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 .
Detailed Action
Applicant’s election of Group I, corresponding to claims 1-18 and 98 without traverse in the reply filed on 01/06/2026 is acknowledged. Thus, claims 1-18, 56 and 98 are pending in this application; elected Group I, corresponding to claims 1-18 and 98 is now under consideration for examination; and claim 56 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions, there being no allowable generic or linking claim.
Priority
This application CON of PCT/US22/17064 filed on 02/18/2022 and claims the benefit of priority under 35 U.S.C. 119(e) to the US Provisional application 63/150,937 filed on 02/18/2021.
Information disclosure statement
The information disclosure statement (IDS) submitted on 02/12/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS statement is considered and initialed by the examiner.
Objections-Specification
The disclosure is objected to because the subject-matter in ¶ [00137], page 30 is not clear; said ¶ [00137] is reproduced below:
PNG
media_image1.png
132
614
media_image1.png
Greyscale
Appropriate correction is required.
Claim Rejections: 35 USC § 112(b)
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.
I. Claim 1 and claims 2-18 and 98 depending therefrom 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 pre-AIA the applicant regards as the invention.
Regarding claim 1, the claimed subject-matter is not clear and is confusing and thus, the scope of the claim is unclear. Examiner takes the position that a key step is missing from the claim 1. Claim 1 recites ”… b) culturing the oleaginous microorganism in a medium comprising a carbon source, wherein the carbon source comprises ethanol at greater than 50% by weight;”, there is no embodiment or Example in specification that provides evidence that the claimed oleaginous microorganism is able to survive and grow in a medium comprising ethanol at greater than 50% by weight. The only embodiment shown in Example 4, pages 27-30 of specification, ¶ [00129-0032] provides evidence for a single oleaginous species C. oleaginous and for lipid production, said C. oleaginous is grown in two steps/phases, an initial step/phase comprise culturing C. oleaginous in a base medium comprising 20 g/L glucose as carbon source for two days at pH 5.5-6.5 and upon depletion of glucose, and subsequently (a second phase or a second step) cultured in carbon source containing Ethanol at a concentration ranging from 4-30 g/L and said concentration of Ethanol is not 50% by weight of the culture medium, as 4-30 g/L Ethanol is equivalent to 0.4%-3% of Ethanol in the culture medium by volume. The instant claim 1 description, describes the issue of the invention in a vague and unclear manner and the main stages of the claimed process are not clearly defined. Due to the lack of disclosure, it is impossible for the person skilled in the art to prepare the invention with precise and reproducible results. The accurate experimental conditions of the process/method are not defined. For examination purposes examiner interprets claims 1-18 and 98 to involve two separate stages or two separate steps; an initial step/phase involving culturing C. oleaginous in a base medium comprising 20 g/L glucose as carbon source for two days at pH 5.5-6.5 and upon depletion of glucose, a second step or second stage involving subsequently cultured in carbon source containing Ethanol at a concentration ranging from 4-30 g/L in the culture medium. Clarification and correction is required. The metes and bounds of claims 1-18 and 98 is not clear and thus, it would not be possible to one of ordinary skill in the art to define the metes and bounds of the desired patent protection. The description of the application does not disclose the invention in a manner sufficiently clear and complete to be carried out by a person skilled in the art.
II. Claims 10-11 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 applicant regards as the invention.
Claims 10-11 recites the phrase “herein the ethanol comprises a 13C/12C ratio similar to that of atmospheric carbon dioxide” in claim 10; and “wherein the oil comprises a 13C/12C ratio similar to that of atmospheric carbon dioxide” in claim 11, the phrase “13C/12C ratio similar to that of atmospheric carbon dioxide” in claims 10-11 renders the claim indefinite and considered to be a relative term which renders the claim indefinite. Claims 10-11 do not recite the conditions under which the “13C/12C ratio of the atmospheric carbon dioxide” is measured. In the art what is considered “13C/12C ratio of the atmospheric carbon dioxide” varies widely depending on the individual situation as well as the person making the determination i.e., the art clearly teaches that there are temporal (time and seasonal) and spatial (place) variations in the “13C/12C ratio of the atmospheric carbon dioxide”, see Nakazawa et al., (J. Geophys. Res., 1997, Vol. 102(D1): 1271-1285). It is not clear to the examiner as to when and where the “13C/12C ratio of the atmospheric carbon dioxide” is measured and encompassed in the above phrase. Thus, the scope of the claim is unclear. A perusal of the specification describes on pages 11-12, ¶ [0063], some exemplary “13C/12C ratio” are recited, and claims 10-11 as written does not recite the specific conditions the applicants' intend to encompass. As such it is unclear what “13C/12C ratio” of interest must be to be included within the scope of the claims; examiner also would like to point out: “Although the claims are examined in the light of the specification, specification cannot be read into the claims, i.e., the limitations of the specification cannot be read into the claims (see MPEP 2111 R-5)”). Clarification and correction is required.
