DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 09, 2026 has been entered. Any previous objection/ rejection not repeated herein has been withdrawn. New and/or modified grounds for rejection, necessitated by the amendments, are discussed.
Claim Interpretation
In the patentability analysis of system claims, aspects or limitations the examiner interprets as functional/process or not positively recited elements are generally italicized whereas aspects interpreted as structural components are normally bolded. The bold font and italics are shown when the structure and function are initially introduced though not necessarily repeated, particularly in dependent claims. Examiner applies this formatting for both the examiner and applicant’s convenience. However, absent the referenced typestyles, the patentability analysis will still be clear regarding which limitations the examiner interprets as structural versus functional.
The claims are apparatus/device/system claims requiring only the recited structural components, although structured with physical features that can perform the stated functions or the intended uses. Functional limitations state either an intended use or operation, a manner of operating a device/apparatus/system (i.e., process limitations), or what the device/apparatus/system does. Apparatus claims cover what a device is, not what a device does. Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). Also, 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. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Of course, in the patentability analysis of these apparatus/system claims, functional/process features are not ignored and Applicant can and should employ such language where appropriate and helpful. However, if a prior art structure is capable of performing the intended use, or if such apparatus can operate in the manner described, then it meets the claim limitation (MPEP §§ 2114, 2173.05(g)).
In summary, while features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997).
Note: the examiner's referral to applicant's specification will generally pertain to the corresponding PG published application, if available, otherwise the original specification. The below patentability analysis provides one or more interpretations and claim mappings of the claimed structures and/or limitations although other interpretations may be possible. In the patentability analysis, the Office applies the broadest reasonable interpretation (BRI) consistent with the specification. However, specific limitations from the specification are not read into the claims. See MPEP §§2111, 2173.01.
Claim Rejections - 35 USC § 102/103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 2, 6-15, and 19 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by or, in the alternative under 35 U.S.C. 103 as obvious over Greller et al., (US 2009/0275121; hereinafter “Greller”).
As to claim 1, Greller teaches bioreactor for cell culturing, the bioreactor comprising:
a container 1 having a base and a side wall defining an internal volume 6, and a lid (reads on cover part 7), wherein the base is moveable toward and away from the lid (the disposable bioreactor having flexible wall 5 which surrounds a reactor interior 6, see para [0024] et seq.,. That is, the flexible walls of Greller include a flexible base wall which by being flexible the base wall would be capable of moving relative to the lid); and
a baffle member 3/9/11 mounted to the lid 7 and positioned in the internal volume of the container and wherein the baffle member extends parallel to the lid (para [0024] et seq., of Greller recites, in this case, the mixer stem 2 penetrates a cover part 7 of the bioreactor 4, which cover part is arranged at the top in the vertical direction. The mixer stem 2 is sealed in relation to the cover part 7).
It is further noted that part of the baffle member 3 in Greller appears to extend across at least 50 percent of the cross-sectional area of the container (see Figs. 1 and 2). While, the Greller disclosure is silent to the size of the baffle member relative to the cross-section area of the container, the prior art drawings must be evaluated for what they reasonably disclose and suggest to one of ordinary skill in the art (see MPEP 2125 I). Moreover, the description of the baffle as pictured can be relied on, in combination with the drawings, for what they would reasonably teach one of ordinary skill in the art (see MPEP 2125 II). As with the claimed device, the baffle of Greller is made for mixing the liquid primarily along the longitudinal axis (Greller- see arrows in Fig. 1, e.g., longitudinal movements, see para [0024] et seq.).
Thus, should the size of the baffle be considered not taught by Greller, then it would have been obvious to one of ordinary skill at the time the claimed invention was effectivity filed determine the optimum length of the baffle in the bioreactor such that the baffle extends across at least 50 percent of the cross-sectional area of the container, since there are a finite number of identified, predictable solutions, a person of ordinary skill in the art has a good reason to pursue the known options within his or her technical grasp. The use of a baffle extending across at least 50 percent of the cross-sectional area of the container in Greller is obvious since it does no more than yield predictable results. (see MPEP 2143). In this case, size of the baffle produces the predictable result of creating the desired amount of mixing inside the bioreactor. Also, it the determination of the size of the baffle relative to the cross-section of the container would have been an obvious matter of design choice, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art, see MPEP 2144.04.
