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 .
Claim Objections
Claims 5, 6, and 22 are objected to because of the following informalities: each claim recites in the preamble "of any of Appropriate correction is required.
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.
Claim 5 is 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 5 recites the limitation "the discrete portions" in line 2. There is insufficient antecedent basis for this limitation in the claim.
It is suggested by the examiner to make claim 5 dependent on claim 4 which recites “a plurality of discrete portions”.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 10, 12, 15, and 24-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Veraitch (US20200190457A1, Published Jun. 18, 2020).
Regarding claim 1, Veraitch discloses:
A bioreactor for cell culturing (Veraitch; Abstract, Para. [0001]), the bioreactor comprising:
a container (Veraitch; Abstract, Para. [0128], Fig. 1a, primary container (10)) comprising a base (Veraitch; Para. [0128], Fig. 1a, base section (12)) and a side wall (Veraitch; Para. [0128], Fig. 1a, wall element (8)) defining an internal volume (Veraitch; Abstract) for holding a cell suspension (Veraitch; Paras. [0001-0003, 0037]), the container being rotatable during use about a rotational axis (Veraitch; Fig. 3, Para. [0133]), and
a sensor element disposed on an internal surface of the container (Veraitch; Para. [0150], Fig. 13, oxygen/pH sensor spots (123)) for interaction with a sensor receiver positioned externally of the container (Veraitch; Para. [0150], Fig. 13, oxygen/pH probes (122)) and operable to interact with the sensor element to detect a characteristic of the cell suspension (Veraitch; Para. [0150]), and
wherein the sensor element is offset from the rotational axis of the bioreactor (Veraitch; Fig. 13 it can be seen that the sensor spots (123) are on the sidewall of the primary container (10) and as a result is offset from the rotational axis of the bioreactor) and arranged to align with the sensor receiver in at least two rotational positions of the bioreactor during use (Veraitch; Fig. 13 it can be seen that there are two sensor spots (123) on the sidewall allowing for alignment of the probe (122) and sensor spots (123) in at least two rotational positions).
Regarding claim 10, Veraitch discloses all of the elements of the current invention as stated with respect to claim 1. Veraitch further discloses.
The bioreactor of claim 1, wherein the side wall comprises a compressible side wall, including a bellows wall (Veraitch; Para. [0010, 0019, 0028, 0030, 0033], primary container (primary container (10) is said to have the structure of function as a reactor bellows, Figs. 1-3)).
Regarding claim 12, Veraitch discloses:
A bioreactor system for cell culturing (Veraitch; Abstract, Para. [0001]), the bioreactor system comprising; a bioreactor comprising:
a container (Veraitch; Abstract, Para. [0128], Fig. 1a, primary container (10)) comprising a base (Veraitch; Para. [0128], Fig. 1a, base section (12)) and a side wall (Veraitch; Para. [0128], Fig. 1a, wall element (8)) defining an internal volume (Veraitch; Abstract) for holding a cell suspension (Veraitch; Paras. [0001-0003, 0037]), the container being rotatable during use about a rotational axis (Veraitch; Fig. 3, Para. [0133]), and
a sensor element disposed on an internal surface of the container (Veraitch; Para. [0150], Fig. 13, oxygen/pH sensor spots (123)) for interaction with a sensor receiver positioned externally of the container (Veraitch; Para. [0150], Fig. 13, oxygen/pH probes (122)) and operable to interact with the sensor element to detect a characteristic of the cell suspension (Veraitch; Para. [0150]), and
wherein the sensor element is offset from the rotational axis of the bioreactor (Veraitch; Fig. 13 it can be seen that the sensor spots (123) are on the sidewall of the primary container (10) and as a result is offset from the rotational axis of the bioreactor) and arranged to align with the sensor receiver in at least two rotational positions of the bioreactor during use (Veraitch; Fig. 13 it can be seen that there are two sensor spots (123) on the sidewall allowing for alignment of the probe (122) and sensor spots (123) in at least two rotational positions); and
a housing adapted to support the bioreactor (Veraitch; Paras. [0132-0133]; It is mentioned that there is a larger device which is said to not be shown which is said to contain the primary container) with the bioreactor being rotatable relative to the housing about the rotational axis (Veraitch; Paras. [0132-0133]; The cell culture device may act to rotate the primary container).