Claim Rejections: 35 U.S.C. 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(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.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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.
Claim 5 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 5 recites “…wherein the ethanol is present in the medium at a concentration of greater than 0.1%” and depends from independent claim 1; said independent claim 1 recites ”… b) culturing the oleaginous microorganism in a medium comprising a carbon source, wherein the carbon source comprises ethanol at greater than 50% by weight;”; and depends from claim 5 and does not further limit independent claim 1. Dependent claim 5 broadens the scope of independent claim 1 (also see 35 U.S.C. 112(b) rejections above for claims interpretation).
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
The U.S. Court of Appeals for the Federal Circuit indicated that although the requirements of pre-AIA 35 U.S.C. 112, 4th paragraph, are related to matters of form, non-compliance with pre-AIA 35 U.S.C. 112, 4th paragraph, renders the claim unpatentable just as non-compliance with other paragraphs of 35 U.S.C. 112 would. See Pfizer, Inc. v. Ranbaxy Labs., Ltd., 457 F.3d 1284, 1291-92, 79 USPQ2d 1583, 1589-90 (Fed. Cir. 2006) (holding a dependent claim in a patent invalid for failure to comply with pre-AIA 35 U.S.C. 112, 4th paragraph). Therefore, if a dependent claim does not comply with the requirements of 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, the dependent claim should be rejected under pre-AIA 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as unpatentable rather than objecting to the claim. See also MPEP § 608.01(n),subsection III, “Infringement Test” for dependent claims.
Claim Rejections: 35 USC § 112(a)
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.
Written-Description
Claims 1-18 and 98 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 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 inventor, or for pre-AIA the inventors, at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
The claimed method of claims 1-18 and 98, require a genus of oleaginous microorganisms able to grow on carbon source comprises ethanol at greater than 50% by weight for the claimed production of an oil comprising triacylglyceride. The claims are not fully supported by the description. Again, a person skilled in the art would not know how to conduct the process/method according to the invention, since the description lacks information on which particular oleaginous microorganisms able to grow on carbon source comprises ethanol at greater than 50% by weight for the claimed production of an oil comprising triacylglyceride are engaged in the process/method and there is no evidence of possession of the entire genus in the claimed process. What is more, the determination of which oleaginous microorganisms able to grow on carbon source comprises ethanol at greater than 50% by weight for the claimed production of an oil comprising triacylglyceride fall within the scope of protection sought requires excessive effort and undue experimentation. There is no guidance in the specification and the skilled person should not be left in any doubt as to which subject matter is covered and which is not. The skilled person should be able to establish the demarcation of the scope of the claim (i.e. its extent of protection) without undue burden (also see 35 U.S.C. 112(b) and 35 U.S.C. 112(d) rejections above for claims interpretation).
To provide evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. Applicants are directed to MPEP § 2163 for guidelines on compliance with the written description requirement.
The purpose of the written description requirement is to ensure that the inventor had possession, at the time the invention was made, of the specific subject matter claimed. For a broad generic claim, the specification must provide adequate written description to identify the genus of the claim.
“A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials." Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) (“In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus.”). Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
MPEP § 2163 further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the biomolecule, it is "not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed biomolecule.”
“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 . . ., reduction to drawings . . ., or by disclosure of relevant, identifying characteristics, i.e., 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.” MPEP 2163.
Furthermore, a “‘representative number of species’ means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure ‘indicates that the patentee has invented species sufficient to constitute the gen[us].’ See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004) (‘[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated.’). ‘A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed.’ In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004).” MPEP 2163.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. However, a showing of possession alone does not cure the lack of a written description. Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 969-70, 63 USPQ2d 1609, 1617 (Fed. Cir. 2002). An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. Amer. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). See MPEP 2163(I).
