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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/9/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The information disclosure statement (IDS) submitted on 11/7/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Interpretation – 112(f)
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are:
In claim 1, “a first cell retention device” and “a second cell retention device” are interpreted to be one of an alternating tangential flow (ATF) filtration device or a tangential flow filtration (TFF) device – evidenced by [0017] in the disclosure.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claims 1, 8-9, and 12 are objected to because of the following informalities:
In claim 1 –“a bleed vessel connected the first bleed pump” should read “a bleed vessel connected to the first bleed pump”.
In claim 8 – “pump fresh medium” should read “pump the fresh medium”.
In claim 9 – it is suggested “wherein the media pump includes a flowrate equal the first harvest pump plus first bleed pump” be rewritten as “wherein a flowrate of the media pump equals a flowrate of the first harvest pump plus a flowrate of the first bleed pump”.
Further, claim 9 objected to under 37 CFR 1.75 as being a substantial duplicate of claim 10, e.g., claim 10 is merely an algebraic rearrangement of the flowrates stated in claim 9. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
In claim 12 – “a flowrate of the first bleed pump” should read “wherein a flowrate of the first bleed pump”
Appropriate correction is required.
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 8-10 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.
Claim 8 recites the limitation “product of interest”. It is unclear if it is the same or different as the “product of interest” recited in claim 1, thus rendering the claim indefinite.
Claims 9 and 10 are similarly rejected as they are dependent on rejected claim 8.
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.
Claims 1-7 and 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Sieck et al. (US 2022/0380712 A1) (see PTO-892).
Regarding claim 1, Sieck et al. teaches a system for harvesting product of interest from a bleed material of a perfusion bioreactor (claim 1), the system comprising:
a bioreactor (Fig. 2, bioreactor 1 – see annotated figure below) arranged and configured to store a medium including a product of interest - note: this limitation is directed toward the intended use of the system; the bioreactor would be structurally capable of storing a medium including a product of interest because the bioreactor has a media inlet ([0010]) - see MPEP § 2114 II;
a first cell retention device (Fig. 2, cell retention device 4; [0073] – note: the claim language is interpreted as one of an alternating tangential flow (ATF) filtration device or a tangential flow filtration (TFF) device, see Claim Interpretation – 112(f) section above) coupled to the bioreactor via tubing, the first cell retention device arranged and configured to separate the product of interest from the medium ([0090], lines 6-8);
a first harvest pump ([0038]) to transfer the product of interest from the first cell retention device to a first harvest tank – note: this limitation is directed toward the intended use of the system; the pump would be structurally capable of transferring the product from the cell retention device to the harvest tank because the pump allows fluid flow ([0076]) – see MPEP § 2114 II;
a bleed recovery system, the bleed recovery system ([0010], bleed recovery device) arranged and configured to receive the bleed material including the product of interest – note: this limitation is directed toward the intended use of the system; the bleed recovery device would be structurally capable of receiving bleed material including product of interest because it contains an inlet for the bleed ([0010]) – see MPEP § 2114 II, wherein the bleed recovery system includes:
a first bleed pump ([0038]; [0040]; [0114], lines 6-9);
a bleed vessel connected the first bleed pump (Fig. 2, means 6 – structure defined in [0080]; [0093], lines 3-6 teach pump at inlet of means 6 for flow of suspension (bleed material) from the bioreactor), the bleed vessel arranged and configured to receive the bleed material including the product of interest from the first bleed pump – note: this limitation is directed toward the intended use of the system; the means would be structurally capable of receiving the bleed material including the product of interest from the first pump because it has an inlet receives the bleed from the bioreactor ([0090] and [0093]) – see MPEP § 2114 II;
a second cell retention device coupled to the bleed vessel via tubing ([0104], lines 1-6 imply second cell retention device connected to means 6 (i.e., bleed vessel) – note: the claim language is interpreted as one of an alternating tangential flow (ATF) filtration device or a tangential flow filtration (TFF) device, see Claim Interpretation – 112(f) section above), the second cell retention device arranged and configured to receive the product of interest – note: this limitation is directed toward the intended use of the system; the cell retention device, as taught by Sieck et al., would be structurally capable of receiving the product of interest because it would receive the liquid portion from means 6 (i.e., bleed vessel), which contains a target product ([0009]) – see MPEP § 2114 II; and
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a second bleed pump connected to the bleed vessel (Fig. 2, outlet 8; [0092]) to transfer the medium to a bleed waste tank ([0090], lines 26-29).
Sieck et al. does not explicitly teach a second harvest pump coupled to the second cell retention device via tubing.