Regarding claim 15, Veraitch discloses all of the elements of the current invention as stated with respect to claim 12. Veraitch further discloses:
The bioreactor system of claim 12 further comprises a sensor receiver positionable externally of the base (Veraitch; Fig. 13 it can be seen that there are two sensor spots (123) on the sidewall allowing for alignment of the probe (120, 121) and sensor spots (123) in at least two rotational positions) and arranged to be aligned with the sensor element in at least two rotational positions of the bioreactor relative to the housing (Veraitch; Fig. 13 it can be seen that there are two sensor spots (123) on the sidewall allowing for alignment of the probe (122) and sensor spots (123) in at least two rotational positions).
Regarding claim 24, Veraitch discloses:
A method of culturing cells in a bioreactor system (Veraitch; Abstract, Para. [0001]), the method comprising:
loading a bioreactor of the bioreactor system into a housing of the bioreactor system (Veraitch; Paras. [0132-0133]; It is mentioned that there is a larger device which is said to not be shown which is said to contain the primary container, which thus implies the loading of said primary container into the large device (housing)), a housing adapted to support the bioreactor (Veraitch; Paras. [0132-0133]; It is mentioned that there is a larger device which is said to not be shown which is said to contain the primary container) with the bioreactor being rotatable relative to the housing (Veraitch; Paras. [0132-0133]; The cell culture device may act to rotate the primary container) about the rotational axis (The fact of the bioreactor being rotatable inherently implies there is a rotational axis),
the bioreactor comprising:
a container (Veraitch; Abstract, Para. [0128], Fig. 1a, primary container (10)) comprising a base (Veraitch; Para. [0128], Fig. 1a, base section (12)) and a side wall (Veraitch; Para. [0128], Fig. 1a, wall element (8)) defining an internal volume (Veraitch; Abstract) for holding a cell suspension (Veraitch; Para. [0078], “the cells may be in suspension culture”), the container being rotatable during use about a rotational axis (Veraitch; Fig. 3, Para. [0133]), and
a sensor element disposed on an internal surface of the container (34. Veraitch; Para. [0150], Fig. 13, oxygen/pH sensor spots (123)) for interaction with a sensor receiver positioned externally of the container (Veraitch; Para. [0150], Fig. 13, oxygen/pH probes (122)) and operable to interact with the sensor element to detect a characteristic of the cell suspension (Veraitch; Para. [0150]), and
wherein the sensor element is offset from the rotational axis of the bioreactor (Veraitch; Fig. 13 it can be seen that the sensor spots (123) are on the sidewall of the primary container (10) and as a result is offset from the rotational axis of the bioreactor) and arranged to align with the sensor receiver in at least two rotational positions of the bioreactor during use (Veraitch; Fig. 13 it can be seen that there are two sensor spots (123) on the sidewall allowing for alignment of the probe (122) and sensor spots (123) in at least two rotational positions);
providing a cell suspension in the container of the bioreactor (Veraitch; Para. [0143]);
rotating the bioreactor (Veraitch; Para. [0132]); and
sensing a characteristic of the cell suspension by the sensor element and sensor receiver in at least two rotational positions of the bioreactor (Veraitch; Fig. 13 , Para. [0150], It is said that the sensor spots (123) may be connected with the probe (122) and does not state that the connection is dependent on the rotational position of the bioreactor, which implies that the connection is constant and thus at more than two rotational positions of the bioreactor. These sensor spots are for the purpose of sensing oxygen and pH levels within the reactor cell suspension.).
Regarding claim 25, Veraitch discloses all of the elements of the current invention as stated with respect to claim 24. Veraitch further discloses:
The method of claim 24, further comprising agitating the cell suspension in the container (Veraitch; Paras. [0028, 0114], Fig. 8d).
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.
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 1-2, 4, 6-9, 11 are rejected under 35 U.S.C. 103 as being unpatentable over Hutmacher (US20060019388A1, Published Jan. 26, 2006) in view of Stangelmayer (US20190178791A1, Published Jun. 13, 2019, Cited in the IDS from Sept. 9, 2024).
