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 .
Applicant’s response to restriction requirement filed 11/24/25 is acknowledged. Applicant elected Group II, claims 13-17 with traverse.
In traversal of restriction requirement applicant argues (1) that Groups I-IV can be readily evaluated without placing undue burden on the examiner because all the claims are interrelated and a search of one group will reveal art for others.
Applicant further explains that even though some additional considerations may be necessary if Groups I and III-IV be rejoined with the elected invention the scope of analysis of all claims of Groups I-IV would have to be so rigorous as when only a single invention is being searched and examined.
Furthermore, applicant submits (2) that restrictions of Groups I-IV, would place an undue burden of payment for three separate filing fees as well as costs associated with prosecuting four applications and maintaining four patents.
Finally, applicant mentions that (3) in case restriction among Groups I-IV is maintained, it should be noted that claims 18-21 are properly examinable with the elected Group II method because they depend directly or indirectly from claim 13 and merely cite additional limitations directed to particular grain-derived feedstocks and or feedstock systems for practicing the same method as Group II and again since no new burden of searching is imposed on the examiner, claims 13-21 should be examined together.
These arguments were fully considered but were found unpersuasive.
With respect to the first argument shown above, firstly, the examiner thanks applicant for pointing out about how rigorous the search and analysis requirements of this invention and scope of thereof should be and how such search and analysis needs to cover all inventions instead of just the elected invention but respectfully, the search is the duty of the examiner and only he/she can decide what scope should be covered and searched and how rigorous said search should be and for exactly said reason the previous restriction letter was sent to applicant.
The examiner respectfully disagrees with applicant that a search of instantly elected invention, which is extremely broad and ambiguous is necessarily adequate to cover the scope of all its inter-related inventions. As applicant is aware, interrelatedness is insufficient criteria for rejoinder. For example, an enzyme and antibody to said enzyme are interrelated but they are patentably distinct in terms of function and structure. Here, similarly, the bioprocessing facility of Group I may be utilized in many methods besides beer (alcohol ) and enzyme production such as amino acid production, organic acid production etc. and hence, rejoinder of said “interrelated” invention with instantly elected claims does impose an undue burden of searching and examination on the examiner.
In response to applicant’s second argument , while the examiner really appreciates applicant’s financial burdens pointed out above, she is fully confident that applicant considered said issues before filing this application and prior to introducing so many different inventions into a single application. Further, it is believed that applicant having worked before the office for many years, had fully contemplated the costs that such application may require. Furthermore, as applicant is aware, it is not the duty of the examiner to worry about applicant’s financial obligations. All the examiner needs to worry about is doing a thorough search and examination of the elected invention to help applicant acquire a valid, proper and solid patent.
Regarding applicant’s third traversal arguments above, the previous restriction letter clearly explained why Groups I-IV (including Group III invention) are patentably distinct showing various class/subclasses for each invention etc. and based on said reasoning and explanations the examiner maintains that a search of Group II invention will be inadequate to be used for searching Groups III-IV. Again, here for example, claim 20 ( a part of Group III invention), requires grain fractionation and introduction of various feedstock components (which were not referred to in Group II invention) into various stages (steps) of enzyme production method and such detailed and complex method has many more limitations than Group II invention and inevitably requires de novo search.
Therefore, due to explanations provided above in addition to those previously presented, the examiner finds no reason to rejoin all inventions together and restriction as mentioned previously, is maintained and is hereby made final.
DETAILED ACTION
Claims 13-17 are 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.
Claims 13-17 are 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) are confusing because of the following:
1. the phrase “fermentation conditions” in lines 3 and 7 of claim 13 are unclear. No definition for said phrase can be found in the disclosure and it remains unknown what temperatures, pressures, stirring rates etc. were used to create “fermentable conditions” in line 3 of claim 1. Also, it is unknown if the “fermentation conditions” of claim 3 of line 13 and line 7 of claim 13 are identical or not.
2. the term “bioproducts” in lines 4-5 of claim 13 , claim 14 is vague as no explicit definition could be found for the term in the disclosure and in [0030] only some embodiments of said term can be found. Also, it is unknown if the “bioproducts” of line 5 of claim 13 have to be different than those recited in line 8 of said claim.
3. it is unclear if the “fermentation composition” in line 7 of claim 13 is identical to the one recited in line 3 of claim 1 and further it is unclear what “fermentation composition” constitutes in terms of its ingredients., see also claim 17 reciting said same phrase.
4. In claim 14, and claim 13, lines 3-4 and line 8 applicant refers to “fermentation system” ,wherein it is unclear what constitutes said phrase (see also claim 17) and further it is unclear what differences between first and second “fomentation systems” exist in claim 13.
5. In claim 13, line 13, it is unknown in what way the stillage “derived from thin stillage” is prepared.
6. In claim 13, line 14, it is vague as to what “process conditions” applicant is referring to, as no explicit definition could be found for the phrase in the disclosure.
