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 .
Status of the Claims
The amendment filed 2/10/2026 has been entered. Claims 1-6, 9, and 12-14 are pending in the application; with claims 9 and 13 withdrawn. Applicant’s amendments to the claims have overcome each objection and 112(b) rejection previously set forth in the Final Office Action mailed 10/10/2025; accordingly, the objections and rejections have been withdrawn.
Response to Arguments
Applicant’s arguments filed 2/10/2026 have been considered but they are moot in view of a new grounds of rejection necessitated by the amendments to the claims.
Applicant added limitations to independent claim 1 for a respective air bubble generator disposed underneath each tray. This new limitation does not distinguish the claimed invention over the prior art. The Examiner acknowledges that neither Ouazzani et al. nor Fukunaga teach a respective air bubble generator disposed underneath each tray, as Fukunaga discloses only one air bubble generator disposed at the bottom of the vessel. However, it would have been obvious to modify the device of Ouazzani et al. in view of Livingston (US 2011/0000836 A1), which will be discussed in further detail in the 35 USC § 103 section below.
Applicant argues on pp. 6-9 of Remarks that the use of MPEP § 2114 does not apply because claim 1 recites structural and operational configurations, not merely intended use. This is not persuasive because using the air bubble generator to generate “air bubbles having a controlled size and frequency, such that the pressure exerted by said air bubbles on the three-dimensional polymer-based element applies a mechanical stimulus thereto so as to stimulate contraction and extension movements and thereby stimulate proliferation and/or differentiation of adherent cells and thereby promote their growth” is a recitation of the intended use of the apparatus and does not distinguish the claimed invention over the prior art. It has been held that apparatus claims cover what a device is, not what a device does (MPEP § 2114 II), and using the claimed air bubble generator to generate air bubbles of a specific size and frequency to exert pressure and apply mechanical stimulus to simulate contraction and extension movements does not introduce a structural difference between the prior art and the claimed invention. Therefore, MPEP § 2114 does apply as Livingston discloses an apparatus which reads on the structural limitation of “a respective air bubble generator disposed underneath each tray” and would be fully capable of achieving the claimed intended use of generating air bubbles that can apply mechanical stimulus to simulate contraction and extension movements, as the prior art apparatus (Ouazzani et al. modified by Livingston) teaches all the structural limitations of the claim (MPEP § 2114).
Applicant argues on p. 9 of Remarks that the cited references are not analogous to the claimed invention. This is not persuasive, as a reference is analogous art to the claimed invention if: (1) the reference is from the same field of endeavor as the claimed invention (even if it addresses a different problem); or (2) the reference is reasonably pertinent to the problem faced by the inventor (even if it is not in the same field of endeavor as the claimed invention) (MPEP § 2141.01(a)). Thus, the device of Ouazzani et al. being directed to a device for culturing cells or microorganisms; Baust et al. being directed to an apparatus for constructing a tissue engineered model; and Matsumoto et al. being directed to an electroculture apparatus still qualify as analogous art even if the inventions address a different problem as the devices are disclosed to be for culturing cells/microorganisms, and would be reasonably pertinent to the problem faced by the inventor (growing cells).
Specification
The disclosure is objected to because of the following informalities: it is recommended that “This application claims benefit to PCT application PCT/ES2019/070006, filed January 4, 2019, said application incorporated herein by reference” be added on page 1 after the Title.
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 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Ouazzani et al. (US 2009/0305396 A1) (already of record) in view of Livingston (US 2011/0000836 A1).
Regarding claim 1, Ouazzani et al. teaches a bioreactor, capable of growing adherent cells for producing tissues and cultivated meat (abstract “culture of cells or micro-organisms”), comprising: a recipient (Fig. 2 110 tank) with a cover (Fig. 2 150 lid), wherein the bioreactor further comprises internally a bracket (Fig. 2 210 support frame) from which protrudes at least one tray (Fig. 2 250 trays) that supports a three-dimensional polymer-based element mounted on the bioreactor (para. 0058 “receive any type of… solid… agar”).
