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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 submission filed on 4/22/2026 has been entered.
Status of the Claims
The amendment filed 4/22/2026 has been entered. Claims 1-19 and 22-26 are pending in the application; claims 23-36 have been newly added.
Response to Arguments
Applicant's arguments filed 4/22/2026 have been fully considered but they are not persuasive.
Applicant argues on p. 8 of Remarks that one of ordinary skill in the art would not have been motivated to replace Mayer et al.'s magnetic elastomer with Germain et al.'s gyroid PLA structure. This is not persuasive, because the examiner did not allege that it was obvious to substitute the magnetic elastomer of Mayer et al. with the porous gyroid construct of Germain et al. It has been held that a determination of obviousness based on teachings from multiple references does not require an actual, physical substitution of elements; the criterion being not whether the references could be physically combined but whether the claim inventions are rendered obvious by the teachings of the prior art as a whole (MPEP § 2145 Ill). As for motivation, Germain et al. discloses that a porous construct with a gyroid pattern allows for good nutrient and waste diffusion and favorable mechanical properties (abstract), and one of ordinary skill in the art would recognize that including a gyroid pattern in a porous construct would favorably yield these properties for cell culture based on the teachings of Germain et al.
Furthermore, Applicant argues that a modification that would be expected to alter the mechanical characteristics of Mayer et al.'s substrata would have been non-obvious because such a modification would change the principle by which Mayer et al. operates and potentially render the substrata unsuitable for its intended purpose. This is not persuasive, as Mayer et al. does not teach away from the addition of a gyroid pattern in the substrata, nor does Mayer et al. teach that the proposed modification would have resulted in an inoperable product or a product with undesirable properties.
Applicant also argues on pp. 8-9 of Remarks that combining Mayer et al. and Germain et al. would result in a gyroid structure, not a gyroid infill micropattern. This is not persuasive, as the examiner maintains that this is a recitation of a product-by-process. An infill micropattern, as described in p. 6, line 29-p. 7, line 4 of the instant specification, is part of the 3D printing process for fabricating the claimed construct. It has been held that determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (MPEP § 2113). Additionally, the scaffold disclosed by Germain et al. is 3D printed (title “3D-printed biodegradable gyroid scaffolds for tissue engineering applications”; abstract “additive manufacturing technique”), and one of ordinary skill in the art would understand that a 3D-printed structure with a gyroid pattern would be achieved by filling in the gyroid pattern.
Furthermore, it has been held that the test for obviousness "is what the combined teachings of those references would have suggested to those of ordinary skill in the art ... combining the teachings of references does not involve an ability to combine their specific structures" (MPEP § 2145 Ill). Germain et al. teaches that a gyroid-patterned structure allows for good nutrient and waste diffusion and favorable mechanical properties (abstract), and this would suggest to one of ordinary skill in the art that a gyroid pattern would be an advantageous pattern to include in a construct for cell culture. Therefore, one of ordinary skill in the art would be motivated to include a gyroid pattern based on the teachings of Germain et al., even if the process of forming the gyroid pattern is different than that of Germain et al.
Regarding the objection to claim 22, Applicant’s amendments to the claim have overcome the objection, and accordingly, the objection has been withdrawn.
Claim Objections
Claim 25 is objected to because of the following informalities: it is recommended that "wherein porous, magnetic, elastomeric construct" read "wherein . Appropriate correction is required.
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.
Claims 1-9, 12-14, 19, 23, and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Mayer et al. (Ultra-Soft PDMS-Based Magnetoactive Elastomers as Dynamic Cell Culture Substrata) (already of record) in view of Germain et al. (3D-printed biodegradable gyroid scaffolds for tissue engineering applications).
Regarding claim 1, Mayer et al. teaches a system for cell culture (abstract “cell culture substrata”) comprising: a vessel (Fig. 5A 24-well); a magnetic, elastomeric construct (abstract “PDMS-based magnetoactive elastomers (MAE)… cell culture substrata”) sized to be positioned within the vessel (Fig. 5A substratum); and a magnet configured to apply a magnetic field within the construct effective to deform the construct (p. 2, Magnetic Field Generation for MAE use in Cell Culture Applications “permanent magnets”).
