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
The present application claims priority to BR1020230196411 (filed on 09/25/2023).
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The listing of references in paragraphs [0060]-[0069] of the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Drawings
The drawings are objected to for the following reasons.
The shading and quality of FIG. 1 is not sufficient to show the details contained therein;
FIGS. 2 and 3 use commas instead of decimal points to delineate decimals;
FIGS. 2 and 4 contain text which is smaller than the minimum text size requirement and the figures are not in sufficient size to be readable when reproduced.
In the interest of compact prosecution, it is recommended that each FIG. be separated to its own page and presented in landscape format in order to maximize size and clarity of the figure.
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.
Specification
The disclosure is objected to because of the following informalities:
Paragraphs [0035], [0036], [0038], [0049], [0051], [0052], [0053], and [0055] contain what appears to be Portuguese unit “m.s.” (materia seca). In order to minimize the necessity in the future for converting dimensions given in the English system of measurements to the metric system of measurements when using printed patents as research and prior art search documents, all patent applicants should use the metric (S.I.) units followed by the equivalent English units when describing their inventions in the specifications of patent applications (MPEP § 608.01(IV)). Accordingly, the specification should be amended to include the S.I. unit of measurement.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112:
(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.
(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.
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 1-11 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement.
The claims contain 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 at the time the application was filed, had possession of the claimed invention.
MPEP § 2163.03(V)
While there is a presumption that an adequate written description of the claimed invention is present in the specification as filed. In re Wertheim, 541 F.2d 257, 262, 191 USPQ 90, 96 (CCPA 1976), a question as to whether a specification provides an adequate written description may arise in the context of an original claim. An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved or (2) a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated.
Therefore, in order to determine whether applicant’s disclosure contains adequate description for a broad method of propagating any and every microorganism, applicant’s specification must be fully considered to determine whether the description contemplates propagating any and every microorganism (or at least a representative number of species encompassed by the broad genus). In order to satisfy the written description requirement for applicant’s broad claim to methods of propagating any “microorganism”, applicant must disclose sufficiently detailed, relevant identifying characteristics. These characteristics include the complete or partial structure, other physical or chemical properties, or functional characteristics when coupled with a known or disclosed correlation between function and structure. Additionally, applicant may meet this requirement by sufficiently describing a representative number of species within the claimed genus.
Applicant’s disclosure has been fully considered and is directed to a narrow embodiment of the claimed genus. Specifically, applicant’s disclosure can be extended to propagating “various microorganisms, mainly microorganisms that suffer inhibition of growth by the feeding medium” ([0001]). Applicant’s disclosure is “exemplified…by the yeast Saccharomyces cerevisiae” (Id.). More specifically, applicant’s disclosure concerns “a method of propagating genetically modified yeasts or…any other yeasts that suffer a positive Crabtree effect or any other microorganisms that use sugars for growth” ([0002]). The genus of “any other microorganisms that use sugars for growth” is very broad and encompasses virtually every microorganism (e.g., by encompassing either yeasts or any microorganism that in any way uses any sugar for growth). It is clear that applicant possessed a method of propagating genetically modified yeasts or yeasts that suffer a positive Crabtree effect but it is not clear that applicant possessed a method of propagating “microorganisms” or even “any other microorganisms that use sugars for growth”.
It is not considered that analyzing propagation of two genetically modified Saccharomyces cerevisiae strains ([0049]) is sufficient disclosure to convey possession of methods of propagating any “microorganism”.
