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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/22/2026 has been entered.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 6-9, 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. (US20140193895) in view of Zhang et al. (WO2006037022A2).
Regarding Claim 1, Smith teaches the following:
A tissue engineering module 118 comprising a rigid spine 200 (cell production plate with a first side and a second side)(para 180)
A bioreactor 202 that may be customized to enable cell culture, proliferation, differentiation, etc. (cell induction and culture tank configured to perform culture of cells)(para 180)
A fluid containment system 206 which is made up of a series of flexible reservoirs 208 for supplying and retrieving cell culture fluids (a culture medium reservoir tank configured to store a culture medium to be supplied to the cell induction and culture tank)(para 181)
A thermoelectric element 236 is present on the module to vary the temperature within the bioreactor 202 (a warming element that is arranged at or near the first side of the cell production plate and is configured to warm the cell induction and culture tank)(para 183)
The reagents are at a reduced temperature (refrigeration) to maintain viability (a cooling element that is arranged at or near the second side of the cell production plate and that is configured to cool the culture medium reservoir tank)(para 183, and Fig. 7 and 8 below)
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The first side and second side of the plate are a left side surface and a right side surface of the cell production plate (see Fig. 7 and 8, above). When viewing the plate lengthwise, the heating element would be on the left side surface or first side and the cooling element would be on the right side surface or second side. Alternatively, assuming arguendo, it would have been an obvious design choice to arrange the elements on the left side surface and the right side surface, absent evidence to the contrary, as a rearrangement of parts has been held prima facie obvious. See MPEP 2144.04(VI)(C)
Smith does not explicitly disclose the cell induction and culture tank is integrally formed with the culture medium reservoir.
Zhang teaches a microscale bioreactor array for use in culturing cells (Abstract). Zhang further teaches a two-vessel bioreactors that comprises a first vessel for culturing cells (cell induction and culture tank) and a second vessel (culture medium reservoir tank) that serves as a source for one or more components such as oxygen, nutrients, buffers, etc. (page 22, lines 10-13).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the bioreactor of Smith with the microscale bioreactor having two vessels as taught by Zhang. One would have been motivated to make this modification as it would allow free transport of oxygen and water into the culture vessel (page 22, lines 16-17). Note this bioreactor replacement would result in a cell induction and culture tank and the culture medium reservoir tank being integrally formed.
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Regarding Claim 6, Smith in view of Zhang teach all of the limitations of Claim 1 (see above). Zhang further teaches the culture tank to be a three-dimensional culture tank (see Zhang’s Fig. 4B, below). The culture tank configured to perform cell suspension culture is an intended use of the device. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim (see MPEP 2114). The culture tank of Zhang would be capable of performing suspension culture and therefore meets the claim.
Regarding Claim 7, Smith in view of Zhang teach all of the limitations of Claim 1 (see above). Zhang further teaches a two-vessel bioreactors that comprises a first vessel for culturing cells (culture tank) and a second vessel (culture medium tank) that serves as a source for one or more components such as oxygen, nutrients, buffers, etc. (page 22, lines 10-13). As seen in Zhang Fig. 2A, below, the tanks are in proximity to each other.
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Regarding Claims 8 and 9, Smith in view of Zhang teach all of the limitations of Claim 1 (see above). Zhang further teaches the two vessels to be separated by a membrane that controls the transport of nutrients (specific component), products, etc. and allows the transport of water and oxygen (the cell induction and culture tank furthers comprises a specific component-permeable member that permits passage of a specific component and culture medium between the culture tank and the culture medium tank)(page 22, lines 15-25).
Regarding Claim 13, Smith in view of Zhang teach all of the limitations of Claim 1 (see above). Smith further teaches a CCD camera may be employed to monitor the optical properties of the scaffold, e.g. optical density or light scattering as a function of cell density)(para 194). The presence of a CCD camera would require an illumination unit that is configured to illuminate the bioreactor from the front or rear of the bioreactor.
Regarding Claim 14, Smith in view of Zhang teach all of the limitations of Claim 1 (see above). Smith further teaches electronic components (i.e. sensors) present on the structural spine or the bioreactor and the sensors can indicate a monitored parameter (e.g. pH) to a CPU which could trigger a control intervention such as replacing the media within the bioreactor (para 181)(the cell induction and culture tank comprises a pH measurement unit configured to measure a pH value of the culture medium used).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. (US20140193895) in view of Zhang et al. (WO2006037022A2) and further in view of Tsuchiya (JP2008259430A).
