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 .
Claims 1, 5, 7 and 9 are pending in this application, Claims 7 and 9 are acknowledged as withdrawn, Claims 1 and 5 were examined on their merits.
The rejection of Claims 1 and 5 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AlA), 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inventor (or for applications subject to pre-AlA 35 U.S.C. 112, the Applicant), regards as the invention, has been withdrawn due to the Applicant’s amendments to the claims filed 10/02/2025.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and 5 are newly rejected under 35 U.S.C. § 112(a) or 35 U.S.C. § 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement, as necessitated by Applicant’s amendments to the claims filed 10/02/2025. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. Reasoning for a lack of enablement is because the Specification is directed to:
1) An assay wherein undisclosed microbial strains (described in the
Specification as “suitable genera” to select from at Pg. 2, Lines 1-12) are cultured in a
medium containing yeast extract and peptone (not sources of carbon) and
Rebaudioside A (RebA). The cells are then lysed and centrifuged to provide a soluble
fraction to which RebA is added and incubating. LC-MS is then used to quantify RebB
in samples prior to and after incubation wherein the difference in RebB concentration
between the start and the end of the incubation was calculated for each supernatant
and each soluble fraction. This difference value was compared to sterile controls that
were processed the same way. A large difference in the soluble fraction and a small difference in supernatant indicate that a strain might have taken up RebA and degraded it to RebB to use the thus liberated glucose molecule to support growth (Specification, Pg. 3).
2) An assay wherein 19 undisclosed microbial strains from Candida utilis, Cyberlindnera jadinii, Kluyveromyces lactis, Kluyveromyces marxianus, Meyerozyma guilliermondii, Pichia guilliermonadii, Pichia jadinii and Zygosaccharomyces rouxii were cultured in a medium containing Rebaudioside A (RebA) as the only carbon source.
The cells are then lysed and centrifuged to provide a soluble fraction to which RebA is added and incubating. LC-MS is then used to quantify RebA wherein the difference in RebA concentration between the start and the end of the incubation was calculated for each soluble fraction. If RebA can be degraded by the soluble fraction of the cell extract, it can be assumed that the strain can assimilate RebA from the culture medium (Specification, Pg. 4 and Pg. 5, Lines 1-3).
3) An assay wherein an undisclosed strain of Kluyveromyces marxianus found to assimilate RebA by the method of 2) was cultivated in a medium containing Rebaudioside A (RebA) as the only carbon source. The cells are then lysed and centrifuged to provide a soluble fraction/supernatant/quench and a cell pellet. The cell pellet was resuspended in methanol and centrifuged three times, the third supernatant/wash was collected and the cells resuspended in methanol and centrifuged a fourth time and LC-MS is then used to quantify RebA in the supernatant/cell extract wherein the concentration of RebA in the cell extract exceeds that found in the quench or wash indicating that RebA has accumulated intracellularly (Specification, Pg. 5, Lines 4-30 and Pg. 6, Lines 1-8 and Fig. 2).
The Specification presents additional embodiments wherein an (undisclosed) microbial strain capable of assimilating RebA hosts expressed genes and respective enzymes for intracellular conversion of RebA to RebD and/or Reb M, said enzymes include at least one UDP-glucosyltransferase (UGT), said enzymes include at least one sucrose synthase for UDP regeneration and recycling, the microbial strain is capable of excreting the intracellular Reb D and/or Reb M, the Reb D and/or Reb M synthesized by microbial strain of this invention is recovered and purified by techniques used in steviol glycosides extraction and purification to provide steviol glycosides compositions comprising the Reb D and/or Reb M (Specification, Pg. 6, Lines 9-20). The Applicant claims a method of producing steviol glycosides, comprising intracellularly converting rebaudioside A to rebaudioside D, rebaudioside M, or a combination thereof by subjecting rebaudioside A to a UDP-glucosyl transferase enzyme produced by a host cell;
wherein the method further comprises the steps of:
i. providing a culture medium comprising rebaudioside A as the only
carbon source:
il. cultivating a candidate microbial strain in the culture medium;
iii. separating cells of the candidate microbial strain from the culture medium;
iv. re-suspending the cells and disrupting them to form a soluble fraction
and a cell debris fraction;
v. adding rebaudioside A to the soluble fraction, analyzing the soluble
fraction for rebaudioside A, and then incubating the soluble fraction;
vi. analyzing the incubated soluble fraction for rebaudioside A; and
vii. identifying the host cell by determining a decrease in the amount of
rebaudioside A in the incubated soluble fraction as compared to the soluble fraction;
wherein the host cell:
a. is capable of expressing genes of enzymes for the intracellular conversion of
rebaudioside A to rebaudioside D, rebaudioside M, or a combination thereof: and
b. is selected from the group consisting of species: Candida utilis, Cyberlindnera
Jadinii, Kluyveromyces lactis, Kluyveromyces marxianus, Meyerozyma guilliermondii, Pichia guilliermondii, Pichia jadinii, and Zygosaccharomyces rouxii.
