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 .
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-50, in the reply filed on 12/12/2025 is acknowledged. The traversal is on the ground(s) that the Marino reference does not disclose the technical feature. This is not found persuasive because the Remarks dated 12/12/2025 do not point out any specific aspects of the technical feature that are lacking in the Marino reference. Therefore, the Examiner maintains that the technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Marino as discussed in the prior Restriction Requirement.
The requirement is still deemed proper and is therefore made FINAL.
Claims 51-54 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 08/14/2025.
Claim Objections
Claims 31, 35, and 49 are objected to because of the following informalities:
In claim 31, it is believed “said membrane” should read “said membrane wall” for consistency with claim 1.
In claim 35, the limitation “the inner portion of said bioreactor chamber” lacks explicit antecedent basis; however, the limitation is not indefinite as it is understood that a bioreactor chamber would necessarily have an inner portion. Nonetheless, it is recommended to amend the claim to recite “an inner portion” rather than “the inner portion” to remove any issues relating to antecedent basis.
In claim 49, it is believed “said chamber” should read “said bioreactor chamber” for consistency with claim 1.
In claim 49, it is believed “said membrane” should read “said membrane wall” for consistency with claim 1.
Appropriate correction is required.
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.
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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 22-25 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 22 recites the limitation "said at least one linear actuator magnet" in line 5. There is insufficient antecedent basis for this limitation in the claim. Line 2 of the claim provides antecedent basis for a single “a linear actuator magnet” rather than at least one linear actuator magnet.
Claim 22 recites the limitation “said at least one scaffold structure magnet” in lines 5-6. There is insufficient antecedent basis for this limitation in the claim. Lines 4-5 of the claim provides antecedent basis for a single “a scaffold structure magnet” rather than at least one scaffold structure magnet.
Claim 24 recites the limitation "said at least one linear actuator magnet" in lines 5-6. There is insufficient antecedent basis for this limitation in the claim. Line 2 of the claim provides antecedent basis for a single “a linear actuator magnet” rather than at least one linear actuator magnet.
Claim 24 recites the limitation “said at least one scaffold structure ferromagnetic material device” in line 6. There is insufficient antecedent basis for this limitation in the claim. Line 5 of the claim provides antecedent basis for a single “a scaffold structure ferromagnetic material device” rather than at least one scaffold structure ferromagnetic material device.
Claim 25 recites the limitation “said at least one scaffold structure magnet” in lines 5-6. There is insufficient antecedent basis for this limitation in the claim. Lines 4-5 of the claim provide antecedent basis for a single “a scaffold structure magnet” rather than at least one scaffold structure magnet.
Dependent claims are rejected for the same reason(s) as the base claim(s) upon which they depend.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-10, 18-22, 31-32, 35-48, and 50 are rejected under 35 U.S.C. 103 as being unpatentable over Marino et al. (US Patent Application Publication 2020/0270561) (already of record).
Regarding claim 1, Marino et al. discloses a device comprising a culture well (para. 27) wherein a biological sample such as a tissue culture sample is stimulated under controlled physiological conditions (para. 27, 44-47) (thus the device reads on a bioreactor and will hereinafter be referred to as such) comprising:
a bioreactor chamber (the biological sample is stimulated within the culture well, as discussed above; thus the culture well reads on a bioreactor chamber and will hereinafter be referred to as such);
a membrane wall (20) disposed on the bioreactor chamber (para. 36) (Fig. 7, sheet 4 of 12), wherein the bioreactor chamber and the membrane wall are configured to maintain sterility within the bioreactor chamber while the bioreactor chamber is closed (para. 36);
a biological sample such as a tissue culture sample disposed inside the bioreactor chamber (para. 27);
a linear actuator disposed outside the bioreactor chamber (para. 43); and
an inner piston (12) and outer piston support (22) coupled together for transferring linear motion between the linear actuator and the biological sample without breaching the membrane wall (para. 27, 36-37, 43) (thus the piston and piston support reads on the claimed linear transfer means, a term that invokes 112(f) and has been interpreted to cover an inner and outer coupling mechanism for transferring linear motion, and structural equivalents thereof for performing the claimed function, consistent with Applicant’s specification).
Marino et al. is silent as to the biological sample disposed inside the bioreactor chamber comprising a scaffold structure, and is silent as to a control system in communication with said linear actuator configured to control the movement of said linear actuator.