Regarding claim 1,
Hutmacher discloses:
A bioreactor for cell culturing (Hutmacher; Abstract, bioreactor (10)), the bioreactor comprising:
a container (Hutmacher; Abstract, chamber (12), Fig. 1) comprising a base (Hutmacher; Figs. 1-2a, bottom flange (6), Paras. [0174, 0179]) and a side wall (Hutmacher; Paras. [0173-0174], Figs. 1-3, glass tube (8)) defining an internal volume (Hutmacher; Figs. 1-3, Internal volume is formed by the volume made within the glass tube (8)) for holding a cell suspension (Veraitch; Para. [0078], “the cells may be in suspension culture”), the container being rotatable during use about a rotational axis (Hutmacher; Para. [0179], Figs. 1-2a, vertical axis (16)), and
a sensor element disposed within the container (Hutmacher; Paras. [0065]) for interaction with a sensor receiver positioned externally of the container (Hutmacher; Para. [0176], Fig. 5, dissolved oxygen sensor (7g), pH sensor (7h); The sensor receiver can be seen to be placed outside of the vessel, while it is understood that the sensor elements (probe) extend through the vessel wall is thus disposed within the vessel) and operable to interact with the sensor element to detect a characteristic of the cell suspension (Hutmacher; Para. [0176], Fig. 5, dissolved oxygen sensor (7g), pH sensor (7h)), and
wherein the sensor element is offset from the rotational axis of the bioreactor (Hutmacher; Para. [0176], Fig. 5, dissolved oxygen sensor (7g), pH sensor (7h); It can be observed in figure 5 that the sensors are offset from the rotational axis) and arranged to align with the sensor receiver in at least two rotational positions of the bioreactor during use (Hutmacher; Para. [0176], Fig. 5, dissolved oxygen sensor (7g), pH sensor (7h); The sensor receiver and elements are always aligned at any rotational position).
Hutmacher does not disclose:
a sensor element disposed on an internal surface of the container.
Stangelmayer discloses:
a sensor element disposed on an internal surface of the container (Stangelmayer; Paras. [0048, 0066], Figs. 1-2, carrier (50), sensor element (10), calibration element (21, 22); The carrier is disposed on the internal surface of the vessel, and the sensor elements are on the carrier) for interaction with a sensor receiver positioned externally of the container (Stangelmayer; Para. [0048], Fig. 1, camera (110); The sensor receiver is the camera which captures the images of the sensor elements within the sample) and operable to interact with the sensor element to detect a characteristic of the cell suspension (Stangelmayer; Paras. [0023, 0054, 0056]; sensor substance coating the sensor element (10) specific to sensing pH, oxygen content, etc.), and
wherein the sensor element is offset from the rotational axis of the bioreactor (Stangelmayer; Para. [0048], Fig. 1, carrier (50); It can be observed in figure 1 that the sensor elements which are part of the carrier are offset from the rotational axis on a wall of the vessel) and arranged to align with the sensor receiver in at least two rotational positions of the bioreactor during use (Stangelmayer; Para. [0023]; there can be more than one sensor element which would ensure the receiver would align with a sensor element in at least two places).
the inclusion of additional sensor elements which are calibration oriented allows for the more accurate data collection and less effort on the part of the user when measurements are taken (Stangelmayer; Para. [0009])
Therefore, it would be obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the sensor elements and sensor receiver of Hutmacher with the sensor elements attached to the vessel’s internal surface and sensor receiver as taught by Stangelmayer. Both Hutmacher and Stangelmayer are directed to biological sample sensing. Stangelmayer discloses that by including built in calibration elements with the sensor elements allows for improved ease of use and data accuracy. This involves applying a known technique (sensor elements disposed on the internal surface of sample vessel which include calibration elements) to a similar device to (sensor elements disposed within a sample vessel) yield predictable results (ease and accuracy of data collected).
Regarding claim 2, Modified Hutmacher (Hutmacher in view of Stangelmayer) discloses all of the elements of the current invention as stated with respect to claim 1.
Modified Hutmacher does not disclose:
The bioreactor of claim 1, wherein the sensor element is disposed on the base.
However, it has been held that a mere rearrangement of elements without modification of the operation of the device involves only routine skill in the art. MPEP §2144.04 (VI)(C). The rearrangement in this case does not modify the operation of the device because the sensor elements present on an internal surface of the device is still able to connect to the sensor receiver. The benefits of this modification include allowing for a clear unobstructed view of the sensor element without the possibility of blockage by another element during the rotation of the container.
