DETAILED ACTION
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 .
Priority
This application is a National-Stage entry of PCT/KR2022/008552, filed 6/16/2022. Applicant’s claim for the benefit of a prior-filed application KR10-2021-0078346 filed 6/16/2021, under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/28/2023, 9/23/2024, 4/11/2025, 7/21/2025 are acknowledged. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claim 13 is objected to because of the following informalities: the reference character “(a)” is used twice, for two distinct steps. It is recommended to amend the two terms into distinct reference characters, such as (a’) and (a”), as already used for (c’) and (c”). Another preferred correction would be (a.1) and (a.2). Appropriate correction is requested.
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 2 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.
Claim 2 recites the limitation "wherein at least one of the (a) to (c) is repeated twice or more". The phrase is indefinite because of the usage of the term “repeated twice or more”. This phrase can be interpreted as meaning that the step must be repeated and thus means that one of steps (a), (b), or (c) is performed at least two times total (as embodied in the spec), or the phrase could be interpreted to require that at least one of the steps must be “repeated twice”, which would mean that the step must be done at least three times total. Because the metes and bounds of the claimed method cannot be determined, the claim is indefinite.
For clarity, it is recommended to remove the word “repeated” and instead recite that “at least one of the steps (a), (b), and (c) is performed two or more times”.
Claim Rejections - 35 USC § 112(a) - Written Description
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 1-13 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 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 recites a method for obtaining a target compound from a fermentation broth, without specifying any target compound. The dependent claims 2-7 and 9-13 do not practically limit the encompassed genus any target compound.
Claims 1-7 and 9-13 thus encompass any possible compound that could be obtained from a fermentation broth. This is not limited to products of fermentation, nor limited to any specific class of compounds.
Claim 8 limits the target compound to an organic acid produced by microbial fermentation. The species of the organic acid is not limited to any particular type or length. A search of the CAS database from the American Chemical Society returns over 3500 entries for “organic acid”. Limiting these substances with references related to microbial production returns more than 2000 results. These amount to different organic acids, such as carboxylic acids, having various carbon chain lengths, ring structures, and many different derivatives.
According to the B.R.I. of the claims, when viewed in light of the specification, there exists a nearly limitless number of structures of the compounds within the claimed scope. Comparatively, the specification only recites a small number of species of the broad genus (essentially one, 3-Hydroxypropionic acid, 3-HP) that meets the recited limitations.
MPEP § 2163.(II)(A)(3)(a) states that 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 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 inventor was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
The specification fails to reasonably describe the full genus of the claimed invention by providing identifying characteristics or functional properties of the target compound. The instant specification does not disclose relevant identifying characteristics, such as key structural or other physical properties, or functional characteristics coupled with a known or disclosed correlation between function and structure, such that the entirety of the claimed genus is encompassed by the description in the disclosure.
The specification states that the invention pertains to obtaining 3-hydroxypropionic acid (3-HP), from a fermentation broth containing this organic acid from a microbial culture ([0004]).
The disclosure discusses various embodiments that include collecting 3-HP ([0052]; [0065]-[0093]; Figs. 6-7). However this is a description of a single embodiment of the claimed genus of organic acids, and there is no disclosed relationship between the compounds that is sufficient to fulfill the written description requirement.
The working examples in the specification include Examples 1-5, ([00101]-[00133]), which all pertain to the production and isolation of 3-HP from a fermentation broth.
Thus, the specification only provides only 1 example of the claimed genus, which cannot be considered a sufficient description of a representative number of species by actual reduction to practice of the full breadth of the vast genus when considering the full breadth of claim 1, encompassing any target compounds or the breadth of claim 8 (any organic acid).
There is no evidence that, at the time of filing, the Applicant possessed additional representative species of the full genus recited in the claims beyond those provided in the working examples. For these reasons, the disclosure fails to provide adequate written description to support the entirety of the broad genus claim to any and all target compounds for purification.
Claims 1 and 8 are thus rejected under 35 U.S.C. § 112(a) because the claimed subject matter is not described in the specification in such a way as to reasonably convey to a skilled artisan that the inventor, or a joint inventor, had possession of the claimed invention.