However, Sieck et al. teaches that a cell retention device (i.e., second cell retention device) inserted into the bleed recovery device (i.e., bleed recovery system) ([0104], lines 1-4), which comprises means 6 (i.e., bleed vessel), that additional pumps may increase the bleed recovery device’s efficiency ([0013], lines 2-4), and that tubing is used to attach pumps and vessels ([0084], lines 1-2).
It would have been obvious to one of ordinary skill in the art to incorporate an additional pump (i.e., second harvest pump) coupled to an additional cell retention device (i.e., second cell retention device) via tubing to increase bleed recovery system efficiency and further filter out cells before refeeding into the bioreactor.
Regarding the limitation wherein the first cell retention device is coupled to the bioreactor via tubing, Sieck et al. teaches that any combination of tubing and cell retention devices may be used ([0073], lines 8-11) with the bioreactor for filtering cells ([0073], lines 1-3). It would have been obvious to one of ordinary skill in the art to couple a cell retention device to the bioreactor via tubing to allow the cell retention device to receive the outflow for filtering cells from the product.
Regarding the limitation wherein the first harvest pump is coupled to the first cell retention device via tubing, Sieck et al. teaches that any combination of pumps and tubing may be used ([0073], lines 8-11). It would have been obvious to one of ordinary skill in the art to use the tubing and pumps, taught by Sieck et al., to couple the first harvest pump to the first cell retention device because it would facilitate the flow of media and the product of interest the first harvest pump from the first cell retention device.
Regarding the limitation wherein the first bleed pump is operatively coupled to the bioreactor via tubing, Sieck et al. teaches a bleed pump associated with the perfusion process to facilitate the flow of bleed to the bleed recovery device ([0114], lines 9-10) and that a bioreactor system includes any combination of tubing and pumps ([0038]; [0040]; [0073], lines 8-11). It would have been obvious to one of ordinary skill in the art to use the tubing and pumps, as taught by Sieck et al. to operatively couple the first bleed pump to the bioreactor via tubing because it would facilitate the flow of the bleed stream from the bioreactor.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system and teachings of Sieck et al. to obtain the invention as claimed in claim 1.
Regarding claim 2, modified Sieck et al. teaches the system of claim 1.
Sieck et al. further teaches wherein means 6 (i.e., bleed vessel) relies on sedimentation (i.e., sedimentation style bleed vessel – [0090], lines 13-16).
Regarding claim 3, modified Sieck et al. teaches the system of claim 2.
Sieck et al. is silent to the manner in which the second cell retention device is coupled with the sedimentation style bleed vessel.
However, Sieck et al. teaches that the liquid part of the bleed may be re-fed into the bioreactor through the second cell retention device ([0104], lines 7-9) and that the liquid part of the bleed is preferably removed through an outlet positioned at the upper half of the means 6 ([0090], lines 34-37) to minimize the disturbance of settled cells ([0090], lines 37-39).
It would have been obvious to one of ordinary skill in the art to modify the device of Sieck et al. to connect the second cell retention device to a top portion of the sedimentation style bleed vessel to avoid disturbing settled cells.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system and teachings of Sieck et al. to obtain the invention as specified in claim 3.
Regarding claim 4, modified Sieck et al. teaches the system of claim 3.
Sieck et al. further teaches wherein an outlet for excess cells and waste (Fig. 2, outlet 8 – see claim 1 rejection), comprising a pump ([0092]) is positioned preferably at the bottom of means (i.e., sedimentation style bleed vessel – [0091], lines 7-9).
Regarding claim 5, modified Sieck et al. teaches the system of claim 1.
Sieck et al. further teaches that it is known in the art that cell retention devices can be alternating tangential flow (ATF) devices ([0073], lines 3-5). The limitation “tangential flow filtration (TFF) device” is phrased in the alternative. At least one of the limitations in the claim is rejected, thus no further rejections are required at the time.
Regarding claim 6, such limitations are directed toward the intended manner of operating the claimed system and does not differentiate the claimed system from the prior art system because all structural limitations are taught in the prior art system (MPEP §2114 II). The system taught by Sieck et al. would be fully capable of achieving every claimed intended use because the prior art system is taught to have pumps that can be controlled by any suitable mechanism ([0076], lines 6-15) and would be structurally capable of having the first bleed pump flowrate equal the second bleed pump flowrate plus the second harvest pump flowrate absent clear evidence to the contrary and absent a showing of unexpected results.
