DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . The amendment filed on 10/15/2025 has been entered. Claims 1-17 are cancelled. Claims 18-34 are pending and are currently under examination.
Priority
This application is a 371 of PCT/EP2021/065685 filed on 06/10/2021 and claims foreign priority of EP 10179785.9 filed on 06/12/2020.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) with appropriate assertion under 37 CFR 1.98 filed on 08/12/2025 has been considered.
Withdrawn Claim Objections/Rejections
The objection of claims 18, 24-27, and 32-34 because of improper recitation, as set forth on pages 2 to 3 of the Non-Final Rejection mailed on 07/18/2025, is withdrawn in view of amended claims.
The objection of claims 18, 25, and 26 because of improper period in the claim, as set forth on page 3 of the Non-Final Rejection mailed on 07/18/2025, is withdrawn in view of amended claims.
The rejection of claims 18-34 under 35 U.S.C. 112(b), as set forth on pages 4 to 5 of the Non-Final Rejection mailed on 07/18/2025, is withdrawn in view of amended claims 18, 21, 25, 26, and 29. Claims 19, 20, 22-24, 28, and 30-34 depend from claim 18. Claim 27 depends from claim 25.
The rejection of claims 18-34 under 35 U.S.C. 102(a)(2) as being anticipated by Malisz et al., as set forth on pages 8-11 of the Non-Final Rejection mailed on 07/18/2025, is withdrawn in view of Remarks filed on 10/15/2025, indicating that both the present application and Malisz were, at all relevant times prior to the effective filing date of the present application, either owned by BASF SE or subject to an obligation of assignment to BASF SE.
New (necessitated by amendment) Claim Objections
Claims 18 and 25-27 are objected to because of the following informalities: In claim 18, change the incorrect recitation “with a sub-step of” (line 13) to “or a sub-step of” because dependent claim 21 recites “a sub-step of concentration and a sub-step of diafiltration is carried out” for further narrowing broad recitation “a first nanofiltration step” of claim 18. In claim 25, change the incorrect recitation “ insert the missing word “first” before the recitation “a membrane filtration and being” (lines 9 to 10) to “a first membrane filtration being”; delete the conjunction “and” at the end of step ix); and insert the conjunction “and” at the end of step x). In claim 26, change the incorrect recitation “by any of the following” (line 2) to “by one or more of the following” because steps a) to d) are provided; replace the recitation “decolourization” (lines 4 and 7) to American English “decolorization”; and delete the conjunction “and/or” at the end of steps a), b), and c) to avoid redundancy with the amended “one or more of the following” (line 2). In claim 27, insert the missing comma “,” immediately before the recitation “wherein” (line 1); and delete the excessive recitation “the last one of” (line 2). Appropriate correction is required.
New (necessitated by amendment) 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 29 and 33 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.
Claims 29 and 33 recite the limitation "said adsorbing agent" (line 1 of claim 29) or “said second membrane” (line 1 of claim 33). There is insufficient antecedent basis for this limitation in the claim. Applicant is advised to change the recitation “claim 18, wherein” (line 1 of claim 29) and “claim 31, wherein” (line 1 of claim 33) to “claim 25, wherein” and “claim 32, wherein”, respectively.
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.
(I) Claims 18-22, 24-26, 28, 29, and 31-33 remain rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang et al. (CN109619591, published on 04/16/2019, hereinafter referred to as Zhang ‘591, English translation is provided for citation).