As to claim 6, Greller teaches the baffle member comprises a sloped surface arranged to face the lid 7 (reads on sloped conically tapered holes 10 in the baffle 3, see para [0024] et seq.).
As to claim 7, Greller teaches the baffle member 3 comprises one or more holes or openings 10 for passage of fluid through the baffle member as the base is moved relative to the lid (see para [0024] et seq.).
As to claim 8, Greller teaches one or more of the holes or openings comprises an angled surface (reads on sloped conically tapered holes 10 in the baffle 3, see para [0024] et seq.).
As to claim 9, Greller teaches the baffle member comprises one or more ribs (Mennenga disclose reads sloped conically tapered holes 10 in the baffle 3, see para [0024] et seq. which in between the holes 10 are ribs).
As to claim 10, Greller teaches an outer edge of the baffle member is circular (see the circular outer edge of the baffle in Figs. 1-2).
As to claim 11, Greller teaches the side wall of the container is compressible (flexible wall 5; see para [0024] et seq.)
As to claim 12-14, Greller teaches the baffle member is movably (i.e., slidably and rotatably) along the longitudinal axis and mounted to the lid through an aperture (see para [0015] et seq.)
As to claim 15, Greller teaches a second baffle member 3’ mounted to the lid 7.
As to claim 17, Greller teaches a mounting portion attached to the lid and supporting the baffle member mounted (i.e., reads on seal provided the sealed relationship between the to the cover part 7 and the baffle member 2) see para [0024] et seq. and Figs. 1-2) and a fluid path (tube 11) formed in the baffle member and the mounting portion, the fluid path extending from an opening in the baffle member through the mounting portion and to an opening via tubes 14 on the external of the container for convey fluid into and/or out of the container (see para [0025] et seq.)
As to claim 18, Greller teaches the tube 11 (considered part of the baffle member) includes a gas-injection unit 15 has a porous structure which is suitable for filtering gas supplied via the lateral inlet 14 and arranged to filter fluid passing through the fluid path, ass para [0042] et seq.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 16 and 20-27 are rejected under 35 U.S.C. 103 as being unpatentable over Greller in view of Mennenga et al., (US 2007/0253288; hereinafter “Mennenga”).
With respect to claim 16, as discussed above, Greller teaches the invention substantially as claimed. However, Greller is silent to the second baffle arranged such that is not be parallel to the other baffle member, such that the second baffle member is angled with respect to the baffle member. In the related art of mixing a flexible bioreactor, Mennenga teaches at least two baffle members 5’’, 5’’ attached to the lid; see para [0042] et seq. and Fig. 8). Mennenga also teaches according to the exemplary embodiment of FIG. 7, two mixers 3''' arranged at right angles in relation to each other are arranged in the interior 2 of the container (see para [0046] et seq.) It would have been obvious to one of ordinary skill in the art at the time the claimed invention was filed to have arranged the second baffle of Greller at an angle relative to the first baffle, as taught by Mennenga for the predictable result of providing the desired mixing inside the flexible container based on considerations such as size of the container.
As to claim 19 and 25, Geller teaches a bioreactor system and method of operating the same;
a bioreactor comprising:
a container 1 having a base and a side wall defining an internal volume 6, and a lid (reads on cover part 7), wherein the base is moveable toward and away from the lid (the disposable bioreactor having flexible wall 5 which surrounds a reactor interior 6, see para [0024] et seq.. That is, the flexible walls of Greller include a flexible base wall which by being flexible the base wall would be capable of moving relative to the lid); and
a baffle member 3/9/11 mounted to the lid 7 and positioned in the internal volume of the container and wherein the baffle member extends parallel to the lid (para [0024] et seq., of Greller recites, in this case, the mixer stem 2 penetrates a cover part 7 of the bioreactor 4, which cover part is arranged at the top in the vertical direction. The mixer stem 2 is sealed in relation to the cover part 7); and
an agitator 8 (see para [0024] et seq.) arranged to move the base of the bioreactor such that during use the baffle member mixes contents of the bioreactor.