Regarding claim 4, Modified Hutmacher (Hutmacher in view of Stangelmayer) discloses all of the elements of the current invention as stated with respect to claim 1. Modified Hutmacher (Hutmacher in view of Stangelmayer) further discloses:
The bioreactor of claim 1, wherein the sensor element comprises a plurality of discrete portions (Hutmacher; Para. [0176], Fig. 5, dissolved oxygen sensor (7g), pH sensor (7h); Multiples of sensors disposed within the container satisfies a plurality of discrete portions).
Regarding claim 6, Modified Hutmacher (Hutmacher in view of Stangelmayer) discloses all of the elements of the current invention as stated with respect to claim 1. Modified Hutmacher further discloses:
The bioreactor of any of claim 1, wherein the sensor element comprises a dot (Hutmacher; Para. [0176], Fig. 5, dissolved oxygen sensor (7g), pH sensor (7h); The sensors having a circular cross section can be said to comprise a dot).
Regarding claim 7, Modified Hutmacher (Hutmacher in view of Stangelmayer) discloses all of the elements of the current invention as stated with respect to claim 1.
Modified Hutmacher discloses:
The bioreactor of claim 1 (See above claim 1), wherein the bioreactor comprises a sensor element disposed on an internal surface of the container (Stangelmayer; Paras. [0048, 0066], Figs. 1-2, carrier (50), sensor element (10), calibration element (21, 22)), the sensor element arranged to align with the sensor receiver positioned externally of the container (Stangelmayer; Para. [0048], Fig. 1, camera (110); The sensor receiver is the camera which captures the images of the sensor elements within the sample) and operable to interact with the sensor element to detect a characteristic of the cell suspension (Stangelmayer; Paras. [0023, 0054, 0056]; sensor substance coating the sensor element (10) specific to sensing pH, oxygen content, etc.)
Modified Hutmacher does not disclose:
wherein the bioreactor comprises a second sensor element disposed on an internal surface of the container, the second sensor element being aligned with the rotational axis of the bioreactor and arranged to align with a second sensor receiver positioned externally of the container and operable to interact with the second sensor element to detect a characteristic of the cell suspension.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date to include a second sensor element as well as a second sensor receiver for the second sensor element within the system, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. MPEP 2144.04(VI)(B).
Additionally, it has been held that a mere rearrangement of element without modification of the operation of the device involves only routine skill in the art. MPEP §2144.04 (VI)(C). The rearrangement in this case does not modify the operation of the device because the sensor element present on any internal surface of the device is still able to connect to the sensor receiver whether or not it is centered on the rotational axis. The benefits of this modification include allowing for a more even distribution of the readings throughout the bioreactor when the sensor element is centered on the rotational axis of the reactor volume.
Regarding claim 8, Modified Hutmacher (Hutmacher in view of Stangelmayer) discloses all of the elements of the current invention as stated with respect to claim 1.
Modified Hutmacher discloses:H
The bioreactor of claim 1, wherein the sensor element is adhered to the internal surface of the container (Stangelmayer; Paras. [0048, 0066], Figs. 1-2, carrier (50), sensor element (10), calibration element (21, 22); The carrier is disposed on the internal surface of the vessel, and the sensor elements are on the carrier; See claim 1 above).
Regarding claim 9, Modified Hutmacher (Hutmacher in view of Stangelmayer) discloses all of the elements of the current invention as stated with respect to claim 1.
Modified Hutmacher discloses:
An oxygen sensor and a pH sensor (Hutmacher; Para. [0176], Fig. 5, dissolved oxygen sensor (7g), pH sensor (7h)).
Modified Hutmacher does not disclose:
The bioreactor of claim 1, wherein the sensor element comprises a sensor chosen from an oxygen-sensitive coating and a pH-sensitive coating.
Stangelmayer further discloses:
The bioreactor of claim 1, wherein the sensor element comprises a sensor chosen from an oxygen-sensitive coating and a pH-sensitive coating (Stangelmayer; Paras. [0023, 0054, 0056]; sensor substance coating the sensor element (10) specific to sensing pH, oxygen content, etc.; Para. [0013] sensor substance (coating) presents an optical behavior depending on the different readings within the sample).
Therefore, it would be obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the oxygen and pH sensor elements of Hutmacher with the sensor elements containing an oxygen-sensitive coating and a pH-sensitive coating as taught by Stangelmayer. Both Hutmacher and Stangelmayer are directed to biological sample sensing. The use of oxygen and pH sensitive coatings which change color depending on the values allows for visual sensor receiving. This involves applying a known technique (oxygen and pH sensitive coatings) to a similar device (Oxygen and pH sensors) to yield predictable results (oxygen and pH sensor that have pH or oxygen dependent optical presentations).