The dependent claims 2-7 and 9-13 are also rejected under 35 U.S.C. § 112(a), because these claims depend on the rejected claims and fail to practically further limit the identity of the target compound.
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.
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.
Claims 1-4, 6, 8-9, and 13 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Abraham et al. (US PGPub No. 20160031792).
Abraham et al. (hereafter “Abraham”) discloses a method for recovering a composition enriched in 3-hydroxypropionic acid from a fermentation broth comprising 3-hydroxypropionic acid (Abstract, claim 1).
The steps of the process described in Abraham include performing fermentation, separating cells from the fermentation broth, evaporation (i.e. increasing the concentration of the target compound), acidification to remove ionic components (i.e. gypsum, sulfate and phosphate ions), performing ion exchange, a second evaporation step, then one or more distillation steps to obtain the organic acid 3-HP (Fig. 1; [0052]).
Thus, Abraham anticipates claim 1, by disclosing a method for obtaining a target compound from a fermentation broth (e.g. Example 10, [0099]-[0118]), the method comprising: removing at least a portion of an insoluble substance or a macromolecule from the fermentation broth (i.e. removing cells via centrifugation [0100]) and performing at least one of following steps (a) to (c), wherein Abraham discloses (a) increasing the concentration of the target compound through evaporation ([0103]-[0105]); (b) reducing the concentration of residual carbon sources (e.g. removing “residual sugars” during distillation, [0120]) and (c) reducing a concentration of an ionic component in the fermentation broth (i.e. [0106]-[0113] removing calcium ions and/or CaSO4 (gypsum) through acidification) and performing ion exchange to reduce the total sulfate ions and phosphate ions present [0114]-[0117]).
Regarding claim 2, Abraham discloses that the purification method can include, in embodiments, multiple repeated steps of distillation including evaporation of water and concentrating the 3HP product (see e.g. Fig 1, [0053], and [0119]-[0120]).
Regarding claim 3, Abraham discloses evaporation and/or evaporation steps in order to concentration the fermentation broth containing 3HP product.
Regarding claim 4, Abraham discloses a step of acidifying the fermentation broth to precipitate an ionic component and removing the precipitated ionic component ([0107]: “Referring to FIG. 1, step 4, sulfuric acid is added to evaporated concentrated 3HP containing broth to lower the pH and convert most of the calcium salts of 3HP to the free acid form. The CaSO4, formed (also known as gypsum) precipitates out of solution”).
Regarding claim 6, Abraham clearly discloses removing insoluble cells ([0025]; [0051]).
Regarding claim 8, Abraham discloses a process for obtaining the organic acid 3-hydroxypropionic acid (3-HP).
Regarding claim 9, Abraham discloses reducing the concentration of residual carbon sources, e.g. removing “residual sugars”, during distillation ([0120]), and the fermentation broth of Abraham includes both glucose and glycerol ([0059]-[0060], see also Table 1). Thus, when performing the concentrating or distilling methods disclosed in Abraham which reduce residual sugars, the residual sugars include any remaining carbon sources of glucose and glycerol.
Regarding claim 13, Abraham discloses a method for obtaining a target compound from a fermentation broth (in [0099]-[0124]), the method comprising: removing at least a portion of an insoluble substance or a macromolecule from the fermentation broth (i.e. removing cells via centrifugation [0100]) and performing: (a) increasing the concentration of the target compound through evaporation ([0103]-[0105]; Fig. 1); (b) reducing the concentration of residual carbon sources (e.g. removing “residual sugars” during distillation, [0120]), (c) reducing a concentration of an ionic component in the fermentation broth (i.e. [0106]-[0113]), (c’) removing calcium ions and/or CaSO4 (gypsum) through acidification and (c”) performing ion exchange to reduce the total sulfate ions and phosphate ions present ([0114]-[0117]), and increasing the concentration of the target compound through one or more evaporation and distillation steps ([0119]-[0124]), in order to recover a concentration purified amount of 3HP (e.g. Table 13-1).
