DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. The Preliminary Amendment filed on February 27, 2025, has been received and entered.
Claim Disposition
3. Claims 1-14 are pending and are under examination.
Information Disclosure Statement
4. The Information Disclosure Statements filed on November 11, 2024, have been received and entered. The references cited on the PTO-1449 Form have been considered by the examiner and a copy is attached to the instant Office action.
Specification Objection
5. The specification is objected to for the following informalities:
The specification is objected to because the sequence notation is improper, see SEQ ID No.7” for example, at paragraph [0075] or page 11, which should be “SEQ ID NO: 7”.
Appropriate correction is required.
Claim objection
6. Claims 1-14 are objected to for the following informalities:
For clarity and precision of claim language it is suggested that claim 1 is amended to recite “…… [[said process]] comprising [[at least]]:
[[-a)]] a) a phase of….; [[, followed by]]
[[-b)]] b) a phase of producing…[[characterized in that said process also comprises]]…...and
[[-c)]] c) a phase of preparing……… and [[capable of consuming]] that consumes…..”. The dependent claims hereto are also included.
For clarity and precision of claim language it is suggested that claims 1-14 are amended to delete “characterized in that” and replace with for example, ‘wherein’.
For clarity it is suggested that claims 1, 4-8, 11 and 13 are amended to delete the phrase ‘notably’.
For clarity and precision of claim language it is suggested that claim 2 is amended to delete ‘preferably’. See also claims 6 and 12-14 with similar language.
For clarity it is suggested that claims 2-14 are amended to delete, “as claimed in” and instead recite “of”, for example, “The process of claim 1…”.
For clarity it is suggested that claim 11 is amended to delete the typographical error of “notably below” which should be ‘notably below’.
Appropriate correction is required.
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.
7. Claims 1-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AlA), 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.
The claimed invention is directed to “a process for producing cellulolytic and/or hemicellulolytic enzymes by a cellulolytic and/or hemicellulolytic microorganisms comprising at least a phase of growing the microorganism in the presence of at least one carbon based substrate followed by a phase of producing the enzymes in the presence of at least one inducing substrate characterized in that said process also comprises: a phase of preparing a carbon-based substrate comprising glucose and /or fructose….the cellulolytic and/or hemicellulolytic microorganism being chosen from microorganism devoid of the invertase gene and capable of consuming glucose and/or fructose, notably strains of fungi…. comprising at least in part an acidic hemicellulosic hydrolysate” (see claim 1 for example).
The claimed invention is not adequately described because it comprises a large genus of microorganism, substrates, enzymes and the microorganism is likened to an activity that is ‘capable of’ which is not a positive recitation of an activity. Thus, the claimed invention is overly broad and not commensurate in scope with the disclosure in the specification. No correlation is made between structure and function for the enzymes of the claimed invention and does not demonstrate possession of the large genus. The specification fails to provide a representative number of species for the claimed genus to show that applicant was in possession of the claimed genus. A representative number of species means that the species, which are adequately described, are representative of the entire genus.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, disclosure of drawings, or by disclosure of relevant identifying characteristics, for example, structure or other physical and/or chemical properties, by
functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), states that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed" (See page 1117). The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed" (See Vas-Cath at page 1116). The skilled artisan cannot envision the detailed chemical structure of the encompassed genus, and therefore, conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993).
Therefore, for all these reasons the specification lacks adequate written description, and one of skill in the art cannot reasonably conclude that the applicant had possession of the claimed invention at the time the instant application was filed.
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.
8. Claims 1-14 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.
Claims 1, 4-8, 11 and 13 are ambiguous for the recitation of “notably” because it is not definitive. For example, ‘notably below’ in claim 6 does not provide a specific number, it just means it is remarkedly below the stated value or to a striking degree but does not mean a settled, conclusive number and leaves room for doubt, thus ambiguous. The dependent claims hereto are also included.
Claims 2, 6 and 12-14 is indefinite for the recitation of "preferably” at a range for or species, as the phrase preferably renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP 2173.05(d)
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
9. Claim(s) 1-18 and 10-14 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated over WO 2013/190214 (of record in the application).
The claimed invention is broadly directed to a process of producing cellulolytic and/or hemicellulolytic enzymes with a cellulolytic and/or hemicellulolytic microorganism (see claim 1 in its entirety).
The primary reference discloses a method for producing an enzyme cocktail using a cellulolytic microorganism, including two steps: a step a) for growing said microorganism in a closed reactor in the presence of a carbon growth solution; and a step b) for producing said enzyme cocktail carried out by supplying a carbon production solution, the carbon substrate concentration of which is between 150 and 400 g/L, said carbon production solution including an inductive carbon substrate, characterized in that said inductive carbon substrate is a liquid residue from a step of pretreating lignocellulosic materials, the C5 sugar oligomers of which are at least 1 wt % of the total sugars in said liquid residue and at least 0.3 wt % of the total sugars in said carbon production solution (see abstract). The reference is silent on an invertase gene, thus can be construed as devoid of an invertase gene as recited in the claim.
The reference discloses the preferred use of other non-inductive carbon substrate selected from glucose, xylose, and sucrose alone or in admixture. It is also disclosed that the preferred cellulolytic microorganism is chosen from fungus strains belonging to the genera Trichoderma, Aspergillus, Penicillium or Schizophyllum. The reference discloses that the cellulolytic microorganism belongs to the species Trichoderma reesei, and teaches a pretreatment step of an acid hydrolysis, an acid cooking or a steam explosion with prior impregnation of said lignocellulosic materials with an aqueous solution of sulfuric acid. The reference further discloses the use of lactose or cellobiose as a carbon inducing substrate (see pages 1-5 of the reference). The reference discloses operating at a pH of 4.8 and preferably, a pH between 3 and 5.5. The reactor for sterilization of medium is at 120 ° C…. The carbonaceous growth substrate glucose is sterilized separately at 120 ° C for 20 minutes and then added sterilely into the reactor, thus falls within the recited range in the claims. The reference also discloses a temperature of 27 degrees as a preference with the acid usage which falls in the ranges of 10-30 degrees recited in the claims (see pages 6-10, and the entire document). Therefore, the limitations of the claims are met by the reference.
Claim Rejections - 35 USC § 103
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.
10. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
11. Claim(s) 1 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2013/190214 (of record in the application).
The teaching of claim 1 is above. The primary reference does not teach sucrose hydrolysis carried out in acid; however, the reference teaches for example glucose hydrolysis carried out in acid and mentions that the carbon induced substrate can be glucose, sucrose, lactose among others. Thus would be obvious to swamp out these sugars with an expected success. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to arrive at the claimed invention as a whole because the reference discloses using a strong acid with the recited temperatures and discloses several sugars that can be utilized with one of them being sucrose. Although not exemplified an ordinary skilled worker in the field would know how to routinely optimize expected results and utilize different sugars which is suggested by the reference.
Moreover, the Supreme Court pointed out in KSR, “a patent composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art.” KSR, 127 S. Ct. at 1741. The Court thus reasoned that the analysis under 35 U.S.C. 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the “inferences and creative steps that a person of ordinary skill in the art would employ.” Id. at 1741. The Court further advised that “[a] person of ordinary skill is…a person of ordinary creativity, not an automation.” Id. at 1742. Therefore, the claimed invention was obvious to make and use at the time the invention was made and was prima facie obvious.
Conclusion
12. No claims are presently allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HOPE A ROBINSON whose telephone number is (571) 272-0957. The examiner can normally be reached 9-5pm on Monday to Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Mondesi can be reached on (408) 918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HOPE A ROBINSON/Primary Examiner, Art Unit 1652
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