Mayer et al. does not explicitly teach a porous construct exhibiting a gyroid infill micropattern. However, Germain et al. teaches a porous construct with a gyroid pattern (abstract “poly(lactic acid) (PLA) gyroid scaffolds… porosity of the gyroid structure was 71%”). Germain et al. teaches that a porous construct with a gyroid pattern allows for good nutrient and waste diffusion and favorable mechanical properties (abstract). It would have been obvious to a person of ordinary skill in the art to use the Germain et al. configuration of a porous construct with a gyroid pattern in Mayer et al.’s device with a reasonable expectation that it would allow for good nutrient and waste diffusion and favorable mechanical properties. This method for improving Mayer et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Germain et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Mayer et al. and Germain et al. to obtain the invention as specified in claim 1.
Regarding claim 2, Mayer et al. teaches a system for cell culture wherein the vessel is substantially cylindrical and comprises a bottom and a side wall (Fig. 5A 24-well).
Regarding claim 3, Mayer et al. teaches a system for cell culture wherein the vessel comprises a well of a multiwell plate having a circular bottom surface and a side wall (pg. 2, Magnetic Field Generation for MAE use in Cell Culture Applications “24 well cell culture plates”; Fig. 5A 24-well).
Regarding claim 4, Mayer et al. teaches a system for cell culture wherein the construct has a substantially cylindrical shape (pg. 9, Cells and Substratum Preparation “circular PDMS or MAE samples of 12 mm diameter and 2 mm thickness”).
Regarding claim 5, Mayer et al. clearly shows in Fig. 5A that the diameter of the construct (substratum) occupies a majority of the inner diameter of the well. Mayer et al. also discloses that the diameter of the construct is 12 mm (pg. 9, Cells and Substratum Preparation) and the vessel is a well of a 24 well cell culture plate (pg. 2, Magnetic Field Generation for MAE use in Cell Culture Applications “24 well cell culture plates”), as discussed above. One of ordinary skill in the art would understand that this would arrive at the construct having a diameter in a range of 60% to 99% of the inner diameter of the well based on the skilled artisan’s knowledge of the standard diameter of a well of a 24 well cell culture plate. It has been held that the description of the article pictured can be relied on, in combination with the drawings, for what they would reasonably teach one of ordinary skill in the art (MPEP § 2125). Therefore, one of ordinary skill in the art would understand from the description of the construct in combination with the drawings that Mayer et al. discloses a construct having a diameter that occupies a majority of the inner diameter of the well.
However, Mayer et al. does not expressly teach wherein the diameter of the construct is from
60% to 99% of the inner diameter of the well. Nonetheless, it has been held that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation (MPEP § 2144.05). Mayer et al. discloses general conditions for the diameter of the construct as compared to the inner diameter of the well, as set forth above, and the skilled artisan would recognize that adjusting the diameter of the construct relative to that of the well would adjust the available surface area for interacting with a cell culture. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to discover an optimum range for the diameter of the construct relative to the inner diameter of the well.
Regarding claim 6, Mayer et al. teaches a system for cell culture wherein the magnetic, elastomeric construct is formed from a composite comprising a biocompatible elastomer and a population of magnetic particles dispersed within the biocompatible elastomer (abstract “embedding magnetic microparticles into a soft PDMS matrix”).
Mayer et al. does not explicitly teach a porous construct exhibiting a gyroid infill micropattern. However, Germain et al. teaches a porous construct with a gyroid pattern (abstract “poly(lactic acid) (PLA) gyroid scaffolds… porosity of the gyroid structure was 71%”). Germain et al. teaches that a porous construct with a gyroid pattern allows for good nutrient and waste diffusion and favorable mechanical properties (abstract). It would have been obvious to a person of ordinary skill in the art to use the Germain et al. configuration of a porous construct with a gyroid pattern in Mayer et al.’s device with a reasonable expectation that it would allow for good nutrient and waste diffusion and favorable mechanical properties. This method for improving Mayer et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Germain et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Mayer et al. and Germain et al. to obtain the invention as specified in claim 6.
