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 1-14) in the reply filed on 06/05/2026 is acknowledged. The traversal is on the grounds that Group II method has a technical feature in common with Group I, and Group II is commensurate in scope with Group I. This is not found persuasive because the shared technical feature applicant argues is acknowledged but it does not make a contribution over the prior art (See 35 USC § 103 Rejection).
The requirement is still deemed proper and is therefore made FINAL.
Priority
Receipt is acknowledged of certified copies (PRO 63/228,436 – filed 08/02/2021) required by 37 CFR 1.78.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 01/17/2025 has been certified and made of record.
Claim Objections
Claim 12 is objected to because of the following informalities:
The term “device geometric parameter” should read “geometric parameter device”. Appropriate correction is required.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 2, 7, 8, 12, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Mayer et al. (WO 2010129422 A1) (referenced in 892) in view of Galiano et al. (US 20140024112 A1) (referenced in 892).
Regarding claim 1, Mayer et al. teaches a device for stretching a cell-seeded scaffold material (See annotated FIG. 4 - scaffold material – element 60) under cell culture conditions (p. 22 – Lines 23-33) comprising:
a stretchable substrate (cell tissue is formed on the scaffold material and structurally acts as a stretchable substrate following cell culturing and seeding (p. 22 – Lines 4-11);
a stretchable substrate holder configured to connect to the stretchable substrate (element 62 and 64 - ends);
an actuator (mounting portions (element 50a and 50b) operable connected to the stretchable substrate holder to exert a multi-axial cyclic stretch on the stretchable substrate (p. 4 – Lines 4- 19). Regarding the limitation “the multi-axial tension device can perform cyclic stretching and periodically stretch the three-dimensional scaffold connected to the stretchable substrate”, it has been held that a claim containing a recitation with respect to the manner in which a claimed containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate from the claimed apparatus from a prior apparatus if the prior art apparatus teaches all the structural limitations of the claim (MPEP § 2114 II).
Therefore, the multi-axial tension device (longitudinal rods, hoops, and mounting portions) employed by Mayer et al. would be fully capable of achieving every intended use because Mayer et al. teaches an using mounting portions and a scaffold attached to said mounting portions to provide multi-axial tension (FIG. 4), and the mounting portions would be structurally capable of perform cyclic stretching and periodically stretch a three-dimensional scaffold connected to the stretchable substrate.
Mayer et al. teaches a sample holder through placement of the tension device/scaffold material assembly (70) into a container (p. 19, Lines 3-10). Regarding the limitation “configured to immerse the three-dimensional scaffold in a tissue culture media and expose the three-dimensional scaffold to cell culture parameter for ongoing viability of living cells supported by the three-dimensional scaffold”, it has been held that a claim containing a recitation with respect to the manner in which a claimed containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate from the claimed apparatus from a prior apparatus if the prior art apparatus teaches all the structural limitations of the claim (MPEP § 2114 II).
Therefore, the container employed by Mayer et al. would be fully capable of achieving every intended use because Mayer et al. teaches that tension device/scaffold material assembly is placed into the container or cell seeding, and allows media to be added into the container for attachment of cells (p. 22 – Lines 23-33), and the container would be structurally capable of immersing a three-dimensional scaffold in a tissue culture media and expose the three-dimensional scaffold to cell culture parameter for ongoing viability of living cells supported by the three-dimensional scaffold.
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Mayer et al. fails to teach:
The stretchable substrate comprises a decellularized tissue
Regarding limitation I, Galiano et al. teaches an in-vivo bioreactor system which includes a chamber (element 14) designed to contain matrices including decellularized tissues (para. [0024]), specifically to grow into a tissue or an organ (para. [0034]). The decellularized matrix can then have stimulation through tension or compression stress or strain be applied to the tissue (para. [0034]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to use Galiano et al.’s teaching of using decellularized matrices in Mayer et al.’s cell culture device as using decellularized matrices enable decellularized tissues or an organ to be grown for further stimulation through tension or compress stress or strain in a bioreactor system. This method of improving Mayer et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Galiano et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Mayer et al. and Galiano et al. to obtain the invention specified in claim 1.
