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 .
This action is in response to the papers filed on 05/30/2024. Claims 1, 2, 7-11, 14, 15, 19-29 are currently pending. Claims 3-6, 12, 13, and 16-18 have been canceled and Claims 1, 7, 9-11, 14, 15, and 21-26 have been amended by applicants’ amendment filed on 05/30/2024.
Claims 1, 2, 7-11, 14, 15, 19-29 are examined on their merits to which the following grounds of rejection are applicable. Claims 1 and 19 are independent claims.
Priority
The instant application is a 371 of PCT/US2022/050202 filed on 11/17/2022.
The instant application claims domestic benefit to US provisional patent application number 63/284,153 filed on 11/30/2021.
Thus, the earliest possible priority for the instant application is 11/30/2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 07/22/2024, was filed before the mailing date of the non-final office action. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 1 is objected for the phrase “growing cell” at line 7. Examiner suggests amending claim to recite “growing cells”
Claim 2 and 22 are in improper Markush form; a Markush group should be in the form “selected from the group consisting of A, B, and C”. Appropriate correction is requested.
Claim 15 and 24, lines 19 and 24, respectively, are objected to because of the following informalities: the claims recite “of rom”. Examiner interprets this phrase to recite “of from”. 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 1, 2, 7-11, 14, 15, 19-29 are is 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 is indefinite in its recitation of the relative term “substantially” at line 6. The term "substantially " is not defined by the claim. The specification does not provide any closed definition as to what is meant by “substantially” and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Appropriate action is required.
Claim 21 recites the limitation "plurality of the substrates" in line 12. There is insufficient antecedent basis for this
Claims 2, 7-11, 14, 15, 19, 20, 22-29 are rejected insofar as they depend on claim 1
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.
Claim(s) 1, 2 9-11 and 14-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ferrie et al (US 20200248121 A1; cited in IDS).
The applied Ferrie reference has a common applicant with the instant
Application (Corning Incorporated). Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(1). The publication dated for Ferrie is 08/06/2020. The earliest effective filing date of the instant application is 11/30/2021. Therefore rejection under 35 U.S.C. 103 CANNOT be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02. Because the reference qualifies as prior art under 102(a)(1), the provisions of MPEP 717.02 do not apply.
Regarding claim 1, Ferrie teaches cell culture matrix comprising
a number of adjacent substrate layers (e.g., a stack of individual layers or a rolled mesh layer) which are parallel (para 0013, 0016, 0084)
with a plurality of openings that are arrayed in a regular pattern passing through the layer (para 0169)
and the substrate has a regular, ordered structure and provides a surface for cell adhesion, growth, and eventual cell release (para 0013)
Mesh substrates may have a different patterns or weaves (para 0087)
the substrate mesh can be fabricated from monofilament or multifilament fibers of polymeric materials (para 0087)
Hence, Ferrie anticipates a cell culture matrix for culturing cells in a fixed bed reactor, the cell culture matrix comprising:
a plurality of substrate layers in a stacked arrangement of parallel layers, each layer of the plurality of substrate layers comprising
a substrate material with an ordered and regular array of openings passing through the layer
the openings being separated by the substrate material having a physical structure that is substantially regular and uniform
and that is configured for growing cell thereon, wherein the plurality of substrate layers comprises a first substrate material and a second substrate material that is different from the first substrate material in at least one physical dimension,
the first substrate material and the second substrate material comprising separate layers of the plurality of substrate layers and wherein the physical structure comprises a plurality of fibers.
Regarding claim 2, the teachings of Ferrie anticipate claim 1. Moreover, Ferrie teaches “Mesh substrates may have a different patterns or weaves” (para 0087), thus anticipating wherein the at least one physical dimension is a pattern of the physical structure.
Regarding claim 9, the teachings of Ferrie anticipates claim 1. Moreover, Ferrie teaches “the matrix can be arranged with multiple pieces of substrate at intermediate angles, or even in random arrangements” (para 0095), hence anticipating a degree of relative rotation between the first substrate material and the second substrate material is random.
Regarding claim 10, the teachings of Ferrie anticipates claim 1. Moreover, Ferrie teaches that the bioreactor system to flow material in a direction that is perpendicular to the woven substrates (para 0016) and the fluid flow is uniform (para 0081), hence anticipating a variation in flow rate of fluid flowing through the cell culture matrix is uniform across a width of the cell culture matrix, the width being in a direction perpendicular to a direction of fluid flow.
