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 with traverse of Group I, Claims 1-11, in the reply filed on 2/17/2026 is acknowledged. The traversal is on the ground(s) that:
More specifically, the special technical features provide a layered frame configuration that ensures that cables, tubing, connectors etc. needed to install a flexible bioprocessing bag to be more quickly be arranged in a logical, less cluttered, and more secure way around a bioreactor vessel. This further reduces potential risks associated with mis-installation of components and of tripping of the personnel involved with the installation of a flexible bioprocessing bag. These special technical features are neither taught nor suggested by Brown et al. (US 2015/0265958). In view of at least the foregoing, the Applicant requests withdrawal of the Office's restriction requirement.
This is not found persuasive because Applicants’ comments are not commensurate in scope with the instant claim language. As a result, the reference of Brown et al. is considered to teach the structure of the special technical feature recited in the claim.
The requirement is still deemed proper and is therefore made FINAL.
Claims 12-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 2/17/2026.
Priority
Receipt is acknowledged of certified copies of papers (INDIA 202011030099 07/15/2020) required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements dated 1/4/2023 and 9/3/2025 have been considered and made of record.
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 9 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.
In claim 9, “the bioreactor vessel and internal baffles of the bioreactor vessel” lack antecedent basis. Note: Claim 9 depends from claim 1 rather than claim 8.
Claim Rejections - 35 USC § 102
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 1-5 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Staheli et al. (US 2011/0207218) (PTO-892 attached).
With respect to claim 1, the reference of Staheli et al. discloses:
A component management apparatus for a bioprocessing system (Figure 1 reproduced below), comprising:
a frame (108A)(¶[0082]) having a plurality of segments, including at least a first segment and a second segment pivotably connected (the first and second segments are pivotably connected at the connector shown in Figure 1) to the first segment such that at least the second segment is movable between a closed position (over the bioreactor opening) and an open position (out of the way of the opening of the bioreactor opening); and
at least one mounting bracket (308A) connected to the frame for connection of a bioprocess component.
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With respect to claims 2 and 3, in the absence of further positively recited structure the connection mechanism (mechanical clamp) disclosed in Fig. 1 is structurally capable of maintaining the second segment in the closed position.
With respect to claims 4 and 5, in the absence of further positively recited structure, mounting bracket (308A) is structurally capable of being used with a filter heater or pinch valve (¶0082]).
With respect to claim 10, at least one of the segments (second segment) is movable so as to extend from an opening in a bioreactor vessel to which the frame is connected (Fig. 1).
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 6 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Staheli et al. (US 2011/0207218) (PTO-892 attached).
The reference of Staheli et al. has been discussed above with respect to claim 1.
With respect to claim 6, while the reference of Staheli et al. discloses the use of a plurality of mounting backets (308A)(Fig. 1)(¶[0082]), claim 6 specifically requires the use of a plurality of filter heater mounting brackets and pinch valve mounting brackets.
The reference of Staheli et al. discloses that filters (298) and lines (264 and 266) can be mounted using the brackets (¶[0082]).
In view of this teaching and in the absence of a showing of unexpected results, it would have been obvious to one of ordinary skill in the art to provide the frame of the primary reference with a plurality of mounting brackets based on the number of filters and/or tubes to be used with the bioreactor. In the absence of further positively recited structure, the brackets disclosed by the reference of Staheli et al. would be capable of supporting filters, filter heaters, tubes and/or pinch valves.
With respect to claim 11, while the reference of Staheli et al. does not specifically disclose a filter heater, the reference discloses that heaters can be applied to the filters (298) (¶[0086]).
In view of this teaching and in the absence of a showing of unexpected results, it would have been obvious to one of ordinary skill in the art to provide the filters with heaters as suggested by the reference of Staheli et al.
With respect to the shape of the filter heater, in the absence of a showing of unexpected results, it would have been obvious to one of ordinary skill in the art to optimize the shape of the filter heater based on the shape of the filter while facilitating the removal and/or replacement of the filter with respect to the heater.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Staheli et al. (US 2011/0207218) (PTO-892 attached) in view of Goodwin et al. (US 2012/0175012) (IDS dated 9/3/2025).
The reference of Staheli et al. has been discussed above with respect to claim 1.
Claim 9 differs by reciting that the frame has a peripheral shape that corresponds to the interior sidewall of the bioreactor vessel.
The reference of Goodwin et al. discloses that when mounting peripheral devices relative to a bioreactor vessel, it is known to provide a mounting frame that corresponds to the shape of the sidewall of the vessel (Fig. 5).
In view of this teaching and in the absence of a showing of unexpected results, it would have been obvious to one of ordinary skill in the art to configure the shape of the frame of the primary reference to correspond to the shape of the bioreactor vessel as is conventional in the art as suggested by the reference of Goodwin et al.
Allowable Subject Matter
Claims 7 and 8 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:
Claims 7 and 8 would be allowable because the prior art of record fails to teach or fairly suggest a component management apparatus, in the claimed environment or scope of claim, where the plurality of segments further include at least a third segment; wherein the first segment is arcuate in shape and has a first end and a second end; wherein the second segment is pivotably connected to the first end of the first segment; and wherein the third segment is pivotably connected to the second end of the first segment. Specifically, the disclosure of Staheli et al. (US 2011/0207218) does not teach or suggest these specific claim limitations.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
The references of Mahajan et al. (US 2016/0304824) (PTO-892 attached) and Topp-Manske et al. (US 2019/0031996) (IDS dated 9/3/2025) are cited as prior art which pertain to frame structures for holding peripheral components with respect to a bioreactor vessel.
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