There is a gap in the guidance provided in the disclosure and the claims in that the Specification provides guidance and direction for screening microbial organisms for the ability to assimilate RebA, but does not provide data for the successful assimilation of RebA for any strain beyond a single undisclosed strain of K. marxianus. The disclosure further does not provide any evidence that the undisclosed strain of K. marxianus, much less any strain, was capable of both assimilation of RebA and its conversion intracellularly into RebD, RebM or a combination thereof as claimed.
The conclusion of non-enablement is set forth additionally because:
1. Quantity of experimentation necessary would be undue because the Specification at best only provides a screening process for detecting RebA assimilation. However, there is no data provided that any microbial strain beyond a single undisclosed strain of K. marxianus had the desired property.
Thus, the ordinary artisan would be required to screen any and all known microbes for the desired property of RebA assimilation as well as additionally screen said microbe for naturally occurring genes and their respective expressed enzymes for intracellular conversion of RebA to RebD and/or Reb M or recombinantly express in said microbes the genes encoding enzymes for the intracellular conversion of RebA to RebD and/or Reb M.
2. Amount of direction or guidance presented is insufficient to predict which embodiments encompassed by the claims would work because the Specification only guides the ordinary artisan toward screening microbes for the ability to assimilate RebA. While the disclosure generally contemplates additional embodiments of an undisclosed microbial strain capable of assimilating RebA which also hosts expressed genes and respective enzymes for intracellular conversion of RebA to RebD and/or Reb M, said enzymes include at least one UDP-glucosyltransferase (UGT), the disclosure does not particularly direct or guide the ordinary artisan to:
a) screen any microbe strain from the 8 disclosed species for the ability to assimilate RebA, b) said microbe either naturally or recombinantly expressing genes and respective enzymes for intracellular conversion of RebA to RebD and/or Reb M, and c) actually converting assimilated RebA to the desired steviol glycosides intracellularly with said enzymes as claimed.
3. Presence of working examples: The working examples are only for specific substances and extension to other compounds has not been specifically taught or suggested. The Specification as discussed above, only provides a screening process for detecting microbial RebA assimilation. However, there is no data/example provided that any microbial strain beyond a single undisclosed strain of K. marxianus had the desired property or any data/example that said undisclosed strain of K. marxianus either naturally or recombinantly expressing genes and respective enzymes for intracellular conversion of RebA to RebD and/or Reb M, and actually converting assimilated RebA to the desired steviol glycosides intracellularly with said enzymes.
4. The nature of the invention: The claims require the screening of any microbe for the ability to assimilate RebA and the capability to express the necessary enzymes to convert said RebA intracellularly and perform said conversion. Thus, the ordinary artisan would have to first screen all possible microbes for the desired assimilation ability, and then either screen for or recombinantly produce in said identified microbe genes and respective enzymes for intracellular conversion of RebA to RebD and/or Reb M, and converting assimilated RebA to the desired steviol glycosides intracellularly with said enzymes.
5. State of the prior art: The Applicant indicates that RebA is a rare compound in nature and it was previously unknown if any microbe had the desired ability to assimilate RebA (Specification, Pg. 1, Lines 23-24).
Markosyan et al. (WO 2013/176738 A1) and Mao et al. (US 10,752,928 B2), both of record, teach whole cell catalysts expressing UDP-glucosyltransferase which are capable of catalyzing RebA to RebD. However, neither reference indicates that the whole cell catalysts are capable of assimilating RebA and the intracellular enzymatic conversion thereof.