Regarding claim 11, the teachings of Ferrie anticipates claim 1. Moreover, Ferrie teaches “wherein the predetermined arrangement comprises stacks of the first mesh and stacks of the second mesh in an alternating arrangement” (para 0188), hence anticipating wherein the first substrate material and the second substrate material are stacked as alternating layers of the plurality of substrate layers.
Regarding claim 14, the teachings of Ferrie anticipates claim 1. Moreover, Ferrie teaches a fiber may have a diameter in a range of about 50 μm to about 1000 μm; about 100 μm to about 750 μm; about 125 μm to about 600 μm; about 150 μm to about 500 μm; about 200 μm to about 400 μm; about 200 μm to about 300 μm; or about 150 μm to about 300 μm (para 0084), hence anticipating wherein the plurality of fibers comprises a first fiber with a first fiber diameter from about 10 μm to about 1000 μm, from about 15 μm to about 600 μm, from about 20 μm to about 400 μm, from about 30 μm to about 325 μm, from about 15 μm to about 200 μm, or from about 150 μm to about 275 pm.
Regarding claim 15, the teachings of Ferrie render obvious claim 1. Moreover, Ferrie teaches “the opening may have a diameter from about 50 μm to about 1000 μm; about 100 μm to about 750 μm; about 125 μm to about 600 μm; about 150 μm to about 500 μm; about 200 μm to about 400 μm; or about 200 μm to about 300 μm.” (para 0084), hence anticipating wherein the openings comprise a diameter from about 20 μm to about 1000 μm, from about 40 μm to about 900 μm, from about 50 μm to about 300 μm, or from about 225 μm to about 800 μm.
Thus, by teaching all the limitations of the claims as written, Ferrie anticipates the instant invention as claimed.
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(s) 1, 2, 7, 8, 19-29 are rejected under 35 U.S.C. 103 as being
unpatentable over Ferrie et al (US 20200248121 A1; cited in IDS) and further in view of Chresand et al (Biotechnology and Bioengineering, 1988, pages 983-992).
Regarding claim 1, Ferrie teaches cell culture matrix comprising
a number of adjacent substrate layers (e.g., a stack of individual layers or a rolled mesh layer) which are parallel (para 0013, 0016, 0084)
with a plurality of openings that are arrayed in a regular pattern passing through the layer (para 0169)
and the substrate has a regular, ordered structure and provides a surface for cell adhesion, growth, and eventual cell release (para 0013)
Mesh substrates may have a different patterns or weaves (para 0087)
the substrate mesh can be fabricated from monofilament or multifilament fibers of polymeric materials (para 0087)
Hence, Ferrie anticipates a cell culture matrix for culturing cells in a fixed bed reactor, the cell culture matrix comprising:
a plurality of substrate layers in a stacked arrangement of parallel layers, each layer of the plurality of substrate layers comprising
a substrate material with an ordered and regular array of openings passing through the layer
the openings being separated by the substrate material having a physical structure that is substantially regular and uniform
and that is configured for growing cell thereon, wherein the plurality of substrate layers comprises a first substrate material and a second substrate material that is different from the first substrate material in at least one physical dimension,
the first substrate material and the second substrate material comprising separate layers of the plurality of substrate layers and wherein the physical structure comprises a plurality of fibers.
Regarding claim 2, the teachings of Ferrie anticipate claim 1. Moreover, Ferrie teaches “Mesh substrates may have a different patterns or weaves” (para 0087), thus anticipating wherein the at least one physical dimension is a pattern of the physical structure.
Regarding claim 7 and 8, the teachings of Ferrie anticipate claim 1.
However, Ferrie does not teach wherein the at least one physical dimension is a fiber spacing between two neighboring fibers of the plurality of fibers.
Chresand teaches a high surface area hollow fiber reactor for mammalian cell culture in which different reactors were studied to optimize fiber sizes and spacing (page 984, left col, para 4). Chresand teaches that optimal fiber spacing aims to give maximum overall reactor cell density (page 989, right col, Optimization) and teaches a procedure for determining the optimal spacing using mathematical equations (page 990, left col, para 1-3). Chresand teaches that the fibers can made into a spiral roll which also forms layers (page 990, left col, Figure 4).
