bottom wall films using a force between 5N and 80N.
With respect to claim 25, Barney, Riese and Gebauer disclose the combination as described above. As previously discussed, Gebauer indicates that it is desirable to use a flexible plastic bag as a cultivation bag characterized by a cultivation chamber configured to receive cultivation medium. Gebauer shows in Figs. 1-3 how the second cultivation compartment is at least 120% the volume of the first cultivation compartment, and how the third cultivation compartment is at least 120% the volume of the second cultivation compartment. See also paragraph [0022].
Claims 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Gebauer (US 20170044477) in view of Riese (US 4637061) as applied to claim 13, and further in view of Dumont (US 5641039).
Gebauer and Riese disclose the combination as described above. Gebauer and Riese each teach a plurality of bag compartments. Gebauer shows how a moving table platform can be manipulated to successively transfer cell culture fluid from one compartment to the next in a controllable manner. Gebauer states that cell density sensors are provided to monitor cell growth, and that the sensors signal when it is time to deliver the cell culture medium from one compartment to the next (“The cultivation in the first compartment may be continued until a predetermined viable cell density (VCD) is reached…VCD may e.g. be measured with an inline biomass sensor…when the predetermined VCD has been reached, steps d) and further may be initiated. The transfer in step e) may be accomplished by gravity, e.g. by inclining the tray with the bags or raising it vertically”). The references, however, do not appear to teach a seam opener capable of pulling a specific gripping means to open a specific frangible weld seam.
Dumont teaches an automated system for opening and closing a bag (Figure 3:51) comprising a gripping means. Dumont states that a seam opener (Figure 2:56) is configured to pull the bag gripping means until the bag is completely open. The seam opener then stops pulling to avoid any damage to the bag. This is described in column 6, line 45 to column 7, line 10.
Before the effective filing date of the claimed invention, it would have been obvious to ensure that the individual compartments of the modified Gebauer bag are opened using automated means that include a seam opener. Dumont teaches that bag manipulation using robotics is well known across a variety of different arts. Those of ordinary skill would have wanted to open the Gebauer frangible seams using an automated system, especially when the Gebauer bag is configured as a bioreactor. Gebauer teaches that valves and frangible seams should be opened automatically when it is detected that the cell culture medium should be transferred to the next bag compartment.
Claims 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Barney (US 5462526) in view of Riese (US 4637061) and Gebauer (US 10450540) as applied to claim 13, and further in view of Dumont (US 5641039).
Barney, Riese and Gebauer disclose the combination as described above. Barney, Riese and Gebauer each teach a plurality of bag compartments. Gebauer shows how a moving table platform can be manipulated to successively transfer cell culture fluid from one compartment to the next in a controllable manner. Gebauer states that cell density sensors are provided to monitor cell growth, and that the sensors signal when it is time to deliver the cell culture medium from one compartment to the next (“The cultivation in the first compartment may be continued until a predetermined viable cell density (VCD) is reached…VCD may e.g. be measured with an inline biomass sensor…when the predetermined VCD has been reached, steps d) and further may be initiated. The transfer in step e) may be accomplished by gravity, e.g. by inclining the tray with the bags or raising it vertically”). The references, however, do not appear to teach a seam opener capable of pulling a specific gripping means to open a specific frangible weld seam.
Dumont teaches an automated system for opening and closing a bag (Figure 3:51) comprising a gripping means. Dumont states that a seam opener (Figure 2:56) is configured to pull the bag gripping means until the bag is completely open. The seam opener then stops pulling to avoid any damage to the bag. This is described in column 6, line 45 to column 7, line 10.
Before the effective filing date of the claimed invention, it would have been obvious to ensure that the individual compartments of the modified Barney bag are opened using automated means that include a seam opener. Dumont teaches that bag manipulation using robotics is well known across a variety of different arts. Those of ordinary skill would have wanted to open the Barney frangible seams using an automated system, especially when the Barney bag is configured as a bioreactor. Gebauer teaches that valves and frangible seams should be opened automatically when it is detected that the cell culture medium should be transferred to the next bag compartment.
Response to Arguments
In response to Applicant’s amendment filed 25 November 2025, the previous 35 U.S.C. 112 and 103 rejections have been withdrawn. However, upon further consideration, a new ground of rejection is made in view of the combination of Gebauer with Riese and the combination of Barney with Riese and Gebauer. A new rejection under 35 U.S.C. 112 has also been made.
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 NATHAN ANDREW BOWERS whose telephone number is (571)272-8613. The examiner can normally be reached M-F 7am-5pm.
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/NATHAN A BOWERS/ Primary Examiner, Art Unit 1799