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 .
Remarks
This Office Action fully acknowledges Applicant’s remarks filed on October 16th, 2025. Claims 1-25 are pending.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 October 16th, 2025 has been entered.
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 24 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.
The metes and bounds of the methodology are indefinitely understood herein in regards to the step of “varying a height of the at least one blade of the impeller assembly responsive to changing from the first direction to the second direction.”
As the claims are presently recited, the “first” and “second” direction may constitute the same direction, wherein the intended operation given by “…responsive to changing from the first direction to the second direction” is indefinitely understood in its metes and bounds as it reads on a continual rotation in the same direction at various time segments thereof. Does Applicant intend to recite that the first and second directions are different from one another (i.e. clockwise/counterclockwise) in order to codify the “…responsive to changing…”?
Clarification is required.
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.
(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.
Claim(s) 1, 2, 4-6, 9 , and 19-22 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Rebei (EP 1776998).
Rebei discloses a mixing device (abstract). With regard to claim 1, Rebei discloses an impeller assembly for a bioprocessing system comprising a hub 7, at least one blade 8 pivotally connected to the hub (and as in a shaft as in cl. 23 as seen in fig. 12 in the center in vicinity of item ‘70’), the at least one blade including a first leg portion 12 and a second leg portion 11extending at an angle from the first leg portion, wherein the at least one blade is rotatable between a first position where the first leg portion extends generally outwardly from the hub and configured to mix and the second leg portion is configured to extend parallel to the hub, and a second position where the second leg portion extends generally outwardly from the hub and configured to mix and the first leg portion is configured to extend parallel to the hub (by way of rotating member and respective drive motors 70, 72 about axes b’, b”; and wherein the blade 8 having the first and second leg portions 11/12 itself is rotatable between the recited first and second positions as claimed by way of motor 2 and shaft 3 wherein such first and second positions are given as two delineated positions within the trajectory of the blade’s rotation about rotary axis x, and noting that the “first” and “second” directions may be the same direction concordantly through the trajectory as presently claimed (pars.[0026,0028,0036,0038,0041,0045,0046], figs. 2,6,7,&12, for example). Further, the amended recitation of claim 1 “wherein a height of the impeller assembly is varied responsive to changing from rotating in the first direction to rotating in the second direction” is not afforded patentable weight as it is drawn to a process recitation in a device claim. With regard to claim 2, the first leg portion has a height that is greater than a height of the second leg portion (see first leg portion 12 extending at a longer height beyond second leg portion 11 as seen in fig. 12) (par.[0034]). With regard to claim 4, Rebei discloses that the at least one blade is connected to the hub via a shaft 3 that extends from the hub (fig. 1 or as in fig. 12 as in the smaller inner circle being drawn to the shaft in the area of roller item 72). With regard to claim 5, the shaft is essentially parallel with a top, side or inclined surface of the hub (as in the shaft being essentially parallel with a side of the hub as in the side edge on the surface adjacent to the designated item ‘7’ in fig. 12). With regard to claim 6, the shaft is given as a horizontal shaft in as much as recited and required herein as it at least exists within a horizontal plane of space. With regard to claim 9, the at least one blade is configured to pivot between the first and second position upon a change in rotation of the hub as such blades are fully capable of being adjusted by their respective drive motors such that they are afforded the ability to pivot, including when a change in a rotation direction of the hub occurs (noting that an active step of changing from one direction to another of the hub’s rotation and coincident pivoting of the leg positions is not required and merely drawn to a capability of the device, in which such capability is afforded herein). With regards to claims 19-22, the recitations are drawn to process recitations (and the particular delineated, intended parameters as in cls. 20-22, which are not a positive element of the system claim and are related by way of a process recitation therein that is not afforded patentable weight) that are not afforded patentable weight in a device claim (Examiner additionally notes pars.[0044-0047] for related discussion in Rebei).
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 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.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rebei.
Rebei has been discussed above.
As discussed therein, Rebei discloses first leg portion 12 extending at a longer height than second leg portion 11, and while diagrammatically in figure 12 it appears that first leg portion 12 has a height that is 1.2 – 3 times the height of second leg portion 11, Rebei does not explicitly disclose the heights or relative heights of each of the first and second leg portions.
