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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/24/2026 has been entered.
Status of the Claims
The amendment filed 2/24/2026 has been entered. Claims 1-4, 8, and 10-20 remain pending in the application; claims 5-7 and 9 have been cancelled. Applicant’s amendments to the claims have overcome each objection, 112(a) rejection, and 112(b) rejection previously set forth in the Final Office Action mailed 11/26/2025.
Response to Arguments
Applicant’s arguments filed 2/24/2026 have been considered but they are moot in view of a new grounds of rejection necessitated by the amendments to the claims.
Applicant argues on p. 9 of Remarks that the claims are not obvious in view of Veraitch et al. as Veraitch et al.’s device collapses the walls of the container whereas the claimed invention does not deform the walls of the container. This is not persuasive, as Veraitch et al. remedies the deficiencies of Finlay et al. as Finlay et al. does not teach at least one closable inlet and outlet for a flow channel to flow through and inlet and outlet valves arranged at the inlet and outlet. Veraitch et al. is not used to teach the limitation of “an elastic element… that is configured to deform… without deformation of the walls” recited in claim 1, rather, this limitation is taught by Finaly et al. (see claim 1 in the 35 USC § 103 section below) and does not cite Veraitch et al. as teaching this limitation.
Regarding the argument that Veraitch et al. uses a different technical approach than the claimed invention by deforming the walls of the container, this is not persuasive. 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 Veraitch et al. being directed to a collapsable container still qualifies as analogous art as the reference is from the same field of endeavor as the claimed invention as the device is disclosed to be a container for cell culture (abstract); and the device of Veraitch et al. is reasonably pertinent to the problem faced by the inventor (at least one closable inlet and outlet for a flow channel to flow through and inlet and outlet valves arranged at the inlet and outlet), which will be discussed in the 35 USC § 103 section below.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
"movement device" in claim 1;
“drive element” in claim 1;
“sealing element” in claim 17;
“fixing element” in claim 19.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-4, 8, 12-14, 17-18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Finlay et al. (US 2015/0376560 A1) (already of record) in view of Veraitch et al. (WO 2018/087558 A1) (already of record).
Regarding claim 1, Finlay et al. teaches a bioreactor for the cultivation of cells (abstract “bioreactor for forming a tissue engineered construct”; Fig. 1 10 bioreactor), the bioreactor comprising: a vessel having walls around an interior (Fig. 1 26 well), which is adapted to accommodate the cells to be cultivated (para. 0091 “tissue construct 12 is formed by seeding a suitable scaffold 13 with cells”) and culture medium (Fig. 1 42 culture medium), a movement device (Fig. 1 18 load applicator) which closes off the vessel interior from an outer environment (Fig. 1 18 load applicator) and can be connected to a drive unit (Fig. 2 56 motor, 58 drive belt) having at least one mechanically, pneumatically, hydraulically, electrically or electropneumatically driven drive element which acts on the movement device to generate a movement (para. 0105) through which the cells are at least intermittently moved to be cultivated or apply a force to them (para. 0091 “load applicator 18 which can be operated to apply a cyclical compressive mechanical load to the tissue construct 12, to stimulate the deposition of tissue matrix in the construct, by the cells which have been seeded in the scaffold 13”); an elastic element within the vessel interior (Fig. 1 13 scaffold which can be a pad (gel, foam etc.) para. 0093) that is configured to deform by movement of the movement device (para. 0006 “scaffold will deform”) without deformation of the walls, the elastic element configured to accommodate at least part of the culture medium (para. 0091 “load applicator 18 which can be operated to apply a cyclical compressive mechanical load to the tissue construct 12, to stimulate the deposition of tissue matrix in the construct, by the cells which have been seeded in the scaffold 13”) wherein the cells to be cultivated at least intermittently adhere to the elastic element (para. 0091 “cells which have been seeded in the scaffold 13”).
Finlay et al. does not teach at least one closable inlet and outlet, through which a flow channel for an air and/or gas flow between the vessel interior and a fluid supply or the environment can be established at least intermittently. However, Veraitch et al. teaches at least one closable inlet (p. 16, line 22 “ inlet in the top may be sealable”) and outlet (p. 16, line 17 “outlet may be sealable”) through which a flow channel for an air and/or gas flow (p. 5, lines 11-12) between the vessel interior and a fluid supply or the environment can be established at least intermittently (p. 2, lines 36-38 “filling of the one or more auxiliary containers with e.g. cell culture medium can then take place by introducing fluid via a separate port in each container”). Veraitch et al. teaches that sealable inlets and outlets allow containers to be detached and re-attached (p. 2, lines 31-32). It would have been obvious to a person of ordinary skill in the art to use the Veraitch et al. configuration of at least one closable inlet and outlet in Finlay et al.’s device with a reasonable expectation that they would allow for detachment and re-attachment. This method for improving Finlay et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Veraitch 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 Finlay et al. and Veraitch et al. to obtain the invention as specified in claim 1.