Regarding claim 7, Mayer et al. teaches a system for cell culture wherein the biocompatible elastomer comprises an acrylonitrile butadiene styrene (ABS), polyphenylene sulfide (PPS), poly(meth)acrylate, polyphenylsulfone (PPSU), cyclic olefin copolymer (COC), polyetheretherketone (PEEK), polyurethane (PU), polyetherimide (PEI), polyphenylene ether (PPE), polycarbonate (PC), poly(ethyleneterephthalate glycol) (PETG), polysiloxane, or any combination thereof (p. 8, material Composition and Preparation “polydimethylsiloxane”).
Regarding claim 8, Mayer et al. teaches a system for cell culture wherein the biocompatible elastomer comprises a polysiloxane (p. 8, material Composition and Preparation “polydimethylsiloxane”).
Regarding claim 9, Mayer et al. teaches a system for cell culture wherein the magnetic particles comprise iron, cobalt, zinc, cadmium, nickel, gadolinium, chromium, copper, gold, silver, platinum, manganese, metal oxide, or an alloy thereof (p. 2, ultra-soft PDMS and MAE Baseline Characteristics “carbonyl iron”).
Regarding claim 12, Mayer et al. teaches a system for cell culture comprising a magnetic, elastomeric construct formed by a crosslinking reaction (p. 2, Ultra-soft PDMS and MAE Baseline Characteristics), but does not teach a magnetic elastomeric construct formed by an additive manufacturing process.
Regarding the limitation “formed by an additive manufacturing process”, it has been held that the patentability of a product does not depend on its method of production; if the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior art product was made by a different process (MPEP § 2113 I). Therefore, the elastomeric construct disclosed by Mayer et al., made by a crosslinking reaction (p. 2, Ultra-soft PDMS and MAE Baseline Characteristics) would be obvious over the elastomeric construct of the claimed invention even though both were made by a different process.
Nonetheless, Germain et al. teaches a porous construct formed by an additive manufacturing process (abstract). Germain et al. teaches that additive manufacturing is a low-cost and easy-to-use manufacturing technique (abstract). It would have been obvious to a person of ordinary skill in the art to use the Germain et al. configuration of forming a porous construct by additive manufacturing in Mayer et al.’s device with a reasonable expectation that it would be low-cost and easy-to-use. This method for improving Mayer et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Germain et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Mayer et al. and Germain et al. to obtain the invention as specified in claim 12.
Regarding claim 13, Mayer et al. teaches a system for cell culture wherein the magnet comprises a permanent magnet (p. 2, Magnetic Field Generation for MAE use in Cell Culture Applications “permanent magnets”).
Regarding claim 14, Mayer et al. teaches a system for cell culture wherein the magnet comprises an electromagnet (p. 2, Magnetic Field Generation for MAE use in Cell Culture Applications “dynamic magnetic circuit comprises two current-driven coils”).
Regarding claim 19, Mayer et al. teaches a system for cell culture wherein the magnetic, elastomeric construct is operatively configured to apply nanovibration, strain, or a combination thereof to a population of cells within the vessel (Fig. 3(B) description “device for introducing displacement field and strain on the surface of the MAE substratum”).
Mayer et al. does not explicitly teach a porous construct exhibiting a gyroid infill micropattern. However, Germain et al. teaches a porous construct with a gyroid pattern (abstract “poly(lactic acid) (PLA) gyroid scaffolds… porosity of the gyroid structure was 71%”). Germain et al. teaches that a porous construct with a gyroid pattern allows for good nutrient and waste diffusion and favorable mechanical properties (abstract). It would have been obvious to a person of ordinary skill in the art to use the Germain et al. configuration of a porous construct with a gyroid pattern in Mayer et al.’s device with a reasonable expectation that it would allow for good nutrient and waste diffusion and favorable mechanical properties. This method for improving Mayer et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Germain et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Mayer et al. and Germain et al. to obtain the invention as specified in claim 19.