However, it would have been obvious to one ordinary skill in the art through routine engineering to optimize the relative heights of the first and second leg portions of Rebei such that the first leg portion has a height 1.2 – 3 times the height of the second leg portion as contemplated by Rebei in pars.[0014,0034] and the depiction in fig. 12 in order to provide a desired topology for effectively mixing the substance(s) at-hand, and this is further seen absent a showing of a criticality or unexpected results arising otherwise with respect to the recited relative height magnitudes.
Claim(s) 7 and 8, is/are rejected under 35 U.S.C. 103 as being unpatentable over Rebei in view of Mattson et al. (US 2015/0165396), hereafter Mattson.
Rebei has been discussed above.
Rebei does not specifically disclose that the at least one blade is pivotably connected to the hub via a living hinge, and wherein the at least one blade is three, four, five, or six blades as in cls. 7&8.
Mattson discloses mixing systems (abstract). Mattson discloses that the impeller blades, which includes four blades, are connected with a living hinge that allows for simple transitions of the blade assembly (pars.[0032,0058,0085,0094], for example).
It would have been obvious to one of ordinary skill in the art to modify Rebei to pivotally connect the at least one blade via a living hinge and utilize four blades such as taught by Mattson in order to provide a hinged connection that affords flexible positioning and transitioning of the blades for various mixing operations and utilizing four blades represents an obvious alternative number of blades for likewise affecting mixing throughout the volumetric space as likewise desired by Rebei and would have a reasonable expectation of success therein.
Claim(s) 10-13, 15-17, as best understood, is/are rejected under 35 U.S.C. 103 as being unpatentable over Rebei in view of Staheli et al. (US 2015/0117142), hereafter Staheli.
Rebei has been discussed above.
With regard to claim 10, Rebei does not specifically disclose a flexible bioprocessing bag comprising the impeller assembly of claim 1 wherein the impeller assembly is enveloped by the bag, and as in those further elements as in cls. 11-13. Further, as in claims 11-13, Examiner notes that the impeller plate is optional, and particularly as in claims 12 & 13, the recitations are improperly further limiting as discussed above.
With regard to claim 15, Rebei does not disclose a flexible bioprocessing bag as in claim 10, however, it is noted that the further recitation provided in claim 15 is drawn to a process recitation not afforded patentable weight herein.
With regard to claim 16, Rebei does not specifically disclose that the bag has a volume between 10 liters and 2500 liters.
With regard to claim 17, Rebei does not specifically disclose a bioreactor mounted in or supported by a rigid support vessel.
Staheli discloses a fluid mixing system with a flexible drive line and foldable impeller (abstract). Staheli discloses container 18 comprises a flexible bag comprising an impeller assembly 46, and wherein the hub 54 is attached to a wall 33 of the bioprocessing bag (and as by an impeller plate 42a), and wherein the impeller assembly is enveloped by the bag (pars.[0005,0009,0010,0053-0055], figs. 2-4, for example). Staheli further discloses that the flexible bioprocessing bag comprises a sparger mounted between the hub and the wall, bottom, or impeller plate (par.[0051], fig. 2, and port 30 between the hub and the wall 33 or impeller plate 42a).
Staheli further discloses that he bag can be manufactured to have virtually any size, shape and configuration, including volumes from 10 liters to 3000 liters (par.[0049]).
Staheli further discloses that flexible bag 18 may be utilized as a part of a bioreactor, and wherein the flexible bag includes heating elements for heating a culture within the container, and provides that the bioreactor given by the bag 18 with applied means for heating cultures therewithin is mounted in or supported by a rigid support assembly 12 (pars.[0045,0052,0065,0116], fig. 1, for example).