Regarding claim 11, Hutmacher discloses all of the elements of the current invention as stated with respect to claim 1. Hutmacher further discloses:
The bioreactor of claim 1, further comprising an interface plate attached to the side wall opposite to the base (Hutmacher; Fig. 2, top flange (7), Para. [0022-0023, 0078, 0202-0205]), the interface plate comprising one or more ports configured for at least one of adding fluid to and extracting fluid from the container (Hutmacher; Fig. 2, top flange (7), Para. [0022-0023, 0078, 0202-0205]).
Claim(s) 3 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hutmacher in view of Stangelmayer as applied to claim 1 above, and further in view of Angelescu (US20180251713A1, Published Sep. 6, 2018).
Regarding claim 3, Modified Hutmacher (Hutmacher in view of Stangelmayer) discloses all of the elements of the current invention as stated with respect to claim 1.
Modified Hutmacher does not disclose:
The bioreactor of claim 1, wherein the sensor element comprises an annulus centered on the rotational axis of the bioreactor.
Angelescu discloses:
The bioreactor of claim 1, wherein the sensor element comprises an annulus (Angelescu; Fig. 11, Paras. [0091, 0169], sensor ring (1101); The sensor is an optical sensor) .
Therefore, it would be obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the shape of the sensor elements of Modified Hutmacher with the optical sensor and annular sensor element as taught by Angelescu. Both Modified Hutmacher and Angelescu are directed to biological sensing. An annular sensor element of an optical sensor within a rotating bioreactor allows for the sensor element to be in view of the sensor receiver while the reactor is rotating when having a non rotating optical sensor receiver. This involves applying a known technique (annular optical sensor element) to a similar device (a biological reactor using sensor elements) to yield predictable results (an annular sensor element within the rotating biological reactor).
Modified Hutmacher in view of Angelescu does not explicitly disclose:
wherein the annular sensor element is centered on the rotational axis of the bioreactor.
However, it has been held that a mere rearrangement of element without modification of the operation of the device involves only routine skill in the art. MPEP §2144.04 (VI)(C). The rearrangement in this case does not modify the operation of the device because the annular sensor elements present on an internal surface of the device is still able to connect to the sensor receiver whether or not it is centered on the rotational axis. The benefits of this modification include allowing for a more even distribution of the readings throughout the bioreactor when the sensor element is centered about the rotational axis of the reactor volume.
Regarding claim 5, Hutmacher discloses all of the elements of the current invention as stated with respect to claim 1.
Modified Hutmacher (Hutmacher in view of Stangelmayer) does not disclose:
The bioreactor of any of claim 1, wherein the sensor element or at least one of the discrete portions of the sensor element comprises an annular sector.
Angelescu discloses:
wherein the sensor element comprises an annulus (Angelescu; Fig. 11, Paras. [0091, 0169], sensor ring (1101); The sensor is an optical sensor) .
Therefore, it would be obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the shape of the sensor elements of Modified Hutmacher with the optical sensor and annular sensor element as taught by Angelescu. Both Modified Hutmacher and Angelescu are directed to biological sensing. An annular sensor element of an optical sensor within a rotating bioreactor allows for the sensor element to be in view of the sensor receiver while the reactor is rotating when having a non rotating optical sensor receiver. This involves applying a known technique (annular optical sensor element) to a similar device (a biological reactor using sensor elements) to yield predictable results (an annular sensor element within the rotating biological reactor).
Modified Hutmacher in view of Angelescu does not explicitly disclose:
wherein the sensor element or at least one of the discrete portions of the sensor element comprises an annular sector.
However, it has been held that a mere change in shape is the matter of choice in which a person of ordinary skill in the art would have found obvious in the absence of persuasive evidence that the particular configuration was significant. MPEP §2144.04 (IV)(B). The change of shape in this case does not modify the operation of the device because an annular sector is simply a portion of the annular shape disclosed and mention with respect to claim 3. The shape of the element does not affect the communication with the sensor receiver in the absence of specific evidence otherwise.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Veraitch as applied to claim 1 above.