6. Level of predictability of the art: As noted above, RebA is a rare compound in nature and it was previously unknown if any microbe had the desired ability to assimilate RebA. Therefore, it would not be predictable that any known microbe would possess the desired RebA characteristic.
7. Breadth of the claims: The claims encompass all possible host cells which have been identified has having the desired RebA assimilation characteristic, and which have also been screened for or recombinantly produce genes and respective enzymes for intracellular conversion of RebA to RebD and/or Reb M, and converting assimilated RebA to the desired steviol glycosides intracellularly with said enzymes.
8. The level of one of ordinary skill in this art: The level of ordinary skill in the art is deemed to be high, at the graduate level of above.
Claims 1 and 5 are newly rejected under 35 U.S.C. § 112(a) or 35 U.S.C. § 112 (pre- AIA ), first paragraph, as failing to comply with the written description requirement, as necessitated by Applicant’s amendments to the claims filed 10/02/2025. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are drawn to host cells which have been identified has having the desired RebA assimilation characteristic, and which are also capable of expressing genes of enzymes for the intracellular conversion of RebA to RebD and/or Reb M, and converting assimilated RebA to the desired steviol glycosides intracellularly with a host cell produced UDP-glucosyl transferase enzyme. Therefore, the host cells as claimed, are associated with the particular function of being able to convert, intracellularly, RebA to RebD and/or Reb M. The disclosure is drawn to methods of screening microbes for the ability to assimilate RebA but does not provide any evidence that any microbe beyond a single undisclosed strain of K. marxianus had the desired property. The disclosure generally contemplates microbes capable of assimilating RebA which (either naturally or recombinantly) express genes and respective enzymes for intracellular conversion of RebA to RebD and/or Reb M, however there is no evidence in the disclosure of any microbial strain which has both RebA assimilation and expresses genes and respective enzymes for intracellular conversion of RebA to RebD and/or Reb M.
Thus, there is a lack of correlation between structure and function as claimed and there is no evidence in the disclosure that at the time of the invention Applicant was in possession of a microbial host cell capable of assimilating RebA, which also intracellularly enzymatically converts said assimilated RebA into RebD, RebM or both as claimed. Claim 5 is rejected as being dependent upon rejected Claim 1.
Response to Arguments
Applicant’s arguments, see Remarks, filed 10/02/2025, with respect to the above withdrawn rejection have been fully considered and are persuasive.
Applicant's arguments filed 10/02/2025 have been fully considered but they are not persuasive.
The Applicant argues that the Examiner’s position conflates enablement with a demand for exhaustive working examples. Applicant notes the claims do not need to be enabled for every possible embodiment but must enable the invention without undue experimentation. Applicant asserts the claimed steps are not abstract suggestions but are standard microbiological procedures, including specific experimental conditions and analytical techniques such that the skilled artisan could understand and practice the invention (Remarks, Pg. 2, Lines 10-24).
This is not found to be persuasive for the following reasons, nowhere in the Examiner’s rationale is a “demand for exhaustive working examples”. As Applicant is no doubt aware, a single working example or no working example may be enough to preclude a rejection under enablement. See the MPEP at 2164.01, I. However, those of ordinary skill in the art would still need to be able to carry out the invention without undue experimentation and is only one factor which is considered in determining whether enablement is present. In this instance, as set forth in the prior action and above, the disclosure provides a screening process which out of 19 undisclosed bacterial strains, only successfully identified a single undisclosed strain with the desired characteristics. The claims require the screening of any microbe for the ability to assimilate RebA and the capability (the Examiner notes that capability does not necessarily correlate to actual expression) to express the necessary enzyme(s) to convert said RebA intracellularly and perform said conversion. Thus, the ordinary artisan would have to first screen all possible microbes for the desired assimilation ability, and then either screen for or recombinantly produce in said identified microbe genes and respective enzymes for intracellular conversion of RebA to RebD and/or Reb M, and converting assimilated RebA to the desired steviol glycosides intracellularly with said enzymes. The Examiner notes the claimed steps are highly generalized and are hardly drawn to any “specific” experimental conditions and analytical techniques.
