Prosecution Insights
Last updated: October 01, 2026
Application No. 18/014,370

BIOPROCESSING SYSTEM AND TUBING AND COMPONENT MANAGEMENT APPARATUS FOR A BIOPROCESSING SYSTEM

Final Rejection §102§103§112
Filed
Jan 04, 2023
Priority
Jul 15, 2020 — IN 202011030099 +1 more
Examiner
BEISNER, WILLIAM H
Art Unit
1799
Tech Center
1700 — Chemical & Materials Engineering
Assignee
Global Life Sciences Solutions USA LLC
OA Round
2 (Final)
62%
Grant Probability
Moderate
3-4
OA Rounds
0m
Est. Remaining
91%
With Interview

Examiner Intelligence

Grants 62% of resolved cases
62%
Career Allowance Rate
598 granted / 968 resolved
-3.2% vs TC avg
Strong +29% interview lift
Without
With
+29.1%
Interview Lift
resolved cases with interview
Typical timeline
3y 6m
Avg Prosecution
27 currently pending
Career history
996
Total Applications
across all art units

Statute-Specific Performance

§101
1.6%
-38.4% vs TC avg
§103
42.8%
+2.8% vs TC avg
§102
19.1%
-20.9% vs TC avg
§112
26.1%
-13.9% vs TC avg
Black line = Tech Center average estimate • Based on career data from 968 resolved cases

Office Action

§102 §103 §112
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 Election/Restrictions Claims 12-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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. Information Disclosure Statement The information disclosure statement dated 7/6/2026 has been considered and made of record. Allowable Subject Matter The indicated allowability of claims 7 and 8 is withdrawn in view of the amendments to claim 1 and newly applied reference to Mahajan et al. (US 2016/0304824) (Attached PTO-892). Rejections based on the newly cited reference follow. 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 7-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mahajan et al. (US 2016/0304824) (Attached PTO-892). With respect to claim 1, the reference of Mahajan et al. discloses: A component management apparatus for a bioprocessing system (Figs. 1B, 1C and Fig. 7A annotated and reproduced below), comprising: an annular frame (102, 800) having a plurality of arcuate segments, including at least a first segment (side wall) (104) and a second segment (door) (112b) pivotably connected to the first segment such that at least the second segment is movable between a closed position in which the first segment and second segment are connected and an open position in which the first segment and second segment are disconnected; and PNG media_image1.png 794 623 media_image1.png Greyscale at least one mounting bracket (804) connected to the frame for connection of a bioprocess component (¶[0030]). With respect to claims 2 and 3, the system of Mahajan et al. discloses a connection mechanism configured to maintain the second segment in the closed position using a mechanical lock (latches)(Figs. 1B and 1C). With respect to claims 4 and 5, in the absence of further positively recited structure, mounting bracket ((708)(Fig. 6) or (804)(Fig. 7A)) is structurally capable of being used with a filter heater or pinch valve. With respect to claims 7-9, the system of Mahajan et al. discloses 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 (See annotated Fig. 7A above). With respect to the shape and/or dimensions of the segments required of claims 8 and 9, in the absence of further positively recited claim language, the system of the reference of Mahajan et al. is considered to be structurally capable of accommodating a bioreactor vessel and an internal baffle of the bioreactor. 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 ((Figs. 1B, 1C and Fig. 7A). 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 Mahajan et al. (US 2016/0304824) (Attached PTO-892). The reference of Mahajan et al. has been discussed above with respect to claims 1 and 4. With respect to claim 6, while the reference of Mahajan et al. discloses the use of a plurality of mounting backets which include mounting brackets for a plurality of filters and filter heaters (Fig. 6), the reference is silent with respect to the use of brackets for pinch valves. The reference of Mahajan et al. discloses the use of manual pinch valves (Fig. 4D) associated with the filters. In view of these disclosures and in the absence of a showing of unexpected results, it would have been obvious to one of ordinary skill in the art to automate the actuation of the pinch valves and provide additional structures for supporting the actuated pinch valves for the known and expected result of automating a manual operation which is not considered a patentable distinction. With respect to the filter heater structure required of claim 11, in the absence of a showing of unexpected results, it would have been obvious to one of ordinary skill in the art to construct of the filter heater of separate parts to facilitate the removal of the filter since it is not inventive to making a unitary structure of separate parts (MPEP 2144.04, V, C.). Response to Arguments Claim Rejections-35 USC 112(b) The rejection of Claim 9 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 has been withdrawn in view of the amendments to claims 9 and related comments on page 6 of the response dated 7/7/2026. Claim Rejections-35 USC 102(a)(1) The rejection of Claims 1-5 and 10 under 35 U.S.C. 102(a)(1) as being anticipated by Staheli et al. (US 2011/0207218) has been withdrawn in view of the amendments to claim 1 and related comments on pages 6-8 of the response dated 7/7/2026. Claim Rejections-35 USC 103 (Claims 6 and 11) The rejection of Claims 6 and 11 under 35 U.S.C. 103 as being unpatentable over Staheli et al. (US 2011/0207218) has been withdrawn in view of the amendments to claim 1 and related comments on pages 8-9 of the response dated 7/7/2026. Claim Rejections-35 USC 103 (Claim 9) The rejection of Claim 9 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) has been withdrawn in view of the amendments to claim 1 and related comments on page 9 of the response dated 7/7/2026. Conclusion Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action. 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. Information regarding the status of an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center for authorized users only. Should you have questions about access to Patent Center, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). Examiner interviews are available via telephone, in-person, 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) Form at https://www.uspto.gov/patents/uspto-automated- interview-request-air-form. /William H. Beisner/ Primary Examiner Art Unit 1799 WHB
Read full office action

Prosecution Timeline

Jan 04, 2023
Application Filed
Apr 07, 2026
Non-Final Rejection mailed — §102, §103, §112
Jul 07, 2026
Response Filed
Sep 23, 2026
Final Rejection mailed — §102, §103, §112 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

3-4
Expected OA Rounds
62%
Grant Probability
91%
With Interview (+29.1%)
3y 6m (~0m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 968 resolved cases by this examiner. Grant probability derived from career allowance rate.

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