It would have been obvious to one of ordinary skill in the art to modify Rebei to provide a flexible bioprocessing bag with the impeller assembly of claim 1, and as in cls. 11-13, such as taught by Staheli in order to provide an integrated mixing assembly to a flexible bioprocessing bag for providing a flexible mixing system suitable for biological mixing applications that avoids puncturing within the flexible bag and unwanted stress on the blades as would be appreciated by the mixing system of Rebei for increased and more dynamic usage thereof and would have a reasonable expectation of success therein. Further, as discussed above, the recitation of claim 15 is drawn to a process recitation not afforded patentable weight in a device claim.
It would have been obvious to one of ordinary skill in the art to modify Robei to provide the flexible bioprocessing bag having a volume between about 10 liters and 2500 liters such as taught by Staheli in order to afford a wide range of volumes to be utilized dependent on the type of application and the scale required so as to provide adaptability for various types of mixing operations.
It would have been obvious to one of ordinary skill in the art to modify Rebei to provide a bioreactor as in claim 17 such as taught by Staheli in order to provide an integrated system that likewise utilizes an impeller mixing assembly for a useful application in a bioreactor for culturing and being structurally sound and connected by a support docking station.
Claim(s) 14 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rebei in view of Staheli as applied to claims 10-13, 15-17 above, and further in view of Wright et al. (US 2010/0014379), hereafter Wright.
Rebei/Staheli does not specifically disclose that the hub comprises a plurality of magnets and wherein the impeller assembly is configured to be magnetically driven by an external magnetic drive, and wherein the rigid support comprises a magnetic drive as in claims 14 and 18.
Wright discloses an agitator apparatus with collapsible impeller in which to reduce the chance of a breach of the environment within the mixing vessel, the mixing vessel employs magnetic drive means for driving the impellers, wherein the magnetic derive means engages the magnets of the agitator apparatus 2 to cause the impellers to move through the contents in the mixing vessel 4 (pars.[0004,0042,0043], fig. 1, for example).
It would have been obvious to one of ordinary skill in the art to modify Rebei/Staheli to provide a plurality of magnets to the hub wherein the impeller assembly is configured to be magnetically driven by an external magnetic drive, and wherein the rigid support comprises a magnetic drive such as suggested by Wright in order to provide means for mixing that reduces the chance of a breach of the environment within the mixing vessel, and providing the magnetic driver to the rigid support as in Staheli represents an obvious connection and placement for the drive as Staheli likewise discloses that the rigid support is drawn to the docking area for connecting and integrating the working pieces of the system and connection therewith provides stable, connected correspondence to the bag for affecting rotation of the impeller as desired.
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rebei in view of Hammad (US 2016/0316972).
Rebei does not specifically disclose that the impeller assembly has a height of about 39.9mm to about 44.1mm.
Further, the amended recitation of claim 23 to “wherein a height of the impeller assembly is varied responsive to changing from rotating in the first direction to rotating in the second direction” is not afforded patentable weight as it is drawn to a process recitation in a device claim.
Hammad discloses an impeller assembly comprising a hub, at least one blade (130, 134, 136, 138 operatively connected to the hub 152 and extending generally outwardly from the hub and wherein the impeller assembly has a height of about 39.9mm to about 44.1mm (pars.[0014-0016], claims 5 and 10, figs.).
It would have been obvious to one of ordinary skill in the art to modify Rebei to provide an impeller assembly that has a height of about 39.9 mm to 44.1mm such as taught by Hammad in the analogous field of an agitator device wherein such a height to the impeller assembly is suitable and obvious to try for affecting a mixing operation as likewise desired in Rebei and would have a reasonable expectation of success therein.
Claim(s) 24, as best understood, is/are rejected under 35 U.S.C. 103 as being unpatentable over Rebei in view of Guedel (USPN 3,907,459).
Rebei is discussed in detail above with respect to the rejection set forth under 35 USC 102a1. As previously presented therein, with regard to claim 24, Rebei discloses a method of operating an impeller assembly as recited therein to the active steps of “providing a hub…”, “providing at least one blade..”. “rotating the at least one blade to a first position…”, “and “rotating the at least one blade to a second position…” as likewise seen in the above discussion to claim 1 and cited with respect to pars.[0026,0028,0041,0045,0046], figs. 2,6,7,&12, for example).
With regard to claim 24, Rebei does not specifically disclose varying a height of the impeller assembly responsive to changing from the first direction to the second direction.
