DETAILED ACTION
Status of Claims:
Claims 33-52 are pending.
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 .
Claim Objections
Claim 43 is objected to because of the following informalities: the claim state “the third fraction a hydrophilic impurity”. This appears to be missing the word “is” between “fraction and “a”. Appropriate correction is required.
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 33-52 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.
Regarding Claim 33:
The claim states “to recover a predetermined desired type of glycolipid…with a preselected recovering liquid to recover the predetermined desired type of glycolipid”. This limitation renders the claim indefinite because it is not clear if the “preselected recovering liquid” is preselected based on the predetermined type of glycolipid or if the claim is merely requiring the recovering liquid to be selected in advance.
Regarding Claim 36:
The claim states contacting the adsorbent with one or more treating liquids…contacting the adsorbent with an alkaline reagent…” It is not clear if the “alkaline reagent” is the treating liquid or in addition to the treating liquid.
Regarding Claim 39:
The claim refers to “a recovery liquid”. It is not clear if this is further limiting the recovering liquid of claim 33 or in addition to the recovering liquid.
The claim states “essentially all of the glycolipids…are removed”. It is not clear if this is referring to the desired type of glycolipids or every type of glycolipid.
Regarding Claim 47:
The claim refers to “the treating liquid”. There is no antecedent basis for this limitation within the claims. Antecedent basis is provided in claim 34.
The claim refers to “the washing liquid”. There is insufficient antecedent basis for this limitation within the claims.
The remaining claims are indefinite because they depend from an indefinite claim.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 33, 38, 39, 44, 45, 47-49, 51 and 52 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Blank et al (WO 2013/087674).
Regarding Claim 33:
Blank teaches the process for isolating and/or purifying an acetylated or non-acetylated form of a glycolipids from a glycolipid-containing composition containing at least one glycolipid, the process comprising (see para. 0027): providing a process unit with an adsorbent ( suitable adsorbent is selected) (see para. 0014), wherein the adsorbent is a polymeric resin (polystyrene resin) (see para. 0035); contacting the glycolipid-containing composition with the adsorbent to load the polymeric resin with a loaded material (immobilized on the adsorbent) (see para. 0014), the loaded material comprising an amount of the at least one glycolipid (see para. 0027); treating the adsorbent to recover a predetermined desired type of glycolipid, wherein treating the adsorbent comprises contacting the adsorbent with a preselected recovering liquid (suitable fluid) to recover (desorption) the predetermined desired type of glycolipid from the loaded material on the adsorbent (see para. 0014); and acquiring (isolating by desorption) the predetermined desired type of glycolipid recovered from the process unit (see para. 0077).
Regarding Claim 38:
Blank teaches the process according to claim 33, wherein the preselected recovering liquid is selected from ionic liquids, liquid carbon dioxide, supercritical solvents, ethyl acetate, methanol (see para. 0106), isopropanol, acetone, ethanol, heptane, tert-butyl-methyl ether, diethylether, acetonitrile, phenoxyethanol, benzyl alcohol, phenethyl alcohol, hydrocinnamyl alcohol, tetrahydrofurfuryl alcohol, dimethylisosorbide, methyl salicylate eugenol, linalool, hexanol, glacial acetic acid, dimethylcarbonate, dipropyleneglycol methyl ether, ethyl-lactate, butyl-lactate, amyl-lactate, ethylhexyl-lactate, or combinations thereof.
Regarding Claim 39:
Blank teaches the process according to claim 33, wherein treating the adsorbent comprises: contacting the adsorbent with a treating solution (washing step) having a first concentration (everything has a concentration) of a treating liquid (solvent) (see para. 0094); contacting the adsorbent with a recovering solution (suitable fluid) having a second concentration of a recovery liquid (desorption) (see para. 0014); wherein: the first concentration is such that that essentially all of the glycolipids within the loaded material are not removed from the adsorbent (see para. 0094); the second concentration is such that essentially all of the glycolipids within the loaded material from the adsorbent are removed from the adsorbent (isolating by desorption) (see para. 0095).
Regarding Claim 44:
Blank teaches the process according to claim 33, wherein the polymeric resin is selected from polymethacrylate resin, acrylic resin, polystyrene resin (see para. 0096), or combinations thereof.
Regarding Claim 45:
Blank teaches the process according to claim 33, wherein the polymeric resin is selected from styrene-divinylbenzene, polymethacrylate, chemically brominated polystyrene, acrylic ester, polystyrene (see para. 0096), crosslinked polystyrene, or methacrylic porous polystyrene-divinylbenzene.
Regarding Claim 47:
Blank teaches the process according to claim 33, further comprising: recycling at least one of the recovering liquid or the treating liquid (solvent and cells that are flushed are fed back to the reactor) (see para. 0095); and optionally recycling the washing liquid.
Regarding Claim 48:
Blank teaches the process according to claim 33, wherein the glycolipid-containing composition is an end-product of a plant extract or a fermentative (fermenter overflows) (see para. 0074), enzymatic, or chemical production method.
Regarding Claim 49:
Blank teaches the process according to claim 33, wherein the process is performed in combination with a fermentation process in an in-situ product recovery set-up (see para. 0074, 0073).
Regarding Claim 51:
Blank teaches the process according to claim 33, further comprising passing the glycolipid- containing composition through a reactor (adsorption column) that comprises the adsorbent (see Figs. 1 and 2). The adsorption column is a reactor.
Regarding Claim 52:
Blank teaches the process according to claim 33, further comprising passing the glycolipid- containing composition over a column packed with the adsorbent (see figs. 1 and 2).
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.
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.
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.
Claim(s) 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over by Blank et al (WO 2013/087674) as applied to claim 33 above, and further in view of Ribeiro et al, the article “Optimization and correlation of HPLC-ELSD and HPLC-MS/MS methods for identification and characterization of sophorolipids”.