As to the claimed scaffold structure, Marino et al. discloses wherein their disclosed invention can be applied to or in combination with the tissue development systems described in WO 2017/062629 A1, which is incorporated by reference in its entirety (para. 2). WO 2017/062629 A1 discloses a system for the culture and stimulation of tissue and that it is desirable to formulate the tissue with the use of a cell seeding scaffold to optimize tissue growth and maintenance (p. 19 line 3-p. 20 line 14), and further discloses that using a scaffold improves biomimicry of tissue physiology (p. 47 lines 5-32).
Therefore, it would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to formulate the tissue sample disclosed by Marino et al. so as to comprise a scaffold structure comprising a cell seeding scaffold, in order to improve tissue growth and maintenance and provide a more accurate model of tissue physiology.
As to the claimed control system, Marino et al. discloses that examples of their linear actuator can be found in WO 2017/062629 A1 (para. 43), which is incorporated by reference in its entirety as discussed above. WO 2017/062629 A1 discloses using a control system in communication with a linear actuator configured to control the movement of the linear actuator to mechanically stimulate tissue in a controlled fashion (p. 18 lines 13-22).
Therefore, it would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the device disclosed by Marino et al. to comprise a control system in communication with the linear actuator configured to control the movement of the linear actuator in order to allow for control of mechanical stimulation applied to tissue samples.
Regarding claim 2, Marino et al. is silent as to wherein the bioreactor chamber and the membrane wall are configured to separate from the linear actuator, the linear transfer means, and the control system while maintaining the sterility or sanitation.
Nonetheless, it has been held that making elements separable is a prima facie obvious modification (MPEP 2144.04), and it would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to make the bioreactor chamber and membrane wall disclosed by Marino et al. configured to separate from the linear actuator, linear transfer means, and control system to allow the bioreactor chamber and membrane wall to be moved to another location after processing, e.g., for analysis of a tissue sample within the bioreactor chamber. As to the limitation of maintaining the sterility or sanitation, this is a recitation of intended use of the device and has therefore been given appropriate patentable weight. The device taught by Marino et al. is fully capable of achieving the claimed intended use, as a user could dissemble the device under clean room conditions to maintain sterility.
Regarding claim 3, Marino et al. discloses wherein the bioreactor chamber is a conventional 24-well plate (para. 27) and therefore the separated bioreactor chamber is fully capable of being for shipping, transporting, or transferring.
Regarding claim 4, Marino et al. discloses wherein the membrane wall (20) has one or more surfaces which form an outer boundary of the bioreactor chamber (para. 36) (Fig. 7, sheet 4 of 12).
Regarding claim 5, Marino et al. discloses wherein the membrane wall comprises a polymer (para. 40).
Regarding claim 6, Marino et al. discloses wherein the biological sample is configured to be able to move along a one directional axis (para. 27, 39), and modified Marino et al. teaches wherein the biological sample comprises a scaffold structure, as set forth above.
Regarding claim 7, modified Marino et al. teaches wherein the scaffold structure comprises one or more cell seeding scaffolds, as set forth above.
Regarding claim 8, modified Marino et al. teaches the scaffold structure, as set forth above, wherein the scaffold structure is a three-dimensional structure (see p. 19 line 3-p. 20 line 14 and p. 29 lines 1-10 of WO 2017/062629 A1) (thus it is understood that the three-dimensional scaffold structure has at least two sides, thereby arriving at the claimed subject matter of double sided).
Regarding claim 9, Marino et al. is silent as to wherein the scaffold structure is configured to be removable from the bioreactor chamber when the bioreactor chamber is in an open position.
Nonetheless, it has been held that making elements separable is a prima facie obvious modification (MPEP 2144.04), and it would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to make the scaffold structure taught by Marino et al. removable to allow for removal and additional analysis of biological samples supported by the scaffold structure.
Regarding claim 10, Marino et al. is silent as to wherein the bioreactor chamber is configured to allow repeated insertion and removal of said scaffold structure when the bioreactor chamber is in an open position.
Nonetheless, it has been held that making elements separable is a prima facie obvious modification (MPEP 2144.04), and it would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to make the scaffold structure and bioreactor chamber taught by Marino et al. configured such that the scaffold structure can be repeatedly inserted and removed into the bioreactor chamber, in order to allow for insertion and removal of one or more biological samples for repeated stimulation and/or analysis.
