DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's request for continued examination filed on 7/23/2026 has been entered. Applicant’s response to Notice of Non-compliant amendment filed on 8/4/2026 has been entered.
Claims 1-7 and 9-13 are currently pending. Claim 8 is cancelled. Claims 14-18 are indicated as Withdrawn, however there is no text for claims 14-18. Claims 1 and 9 are currently amended.
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Claim Objections - Withdrawn
Applicants’ amendment submitted 8/4/2026 obviates the previous objection to claims 1 and 9.
Claim Interpretation
Regarding claims 9 and 10, it is noted that claim 9 recites the following limitation:
“wherein the bulk-modified elastomer is obtainable or obtained by mixing a vinyl-functionalized and/or a hydride-functionalized elastomer or at least one precursor thereof and a residue precursor as defined herein in a concentration in the range of 2.10-4 to 2.10-2 mol/kg by weight of the total weight of the bulk modified elastomer and heating the mixture, preferably, when the elastomer is a silicone based elastomer the range is 2.10-4 to 1.10-2 mol/kg.”
Claim 10 recites “wherein the heating is performed in a reaction vessel having a metal oxide inner surface.”
It is noted these limitations are directed to the process used to prepare the claimed cell culturing substrate. Such limitations are product-by-process limitations which appear to define the cell culturing substrate. Product-by-process limitations are considered only insofar as the method of production imparts distinct structural or chemical characteristics or properties to the product. Therefore, if the product, as claimed, is the same or obvious over a product of the prior art (i.e., it is not structurally or chemically distinct), the claim is considered unpatentable over the prior art, even though the prior art product is made by a different process. In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985), and In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979). See also MPEP § 2113.
If the product by process limitations are considered, the process imparts these features: the plurality of residues are present at a concentration ranging from 2.10-4 to 1.10-2 mol/kg by weight of the total weight of the elastomer.
REJECTION(S) MAINTAINED
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.
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.
This application currently names joint inventors Beckers and Van Gijsel. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-7 and 9-13 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/015988, inventors Beckers and Kriege, published 24 January 2019, IDS 3/22/2022 (“WO ‘988”).
The rejection has been updated in view of Applicant’s amendment submitted 12/10/2025.
Regarding claims 1 and 9, WO ‘988 is directed to a material for cell culturing (i.e., a cell culturing substrate) wherein the material contains a bulk-modified elastomer comprising a plurality of fatty acid moieties covalently bound to the elastomer bulk, and the material can be used to form a (monolithic) biocompatible fluidic device (i.e., a material for culturing cells thereon) (Abstract; page 1, lines 1-5; page 3, lines 13-14).
WO ‘988 teaches the fatty acid moieties (e.g. unsaturated fatty acids) are covalently bound to the elastomer bulk through cross-linking between a vinyl functional group or a hydride functional group of the elastomer and an unsaturated carbon-carbon bond of the unsaturated fatty acid (i.e., the plurality of residues being covalently bound to the elastomer bulk) (page 4, lines 14-18). FIG. 2 (page 15, lines 7-16) of WO ‘988 illustrates the fatty acid carboxylic acid groups are available on the external surface of the cell culturing substrate. The unsaturated fatty acids are selected from myristoleic acid, palmitoleic acid, sapienic acid, oleic acid, elaidic acid, vaccenic acid, linoleic acid, linoeladic acid, α-linolenic acid, arachidonic acid, eicospaentaenoic acid, erucic acid and docosahexaenoic acid (page 4, lines 19-23).
FIG. 2 of WO ‘988 further illustrates the cell culture substrate is coated with a cell culture protein (e.g., fibronectin, collagen, elastin) that binds to unsaturated fatty acids. WO ‘988 teaches the cells (MDA-MB231 and MCF-7) are immobilized/bound to the culture substrate and the culture is exposed to therapeutic drug candidates by passing a fluid containing the drug candidate over the immobilized cells in order to monitor the cell response and test the efficacy of the drug candidate, thus the cells remain attached to the cell culture surface while the fluid is being flushed through the fluidic device which demonstrates the cells remain attached to the device surface (page 18, lines 19-29; page 24, lines 13-28). WO ‘988 teaches that trypsin must be employed to dissociate the cells from the external surface (page 24, lines 13-28). Thus, WO ‘988 reads on “wherein the external surface is adapted to allow cells to proliferate directly on the external surface” (claim 1).
WO ‘988 teaches the elastomer bulk (e.g., polybutadiene) and the unsaturated fatty acid may be mixed in any suitable ratio to form the bulk-modified elastomer, such as the unsaturated fatty acid is present in a range of 0.05-35% by weight of the elastomer to permit that the elastomer retains its flexibility to the remaining presence of carbon-carbon double bonds in the elastomer bulk (page 14, lines 3-10).
Synthesis example 1 (page 14) specifically teaches mixing polybutadiene elastomer with 1-30% of linoleic acid (60-74% concentrated) (i.e., plurality of residues comprising acid groups in free form), where in the resulting extruded mixture yields a monolithic fluidic device module of a polybutadiene rubber cross-linked (i.e., covalently bound) with the linoleic acid.