It would have been prima facie obvious to one of ordinary skill, in the art at the time of the effective filing date, to modify the teachings of Ferrie of a cell culture matrix with the teachings of Chresand for optimizing the fiber spacing for cell culture to achieve a cell culture matrix where the fiber spacing between two neighboring fibers is taken into consideration in the design of the cell culture matrix to give maximum overall reactor cell density. One would be motivated to do so since Chresand teaches that optimization of the fiber spacing is imperative to enhancing the cell density of the cell culture matrix.
Moreover, in relation to the claimed ratio of fiber spacing of the first substrate material to the fiber spacing of the second substrate material in claim 8, it has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980). Since the prior art of Chresand teaches the process of optimization of fiber spacing for cell culture bioreactors, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the fiber spacing disclosed by the prior art by normal optimization procedures known in the biotech art.
Regarding claim 19, and 26-29 Ferrie teaches a cell culture matrix comprising:
a number of adjacent substrate layers (e.g., a stack of individual layers or a rolled mesh layer) which are parallel (para 0013, 0016, 0084)
and the substrate has a regular, ordered structure and provides a surface for cell adhesion, growth, and eventual cell release (para 0013) the substrate mesh can be fabricated from monofilament or multifilament fibers of polymeric materials (para 0087)
with a plurality of openings that are arrayed in a regular pattern passing through the layer (para 0169)
Hence, Ferrie anticipates a cell culture matrix for culturing cells in a fixed bed reactor, the cell culture matrix comprising:
a plurality of substrate layers in a stacked arrangement of parallel layers
each layer of the plurality of substrate layers comprising a plurality of fibers configured for culturing cells thereon, and
an ordered and regular array of openings defined by the plurality of fibers and passing through the layer
Ferrie does not explicitly teach wherein each layer of the plurality of substrate layers is rotated about a center of the layer relative to an immediately neighboring layer in the stack (claim 19) and that an orientation of fibers in one layer of the plurality of substrate layers is different from an orientation of fibers in an immediately adjacent layer of the plurality of substrate layers (claim 26).
However, Ferrie teaches that “the cell culture matrix includes one or more substrate layers at a first orientation with respect to the bulk flow, and one or more other layers at a second orientation that is different from the first orientation. For example, various layers may have first and second sides that are parallel or perpendicular to the bulk flow direction, or at some angle in between.” (para 0109). Ferrie teaches “the matrix can be arranged with multiple pieces of substrate at intermediate angles, or even in random arrangements with respect to fluid flow. This flexibility in orientation is enabled by the essentially isotropic flow behavior of the woven substrate” (para 0095). Hence, Ferrie teaches that the substrate layers could be rotated about a center of the layer relative to an immediately neighboring layer in the stack, which includes the fibers therein, and this rotation (i.e. orientation) would be permitted and have flexibility due to the isotropic flow rate provided by the woven substrate, , thus rendering obvious claim 19 and 26.
Regarding claim 20, and 27-29, the teachings of Ferrie render obvious claims 19 and 26. Moreover, in relation to the claimed degree of rotation of the plurality of substrate layers and fibers, it has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980). Since the prior art teaches that the substrate layers are substantially parallel, hence could be rotated, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum rotation of the substrate layers disclosed by the prior art to obtain an isotropic flow rate of the woven substrate by normal optimization procedures of the substrate rotation known in the biotech art.
Regarding claim 21, the teachings of Ferrie render obvious claim 19. Moreover, Ferrie teaches “the adjacent layers can be tightly nestled together, but in a second alignment, the adjacent layers can have zero overlap, such as when the lower-most point of the upper layer is in direct contact with the upper-most point of the lower layer.” (para 0085), rendering obvious wherein at least a portion of the plurality of substrates are not separated by a spacer material or barrier, or are in physical contact with each other.
