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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/24/26 has been entered.
Claims 2, 5, 7, 21, 30-32 remain withdrawn till allowable subject matter is identified. Once allowable subject matter is identified, it is possible to rejoin said claims.
Claims 4, 6, 8, 10, 12-13, 15, 17-20, 22-27, 33-34, 36-41, 43-50, 52-127 have been canceled.
Applicants' arguments filed on 8/24/26, have been fully considered and are deemed to be persuasive to overcome some of the rejections previously applied. Rejections and/or objections not re-iterated from previous office actions are hereby withdrawn.
Claims 1, 3, 9, 11, 14, 16, 21, 28-29, 35, 42, 51, 128 are still under examination on the merits.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 42 remains 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 according to previous office action. In response to this rejection, applicant only repeats what has already been recited in claim 42 which is unpersuasive. The question remains as follows: if less than 3 g/l of the “fermentation product” is ethanol, what are the other (major) constituents of the fermentation product.
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, 3, 9, 11, 14, 16, 28-29, 42, 51, 128 remain 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. 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.
Claim 1 (and its dependent claims 3, 9, 11, 14, 16, 28-29, 35, 42, 51, 128) are rejected because applicant is claiming a generic fermentation process comprising a step (b) of preparing a two-phase solution comprising a first phrase and second phase, wherein the first phase comprises about 30 wt% to about 70 wt% glucose based on total carbohydrate present in the first phase of the two-phase solution and wherein the second phase of the two-phase solution comprises a higher amount of total suspended solids than the first phase and (c) draining the first phase from the tank to isolate the first phase from the second phase, wherein said fermentation process (steps b-c) is inadequately described in the disclosure.
The court of Appeals for the Federal Circuit has recently held that such a general definition does not meet the requirements of 35 U.S.C. 112, first paragraph. “ A written description of an invention involving chemical genus, like a description of a chemical species, requires a precise definition, such as be structure, formula {or} chemical name, of the claimed subject matter sufficient to distinguish it from other materials.” University of California v. Eli Lilly and Co., 1997 U.S. App. LEXIS 18221, at *23, quoting Fiers v. Revel, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993). The court held that “ in claims involving chemical materials, generic formulae usually indicate with specificity what generic claims encompass. One skilled in the art can distinguish such a formula from others and can identify many of the species that the claims encompass. accordingly, such a formula is normally an adequate description of the claimed genus. In claims to genetic material, however, a generic statement such as “vertebrate insulin cDNA” or “mammalian insulin cDNA,’ without more, is not an adequate written description of the genus because it does not distinguish it from others. One skilled in the art therefore cannot, as one can do with a fully described genus visualize the identity of the members of the genus”. Here, applicant is claiming a process comprising forming a “two-phase solution” comprising a first phase and a second phase by very little information.
In his/her response, applicant argues: the amended language is fully supported by the Specification. For example, the Specification explains that the process includes contacting a starch hydrolysate with glucoamylase with agitation, ceasing agitation to allow settling, and forming a phase-separated solution including a first phase and a second phase. See Spec [0002]. The Specification further explains that forming the phase-separated solution requires balancing agitation and settling, and that those steps control the glucose content of the first phase. See Specifiaction [0016]. Thus, as amended, claim 1 expressly recites the two phases used in the process and no longer raises any issue regarding unidentified additional phases.
However, said information referred to by applicant, does not provide any specific values for variables required to control and establish a two-phase solution. Said paragraphs [0016-0017] applicant mentioned above, focus on preparation of a “multi-phase solution” and even then, they are not specific. In addition, an online search of distinct phase creation with glucoamylase and starch hydrolysate (see Distinct Phase Creation with Glucoamylase and Starch Hydrolysate, commercial database search online, 9/20/26 indicates that controlling distinct phase establishment when mixing glucoamylase with a starch hydrolysate is a common challenge in enzymatic hydrolysis processes. Said online disclosure reveals that phase separation can occur due to differences in solubility, viscosity, and interfacial tension between the enzyme solution and the hydrolysate. Prior art in general further reveals that when glucoamylase is mixed with starch hydrolysate, at first attempt “a multi-phase solution” is established.
Said attachment mentions that: in order to control phase separation various factors should be considered such as mixing (agitation) intensity, hydrolysate viscosity, enzyme concentration, temperature and pH control etc.
However, instant generic claim 1 fails to mention/ identify any of said specific and critical factors (variables) that were used to establish a “two-phase solution” The only specific information in claim 1, is glucose concentration in the first phase and according to the disclosure said first phase is derived from a “multi-phase solution.
Given the challenge of controlling and establishing a distinct “two phase solution” in the field of glucoamylase treatment of starch hydrolysate and given the unpredictability of prior art, some more specific information as to which specific conditions (viscosity, temperature, pressure, agitation speed and time etc.) are likely to result is a distinct “two-phase solution” preparation deems necessary that is lacking in the disclosure as the disclosure.
Therefore, based on the information provided, one of skill in the art cannot reasonably conclude that applicant had full possession of the invention before the effective filing of this application.
In claims 9, 11, 16, 29 some more information about steps (b-c) of claim 1 is provided but the said information is insufficient or inadequate to fully describe all variables that are necessary to fully describe the claimed invention.
Therefore, based on the information provided one of skill in the art cannot reasonably conclude that applicant had full possession of the invention, before the effective filing of this application.
Claims 1, 3, 5, 11, 14, 16, 28-29, 35, 42, 51, 128) are rejected are also 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. 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. Claim 1 (and its dependent claims 3, 9, 11, 14, 16, 28-29, 35, 42, 51, 128) are rejected because the examiner could not find explicit support for a fermentation process, whose step(b) is identical to what applicant recites in claim 1(b). It is noted that applicant has amended the originally examined concentration of glucose from 30 wt%-70 wt% in the total of the first and second phase to “from 30 wt%-70 wt% in only the first phase. Therefore, said amendment is considered to be new matter. Applicant is advised to direct the examiner to where a process with step(b) as instantly amended, can be explicitly found in the body of the disclosure.
Claims 3, 9, 11, 14, 16, 28-29, 35, 42, 51, 128 are merely rejected for depending from claim 1.
No claim is 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 MARYAM MONSHIPOURI whose telephone number is (571)272-0932. The examiner can normally be reached full-flex.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie L Gordon can be reached at 571-272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARYAM MONSHIPOURI/Primary Examiner, Art Unit 1651
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