Regarding claim 18, Marino et al. discloses wherein the linear actuator is configured to be activated cyclically (para. 43).
Regarding claim 19, Marino et al. is silent as to wherein the linear actuator is configured to be detachable from the bioreactor chamber while maintaining the sterility or sanitation.
Nonetheless, it has been held that making elements separable is a prima facie obvious modification (MPEP 2144.04), and it would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to make the linear actuator disclosed by Marino et al. configured to be detachable from the bioreactor for the purpose of inspecting and/or repairing the linear actuator. As to the limitation of maintaining the sterility or sanitation, this is a recitation of intended use of the device and has therefore been given appropriate patentable weight. The device taught by Marino et al. is fully capable of achieving the claimed intended use, as a user could dissemble the device under clean room conditions to maintain sterility.
Regarding claim 20, Marino et al. discloses wherein the linear transfer means is comprised of a coupling mechanism, comprising an inner piston (12) and outer piston support (22) coupled together (para. 37), wherein the coupling mechanism is configured to couple the linear actuator to the biological sample in response to linear motion on opposing sides of the membrane wall (20) without breaching the membrane wall (para. 27, 36-37, 43) (Fig. 7, sheet 4 of 12) (wherein modified Marino et al. teaches wherein the biological sample is a scaffold structure as discussed above);
wherein the coupling mechanism comprises a linear actuator coupling that is disposed on the linear actuator (piston support 22 is coupled to and disposed on the linear actuator, see para. 43); and
wherein the coupling mechanism comprises a scaffold structure coupling that is disposed on the scaffold structure (piston 12 couples to and is disposed on the biological sample, see para. 27).
Marino et al. is silent as to wherein either said linear actuator coupling or scaffold structure coupling is an adhesive material; or both said linear actuator coupling or scaffold structure coupling is an adhesive material.
However, Marino et al. discloses wherein the linear actuator coupling and the scaffold structure coupling may be coupled together using a screw (para. 37).
Furthermore, WO 2017/062629 A1, which is incorporated by reference in its entirety by Marino et al. as discussed above, discloses a tissue development system wherein a component thereof comprises an adhesive material for secure coupling to another component (p. 6 line 20-p. 7 line 8).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify either or both of the linear actuator coupling or scaffold structure coupling disclosed by Marino et al. to be an adhesive material, as such a modification represents simple substitution of one known element for another to obtain predictable results (MPEP § 2143), in this case, substitution adhesive materials for a screw connection in order to obtain the predictable result of coupling separate components together.
Regarding claim 21, Marino et al. discloses wherein the linear transfer means is comprised of a coupling mechanism, comprising an inner piston (12) and outer piston support (22) coupled together (para. 37), wherein the coupling mechanism is configured to couple the linear actuator to the biological sample in response to linear motion on opposing sides of the membrane wall (20) without breaching the membrane wall (para. 27, 36-37, 43) (Fig. 7, sheet 4 of 12) (wherein modified Marino et al. teaches wherein the biological sample is a scaffold structure as discussed above).
Regarding claim 22, Marino et al. teaches the coupling mechanism, as set forth above.
Marino et al. is silent as to the coupling mechanism comprising at least one magnet disposed on the linear actuator to define a linear actuator magnet; and at least one magnet disposed on the scaffold structure to define a scaffold structure magnet, wherein the at least one linear actuator magnet and the at least one scaffold structure magnet are configured to join with one another, in response to the linear motion, so as to accomplish the coupling on opposing sides of said membrane wall without breaching the membrane wall.
However, Marino et al. discloses wherein the linear actuator coupling and the scaffold structure coupling may be coupled together using a screw so as to accomplish coupling on opposing sides of the membrane wall without breaching the membrane wall (para. 37) (Fig. 7, sheet 4 of 12).
Furthermore, WO 2017/062629 A1, which is incorporated by reference in its entirety by Marino et al. as discussed above, discloses a tissue development system wherein a component thereof can be coupled to another component using magnetic attraction (p. 34 line 24-p. 35 line 9).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the coupling mechanism disclosed by Marino et al. to comprise at least one magnet disposed on the linear actuator to define a linear actuator magnet; and at least one magnet disposed on the scaffold structure to define a scaffold structure magnet, wherein the at least one linear actuator magnet and the at least one scaffold structure magnet are configured to join with one another, in response to the linear motion, so as to accomplish the coupling on opposing sides of said membrane wall without breaching the membrane wall, as such a modification represents simple substitution of one known element for another to obtain predictable results (MPEP § 2143), in this case, substitution of a magnetic connection for a screw connection in order to obtain the predictable result of coupling separate components together.
