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 .
DETAILED ACTION
Status of the claims
This application is a 371 of PCT/EP2020/068199, filed on 12/20/2021.
Claims 1-7, 15 and 16-18 are pending and subject to examination on the merits.
In response to a previous Office action, a Final Rejection Office action (mailed on 10/17/2025), Applicants filed a notice of Appeal filed on 01/18/2026, and a Pre-Brief Appeal Conference has been held on 02/02/2026, and the decision to reopen the case has been mailed on 02/05/2026.
Priority
The instant application 17620786 filed 12/20/2021 is a 371 of PCT/EP2020/068199 filed 6/29/2020 which claims foreign priority to EP19183954.7 filed 7/2/2019. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
New-Claim Rejections - 35 USC § 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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
According to MPEP 2143:
“Exemplary rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield
predictable results;
(B) Simple substitution of one known element for another to obtain predictable
results;
(C) Use of known technique to improve similar devices (methods, or products)
in the same way;
(D) Applying a known technique to a known device (method, or product) ready
for improvement to yield predictable results;
(E) “ Obvious to try ” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in
either the same field or a different one based on design incentives or other market
forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art
reference teachings to arrive at the claimed invention.
Note that the list of rationales provided is not intended to be an all-inclusive list. Other rationales to support a conclusion of obviousness may be relied upon by Office personnel.”
Claim(s) 1-6, 7, 15 and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Youssef et al (J Adv Res; 2016; cited on PTO-892) in view of Hage et al. (Fermentation medium comprising chelating agent. WO 2018/011242A1, publication 01/18/2018).
Youssef et al. teach a plant-based liquid culture media for the cultivation in a process of fermentation of bacterial cell including rhizobacteria, e.g. Rhizobium, a root associated bacterium, Enterobacter spp., Klebsiella spp., and Azospirillum spp. wherein the plant-based material is cactus plant powder (4 g dry powder per Liter water, which is within 0.5%-30% w/v as claimed, and the cactus powder contains both carbon source (52.44% carbohydrate), and nitrogen sources (8.5% protein), which is also within the claimed invention (see, Table 1), wherein the pH for saps, juices and slurry homogenates was in the range of 3.6–5.2 (pg 306, C2, 3rd paragraph), which is the pH of the medium before autoclaving and fermentation, meets the claim limitation of step b) of claim 1.
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The plant homogenates, juices and saps obtained from the tested cactus plants were diluted with distilled water (v/v); from 1:10 to 1:100 (which would be within the claimed v/w). All media were adjusted to pH 7.0 and autoclaved at 121oC for 20 min for culturing microbial cell for fermentation, and the limitation of saturated steam in claim 1, step c) is in fact associated with the autoclaving process for sterilization, meets the claim limitation of claim 1, step c) (see, pg 306, C2, 4th paragraph), and the pH of the fermentation medium was 7.2-8.0 (neutral pH), after autoclaving for culturing said microbial bacterial cell in a flask.
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The bacteria were cultured in liquid culture medium in a flasks having about 100 ml medium with 4 g/L of cactus powder for fermentation (see, Title, abstract, pg. 307, right Col, para 2, pg. 310, left Col, para 2, Fig. 3-4, pg 311, right Col para 3, Table 1-2).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456,105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416, 82 USPQ2d 1385, 1395 (2007) (identifying "the need for caution in granting a patent based on the combination of elements found in the prior art.")
Generally, changes in sequence of steps are prima facie obvious. See MPEP 2144.04 IV. and Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959) (Prior art reference disclosing a process of making a laminated sheet wherein a base sheet is first coated with a metallic film and thereafter impregnated with a thermosetting material was held to render prima facie obvious claims directed to a process of making a laminated sheet by reversing the order of the prior art process steps.). See also In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results); In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients is prima facie obvious.).
As there is no evidence the order of steps or concentrations were critical or provided unexpected outcomes, it would have been obvious to one of ordinary skill in the art to optimize or adjust the medium taught by Youssef as needed or desired to arrive at the claimed invention.
However, Hage et al. teach a fermentation medium comprising a basal medium with a chelating agent for culturing Bacillus subtilis cell and a process for fermentation of a cellulosic hydrolyzate for producing industrially important proteins, enzymes, the process comprising the steps of mixing the components of the medium, and adjusted the pH 7.3, followed by the sterilization of the medium for 30 mins at 121oC. The sterile medium was cooled down to desired temperature and cultured the microorganism Bacillus subtilis in the medium for fermentation at pH 7.7, wherein the bacterial strains are Bacillus subtilis, Bacillus licheniformis and Bacillus thuringiensis, wherein the cultured bacterial strains secrets enzymes including oxidoreductase, transferase, hydrolase, lyase, cellulases, beta-glucosidase, hemicellulases, beta-xylosidase and mixtures thereof (see, abstract, pg 16, para 3-4, pg 17, para 3-4, pg 18, para 1, 3, pg 25, para 1, 3, pg 26, para 1, Example 1, 2, 3, and 4, and claims 1-15) .
Therefore, it would have been obvious to one of ordinary skill in the art to arrive at the claimed invention as a whole before the effective filing date of the invention was made by combining the teachings of Youssef et al., and Hage et al to adjusting pH of the liquefied culture medium before autoclaving or sterilization at 4.5-6.5, of the plant-based culture medium as taught by Yussef et al., and followed by the fermentation with cultured bacteria as taught by Hage et al. and modify Youssef et al., to make a culture medium using plant-based liquefied culture medium to adjust pH 4.5-6.5 and fermenting the medium at pH >7.0 to make the culture medium ideal for fermentation to produce downstream product enzymes or proteins to arrive the claimed invention.
One of ordinary skilled in the art would have been motivated to reduce the pH of the culture medium before fermentation to 4.5-6.% in order to produce fermentation product, which is commercially, industrially and financially beneficial.
One of ordinary skilled in the art would have a reasonable expectation of success because Youssef et al., could successfully use plant-based liquid culture media for the cultivation in a process of fermentation of bacterial cell including rhizobacteria, e.g. Rhizobium, a root associated bacterium, Enterobacter spp., Klebsiella spp., and Azospirillum spp. for producing down-stream fermentation product.
Thus, the above references render the claims prima facie obvious to one of ordinary skill in the art.
Conclusion
Claims 1-7, 15 and 16-18 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IQBAL H CHOWDHURY whose telephone number is (571)272-8137. The examiner can normally be reached on M-F, at 9:00-5:00 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath N. Rao, can be reached on 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Dr. Iqbal H. Chowdhury, PhD
Primary Patent Examiner
Art Unit 1656 (Recombinant Enzymes and Protein Crystallography)
US Patent and Trademark Office
Full-Time Hoteling
Ph. (571)-272-8137 and Fax (571)-273-8137
/IQBAL H CHOWDHURY/
Primary Examiner, Art Unit 1656
Prosecution Insights