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 .
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.
Election/Restrictions
Applicant’s election of Group I, Claims 1-12, in the reply filed on 5/12/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 13-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/12/2026.
Priority
Receipt is acknowledged of certified copies of papers (UNITED KINGDOM 2105923.3 04/26/2021) required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements dated 9/11/2023 and 5/13/2026 have been considered and made of record.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “control system” of claim 1 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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: “a control system” (ASCO controller)(¶[0066] of the instant specification)(a control device designed to manage solenoid valves, process actuators and pneumatic systems) in claim 1.
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 as performing the claimed function, and equivalents thereof.
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 § 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.
Claims 3, 4, 11 and 12 are 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.
In claim 3, at line 1, “the pattern” lacks antecedent basis. I appears that claim 3 should depend from claim 2 and will be treated on its merits as though it depends from claim 2.
Claim 4 is included in this rejection because it depends from claim 3 and does not cure the deficiencies of claim 3.
Claims 11 and 12 are considered indefinite because the claim merely recites that the “system” is “further operable” without recitation of any further positively recited structure or further limitations of previously recited structures of the system. As a result, the metes and bounds of the claims cannot be clearly determined.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Fitzpatrick et al. (US 2020/0297911) (Attached PTO-892) in view of Vlassov et al. (US 2021/0190809) (Attached PTO-892).
With respect to claim 1, the reference of Fitzpatrick et al. discloses:
A bioprocessing system (Figs. 1a-1d) operable to perform a predetermined bioprocessing operation therein, the reconfigurable bioprocessing system comprising:
a base unit (100, 130, 1200) comprising a plurality of valve actuators (valve assembly)(120), wherein at least one of the plurality of valve actuators is operable to releasably engage with at least part of a pinch valve cassette (single use kit)(1205)(¶[0031]) to control fluid flow through the pinch valve cassette, and wherein at least part of the pinch valve cassette is removably attachable to the base unit (¶[0010]-[0020] and [0068]; and
a control system (system controller) (¶[0017] and [0132]) operable to selectively actuate respective of said plurality of valve actuators to provide a valve configuration within the pinch valve cassette to enable the base unit and the pinch valve cassette together to perform the predetermined bioprocessing operation.
While the reference disclose the use of a control system to perform a predetermined bioprocessing operation, the reference does not specifically disclose that the control system is operable to selectively perform one of a predetermined set of bioprocessing operations.
The reference of Fitzpatrick et al. does disclose that the system is suitable for application in numerous processes for separating or accumulating small particles in a fluid suspension (¶[0147]-[0152]) and can be used for other applications (¶[0153]).
The reference of Vlassov et al. discloses that it is known in the art to provide single use cassettes (cartridges)(¶[0290]) with identifiers and that it is known in the art to provide the control system with a set of different protocols (¶[0296]-[0300]) wherein the protocol performed is based on sensor data including that provided on the single use cassette.
In view of these teachings and in the absence of a showing of unexpected results, it would have been obvious to one of ordinary skill in the art to modify the control system of the primary reference of Fitzpatrick et al. to allow for the automated operation of the system to perform more than one protocol or bioprocessing operation as suggested by the disclosures of the reference of Fitzpatrick et al. and Vlassov et al.
With respect to claims 2 and 3, the valve system or actuators of the reference of Fitzpatrick et al. are provided in a plate attached to the base unit in a non-rectangular or non-square pattern (Fig. 1d).
With respect to claim 4, in the absence of a showing of unexpected results, it would have been well within the purview of one having ordinary skill in the art to determine the optimum pattern of the arrangement of valve actuators while optimizing the operation of the system. Note: The rearrangement of parts is not considered a patentable distinction if the operation of the device is not modified (MPEP 2144.04,VI., C.)
With respect to claim 5, if the bioprocessing operations of the reference of Fitzpatrick et al. do not meet the limitations of claim 5, one of ordinary skill in the art would have envisioned that the system of Fitzpatrick et al. could be used for any of the bioprocessing operations recited in claim 5 in view of the disclose in Fitzpatrick et al. that the system could be used for other applications (¶[0153]).
With respect to claim 6, the valve actuators are operable as pinch valve actuators (¶[0068]).
With respect to claims 7-10, while the instant claims do not positively recite the pinch valve cassette as part of the claimed device, the reference of Fitzpatrick et al. clearly evidences that the system is structurally capable of being used with a cassette as encompassed in claims 7-10 in view of the single use kit (1205) disclosed by the reference of Fitzpatrick et al.
With respect to claims 11 and 12, the structure resulting from the combination of the references as disclosed above with respect to claim 1 would encompass a system that can automatically identify a cassette or cartridge and perform a specific bioprocessing operation based on a cassette identifier.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM H BEISNER whose telephone number is (571)272-1269. The examiner can normally be reached on Mon-Fri from 8am to 5pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MICHAEL A MARCHESCHI, can be reached at telephone number (571)272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/William H. Beisner/
Primary Examiner
Art Unit 1799
WHB
Prosecution Insights