Regarding claim 22, the teachings of Ferrie render obvious claim 19. Moreover, Ferrie teaches “he substrate mesh can be fabricated from monofilament or multifilament fibers of polymeric materials compatible in cell culture applications, including, for example, polystyrene, polyethylene terephthalate, polycarbonate, polyvinylpyrrolidone, polybutadiene, polyvinylchloride, polyethylene oxide, polypyrroles, and polypropylene oxide” (para 0087), rendering obvious wherein the plurality of substrate layers comprises at least one of polystyrene, polyethylene terephthalate, polycarbonate, polyvinylpyrrolidone, polybutadiene, polyvinylchloride, polyethylene oxide, polypyrroles, and polypropylene oxide.
Regarding claim 23, the teachings of Ferrie render obvious claim 19. Moreover, Ferrie teaches a fiber may have a diameter in a range of about 50 μm to about 1000 μm; about 100 μm to about 750 μm; about 125 μm to about 600 μm; about 150 μm to about 500 μm; about 200 μm to about 400 μm; about 200 μm to about 300 μm; or about 150 μm to about 300 μm (para 0084), rendering obvious wherein the plurality of fibers comprises a first fiber with a first fiber diameter from about 10 μm to about 1000 μm, from about 15 μm to about 600 μm, from about 20 μm to about 400 μm, from about 30 μm to about 325 μm, from about 15 μm to about 200 μm, or from about 150 μm to about 275 pm.
Regarding claim 24, the teachings of Ferrie render obvious claim 19. Moreover, Ferrie teaches “the opening may have a diameter from about 50 μm to about 1000 μm; about 100 μm to about 750 μm; about 125 μm to about 600 μm; about 150 μm to about 500 μm; about 200 μm to about 400 μm; or about 200 μm to about 300 μm.” (para 0084), rendering obvious wherein the openings comprise a diameter from about 20 μm to about 1000 μm, from about 40 μm to about 900 μm, from about 50 μm to about 300 μm, or from about 225 μm to about 800 μm.
Regarding claim 25, the teachings of Ferrie render obvious claim 19. Moreover, Ferrie teaches “The cell culture matrix has a plurality of woven substrates each including a plurality of interwoven fibers” (para 0016), rendering obvious wherein the plurality of fibers are interwoven.
Double Patenting Rejection – Statutory
The nonstatutory double patenting rejection is based on a judicially created
doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the
unjustified or improper timewise extension of the “right to exclude” granted by a patent
and to prevent possible harassment by multiple assignees. A nonstatutory double
patenting rejection is appropriate where the conflicting claims are not identical, but at
least one examined application claim is not patentably distinct from the reference
claim(s) because the examined application claim is either anticipated by, or would have
been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46
USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed.
Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum,
686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619
(CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d)
may be used to overcome an actual or provisional rejection based on nonstatutory
double patenting provided the reference application or patent either is shown to be
commonly owned with the examined application, or claims an invention made as a
result of activities undertaken within the scope of a joint research agreement. See
MPEP § 717.02 for applications subject to examination under the first inventor to file
provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for
applications not subject to examination under the first inventor to file provisions of the
AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a
nonstatutory double patenting (NSDP) rejection. A complete reply requires that the
terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete.
See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR
1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for
reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for
consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be
used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the
application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal
Disclaimer may be filled out completely online using web-screens. An eTerminal
Disclaimer that meets all requirements is auto-processed and approved immediately
upon submission. For more information about eTerminal Disclaimers, refer to
www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1, 2, 7-11, 14, 15, 19-29 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claim 1, 2, and 3 of prior U.S. Patent No. 11661576 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are obvious over the cited claims of U.S. Patent No. 11661576 B2.
Claim 1 of Patent No. 11661576 B2 is directed to a bioreactor system comprising a cell culture matrix comprising: a plurality of woven substrates, each woven substrate of the plurality of woven substrates comprising a woven mesh having a plurality of interwoven fibers with surfaces configured for adhering cells thereto, wherein the plurality of woven substrates comprises woven meshes of differing geometries, wherein the differing geometries are different in at least one of fiber diameter, opening diameter, or opening geometry. Claim 1 is further limiting to wherein each woven substrate of the plurality of woven substrates comprises a uniform arrangement of the plurality of interwoven fibers (claim 2) and comprises a plurality of openings disposed between the plurality of fibers (claim 3).