Regarding claim 2, modified Mayer et al. teaches the device according to claim 1. Furthermore, Mayer et al. teaches that the scaffold material is a 50:50 blend of poly(lactic acid) fibers and poly(glycolic acid) fibers (p. 18, Lines 24-30). This material comprises an artificial scaffold. Thus, the claim is prima facie obvious.
Regarding claim 7, modified Mayer et al. teaches the device according to claim 1. Mayer et al. teaches that scaffold material is attached to one or more hoops, as hoops apply radial tension to the material (p. 16 – 2nd paragraph). Thus, the claim is prima facie obvious.
Regarding claim 8, modified Mayer et al. teaches the device according to claim 1. Furthermore, the combination of references of claim 1 would encompass a device structurally capable of providing a stretch up to 100%, including up to 20% stretch, for a time period up to 2 months under the cell culture parameters. Therefore, the claim is prima facie obvious.
Regarding claim 12, modified Mayer et al. teaches the device according to claim 1. Furthermore, Mayer et al. teaching of placing of the tension device/scaffold material assembly (70) into a container (p. 19, Lines 3-10) is structurally a geometric parameter device, as container acts as a cell culture incubator. Regarding the limitation “configured to position at least the stretchable substrate and three-dimensional scaffold into a cell culture incubator that provides the cell culture parameters”, it has been held that a claim containing a recitation with respect to the manner in which a claimed containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate from the claimed apparatus from a prior apparatus if the prior art apparatus teaches all the structural limitations of the claim (MPEP § 2114 II).
Therefore, the container employed by Mayer et al. would be fully capable of achieving every intended use because Mayer et al. teaches that tension device/scaffold material assembly is placed into the container or cell seeding, and allows media to be added into the container for attachment of cells (p. 22 – Lines 23-33), and the container would be structurally capable being configured to position at least the stretchable substrate and three-dimensional scaffold into a cell culture incubator that provides the cell culture parameters.
Regarding claim 13, modified Mayer et al. teaches the device according to claim 1. Mayer et al. fails to teach a sensor for monitoring cell culture parameters. Galiano et al. teaches an in vivo bioreactor system that uses sensor (element – 70). Galiano et al. specifically teaches that sensor (element 70) may be a temperature sensor, pH sensor, oxygen sensor (para. [0025]), as sensor (70) can be used to take various sensor measurements to determine the conditions in which the substance 78 (matrix an scaffold) is growing, to determine how well the substance 78 is growing, or to take other sensor measurements to make other determinations (para. [0030]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to use Galiano et al.’s teaching of sensors in Mayer et al.’s cell culture device because sensors enable measurements to be taken for determination of how well the matrix and scaffold are growing. This method of improving Mayer et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Galiano et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Mayer et al. and Galiano et al. to obtain the invention specified in claim 13.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Mayer et al. (already referenced), Galiano et al. (already referenced), and further in view of Wikswo et al. (US 7790443 B2) (already referenced in IDS).
Regarding claim 4, modified Mayer et al. teaches the device of claim 1, but fails to teach a biocompatible layer positioned between the stretchable substrate and scaffold. Wikswo et al. teaches a bioreactor device (abstract) comprising a biocompatible layer positioned between the substrate and three-dimensional scaffold (biocompatible coating layer – elements 1205a and 1205b) between porous material (element 1220 – structurally cable of being a cell culture scaffold (Co. 34, Lines 39-42)) and outer wall of bioreactor (element 1200). Wikswo et al. further teaches that adding the biocompatible layer can enhance cell adhesion for the cells in the system (Col. 34, 6th paragraph).
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to use Wikswo et al. teaching of a biocompatible layer in modified Mayer et al.’s cell culture device because adding the layers can enhance cell adhesion of cells in the system. This method of improving modified Mayer et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Wikswo et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of modified Mayer et al. and Wikswo et al. to obtain the invention specified in claim 4.
Claims 5, 6, 9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Mayer et al. (already referenced), Galiano et al. (already referenced), and further in view of Altman et al. (US 20040219659 A1) (referenced in 892).
Regarding claim 5, modified Mayer et al. teaches the device of claim 1, but fails to teach a power supply, a cam, and a gearbox that generate the translational motion. Altman et al. teaches a power supply (para. [0065]) and translational gear train (para. [0058] – structurally the gearbox and cam), which provide the translation deformation through a motion control software system (para. [0058-0065]
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to use Altman et al. teaching of a power supply and gear train in modified Mayer et al.’s cell culture device because the power supply and gear train provide translational deformation through a motion control software system. This method of improving Mayer et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Altman et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of modified Mayer et al. and Altman et al. to obtain the invention specified in claim 5.