The only difference between WO ‘988 and the instant invention is that WO ‘988 does not define the concentration of the fatty acid residues as mol/kg by weight of the elastomer. WO ‘988 indicates the concentration of the fatty residues as 1-30% or 0.05-35% by weight of the elastomer. However, the instant specification (page 8, lines 14-18) discloses a useful concentration of fatty acid residues ranges from 0.5-5% by weight of the total weight of the elastomer and Synthesis example 1 (specification page 25) discloses mixing 1-5% of linoleic acid (60-75% concentrated) by weight of the polybutadiene bulk elastomer. Thus, it is reasonable to consider that the concentration of fatty acid residues taught by WO ‘988 encompasses the claimed concentrations, thus meeting the limitation of claims 1 and 9.
Further regarding claim 10 and the limitation directed to heating is performed in a reaction vessel having a metal oxide inner surface, it is noted as set forth above at Claim Interpretation, this limitation is a product-by-process limitation.
If the product by process limitations are considered, the process imparts these features: the plurality of residues are present at a concentration ranging from 2.10-4 to 1.10-2 mol/kg by weight of the total weight of the elastomer.
Thus, claim 10 does not further limit the composition of claim 9 and is therefore included in the rejection of claim 9.
Regarding claims 2 and 3, FIG. 2 WO ‘988 illustrates the carboxylic acid groups are available on the external surface and Synthesis examples 1 and 2 teach linoleic acid, thus meeting the limitations of claims 2 and 3.
Regarding claims 4 and 5, WO ‘988 teaches the residues are selected from myristoleic acid, palmitoleic acid, sapienic acid, oleic acid, elaidic acid, vaccenic acid, linoleic acid, linoeladic acid, α-linolenic acid, arachidonic acid, eicospaentaenoic acid, erucic acid and docosahexaenoic acid (page 4, lines 19-23), thus meeting the limitation of claims 4 and 5.
Regarding claim 6, WO ‘988 Synthesis examples 1 and 2 teach the elastomer bulk comprises polybutadiene and silicone, respectively, thus meeting the limitation of claim 6.
Regarding claim 7, it is noted FIG. 1 of WO ‘988 schematically depicts the cross-linking reaction for producing the bulk-modified elastomer material according to embodiments of the present invention. In this cross-linking reaction, a vinyl- functionalized elastomer is cross-linked to an unsaturated fatty acid by a cross-linking reaction between one of the carbon-carbon double bonds of the elastomer 10 and one of the carbon-carbon double bonds of the unsaturated fatty acid, which cross-linking reaction may be catalyzed using an appropriate cross-linking catalyst. It has surprisingly been found by the present inventors that such a cross-linking reaction can provide a bulk-modified elastomer in which the carboxylic acid groups of at least a fraction of the unsaturated fatty acid molecules having engaged in the cross-linking reaction with the elastomer are presented on an external surface of the bulk-modified elastomer, such that these carboxylic acid groups are available for binding reactions with cell-stabilizing (i.e. cell-culturing) proteins such as fibronectin, collagen or elastin (page 8, lines, 30-34 to page 9, lines 1-8).
Regarding claims 11-13, WO ‘988 teaches a fluidic device module including a flow channel extending over a membrane, the membrane comprising the inventive material. The fluidic device module comprises a first major surface comprising a first recessed structure defining a first flow channel; a second major surface opposing the first major surface and comprising a second recessed structure defining a second flow channel; with the membrane separating the first flow channel from the second flow channel. WO ‘988 teaches the fluidic device module is a monolithic fluidic device (page 5, lines 7-16). The teaching of WO ‘988 meets the limitations of claims 11-13.
Response to Remarks
Rejection under 35 USC 103:
Applicant has traversed the rejection of record on the ground that WO ‘988 fails to disclose a cell surface substrate that does not require a medium, such as culturing proteins across the surface, as discussed at Applicant’s remarks (page 4).
Applicants’ remarks have been fully considered but are not found persuasive since the claims as currently drafted do not exclude a cell surface substrate that comprises a medium that includes culturing proteins. The claims employ the transitional phrase “comprising”. The transitional term “comprising”, which is synonymous with “including,” “containing,” or “characterized by,” is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004) (“[L]ike the term ‘comprising,’ the terms ‘containing’ and ‘mixture’ are open-ended.”). “The word ‘comprising’ transitioning from the preamble to the body signals that the entire claim is presumptively open-ended.” Id. MPEP 2111.03
As to Applicant’s remarks regarding the concentration ranges enable the cells to be cultured on the claimed substrate, as discussed at Applicant’s remarks (page 4), it is noted that Applicants’ remarks have been fully considered but are not found persuasive since WO ‘988 teaches cells are cultured on the prior art substrate. Moreover, the instant specification (page 8, lines 14-18) discloses a useful concentration of fatty acid residues ranges from 0.5-5% by weight of the total weight of the elastomer and Synthesis example 1 (specification page 25) discloses mixing 1-5% of linoleic acid (60-75% concentrated) by weight of the polybutadiene bulk elastomer and WO ‘988 indicates the concentration of the fatty residues as 1-30% or 0.05-35% by weight of the elastomer. Thus, it is reasonable to consider that the concentration of fatty acid residues taught by WO ‘988 encompasses the claimed concentrations, thus meeting the limitation of claims 1 and 9.
Conclusion
No claim is allowed. No claim is free of the prior art.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to E. YVONNE PYLA whose telephone number is (571)270-7366. The examiner can normally be reached M-F 9am - 6pm.
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E. YVONNE PYLA
Primary Examiner
Art Unit 1633
/EVELYN Y PYLA/Primary Examiner, Art Unit 1633
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