The specification discloses and is limited to a single species in the claimed process/method for producing oil comprising a triglyceride i.e., the only embodiment shown in Example 4, pages 27-30 of specification, ¶ [00129-0032] provides evidence for a single oleaginous species C. oleaginous and for lipid production, said C. oleaginous is grown in two steps/phases, an initial step/phase comprise culturing C. oleaginous in a base medium comprising 20 g/L glucose as carbon source for two days at pH 5.5-6.5 and upon depletion of glucose, and subsequently (a second phase or a second step) cultured in carbon source containing Ethanol at a concentration ranging from 4-30g/L, which is insufficient to put one of skill in the art in possession of the attributes and features of all species within the claimed genus of oleaginous microorganisms.
While generically the methods for producing oil comprising a triglyceride with specific oleaginous microorganism with defined genotype and phenotype for production specific fatty acids is known, the structural and functional elements of the presently recited claims and in the instant method can vary substantially within the above given claimed recitations.
The prior art clearly teaches that there is wide variation in the ability of oleaginous microorganisms to produce lipids with different substrates, is challenging and requires optimization various parameters such as composition of substrates/carbon sources and screening for performance of isolates and strains of oleaginous microorganisms (Slininger et al., Biotechnol. Bioeng., 2016, Vol. 113(8): 1676-1690; see Abstract; Fig. 1-4, Table I-V; and entire document).
Therefore, those of skill in the art would not accept that the inventor had been in possession of the full genus of oleaginous microorganisms able to grow on carbon source comprises ethanol at greater than 50% by weight for the claimed production of an oil comprising triacylglyceride as claimed in the instant claims. The specification does not provide accurate experimental conditions of the process and are not defined and it is not clear what is encompassed in the instant method claims.
Consequently, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus of oleaginous microorganisms able to grow on carbon source comprises ethanol at greater than 50% by weight for the claimed production of an oil comprising triacylglyceride encompassed by the claimed method would meet the limitations of the claims.
The skilled artisan cannot envision the detailed genus of oleaginous microorganisms able to grow on carbon source comprises ethanol at greater than 50% by weight for the claimed production of an oil comprising triacylglyceride to be used in the instant method claims, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of identification of oleaginous microorganism producing oil comprising triacylglycerides.
Scope of Enablement
Claims 1-18 and 98 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification does not provide adequate written description of the claimed genus of oleaginous microorganisms able to grow on carbon source comprises ethanol at greater than 50% by weight for the claimed production of an oil comprising triacylglyceride nor guidance as to which of the myriad of oleaginous microorganisms encompassed by the claimed method would meet the limitations of the claims, and does not reasonably provide enablement for all of the embodiments embraced by the claims in the claimed process i.e., a genus of oleaginous microorganisms able to grow on carbon source comprises ethanol at greater than 50% by weight for the claimed production of an oil comprising triacylglyceride. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make or use the invention commensurate in scope with these claims.
In In re Wands, 8USPQ2d, 1400 (CAFC 1988) page 1404, the factors to be considered in determining whether a disclosure would require undue experimentation include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.
The claims are broadly drawn to a genus of oleaginous microorganisms able to grow on carbon source comprises ethanol at greater than 50% by weight for the claimed production of an oil comprising triacylglyceride nor guidance as to which of the myriad of oleaginous microorganisms encompassed by the claimed method would meet the limitations of the claims. There is no guidance regarding the method comprising a genus of oleaginous microorganisms able to grow on carbon source comprises ethanol at greater than 50% by weight for the claimed production of an oil comprising triacylglyceride nor guidance as to which of the myriad of oleaginous microorganisms encompassed by the claimed method, nor are there any working examples of such. Thus, the scope of the claims is extremely broad compared to the guidance and exemplification provided in the specification. The scope of the claims must bear a reasonable correlation with the scope of enablement. See In re Fisher, 166 USPQ 19 24 (CCPA 1970).
Thus, the state of the art recognized that it would be highly unpredictable that wide variation in the ability of oleaginous microorganisms to produce lipids with different substrates, is challenging and requires optimization various parameters such as composition of substrates/carbon sources and screening for performance of isolates and strains of oleaginous microorganisms. One of ordinary skill in the art could not predictably extrapolate the teachings in the specification to those with the claimed method.
In summary, in view of the lack of the predictability of the art to which the invention pertains as evidenced by Slininger et al., (Biotechnol. Bioeng., 2016, Vol. 113(8): 1676-1690; see Abstract; Fig. 1-4, Table I-V; and entire document; for details see written-description above) the lack of guidance and direction provided by applicant, and the absence of working examples, the Examiner concludes that undue experimentation would be required to practice the invention as claimed.