Moreover, it is noted that the instant claim requires (with consideration of the numerous 112(b) deficiencies described below). A method of propagating microorganisms to produce inoculum for fermentation comprising a step of “inoculum growth” with two feeding phases with an exponential feeding profile in fed-batch without feedback control and in a single reactor. Phase 1 requires a low initial cell concentration and high amount of sugar and a second phase with a cell concentration between 3 and 10 g/L and a supply of relatively low sugar. What is claimed is far different from what is disclosed in the specification. Applicant identifies that the present invention “specifically addresses to the propagation step” and this includes taking advantage of a diluted hydrolysate stream added or not with molasses and supplemented with yeast extract ([0044]). Propagation takes place with temperatures between 25 and 35 °C, pH controlled between 4 and 6 through automatic addition of an aqueous solution (notably contradicting line 4 of claim 1 which requires the method to be “without feedback control”), dissolved oxygen above 30% through automatic cascade control (also contradicting line 4 of claim 1 which requires the method to be “without feedback control”), and a pre-set air flow rate ([0045]). Applicant reports “strategy #3” as being representative of the claimed invention but also concedes that “in the reported experiments, dissolved oxygen was maintained above 30% of saturation, by automatic cascade control” ([0055]). Accordingly, even the closest representative example of the specification is not commensurate with what is claimed and a person having ordinary skill in the art would not recognize applicant’s possession of a method of propagation of any microorganism by the two phases and without feedback control.
For at least the above reasons, a person having ordinary skill in the art would recognize applicant’s possession of the narrow “strategy #3” for propagation of genetically modified S. cerevisiae but would not recognize applicant’s possession of the broader propagation method for any “microorganisms” recited in the instant claims. It is noted that none of the dependent claims remedy this deficiency such as by narrowing the scope of the invention such that it encompasses an embodiment which applicant possessed at the time of filing.
Claims 1-11 are rejected under 35 U.S.C. 112(a) as failing to comply with the enablement requirement.
The claims contain 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 use the invention.
The factors considered when determining if there is sufficient evidence to support that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue” include, but are not limited to: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. See In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). MPEP § 2164.04
further states that although the analysis and conclusion of a lack of enablement are based on these factors and the evidence as a whole, it is not necessary to discuss each factor in the enablement rejection.
With respect to the breadth of the claims and the nature of the invention, applicant’s claims are broadly directed to a method of propagating “microorganisms to produce inoculum for fermentation”. The method comprises a step of inoculum growth and has two feeding phases with an exponential feeding profile in fed-batch, without feedback control, in a single reactor.
Phase 1 occurs in the first 6-9 hours and requires a low initial cell concentration and a supply of “relatively high amount of sugar”.
Phase 2 occurs from 6-9 hours to 15-30 hours and requires an initial cell concentration between 3 and 10 g/L and supply of a “relatively low amount of sugar”.
The breadth of “microorganisms” is not limited to any particular subset of this genus and encompasses every microorganism (e.g., bacteria, viruses, fungi, nematodes, etc.).
Claim 2 defines the “exponential feeding profile” of claim 1 as being automatically controlled by a supervisory system of a bioreactor system based upon equation 1.
Claim 3 requires that the “yeast propagation” (deficiency described below in the 112(b) section) occurs in a fed-batch with temperatures between 25 and 35 °C and pH between 4 and 6, and further requires a specific method of pH maintenance, and automatic control of dissolved oxygen.
Claim 4 requires a minimum concentration of hydrolysate.
Claim 5 requires a lignocellulosic hydrolysate stream to be diluted and requires a minimum concentration.
Claim 6 requires a lignocellulos hydrolysate stream to be provided to the reactor.
Claim 7 requires an approximate initial cell concentration.
Claim 8 requires a particular “adopted specific cell growth rate”.
Claim 9 merely describes how many cells are “achieved” at the end of Phase 1.
Claim 10 limits “the yeast” (deficiency described below in the 112(b) section) to be those capable of consuming xylose or sugars listed as equivalent glucose.
Claim 11 merely describes what the method achieves.