Finlay et al. does not teach an inlet valve arranged in the inlet and an outlet valve arranged in the outlet and are designed in such a manner that opening and closing the inlet valve and/or the outlet valve is affected by a pressure change in the vessel interior. However, Veraitch et al. teaches an inlet valve arranged in the inlet and an outlet valve is arranged in the outlet (p. 10, lines 28-29 “a container of the invention may have a means such as a valve in both its top section and its base section”) and are designed in such a manner that opening and closing the inlet valve and/or the outlet valve is affected by a pressure change in the vessel interior (claim 10 “valves in the two opposed sides of the container are configured to interact by forming a channel when the container is fully compressed”). Veraitch et al. teaches that valves allow fluid communication to be controlled (p. 10, lines 14-15). It would have been obvious to a person of ordinary skill in the art to use the Veraitch et al. configuration of inlet and outlet valves in Finlay et al.’s device with a reasonable expectation that they would allow fluid communication to be controlled. This method for improving Finlay et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Veraitch 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 Finlay et al. and Veraitch et al. to obtain the invention as specified in claim 1.
Regarding claim 2, Finlay et al. teaches a bioreactor characterized in that the elastic element comprises a sponge (para. 0093 “sponge”) configured to at least intermittently adhere to the cells (abstract “seeding a scaffold with cells”), absorb the culture medium (para. 0043 “promote the passage of materials (e.g. culture medium) into the construct comprising the scaffold”), and capable of being deformed by the movement device to release absorbed culture medium from the sponge.
Regarding the limitation “deform by the movement device which releases absorbed culture medium from the sponge”, 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 Finlay et al. would be fully capable of achieving every claimed intended use because the prior art apparatus is disclosed to be for applying a compressive mechanical load to the sponge with cells seeded on it (abstract) while in a well of culture medium (Fig. 1) and would be structurally capable of absorbing and releasing culture medium absent clear evidence otherwise.
Regarding claim 3, Finlay et al. teaches a bioreactor characterized in that the elastic element comprises a foam (para. 0093 “foams”) configured to at least intermittently adhere to the cells (abstract “seeding a scaffold with cells”), absorb the culture medium (promote the passage of materials (e.g. culture medium) into the construct comprising the scaffold), and is capable of being deformed by the movement device to release absorbed culture medium from the foam.
Regarding the limitation “deform by the movement device which releases absorbed culture medium from the foam”, 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 Finlay et al. would be fully capable of achieving every claimed intended use because the prior art apparatus is disclosed to be for applying a compressive mechanical load to the sponge with cells seeded on it (abstract) while in a well of culture medium (Fig. 1) and would be structurally capable of absorbing and releasing culture medium absent clear evidence otherwise.
Regarding claim 4, Finlay et al. teaches a bioreactor characterized in that the elastic element comprises in vitro meat, bacteria, at least one polymer (para. 0093 “polymers”), a protein structure, glucomannan, zein, collagen, alginate, chitosan and/or cellulose.
Regarding claim 8, Finlay et al. teaches a bioreactor, but does not teach at least one closable access via which a connection from outside the vessel to the vessel interior can be established at least intermittently. However, Veraitch et al. teaches at least one closable access (p. 16, line 22 “ inlet in the top may be sealable”) via which a connection from outside the vessel to the vessel interior can be established at least intermittently (p. 14, lines 32-33 “inlet may be adapted for connection to a connector, for connection to one or more further containers”). Veraitch et al. teaches that sealable inlets and outlets allow containers to be detached and re-attached (p. 2, lines 31-32). It would have been obvious to a person of ordinary skill in the art to use the Veraitch et al. configuration of at least one closable access in Finlay et al.’s device with a reasonable expectation that it would allow detachment and re-attachment. This method for improving Finlay et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Veraitch 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 Finlay et al. and Veraitch et al. to obtain the invention as specified in claim 8.
Regarding claim 12, Finlay et al. teaches a bioreactor characterized in that the movement device has at least one membrane (Fig. 1 64 sealing film) and/or screw which is movably mounted in or on the vessel and during the movement of the movement device the elastic element is compressed and relaxed at least in certain regions at successive time intervals (abstract “apply a cyclical compressive mechanical load to the tissue construct”).
Regarding claim 13, Finlay et al. teaches a bioreactor characterized in that the movement device has at least one membrane which at least partially closes off the vessel interior from the environment and which, during operation, is at least intermittently deformed by a piston element connected directly or indirectly to the drive unit (Fig. 1 48 plunger head).
Regarding claim 14, Finlay et al. teaches a bioreactor characterized in that during operation, the at least one membrane contacts the elastic element at least intermittently (Fig. 1 48 plunger head).