Smith in view of Zhang teach all of the limitations of Claim 1 (see above). Smith further teaches it would be obvious to use alternate thermal regulation devices to obtain the desired thermal profiles (para 185). Smith in view of Zhang does not teach explicitly teach the warming element to comprise a transparent plate arranged in the cell culture tank and a transparent conductive film fixed to the transparent plate.
Tsuchiya teaches an incubator for microscopic observation (para 25). Tsuchiya further teaches a substrate 57 which is a plate like material that is transparent and a transparent conductive film 59 which serves as a transparent heating element formed directly on the lower surface of the substrate (para 26).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the heating element as taught by Smith in view of Zhang with the heating element configuration as taught by Tsuchiya. One would have been motivated to make this modification as it would have provided an effective heating element with the ability to observe what is happening inside the bioreactor.
Further, the selection of the transparent heating element is prima facie obvious as it is suited for the purpose of being able to observe the inside of the reactor. See MPEP 2144.07.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. (US20140193895) in view of Zhang et al. (WO2006037022A2) and further in view of Maisch et al. (US20160326476A1) and further in view of Oda et al. (JP2010142196A).
Smith in view of Zhang teach all of the limitations of Claim 1 (see above). Smith in view of Zhang do not explicitly teach the cooling element to be a Peltier element with a cooling side and a heating side, and a heat conduction member that conducts heat generated on the heating side of the cooling element to the warming element.
Maisch teaches a microfluidic bioreactor which is divided by a membrane creating a chamber for receiving cells and a chamber in which a liquid solution flows (Abstract). Maisch further teaches a cold-generating device in which a Peltier element is used (para 44).
Oda teaches a cell culture device including a reagent container and a cell culture container (para 8). Oda further teaches the radiator (heating side) provided in the refrigeration circuit (cooling element) is used as a heating unit that heats the reagent.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the refrigeration/cooling element of Smith in view of Zhang with the Peltier module as taught by Maisch and to provide a heat conduction member to use the heat from the heating side to help heat the heating element as taught by Oda. One would have been motivated to make this modification as Maisch teaches the Peltier module to be the preferred device for controlling reaction condition (e.g. temperature)(para 44) and Oda teaches the heating and cooling can be achieved simultaneously, thereby reducing power consumption of the cell culture device (Oda, para 108).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. (US20140193895) in view of Zhang et al. (WO2006037022A2) and further in view of Galliher et al. (WO2013106809A1).
Smith in view of Zhang teach all of the limitations of Claim 1 (see above). Smith in view of Zhang do not explicitly teach a base plate detachably connected to the cell production plate, wherein the cooling element is arranged on the base plate.
Galliher teaches a heat exchange module for use in a biological reactor system (Abstract). Galliher further teaches the system includes an integral cooling support structure (cooling element) which can be in the form of a flat plate system (base plate with cooling element arranged on the base plate)(para 66). The inner container (the culture tank) is inserted into the cooling support structure (para 66) which means it is detachably connected to the cell production plate.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device and the cooling element of Smith in view of Zhang with the flat plate cooling system detachably connected to the production plate as taught by Galliher. One would have been motivated to make this modification as Smith teaches it would be obvious to use alternate thermal regulation devices to obtain the desired thermal profiles (para 185) and it would have provided an effective cooling system for the culture tank of Smith.
Further, the selection of a base plate with the cooling element arranged on the base plate is prima facie obvious as it is suited for the purpose of having the ability to remove the cooling element from the culture tank. See MPEP 2144.07.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. (US20140193895) in view of Zhang et al. (WO2006037022A2) and further in view of Wiles et al. (WO2016172527A2).
Smith in view of Zhang teach all of the limitations of Claim 1 (see above). Smith in view of Zhang do not explicitly teach a portion of the cell induction and culture tank to be white or black.
Wiles teaches an imaging system for cell growth (Abstract). Wiles further teaches lighting to be used on either a black or white background (part of the culture tank is white or black)(para 63). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the culture tank of Smith in view of Zhang to have a portion of the background relative to the imaging device to be white or black. One would have been motivated to make this modification as it increases the contrast of an object (or cell) against the background (para 63), allowing the ability to see the cells clearer.
Response to Arguments
Applicant's arguments filed 04/22/2026 have been fully considered but they are not persuasive.
Applicant’s arguments are directed toward the newly amended claims which are addressed above. Further, arguments presented by the Applicant are incomplete as they do not explicitly point out how Smith does not teach the features of Claim 1.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN E LEPAGE whose telephone number is (571)270-3971. The examiner can normally be reached 8:30-5:30 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.E.L./ Examiner, Art Unit 1796
/MICHAEL A MARCHESCHI/ Supervisory Patent Examiner, Art Unit 1799
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