With respect to the state of the prior art, the closest prior art is van Hoek et al. (Biotechnology and Bioengineering, 2000, Vol. 68(5), pages 473-587) which teaches high-cell density fed batch cultivation of S. cerevisiae (abstract; p. 519, right col., par. 3). van Hoek teaches exponentially increasing the feed rate to maintain a specific growth rate (Id.). The feed rate was maintained until a given biomass concentration (p. 519, right col., par. 4). van Hoek also teaches maintaining the amount of dissolved-oxygen (Id.). van Hoek teaches that substantial fermentative capacity was apparent with excess glucose and once the feed rate was constant, the fermentative capacity decreased sharply and this decrease coincided with the decrease of specific growth rate resulting from constant and then decreasing feed rate (p. 520, right col., par. 3).
Neither van Hoek nor the prior art as a whole teach or suggest a method of propagating microorganisms with a method comprising at least two feeding phases without feedback control, and in a single reactor in which phases 1 and 2 are performed under the recited conditions.
With respect to the amount of direction provided by the inventor and the existence of working examples, apart from prophetic examples, applicant provides a specific working example wherein three “strategies” were compared.
Strategy #1 resulted in an expansion of 12-14 x of cell mass and relatively lower yields ([0052]).
Strategy #2 resulted in an expansion of 5-7 x of cell mass and relatively higher yields ([0052]).
Strategies 1 and 2 had the same operating conditions and differed only in the carbon source feeding curve and the initial concentration of the inoculum ([0052]).
Applicant then developed Strategy #3 with the aim of allowing a process with high cell expansion from low inoculum and guaranteeing a high cell yield ([0054]). This developed strategy resulted in an expansion of 50-117x of cell mass with cell yields ranging from those seen in strategies 1 and 2 ([0055]). This strategy presents 2 distinct feeding regime phases which combine strategies 1 and 2.
Applicant states that “it is worth emphasizing that, in the reported experiments, dissolved oxygen was maintained above 30% of saturation, by automatic cascade control (with adjustment of stirring speed and air flow rate” and this was not a variable studied in the present invention ([0055]).
Applicant tested this new strategy on two genetically modified strains of S. cerevisiae which were capable of consuming xylose and found that between both strains, the strategy “resulted in satisfactory growth” ([0056]). However, applicant notes that “it is recommended to adjust the parameters of the equations to the specific rates of each strain, in order to obtain the best possible yields” (Id.).
Applicant then presents Table 1 which shows an exemplary composition of a sugarcane lignocellulosic hydrolysate and molasses stream before dilution.
With respect to the level of one of ordinary skill, a person having ordinary skill in the art is a person having an advanced understanding of microbiology or biological sciences.
With respect to the quantity of experimentation and the level of predictability, as discussed above, the prior art as a whole does not teach or suggest a method of propagating microorganisms with a method comprising at least two feeding phases without feedback control, and in a single reactor in which phases 1 and 2 are performed under the recited conditions. Accordingly, when performing the claimed process, a person having ordinary skill in the art could look only to applicant’s disclosure to enable the invention. Applicant’s disclosure provides a single specific working example wherein two strains of the same species of yeast were tested under specific reaction conditions. Applicant’s Figure 4 provides a demonstration that the claimed invention is unpredictable. Namely, FIG. 4 shows a lab-scale and a pilot-scale study (left and right, respectively). The left panel of this figure shows that among the same strains under the same conditions, there is variation in resulting cell concentration. For example, strain A (indicated by squares) had resulting concentrations varying from ~10.5 gdcw/kg to 14 gdcw/kg. The right panel shows that at pilot scale, the amount of feeding stream elicits a widely divergent cell concentration when using the same strain. Accordingly, it is clear that even when the reaction conditions are replicated, the results vary and the results vary even more when the reaction is performed under different conditions (such as by providing a less-dilute hydrolysate stream).
Conclusion
Upon consideration of the Wands factors and the evidence as a whole, the claimed invention fully lacks enablement.
Specifically, the claims lack enablement over their entire breadth for the following reasons.
