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 Rejections - 35 USC § 102
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 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.
Claims 1, 2, 8, 10, 12, 13, 16, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Baust (U.S. Publication 2016/0097583).
Regarding claim 1, Baust teaches a rocking mechanism for a bioreactor vessel (the rocking mechanism is shown in figure 13, the bioreactor is considered intended use), comprising: a base (item 186); a motor mounted to the base (the motor is taught in paragraph 40, motor and flywheel 214) and having an eccentric roller driven by the motor (item 213 rocker bearing is considered reading on an eccentric roller and paragraph 40 teaches item 213 can be off center); and a rocking plate (item 112) in contact with the eccentric roller (item 112 is housed on item 213), the rocking plate configured to receive the bioreactor vessel thereon (item 140 is housed on item 112, however item 140 is considered intended use); wherein the eccentric roller is positioned to directly engage an underside surface of the rocking plate (item 213 is placed underneath item 112), wherein the motor is controllable to drive the eccentric roller to transmit a force against the underside surface of the rocking plate to tilt the rocking plate and bioreactor vessel (paragraph 49 teaches a system control center 180 including microprocessor 178 which is used to control the motor and motion of the rocking mechanism).
Regarding claim 2, Baust teaches the motor and eccentric roller are configured to produce a continuous, sinusoidal rocking profile for the bioreactor vessel (item 213 is considered capable of being moved by motor in paragraph 40 and teaches oscillations and is considered capable of being moved in a continuous, sinusoidal rocking profile).
Regarding claim 8, Baust teaches a fulcrum defining a pivot axis of the rocking plate (item 213 is considered reading on a fulcrum since it pivots along its axis as taught in paragraph 40), the rocking plate being received atop the fulcrum (item 112 is above and placed on top of item 213).
Regarding claim 10, Baust teaches wherein the eccentric roller is a circular roller configured to move along an eccentric path (paragraph 40 teaches a pivot point offset from the center which is considered reading on an eccentric path).
Regarding claim 12, Baust teaches a method of bioprocessing (paragraph 9 taches a biological sample, figures 8 and 13, are used to process a biological sample) comprising the steps of: receiving a bioreactor vessel (item 140) atop a rocking plate (item 112), actuating a motor (paragraph 40 teaches a motor) to drive an eccentric roller that directly engages an underside surface of the rocking plate (item 213 which is directly under and engaging item 112) to exert a force on an underside surface of the rocking plate (item 213 acts as a pivot point to exert a force on the underside of item 112) to tilt the rocking plate and the bioreactor vessel about a horizontal axis (an axis can be drawn through item 213, with item 112 being tilted along the axis).
Regarding claim 13, Baust teaches the rocking plate is received atop a fulcrum (item 213 is considered reading on a fulcrum since it pivots along its axis as taught in paragraph 40) such that exertion of the force on the underside of the rocking plate causes the rocking plate to pivot about the fulcrum (item 112 is above and placed on top of item 213 and pivots as taught in paragraph 40).
Regarding claim 16, Baust teaches an eccentric roller is a circular roller (item 213 is a bearing and considered a roller) configured to move along an eccentric path (paragraph 40 teaches a pivot point offset from the center which is considered reading on an eccentric path).
Regarding claim 19, Baust teaches a bioprocessing system (shown in figures 8 and 13), comprising: a base (item 186); a fulcrum mounted to the base (item 213); a rocking plate received atop the fulcrum (item 112) and being configured to pivot thereon (paragraph 40 teaches oscillations which inherently requires pivoting); an eccentric roller positioned to directly engage an underside surface of the rocking plate (item 213 bearing is considered an eccentric roller since paragraph 40 teaches it may be offset from the center of the motion table, item 213 directly engages an underside surface of item 112); a motor configured to drive the eccentric roller to cause the eccentric roller to exert a force on the underside of the rocking plate to pivot the rocking plate about the fulcrum (paragraph 40 teaches a motor which generates movement of the motion table); and a bioreactor vessel received atop the rocking plate (item 140 is considered reading on a bioreactor vessel and is placed on top of item 112).
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.
Claims 3, 4, 7, 17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Baust (U.S. Publication 2016/0097583).
