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 .
Election/Restrictions
Claims 15-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on March 2, 2026.
Applicant's election with traverse of Group I, claims 1-14, in the reply filed on March 2, 2026 is acknowledged. The traversal is on the ground(s) that the technical features shared between the alleged inventions are special technical features and that the reference does not directly and unambiguously disclose or suggest the special technical features of separate process and storage drawers, nor of the provisions of at least one vertical storage drawer slidably received within a (separate) vertically stacked cabinet. This is not found persuasive because the instant application is a national stage entry filed under 35 U.S.C. 371 and is subject to lack of unity practice, see MPEP 1893.03(d). It is noted that inventions listed as Groups I and II do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features as set forth on pages 4-5 of the previous Office Action, specifically that the special technical feature is bioprocessing apparatus comprising a drawer described in both independent claims 1 and 20, but wherein the recited drawer of the bioprocessing apparatus of claim 1 is not recited in the disposable kit of claim 15.
The requirement is still deemed proper and is therefore made FINAL.
Drawings
The drawings were received on 5/25/2023. These drawings are acceptable.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“mechanism for supporting at least one media bag” in claim 5;
“mechanism for supporting at least one reagent bag” in claim 5; and
“interlock mechanism” in claim 8.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification filed 5/24/2023 as performing the claimed function, and equivalents thereof:
“mechanism for supporting at least one media bag” in claim 5: Para. 0154 describes the use of hooks (118) for suspending a plurality of bags for containing or receiving fluids used in the bioprocessing operations;
“mechanism for supporting at least one reagent bag” in claim 5: Para. 0154 describes the use of hooks (118) for suspending a plurality of bags for containing or receiving fluids used in the bioprocessing operations; and
“interlock mechanism” in claim 8: Para. 0204 of applicant’s specification recites that the interlock mechanism may be a pneumatic latch or pin.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim(s) 1-7, 9, and 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Griffin et al WO 2019/106207 A1) (provided by applicant in IDS filed 5/12/2026) in view of Yamamoto et al (US 2004/0152188 A1) (provided by applicant in IDS filed 5/24/2023).
With respect to claim 1 Griffin discloses a bioprocessing apparatus (700, See Para. 0166 and Fig. 23) comprising:
A housing (housing 710, See Para. 0166 and Figs. 23-24);
A process drawer (drawer 712) receivable within the housing and moveable between a closed position and an open position (See Fig. 24 and Para. 0167-0168), the process drawer being configured to receive at least one culture vessel therein (kit 600 is received by the bioprocessing apparatus); and
A cabinet (drawer(s) 714,716) that also functions as a slidable drawer (See Para. 0166 for discussion of how the drawers are received in a dedicated housing and can be stacked atop one another).
Applicant should note the italicized limitations are directed to the function of the apparatus and/or the manner of operating the apparatus. All the structural limitations of the claim identified above have been disclosed by Griffin and the apparatus of Griffin is capable of the recitation of claim 1. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Griffin (see MPEP §2114).
Griffin fails to disclose that the cabinet is positioned in stacked vertical relative to the housing, the cabinet including at least one vertical storage drawer.
Yamamoto teaches an incubator 1 comprising a chamber 11 having a front opening 10 and a door 12 for closing the opening 10. An incubator unit 2 is accommodated in the interior of the chamber 11 (See Para. 0053). The incubator unit 2 comprises, as mounted on a base 21, a microplate transport device 5 having a microplate transport table 50, and a pair of left and right stacker holders 23, 23 arranged on opposite sides of the transport device 5. The stacker holder 23 retains thereon a plurality of stackers 3 arranged forward or rearward for accommodating microplates. The stackers 3 on a drawer 22 can be brought out of the opening 10 by withdrawing the drawer 22 through the opening 10 with the door 12 opened as seen in FIG. 2, and the stackers 3 can be withdrawn from the holder 23. The stacker 3 can then be readily replaced by another one and the stacker 3 can be cleaned after use (See Figs. 1-4 and Paras. 0056-0057). In the incubator 1 of the present invention, the stackers 3 are arranged within the chamber 1 symmetrically about the transport device 5 on opposite sides thereof as seen in FIG. 1, so that a larger number of stackers 3 can be installed inside the chamber 11 than in the conventional incubator wherein the microplate accommodating racks are provided at only one side of the microplate transport device. An increased number of microplates 31 can therefore be accommodated in the chamber (See Para. 0060).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the vertical orientation of the cabinet and drawer(s) of Yamamoto into the cabinet and drawer(s) of the bioprocessing apparatus of Griffin to enable a larger number of devices to be held and maintained by the cabinet (See Para. 0060 of Griffin).
