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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 8/14/2026 is acknowledged.
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 1-3,5-11,13-14,27-30 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 1 and this all claims dependent there upon require that flow satisfies:
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It is noted that the claims do not define the variables of this expression and thus one of ordinary skill in the art would not be appraised how such an expression relates to flow or bioreactor structure and the claims are rendered unclear.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3,5-7,9-11,13-14 and 27-30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ferrie et al. (WO 2020/163329).
Regarding claims 1-3,5, 9-10 Ferrie discloses a bioreactor system for culturing cells, the system comprising: (See Ferrie Abstract and [0002])
a cell culture vessel comprising at least one interior reservoir, an inlet fluidly connected to the reservoir, and an outlet fluidly connected to the reservoir; and a cell culture matrix disposed in the reservoir, the cell culture matrix comprising a substrate configured for adhering cells thereto, wherein the cell culture matrix is configured to maintain a uniform flow of liquid media through the cell culture matrix. (See Ferrie Figs., [0014]-[0019], [0097], and [00147] wherein the system includes a cell culture vessel, i.e. bioreactor, within inlet and outlets connected to a reservoir and a cell culture matrix disposed in the reservoir to adhere cells and maintain a uniform flow.
In regards to limitations directed to the flow satisfying
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with N less than 0.5, P greater than 0.9, wherein E(Θ) is less than 0.2 and E’(Θ)=0 when Θ is less than 0.8 and greater than 1.2; E(Θ) curve has a single peak across all Θ values and has a single peak at Θ values between 0.8 and 1.2 it is noted that the claims do not define the variables of such an equation and thus the device of Ferrie which has complete flow uniformity would satisfy such an expression.
Furthermore the flow and uniformity thereof is directed to an intended use and materials worked on by the device which do not define structural elements which differentiate the claimed invention from the cited prior art as the cited prior art is fully capable of having such flow and uniformity satisfying such an expression by providing the device with appropriate materials at appropriate conditions. See MPEP 2114 and 2115.
Regarding claim 6 Ferrie discloses all the claim limitations as set forth above as well as the device wherein the cell culture matrix is configured to maintain the uniform flow of liquid media through the cell culture matrix with a normalized variance of less than or equal to about 0.9(See Ferrie Figs. 27A and [00147] wherein the flow is uniform throughout the cell culture matrix, i.e. has variance of less than 0.9)
Furthermore the variance of flow uniformity is directed to an intended use and materials worked on by the device which do not define structural elements which differentiate the claimed invention from the cited prior art as the cited prior art is fully capable of having such variance of flow uniformity by providing the device with appropriate materials at appropriate conditions. See MPEP 2114 and 2115.
Regarding claim 7 Ferrie discloses all the claim limitations as set forth above as well as the device the cell culture matrix is arranged in a fixed bed configuration in the interior reservoir. (See Ferrie Abstract [00112] wherein the matrix is a fixed bed within the interior reservoir.)
Regarding claim 11 Ferrie discloses all the claim limitations as set forth above as well as the device wherein the cell culture matrix is configured for liquid media to flow through the cell culture matrix such that at least 90% of an entire liquid volume of the interior reservoir is replaced within 1.2 bioreactor volumes of liquid media flow through the interior reservoir. (See Ferrie [00103]-[00104] wherein flow rate if controlled.)
Furthermore the flow rate and uniformity thereof is directed to an intended use and materials worked on by the device which do not define structural elements which differentiate the claimed invention from the cited prior art as the cited prior art is fully capable of having such flow rate uniformity by providing the device with appropriate materials at appropriate conditions. See MPEP 2114 and 2115.
Regarding claim 13 modified Ferrie discloses all the claim limitations as set forth above as well as the device wherein the cell culture matrix is configured for liquid media to flow through the cell culture matrix such that a flow rate of the liquid media at any point within the cell culture matrix is within 15%, 10%, 5%, or 2% of the flow rate at any other point along within the cell culture matrix, the flow rate being measured in a direction parallel to the direction from the inlet to the outlet. (See Ferrie Figs. 27A and [00147] wherein flow velocity, i.e. flow rate, is constant, i.e. flow rate within one point is at least within 15% of that within any other point.)
Furthermore the flow rate and uniformity thereof is directed to an intended use and materials worked on by the device which do not define structural elements which differentiate the claimed invention from the cited prior art as the cited prior art is fully capable of having such flow rate uniformity by providing the device with appropriate materials at appropriate conditions. See MPEP 2114 and 2115.
Regarding claim 14 Ferrie discloses all the claim limitations as set forth above as well as the device wherein the cell culture matrix comprises a multilayer substrate, wherein each layer of the multilayer substrate comprises a physical structure and a porosity that are substantially regular and uniform. (See Ferrie Figs. 1A04 and [0074]-[0085] wherein the matric includes stacked, i.e. a multilayer, substrate with each layer having regular and uniform porosity and structure.)
Regarding claim 27 Ferrie discloses all the claim limitations as set forth above as well as the device wherein the cell culture matrix exhibits uniform fluid flow across at least 90% of a surface area of the cell culture matrix. (See Ferrie Figs. 27A and [00147] wherein flow is uniform across the entire cell culture matrix.)
Furthermore the flow rate and uniformity thereof is directed to an intended use and materials worked on by the device which do not define structural elements which differentiate the claimed invention from the cited prior art as the cited prior art is fully capable of having such flow rate uniformity by providing the device with appropriate materials at appropriate conditions. See MPEP 2114 and 2115.
Regarding claim 28 Ferrie discloses all the claim limitations as set forth above as well as the device wherein the cell culture matrix exhibits plug flow through a length of the cell culture matrix in a direction of fluid flow. (See Ferrie [00147] and Fig. 27A wherein the flow is uniform along the length and width of the cell culture matrix, i.e. it exhibits plug flow.)
Furthermore it is noted that plug flow is a result of intended uses and materials worked on by the device which do not define structural elements which differentiate the claimed invention from the cited art as the cited art is fully capable of having plug flow given the right materials and flow conditions. See MPEP 2114 and 2115.
Regarding claim 29 Ferrie discloses all the claim limitations as set forth above as well as the device the cell culture matrix is disposed in the interior reservoir at 95%or greater occupancy. (See Ferrie [00111] wherein the cell culture matrix occupies the entirety of the culture chamber, i.e. at least 95%.)
Regarding claim 30 Ferrie discloses all the claim limitations as set forth above as well as the device wherein the cell culture matrix is disposed in the interior reservoir in a compressed packing configuration. (See Ferrie Figs. 8-9 wherein the culture matrix is wound, i.e. compressed packing, in the reservoir.)
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.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Ferrie et al. (WO 2020/163329) as applied to claims above.
Regarding claim 8 Ferrie discloses all the claim limitations as set forth above as well as the device wherein uniform flow is maintained through the bed height and that the device size and layers of culture matrix, i.e. bed height, mya be chosen according to use but does not specify a bed height of 20 cm or more.
Such a modification would have required a mere change in size of the device, i.e. bed height, which would have been obvious to one of ordinary skill in the art at the time of filing to optimize material costs and product production and because a change in size (dimension) is generally recognized as being within the level of ordinary skill in the art. In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955). Where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device, and the device having the claimed dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device, Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN M HURST whose telephone number is (571)270-7065. The examiner can normally be reached on M-F 7AM-4PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached on 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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/JONATHAN M HURST/ Primary Examiner, Art Unit 1799
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