Regarding claim 13, Veraitch discloses all of the elements of the current invention as stated with respect to claim 12. Veraitch further discloses:
The bioreactor system of claim 12, wherein the bioreactor comprises an interface plate attached to the side wall opposite to the base (Veraitch; Paras. [0130-0131, 0138], Figs. 1a, top section (14), auxiliary containers (16a-16e); The examiner is understanding the interface plate to be top section (14), which is opposite of the base section (12) since the top section (14) and the base section (12) are separated by the cylindrical wall element (8) and are thus on opposite ends of the primary container (10); top section is shown to be attached to wall element (8)), and wherein the housing comprises a bioreactor receiving portion (Veraitch; Paras. [0132-0133, 0138], Fig. 3; The receiving portion is the side of the larger device (housing) to which the primary container is placed).
However, Veraitch in the current embodiment does not disclose wherein the bioreactor receiving portion is adapted to support the interface plate with the side wall and base suspended below the interface plate.
In the separate embodiment of the invention Veraitch discloses that the auxiliary containers are able to be attached to the sides or base section of the primary container, as can be seen in Figure 6 (Veraitch; Para. [0138], Fig. 6; It is shown and stated that the auxiliary containers (16) can also be disposed on the base section (12) of the primary container (10) and hanging off of the container). The benefit of the attachment of the auxiliary container and changing the embodiment is that it adds multiple places that could be used for sampling allowing for testing and quality control (Veraitch; Para. [0112]), while freeing up the top section (14) to be attached to the housing to suspend the base section (12) with the auxiliary containers (16) below.
Therefore, it would be obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the embodiment of Veraitch in order to provide: wherein the bioreactor receiving portion is adapted to support the interface plate with the side wall and base suspended below the interface plate. The benefit of the attachment of the auxiliary container and changing the embodiment is that it adds multiple places that could be used for sampling allowing for testing and quality control (Veraitch; Para. [0112]), while freeing up the top section (14) to be attached to the housing to suspend the base section (12) with the auxiliary containers (16) below.
Claims 14 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Veraitch as applied to claims 13 and 15 above, and further in view of Hutmacher (US20060019388A1).
Regarding claim 14, Veraitch discloses all of the elements of the current invention as stated with respect to claim 13.
Veraitch does not disclose:
The bioreactor system of claim 13, wherein the bioreactor receiving portion comprises an actuator operable to rotate the bioreactor.
Hutmacher discloses:
an actuator operable to rotate the bioreactor (Hutmacher; Paras. [0212, 0221], control unit (112), servo motors (86a', 86b'); The control unit (112) is able to change the speed of the servo motors (86a', 86b'))
Therefore, it would be obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the housing of Veraitch by including an actuator to rotate the bioreactor as taught by Hutmacher. Both Veraitch and Hutmacher are directed to rotating bioreactor systems. Hutmacher teaches that the actuator allows for variable control of the rotation speed of the bioreactor. This involves applying a known technique (actuators to rotate a bioreactor) to a similar device (a rotating bioreactor) to yield predictable results (a rotating bioreactor with variable speed controlled by the actuator).
Regarding claim 16, Veraitch discloses all of the elements of the current invention as stated with respect to claim 15.
Veraitch discloses:
The bioreactor system of claim 15, wherein the sensor receiver comprises an optical receiver (Veraitch; Fig. 1, probe (122)), including an optical fiber (Veraitch; Para. [0028]).
Veraitch does not disclose:
wherein the bioreactor system further comprises a sensor meter arranged to receive an optical signal from the optical receiver.
Hutmacher discloses:
wherein the bioreactor system further comprises a sensor meter arranged to receive an optical signal from the optical receiver (Hutmacher; Paras. [0182-0183], the PID controller receiving sensor data from dissolved oxygen sensor).
Therefore, it would be obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the sensors of Veraitch by including a data transfer system that receives a signal from the sensor receiver as taught by Hutmacher. Both Veraitch and Hutmacher are directed to rotating bioreactors. Hutmacher teaches that the data transfer system allows for easier control of the reactor variables due to efficient data transfer. This involves applying a known technique (data transfer system of sensor to controller) to a similar device (a sensor system) to yield predictable results (efficient data transfer and accurate control of bioreactor operating conditions).