Therefore, the embodiments of Abraham are deemed to anticipate the subject matter of the instant claims 1-4, 6, 8-9, and 13.
Claims 1, 3, 6, and 10-12 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Hilaly et al. (US PGPub No. 20020133049)
Hilaly discloses a method of recovering a target compound of 1,3-propanediol (PDO) from a fermentation broth (Title, Abstract).
Hilaly discloses that after fermentation, which can be batch fermentation or continuous fermentation, the broth is separated from the microorganisms ([0032]), thus disclosing that a portion of an insoluble substance is removed from the fermentation broth. Next, Hilaly discloses methods for (b) reducing a concentration of a residual carbon source or alcohol in the fermentation broth ([0032]: “Impurities in fermentation broth typically include unconverted sugars, residual salts and by-products... The first fraction contains impurities and contains mainly salts, sugars and other by-products. The first fraction can be recycled back to fermentation for further utilization of residual carbon sources and other ingredients”), and (c) reducing a concentration of an ionic component in the fermentation broth, and collecting the target compound ([0032]: “PDO elutes from column later than other ionic components (e.g. salts)”).
Because Hilaly teaches steps for separation of a target compound from residual carbon sources and teaches reducing concentration of an ionic compound (i.e. salts), Hilaly is found to disclose all of the limitations of claim 1.
Regarding claim 3, Hilaly discloses that ionic components (i.e. salts) are removed from the fermentation product mixture by chromatography (see e.g. Examples 1-3, [0033]-[0035]).
Regarding claim 6, Hilaly discloses separating the broth from insoluble microorganism cells ([0032]).
Regarding claims 10 and 11, Hilaly discloses in an embodiment ([0032]) that two fractions from the column are collected, wherein the first fraction contains impurities and contains mainly salts, sugars and other by-products which are recycled back to fermentation for further utilization of residual carbon sources and other ingredients (see also claim 15). Hilaly states that the separate second fraction contains mainly PDO with high purity values ([0032]). The alcohol, i.e. the target compound, is then collected from the column by elution. Therefore, Hilaly is found to disclose a step for reducing the concentration of PDO in the fermentation broth, by selectively enriching for it via one or more step of ion-exclusion chromatography ([0032]). Thus, under the B.R.I. of the limitations, because the fermentation broth has a lower concentration of the alcohol, 1,3-propanediol, Hilaly is deemed to disclose a method for removing an alcohol (in this case also the target compound, which is not excluded in the claim language under the B.R.I.).
The instant claim 12 recites a step of reducing a residual carbon source or alcohol in the fermentation broth using simulated moving bed chromatography. Hilaly further discloses that the purification process uses simulated moving bed chromatography ([0017]: “It is a further object of the present invention to utilize simulated moving bed technology to effect the recovery of 1,3-propanediol from a liquid composition” and [0021]: “In another embodiment, the method of the current invention utilizes a simulated moving bed (SMB) apparatus”; see also Claims 3-4).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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 1-9 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Abraham (US PGPub No. 20160031792) in view of Rezkallah (US PGPub No. 20110160483).
As discussed above, Abraham teaches methods for obtaining a target compound from a fermentation broth (in [0099]-[0124]), the methods comprising: removing at least a portion of an insoluble substance or a macromolecule from the fermentation broth (i.e. removing cells via centrifugation [0100]) and performing: (a) increasing the concentration of the target compound through evaporation ([0103]-[0105]; Fig. 1); (b) reducing the concentration of residual carbon sources (e.g. removing “residual sugars” during distillation, [0120]), (c) reducing a concentration of an ionic component in the fermentation broth (i.e. [0106]-[0113]), (c’) removing calcium ions and/or CaSO4 (gypsum) through acidification and (c”) performing ion exchange to reduce the total sulfate ions and phosphate ions present ([0114]-[0117]), and increasing the concentration of the target compound through one or more evaporation and distillation steps ([0119]-[0124]), in order to recover a concentration purified amount of 3HP (e.g. Table 13-1).