Regarding claim 31, Marino et al. discloses wherein the coupling mechanism is attached to the membrane wall via screw connection (para. 37) (reads on a permanent or temporary attachment).
Regarding claim 32, Marino et al. discloses wherein the coupling mechanism is permanently or temporarily coupling the linear actuator to the biological sample (para. 43) (wherein modified Marino et al. teaches the biological sample comprising a scaffold structure as discussed above).
Regarding claim 35, Marino et al. discloses wherein the bioreactor chamber has an inner portion (para. 27) (Fig. 5, sheet 3 of 12), and the reference is devoid of mention of the inner portion containing any exposed metal surfaces (see entire reference), thereby fulfilling the claimed subject matter.
Regarding claim 36, Marino et al. teaches wherein the control system and linear actuator are disposed outside the bioreactor chamber and do not permeate the bioreactor chamber (para. 36, 43 and Fig. 7; see also p. 18 lines 13-22 and Fig. 9 of WO 2017062629 A1, which is incorporated by reference by Marino et al. as discussed above).
Regarding claim 37, Marino et al. discloses the bioreactor chamber for stimulating a tissue sample, as set forth above.
Marino et al. is silent as to one or more ports disposed on the bioreactor chamber.
However, WO 2017062629 A1, which is incorporated by reference in its entirety as set forth above, discloses disposing one or more ports on a bioreactor chamber to allow one or more nutrients to be delivered for stimulation of tissue (Abstract, p. 3 lines 13-29).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the bioreactor chamber disclosed by Marino et al. to comprise one or more ports disposed thereon for the delivery of one or more nutrients for further stimulation of tissue, thereby enhancing the experimental utility of the device.
Regarding claim 38, Marino et al. discloses wherein the bioreactor chamber is configured to permit gas exchange (para. 44-46).
Regarding claim 39, Marino et al. discloses a removable lid assembly (para. 38).
Regarding claim 40, Marino et al. discloses wherein the removable lid assembly has one or more holes (reads on one or more ports for the flow of gases and/or nutrients) (para. 38).
Regarding claim 41, Marino et al. discloses wherein the removable lid assembly has one or more holes (reads on configured to permit gas and/or nutrient exchange) (para. 38).
Regarding claim 42, Marino et al. discloses wherein the membrane wall has sufficient flexibility whereby the membrane wall can be displaced resultant to the linear motion in a linear direction for a distance (para. 36-38, 40).
Although Marino et al. does not expressly teach the distance within the ranges recited in claim 42, Marino et al. does disclose general conditions for the distance (see piston travel distances disclosed para. 49). Furthermore the skilled artisan would recognize that the particular parameter achieves a recognized result (i.e., a distance pistons are permitted to travel to apply force to biological samples).
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, when the particular parameter is recognized as a result-effective variable (MPEP §2144.05). Therefore, it would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to arrive at an optimum or workable distance by routine experimentation.
Regarding claim 43, Marino et al. discloses wherein the membrane wall has sufficient flexibility whereby the membrane wall can be displaced resultant to the linear motion in a linear direction for a distance (para. 36-38, 40).
Although Marino et al. does not expressly teach the distance within the ranges recited in claim 43, Marino et al. does disclose general conditions for the distance (see piston travel distances disclosed para. 49). Furthermore the skilled artisan would recognize that the particular parameter achieves a recognized result (i.e., a distance pistons are permitted to travel to apply force to biological samples).
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, when the particular parameter is recognized as a result-effective variable (MPEP §2144.05). Therefore, it would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to arrive at an optimum or workable distance by routine experimentation.
Regarding claim 44, Marino et al. discloses wherein the membrane wall has sufficient flexibility in the linear direction so as to permit the linear actuator and scaffold structure to travel with respect to one another in response to the linear motion, causing the membrane wall to flex in an ample manner so as to allow the linear actuator and scaffold structure to couple with one another (para. 36-38, 40).