Regarding claim 23, Mayer et al. teaches a system for cell culture comprising a magnetic, elastomeric construct formed by a crosslinking reaction (p. 2, Ultra-soft PDMS and MAE Baseline Characteristics), but does not teach a magnetic elastomeric construct formed by an additive manufacturing process. However, it has been held that the patentability of a product does not depend on its method of production; if the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior art product was made by a different process (MPEP § 2113 I). Therefore, the elastomeric construct disclosed by Mayer et al., made by a crosslinking reaction (p. 2, Ultra-soft PDMS and MAE Baseline Characteristics) would be obvious over the elastomeric construct of the claimed invention even though both were made by a different process.
Nonetheless, Germain et al. teaches a porous construct formed by an additive manufacturing process (abstract). Germain et al. teaches that additive manufacturing is a low-cost and easy-to-use manufacturing technique (abstract). It would have been obvious to a person of ordinary skill in the art to use the Germain et al. configuration of forming a porous construct by additive manufacturing in Mayer et al.’s device with a reasonable expectation that it would be low-cost and easy-to-use. This method for improving Mayer et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Germain et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Mayer et al. and Germain et al. to obtain the invention as specified in claim 23.
Regarding claim 25, Mayer et al. teaches a system for cell culture wherein the magnetic, elastomeric construct exhibits a Young's modulus of from 8 KPa to 45 Kpa (p. 2 Ultra-soft PDMS and MAE Baseline Characteristics “Young’s moduli (<20kPa, Fig. 2A)“).
Mayer et al. does not explicitly teach a porous construct exhibiting a gyroid infill micropattern. However, Germain et al. teaches a porous construct with a gyroid pattern (abstract “poly(lactic acid) (PLA) gyroid scaffolds… porosity of the gyroid structure was 71%”). Germain et al. teaches that a porous construct with a gyroid pattern allows for good nutrient and waste diffusion and favorable mechanical properties (abstract). It would have been obvious to a person of ordinary skill in the art to use the Germain et al. configuration of a porous construct with a gyroid pattern in Mayer et al.’s device with a reasonable expectation that it would allow for good nutrient and waste diffusion and favorable mechanical properties. This method for improving Mayer et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Germain et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Mayer et al. and Germain et al. to obtain the invention as specified in claim 25.
Regarding claim 26, Mayer et al. teaches a cell culture system wherein the magnetic, elastomeric construct is capable of reversing back to its original height after dynamic actuation cycles with an applied magnetic field (p. 2 Introduction “magnetically tunable elastic modulus”; p. 4 Magnetic field-induced elasticity modulation).
Mayer et al. does not explicitly teach a porous construct exhibiting a gyroid infill micropattern. However, Germain et al. teaches a porous construct with a gyroid pattern (abstract “poly(lactic acid) (PLA) gyroid scaffolds… porosity of the gyroid structure was 71%”). Germain et al. teaches that a porous construct with a gyroid pattern allows for good nutrient and waste diffusion and favorable mechanical properties (abstract). It would have been obvious to a person of ordinary skill in the art to use the Germain et al. configuration of a porous construct with a gyroid pattern in Mayer et al.’s device with a reasonable expectation that it would allow for good nutrient and waste diffusion and favorable mechanical properties. This method for improving Mayer et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Germain et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Mayer et al. and Germain et al. to obtain the invention as specified in claim 26.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Mayer et al. (Ultra-Soft PDMS-Based Magnetoactive Elastomers as Dynamic Cell Culture Substrata) (already of record) in view of Germain et al. (3D-printed biodegradable gyroid scaffolds for tissue engineering applications) as applied to claim 6 above, and further in view of Mckean et al. (US 2019/0032007 A1) (already of record).