Regarding claim 17, Finlay et al. teaches a bioreactor characterized in that a sealing element is arranged at least in regions between the movement device and the vessel, which the sealing element seals the vessel interior in a liquid-tight and/or gas-tight manner against the environment (Fig. 1 64 sealing film).
Regarding claim 18, Finlay et al. teaches a bioreactor characterized in that the elastic element is at least partially surface-treated (para. 0093 “scaffold 13 takes the form of a pad comprising a plurality of filaments (typically monofilaments) which have been entangled by a suitable process, such as needle punching or hydro-entanglement”).
Regarding claim 20, Finlay et al. teaches a method of cultivating mammalian cells, comprising culturing mammalian cells in the bioreactor of claim 1 (para. 0122-0123 “employing the method and bioreactor of the present invention… synoviocytes (obtained from the synovia of 6-month-old bovine metatarsophalangeal joints)”).
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Finlay et al. (US 2015/0376560 A1) (already of record) in view of Veraitch et al. (WO 2018/087558 A1) (already of record) as applied to claim 1 above, and further in view of Shevitz (US 2013/0270165 A1) (already of record).
Regarding claim 10, Finlay et al. teaches a bioreactor comprising a movement device (Fig. 1 18 load applicator) and during movement of the movement device the elastic element is compressed and relaxed at least in certain regions at successive time intervals (abstract “apply a cyclical compressive mechanical load to the tissue construct”), but does not explicitly teach that the movement device has at least one piston. However, Shevitz teaches that a piston is known in the art (para. 0228; Fig. 3c-3d 636 piston). Shevitz teaches that the piston pumps contents from one chamber to another, and accurately controls fluid flow rate (para. 0228). Though modified Finlay et al. does not explicitly teach a piston, it would have been obvious to a person of ordinary skill in the art to use a piston because the substitution of one known element for another would have predictably resulted in a bioreactor that pumps the contents in a chamber and accurately controls flow rate, 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 Finlay et al. with the teachings of Shevitz to obtain the invention as specified in claim 10.
Regarding claim 11, Finlay et al. teaches a bioreactor characterized in that the drive unit comprises at least one rotatably mounted cam as a drive element which initiates the movement of the motor (para. 0106 “cam 60”).
Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Finlay et al. (US 2015/0376560 A1) (already of record) in view of Veraitch et al. (WO 2018/087558 A1) (already of record) as applied to claim 13 above, and further in view of Stobbe (US 2018/0155667 A1) (already of record).
Regarding claim 15, Finlay et al. teaches a bioreactor comprising a piston element (Fig. 1 18 load applicator), but does not teach that during operation, the load applicator is adapted to carry out a stroke of 90 to 110 mm. However, Stobbe teaches a piston pump with a stroke of 0.1 mm and a 150 mm max stroke (para. 0172). Stobbe teaches that the piston pump exchanges the exact broth volumes of the inside volume of the Cross-Flow-Filter (CFF) at each pulse (para. 0172). It would have been obvious to a person of ordinary skill in the art to use the Stobbe configuration of a stroke range of 0.1 mm to 150 mm in modified Finlay et al.’s device with a reasonable expectation that it would pump exact amounts at each pulse. This method for improving modified Finlay et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Stobbe. 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 Finlay et al. and Stobbe to obtain the invention as specified in claim 15.
Regarding claim 16, Finlay et al. teaches a bioreactor characterized in that during operation, the load applicator (18) at least intermittently performs a linear or circular movement (linear movement seen in Fig. 1 indicated by arrow 44).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Finlay et al. (US 2015/0376560 A1) (already of record) in view of Veraitch et al. (WO 2018/087558 A1) (already of record) as applied to claim 1 above, and further in view of De et al. (US 2019/0048305 A1) (already of record).
Regarding claim 19, Finlay et al. teaches a bioreactor comprising an elastic element inside a bioreactor (Fig. 1 13 scaffold), but does not teach at least one fixing element is provided for fixing the elastic element at least in certain regions to an inner side of at least one vessel wall facing the vessel interior and/or to the movement device. However, De et al. teaches a membrane fixed to the inner vessel with adhesives (para. 0032). De et al. teaches that adhering the membrane to the vessel helps avoid routine cell to membrane contact (para. 0032). It would have been obvious to a person of ordinary skill in the art to use the De et al. configuration of a membrane fixed to the inner vessel with adhesives in modified Finlay et al.’s device with a reasonable expectation that it would help avoid routine cell to membrane contact. This method for improving modified Finlay et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of De 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 Finlay et al. and De et al. to obtain the invention as specified in claim 19.
Conclusion
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/ASHLEY LOPEZLIRA/Examiner, Art Unit 1799
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799