Regarding claim 7, 11, and 13, such limitations are directed toward the intended manner of operating the claimed system and does not differentiate the claimed system from the prior art system because all structural limitations are taught in the prior art system (MPEP §2114 II). The system taught by Sieck et al. would be fully capable of achieving every claimed intended use because the prior art system is taught to use peristaltic pumps, magnetically coupled pumps, or membrane pumps ([0084], lines 7-9) that can operate semi-continuously (Fig. 4 shows semi-continuous pump flowrates in vessel volumes/day (vvd) – see figure below) or constantly continuous ([0078], lines 1-3) and would be structurally capable of operating with a semi-continuous or constantly continuous flowrate.
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The limitation “dynamically continuous” is phrased in the alternative. At least one of the limitations in the claim (e.g., semi-continuously and constantly continuous) is rejected, thus no further rejections are required at the time.
Regarding claim 12, Sieck et al. further teaches it is known in the art to control a flowrate of a bleed pump to maintain a target cell density within the bioreactor (Fig. 4 – see rejection for claims 7, 11, and 13 above; [0114]).
Regarding claim 14, such limitations are directed toward the intended manner of operating the claimed system and does not differentiate the claimed system from the prior art system because all structural limitations are taught in the prior art system (MPEP §2114 II). The system would be fully capable of achieving every claimed intended use because the prior art system teaches that fluid flow is controllable by various means ([0076], lines 11-15) and that the system may include sensors, including a liquid level sensor, for detecting operational parameters ([0086], lines 1-11) and would be structurally capable of operating with a flowrate of the second bleed pump equal to the flowrate of the first bleed pump minus the flowrate of the second harvest pump once a level of bleed material in the bleed vessel reaches an inlet of the second cell retention device.
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Sieck et al. (already referenced) in view of Angelini et al. (US 2019/0153381 A1) (see PTO-892).
Regarding claim 8, Sieck et al. teaches the system of claim 1.
Sieck et al. fails to teach the system further comprising a fresh media tank including fresh medium including product of interest and a media pump arranged and configured to pump fresh medium into the bioreactor.
However, Angelini et al. further teaches a feed reservoir including fresh medium including product of interest (i.e., fresh media tank; Fig. 1, feed reservoir 28 – see annotated figure below; [0070], lines 8-9) and a feed pump arranged and configured to pump fresh medium into the bioreactor (i.e., media pump; Fig. 1, feed pump 30; [0070], lines 9-10, “…nutrient feed may be directed to bioreactor tank 10 via feed pump 30…).
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Angelini et al. teaches that the feed reservoir (i.e., fresh media tank) includes suitable source of nutrient feed which may be directed to a perfusion bioreactor via the feed pump ([0070], lines 8-10).
It would have been obvious to one of ordinary skill in the art to modify the system of Sieck et al. to incorporate the feed reservoir (i.e., fresh media tank) and feed pump (i.e., media pump) of Angelini et al. to hold and provide a source of nutrient feed for cell cultures housed in the bioreactor.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Sieck et al. and Angelini et al. to obtain the invention as specified in claim 8.
Regarding claim 9, modified Sieck et al. teaches the system of claim 8.
Sieck et al. further teaches it is known in the art to achieve steady-state operation in a bioreactor (i.e., the media pump flowrate is equal to the first harvest pump flowrate plus the first bleed pump flowrate – [0007], Q-in = Q-harvest + Q-bleed). In addition, such limitations are directed toward the intended manner of operating the claimed system and does not differentiate the claimed system from the prior art system because all structural limitations are taught in the prior art system (MPEP §2114 II). The system taught by Sieck et al. would be fully capable of achieving every claimed intended use because the prior art system is taught to have pumps that can be controlled by any suitable mechanism ([0076], lines 6-15) and would be structurally capable of having these flowrates absent clear evidence to the contrary and absent a showing of unexpected results.
Regarding claim 10, modified Sieck et al. teaches the system of claim 8.
It appears claim 10 claims the same limitation as claim 9 (see claim 9 objection), which has been rejected. Sieck et al. further teaches it is known in the art (i.e., the first harvest pump flowrate is equal to the media pump flowrate minus the first bleed pump flowrate – [0007], Q-in = Q-harvest + Q-bleed is the same as Q-harvest = Q-in – Q-bleed). In addition, such limitations are directed toward the intended manner of operating the claimed system and does not differentiate the claimed system from the prior art system because all structural limitations are taught in the prior art system (MPEP §2114 II). The system taught by Sieck et al. would be fully capable of achieving every claimed intended use because the prior art system is taught to have pumps that can be controlled by any suitable mechanism ([0076], lines 6-15) and would be structurally capable of having these flowrates absent clear evidence to the contrary and absent a showing of unexpected results.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Mawdsley et al. (US 2018/0355383 A1) teaches a process for enhanced recovery of a desired fermentation product.
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/A.J.C./Examiner, Art Unit 1799
/William H. Beisner/Primary Examiner, Art Unit 1799