Regarding the limitation “when the bioreactor is filled with a culture medium, the at least one tray and the three-dimensional polymer-based element are surrounded by the culture medium”, it has been held that a claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim (MPEP § 2114 II). Therefore, the apparatus disclosed by Ouazzani et al. would be fully capable of achieving every claimed intended use because the prior art apparatus is disclosed to hold liquid culture medium (para. 0058) and would be structurally capable of filling the tray and surrounding the three-dimensional polymer-based element in culture medium absent clear evidence otherwise.
Regarding the preamble limitation of the apparatus being a bioreactor “for the growth of adherent cells for producing tissues and cultivated meat”, the inclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims (MPEP § 2115). Therefore, the apparatus disclosed by Ouazzani et al. would be fully capable of achieving every claimed intended use because the prior art apparatus is disclosed to be for culturing cells or microorganisms (abstract) and would be structurally capable of growing adherent cells for producing tissues and cultivated meat, absent clear evidence otherwise.
Ouazzani et al. does not teach an air bubble generator disposed underneath each tray. However, Livingston teaches a bioreactor comprising an air bubble generator disposed underneath each cassette (Fig. 4 pipe 50 underneath each cassette/membrane unit 22; para. 0050 “air, which can be provided by a series of submerged air diffusers or bubblers such as indicated by pipes at 50… One pipe 50 is shown below each membrane unit 22”) which have higher efficiency operation (para. 0001).
It would have been obvious to a person of ordinary skill in the art to use the Livingston configuration of an air bubble generator disposed underneath each shelf/tray in Ouazzani et al.’s device with a reasonable expectation that it would have higher efficiency operation. This method for improving Ouazzani et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Livingston. 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 Ouazzani et al. and Livingston to obtain the invention as specified in claim 1.
Regarding Livingston, the problem faced by the inventor is having a respective air bubble generator disposed underneath each unit in the vessel. Livingston’s configuration of a submerged membrane bioreactor with air diffusers disposed underneath each cassette/membrane unit is reasonably pertinent to solving this problem.
Regarding the limitation “wherein each respective air bubble generator is configured to generate air bubbles having a controlled size and frequency, such that the pressure exerted by said air bubbles on the three-dimensional polymer-based element applies a mechanical stimulus thereto so as to stimulate contraction and extension movements and thereby stimulate proliferation and/or differentiation of adherent cells and thereby promote their growth”, it has been held that a claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim (MPEP § 2114 II). Therefore, the air bubble generators disclosed by Livingston would be fully capable of achieving every claimed intended use because Livingston discloses that air diffusers have an upward velocity of 0.5-1.5 ft/sec (para. 0009) and would be structurally capable of generating air bubbles having a controlled size and frequency, such that the pressure exerted by said air bubbles on the three-dimensional polymer-based element applies a mechanical stimulus thereto so as to stimulate contraction and extension movements and thereby stimulate proliferation and/or differentiation of adherent cells and thereby promote their growth, absent clear evidence otherwise.
Regarding claim 2, Ouazzani et al. teaches a bioreactor wherein the bracket is suspended from the cover (Fig. 2).
Regarding claim 3, Ouazzani et al. teaches a bioreactor wherein the bracket protrudes perpendicularly from the cover (Fig. 2).
Claims 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Ouazzani et al. (US 2009/0305396 A1) (already of record) in view of Livingston (US 2011/0000836 A1) as applied to claim 1 above, and further in view of Baust et al. (US 2014/0273063 A1) (already of record).
Regarding claim 4, Ouazzani et al. teaches a bioreactor comprising a bracket (Fig. 2 210 support frame), but does not teach wherein the bracket is supported on the base of the bioreactor. However, Baust et al. teaches a bracket that is supported on the base of the bioreactor (Fig. 16 124 bottom plate, 132 risers). Baust et al. teaches that the risers ensure the plate does not rest on the bottom of the container and facilitate circulation of media and nutrients (para. 0033).
It would have been obvious to a person of ordinary skill in the art to use the Baust et al. configuration of a bracket supported on the base of the bioreactor in modified Ouazzani et al.’s device with a reasonable expectation that it would ensure the bottom plate does not rest on the bottom of the container while facilitating circulation of media and nutrients. This method for improving modified Ouazzani et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Baust 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 Ouazzani et al. and Baust et al. to obtain the invention as specified in claim 4.