Regarding Claim 42:
Blank teaches the process according to claim 33, wherein.
Blank does not teach treating the adsorbent comprises contacting the adsorbent with a second treating liquid that is an apolar solvent, to remove a second fraction of one or more secondary components from the loaded material; the second fraction is selected from free fatty acids, fatty alcohols, triacyl glycerides, dicarboxylic acids, diols, alkanes, and/or oils; and the second treating liquid is chosen from hexane, heptane, or methyl tert-butyl ether.
Ribeiro teaches a process for remove additional secondary components by contacting with a second treating liquid (hexane); the second fraction selected from free fatty acids (oleic acid), fatty alcohols, triacyl glycerides, dicarboxylic acids, diols, alkanes, and/or oils (see pg. 74, left column, 1st paragraph).
Blank and Ribeiro are analogous inventions in the art of isolating glycolipids. It would have been obvious to one skilled in the art to add the contacting with the second treating liquid step of Ribeiro to the adsorbent of Blank because it allows for further isolation of materials (see Ribeiro pg. 74, left column, 1st paragraph) and because it is the simple addition of a known separation step to a known process, obviously resulting in the removal of fatty acids from the adsorbent, with an expectation of success. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. __,__, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.).
Claim(s) 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blank et al (WO 2013/087674).
Regarding Claim 43:
Blank teaches the process according to claim 3, wherein treating the adsorbent comprises contacting the adsorbent with a third treating liquid to remove a third fraction of one or more secondary components from the loaded material (washing to remove host cells) (see para. 0094).
Blank does not teach the third fraction is a hydrophilic impurity selected from sugars, proteins, peptides, polyols, organic acids, inorganic acids, carbohydrates, or salts.
Blank further teaches that the solvent for the washing step can be easily determined (see para. 0094), that hydrophilic solvents can be used to remove hydrophilic materials from the adsorbent (see para. 0090, 0099). Blank also teaches that the culture broth can be hydrophilic and contain sugars (see para. 0138). It would have been obvious to remove hydrophilic impurities selected from sugars by contacting the adsorbent with the third treating liquid because it is the use of the known technique of washing (see Blank para. 0094) to removal compounds known to be present in the system (see Blank para. 0138), obviously resulting in the removal of a hydrophilic third fraction. The use of a known technique to improve similar devices (methods or products) in the same way is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. __,__, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, C.).
Claim(s) 46 is/are rejected under 35 U.S.C. 103 as being unpatentable over by Blank et al (WO 2013/087674) as applied to claim 33 above, and further in view of Khanzhin et al (WO 2020/128945).
Regarding Claim 46:
Blank teaches the process of claim 33.
Blank does not teach that the polystyrene is chemically brominated polystyrene.
Khanzhin teaches adsorption with chemically brominated polystyrene (bromine functionalized) (see Abstract).
Blank and Khanzhin are analogous inventions in the art of adsorption. It would have been obvious to one skilled in the art before the effective filing date of the invention to replace the adsorbent of Blank with the chemically brominated polystyrene of Khanzhin because it is the simple substitution of one known adsorbent material for another known adsorbent material, obviously resulting in the adsorption of glycolipids with an expectation of success. And because Blank is open to the use of different materials (see Blank para. 0035-0036). The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. __,__, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B.).
Claim(s) 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over by Blank et al (WO 2013/087674) as applied to claim 33 above, and further in view of Roelants et al (WO 2020104582).
Regarding Claim 50:
Blank teaches the process of claim 33:
Blank does not explicitly teach the glycolipids are selected from acetylated or non-acetylated forms of bola sophorolipids, bola sophorosides, alkyl sophorosides, alcohol glucosides, sucrose esters, bola glucosides, alkyl glucosides, glucolipids, or combinations thereof.
Roelants teaches a method of extracting acetylated or non-acetylated forms of at least bola sophorolipids (see pg. 4 lines 5-9).
Blank and Roelants are analogous inventions in the art of producing glycolipids. It would have been obvious to one skilled in the art before the effective filing date of the invention to use the method of Blank to isolate the bola sophorolipids of Roelants because through routine experimentation one skilled in the art would have found appropriate uses for the known method. The use of a known technique to improve similar devices (methods or products)
in the same way is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550
U.S. __,__, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, C.).
Allowable Subject Matter
Claims 34-37, 40 and 41 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Claims 34-37, 40, and 41 contain limitations that would be allowable in view of the prior art. The prior art does not teach or render obvious contacting the adsorbent with one or more treating liquids to modify the at least one glycolipid (see claims 34, 36, and 40). Although modifying glycolipids and is known in the art (see Roelants, pg. 10 lines 12-15) the step of contacting with a treating liquid is not performed in conjunction with an adsorbent. Therefore one skilled in the art would not have been motivated to modify Blank to include the contacting with a treating liquid as claimed. Regarding Claim 41, Blank does not teach the glycolipid comprises acetylated and/or non-acetylated bola sophorolipids; and the process converts the acetylated and/or non-acetylated bola sophorolipids into acetylated and/or non-acetylated acidic sophorolipids and acetylated and/or non- acetylated sophorose. Although processes isolating acetylated and/or non-acetylated bola sophorolipids are known (See Roelants, whole document). It would not have been obvious to modify the process to convert the acetylated and/or non-acetylated bola sophorolipids into acetylated and/or non-acetylated acidic sophorolipids that it is desirable to be free of sophorolipids (see Roelants pg. 7 lines 3-5).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CLAIRE A NORRIS whose telephone number is (571)272-5133. The examiner can normally be reached M-Th 7:30-5 F: 8-12.
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/CLAIRE A NORRIS/Primary Examiner, Art Unit 1779 2/25/2026