Claim Rejections: 35 USC § 102 (AIA )
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.
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 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.
Claims 1-9 and 98 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Wu et al., (FEMS Yeast Res., 2020, Vol. 20(4), pages 1-14; publication date 06/18/2020) when given the broadest reasonable interpretation.
Claims 1-9 and 98 as interpreted for examination purposes are directed to and examiner interprets claims 1-9 and 98 to involve two separate stages or two separate steps; an initial step/phase involving culturing C. oleaginous in a base medium comprising 20 g/L glucose as carbon source for two days at pH 5.5-6.5 and upon depletion of glucose, a second step or second stage involving subsequently cultured in carbon source containing Ethanol at a concentration ranging from 4-30g/L in the culture medium (also see 35 U.S.C. 112(b), 35 U.S.C. 112(d) and 35 U.S.C. 112(a) for claims interpretation).
Wu et al., (FEMS Yeast Res., 2020, Vol. 20(4), pages 1-14; publication date 06/18/2020) disclose oleaginous microbial organism Rhodotorula toluroides capable of producing high lipid titer under Ethanol induced stress and said lipids comprising omega-6 fatty acids such as unsaturated fatty acids C16:1, C18:1, C18:2 and C18:3; said Ethanol concentration in the culture medium 30 g/L Ethanol (see Abstract; Materials & Methods; Fig. 1-6; Table 1-2; Col. 1-2, page 7; Col. 1, page 12; and entire document). Therefore, the reference of Wu et al., (FEMS Yeast Res., 2020, Vol. 20(4), pages 1-14; publication date 06/18/2020) is deemed to anticipate claims 1-9 and 98 as written and when given the broadest reasonable interpretation.
Since the Office does not have the facilities for examining and comparing applicants’ method with the method of the prior art, the burden is on the applicant to show a novel or unobvious difference between the claimed method and the method of the prior art (i.e., that the method of the prior art does not possess the same material structural and functional characteristics of the method of the instant invention). See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
Claim Rejections: 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-18 and 98 are rejected under 35 U.S.C. 103(a) as being unpatentable over Wu et al., (FEMS Yeast Res., 2020, Vol. 20(4), pages 1-14; publication date 06/18/2020) as applied to claims 1-9 and 98 (see 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) rejection above) and further in view of Jamin et al., (J. AOAC Int., 2004, Vol. 87(3): 621-631), Philippini et al., (Front. Energy Res., 2020, Vol. 8(152), pages 1-23), Gao et al., (ACS Synth. Biol., 2018, Vol. 7: 1371-1380), Botti A., (PhD., Thesis, 2019, Univ., Bologna, Italy, pages 1-81) and Sitepu et al., (Biotechnol. Advan., 2014, JBA-06836, pages 1-25).
The disclosures of Wu et al., (FEMS Yeast Res., 2020, Vol. 20(4), pages 1-14; publication date 06/18/2020) as applied to claims 1-9 and 98 is described above. However, Wu et al., are silent regarding wherein the ethanol comprises a 13C/12C ratio similar to that of atmospheric carbon dioxide (as in claims 10-11); comprising sourcing the ethanol from an ethanol manufacturing facility (as in claims 12-14); and wherein culturing the oleaginous microorganism further comprises the use of an acid or base to maintain a desired pH (as in claims 15-16); and further comprising simultaneous measuring a dissolved oxygen level during the process (as in claims 17-18).
Regarding claims 10-11, the following reference, Jamin et al., (J. AOAC Int., 2004, Vol. 87(3): 621-631), discloses a method of determination of 13C/12C ratio of ethanol derived from fruit juices and maple syrup (see Abstract; and entire document).
Regarding claims 12-14, the following reference Philippini et al., (Front. Energy Res., 2020, Vol. 8(152), pages 1-23), teaches integrated approach in biorefinery involving utilization of agro-industrial byproducts and raw materials for the production of several biobased products like biofuels and high value chemicals including the use of oleaginous yeasts for production of lipids depending on the experimental need (see Abstract; pages 10-11; and entire document).
Regarding claims 15-18, the following references provide teaching, suggestion and motivation for wherein culturing the oleaginous microorganism further comprises the use of an acid or base to maintain a desired pH (as in claims 15-16); and further comprising simultaneous measuring a dissolved oxygen level during the process (as in claims 17-18).