Regarding claim 5, Ouazzani et al. teaches a bioreactor comprising at least one tray (Fig. 2 250 trays), but does not teach wherein the at least one tray comprises a series of through holes. However, Baust et al. teaches a tray comprising through holes (Fig. 14 124 bottom plate, 126 holes). Baust et al. teaches that the holes facilitate circulation of media and nutrients through the container (para. 0033).
It would have been obvious to a person of ordinary skill in the art to use the Baust et al. configuration of through holes in modified Ouazzani et al.’s device with a reasonable expectation that it would facilitate circulation of media and nutrients through the container. This method for improving modified Ouazzani et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Baust 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 Ouazzani et al. and Baust et al. to obtain the invention as specified in claim 5.
Regarding claim 6, Ouazzani et al. teaches a bioreactor further comprising trays (Fig. 2 250 trays), but does not teach at least one ring protruding from the bracket, such that each ring is arranged in parallel to a corresponding tray, bearing the three-dimensional polymer-based element located between the corresponding tray and the corresponding ring.
However, Baust et al. teaches a plate (Fig. 14 136 top plate) secured to a bracket (Fig. 14 122 positioning posts) parallel to a tray (Fig. 14 124 bottom plate) bearing a three-dimensional polymer-based element located between the tray and the plate (Fig. 16 114 TEM segments, 136 top plate, 124 bottom plate). Regarding the limitation “ring”, Baust et al. discloses that the frame for the TEM structure can be ring shaped (para. 0024) and the posts and container can be any shape depending on the shape of the TEM structure (para. 0032, 0038). Though Baust et al. does not explicitly disclose that the top plate is ring shaped, Baust et al. discloses a top plate that is capable of being ring shaped. Baust et al. teaches that the top plate holds the TEM segments in place within a scaffold apparatus (para. 0034).
It would have been obvious to a person of ordinary skill in the art to use the Baust et al. configuration of a top plate in modified Ouazzani et al.’s device with a reasonable expectation that it would hold the three-dimensional polymer-based element in the bracket. This method for improving modified Ouazzani et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Baust 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 Ouazzani et al. and Baust et al. to obtain the invention as specified in claim 6.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Ouazzani et al. (US 2009/0305396 A1) (already of record) in view of Livingston (US 2011/0000836 A1) as applied to claim 1 above, and further in view of Matsumoto et al. (JP 2011188845 A) (already of record) (machine translated).
Regarding claim 12, Ouazzani et al. teaches a bioreactor comprising a bracket (Fig. 2 210 support frame), but does not teach wherein the bracket comprises a series of electrical contacts able to be fed with alternating current or direct current. However, Matsumoto et al. teaches a support (Fig. 5 6 support) comprising electrical contacts (Fig. 5 9 working electrode, 10 counter electrode) able to be fed with alternating current or direct current (p. 7 “current is passed between the working electrode 9 and the counter electrode 10”). Matsumoto et al. teaches that electrodes allow a colony of the same type of microorganisms to be formed (para. 0018).
It would have been obvious to a person of ordinary skill in the art to use the Matsumoto et al. configuration of electrodes in modified Ouazzani et al.’s device with a reasonable expectation that it would allow a colony of the same type of microorganisms to be formed. This method for improving modified Ouazzani et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Matsumoto 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 Ouazzani et al. and Matsumoto et al. to obtain the invention as specified in claim 12.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Ouazzani et al. (US 2009/0305396 A1) (already of record) in view of Livingston (US 2011/0000836 A1) as applied to claim 1 above, and further in view of Fukunaga (JP 2014132846 A) (already of record) (machine translated).
Regarding claim 14, Ouazzani et al. modified by Livingston teaches a bioreactor comprising an air bubble generator disposed underneath shelf/cassette (see claim 1 above). Modified Ouazzani teaches that the air bubble generator is an air diffuser (para. 0050), but does not explicitly teach a sparger. However, Fukunaga teaches that a sparger is a known air bubble generator in the art (p. 3).
Though modified Ouazzani et al. does not explicitly teach a sparger, it would have been obvious to a person of ordinary skill in the art to use a sparger because the substitution of one known element for another would have predictably resulted in a component that generates air bubbles with reasonable expectation. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the teachings of modified Ouazzani et al. with the teachings of Fukunaga to obtain the invention as specified in claim 14.
Conclusion
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/ASHLEY LOPEZLIRA/Examiner, Art Unit 1799
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799