Regarding claim 45, Marino et al. discloses wherein the membrane wall has sufficient elasticity in the linear direction so as to permit the linear actuator and the scaffold structure to travel with respect to one another in response to the linear motion, causing the membrane wall to stretch in an ample manner so as to allow the linear actuator and the scaffold structure to couple with one another (para. 36-38, 40).
Regarding claim 46, Marino et al. discloses wherein the membrane wall has sufficient deformability in the linear direction so as to permit the linear actuator and the scaffold structure to travel with respect to one another in response to the linear motion, causing the membrane wall to deform in an ample manner so as to allow the linear actuator and the scaffold structure to couple with one another (para. 36-38, 40).
Regarding claim 47, Marino et al. discloses wherein the membrane wall is configured to allow movement in the linear direction so as to permit the linear actuator and the scaffold structure to travel with respect to one another in response to the linear motion, causing the membrane wall to move in an ample manner so as to allow the linear actuator and the scaffold structure to couple with one another (para. 36-38, 40).
Regarding claim 48, Marino et al. teaches providing the scaffold structure, as set forth above.
Marino et al. is silent as to a securement means for securing the scaffold structure in place (this limitation invokes 112(f) and has been interpreted to cover a clamp, screw, or other fastening system, or structural equivalents thereof for performing the claimed function of securing a scaffold structure in place, consistent with Applicant’s specification).
However, WO 2017062629 A1, which is incorporated by reference in its entirety as set forth above, discloses using a perforated insert to hold the scaffold in place (p. 49 lines 25-32).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the device disclosed by Marino et al. to comprise an insert for holding the scaffold in place (reads on the claimed securement means) to ensure that the scaffold is correctly positioned during processing.
Regarding claim 50, Marino et al. discloses wherein the bioreactor chamber includes a container (para. 27, claim 1).
Claims 11 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Marino et al. (US Patent Application Publication 2020/0270561) (already of record) in view of Vilendrer (US Patent Application Publication 2005/0153436).
Regarding claim 11, Marino et al. discloses the linear actuator, as set forth above, wherein the linear actuator transfers linear motion for the stimulation of the tissue sample (para. 27, 43).
Marino et al. is silent as to any particular mechanism for the linear actuator.
Vilendrer discloses a bioreactor comprising a linear actuator configured to transfer linear motion to a tissue within the bioreactor for mechanical conditioning thereof (claim 1) (Fig. 1, sheet 1 of 9), wherein the linear actuator comprises a stepper motor or servomotor (claims 17 and 23).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the linear actuator disclosed by Marino et al. to comprise a stepper motor or servomotor, based on the teachings of Vilendrer, in order to use a mechanism recognized in the art to be effective for transferring linear motion for the mechanical stimulation of tissue.
Regarding claim 16, Marino et al. discloses the linear actuator, as set forth above, wherein the linear actuator transfers linear motion for the stimulation of the tissue sample (para. 27, 43).
Marino et al. is silent as to any particular mechanism for the linear actuator.
Vilendrer discloses a bioreactor comprising a linear actuator configured to transfer linear motion to a tissue within the bioreactor for mechanical conditioning thereof (claim 1) (Fig. 1, sheet 1 of 9), wherein the linear actuator comprises a solenoid (claim 19).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the linear actuator disclosed by Marino et al. to comprise a solenoid, based on the teachings of Vilendrer, in order to use a mechanism recognized in the art to be effective for transferring linear motion for the mechanical stimulation of tissue.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Marino et al. (US Patent Application Publication 2020/0270561) (already of record) in view of Dennis et al. (US Patent 6,114,164).
Regarding claim 12, Marino et al. discloses the linear actuator, as set forth above, wherein the linear actuator transfers linear motion for the stimulation of the tissue sample (para. 27, 43).
Marino et al. is silent as to any particular mechanism for the linear actuator.
Dennis et al. discloses a system for applying a mechanical stimulation to a tissue sample in a culture environment (Abstract) comprising a rack and pinion actuator for transferring linear motion for the mechanical stimulation (col. 4 lines 29-49)
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the linear actuator disclosed by Marino et al. to comprise a rack and pinion, based on the teachings of Dennis et al., in order to use a mechanism recognized in the art to be effective for transferring linear motion for the mechanical stimulation of tissue.
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Marino et al. (US Patent Application Publication 2020/0270561) (already of record) in view of Vogel et al. (US Patent Application Publication 2023/0050194).
