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 1-12 have been canceled. Claims 13-17 and newly added claims 22-33 are still at issue and are present for examination. Claims 18-21 remain withdrawn as drawn to non-elected invention.
Applicants' arguments filed on 7/2/26, 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 Rejections and/or objections not re-iterated from previous office actions are hereby withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 13-17, 22-33 remain rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 13 and its dependent claims 14-17 and 22-33, remain unclear for the following reasons:
if the “fermentable composition” in line 5 of claim 13 has the same composition as “fermentable composition” in line 10. If said products are different, then applicant should rewrite claim 13 to distinguish between said products. Applicant may consider indenting various steps of claim 13, such that they could be referred to as steps (a), (b), (c), etc. and bringing in the limitations of claim 24 into claim 13.
it is unknown if “fermentation conditions” recited in line 5 of claim 13 is identical to “fermentation conditions” in line 10. Again, if they are different applicant needs to rewrite claim 13 such that said phrases could be distinguished from each other. Applicant is advised to bring in the limitations of claims 15-16 into claim 13 to overcome this rejection.
in claim 13, line 5, it is unclear what was utilized for fermentation: enzymes or microorganism. Also, in claim 13, line 11 it is totally unclear what said "one or more microorganisms” are. Applicant may for example, bring in the limitations of claims 27-28 into claim 13.
(4) in claim 13, line 14, it is ambiguous if the “the one or more stillage compositions” in the bioprocessing facility are the same stillage compositions referred to in line 9 of claim 13. Appropriate clarification is required.
(5) in claim 13, and claim 17, it is totally unclear what “one or more process compositions” are.
(6) in claim 13, line 12, and claim 17, it is indefinite as to what "a whole secondary fermentation broth” is. No definition is provided for said phrase in the disclosure. Hence, its metes and bounds are unknown.
(7) in claim 13, lines 1 and 13, it is unknown what “one or more enzymes’ are referred to and if said enzymes are recombinantly produced or not.
(8) the preamble of claim 13 reciters” a method of producing one or more enzymes …” but the end product of the claim recovers no enzymes whatsoever. It appears that the instantly claimed method is a loop within a more extensive network of processes, wherein said loop produces enzymes to be supplied to the primary fermenter to produce only a target product, namely ethanol. If that is the case, then applicant must rewrite claim 13. Appropriate clarification is required.
Claims 14-17 and 22-30-33 are rejected for depending from claim 13.
Claim 25 is 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. In claim 25, it is unknown which “one or more stillage compositions” is referred to. The one recited in line 8 of claim 13 or the one in line 14 of claim 13.
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 13-17, 22-33 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 according to previous office action. Claim 13 and (its dependent claims 14-17, 22-33) remain rejected according to previous office action.
In traversal of this rejection, applicant refers to Fig. 2 and mentions that said figure helps illustrate the process claimed. More specifically, according to applicant, in FIG. 2, one or more sources 202 provide material, including feedstock derived from grain such as corn flour, to primary fermenter 205 to form a fermentable composition. Primary fermenter 205 exposes the fermentable composition to fermentation conditions to produce beer 207 comprising one or more bioproducts, such as ethanol. Separation system 210 receives beer 207 and separates at least a portion of a bioproduct from the beer to form target biochemical stream 211 and whole stillage stream 212. A portion 218 of whole stillage stream 212 is then provided to secondary fermentation system 230 and used as growth medium for an enzyme-producing microorganism.
Secondary fermentation system 230 exposes the fermentable composition formed from the portion 218 of whole stillage stream 212 to fermentation conditions so that one or more microorganisms produce one or more enzymes and form whole broth 232. Whole broth 232 can be combined one or more process compositions in the bioprocessing facility 200. For example, whole broth could be used as backset so the enzymes can be used in primary fermenter 205.
Therefore, in view of applicant, this rejection should be withdrawn.
These arguments were fully considered but were found to be unpersuasive. This is because looking at Fig. 2, at least the section applicant discussed above, the only product that has shown to be collected is ethanol (namely 211). However, instant invention is directed to a “method of producing one or more enzymes in a bioprocessing facility”.
Again, as mentioned previously, the primary and secondary fermenters in claim 13 are referred to generically and the specification fails to provide examples of products that may be fermented therein beyond ethanol and “whole broth” (whatever whole broth, may be, see 112 second rejection above).
The examiner maintains that looking at claim 13, the specification provides no specific structural information about the products and biocatalysts used and/or made as claimed. No information about the fermenters is recited. It is unclear what members constitutes the genus of microorganisms (beyond yeast and bacteria, namely 2 species) and the genus of enzymes (represented by only those involved with hydrolysis, a single species, which), which may be used in the primary fermenter and whether they are identical to those utilized in the secondary fermenter.
Regarding the genus of fermenters utilized, applicant has merely provided aerobic (a single species) for the first fermenter and anaerobic (a single species) for the secondary fermenter. However, the fermenters may have many different structures, such as stirred tank fermenter, bubble column fermenter, membrane fermenters, fluidized bed fermenters, rotating disc fermenter, Volkov type bioreactor etc. Given the breadth of the term “fermenter”, merely providing a single species, is hardly adequate to fully describe the genus of fermenters referred to in instant claims.
Considering the genus of operating fermentation conditions associated with primary and secondary fermentation, said conditions are merely described by a single species each (see claims15), which is a totally inadequate to fully describe the genus of “fermentation conditions” employed. Considering that fermentations conditions embrace, stirring rate, pressure, temperature and viscosity of products etc. utilized, the specification merely focuses on ethanol and syrup preparation conditions and nothing beyond. Further, claim 13 fails to specify what biocatalyst is used for each primary and secondary fermentation. In other words, do they only employ microorganisms or enzymes or whether they may employ both. If the fermenters employ both microorganisms and enzymes, it is unknown if they are separated or not after the fermentation is complete. In terms of substrates used under “fermentation conditions”, the only feedstock example that can be found is “corn feedstock” which is a single species. Similarly, the only products that are produced (see for example Fig 2) are ethanol, syrup and wet cake, which are too few species to fully describe the genus of products which may be prepared by this invention.
Therefore, even though Fig. 2, as applicant mentions above, to some extent helps describe what instant invention is, said description is inadequate to fully describe the full breadth of the genus of production methods claimed and hence, one of skill in the art cannot reasonably conclude that applicant had full possession of the invention.
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.
Claim(s) 13-17 and 22-33 remain rejected under 35 U.S.C. 103 as being unpatentable over DE Castro (cited previously), according to previous office action.
In traversal of this rejection, applicant argues that De Castro reference does show or suggest forming a “whole fermentation broth” that includes enzymes in a secondary fermentation system using stillage composition produced in the bioprocessing facility and/or combining the “whole fermentation broth” with a process composition in the bioprocessing facility and hence, this rejection should be withdrawn.
This argument was fully considered but was found unpersuasive. This is because of two reasons:A. the phrase “whole fermentation broth” is indefinite. It is unknown what exactly constitutes said phrase, and
B. the preamble of instant claim 13 mentions a process of producing one or more enzymes but the claim 13 end (harvested) product is unclear and is most likely ethanol.
Therefore, in view of said ambiguities, the examiner maintains that De Castro continues to render this invention obvious for the reasons provided previously.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 13-17 and 22-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 10,858,674. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-18 of said patent are nested in instant claim 13, see the combining paragraph at the end of claim 13. More specifically, the patented method is claiming the fermentation broth preparation method of instant claim 13 (see lines 11-16) and then combining it with the “fermentable composition” of line 5 or instant claim 13.
Therefore, the scope of instant claims embraces the scope of said patented claims.
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 case, 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.
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 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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