Note: With respect to the functional/process language in apparatus claims 20-24 and 26-27, (ex: “wherein agitator is the arranged to move the base of the bioreactor such that during use the baffle member mixes contents of the bioreactor) has not received patentable weight. The functional/process language does not add any further structure beyond a capability (see MPEP § 2114 & § 2173.05(g)). Nevertheless, agitator Geller teaches the vibration mixer 1 is driven via a drive 8 which can be connected to the mixer stem 2 outside the reactor interior 6. The mixer stem 2 is thrown by the drive 8 into longitudinal movements which are transmitted to the mixing element 3 arranged on the mixer stem 2, which is capable of resulting in moving the flexible base member which would necessarily cause the baffle member to mix the contents of the bioreaction as the base.
In the interest of compact prosecution the examiner will provide an interpretation in which the operation of the agitator is considered to directly move the base of the bioreactor by direct physical communication such that during use the baffle member mixes the contents of the bioreactor. In which case, Geller is considered as not teaching the agitator is in direct communication to move the base of the bioreactor by direct communication such that during use the baffle member mixes the contents of the bioreactor.
However, in the related art of mixing a flexible bioreactor, Mennenga teaches a baffle member mounted to the lid and one baffle member mounted to the base a least two baffle members 5’’, 5’’ attached to the lid. Mennenga also teaches according another exemplary embodiment of FIG. 5, a pneumatic force introducing device 25 acts on the coupling piece 26 with compressed air pulses. Instead of the pneumatic force introducing device 25, a mechanical force introducing device 27 having an oscillating pressure plunger 28 (see FIG. 11) can also be used. The pressure plunger 28 executes an up and down movement 29, 30, raising the mixer 3''' in the upward movement 29 via the coupling piece 26 which, during the downward movement 30, follows the pressure plunger 28 with the mixer 3''' as a result of gravity. This direct mechanical force on the base of the flexible container necessarily causes the base to tilt relative to the lid and thereby provide a cell suspension where the drive of the mixer is carried out via the external coupling piece (outside the container). Mennenga teaches the advantage of using external operatively connected force by the drive would produce a simple, reliable, effective and economical mixing apparatus which does not have known sealing problems found in drive means that penetrate the flexible container, see para [0014] et seq.
Accordingly, it would have been obvious to one ordinary skill in the art at the time the claimed invention was effectively filed to substitute the agitator of Greller with the external vibrator of Mennenga, since Mennenga teaches that the use of external operatively connected force by the drive would produce a simple, reliable, effective and economical mixing apparatus which does not have known sealing problems found in drive means that penetrate the flexible container, see para [0014] et seq.
As discussed above, with respect to the size of the baffle member 3/9 in Greller it appears to extend across at least 50 percent of the cross-sectional area of the container (see Figs. 1 and 2). While, the Greller disclosure is silent to the size of the baffle member relative to the cross-section area of the container, the prior art drawings must be evaluated for what they reasonably disclose and suggest to one of ordinary skill in the art (see MPEP 2125 I). Moreover, the description of the baffle as pictured can be relied on, in combination with the drawings, for what they would reasonably teach one of ordinary skill in the art (see MPEP 2125 II). As with the claimed device, the baffle of Greller is made for mixing the liquid primarily along the longitudinal axis (Greller- see arrows in Fig. 1, e.g., longitudinal movements, see para [0024] et seq.).