Regarding claim 13, Marino et al. discloses the linear actuator, as set forth above, wherein the linear actuator transfers linear motion for the stimulation of the tissue sample (para. 27, 43).
Marino et al. is silent as to any particular mechanism for the linear actuator.
Vogel et al. discloses a bioreactor (Abstract) configured to apply mechanical stimulation to a biological sample via linear motion transferred between a pneumatic piston actuator and a piston element (para. 24, 55).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the linear actuator disclosed by Marino et al. to comprise a pneumatic piston, based on the teachings of Vogel et al., in order to use a mechanism recognized in the art to be effective for transferring linear motion for the mechanical stimulation of tissue.
Regarding claim 14, Marino et al. in view of Vogel et al. teaches a pneumatic piston, as set forth above.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Marino et al. (US Patent Application Publication 2020/0270561) (already of record) in view of Li et al. (CN 110577895 A) (machine translation).
Regarding claim 15, Marino et al. discloses the linear actuator, as set forth above, wherein the linear actuator transfers linear motion for the stimulation of the tissue sample (para. 27, 43).
Marino et al. is silent as to any particular mechanism for the linear actuator.
Li et al. discloses a cell culture device comprising a crank and slider mechanism actuator for transferring linear motion for the mechanical stimulation of a biological sample (p. 8 para. 2-3).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the linear actuator disclosed by Marino et al. to comprise a crank and slider mechanism, based on the teachings of Li et al., in order to use a mechanism recognized in the art to be effective for transferring linear motion for the mechanical stimulation of tissue.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Marino et al. (US Patent Application Publication 2020/0270561) (already of record) in view of Botvinick et al. (US Patent Application Publication 2012/0272745).
Regarding claim 17, Marino et al. discloses the linear actuator, as set forth above, wherein the linear actuator transfers linear motion for the stimulation of the tissue sample (para. 27, 43).
Marino et al. is silent as to any particular mechanism for the linear actuator.
Botvinick et al. discloses an apparatus for applying a mechanical stimulation to a biological sample (Abstract, para. 40) comprising leadscrew actuator mechanism configured to impart mechanical stimulation to the sample (para. 41).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the linear actuator disclosed by Marino et al. to comprise a leadscrew mechanism, based on the teachings of Botvinick et al., in order to use a mechanism recognized in the art to be effective for transferring motion for the mechanical stimulation of tissue.
Claims 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Marino et al. (US Patent Application Publication 2020/0270561) (already of record) in view of Berger (US Patent 4,045,291).
Regarding claim 23, Marino et al. teaches the at least one linear actuator magnet and the at least one scaffold structure magnet, as set forth above.
Marino et al. does not expressly teach wherein the aforementioned magnets are permanent type magnets, electromagnet type magnets, or a combination of both permanent magnet and electromagnet type magnets.
Berger discloses a tissue sample container (Abstract) comprising two members coupled together such that a screen member is sandwiched between the two members to form a closed container (col. 1 line 65-col. 2 line 20) (Fig. 1, sheet 1 of 1). Berger discloses wherein the two members each comprise a permanent magnet to facilitate a magnetic coupling between the members (col. 1 lines 46-48).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the at least one linear actuator magnet and the at least one scaffold structure magnet taught by Marino et al. to comprise permanent type magnets, based on the teachings of Berger, as the skilled artisan would have been motivated to select a configuration recognized in the art to be suitable for providing magnetic coupling between two components.
Regarding claim 24, Marino et al. discloses the coupling mechanism, as set forth above, wherein the coupling mechanism comprises an inner piston (12) disposed on the biological sample and an outer piston support (22) disposed on the linear actuator (para. 27, 36-37, 43) (Fig. 7, sheet 4 of 12).
Marino et al. is silent as to the coupling mechanism comprising at least one magnet disposed on the linear actuator to define a linear actuator magnet; and at least one ferromagnetic material device disposed on the scaffold structure to define a scaffold structure ferromagnetic material device, wherein said at least one linear actuator magnet and said at least one scaffold structure ferromagnetic material device are configured to join with one another, in response to said linear motion, so as to accomplish said coupling on opposing sides of said membrane wall without breaching said membrane wall.
However, Marino et al. discloses wherein the elements of the coupling mechanism are coupled together using a screw so as to accomplish coupling on opposing sides of the membrane wall without breaching the membrane wall (para. 37) (Fig. 7, sheet 4 of 12).