Regarding claim 3, Baust teaches the rocking plate includes a plurality of mounting springs for retaining the bioreactor vessel on the rocking plate (figure 8 item 164 and paragraph 39). Regarding claim 3, Baust is silent to the shape of the mounting devices being pins. Regarding claim 3, absent any unexpected results, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the shape of the mounting elements in order to obtain the desired degree of mixing since it is well settled that it is an obvious matter of design choice to change the general shape or size of a known element in the absence of a disclosed non-obvious advantage associated with the change. Gardner vs. TEC Systems Inc., 725 F.2d 1338, 1349-50 (Fed. Cir. 1984); In re Kuhle, 526 F.2d 553, 555 (CCPA 1975); In re Dailey, 357 F.2d 669, 672 (CCPA 1966).
Regarding claim 4, Baust teaches four mounting springs (see figure 8 items 164 paragraph 39) housed adjacent to corners of the bioreactor vessel (see orientation of items 164 proximate the corners). Regarding claim 4, Baust is silent to the shape of the mounting devices being pins. Regarding claim 4, absent any unexpected results, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the shape of the mounting elements in order to obtain the desired degree of mixing since it is well settled that it is an obvious matter of design choice to change the general shape or size of a known element in the absence of a disclosed non-obvious advantage associated with the change. Gardner vs. TEC Systems Inc., 725 F.2d 1338, 1349-50 (Fed. Cir. 1984); In re Kuhle, 526 F.2d 553, 555 (CCPA 1975); In re Dailey, 357 F.2d 669, 672 (CCPA 1966).
Regarding claim 7, Baust teaches the plurality of mounting devices maintain the bioreactor vessel (figure 8 items 164 paragraph 39) in spaced vertical relation from the rocking plate (items 164 are spaced apart from the bottom wall of item 112), enabling a bottom surface of the bioreactor vessel to be accessible for heat transfer and/or aeration (heat and air are considered capable of entering the hollow space of item 112). Regarding claim 7, Baust is silent to the shape of the mounting devices being pins. Regarding claim 7, absent any unexpected results, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the shape of the mounting elements in order to obtain the desired degree of mixing since it is well settled that it is an obvious matter of design choice to change the general shape or size of a known element in the absence of a disclosed non-obvious advantage associated with the change. Gardner vs. TEC Systems Inc., 725 F.2d 1338, 1349-50 (Fed. Cir. 1984); In re Kuhle, 526 F.2d 553, 555 (CCPA 1975); In re Dailey, 357 F.2d 669, 672 (CCPA 1966).
Regarding claim 17, Baust teaches controlling the motor to tilt the rocking plate back and forth to produce a rocking profile for the bioreactor vessel (paragraph 40 teaches the rocker bearing provides various types of motion, paragraph 41 teaches the motion may have any other orientation as desired for a particular configuration). Regarding claim 17, Baust is silent to the specific continuous sinusoidal movement. Regarding claim 17, absent any unexpected results, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the motion of the rocker in order to obtain the desired degree of mixing since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)
Regarding claim 20, Baust teaches the rocking plate includes a plurality of mounting springs for retaining the bioreactor vessel on the rocking plate (figure 8 item 164 and paragraph 39) in spaced vertical relation with respect to the rocking plate (items 164 are spaced apart from the bottom wall of item 112) enabling a bottom surface of the bioreactor vessel to be accessible for heat transfer and/or aeration (heat and air are considered capable of entering the hollow space of item 112). Regarding claim 20, Baust is silent to the shape of the mounting devices being pins. Regarding claim 20, absent any unexpected results, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the shape of the mounting elements in order to obtain the desired degree of mixing since it is well settled that it is an obvious matter of design choice to change the general shape or size of a known element in the absence of a disclosed non-obvious advantage associated with the change. Gardner vs. TEC Systems Inc., 725 F.2d 1338, 1349-50 (Fed. Cir. 1984); In re Kuhle, 526 F.2d 553, 555 (CCPA 1975); In re Dailey, 357 F.2d 669, 672 (CCPA 1966).
Claims 5 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Baust (U.S. Publication 2016/0097583) in view of McCarty (U.S. Publication 2016/0376604).
Regarding claim 5, Baust is silent to a tilt sensor configured to measure a tilt angle of the rocking plate. Regarding claim 5, McCarty teaches the use of a motion sensor (paragraph 97) and detecting the center of mass to adjust the mixing operation (paragraph 106). Regarding claim 5, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the shaker of Baust with the motion sensor of McCarty in order to obtain the desired degree of mixing.