The Applicant argues that the Examiner’s concern over the single identified (but undisclosed) strain of K. marxianus is misplaced as the claims are not drawn to a single strain but to a method of identifying strains with the desired characteristics. Applicant notes the method was applied to 19 undisclosed microbial strains (reflected in the claims). Applicant asserts that the fact that the identities of the strains are not disclosed does not render the disclosure not enabled and the Specification provides detailed and reproducible method for identifying strains with the desire characteristics. Applicant notes the disclosure need not teach every possible variation and complex experimentation is not undue (Remarks, Pg. 2, Lines 25-31 and Pg. 3, Lines 1-6 and Pg. 4, Lines 12-19).
The Examiner notes that the non-disclosure of the screened strains and identified strain are but one aspect of the whole of the enablement rejection. The rejection set forth in the prior action and above, provides detailed rationale as to why the ordinary artisan would face an undue amount of experimentation in trying to implement the claimed method given the disclosure. The fact that only a single undisclosed strain of K. marxianus was identified using the claimed method is not indicative of being either “detailed” or “reproducible”. The claims require the screening of any microbe for the ability to assimilate RebA and the capability (the Examiner notes that capability does not necessarily correlate to actual expression) to express the necessary enzyme(s) to convert said RebA intracellularly and perform said conversion.
Thus, the ordinary artisan would have to first screen all possible microbes for the desired assimilation ability, and then either screen for or recombinantly produce in said identified microbe genes and respective enzymes for intracellular conversion of RebA to RebD and/or Reb M, and converting assimilated RebA to the desired steviol glycosides intracellularly with said enzymes. This amount to experimentation which is not merely complex but is also undue for the reasoning set forth above and in the prior action.
The Applicant argues that the Examiner’s interpretation that the disclosure does not provide any evidence that the undisclosed K. marxianus strain, much less any strain was capable of both RebA assimilation and the intracellular conversion thereof, overlooks key disclosures. Applicant cites Fig. 2 as demonstrating RebA uptake by the cell and the conversion is supported by the disclosure that the microbial strain “hosts expressed genes and respective enzymes” for the intracellular conversion of RebA, including “at least one UDP-glucosyltransferase” and “at least one sucrose synthase”. Applicant asserts that recombinant expression systems in yeast are well known and the ordinary artisan would understand the recombinant expression of the enzyme genes (Remarks, Pg. 3, Lines 7-31 and Pg. 4, Lines 1-4).
This is not found to be persuasive for the following reasons, Fig. 2 merely indicates that an undisclosed K. marxianus strain was capable of RebA uptake. The disclosure says nothing about the strains ability to intracellularly convert the assimilated RebA by either endogenous or recombinant expression of a UDP-glucosyl transferase enzyme. That recombinant expression of enzymes as well as particular enzymes being known in the art, does not negate the ordinary artisan from a) having to screen any and all microbes for the ability to assimilate RebA, b) said microbe either naturally or recombinantly expressing genes and respective enzymes for intracellular conversion of RebA to RebD and/or Reb M, and c) actually converting assimilated RebA to the desired steviol glycosides intracellularly with said enzymes as claimed. As discussed above, this amounts to an undue amount of experimentation.
The Applicant argues that the Examiner’s position that there is a “gap in the guidance” because only one strain is shown to assimilate RebA overlooks the fact that the claims are directed to a method of identifying and engineering such strains, not a specific strain. Applicant alleges that the disclosure provides sufficient guidance for the skilled artisan to practice the full scope of the claimed invention without undue experimentation. Applicant argues that the guidance teaches how to identify suitable host strains, how to confirm RebA assimilation and how to achieve intracellular conversion using known enzymes (Remarks, Pg. 4, Lines 5-11).
This is not found to be persuasive for the following reasons, as discussed above,
the claims require the screening of any microbe for the ability to assimilate RebA (acknowledged by Applicant as a rare property and thus unpredictable) and the capability (the Examiner notes that capability does not necessarily correlate to actual expression) to express the necessary enzyme(s) to convert said RebA intracellularly and perform said conversion. Thus, the ordinary artisan would have to first screen all possible microbes for the desired assimilation ability, and then either screen for or recombinantly produce in said identified microbe, genes and respective enzymes for intracellular conversion of RebA to RebD and/or Reb M, and converting assimilated RebA to the desired steviol glycosides intracellularly with said enzymes. As discussed above, this amounts to an undue amount of experimentation.