Claims 17-23 are rejected under 35 U.S.C. 103 as being unpatentable over Veraitch as applied to claim 12 above, and further in view of Afshar (US20200056140A1, Published Feb. 20, 2020).
Regarding claim 17, Veraitch discloses all of the elements of the current invention as states with respect to claim 15.
Veraitch does not disclose:
The bioreactor system of claim 15, wherein the sensor receiver is movably mounted and movable to an operational position in which the sensor receiver is in a position chosen from contact with, or adjacent to, the container of the bioreactor proximal to the sensor element.
Afshar discloses:
A system for the automated cell culture of fluidly connected culture vessels (Afshar; Abstract). The automated cell culture system includes a sensor receiver is movably mounted (Afshar; Para. [0093], “the base unit includes a sensor movably coupled to the housing and configured to produce a cell signal associated with a quantity of cells within the first container”) and movable to an operational position (Afshar; Para. [0097]) in which the sensor receiver is in a position adjacent to (Afshar; Para.[0097], “control movement of the cell sensor relative to the housing such that the cell sensor can be aligned with the first container”), the container of the bioreactor (Afshar; Para.[0097], “control movement of the cell sensor relative to the housing such that the cell sensor can be aligned with the first container”), proximal to the sensor element (Afshar; Para. [0104], “the sensor is a part of an optical measurement assembly configured to move the sensor , and the method further includes sending a position signal to the optical measurement assembly to move the sensor into a measurement position relative to at least one of the first container or the second container”).
Therefore, it would be obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to combine the sensor system of Veraitch with the sensor system with movable sensors to their operable positions as taught by Afshar. Both Veraitch and Afshar are directed to cell culture systems containing cells in suspension. Afshar discloses that the movability of the sensors allows for interchangeability of the types of readings. This involves applying a known technique (movably coupled sensors) to a similar device (a bioreactor system) to yield predictable results (a bioreactor with movable sensors to allow for variability in the data being collected).
Regarding claim 18, Modified Veraitch discloses all of the elements of the current invention as stated with respect to claim 17. Modified Veraitch further discloses:
The bioreactor system of claim 17, further comprising an actuator operable to move the sensor receiver into the operational position (Paras. [0093, 0097, 0104] of Afshar, as previously stated in claim 17, disclose a system which controls and moves the sensor to be aligned with the desired containers. Therefore, it is inherent that an actuator (definition: a device which causes a machine or other device to operate) is present to cause the operation of moving the sensor receiver into the operational position within the system of claim 18.)
Regarding claim 19, Modified Veraitch discloses all of the elements of the current invention as stated with respect to claim 17. Veraitch further discloses:
The bioreactor system of claim 17, wherein the side wall of the bioreactor comprises a compressible side wall, including a bellows wall (Veraitch; Paras. [0028, 0117], Fig. 11, primary container (reactor bellows, 13)), and wherein the bioreactor system further comprises an agitator operable to engage the base of the bioreactor (Veraitch; Para. [0028], “a rocking means for maintaining a rocking motion of a container ; and / or may comprise a platform which can be vibrated to permit a container stationed thereon to be thus agitated”; Para. [0114], Fig. 8d, the reactor being rocked to resuspend settled cellular material).
Regarding claim 20, Modified Veraitch discloses all of the elements of the current invention as stated with respect to claim 19. Veraitch further discloses:
The bioreactor system of claim 19, wherein the agitator is operable to perform at least one of compress the container of the bioreactor, and/or to tilt the base of the bioreactor (Veraitch; Paras. [0028, 0114], Fig. 8d).
Regarding claim 21, Modified Veraitch discloses all of the elements of the current invention as stated with respect to claim 19.
Veraitch does not disclose:
The bioreactor of claim 19, wherein the sensor receiver is mounted to the agitators the sensor receiver configured to be in the operational position when the agitator engages the base of the bioreactor.
Afshar discloses:
wherein the sensor receiver is mounted to the agitators (Afshar; Paras. [0093, 0102]) the sensor receiver configured to be in the operational position when the agitator engages the base of the bioreactor (Afshar; Paras. [0093, 0102]).
Therefore, it would be obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the sensor receivers of Veraitch by mounting the sensors to the agitator as taught by Afshar. Veraitch and Afshar are directed to cell culture systems containing cells in suspension. Afshar teaches that the mounting of the sensors to the agitator allows for the sensors to collect data when the cell container is coupled to the agitator (Afshar; Para. [0104]). This involves applying a known technique (mounting sensors to an agitator coupled to a cell container) to a similar device (a cell container with sensors) to yield predictable results (a cell container that is able to collect sensor data when coupled to the agitator).