Guedel discloses a mixing apparatus wherein the impeller of the mixing apparatus simultaneously rotates about the vertical axis of the apparatus and is movable up and down said vertical axis, which provides superior mixing, blending, and agitating of liquids used in chemical, pharmaceutical, and paint industries (abstract). Guedel discloses that the double threaded member 15 allows the impeller, which is reciprocally and rotatably mounted on the slotted drive tube 16, to be simultaneously guided both rotationally and vertically when the device is operating (wherein the vertical movement of the impeller provides a coincident vertical movement of the blade(s) 23 connected therewith; lines 38-67, col. 2, figs. 1&2, for example)
It would have been obvious to one of ordinary skill in the art to modify Rebei to vary a height of the impeller assembly responsive to changing from the first direction to the second direction such as suggested by the analogous art of Guedel to a mixing apparatus for chemical and paint products (see par.[0027] of Reber) in order to provide super mixing and blending of the liquids used therein.
As discussed above, the claimed “first” and “second” direction may be drawn to the same direction, and also, such recitation is accordingly rejected under 35 USC 112 b/2nd paragraph as discussed above as it pertains to the language “varying a height…responsive to changing from the first direction to the second direction” that reads on a continual rotation at different points in time, for example.
Further, and even assuming amendments to the claims to provide that the first and second directions are different from one another, the step of varying the height of the blade responsive to changing from the first direction to the second direction is drawn to an obvious engineering design choice as seen through the prior art of Reber in view of Guedel, wherein the principle remains as taught by Guedel that simultaneously rotating while changing the height of the blade of the impeller assembly provides superior mixing, blending, and agitating of liquids used in chemical, pharmaceutical, and paint industries, and doing so coincident with a change in direction of rotation amounts to an obvious engineering design choice for the reasons discussed above wherein such modification would have a reasonable expectation of success for the likewise desired superior mixing principle, and further seen absent a showing of a criticality or unexpected results arising otherwise. *It is further noted that Guedel speaks to implementation with a standard drill to drive the impeller, wherein standard drills are well-known for providing clockwise and counterclockwise rotation by switch activation (abstract; lines 38-52, col. 4).
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rebei in view of Hammad (US 2016/0316972).
Rebei does not specifically disclose wherein the first leg portion includes a depending leg portion that extends downwardly adjacent to a periphery of the hub.
Hammad discloses a blending appliance including a blade assembly comprising a first leg portion 134 that includes a depending leg portion 134b that extends downwardly adjacent to a periphery of the hub and provide that substances are prevented from building up at the bottom of the jar (pars.[0016,0017], fig. 4, for example).
It would have been obvious to one of ordinary skill in the art to modify Rebei so as to provide the first leg portion including a depending leg portion that extends downwardly adjacent to a periphery of the hub such as suggested by Hammad in order to provide an additional blade wing portion that may more effectively cover a fuller extent of the space occupied for homogenizing the mixture and avoiding unwanted build up at the bottom.
Response to Arguments
Applicant's arguments filed July 11th, 2025 have been fully considered but they are not persuasive.
With regards to claims 1, 2, 4-6, 9, and 19-22 rejected under 35 USC 102a1 as being anticipated by Reber, Applicant traverses the rejection.
Applicant asserts that Reber does not contemplate the blades being configured to rotate in a first direction and a second direction, let alone adjusting which portion of the blades mixes the liquid based on the direction of rotation, as recited in claim 1.
Examiner asserts that upon further consideration of the amended claims and of the prior art of Reber that the prior art of Reber is maintained to be anticipatory of the claims.
Herein, in claim 1, it is provided that the at least one blade is rotatable between a first position and a second position as claimed. The active process at each of these first and second positions (“where the at least one blade rotates in a first…for mixing…” and “where the at least one blade rotates in a second…for mixing”) are not required to be carried out as the claims are drawn to a device.
Examiner asserts that the device of Rebei is commensurately structurally arranged as claimed and also functionally provides for (“configured to” as amended herein) the at least one blade that is rotatable between a first position and a second position as claimed.