Berger discloses a tissue sample container (Abstract) comprising two members coupled together such that a screen member is sandwiched between the two members to form a closed container (col. 1 line 65-col. 2 line 20) (Fig. 1, sheet 1 of 1), wherein one of the two members comprises a magnet and the other of the two members comprises a ferromagnetic material to facilitate a magnetic coupling between the members (Abstract, col. 1 lines 34-46).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the coupling mechanism disclosed by Marino et al. to comprise at least one magnet disposed on the linear actuator to define a linear actuator magnet (e.g., by providing at least one magnet on the piston support); and at least one ferromagnetic material device disposed on the scaffold structure to define a scaffold structure ferromagnetic material device (e.g., by providing at least one ferromagnetic material device on the piston), wherein said at least one linear actuator magnet and said at least one scaffold structure ferromagnetic material device are configured to join with one another, in response to said linear motion, so as to accomplish said coupling on opposing sides of said membrane wall without breaching said membrane wall, as such a modification represents simple substitution of one known element for another to obtain predictable results (MPEP § 2143), in this case, substitution of a magnetic connection for a screw connection in order to obtain the predictable result of coupling separate components together.
Regarding claim 25, Marino et al. discloses the coupling mechanism, as set forth above, wherein the coupling mechanism comprises an inner piston (12) disposed on the biological sample and an outer piston support (22) disposed on the linear actuator (para. 27, 36-37, 43) (Fig. 7, sheet 4 of 12).
Marino et al. is silent as to wherein the coupling mechanism comprises at least one ferromagnetic material device disposed on the linear actuator to define a linear actuator magnet; and at least one magnet disposed on the scaffold structure to define a scaffold structure magnet, wherein the at least one linear actuator ferromagnetic material device and the at least one scaffold structure magnet are configured to join with one another, in response to said linear motion, so as to accomplish the coupling on opposing sides of the membrane wall without breaching the membrane wall.
However, Marino et al. discloses wherein the elements of the coupling mechanism are coupled together using a screw so as to accomplish coupling on opposing sides of the membrane wall without breaching the membrane wall (para. 37) (Fig. 7, sheet 4 of 12).
Berger discloses a tissue sample container (Abstract) comprising two members coupled together such that a screen member is sandwiched between the two members to form a closed container (col. 1 line 65-col. 2 line 20) (Fig. 1, sheet 1 of 1), wherein one of the two members comprises a magnet and the other of the two members comprises a ferromagnetic material to facilitate a magnetic coupling between the members (Abstract, col. 1 lines 34-46).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the coupling mechanism disclosed by Marino et al. to comprise at least one ferromagnetic material device disposed on the linear actuator to define a linear actuator magnet (e.g., by providing at least one ferromagnetic material device on the piston support); and at least one magnet disposed on the scaffold structure to define a scaffold structure magnet (e.g., by providing at least one magnet disposed on the piston), wherein the at least one linear actuator ferromagnetic material device and the at least one scaffold structure magnet are configured to join with one another, in response to said linear motion, so as to accomplish the coupling on opposing sides of the membrane wall without breaching the membrane wall, as such a modification represents simple substitution of one known element for another to obtain predictable results (MPEP § 2143), in this case, substitution of a magnetic connection for a screw connection in order to obtain the predictable result of coupling separate components together.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Marino et al. (US Patent Application Publication 2020/0270561) (already of record) in view of Saxholm (US Patent 4,591,556).
Regarding claim 26, Marino et al. discloses wherein the linear transfer means is comprised of a coupling mechanism, comprising an inner piston (12) and outer piston support (22) coupled together (para. 37), wherein the coupling mechanism is configured to couple the linear actuator to the biological sample in response to linear motion on opposing sides of the membrane wall (20) without breaching the membrane wall (para. 27, 36-37, 43) (Fig. 7, sheet 4 of 12) (wherein modified Marino et al. teaches wherein the biological sample is a scaffold structure as discussed above);
wherein the coupling mechanism comprises a linear actuator coupling that is disposed on the linear actuator (piston support 22 is coupled to and disposed on the linear actuator, see para. 43); and
wherein the coupling mechanism comprises a scaffold structure coupling that is disposed on the scaffold structure (piston 12 couples to and is disposed on the biological sample, see para. 27).