Regarding claim 10, Mayer et al. teaches a system for cell culture comprising a magnetic elastomeric construct wherein magnetic particles are present (abstract “embedding magnetic microparticles into a soft PDMS matrix”), but does not teach that the magnetic particles are present in an amount from 0.5% to 20% by weight, based on the total weight of the construct. However, Mckean et al. teaches magnetic particles present in an amount from 0.5% to 20% by weight (para. 0110 “less than or equal to 5.0 weight %”). Mckean et al. teaches that this concentration of magnetic material in the scaffold increases the ease with which the microscaffolds may be maintained in suspension and manipulated externally (para. 0158). It would have been obvious to a person of ordinary skill in the art to use the Mckean et al. configuration of magnetic particles present in an amount from 0.5% to 20% in modified Mayer et al.’s device with a reasonable expectation that it would increase the ease with which the microscaffolds may be maintained in suspension and manipulated externally. This method for improving modified Mayer et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Mckean et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Mckean et al. and modified Mayer et al. to obtain the invention as specified in claim 10.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Mayer et al. (Ultra-Soft PDMS-Based Magnetoactive Elastomers as Dynamic Cell Culture Substrata) (already of record) in view of Germain et al. (3D-printed biodegradable gyroid scaffolds for tissue engineering applications) as applied to claim 1 above, and further in view of Mohanty et al. (Fabrication of scalable and structured tissue engineering scaffolds using water dissolvable sacrificial 3D printed moulds) (already of record).
Regarding claim 11, modified Mayer et al. teaches a system for cell culture comprising a porous, magnetic, elastomeric construct that has a porosity (abstract “porosity of the gyroid structure was 71%”), but does not teach that the porosity is from 10% to 50%. However, Mohanty et al. teaches that porosity can range from 20-80% (p. 571, 2.2.3. Mechanical testing). Mohanty et al. teaches that energy absorption of scaffolds is greatly reduced and there is a dramatic decrease in compressive modulus with increasing porosity in this range (p. 573 3.2.3. Mechanical testing). It would have been obvious to a person of ordinary skill in the art to use the Mohanty et al. configuration of a porosity of 20-80% in modified Mayer et al.’s device with a reasonable expectation that energy absorption of scaffolds would be greatly reduced and there would be a dramatic decrease in compressive modulus with increasing porosity in this range. This method for improving modified Mayer et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Mohanty et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Mohanty et al. and modified Mayer et al. to obtain the invention as specified in claim 11.
Claims 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Mayer et al. (Ultra-Soft PDMS-Based Magnetoactive Elastomers as Dynamic Cell Culture Substrata) (already of record) in view of Germain et al. (3D-printed biodegradable gyroid scaffolds for tissue engineering applications) as applied to claim 1 above, and further in view of Koo et al. (US 2020/0318049 A1) (already of record).
Regarding claim 15, modified Mayer et al. teaches a system for cell culture, but does not teach wherein the system further comprises a porous, non-magnetic construct sized to be positioned within the vessel. However, Koo et al. teaches a porous, non-magnetic construct (claims 1-2 “three-dimensional network structure… porosity of 40 to 90%”) sized to be positioned within a vessel (para. 0021 “housing having the scaffold”). Koo et al. teaches that the porous scaffold creates a suitable microenvironment for improving cell proliferation and viability (abstract). It would have been obvious to a person of ordinary skill in the art to use the Koo et al. configuration of a porous, non-magnetic construct sized to be positioned within a vessel in modified Mayer et al.’s device with a reasonable expectation that it would create a suitable microenvironment for improving cell proliferation and viability. This method for improving modified Mayer et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Koo et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of modified Mayer et al. and Koo et al. to obtain the invention as specified in claim 15.
Regarding claim 16, Mayer et al. teaches a system for cell culture, but does not teach wherein the system further comprises a 3D cell culture matrix sized to be positioned within the vessel. However, Koo et al. teaches a 3D cell culture matrix (abstract “scaffold… three-dimensional network structure”) sized to be positioned within a vessel (para. 0021 “housing having the scaffold”). Koo et al. teaches that the porous scaffold creates a suitable microenvironment for improving cell proliferation and viability (abstract). It would have been obvious to a person of ordinary skill in the art to use the Koo et al. configuration of a 3D cell culture matrix sized to be positioned within a vessel in modified Mayer et al.’s device with a reasonable expectation that it would create a suitable microenvironment for improving cell proliferation and viability. This method for improving modified Mayer et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Koo et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of modified Mayer et al. and Koo et al. to obtain the invention as specified in claim 16.