Regarding claim 6, modified Mayer et al. fails to teach that the actuator comprises of motors, Altman et al. teaches a bioreactor system that uses high torque stepper motors (incorporating both linear and thrust bearing designs) to perform accurate and precise control for both translational and rotational strains, either independently or in combination on the tissue [para. 0103].
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to use Altman et al. teaching of motors in modified Mayer et al.’s cell culture device because motors enable translational and rotational trains be performed and controlled on the tissue. This method of improving Mayer et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Altman et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of modified Mayer et al. and Altman et al. to obtain the invention specified in claim 6.
Regarding claim 9, modified Mayer et al. fails to teach that the device further comprises an electronic controller connected to actuator to provide a user specified stretch protocol (strain rate). Altman et al. teaches a bioreactor system that includes components which exert translation and rotational strain on growing bioengineered tissue (abstract). Specifically, Altman et al. describes the usage of computer-controlled bench-top bioreactor to apply mechanical strains (para. [0043]) through a motion control software (para. [0065]). This motion control software allows precise independent control over the rotational and linear movements, allowing several different cycles with varying strain regimes can be programmed and run for the duration of an experiment (para. [0065]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to use Altman et al. teaching of a computer-controlled motion control software in modified Mayer et al.’s cell culture device because the software enables allows precise independent control over the rotational and linear movements, enabling programs to be run during an experiment. This method of improving Mayer et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Altman et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of modified Mayer et al. and Altman et al. to obtain the invention specified in claim 9.
Regarding claim 11, modified Mayer et al. fails to teach a controller that maintains specific cell culture conditions (temperature between 32°C and 40°C). Altman et al. teaches that the computer-controlled bench-top bioreactor system maintained a temperature at 37+/-0.2°C, as this supported cell spreading and growth on the matrices (para. [0043]). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists (MPEP 2144.05 I). The claimed range of between 32°C and 40°C overlaps with the prior art’s 37+/-0.2°C of Altman et al. Thus, a prima facie case of obviousness exists, as one of ordinary skill in the art would be motivated to use the claimed range due to its supporting of cell spreading and growth on the matrices.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Mayer et al. (already referenced), Galiano et al. (already referenced), and further in view of Naughton et al. (WO 0100783 A2) (referenced in 892).
Regarding claim 10, modified Mayer et al. teaches the device of claim 1, but fails to teach that the device further comprises a power source that is a battery. Naughton et al. teaches tissue culture style comprising biosensors (abstract). Naughton et al. further teaches that Mechanical or Electromechanical biosensors capable of measuring physical properties such as pressure, temperature, stress or strain typically require a battery or other power source and a transponder to communicate measured signals (p. 40 – 4th paragraph).
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to use Naughton et al.’s teaching of a battery in modified Mayer et al.’s cell culture device because batteries provide power for biosensor measurement of physical properties. This method of improving modified Mayer et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Naughton et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of modified Mayer et al. and Naughton et al. to obtain the invention specified in claim 10.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Mayer et al. (already referenced), Galiano et al. (already referenced), and further in view of Gershlak et al. (doi:10.1016/j.biomaterials.2017.02.011) (referenced in IDS).
Regarding claim 14, modified Mayer et al. teaches the device of claim 1, but fails to teach that the scaffold comprises decellularized plant tissue. Gershlak et al. teaches the usage of decellularized plants to provide sustainably produced scaffolding for tissue engineering. Gershlak et al. specifically teaches using decellularized plant tissue provides innate vascular networks with a more sustainable method of production (p. 21, 3rd – 5th paragraph).
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to use Gershlak et al. teaching of decellularized plant tissue in modified Mayer et al.’s cell culture device because decellularized offers a sustainable, vascular network as a scaffold. This method of improving modified Mayer et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Gershlak et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of modified Mayer et al. and Gershlak et al. to obtain the invention specified in claim 14.
Conclusion
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/J.F.Y./Examiner, Art Unit 1799
/William H. Beisner/Primary Examiner, Art Unit 1799
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