Gao et al., (ACS Synth. Biol., 2018, Vol. 7: 1371-1380), provide teaching, suggestion and motivation to a skilled artisan for overproduction of fatty acid ethyl esters by an engineered oleaginous Yarrowia lipolytica possessing the cellular machinery/metabolic pathway for production of increased fatty acid and cultured in the presence of ethanol, ethanol concentration ranging from 2%-10% in the culture medium (see Abstract; Fig. 2, page 1373; Fig. 6, page 1376; and entire document);
Botti A., (PhD., Thesis, 2019, Univ., Bologna, Italy, pages 1-81) provide teaching, suggestion and motivation to a skilled artisan for optimizing the pH of culture medium, as pH of medium determines the type of fatty acid produced by oleaginous microorganism/engineered oleaginous C. oleaginous (see Abstract; Table 1, page 10; Table 2, page 12; Table 3-4 & Fig. 4, pages 14-15; and entire document); and
Sitepu et al., (Biotechnol. Advan., 2014, JBA-06836, pages 1-25) also provide teaching, suggestion and motivation to a skilled artisan for process development encompassing culture parameters such as optimizing aeration rate and dissolved oxygen (DO) concentration, pH, for increased lipid production in oleaginous yeasts (see Abstract; pages 16-19; and entire document).
As such, disclosure of strategy and methods for “wherein the ethanol comprises a 13C/12C ratio similar to that of atmospheric carbon dioxide; comprising sourcing the ethanol from an ethanol manufacturing facility; and wherein culturing the oleaginous microorganism further comprises the use of an acid or base to maintain a desired pH; and further comprising simultaneous measuring a dissolved oxygen level during the process; as in claims 10-18 of the instant invention, such as that of references of Jamin et al., Philippini et al., Gao et al., Botti A., and Sitepu et al., teaching the advantages of said modifications, clearly suggests to a skilled artisan to modify the teachings of Wu et al., and incorporate the structural and functional elements of Jamin et al., Philippini et al., Gao et al., Botti A., and Sitepu et al., in the claimed method for increased production of lipids from oleaginous yeasts as claimed in the instant invention. One of ordinary skill in the art would have a reasonable expectation of success, since the use of oleaginous yeasts and method of use for the production of lipids are well known in the art.
Regarding specific choice of pH, optimizing aeration rate and dissolved oxygen (DO) concentration for increased lipid production in oleaginous yeasts are also provided/suggested in the combination of references, and examiner also takes the position the following position; optimization of known variables, and the examiner finds support in: MPEP 2144.05 [R-5]: A. Optimization Within Prior Art Conditions or Through Routine Experimentation Generally, differences in pH, optimizing aeration rate and dissolved oxygen (DO) concentration etc., will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation". As to optimization results, a patent will not be granted based upon the optimization of result effective variables when the optimization is obtained through routine experimentation unless there is a showing of unexpected results which properly rebuts the prima facie case of obviousness. See In re Boesch, 617 F.2d 272,276,205 USPQ 215,219 (CCPA 1980). See also In re Woodruff, 919 F.2d 1575, 1578, 16 USPQ2d 1934, 1936-37 (Fed. Cir. 1990), and In re Aller, 220 F2d 454,456,105 USPQ 233,235 (CCPA 1955). Furthermore, "it is prima facie obvious to combine two or more methods each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition or third method to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980)”. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Therefore, claims 1-18 and 98 are rejected under 35 U.S.C. 103(a) as being unpatentable over Wu et al., (FEMS Yeast Res., 2020, Vol. 20(4), pages 1-14; publication date 06/18/2020) as applied to claims 1-9 and 98 (see 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) rejection above) and further in view of Jamin et al., (J. AOAC Int., 2004, Vol. 87(3): 621-631), Philippini et al., (Front. Energy Res., 2020, Vol. 8(152), pages 1-23), Gao et al., (ACS Synth. Biol., 2018, Vol. 7: 1371-1380), Botti A., (PhD., Thesis, 2019, Univ., Bologna, Italy, pages 1-81) and Sitepu et al., (Biotechnol. Advan., 2014, JBA-06836, pages 1-25).
Allowable Subject Matter/Conclusion
None of the claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GANAPATHIRAMA RAGHU whose telephone number is (571)272-4533. The examiner can normally be reached on M-F 8:30am-5pm EST.
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, 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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GANAPATHIRAMA RAGHU/ Primary Examiner, Art Unit 1652