7. In claim 13, it is unknown what exact substrates are used.
8. The preamble of claim 13 recites “a method of producing one or more enzymes….” but the end of claim 13 does not refer to any enzymes and ends with hydrolysis of some unknown substrates. Further, it is unclear which specific enzymes have been recovered. Furthermore, it is unknown if the enzymes produced are within the “microorganism” recited in line 8 of claim 13 or whether the enzymes produced are in solution. Finally, it is unknown what is the relationship between “whole stillage” in line 6 of claim 13 and “stillage”, “thin stillage” and “a stillage derived from thin stillage” recited in claim 13, line 13.
9. In claim 13, it is unclear what is the relationship between “the whole stillage” of line 6 and the “fermentable composition” of line 7.
Claim 14 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 14, it is unclear what is a “at least a portion of at least one or more bioproducts”. Also, applicant needs to specify which specific bioproducts are recovered or separated.
Claim 16 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 dependent claim 16, it is unknown which “bacteria” are referred to and whether “the one or more enzymes” in the bacteria are identical to the “one or more enzymes” at the preamble of claim 13.
Claim 17 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 17, it is unknown what compositions are “process compositions” and once again no definition for said phrase can be found in the specification.
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 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. 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 13 (and its dependent claims 14-17) are directed to a genus of methods using a genera of products (namely enzymes, microorganisms , etc.) and genus of conditions and systems , wherein said genus of methods has been merely defined by function.
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 generic method of preparing enzymes, utilizing a genus of “fermentation compositions” (which is unclear, see above rejection) inherently comprising a genus of substrates, and a genus of microorganisms from any source and species by what said products do rather than what they structurally are and tis kind of description fails to satisfy the requirements of 112 first paragraph.
As mentioned above, regarding the genus “fermentation compositions” used, applicant has provided no specific temperature, pressure etc., conditions for the primary or secondary fermentation processes.
Regarding the genus of substrates utilized, applicant has merely provided examples about substrates utilized in the secondary fermentation procedure (see page 17) and has not defined what substrates are present in the “stillage” utilized. As applicant is aware, instant invention is a method of preparing one or more enzymes and not a process of utilizing said enzymes. All applicant has provided regarding the potential use of a substrate in this invention is a method of use of corn (which is a single species) and is totally adequate to fully describe all the genus of substrates instantly claimed.
Regarding the genus of enzymes utilized/produced, it appears that applicant has merely provided two examples for those used in primary fermentation , namely alpha amylases (see [0053]) and glucoamylases (two species) which again is inadequate to fully describe the genus of enzymes utilized.
Therefore, based on the information provided in the disclosure, one of skill in the art cannot reasonably conclude that applicant had full possession the invention before the effective filing of this application.
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 are rejected under 35 U.S.C. 103 as being unpatentable over De Castro et al., “De Castro”(BR 112013005916-8, 5/1/21, see also its English machine translation attached). As mentioned above, instant invention is totally confusing but in the spirit of cooperation the examiner did her best to cite relevant art.
De Castro teaches and claims (see claim 1) an integrated process for biofuel production as following:
INTEGRATED PROCESS FOR PRODUCTION OF BIOFUELS, characterized by using enzymatic formulations obtained from residues and agro-industrial materials (such as those comprising corn starch) to hydrolyze granular starch, which comprises the steps of: - feeding in a first reactor (100) for the production of enzymes to raw material agro-industrial waste (10), with granulometry in the range of 0.05 mm - 2.00 mm, a first stream of water (15), to adjust and maintain the moisture content in the range of 40% - 80%, and cells of filamentous fungi (20) grown, with concentration ranging from 1 gram to 7 grams of cells on a dry basis per liter of suspension selected from strains of fungi of the genus “Aspergillus”, to form a solid matrix (30); maintain fermentation (F1 ) in solid state (FES) for 12 hours - 168 hours, at a temperature in the range of 20 ° C - 55 ° C; - proceed with the extraction of the enzymes produced from the solid matrix (30) from the fermentation broth or beer, to a liquid phase, by means of addition of a second stream of water (35), in u m stirred reactor (F2) mechanically between 150 rpm and 1,500 rpm, in the liquid: solid ratio between 5 (L / kg) and 15 (L / kg); - separate the solid matrix (30) from the liquid containing the enzymatic extract (40), by means of a filtration step (S) and / or sedimentation and / or centrifugation (S), to remove the residue from the fermentation (50); - concentrate the liquid stream containing the enzymatic extract (40), by means of membrane ultrafiltration or lyophilization (C), to obtain a concentrated stream of enzymatic extract, which comprises the enzymatic formulation (45), and a concentrated residue (50 ') fermentation; - conduct a new stream (M) of raw material, formed by waste and / or agro-industrial material (10) and enzymatic formulation (45) to a second reactor (200), to be subjected to enzymatic hydrolysis and submerged fermentation (F3 ), in the presence of the enzyme formulation (45) obtained, using microbial cells (60) suitable for the production of biofuel or other desired chemical (70), said microbial cells selected from bacteria, actinomycetes, yeasts and filamentous fungi.
Therefore, it is believed that the teachings of De Castro as a whole render this invention obvious.
No claim is allowed.
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.
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.
/MARYAM MONSHIPOURI/Primary Examiner, Art Unit 1651