Thus, in case it is determined that the size of the baffle is not taught by Greller, then it would have been obvious to one of ordinary skill at the time the claimed invention was effectivity filed determine the optimum length of the baffle in the bioreactor such that the baffle extends across at least 50 percent of the cross-sectional area of the container, since there are a finite number of identified, predictable solutions, a person of ordinary skill in the art has a good reason to pursue the known options within his or her technical grasp. The use of a baffle extending across at least 50 percent of the cross-sectional area of the container in Greller is obvious since it does no more than yield predictable results. (see MPEP 2143). In this case, size of the baffle produces the predictable result of creating the desired amount of mixing inside the bioreactor. Also, it the determination of the size of the baffle relative to the cross-section of the container would have been an obvious matter of design choice, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art, see MPEP 2144.04.
Note: claims 20-24, 26 and 27 are apparatus type claims and limitations directed to the operation or results of the agitator are considered functional/process limitations that do not further limit the structure of the bioreactor. However, in a case these limitations are not considered functional/process language then it would have been obvious to one of ordinary skill in the art at the time the claimed invention was effectively filed to determine the desired stroke length, frequency, angle, tilt of the base relative to the baffle member necessary to adequately suspend the cells to prevent adhesion of the cells to the inner surfaces of the container since this involves only routine skill in the art. The applicant is advised that the Supreme Court has clarified that a claim can be proved obvious merely by showing that the combination of known elements was obvious to try. In this regard, the Supreme Court explained that “[w]hen there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill in the art has a good reason to pursue the known options within his or her technical grasp.” An obviousness determination is not the result of a rigid formal disassociated from the consideration of the facts of the case. See MPEP 2143.
Response to Arguments
Applicant's arguments filed December 09, 2025, in so much applicant’s arguments apply to the instant rejections above, the examiner respectfully does not agree that the Office has not articulated the obvious to try rational to the functional/process limitations 20-24 and 26-27. The examiner argues that it would have been obvious to one of ordinary skill in the art at the time the claimed invention was effectively filed to determine the desired stroke length, frequency, angle, tilt of the base relative to the baffle member necessary to adequately suspend the cells to prevent adhesion of the cells to the inner surfaces of the container since this involves only routine skill in the art. The applicant is advised that the Supreme Court has clarified that a claim can be proved obvious merely by showing that the combination of known elements was obvious to try. In this regard, the Supreme Court explained that “[w]hen there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill in the art has a good reason to pursue the known options within his or her technical grasp.” An obviousness determination is not the result of a rigid formal disassociated from the consideration of the facts of the case. See MPEP 2143. The MPEP 2144.05(ii) also states in the absence of a showing of criticality, "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.). The Office maintains the instant facts are similar because the claimed the agitator and the agitator in both Greller and Mennenga are both directed to mixing flexible container and the agitator would be capable of being operated as the claimed. In the absence of a showing of criticality, the Office maintains it would have been within the skill of the art to modify as optimization of a workable range by routine experimentation.
Citations to art
In the above citations to documents in the art, an effort has been made to specifically cite representative passages, however rejections are in reference to the entirety of each document relied upon. Other passages, not specifically cited, may apply as well.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure include:
Morrissey et al., (US 2012/0027324) which teach a closed bag having a disposable mixing element within it, a drive mechanism outside of the bag for rotating the mixing element without voiding sterility and a vortex breaker in the form of one or more plastic sheet materials that are attached to various inner surfaces of the bag which disrupt the formation of vortices within the bag. Preferably the sheet materials are formed of the same material as the bag and are sealed to the bag surfaces. More preferably, the sheet(s) extend across a diameter of the bag. Most preferably, the sheet(s) are perforated with one or more slits or openings to allow for good flow and mixing without a vortex being formed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to P. Kathryn Wright whose telephone number is (571)272-2374. The examiner can normally be reached on 9:30am-7:30 pm EST.
Examiner interviews are available via telephone and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
E-mail communication Authorization
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting the following statement via EFS Web (using PTO/SB/439) or Central Fax (571-273-8300):
Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached on (571) 270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P. Kathryn Wright/Primary Examiner, Art Unit 1798