First, when the invention is directed to the specific embodiment disclosed in the specification (performing strategy #3 on S. cerevisiae), there is clear unpredictability in the results (as discussed above). And to the extent that the invention may be guided by some exponential feeding profile by a supervisory system, the specification states that it should use the Enfors and Häggstrӧm equation ([0036]). Applicant’s disclosure has not provided the necessary variables to adopt a feeding profile even for their working example. For example, applicant has not disclosed M0, YX/S, and CX0 and a person having ordinary skill in the art would have to therefore experiment with various combinations of at least these variables in order to manually or automatically determine F(t) for each phase of the propagation process. Moreover, claim 1 disallows “feedback control” but also provides that the adjustment of these parameters between phases 1 and 2 is either provided automatically (see claim 2) or “manually…in order to avoid overfeeding the carbon and nutrients source” ([0036]). Automatic or manual manipulation of the feeding profile by changing variables such as µset is necessarily a form of “feedback control”. As such, there is no guidance on performing the method “without feedback control” as required by the claims. Moreover, even though the claims explicitly prohibit “feedback control”, this level of control is apparently necessary to maintain at least dissolved oxygen and pH and to regulate the hydrolysate stream (see claims 3-5).
Second, when the invention is directed to microorganisms which are not S. cerevisiae yeast strains A and B, because the results of the method are widely varied even among the strains tested, there is therefore an undue amount of experimentation needed to determine which, if any, reaction conditions are suitable for propagating microorganisms to produce inoculum for fermentation using the recited method for other species of Saccharomyces, let alone other genera or even taxonomic kingdoms encompassed by the broad claim to “propagating microorganisms”. Applicant contemplates this level of experimentation by stating “it is recommended to adjust the parameters of the equations to the specific rates of each strain, in order to obtain the best possible yields” ([0056]).
Claims 1-11 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
Claim 1 is rejected as indefinite for the following reasons.
First, lines 3-4 recite an “Exponential feeding profile F(t)” but the claim does not define what is meant by the variable “F(t)”. Claim 2 defines the variable as meaning “fresh medium feeding flow rate (kg/h)”. If applicant wishes to use “F(t)” in claim 1, it should be fully defined when first used in the claims.
Second, line 5 recites the phrase “first 6 to 9 hours of testing”. It is not clear what applicant means by “testing”. The claim is to a method of propagating microorganisms to produce inoculum for fermentation and makes no mention of a “test” or performing “testing”. Therefore, it is not clear when in the process this phase occurs.
Third, line 5 recites the relative terminology “low initial cell concentration”. Acceptability of the claim language depends on whether one of ordinary skill in the art would understand what is claimed, in light of the specification (MPEP § 2173.05(b)(I)). Applicant’s specification has been fully considered but does not provide sufficient description in order to reasonably apprise what applicant means by the term “low”. The closest description of this term is “Cx0 ~ 0.2-1.5 m.s./kg” (Specification, [0038]) but it is not clear what is meant by “m.s.”. Given the priority document, it appears that this is a Portuguese unit of measurement (materia seca). If it was clear what was meant by this term, the claim is still indefinite because the claim does not require a “low” concentration in this amount and the specification does not clearly define the term “low” as requiring this amount. Even if the claim did require this amount, the use of the tilde to indicate approximation (“~”) allows for other amounts but it is not clear what is considered to be approximately 0.2-1.5. Thus, the specification does not provide an objective standard to interpret the meaning of “low” in this context.
Fourth, lines 5-6 recite the phrase “a low initial cell concentration in the initial volume and supply of a relatively high amount of sugar”. In this phrase, it is not clear what is meant by “the initial volume” as there is no antecedent basis for the term. In the interest of compact prosecution, it is recommended that “the initial volume” be amended to “an initial volume”.
Fifth, line 6 recites the relative terminology “relatively high amount of sugar”. Similar to the analysis provided above, the specification does not reasonably apprise what is meant by “relatively high”. First, it is not clear what the concentration is “relatively” higher than and second, it is not clear what is meant by “high”.
