DETAILED ACTION
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 .
Priority
This application is a 371 of PCT/GB2021/051820, filed 7/15/2021. This application claims benefit to foreign application UNITED KINGDOM 2010934.4, filed 7/15/2020. Claims 1-16, 32 and 38 are pending.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-16, 32 and 38, in the reply filed on 3/9/2026 is acknowledged. All claims drawn to nonelected inventions have been canceled; hence, claims 1-16, 32 and 38 have been examined on the merits.
Information Disclosure Statement
The information disclosure statements submitted on 12/28/2022, 4/4/2025 and 12/3/2025 have been considered by the examiner.
Drawings
The drawings are objected to for the following reasons:
37 CFR 1.84 (u)(1) states "View numbers must be preceded by the abbreviation "FIG."" In the instant application, the view numbers for Figures 1A-29C are preceded by the word "Figure" instead of the abbreviation "FIG.".
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 Objections
Claims 10 and 14 are objected to because of the following informalities:
Claim 10 recites “to provide a first sent of process conditions” which should be “to provide a first set of process conditions”. Appropriate correction is required.
Claim 14 recites “changing over a predetermined period of time one or more process condition stepoints from a batch phase setpoint to a production phase setpoint” which should be “changing over a predetermined period of time one or more process condition setpoints from a batch phase setpoint to a production phase setpoint”. Appropriate correction is required.
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 38 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 38 recites the broad recitation “wherein the oxygen supply reaches maximum oxygen supply before the agitation reaches maximum agitation”, and the claim also recites “preferably wherein, when the oxygen supply reaches the maximum oxygen supply, the agitation is between 75% and 85% of the maximum agitation” and “more preferably approximately 80%” which is the narrower statement of the range/limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Rejections - 35 USC § 102/103
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claims 1-8, 10-16, 32 and 38 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Manoosingh et al., US 2009/0220934 (US Patent Application Publications cite 1, IDS, 12/28/2022; herein “Manoosingh”).
Manoosingh teaches a method of controlling operation of a fed batch fermentation in a bioreactor vessel for the production of protein (Abst.; [0002]) comprising measuring the dissolved oxygen (DO) and pH levels of the fed batch protein production process during the growth phase, increasing the airflow and stirrer rate of the system to a maximum value when the DO reaches a predetermined value, adding a first nutrient feed to the system when there is an increase in the DO level and/or an increase in the pH level, ceasing the first nutrient feed when the DO levels are reduced wherein a DO-stat setpoint is determined by adding a preset value to the lowest DO level measured during the growth phase; measuring dissolved oxygen (DO) and pH levels in the fermentation system during the induction phase, increasing the DO-stat setpoint when the pH falls below the pH-stat setpoint or (ii) decreasing the DO-stat setpoint when the pH increases above the pH-stat setpoint, feeding the cells with a second nutrient feed when the DO level goes above the DO-stat setpoint ([0012-0018], demonstrated in Fig. 1a) anticipating a method of controlling operation of a fed batch process in a bioreactor vessel, comprising transitioning from a batch phase to a production phase in dependence on a relationship between an oxygen supply parameter O and a dissolved oxygen value DO, wherein the oxygen supply parameter O is determined in dependence on one or more of: an agitation speed; a gas supply rate; and an oxygen supply concentration; wherein the oxygen supply parameter O is a sum or product of two or more of: an agitation speed value, a gas supply rate value, and an oxygen supply concentration value; wherein the relationship is a ratio O/DO; comprising transitioning from a batch phase to a production phase when the ratio O/DO falls below a threshold k; comprising transitioning from a batch phase to a production phase when the ratio O/DO falls below a threshold k only if the ratio O/DO has previously exceeded a threshold j; comprising transitioning from a batch phase to a production phase when the ratio O/DO falls below a threshold k only if the ratio O/DO has previously exceeded a threshold j for at least a predetermined period of time; wherein the process is a protein expression process and a target protein expressed in the production phase is a recombinant protein as set forth in claims 1-8, 11-16, 32 and 38.
Manoosingh teaches that the method set forth above can be automated and done by a computer which would necessitate controlling actuators, i.e. the method further comprising controlling one or more actuators to provide a first set of process conditions during the batch phase; and controlling the actuators to provide a second set of process conditions during the production phase, with the first and second set of process conditions being different at least in part, anticipating claim 10.
Although it is believed that the passages cited above, together with the demonstration of the control method in Fig. 1a, anticipate claims 1-8, 10-16, 32 and 38, the claims are also obvious over Manoosingh as Manoosingh teaches transitioning from a batch phase to a production phase when the DO first rises in a growth phase then goes down to a minimum to trigger the induction phase which comprises changing the DO setpoint which is regulated by controlling air supply and stirrer rate (Abst.; [0002], [0012-0018], Fig. 1a); therefore, claims 1-8, 10-16, 32 and 38 are prima facie obvious over the disclosure of Manoosingh.
Claim Rejections - 35 USC § 103
Claims 1-16, 32 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Manoosingh in view of Khan et al., US 2017/0356022 (cite A, attached PTO-892; herein “Khan”).
The discussion of Manoosingh regarding claims 1-8, 10-16, 32 and 38 set forth in the rejection above is incorporated herein.
Although Manoosingh teaches that the method of controlling operation of a fed batch process in a bioreactor vessel can comprise a fermentative fed batch process for producing recombinant proteins [0002], Manoosingh does not specifically teach that the protein is a botulinum neurotoxin. However, a person of ordinary skill in the art at the time of filing would have found it obvious for the recombinant protein to be a botulinum neurotoxin in view of the disclosure of Khan.
Khan teaches fed batch processes in bioreactor vessels for producing protein (Abst.; Fig. 8A) wherein the protein can be botulinum toxin ([0138], [0140], [0144]; Tables 1, 4).
Hence, a person of ordinary skill in the art at the time of filing would have found it obvious to practice the method made obvious by Manoosingh wherein the recombinant protein is a botulinum neurotoxin; therefore, claim 9 is prima facie obvious.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Trent R Clarke whose telephone number is (571)272-2904. The examiner can normally be reached M-F 10-7 MST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie Gordon can be reached at 571-272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TRENT R CLARKE/ Examiner, Art Unit 1651
/DAVID W BERKE-SCHLESSEL/ Primary Examiner, Art Unit 1651
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