Regarding claim 17, Mayer et al. teaches a system for cell culture, but does not teach a 3D cell culture matrix, wherein the 3D cell culture matrix comprises a population of cells seeded within a degradable polymer matrix. However, Koo et al. teaches a population of cell seeded (para. 0061) within a degradable polymer matrix (claim 11). Koo et al. teaches that a biodegradable scaffold may be grafted into a body without a separate operation to remove the scaffold (para. 0046). It would have been obvious to a person of ordinary skill in the art to use the Koo et al. configuration of a population of cell seeded within a degradable polymer matrix in modified Mayer et al.’s device with a reasonable expectation that it may be grafted into a body without a separate operation to remove the scaffold. This method for improving modified Mayer et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Koo et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of modified Mayer et al. and Koo et al. to obtain the invention as specified in claim 17.
Regarding claim 18, Mayer et al. teaches a system for cell culture, but does not teach a polymer matrix, wherein the polymer matrix comprises alginate, chitosan, agarose, fibrin, collagen, hyaluronic acid, a polyhydroxyalkanoate, a polyester, a polyalkylene oxide, a copolymer thereof, or a blend thereof. However, Koo et al. teaches a polymer matrix comprising a polyester (claim 11 “polycaprolactone”). Koo et al. teaches that a biodegradable scaffold may be grafted into a body without a separate operation to remove the scaffold (para. 0046). It would have been obvious to a person of ordinary skill in the art to use the Koo et al. configuration of a degradable polymer matrix comprising a polyester in modified Mayer et al.’s device with a reasonable expectation that it may be grafted into a body without a separate operation to remove the scaffold. This method for improving modified Mayer et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Koo et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of modified Mayer et al. and Koo et al. to obtain the invention as specified in claim 18.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Mayer et al. (Ultra-Soft PDMS-Based Magnetoactive Elastomers as Dynamic Cell Culture Substrata) (already of record) in view of Germain et al. (3D-printed biodegradable gyroid scaffolds for tissue engineering applications) as applied to claim 1 above, and further in view of Lind et al. (US 2019/0339261 A1) (already of record).
Regarding claim 22, Mayer et al. teaches a system for cell culture wherein the magnetic particles are present (abstract “embedding magnetic microparticles into a soft PDMS matrix”), but does not teach that the magnetic particles are present in an amount of greater than 5% to 20% by weight, based on the total weight of the construct. However, Lind et al. teaches magnetic beads comprising magnetic particles comprising 5-15% weight of the magnetic beads (para. 0041). Lind et al. teaches that this weight range makes it easy for the beads to retain with a magnetic field without increasing the density and without obstructing mass transport in the porous matrix (para. 0041). It would have been obvious to a person of ordinary skill in the art to use the Lind et al. configuration of magnetic particles present in an amount of 5-15% total weight of the construct in modified Mayer et al.’s device with a reasonable expectation that it would make it easy for the beads to retain with a magnetic field without increasing the density and without obstructing mass transport in the porous matrix. This method for improving modified Mayer et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Lind et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of modified Mayer et al. and Lind et al. to obtain the invention as specified in claim 22.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Mayer et al. (Ultra-Soft PDMS-Based Magnetoactive Elastomers as Dynamic Cell Culture Substrata) (already of record) in view of Germain et al. (3D-printed biodegradable gyroid scaffolds for tissue engineering applications) as applied to claim 1 above, and further in view of Lee et al. (US 2021/0040427 A1).
Regarding claim 24, modified Mayer et al. teaches a cell culture system comprising a porous, magnetic, elastomeric construct that exhibits actuated strain (p. 4 MAE as actuators in time-varying magnetic fields; Fig. 7), but does not explicitly teach a strain actuation of from 2% to 11% with increased magnetic field. However, Lee et al. teaches a strain of 5% to 10% with increasing magnetic field strength (para. 0014; Fig. 5C) which enables various physiological environments to be modeled for cell culture (para. 0006). It would have been obvious to a person of ordinary skill in the art to use the Lee et al. configuration of a strain of 5% to 10% in modified Mayer et al.’s device with a reasonable expectation that it would allow certain physiological environments to be modeled for cell culture. This method for improving modified Mayer et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Lee et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of modified Mayer et al. and Lee et al. to obtain the invention as specified in claim 24.
Conclusion
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/ASHLEY LOPEZLIRA/Examiner, Art Unit 1799
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799
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