Applicant argues the Specification discloses a reproducible screening assay with a bounded set of candidates, instructs the practitioner to provide RebA medium and quantify any assimilation which is a concrete process within a defined group and not the unlimited universe of microbes (Remarks, Pg. 4, Lines 26-30 and Pg. 5, Lines 1-9).
This is not found to be persuasive for the following reasons, the bounded set of candidates is any strain falling into the 8 recited species and is thus not “bounded”, the Specification at best only provides a screening process for detecting RebA assimilation.
However, there is no data provided that any microbial strain beyond a single undisclosed strain of K. marxianus had the desired property. This indicates the rarity of the characteristic and thus its unpredictability.
The ordinary artisan would be required to screen any and all known microbial strains from the 8 claimed species for the desired (rare) property of RebA assimilation as well as additionally screen said microbes for naturally occurring genes and respective enzymes for intracellular conversion of RebA to RebD and/or Reb M or recombinantly express in said microbes genes and respective enzymes for intracellular conversion of RebA to RebD and/or Reb M.
The Applicant argues teaches a full discovery, confirmation, conversion workflow of how to select/culture candidates, how to detect intracellular accumulation/assimilation and enzymatic intracellular conversion. The claims do not require every strain naturally possess the conversion enzymes (can be introduced recombinantly) and describes the processes to achieve each route (Remarks, Pg. 5, Lines 11-24).
This is not found to be persuasive for the following reasons, the amount of direction or guidance presented is insufficient to predict which embodiments encompassed by the claims would work because the Specification only guides the ordinary artisan toward screening microbes for the ability to assimilate RebA. While the disclosure generally contemplates additional embodiments of undisclosed microbial strains capable of assimilating RebA which also host expressed genes and their respective enzymes for intracellular conversion of RebA to RebD and/or Reb M, said
enzymes include at least one UDP-glucosyltransferase (UGT),
the disclosure does not particularly direct or guide the ordinary artisan to screen any microbe strain for the ability to assimilate RebA, said microbe either naturally or recombinantly expressing genes and respective enzymes for intracellular
conversion of RebA to RebD and/or Reb M, and actually converting assimilated
RebA to the desired steviol glycosides intracellularly with said enzymes as claimed.
The Applicant argues that the Specification contains screening results for 19 candidate strains and data showing intracellular accumulation of RebA in only one strain of K. marxianus and a teaching that isolates “may” host UGT enzymes and that Reb products can be produced. Applicant asserts the law does not demand an example from every species when representative examples and a full reproducible method are disclosed. Applicant opines the specification provides guidance such that the skilled artisan could demonstrate uptake, intracellular accumulation and conversion of RebA as claimed (Remarks, Pg. 5, Lines 26-30 and Pg. 6, Lines 1-8).
This is not found to be persuasive for the following reasons, the Specification does not provide “representative examples” as only one strain was identified and as such the method has not been shown to be “reproducible”. The Specification as
discussed above, only provides a screening process for detecting microbial RebA
assimilation.
However, there is no data/example provided that any microbial strain
beyond a single undisclosed strain of K. marxianus had the desired property or any
data/example that said undisclosed strain of K. marxianus either naturally or
recombinantly expressing genes and respective enzymes for intracellular conversion of
RebA to RebD and/or Reb M, and actually converting assimilated RebA to the desired
steviol glycosides intracellularly with said enzymes.
The Applicant argues that the claims and Specification are not drawn to an unlimited, blind search but are limited to 19 undisclosed strains from the recited microbes which were screened for RebA uptake. Applicant asserts the practitioner would follow the disclosed process and would not need to screen all possible microbes (Remarks, Pg. 6, Lines 10-21).
