Prosecution Insights
Last updated: October 02, 2026
Application No. 18/297,504

METHODS FOR OPERATING A BIOREACTOR WITH IMPELLER ASSEMBLY AND RELATED BIOREACTORS

Final Rejection §102§103§112
Filed
Apr 07, 2023
Priority
Mar 22, 2014 — provisional 61/969,094 +3 more
Examiner
SORKIN, DAVID L
Art Unit
1774
Tech Center
1700 — Chemical & Materials Engineering
Assignee
Thermo Fisher Scientific
OA Round
4 (Final)
67%
Grant Probability
Favorable
5-6
OA Rounds
0m
Est. Remaining
80%
With Interview

Examiner Intelligence

Grants 67% — above average
67%
Career Allowance Rate
803 granted / 1191 resolved
+2.4% vs TC avg
Moderate +13% lift
Without
With
+12.8%
Interview Lift
resolved cases with interview
Typical timeline
3y 2m
Avg Prosecution
60 currently pending
Career history
1231
Total Applications
across all art units

Statute-Specific Performance

§101
0.9%
-39.1% vs TC avg
§103
34.2%
-5.8% vs TC avg
§102
30.9%
-9.1% vs TC avg
§112
28.0%
-12.0% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1191 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 . 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 2 and 8 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: Applicant amended claim 1, from which claim 2 depends, deleting “a length” and adding “a selected length of the second tubular connector”. It is unclear whether “the length of the second tubular connector” in claim 2 refers to the “selected length” of claim 1, or to the entire length or some other length. In claim 8, there is lack of antecedent basis for “the second tubular member”. There is no other mention of any “member” in any claim. Claim Rejections - 35 USC § 102 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 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 6, 9, 10 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Watkins (US 2010/0149907): Regarding claim 6, Watkins discloses a method for operating a bioreactor, comprising passing a drive shaft (22) through a first tubular connector (18) and into a second tubular connector (38), the first tubular connector at least partially disposed within a container (12); disposing a first mixing element (36) on the second tubular connector such that the first mixing element encircles and is supported by the second tubular member connector (see Fig. 3 and [0030]: "impellor 36 may have a central shaft element 38"); and rotating the drive shaft so as to rotate the second tubular connector and the first mixing element within the container, wherein the drive shaft engages an interior surface of the second tubular connector over a selected length (40) of the second tubular connector to impart the rotation of the second tubular connector. Regarding claim 9, the second tubular connector projects from the first tubular connector (see Fig. 3). Regarding claim 10, the first tubular connector is more flexible than the second tubular connector (see [0030]). Regarding claim 13, the drive shaft is linear (see Fig. 3). 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. Claims 1-5, 7, 8, 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Watkins (US 2010/0149907): Regarding claims 1 and 2, Watkins discloses a method for operating a bioreactor comprising passing a drive shaft (22) into a first tubular connector (18) and a second tubular connector (38) projecting from the first tubular connector (see Fig. 3), the first tubular connector and the second tubular connector being at least partially disposed within a container (12), the first tubular connector being more flexible than the second tubular connector (see [0030]), wherein the drive shaft engages an interior surface of the second tubular connector over a selected length (40) of the second tubular connector thereof to impart the rotation of the second tubular connector (see Fig. 3). The relative lengths of the connectors are not numerically stated; however, the discussions of length in [0023], [0029] and [0044] would have suggested finding a workable length ratio range to one of ordinary skill in the art before the effective filing date. Regarding claims 3 and 4, mixing elements (blades of 36) are disposed on the second tubular connector, but are not disclosed to be removable from them tubular connector. See In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961) concerning the obviousness of making parts removable. It would have been obvious to one of ordinary skill in the art to have made the mixing elements removable to facilitate, repair, cleaning, assembly and/or disassembly. Regarding claim 5, the first tubular connector is comprised of an elastomeric material (see [0040]) and the second tubular connector is not comprised of elastomeric material (see [0039]). Regarding claim 7, the mixing element is not disclosed to be removable from them tubular connector. See In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961) concerning the obviousness of making parts removable. It would have been obvious for one of ordinary skill in the art before the effective filing date to have made the mixing element removable to facilitate, repair, cleaning, assembly and/or disassembly. Regarding claim 8, while blades are disclosed, it also would have been obvious for one of ordinary skill in the art before the effective filing date to have duplicated the entire set of blades, to improve mixing. See also In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) concerning the obviousness of duplicating parts. Regarding claims 11 and 12, one of ordinary skill in the art before the effective filing date would have understood from [0023], [0029] and [0044] and Fig. 3 to have discovered optimal or workable ranges for these recited numerical parameters. Response to Arguments Concerning claim 6, applicant states “Watkins does not disclose or suggest selecting the length of engagement between the drive shaft and the central shaft element so as to strengthen the central shaft element for higher torque applications, as expressly required by the present specification and reflected in amended claim 6.” However, applicant’s statement that claim 6 expressly recites anything about “higher torque” or strengthening is simply false. Watkins discloses that the drive shaft engages an interior surface of the second tubular connector (38) along a length (40) thereof to impart the rotation of the second tubular connector. In Watkins, drive coupling recess (40), as depicted in Fig. 3, corresponds to about 28% of the entire length of tubular connector (38) when barb (42) is included, and even more than 28% if barb (28) is considered a separate element. 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 DAVID L SORKIN whose telephone number is (571)272-1148. The examiner can normally be reached 7am-3:30pm. 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) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Claire X Wang can be reached at (571) 270-1051. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. DAVID L. SORKIN Examiner Art Unit 1774 /DAVID L SORKIN/Primary Examiner, Art Unit 1774
Read full office action

Prosecution Timeline

Show 1 earlier event
Aug 13, 2025
Non-Final Rejection mailed — §102, §103, §112
Dec 15, 2025
Response Filed
Jan 08, 2026
Final Rejection mailed — §102, §103, §112
Apr 08, 2026
Request for Continued Examination
Apr 10, 2026
Response after Non-Final Action
Apr 22, 2026
Non-Final Rejection mailed — §102, §103, §112
Jul 22, 2026
Response Filed
Aug 05, 2026
Final Rejection mailed — §102, §103, §112 (current)

Precedent Cases

Applications granted by this same examiner with similar technology

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Patent 12734492
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Patent 12722128
AXISYMMETRIC CONFINED IMPINGING JET MIXER
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TUBE HOLDER
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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

5-6
Expected OA Rounds
67%
Grant Probability
80%
With Interview (+12.8%)
3y 2m (~0m remaining)
Median Time to Grant
High
PTA Risk
Based on 1191 resolved cases by this examiner. Grant probability derived from career allowance rate.

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