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 .
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on 8/7/2026 is acknowledged. The traversal is on the ground(s) that the prior art does not disclose the special technical features. This is not found persuasive because the rejections below show the cited art teaches or renders obvious all features of the claims and as such these are not special technical features. However due to the amendments to claim 15 the restriction requirement with respect to claim 15 alone is withdrawn.
The requirement is still deemed proper and is therefore made FINAL.
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 1-11 and 15 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.
Claim 1 and thus all claims dependent thereon recites the limitation "the fermentation from from (ii)". There is insufficient antecedent basis for this limitation in the claim.
Regarding Claim 15 it is noted that claim 15 depends upon claim 1. Both claims 1 and 15 have steps (i), (ii), and (iii). Thus when claim 15 requires “varying the time of (i) and the amount of (ii)” as well as “adjusting the time in (i) and/ or the amount of the part of fermentation broth in (ii)” it is unclear if this is refereeing to the steps of claim 1 or the steps of claim 15. As such the meets and bounds of the claim cannot be ascertained and the claim is rendered unclear.
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, 7-8, and 10-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Niazi (US 2010/0261226).
Regarding claim 1 Niazi discloses a method for cultivating a microorganism, comprising (See Niazi Abstract [0001] and Figs. 3-6 wherein a microorganisms is cultured in a fed-batch manner)
(i) adding into a first bioreactor a medium and an inoculum comprising the microorganism and producing a fermentation broth in fed-batch culture; (See Niazi Fig. 4 and [0008] and [0054] wherein medium and microorganism inoculum is added to a first bioreactor and a fermentation broth in fed-batch culture is made.)
(ii) adding into a second bioreactor a second medium and part of the fermentation broth from (i) and producing a second fermentation broth in a second fed-batch culture; and (See Niazi Fig. 4 and [0008] and [0054] wherein medium and fermentation broth from the first bioreactor is added to a second bioreactor to produce a second fermentation broth in a second fed-batch culture.)
(iii) adding into a next bioreactor a next medium and a part of the fermentation broth from (ii), and producing a next fermentation broth in a next fed-batch culture, wherein a feed is introduced into the first, second and next bioreactor. (See Niazi Fig. 4 and [0008],[0036], and [0054] wherein medium and fermentation broth from the second bioreactor is added to a next, i.e. third, bioreactor to produce a next fermentation broth in a third fed-batch culture and culture medium is added to the first, second, and next bioreactors.)
Regarding claim 2 Niazi discloses all the claim limitations as set forth above as well as the method wherein (ii) and / or (iii) further comprise(s) adding an inoculum comprising the microorganism into the second and / or next bioreactor. (See Niazi [0008] and [0054] wherein when materials are moved in (ii) and (iii) it comprises a portion of inoculum comprising microorganisms.)
Regarding claim 3 Niazi discloses all the claim limitations as set forth above as well as the method further comprising preparing an inoculum comprising the microorganism in an inoculum bioreactor before (i), (ii) and / or (iii). (See Niazi Fig. 4 wherein a first bioreactor 1 et al. is an inoculum bioreactor is provided to prepare the microorganism before (i),(ii), and (iii))
Regarding claims 4-5 Niazi discloses all the claim limitations as set forth above as well as the method further comprising (iv) comprising repeating (iii), wherein the part of the fermentation broth is from i ii and/or iii a previous step and repeating (iii) requires repeating at least 1 times. (See Niazi [0008] wherein (iii) is repeated, i.e. repeating comprises at least 1 repeat.)
Regarding claim 7 Niazi discloses all the claim limitations as set forth above as well as the method further comprising removing a part of the fermentation broth from the first, second and / or next bioreactor, and adding the part of fermentation broth that is removed into the second and / or next bioreactor in (ii), (iii) and / or thereafter. (See Niazi [0048] and [0054] wherein part of the fermentation broth is removed from a first second or next bioreactor and added into the second or next bioreactor thereafter.)
Regarding claim 8 Niazi discloses all the claim limitations as set forth above as well as the method further comprising continuing producing a fermentation broth in fed-batch culture in (i), (ii), (iii). (See Niazi Figs. 4-6 and [0052] wherein a fermentation broth is continually produced in fed-batch culture in (i)(ii) or and (iii)
Regarding claim 10 Niazi discloses all the claim limitations as set forth above as well as the method wherein cultivating the microorganism comprises producing a compound of interest. (See Niazi [0037] wherein a biological product, i.e. compound of interest, are created by the microorganisms.)
Regarding claim 11 Niazi discloses all the claim limitations as set forth above as well as the method wherein adding part of the fermentation broth into the second or next bioreactor in (ii), (iii) and / or thereafter takes place intermittently. (See Niazi [0036] and [0054] wherein the adding fermentation broth takes place in a periodic manner, i.e. intermittently.)
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.
Claims 6 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Niazi (US 2010/0261226) as applied to claims above.
Regarding claim 6 Niazi discloses all the claim limitations as set forth above as well as the method wherein in (ii), (iii) and / or thereafter, said part of the fermentation broth is from 3 to 60% (w/w) of the fermentation broth from a previous step.
Niazi discloses varying the amount of fermentation broth added from a previous step but does not specifically disclose 3% to 60% w/w.
As the cost of materials fed and amount of product produced are variables that can be modified, among others, by adjusting said amount of fermentation broth moved into another bioreactor, with said cost and amount of product produced both increasing as the said amount of fermentation broth moved into another bioreactor is increased, the precise said amount of fermentation broth moved into another bioreactor would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed said amount of fermentation broth moved into another bioreactor cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the said amount of fermentation broth moved into another bioreactor in the method of Niazi to obtain the desired balance between the cost of materials fed and the amount of product produced (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
Regarding claim 9 Niazi discloses all the claim limitations as set forth above as well as the method wherein the amount of time the fermentation broth is in a given bioreactor before moving into another bioreactor varies according to controlled conditions but does not specifically disclose being between 2 hours and 20 days.
As the cost of operation and amount of product produced are variables that can be modified, among others, by adjusting said time the fermentation broth is in a given bioreactor before moving into another bioreactor, with said cost and amount of product produced both increasing as the time the fermentation broth is in a given bioreactor before moving into another bioreactor is increased, the precise time the fermentation broth is in a given bioreactor before moving into another bioreactor would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed time the fermentation broth is in a given bioreactor before moving into another bioreactor cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the time the fermentation broth is in a given bioreactor before moving into another bioreactor in the method of Niazi to obtain the desired balance between the operation cost and the amount of product produced (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN M HURST whose telephone number is (571)270-7065. The examiner can normally be reached on M-F 7AM-4PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached on 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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/JONATHAN M HURST/ Primary Examiner, Art Unit 1799
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