As seen through figure 12 and par.[0041,0044], the blade 8 is rotatable in a first and a second direction (and as previously noted, such “first” and “second” direction may be the same direction as presently claimed), and the two leg portions (first 12, second 11) are both afforded to extend outwardly and parallel as recited herein.
Reber provides that the first and second leg portions are each rotatably about their own rotation axes b”, b’ wherein it is seen that such leg portions are able to be rotated (i.e. “configured to” herein) such that the first leg extends generally outwardly from the hub and is configured to mix and the second leg portion is configured to extend parallel to the hub, and a second position where the at least one blade is configured to rotate in a second direction and the second leg portion extends generally outwardly from the hub and is configured to mix and the first leg portion is configured to extend parallel to the hub. This is clearly seen as both legs may individually rotate about their respective axes.
Applicant further asserts that the mixing device of Reber does not contemplate or suggest a different portion of the blade that extends outwardly form the shaft for mixing based on the direction of rotation as recited in the present claims.
Examiner asserts that such arguments are not persuasive as they are not commensurate in scope with the present claims and in which such mixing and process are not necessitated in claims 1, 2, 4-6, 9, and 19-22.
As such, Examiner maintains rejection of claims 1, 2, 4-6, 9, and 19-22 as being anticipated by Reber for the reasons discussed above and in the body of the action.
Further, as in the method of claim 24, as seen in par.[0041] and fig. 12 of Rebei, respective drive motors 72 are connected to the first and second leg portions 11/12 and for actively rotating the respective portions 11/12 around the respective axes b’, b” wherein Reber provides disclosure to likewise processes as in the method of claim 24.
Furthermore, to this, and as seen in pars. [0026,0028,0036,0038], for example, the blade 8 (having the first and second leg portions 11/12) itself is rotatable (and actively rotated as in cl. 24) between the recited first and second positions as claimed by way of motor 2 and shaft 3, and wherein rotation of the agitating member that carries the blade(s) 8 provides to concordantly rotate the blade as claimed in the mixing process in Rebei wherein, as discussed above, the blade 8 and its legs 11/12 at these two positions are controllably affected in their first and second directions by their respective drive motors 72 and in which such rotation necessarily provides that the first portion “extends generally outwardly form the hub…” and the second leg “extends generally outwardly from the hub…” as claimed. The recitation to the first and second legs as “extending generally outwardly from the hub” in these rotation steps is a highly broad characterization of their orientation in the space in which in any position of the first leg portion to that of the second leg portion can be deemed to be “generally outwardly from the hub” as these leg portions exist within the physical confines of the device and protrude from the hub all the way about their respective axes.
The amendment to “varying a height of the at least one blade of the impeller assembly responsive to changing from the first direction to the second direction is given by the added prior art of Guedel, as discussed above in the body of the action.
With regard to claim 3, Examiner asserts that as discussed above there are no such deficiencies with respect to Rebei and claim 3 is maintained rejected for the reasons discussed above in the body of the action.
With regard to claims 7 and 8, Examiner asserts that as discussed above there are no such deficiencies with respect to Rebei and claims 7 and 8 are maintained rejected for the reasons discussed above in the body of the action.
With regard to claims 10-13 and 15-17, Examiner asserts that as discussed above there are no such deficiencies with respect to Rebei and claims 10-13 and 15-17 are maintained rejected for the reasons discussed above in the body of the action.
With regard to claims 14 and 18, Examiner asserts that as discussed above there are no such deficiencies with respect to Rebei and claims 14 and 18 are maintained rejected for the reasons discussed above in the body of the action.
With regard to claim 23, Examiner asserts that as discussed above there are no such deficiencies with respect to Rebei and claim 23 is maintained rejected for the reasons discussed above in the body of the action.
With regard to claim 25, Examiner asserts that as discussed above there are no such deficiencies with respect to Rebei and claim 25 is maintained rejected for the reasons discussed above in the body of the action.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NEIL N TURK whose telephone number is (571)272-8914. The examiner can normally be reached M-F 930-630.
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/NEIL N TURK/Primary Examiner, Art Unit 1798