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 .
Claim Rejections - 35 USC § 102
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 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 2-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tanabe et al. (US 2019/0085299).
Regarding claim 2 Tanabe discloses a cell cultivation system comprising: at least one growth substrate for growing one or more cell types, wherein the at least one growth substrate has a mesh porosity and a surface area, and wherein cell growth density per unit area of the at least one growth substrate increases with: 1) increasing mesh porosity of the at least one growth substrate, or 2) decreasing surface area per unit area of the at least one growth substrate. (See Tanabe Abstract, Figs. 1a and 6(A)-6(B),0 and [0026]-[0027] wherein a growth substrate for growing cells is formed from a wire mesh, i.e. it has a mesh porosity and a surface area)
In regards to limitations directed to cell growth density per unit area increasing with increased mesh porosity or decreasing surface area per unit surface area it is noted that such limitations are directed to intended uses, i.e. replacing the growth substrate with one having increased mesh porosity or decreased surface area and materials worked on, i.e. cell growth density which do not differentiate the claimed invention from the cited prior art as the cited prior art includes all required structural elements. See MPEP 2114 and 2115
Regarding claim 3 Tanabe discloses all the claim limitations as set forth above as well as the device wherein the mesh porosity and the surface area per unit area are based on a number of openings in the at least one growth substrate, and wherein the openings are arranged in a repeating pattern across a surface of the at least one growth substrate. (See Tanabe [0026]-[0027],Figs. 1a 6(A)-6(B) wherein the openings are arranged in repeating patterns across the growth substrate and porosity and surface area are inherently based on the number of openings
Regarding claims 4-5 Tanabe discloses all the claim limitations as set forth above as well as the device wherein the cell growth density per unit area on the at least one growth substrate increases with the number of openings by at least 5% when the number of openings is increased by at least 10% and wherein the cell growth density per unit area on the at least one growth substrate increases by at least 5% when the surface area per unit area is decreased by at least 10%. (See Tanabe Abstract, Figs. 1a and 6(A)-6(B),0 and [0026]-[0027] wherein a growth substrate for growing cells is formed from a wire mesh, i.e. it has a mesh porosity and a surface area)
In regards to limitations directed to cell growth density per unit area increasing with increased mesh porosity or decreasing surface area per unit surface area it is noted that such limitations are directed to intended uses, i.e. replacing the growth substrate with one having increased mesh porosity or decreased surface area and materials worked on, i.e. cell growth density which do not differentiate the claimed invention from the cited prior art as the cited prior art includes all required structural elements. See MPEP 2114 and 2115
Claims 7-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Castillo et al. (US 2018/0282678).
Regarding claims 7-10 Castillo discloses a cell cultivation system comprising: at least one growth substrate for growing one or more cell types; and at least one spacer substrate adjacent to the at least one growth substrate, wherein the at least one spacer substrate is sized to influence a cell growth density per unit area on the at least one growth substrate such that a higher cell growth density per unit area is achieved on the at least one growth substrate when using a smaller spacer substrate as compared to a larger spacer substrate and wherein a size of the at least one spacer substrate is based on a dimension as measured along a radial or longitudinal direction of the at least one spacer substrate. (See Castillo Abstract Figs. 2A-2D and [0035]-[0037] wherein a cell growth substrate 10 grows cells and an adjacent spacer substrate 11 provides for flow and influence over growth of cells in substrate 10.)
In regards to limitations directed to cell growth density per unit area using smaller or larger spacer substrates it is noted that such limitations are directed to intended uses, i.e. replacing the spacer with one having smaller or larger size, and materials worked on, i.e. cell growth density, which do not differentiate the claimed invention from the cited prior art as the cited prior art includes all required structural elements. See MPEP 2114 and 2115
Regarding claim 11 Castillo discloses all the claim limitations as set forth above as well as the device wherein a size of the at least one growth substrate is substantially equal to or greater than a size of the at least one spacer substrate. (See Castillo Abstract and Figs. 2A-2D wherein the growth and spacer substrates are substantially equal in size.)
Claims 14-17, 20-22, and 25-26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Patel (US 2018/0187139).
Regarding claim 14 Patel discloses a container configured to retain a growth medium; a rotatable shaft disposed in the container; a first growth substrate and a second growth substrate , wherein the first growth substrate and the second growth substrate are coupled to the rotatable shaft and configured to grow a biological material; and a first spacer substrate disposed between the first growth substrate and the second growth substrate. (See Patel Abstract, Fig. 2a-2b and 5, [0065] and [0079] wherein a bioreactor container includes a rotatable shaft with a plurality, i.e. at least first and second growth substrates 11 separated by spacer substrates 11(a) disposed therebetween.)
Regarding claim 15 Patel discloses all the claim limitations as set forth above as well as the device wherein a growth surface on the first growth substrate or second growth substrate is substantially planar. (See Patel Fig. 5 wherein the growth surfaces of the first and second substrates are substantially planar.)
Regarding claim 20 Patel discloses all the claim limitations as set forth above as well as the device further comprising a plurality of growth substrates and a plurality of spacer substrates, wherein the plurality of growth substrates are arranged substantially parallel to the plurality of spacer substrates. (See Patel Fig. 5 wherein the plurality of growth and spacer substrates are arranged parallel to one another.)
Regarding claim 21 Patel discloses all the claim limitations as set forth above as well as the device wherein the biological material comprises cells, tissues, organs, cell-based meat, cell-based fat, or a combination thereof. (See Patel Abstract and [0064] wherein the material comprises cells.)