Sixth, line 7 recites the relative terminology “a cell growth speed close to that of maximum specific growth speed”. Similar to the analysis provided above, the specification does not reasonably apprise what is meant by “close to that of maximum specific growth speed”. For example, should the cell growth speed be within a specific deviation from maximum specific growth speed in order to be considered “close” or is there some other objective standard by which a person having ordinary skill in the art would consider the speed to be “close” to maximum specific growth speed?
Seventh, line 9 recites the relative terminology “relatively low amount of sugar”. As discussed above, it is not clear what the concentration is “relatively” lower than and it is not clear what is meant by “low”.
Finally, the claim is indefinite because it is not clear what the actual manipulative steps are. It is acknowledged that the claim is “a method of propagating microorganisms to produce inoculum for fermentation” but the claim construction does not actually require a step of “propagating microorganisms to produce inoculum for fermentation”. The only step required by the claim is “inoculum growth” and the limitations which make up the majority of the body of the claim are limiting to “said method” which does not actually require “two feeding phases, with an exponential feeding profile F(t), in fed-batch, phases 1 and 2, without feedback control, in a single reactor”. In other words, the recited list of description of said method merely describe a generic method and the reaction conditions of certain phases of a propagation method but the method does not specifically set forth how these conditions are integrated into the process (such as by stating that the method comprises step 1, step 2, step 3, etc.).
Although the claim as written can be interpreted to only definitely require a step of “inoculum growth”, the claim has been examined for prior art purposes as if the claim required inoculum growth under the conditions recited in the claim.
Claim 2 is rejected as indefinite for the following reasons:
First, lines 2-3 require that the exponential feeding profile is “automatically controlled by the supervisory system of the bioreactor system based on equation 1 below”. The claim does not require growth in a “bioreactor system” and it is further unclear what is meant by “the supervisory system” because neither the instant claim not the claim from which this claim depends requires a “supervisory system”. Therefore, the terms lack antecedent basis. In the interested of compact prosecution, it is recommended that the method be amended to definitively require reaction in a bioreactor system and to amend “the supervisory system” to “a supervisory system”. See the rejection under 35 U.S.C. § 112(d) for further discussion on this limitation.
Second, line 4 requires that “equivalent glucose is considered to be the sugars present in the feeding stream that are preferentially consumed by the microorganism”. This limitation is indefinite for two reasons. First, it is unclear what is meant by “preferentially consumed” because it is not clear to what the consuming is being compared (e.g., preferentially to other sugars?). Second, neither this claim nor the claim from which this claim depends (claim 1) recite a “feeding stream” and the term therefore lack antecedent basis.
Third, lines 11-12 recite the unit “m.s./g”. It is unclear what is meant by “m.s.”. As discussed above, it appears that this is a foreign unit “materia seca”. Units of measurement should be in terms of the metric system (MPEP § 608.01(IV)).
Fourth, lines 16-17 discuss “the application example”. It is improper to reference what is discussed in the specification in the claims. An issue of indefiniteness arises because it is unclear whether applicant intends to limit claim 2 to require that “the equivalent glucose corresponds to the sum of glucose, fructose and sucrose/0.95” or if this is merely an example of how to measure equivalent glucose.
Fifth, claim 2 recites an amount of glucose “in the feeding medium”. As discussed above, the claim does not require a fermentation step and also does not explicitly or implicitly require a “feeding medium”. As such, there is insufficient antecedent basis for this term.
Finally, the equation is unclear because it recites Cs but the definitions of the equation refer to Cs0. Therefore, it is not clear if the Cs denominator in the equation is the “equivalent glucose concentration in the feeding medium” or is some other variable.
Claim 3 is rejected as indefinite for the following reasons:
First, line 2 requires that “the yeast propagation occurs in a fed-batch” but neither this claim nor the claim from which it depends (claim 1) require “yeast propagation”. Claim 1 is directed to a method of propagating microorganisms but does not definitively require the microorganisms to be yeast. Thus, it is not clear what yeast propagation is being referenced.
