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 1/16/2026 is acknowledged.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-6, 8-9, and 13-14 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Engelmayr Jr et al. (US 2023/0100306).
Regarding claim 1 Engelmayr discloses a packed-bed bioreactor system for culturing cells, the system comprising (See Engelmayr Abstract and Figs. And [0069] Wherein a bioreactor 1 packed with substrate 10, i.e. packed-bed bioreactor, is used for culturing cells.)
a cell culture vessel comprising an inlet, an outlet, and at least one interior reservoir fluidly connected to and disposed in a fluid pathway between the inlet and the outlet;(See Engelmayr Figs. 1 and 5 and [0069] and [0081] wherein a culture vessel 1 has an inlet at outlet, i.e. openings, an interior fluid reservoir connected to a fluid pathway between inlet and outlet.)
a cell culture matrix disposed in the reservoir, the cell culture matrix comprising a structurally defined substrate comprising a substrate material defining a plurality of pores, the substrate material being configured for adhering cells thereto; (See Engelmayr Fig. 5,9, [0061]-[0062], and [0069]-[0070] wherein a cell culture matrix is formed from a substrate material having a plurality of pores and configured to adhere cells.)
and at least one permeability zone in a portion of the cell culture matrix, the at least one permeability zone comprising a higher permeability than a standard permeability of the cell culture matrix outside of the at least one permeability zone, wherein the permeability zone comprises an opening in the substrate, the opening being larger than a diameter of any of the plurality of pores. (See Engelmayr Figs. 9 and 17 and [0070]-[0071], and [0108] wherein larger opening and spacer substrates form permeability zone with higher permeability, i.e. it is more porous, and comprises a larger opening 1 larger in diameter than any of the pores)
Regarding claim 2 Engelmayr discloses all the claim limitations as set forth above as well as the device wherein the cell culture matrix comprises a plurality of layers of the substrate, wherein the plurality of layers of the substrate are in a stacked or rolled cylindrical arrangement. (See Engelmayr Figs 5 and 9, and [0070] wherein the matrix comprises a plurality of layers of substrate in a stacked arrangement.)
Regarding claim 3 Engelmayr discloses all the claim limitations as set forth above as well as the device wherein each layer of the plurality of layers of the substrate comprises an ordered and substantially uniform array of pores.(See Engelmayr [0019] wherein the layers of substrate are formed from a repeating pattern of pores, i.e. an ordered and uniform array.)
Regarding claim 4 Engelmayr discloses all the claim limitations as set forth above as well as the device wherein the permeability zone comprises multiple layers of the plurality of layers that comprise the opening.(See Engelmayr [0108] wherein the permeability zone comprises multiple layers that comprise the opening.)
Regarding claim 5 Engelmayr discloses all the claim limitations as set forth above as well as the device wherein the opening in at least a portion of the multiple layers is in a different area of a horizontal cross-section of the cell culture matrix than the opening in at least one of the multiple layers. (See Engelmayr [0108] wherein an opening, i.e. larger openings, in at least one layer is in a different area of a horizontal cross-section, i.e. it is shifted relative to the other layers openings.)
Regarding claim 6 Engelmayr discloses all the claim limitations as set forth above as well as the device wherein each of the multiple layers comprising the opening comprises a same opening arrangement. (See Engelmayr [0108] wherein there are multiple of the same opening arrangement, i.e. non-shifted, openings.)
Regarding claim 8 Engelmayr discloses all the claim limitations as set forth above as well as the device, wherein one or more of the plurality of layers comprises multiple openings in the substrate. (See Engelmayr [0108] and Fig. 17 wherein there are multiple openings.)
Regarding claim 9 Engelmayr discloses all the claim limitations as set forth above as well as the device wherein the one or more of the plurality of layers having multiple openings has rotational symmetry about a longitudinal axis of the cell culture matrix. (See Engelmayr [0108] and Fig. 17 wherein the multiple openings 1 have rotational symmetry about a longitudinal axis passing through the center of the cell culture matrix.)
Regarding claims 13-14 Engelmayr discloses all the claim limitations as set forth above as well as the device wherein the standard permeability is an average permeability of the cell culture matrix or wherein the standard permeability is a permeability of a section of the cell culture matrix consisting of the substrate without the opening.(See Engelmayr [0061] and [0070]-[0071] wherein the device inherently has a standard permeability which may be defined as the average permeability or permeability of a section without an opening.)
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 7 is rejected under 35 U.S.C. 103 as being unpatentable over Engelmayr Jr et al. (US 2023/0100306) as applied to claims above.
Regarding claim 7 Engelmayr discloses all the claim limitations as set forth above as well as the device wherein at least a portion of the multiple layers comprising the opening are shifted relative to at least one of the multiple layers comprising the opening.
Egelmayr does not specifically disclose the shifting being a shifting such that the openings are rotated relative to at least one of the multiple layers comprising the opening, wherein the rotation is about a longitudinal axis of the cell culture matrix.
It is noted that the openings may only either be shifted rotationally or on a different radius with respect to other openings and the selection of one form of shifting would have been obvious because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.”
Furthermore such a specific form of shifting would have required a mere rearranging of the openings which would have been obvious to one of ordinary skill in the art at the time of filing because it has been held that rearranging parts of an invention involves only routine skill in the art while the device having the claimed dimensions would not perform differently than the prior art device, In re Japikse, 86 USPQ 70 and since it has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art, In re Einstein, 8 USPQ 167.
Claims 12 is rejected under 35 U.S.C. 103 as being unpatentable over Engelmayr Jr et al. (US 2023/0100306) as applied to claims above, and further in view of Ling et al. (US 2017/0321178).
Regarding claim 12 Engelmayr discloses all the claim limitations as set forth above but does not specifically disclose a flow distributor plate.
Ling et al. discloses a packed bed bioreactor comprising a flow distributor plate between and inlet and growth substrate, i.e. cell culture matrix, such that fluid entering a reservoir holding the growth substrate flows in a a desirable manner through the device. (See Ling Abstract Fig. 8 and [0088] wherein a flow distributor 22 is provided between and inlet and cell culture substrate.)
It would have been obvious to one of ordinary skill in the art at the time of invention to provide a fluid distribution plate as described by Ling in the device of Engelmayr because such a flow distributor provides desirable flow properties to a cell culture substrate and reduces shear stress as would be desirable in the device of Engelmayr.
It is noted that Ling appears to disclose the flow distributor being plate shaped but assuming arguendo with respect to such it is noted that such a modification would have required a mere change in shape which would have been obvious to one of ordinary skill in the art to optimize space considerations within the bioreactor and because the change in configuration of shape of a device is obvious absent persuasive evidence that the particular configuration is significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
It is noted that limitations directed to flow being at different velocities across a width of the interior reservoir and having a permeability zone which causes a uniform perfusion velocity profile through the cell culture matrix are directed to intended uses 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 different velocities and perfusion velocity profile depending upon the specific fluid properties, i.e. viscosity, temperature, density,, etc. and flow thereof, i.e. flow rate, pressure, etc.
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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