Regarding claim 22, Modified Veraitch discloses all of the elements of the current invention as stated with respect to claim 19.
Veraitch does not disclose:
The bioreactor of claim 19, wherein the agitator is configured to couple to the base of the bioreactor.
Afshar discloses:
wherein the agitator is configured to couple to the base of the bioreactor (Afshar; Para. [0083, 0086]) and decouple from the base of the bioreactor (Afshar; Para. [0083, 0086, 0092]).
Therefore, it would be obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to combine the agitator of Veraitch with the agitator and base assembly as taught by Afshar in order to provide: wherein the agitator is configured to couple to the base of the bioreactor. Veraitch and Afshar are directed to cell culture systems containing cells in suspension. Afshar teaches that the ability to couple the cell container allows controlled agitation of the volume. This involves applying a known technique (an agitator able to couple to a cell container) to a similar device (a cell container with an agitator) to yield predictable results (a cell container that is able to be coupled to the agitator).
Regarding claim 23, Modified Veraitch discloses all of the elements of the current invention as stated with respect to claim 22.
Modified Veraitch further teaches:
rotation of the bioreactor relative to the housing (Veraitch; Paras. [0132-0133]; The cell culture device may act to rotate the primary container).
Modified Veraitch does not teach:
wherein the agitator is configured to decouple from the base to permit rotation of the bioreactor relative to the housing.
Afshar does teach:
wherein the agitator is configured to decouple from the base (Afshar; Para. [0083, 0086, 0092]) .
Therefore, it would be obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to combine the agitator of Veraitch with the agitator and base assembly as taught by Afshar in order to provide: wherein the agitator is configured to decouple from the base of the bioreactor. Veraitch and Afshar are directed to cell culture systems containing cells in suspension. Afshar teaches that the ability to couple the cell container allows controlled agitation of the volume. This involves applying a known technique (an agitator able to couple to a cell container) to a similar device (a cell container with an agitator) to yield predictable results (a cell container that is able to be coupled to the agitator).
Additionally, the recitation of “to permit rotation of the bioreactor relative to the housing” is an intended use of function claim. See MPEP 2114(II). 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. In this case Veraitch teaches all structural limitations requiring the rotation of the bioreactor relative to the housing as previously stated with respect to claim 12 above.
Therefore, modified Veraitch further discloses:
wherein the agitator is configured to decouple from the base to permit rotation of the bioreactor relative to the housing.
In an alternative interpretation of claim 18, claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Veraitch in view of Afshar as applied to claim 17 above, and further in view of Damren (US20140260712A1, Published 2014).
In this alternative interpretation, modified Veraitch is interpreted as not teaching “an actuator operable to move the sensor receiver into the operational position.
Regarding claim 18, modified Veraitch (Veraitch in view of Afshar) discloses all of the elements of the current invention as stated with respect to claim 17.
Modified Veraitch does not explicitly disclose:
The bioreactor system of claim 17, further comprising an actuator operable to move the sensor receiver into the operational position.
Damren discloses:
A probe assembly for inserting a probe into a vessel to allow for probe measurements of the vessel contents (Damren; Abstract). Additionally, the probe assembly uses an actuator for the movement of the probe into an operational position to allow for sensor readings (Damren; Para. [0008]).
Therefore, it would be obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the sensor receiver positioning system of Modified Veraitch (Veraitch in view of Afshar) by including an actuator operable to move a sensor as taught by Damren in order to provide: wherein the system for moving the sensor receiver comprises an actuator operable to move the sensor receiver into the operational position. Both Modified Veraitch and Damren are directed to sensing vessel contents within a reaction system. The inclusion of an actuator allows for a system to communicate and signal for activation of a device or machine in this case the sensor positioning system to tell the sensor positioning actuator to move the sensor to an operable position. This involves applying a known technique (the use of an actuator for positioning of a sensor) to a similar device (a sensor positioning system) to yield predictable results (a sensor positioning system using and actuator for the operable movement of a sensor).
Conclusion
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/D.L.B./Examiner, Art Unit 1758
/HENRY H NGUYEN/Primary Examiner, Art Unit 1758
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