Second, line 5 recites a “preferable” limitation. Description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim (MPEP § 2173.05(d)). In this case, it is not clear whether applicant is requiring the addition to be NH4OH and H2SO4 and if so, whether the amount recited in the parenthetical is required by the claim as well.
Third, lines 4 and 6 reference “the medium”. As discussed above, there is no mention of a medium and the closest mention of a medium is in claim 2 (which is not in the dependency of this claim), which refers to a “feeding medium”. It is not clear if this is the same medium.
Fourth, line 7 recites “the stirring speed”. The method does not previously establish a “stirring speed”. Accordingly, this phrase lacks proper antecedent basis. In the interest of compact prosecution, it is recommended that “the stirring speed” be amended to “a stirring speed”.
Fifth, the use of parenthetical language in lines 5 and 8-9 is unclear because it is not clear if applicant is positively reciting these ranges. If applicant intends for the claims to require these ranges, the claim should definitively define the ranges as required. For example, “…with adjustment of the stirring speed (between 100 and 900 rpm)” may be amended to instead read “…with adjustment of a stirring speed wherein said stirring speed is adjusted to between 100 and 900 rpm”.
Claim 4 is rejected as indefinite for the following reasons:
First, lines 2-3 reference “the minimum concentration of hydrolysate used in the propagation process”. Neither this claim nor the claim from which it depends sets forth a “minimum concentration of hydrolysate” nor does either claim even refer to a hydrolysate. Accordingly, the phrase lacks antecedent basis. In the interest of compact prosecution, it is recommended that this phrase be rewritten as “…wherein a minimum concentration of hydrolysate…”.
Second, the above phrase refers to hydrolysate “used in the propagation process”. As discussed above, claim 1 is a method of propagating microorganisms but only requires a step of “inoculum growth”. Accordingly, there is insufficient antecedent basis for this term because it is into clear what “propagation process” is being referenced.
Third, claim 4 compares “minimum concentration of hydrolysate” “in the propagation process” in relation to “hydrolysate from the fermentation step”. Claim 1 does not set forth “a propagation process” and does not set forth a “fermentation” step. Accordingly, it is not clear where in the method this comparison is made.
Fourth, it is not clear what is meant by “as the only source of carbon or as a complementary source” means. This phrase appears to be modifying the “minimum concentration of hydrolysate” but it is not clear what applicant is limiting. If applicant means to require that the hydrolysate is the only source of carbon or is a complementary source of carbon, then the claim should be amended to distinctly require this (e.g., “…wherein said hydrolysate is the only source of carbon or is a complementary source of carbon”).
Claim 5 is rejected as indefinite for the following reasons.
First, lines 2-3 require “the lignocellulosic hydrolysate stream is a diluted lignocellulosic hydrolysate stream”. This limitation lacks proper antecedent basis because neither claim 5 nor claim 1 refer to a lignocellulosic hydrolysate stream. Accordingly, it is not clear what applicant intends to limit.
Second, the above phrase refers to a “diluted” stream but it is not clear what constitutes a “diluted” stream (e.g., is there a particular amount which is considered to be “diluted” or is this stream “diluted” in comparison to some other standard?).
Third, the claim requires a comparison to “the hydrolysate from the fermentation step”. As discussed above, the claims do not positively recite or require a “fermentation step”. As such, it is not clear to what step the comparison is being made.
Claim 6 is rejected as indefinite for the following reasons.
First, lines 2-3 require “the lignocellulosic hydrolysate stream is provided to the reactor”. Although claim 1 requires a “reactor”, as discussed above, this claim does not provide a “lignocellulosic hydrolysate stream” and it is therefore not clear what stream is being referenced.
Second, line 3 recites an “optional” followed by a “preferable” limitation. It is not clear which, if any, of these limitations are actually required by the claim.