With respect to claim 2 the combination of Griffin and Yamamoto teaches a first door (door 12) hingedly connected to the cabinet and providing access to the at least one vertical storage drawer (See Figs. 1-2 of Yamamoto) the at least one door including structure configured to releasably retain at least one of a sampling card and a tubing organizer on an interior face of the first door (applicant should note that the recited structures of a sampling card and tubing organizer have not been positively recited as claimed features of the current invention). Applicant should note the italicized limitations are directed to the function of the apparatus and/or the manner of operating the apparatus. All the structural limitations of the claim identified above have been taught by the combination of Griffin and Yamamoto and the apparatus of combined Griffin and Yamamoto is capable of the recitation of claim 2. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of combined Griffin and Yamamoto (see MPEP §2114).
With respect to claim 3, applicant should note that the recited “tubing organizer” has not been positively recited as a claimed feature of the current invention.
With respect to claim 4, applicant should note that the recited “sampling card” has not been positively recited as a claimed feature of the current invention.
With respect to claim 5 the combination of Griffin and Yamamoto teaches that the at least one vertical storage drawer is a plurality of vertical storage drawers (plurality of stackers 3 depicted in Figs. 1, 2, 4, and 5 of Yamamoto) including a first vertical storage drawer having a mechanism (holders 23 on first vertical drawer depicted in Figs. 2 and 4 of Yamamoto) for supporting at least one media bag thereon, and a second vertical storage drawer having a mechanism (holders 23 on second vertical drawer depicted in Figs. 2 and 4 of Yamamoto) for supporting at least one reagent bag thereon. Applicant should note the italicized limitations are directed to the function of the apparatus and/or the manner of operating the apparatus. All the structural limitations of the claim identified above have been taught by the combination of Griffin and Yamamoto and the apparatus of combined Griffin and Yamamoto is capable of the recitation of claim 2. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of combined Griffin and Yamamoto (see MPEP §2114).
With respect to claim 6 the combination of Griffin and Yamamoto teaches that the first vertical storage drawer and the second vertical storage drawer include a drip tray (reservoir pan 60, See Fig. 4 and Para. 0059 of Yamamoto). Although the combination fails to teach that the drip tray is removable, applicant should note that the courts have held In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961) that even if a reference does not teach that something is separable, the mere modification of making something removable/separable has no patentable significance unless a new and unexpected result is produced. Additionally, the courts have held In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) that even if a reference does not teach a plurality of a feature, a mere duplication of parts has no patentable significance unless a new and unexpected result is produced.
With respect to claim 7 the combination of Griffin and Yamamoto teaches that at least one of the first vertical storage drawer and the second vertical storage drawer is refrigerated (See Para. 0168 of Griffin for discussion of how the auxiliary compartment 730 may be refrigerated).
With respect to claim 9 the combination of Griffin and Yamamoto teaches a load cell (See para. 0170 of Griffin for discussion of a plate 750 being configured with load cells positioned adjacent to bed plates 746,748) configured to receive a waste bag, the load cell being configured to facilitate measurement of a weight of fluid within the waste bag. Applicant should note the italicized limitations are directed to the function of the apparatus and/or the manner of operating the apparatus. All the structural limitations of the claim identified above have been taught by the combination of Griffin and Yamamoto and the apparatus of combined Griffin and Yamamoto is capable of the recitation of claim 9. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of combined Griffin and Yamamoto (see MPEP §2114).