This is not found to be persuasive for the following reasons, the claims require the screening of any microbe strain which falls within the 8 disclosed species strains (of which there are at least, if not more than 19) for the ability to assimilate RebA, express the necessary enzymes to convert said RebA intracellularly and perform said conversion. Thus, the ordinary artisan would have to first screen all possible microbes for the desired assimilation ability, and then either screen for or recombinantly produce in said identified microbe genes and respective enzymes for intracellular conversion of RebA to RebD and/or Reb M, and converting assimilated RebA to the desired steviol glycosides intracellularly with said enzymes.
The Applicant argues the Specification acknowledges that RebA is a rare compound in nature and it was not previously known if any microbe had the ability to uptake RebA. Applicant notes the Specification provides a screening assay for RebA uptake plus disclosure of the enzymes necessary for intracellular conversion thereof. (Remarks, Pg. 6, Lines 23-28 and Pg. 7, Lines 1-5).
The Applicant indicates that RebA is a rare compound in nature and it was previously unknown if any microbe had the desired ability to assimilate RebA (Specification, Pg. 1, Lines 23-24). Markosyan et al. (WO 2013/176738 A1) and Mao et al. (US 10,752,928 B2), both of record, teach whole cell catalysts expressing UDP-glucosyltransferase which are capable of catalyzing RebA to RebD. However, neither reference indicates that the whole cell catalysts are capable of assimilating RebA and the intracellular enzymatic conversion thereof. Thus, the state of the art to the ordinary artisan would be an art with a high degree of unpredictability and which would require an undue amount of experimentation as set forth above and in the prior action.
The Applicant argues the invention provides a reproducible discovery-confirmation workflow, noting that in fields of low predictability the courts and Patent Office accept representative positive data plus full method disclosure to satisfy enablement (Remarks, Pg. 7, Lines 7-16).
This is not found to be persuasive for the following reasons, as discussed above the Specification does not provide “representative positive data” as only one strain was identified and as such the method has not been shown to be “reproducible”. The Specification as discussed above, only provides a screening process for detecting microbial RebA assimilation. However, there is no data/example provided that any microbial strain beyond a single undisclosed strain of K. marxianus had the desired property or any data/example that said undisclosed strain of K. marxianus either naturally or recombinantly expressing genes and respective enzymes for intracellular conversion of RebA to RebD and/or Reb M, and actually converting assimilated RebA to the desired steviol glycosides intracellularly with said enzymes. As acknowledged by the Applicant, RebA is a rare compound in nature and it was previously unknown if any microbe had the desired ability to assimilate RebA (Specification, Pg. 1, Lines 23-24). Markosyan et al. (WO 2013/176738 A1) and Mao et al. (US 10,752,928 B2), both of record, teach whole cell catalysts expressing UDP-glucosyltransferase which are capable of catalyzing RebA to RebD. However, neither reference indicates that the whole cell catalysts are capable of both assimilating RebA and the intracellular enzymatic conversion thereof. Thus, the state of the art to the ordinary artisan would be an art with a high degree of unpredictability and which would require an undue amount of experimentation as set forth above and in the prior action.
The Applicant argues that the breadth of the claims concerns are mitigated by how the claims functionally define the host and allows the artisan to objectively determine whether a candidate falls within the claim scope without conjecture (Remarks, Pg. 7, Lines 18-27).
This is not found to be persuasive for the following reasons, as discussed previously, the claims encompass all possible host cells falling within the claimed species which have previously been identified as having the desired RebA assimilation characteristic, and which have also been screened for or recombinantly produce genes and respective enzymes for intracellular conversion of RebA to RebD and/or Reb M, and converting assimilated RebA to the desired steviol glycosides intracellularly with said enzymes.
The Applicant argues that the high level of ordinary skill in the art combined with the guidance in the disclosure would allow the artisan to predictably practice the invention without undue experimentation (Remarks, 8, Lines 1-9).
This is not found to be persuasive for the following reasons, while the level of ordinary skill may be high this does not in itself render the claims enabled for the reasoning provided both above and in the prior action.
The Examiner notes that the Applicant did not address the rejection of Claims 1 and 5 are rejected under 35 U.S.C. § 112(a) or 35 U.S.C. § 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
Conclusion
No claims are allowed.
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 PAUL C MARTIN whose telephone number is (571)272-3348. The Examiner can normally be reached Monday-Friday 12pm-8pm EST.
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, Sharmila G Landau can be reached at (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL C MARTIN/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653