Claim 1 of the instant application is directed to a cell culture matrix for culturing cells in a fixed bed reactor, the cell culture matrix comprising: a plurality of substrate layers, each layer of the plurality of substrate layers comprising a substrate material with an ordered and regular array of openings passing through the layer, the openings being separated by the substrate material having a physical structure that is substantially regular and uniform and that is configured for growing cell thereon, and wherein the plurality of substrate layers comprises a first substrate material and a second substrate material that is different from the first substrate material in at least one physical dimension, the first substrate material and the second substrate material comprising separate layers of the plurality of substrate layers and wherein the physical structure comprises a plurality of fibers.
The instant claims differ from claim 1 by requiring the plurality of substrate materials being in a stacked arrangement.
However, the specification of Patent No. 11661576 B2 discloses that plurality of substrates are stacked such that each woven substrate is substantially parallel to each of the other woven substrates (para 15). Furthermore, para 80 of the specification of Patent No. 11661576 B2 discloses “By allowing stacking of substrate layers in this way, the system can be easily scaled up without negative impacts on cell attachment and proliferation, due to the defined structure and efficient fluid flow through the stacked substrates”.
Claims 1, 2, 7-11, 14, 15, 19-29 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 3, 9, 10, 12-15, 20, 23, 24, 27-31, 34, and 37 of copending Application no. 19/100854 in view of YekrangSafakar (Biomedical Microdevices, 2019, page 1-10). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are obvious over the cited claims of Application no. 19/100854.Claim 1 of Application no. 19/100854 is drawn to a cell culture matrix for culturing cells in a fixed bed reactor, the cell culture matrix comprising: a first substrate material comprising a first layer with opposing faces separated by a thickness of the layer, an ordered and regular first array of openings passing through the first layer, and a first physical structure that is substantially regular and uniform and that is configured for growing cell thereon, the first physical structure separating openings of the first array of openings from each other; and a second substrate material comprising a second layer with opposing faces separated by a thickness of the layer, an ordered and regular second array of openings passing through the second layer, and a second physical structure that is substantially regular and uniform and that is configured for growing cell thereon, the second physical structure separating openings of the second array of openings from each other, wherein the first substrate material and the second substrate material are rolled together to form a rolled cell culture bed, and wherein the first physical structure is different from the second physical structure, whereby a packing density of the first substrate material and the second substrate material is substantially uniform throughout the rolled cell culture bed.
Claim 1 of the instant application is directed to a cell culture matrix for culturing cells in a fixed bed reactor, the cell culture matrix comprising: a plurality of substrate layers, each layer of the plurality of substrate layers comprising a substrate material with an ordered and regular array of openings passing through the layer, the openings being separated by the substrate material having a physical structure that is substantially regular and uniform and that is configured for growing cell thereon, and wherein the plurality of substrate layers comprises a first substrate material and a second substrate material that is different from the first substrate material in at least one physical dimension, the first substrate material and the second substrate material comprising separate layers of the plurality of substrate layers and wherein the physical structure comprises a plurality of fibers.
The instant claims differ from claim 1 by requiring the plurality of substrate materials being in a stacked arrangement of parallel layers.
However, YekrangSafakar teaches the development of rolled scaffold for high-density adherent cell culture. YekrangSafakar teaches that rolled scaffolding in cell culture permits high surface-area-to-volume ratio and can transport nutrients and gases with significantly reduced shear stress (abstract). YekrangSafakar teaches that various aspects of the rolled scaffold can be precisely tailored for specific applications (page 8, right col, Conclusion).
It would have been prima facie obvious to one of ordinary skill, in the art at the time of the effective filing date, to modify the teachings of a parallel stacked matrix for cell culture from the instant application to be in a rolled configuration as taught by Application no. 19/100854 as the rolled configuration permits high surface-area-to-volume ratio and can transport nutrients and gases with significantly reduced shear stress and various aspects of the rolled scaffold can be precisely tailored for specific applications, as taught by YekrangSafakar. One would be motivated to do so to maximize cell number yield and viability from the in vitro culture system. As cell culture in rolled and parallel configuration are known in the art, one would have a reasonable expectation of success.
This is a provisional obviousness-type double patenting rejection because the
conflicting claims have not in fact been patented.
Conclusion
Claims 1, 2, 7-11, 14, 15, 19-29 are rejected.
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/JULIANA IRENE CANDELARIA/ Examiner, Art Unit 1634
/MARIA G LEAVITT/ Supervisory Patent Examiner, Art Unit 1634
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