Marino et al. is silent as to wherein either the linear actuator coupling or scaffold structure coupling is a suction cup; or both the linear actuator coupling or scaffold structure coupling is a suction cup.
However, Marino et al. discloses wherein the linear actuator coupling and the scaffold structure coupling may be coupled together using a screw (para. 37).
Saxholm discloses a biological container (col. 14 line 48-62) wherein a component of the container can be coupled with another surface thereof using a suction cup connection (col. 21 lines 3-36).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify either or both of the linear actuator coupling or scaffold structure coupling disclosed by Marino et al. to be a suction cup, as such a modification represents simple substitution of one known element for another to obtain predictable results (MPEP § 2143), in this case, substitution of a suction cup connection for a screw connection in order to obtain the predictable result of coupling separate components together.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Marino et al. (US Patent Application Publication 2020/0270561) (already of record) in view of Barrett et al. (US Patent Application Publication 2019/0345431).
Regarding claim 27, Marino et al. discloses the coupling mechanism, as set forth above, wherein the coupling mechanism comprises a linear actuator coupling that is disposed on the linear actuator (piston support 22 is coupled to and disposed on the linear actuator, see para. 43) and a scaffold structure coupling that is disposed on the scaffold structure (piston 12 couples to and is disposed on the biological sample, see para. 27).
Marino et al. is silent as to the coupling mechanism comprising a buckle device, wherein the buckle device includes a first buckle and a second buckle, wherein said first buckle is disposed on the linear actuator and said second buckle is disposed on the scaffold structure, wherein said first buckle and said second buckle are configured to join with one another, in response to said linear motion, so as to accomplish the coupling on opposing sides of said membrane wall without breaching said membrane wall.
However, Marino et al. discloses wherein the elements of the coupling mechanism are coupled together using a screw so as to accomplish coupling on opposing sides of the membrane wall without breaching the membrane wall (para. 37) (Fig. 7, sheet 4 of 12).
Barrett et al. discloses a cell culture device (Abstract) wherein two elements of the device are secured to one another using buckles (para. 31).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the coupling device disclosed by Marino et al. to comprise a buckle device, wherein the buckle device includes a first buckle and a second buckle, wherein said first buckle is disposed on the linear actuator and said second buckle is disposed on the scaffold structure (e.g., by providing respective buckles on the piston and piston support), wherein said first buckle and said second buckle are configured to join with one another, in response to said linear motion, so as to accomplish the coupling on opposing sides of said membrane wall without breaching said membrane wall, as such a modification represents simple substitution of one known element for another to obtain predictable results (MPEP § 2143), in this case, substitution of a buckle connection for a screw connection in order to obtain the predictable result of coupling separate components together.
Claims 33-34 are rejected under 35 U.S.C. 103 as being unpatentable over Marino et al. (US Patent Application Publication 2020/0270561) (already of record) in view of Applegate et al. (US Patent 5,843,766).
Regarding claim 33, Marino et al. discloses wherein the bioreactor chamber is configured to maintain sterility (Abstract).
Marino et al. does not expressly teach wherein the bioreactor chamber is configured to be hermetically sealed.
Applegate et al. discloses that it was known in the art to form a tissue culture chamber to be hermetically sealed to protect an internal environment thereof from contamination (Abstract, col. 7 lines 64-66).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the bioreactor chamber disclosed by Marino et al. to be configured to be hermetically sealed, based on the teachings of Applegate et al., to improve maintenance of sterile conditions within the chamber.
Regarding claim 34, Marino et al. discloses wherein the bioreactor chamber is configured to maintain sterility (Abstract).
Marino et al. does not expressly teach wherein the bioreactor chamber is configured to be aseptically sealed.
Applegate et al. discloses that it was known in the art to form a tissue culture chamber to be aseptically sealed to protect an internal environment thereof from contamination (Abstract).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the bioreactor chamber disclosed by Marino et al. to be configured to be aseptically sealed, based on the teachings of Applegate et al., to improve maintenance of sterile conditions within the chamber.
Allowable Subject Matter
Claims 28-30 and 49 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Akra et al. (US Patent Application Publication 2014/0038258) is directed to a bioreactor configured to impart a force to a scaffold via a linear actuator and a membrane.
Conclusion
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/HOLLY KIPOUROS/Primary Examiner, Art Unit 1799