However, Abraham does explicitly teach nor suggest a method using simulated moving bed (SMB) chromatography, as required in claims 5, nor a method wherein macromolecules such as protein, polysaccharide, or lipids are explicitly removed, as in claim 7.
Rezkallah pertains to methods using a solid bed adsorptive separation of organic acid and/or amino acids from fermentation broths containing organic acid and/or amino acid (Abstract, [0002]), and teaches specifically methods for the chromatographic separation of lactic acid from fermentation broths ([0008], Fig. 1, Claims 1 and 2).
Rezkallah teaches that countercurrent moving bed or simulated moving bed countercurrent flow systems have a greater separation efficiency than fixed adsorbent bed systems and are therefore another alternative known in the art ([0029]). Rezkallah teaches that in the simulated moving bed process, the adsorption operations are continuously taking place which allows both continuous production of an extract and a raffinate stream and the continual use of feed and desorbing streams, and that a preferred embodiment of the process utilizes what is known in the art as a simulated moving bed countercurrent flow system ([0029], Claim 4).
Regarding claim 7, Rezkallah teaches that the fermentation product additionally contains carbohydrates, amino acids, proteins and salts as well as the target organic acid, which must be separated from the fermentation broth ([0004]).
Therefore, to one of ordinary skill in the art, prior to the effective filing date of the instant invention, it would have been obvious to modify the method taught in Abraham, by including steps of simulated moving bed chromatography (i.e. a SMB flow system) for the separation of the target compound from undesired impurities using ion exchange chromatography, for the predictable benefits taught in Rezkallah of continuous production.
One would have been motivated to use the SMB chromatography because Rezkallah teaches that SMB allows for sustained, continuous production as well as recycling of the feed stream (the fermentation broth), and one of ordinary skill would have recognized the advantages to employing this known chromatography method when obtaining the 3-HP from the fermentation broth of Abraham. This amounts to a matter of judicious selection from among known techniques in the art. One would have predicted the use of SMB leads to an improved process, because of the ability to perform continuous separation of the target compound.
Because such purification methods are very well known to the art, and because Rezkallah specifically teaches that SMB is used successfully for purification of organic acids, there would have been a reasonable expectation of success when incorporating the SMB methods for the purification processes taught in Abraham.
Regarding claim 7, it would have been obvious that methods for separating insoluble components such as filtration, centrifugation, and distillation used in Abraham for isolating organic acids would also predictably result in the removal of unwanted macromolecules such as proteins and large carbohydrates, which are known contaminants according to Rezkallah. One of ordinary skill in the art would be aware of suitable methods for removing these impurities.
There would have been a reasonable expectation of success, because of the high level of knowledge in separation techniques, as evidenced in both Abraham and Rezkallah.
Thus, claims 1-9 and 13 are rejected as being obvious over the combined teachings of Abraham and Rezkallah.
Claims 1-4, 6, 8-11, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Abraham (US PGPub No. 20160031792) in view of Lynch et al. (US PGPub No. 20130071893).
As discussed above, Abraham teaches methods for obtaining a target compound from a fermentation broth and teaches all of the steps of claims 1-4, 6, 8, 9, and 13.
Abraham teaches that the fermentation broth may contain alcohol by-products of the yeast fermentation (see [0056]: “3-Hydroxypropionic acid (3HP), acrylic acid, and various other organic acids, alcohols, and sugars in the samples are analyzed using high performance liquid chromatography”), Abraham also states that the fermentation broth may contain unfermented sugars ([0062]).
However, Abraham does not explicitly teach a step for reducing the concentration of an alcohol produced from the microbial fermentation, nor that such an alcohol is 1,3-propanediol, as required in claims 10 and 11.
Lynch pertains to methods for using engineered microorganism strains for production of a chemical product, which includes 3-hydroxypropionic acid (Title, Abstract).
Lynch teaches that 3-hydroxypropionic acid or “3-HP”, is a highly valued chemical with multiple industrial uses ([0006]-[0007]), including producing acrylic acid, used for consumer products ([0008], [0021]).