With respect to claim 12 the combination of Griffin and Yamamoto fails to teach that the process drawer is configured to receive at least two culture vessels therein, in a front to back relation. However, applicant should note that the courts have held in In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) and In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) that even if a reference does not teach a plurality of a feature or a rearrangement of features, a mere duplication of parts or rearrangement of parts has no patentable significance unless a new and unexpected result is produced.
With respect to claim 13 the combination of Griffin and Yamamoto teaches that the process drawer is configured to receive a disposable kit including a drip tray, the at least one culture vessel positioned within the drip tray, and a valve manifold. Applicant should note that the italicized limitations are directed to the function of the apparatus and/or the manner of operating the apparatus. All the structural limitations of the claim identified above have been taught by the combination of Griffin and Yamamoto and the apparatus of combined Griffin and Yamamoto is capable of the recitation of claim 13. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of combined Griffin and Yamamoto (see MPEP §2114). Additionally, Griffin teaches the incorporation of first and second bioreactor vessel 410,420, each including a respective valve (See Para. 0123). The first and second bioreactor vessels 410, 420 and the fluid architecture 400 may be integrated into a single-use, disposable assembly or kit 600 (See Para. 0156).
With respect to claim 14 the combination of Griffin and Yamamoto teaches a linear actuator array (linear actuator 768, See Paras. 0168 and 0177 of Griffin) configured to interface with the valve manifold for controlling a routing of fluid throughout the bioprocessing apparatus; and a peristaltic pump assembly (peristaltic pump assembly 738, See Figs. 24 and 33-39 and Para. 0180 of Griffin) for flowing a fluid throughout the bioprocessing apparatus. Applicant should note that the italicized limitations are directed to the function of the apparatus and/or the manner of operating the apparatus. All the structural limitations of the claim identified above have been taught by the combination of Griffin and Yamamoto and the apparatus of combined Griffin and Yamamoto is capable of the recitation of claim 14. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of combined Griffin and Yamamoto (see MPEP §2114).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Griffin et al WO 2019/106207 A1) and Yamamoto et al (US 2004/0152188 A1) in view of Moffitt et al (US 2003/0136716 A1).
Refer above for the combined teachings of Griffin and Yamamoto.
With respect to claim 8 the combination of Griffin and Yamamoto fails to teach an interlock mechanism configured to maintain the first door in a closed position with respect to the cabinet and to prevent opening of the first door when a bioprocessing operation is in progress.
Moffitt teaches an arrangement of a reservoir and bioreactor system within a cabinet (23) (See Figs. 3 and 7 and Para. 0055). The cabinet has a hinged door (25) and an internal latching/locking mechanism (24) allowing the door to be padlocked. Such a mechanism advantageously excludes the necessity of an external latching system. It actually makes the door "easy to use" and it eliminates the necessity of using an external bulky hardware as was previously employed. As also shown in FIG. 7, the door now opens a full 180° to facilitate servicing. Moreover, the locking mechanism has been simplified and improved to provide a more secure closure (See Para. 0093).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the latching/locking mechanism of the door of Moffitt into the door of combined Griffin and Yamamoto in order to provide a more secure closure of the door (See Para. 0093 of Moffitt).
Allowable Subject Matter
Claims 10, 11 are 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 claims.
The following is a statement of reasons for the indication of allowable subject matter: the closest cited prior art of reference fails to teach or disclose:
That the load cell includes a plate within the housing beneath the process drawer (Para. 0170 of Griffin discloses that the plate 750 is located inside the process drawer 712); and
That the load cell includes a peg configured to receive a waste bag, the peg being connected to one of the at least one vertical storage drawers (claim 11).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRITTANY I FISHER whose telephone number is (469)295-9182. The examiner can normally be reached IFP.
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/BRITTANY I FISHER/Examiner, Art Unit 1796 May 25, 2026
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