Regarding claim15, Baust is silent to a detecting a tilt angle of the rocking plate. Regarding claim 15, McCarty teaches the use of a motion sensor (paragraph 97) and detecting the center of mass to adjust the mixing operation (paragraph 106 which is considered measuring the tilt angle). Regarding claim 15, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the shaker of Baust with the motion sensor of McCarty in order to obtain the desired degree of mixing.
Claims 6 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Baust (U.S. Publication 2016/0097583) in view of Brutsch (U.S. Publication 2018/0327707).
Regarding claim 6, Baust is silent to the load cell configuration. Regarding claim 6, Brutsch teaches at least one load cell associated with the base plate, the at least one load cell permitting measurement of a mass of the bioreactor vessel received atop the rocking plate (paragraph 67 load or weight sensor for monitoring the position of the bioreactor or its holder).Regarding claim 6, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the shaker of Baust with the load sensor of Brutsch in order to better monitor the mixing operation.
Regarding claim 11, Baust is silent to the load cell configuration. Regarding claim 11, Brutsch teaches at least one load cell associated with the base plate, the at least one load cell permitting measurement of a mass of the bioreactor vessel received atop the rocking plate (paragraph 67 load or weight sensor for monitoring the position of the bioreactor or its holder). Regarding claim 11, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the shaker of Baust with the load sensor of Brutsch in order to better monitor the mixing operation. Regarding claim 11, absent any unexpected results, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to duplicate the number of load cells to obtain a more accurate reading since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Response to Arguments
Regarding the 35 U.S.C. 102(a)(1) rejection, Applicant argues that amended claims 1, 12, and 19 differ fundamentally from Baust (U.S. Publication 2016/0097583) since the force in the claim 13 embodiment of Baust is applied by a motor and a drive shaft to a console structure that rocks about a pivot bearing, with any vessel-support plate being structurally separated from the driven surface. However, the amendment to claim 1 requires the eccentric roller is positioned to directly engage an underside surface of the rocking plate, and item 22 is considered directly on the underside of item 112. Additionally, applicant argues that “Baust does not teach a rocking plate configured to receive a bioreactor system thereon.” However, the bioreactor system is considered intended use, and Baust item 112 is considered capable of receiving a bioreactor system thereon since the references teaches a cell therapy bag in paragraph 41. Applicant additionally argues that the rocker bearing 213 of Baust is not driven by the motor and does not function as an eccentric-force applying element. However, Item 213 is driven by motor, flywheel, and motion table as taught in paragraph 40. Additionally, paragraph 40 of Baust teaches the bearing may be located offset from center, which is considered reading on an eccentric roller.
The remarks regarding the 35 U.S.C. 103 rejection of claims 3, 4, 7, 17 and 20 are based off the rejection of claims 1, 12, and 19, and are rejected accordingly.
Regarding the 35 U.S.C. 103 rejections of claims 5 and 15, Applicant argues that McCarty (U.S. Publication 2016/0376604) employs an alternative actuation for imparting motion to a bioreactor vessel. However, McCarty teaches the plate may include rotational movements (see paragraph 20). Additionally, regarding claims 5 and 15, Applicant argues that McCarty is silent to the motor-driven eccentric roller that itself applies force toa surface supporting the bioreactor vessel. These remarks are based off the rejection of claims 1, 12, and 19, and the claims are rejected accordingly.
Regarding the 35 U.S.C. 103 rejections of claims 6 and 11, Applicant argues that Brutsch (U.S. Publication 2018/0327707) does not disclose or suggest modifying the console-driven pivot arrangement to include the motor-driven eccentric roller that islet appliance force to a surface supporting the bioreactor vessel. These remarks are based off the rejection of claims 1, 12, and 19, and the claims are rejected accordingly. Additionally, Applicant argues that Brutsch provides no teaching or motivation to replace Baust’s console and pivot force path with a direction force transmission from a motor driven roller. However, both references deal with platforms that tils on the axis of a bearing and paragraph 67 of Brutsch teaches the use of a load or weight sensor to generate a synchronization readout.
Allowable Subject Matter
Claims 9, 14, and 18 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 claim for the reasons stated in the Non-Final Rejection mailed 12/23/2025.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANSHU BHATIA whose telephone number is (571)270-7628. The examiner can normally be reached Monday - Friday 11 a.m. to 7:30 p.m..
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/ANSHU BHATIA/Primary Examiner, Art Unit 1774
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