Third, as discussed above, this claim refers to a “the hydrolysate from the fermentation step”. The claims do not recite a “hydrolysate” or a “fermentation step” and this phrase therefore lacks proper antecedent basis.
Fourth, lines 5-6 recite “in order to guarantee the equivalent glucose concentration (sucrose, glucose and fructose) between 40 and 140 g/L”. This phrase is indefinite for multiple reasons. First, neither claim 1 or 6 recite an “equivalent glucose concentration”. Therefore, it is not clear what the phrase limits. Second, the parenthetical language makes it unclear whether the equivalent glucose molecules are required to be these three sugars. Third, it is not clear how this phrase is limiting the claim because it appears to merely describe why the “hydrolysate stream is provided to the reactor” rather than imparting an actual limitation on the claim.
Claim 7 is rejected as indefinite for the following reasons.
First, line 2 refers to “the initial cell concentration of the propagation process”. Although claim 1 recites an “initial cell concentration”, claim 1 does not positively recite a “propagation process”. Therefore, it is not clear to what this phrase is limiting.
Second, line 3 recites the unit “m.s./g”. It is unclear what is meant by “m.s.”. As discussed above, it appears that this is a foreign unit “materia seca”. Units of measurement should be in terms of the metric system (MPEP § 608.01(IV)).
Claim 8 is rejected as indefinite because it is not clear what “adopted specific cell growth rate” in phase 1 and phase 2 is being referenced. Although claim 1 recites “a cell growth speed”, “specific growth speed”, and “growth rate”, none of the limitations in claims 1 and 8 recite an “adopted specific cell growth rate”.
Claim 9 is rejected as indefinite for the following reasons.
First, line 2 recites the unit “m.s./g”. It is unclear what is meant by “m.s.”. As discussed above, it appears that this is a foreign unit “materia seca”. Units of measurement should be in terms of the metric system (MPEP § 608.01(IV)).
Second, line 2 recites the approximation “approximately”. It is not clear what applicant considers to be “approximately” 3-10 m.s./kg. For example, is “2” considered to be “approximately 3” or is there some other definitive beginning and end to the approximation. Applicant’s specification has been fully considered but does not provide guidance as to the metes and bounds of the claim.
Claim 10 is rejected as indefinite for the following reasons.
First, line 2 limits the “yeast” to be “chosen from the group of those capable of consuming xylose or the sugars listed as equivalent glucose”. As discussed above, the claims are for “microorganisms” but do not positively require “yeast”. Accordingly, it is not clear what is being limited by the phrase “the yeast”.
Second, the yeast are required to be capable of consuming “the sugars listed as equivalent glucose”. It is not clear what list applicant considers to be equivalent glucose. The claim should positively recite the equivalents rather than referencing an unknown “list”.
Claim 11 is rejected as indefinite because it is unclear if the parenthetical (“(between 15 and 30 h)” is required. It is recommended that applicant amend the claim to remove the parenthetical language.
Claims 2-3 and 11 are rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which they depend, or for failing to include all the limitations of the claim upon which they depend.
Claims 2-3 are limiting to “automatic controls” (supervisory systems and automatic cascade controls, respectively). These claims do not properly depend from claim 1 because claim 1 explicitly states that the method does not have “feedback control”. As such, the claim broadens the scope by adding feedback controls to a claim which explicitly cannot have them.
Claim 11 is not further limiting because it merely states what the “fed-batch strategy” does. Therefore, merely stating that the process increases productivity and reduces propagation time does not further limit the method of claim 1.
Applicant may cancel the claims, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims comply with the statutory requirements.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GRANT C CURRENS whose telephone number is (571)272-0053. The examiner can normally be reached Monday - Thursday: 7:00-5:00.
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, 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.
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.
/GRANT C CURRENS/Examiner, Art Unit 1651
Prosecution Insights