Regarding claim 22 Patel discloses all the claim limitations as set forth above as well as the device wherein the rotatable shaft is coupled to a lateral center of the first growth substrate and to a lateral center of the second growth substrate. (See Patel Fig. 5 wherein the rotatable shaft is coupled to a lateral center of the growth substrates.)
Regarding claim 25 Patel discloses all the claim limitations as set forth above as well as the device wherein the container comprises a hermetically sealable container. (See Patel [0074] wherein the container is made air/liquid tight, i.e. it is hermetically sealable.)
Regarding claim 26 Patel discloses all the claim limitations as set forth above as well as the device wherein the plurality of growth substrates are formed from a first material, and wherein the plurality of spacer substrates are formed from a second material, the first material being different than the second material. (See Patel [0079] wherein the growth substrates and spacers may be chosen from different materials.)
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 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Castillo et al. (US 2018/0282678).
Regarding claims 12-13 Castillo discloses all the claim limitations as set forth above as well as the device wherein the at least one growth substrate and the at least one spacer substrate comprise a same number of openings per unit area and/or the at least one spacer substrate each comprise a different number of openings per unit area. (See Castillo [0035]-[0037] wherein the cell growth matrix and spacer have a number of openings per unit area.)
It is noted that such a limitations would have required a mere change in size of the substrate openings which would have been obvious to one of ordinary skill in the art at the time of filing in order to optimize material flows 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).
Claims 19 and 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Patel (US 2018/0187139).
Regarding claim 19 Patel discloses all the claim limitations as set forth above as well as the device wherein the first growth substrate is disposed 1 µm to 5,000 µm from the first spacer substrate.
It is noted that such a modification would have required a mere change in dimension, i.e. space between objects which would have been obvious to one of ordinary skill in the art at the time of filing to optimize materials flows 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).
Regarding claim 23 Patel discloses all the claim limitations as set forth above as well as the device wherein a ratio of an area of the plurality of growth substrates to an area of the plurality of spacer substrates is 1000:1 to 1:1. (See Patel [0079] wherein the spacers and growth substrates diameters, i.e. ratios of area, is known to be modified.)
It is noted that such a modification would have required a mere change in size of the spacers which would have been obvious to one of ordinary skill in the art at the time of invention in order to optimize material flows 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).
Regarding claim 24 Patel discloses all the claim limitations as set forth above as well as the device wherein the plurality of growth substrates have an average pore size which may be modified (See Patel [0083] but does not specifically disclose them being greater than an average pore size of the plurality of spacer substrates.
It is noted that such a modification would have required a mere change in size of the pores of the growth substrates which would have been obvious to one of ordinary skill in the art at the time of invention in order to optimize cell growth and material flows 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).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Tanabe et al. (US 2019/0085299) as applied to claims above, and further in view of Patel (US 2018/0187139)
Regarding claim 6 Tanabe discloses all the claim limitations as set forth above but does not specifically disclose the use of a spacer.
Regarding claim Patel discloses a first growth substrate and second growth substrate are configured to grow a biological material; and a first spacer substrate is disposed between the first growth substrate and the second growth substrate. (See Patel Abstract, Fig. 2a-2b and 5, [0065] and [0079] wherein a bioreactor container includes a plurality, i.e. at least first and second growth substrates 11 separated by spacer substrates 11(a) disposed therebetween.)
It would have been obvious to one of ordinary skill in the art to provide a plurality of cell growth substrates separated by spacer substrates as described by Patel in the device of Tanabe because such a stack of growth substrates and spacers therebetween allow the growth of extended amounts of cells as well as allowing the effective flow of nutrients and materials within the device as would be desirable in the device of Tanabe.
Claims 16-18 are rejected under 35 U.S.C. 103 as being unpatentable Patel (US 2018/0187139) as applied to claims above, and further in view of over Tanabe et al. (US 2019/0085299).
Regarding claims 16 and 27 Patel discloses all the claim limitations as set forth above as well as the first growth substrate may be formed from any number of biocompatible materials but does not specifically disclose a mesh formed from a plurality of wires.
Tanabe discloses a growth substrate for use in a bioreactor wherein a plurality of growth substrates comprise a mesh formed from a plurality of wires and coated by biocompatible materials including collagen. (See Tanabe [Abstract and [0026]-[0027] wherein growth substrates comprise meshes formed from a plurality of wires and See Tanabe [0033] wherein the growth substrates are coated with materials including collagen to adhere cells.)
It would have been obvious to one of ordinary skill in the art at the time of filing to form the growth substrates of Patel from the coated wire mesh materials of Tanabe because such materials allow for cell proliferation, high strength, and large growth area as would be desirable in the device of Patel to more effectively and efficiently grow cells.
Regarding claim 17 Patel discloses all the claim limitations as set forth above as well as the device wherein adjacent wires of the plurality of wires are separated by a distance of 1 µm to 5,000 µm. (See Tanabe [0027] wherein the plurality of wires have openings, i.e. are separated, by 30 to 400 µm.)
Regarding claim 18 Patel discloses all the claim limitations as set forth above as well as the device the first growth substrate and the second growth substrate are porous and have a porosity of 0.001 to 0.999.(See Tanabe [0026]-[0027] wherein the mesh has openings, i.e. it is porous, and the diameters of the wires in relation to the diameter in the openings results in a porosity between 0.001 and 0.999. Furthermore the examiner notes that such a porosity is essentially all possible porosity levels.)
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