Lynch teaches in some embodiments, that the fermentation broth comprises a high concentration of 3-hydroxypropionate, and a low concentration of 1,3-propanediol (“said aqueous broth comprises... (ii) a concentration of 1,3-propanediol selected from less than 30 g/L; less than 20 g/L; less than 10 g/L; less than 5 g/L; less than 1 g/L; or less than 0.5 g/L... the 3-HP/1,3-propanediol ratio (g3-HP/g 1,3-propanediol) is greater than 1.5, greater than 3, greater than 10, greater than 30, greater than 60, greater than 100, greater than 150 or greater than 200” ([0029]). Lynch teaches that 1,3-propanediol is a side-product which may be formed from 3-HP via a reduction reaction ([0365]), and this alcohol can be made through alternative biological methods ([0392]; [0414]).
Lynch further teaches that many methods of separation and purification are known in the art ([0343]), including centrifugation, liquid-liquid separations, extractions, chromatography and ion-exchange, in various forms ([0344]). Lynch also teaches means for removing the biomass and other solids ([0344]-[0349]). Lynch teaches ion exchange and various means for chromatographic and/or extractive separation of organic acids that concentrate acids such as 3-HP ([0350]-[0356]).
Thus, prior to the effective filing date of the instant invention, it would have been obvious to one of ordinary skill in the art to modify the method taught in Abraham by including one or more steps for removing or reducing the amount of contaminant alcohols found in the fermentation broth, including the by-product 1,3-propanediol, in order to improve the yield and industrial applications of the purified 3-HP target compound, according to the teachings and suggestions of Lynch regarding 3-HP fermentation.
Lynch teaches the economical value of 3-HP and acrylic acid, and it would be evident to one having ordinary skill that by-products need to be reduced when obtaining 3-HP.
Means for purifying a desired compound and removing unwanted impurities are known to the art, as evidenced in both Lynch and Abraham. One would recognize that enriching an organic acid via one or more steps of chromatography and/or distillation, such as those steps taught in Lynch, will predictably remove unwanted alcohols, due to the differences in their chemical properties (e.g. the ionic properties of organic acids). See MPEP § 2144.01 which states: "[I]n considering the disclosure of a reference, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom." In re Preda, 401 F.2d 825, 826, 159 USPQ 342, 344 (CCPA 1968).
Because Lynch teaches that lower amounts of 1,3-propanediol is desired (in some embodiments, when other products are wanted), one having ordinary skill would seek means to remove this impurity (and others) in order to purify the desired 3-HP. Means for removing unwanted products of microbial fermentations are known to the art, and selection of such steps amounts to routine optimization or standard process improvement.
From the teachings of the cited references Abraham and Lynch, it is apparent that there would have been a reasonable expectation of success in combining the teachings therein to arrive at the claimed invention because both pertain to producing and obtaining 3-HP
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date, as evidenced by the cited references, especially in the absence of evidence to the contrary.
Citation of Pertinent Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
CN103304374A to Jiangsu Hanbon Science and Technology Co Ltd, which teaches a method for separating and purifying 1,3-propylene glycol in fermentation liquor by a five-region simulated moving bed (Title, Abstract).
CN100339351C to Jiangnan University, which teaches a method for separating residual sugar from organic acid fermentation broth and a corresponding organic acid product mother liquor to purify the organic acid (Title, Abstract).
“Rosin”, US PGPub No. 20210115389, which pertains to the separation of acetate from fermentation broth, teaches passing a fermentation broth to a separation unit having an ion exchange resin in a continuous ion exchange simulated moving bed (Abstract, Fig. 1). Rosin also teaches that “Alternatively, the fermentation broth is passed to a first separation zone to separate and recycle a first portion of the fermentation broth comprising the microorganism to the bioreactor and then a second portion of the fermentation broth is passed to a second separation zone comprising ion exchange resin which selectively retains the target component through ion exchange with the resin” (Abstract).
Conclusion
No claims are allowable.
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/A.T.M./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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