With regard to structural limitations “a method for demineralization of one or more fine chemicals (defined in the specification), comprising the steps of: providing the solution comprising one or more oligosaccharides (and biomass); adjusting (or setting) the pH to the desired value below 7 or less (or pH 3.0 to 5.5) by adding at least one acid; decolorization step by adding an adsorbing agent (or in an amount of 0.5 % to 3 % by weight); carrying out a first membrane filtration (or at a temperature of 8 °C to 55 °C) being microfiltration (defined as “a pore size of 0.1 μm to 10 μm or a cut-off for a molecular mass of more than 250 kDa” in the specification) or ultrafiltration (defined as “a pore size of 2 nm to 100 nm or a cut-off for a molecular mass of 2 kDa to 250 kDa” in the specification); a second membrane filtration (or at a temperature of 5 °C to 15 °C) being microfiltration or ultrafiltration of the permeate of the first membrane filtration; and a first nanofiltration (defined as “pore sizes from 1-10 nm” in the specification) step” (claims 18-21, 25, 26, 28, 29, and 31-33):
Zhang ‘591 disclosed a preparation method of bergamot pectin oligosaccharide. Dissolving the pectin in water, adding pectinase, and enzymatically digesting at pH 3.5-4.5, 40-50 ° C; after 3-5h, the enzyme is boiled to obtain an enzymatic hydrolysate; the enzymatic hydrolysate is filtered, the supernatant is added to the yeast, and the fermentation is carried out at 25-40 ° C to obtain fermentation solution; the fermentation liquid is adjusted to a pH of 3.0-4.0, activated carbon is added, decolorized at 40-60 ° C, centrifuged (preferably 4 ° C, centrifuged at 10,000 rpm for 10 min), and the supernatant is taken and decompressed and concentrated (45 ° C) (preferably concentrated to 1/4 of the original volume) to obtain a concentrate; the concentrate is filtered with a polyethersulfone membrane having a molecular weight cut off of 5 KDa, and the filtrate is re-used with regenerated cellulose having a molecular weight of 1 kDa. Membrane ultrafiltration separation Liquid is freeze-dried to obtain pectin oligosaccharides bergamot (page 2/23, last paragraph; page 3/23, lines 1 to 2). The amount of the activated carbon added is 10 g/L. Direct freeze-drying of the sample at 4 ° C can better preserve the original biological activity. Ultrafiltration membranes with molecular weight cutoff of 5KDa and 1 KDa were selected for sample separation and purification (page 3/23, lines 10 and 28-31).
Thus, these teachings of Zhang ‘591 anticipate Applicant’s claims 18-22, 24-26, 28, 29, and 31-33, because membranes with molecular weight cutoff of 5KDa and 1 KDa were selected and 4 ° C can better preserve the original biological activity, and thus would achieve the same intended results, including “the concentration factor is at least 3 or more”, and “the nanofiltration membrane has a NaCl retention between 5 to 30 % of initial amount”, required by claims 22 and 24.
Applicant’s Arguments/Remarks filed on 10/15/2025 have been fully considered. Applicant argued “Zhang fails to discloses step (h) "a first nanofiltration step; with a sub-step of concentration and a sub-step of diafiltration," and neither the term nanofiltration nor diafiltration is found in the document” (p. 7, para. 6).
In response, these arguments are found not persuasive because of the following reasons. The step (h) is now interpretated as “a first nanofiltration step; or a sub-step of concentration and a sub-step of diafiltration” because dependent claim 21 recites only “a sub-step of concentration and a sub-step of diafiltration is carried out”. See also Claim Objections section above. Furthermore, the “nanofiltration” is defined as “the term "nanofiltration" refers to a type of physical filtration process where a fluid comprising undesired particles, for example contaminated fluid, is passed through a special pore-sized membrane to separate larger compounds from smaller compounds in the solution. It uses membranes with smaller pores than ultrafiltration membranes. An example of nanofiltration membranes are those having pore sizes from 1-10 nm” in the Specification “p. 15, lines 14-18). The molecular weight cutoff of 1 KDa as taught by Zhang ‘591 is encompassed by 1 to 10 nm, as evidenced by Lenntech (https://www.lenntech.com/services/mwco.htm). The nanofiltration filtration functions as a concentration step. The diafiltration is not specifically defined and would encompass any nanofiltration. To overcome the current 102 rejection, additional structural limitation that is not taught by the reference can be included. Any amendment after Final may not be entered if new issue arises or extensive search is required.
(II) Claims 18, 19, 21-27, 30-32, and 34 remain rejected under 35 U.S.C. 102(a)(1) or 102(a)(2) as being anticipated by Jennewein (WO 2019/110800, published on 06/13/2019 and PCT filed on 12/07/2018, hereinafter referred to as Jennewein ‘800).
With regard to structural limitations “a method for demineralization of one or more fine chemicals (defined in the specification), comprising the steps of: providing the solution comprising one or more oligosaccharides (and biomass; or human milk oligosaccharide); adjusting (or setting) the pH to the desired value below 7 or less by adding at least one acid; decolorization step by adding an adsorbing agent; carrying out a first membrane filtration (or at a temperature of 8 °C to 55 °C) being microfiltration (defined as “a pore size of 0.1 μm to 10 μm or a cut-off for a molecular mass of more than 250 kDa” in the specification; or cross-flow microfiltration) or ultrafiltration (defined as “a pore size of 2 nm to 100 nm or a cut-off for a molecular mass of 2 kDa to 250 kDa” in the specification; or cross-flow ultrafiltration); a second membrane filtration being microfiltration or ultrafiltration of the permeate of the first membrane filtration; and a first nanofiltration (defined as “pore sizes from 1-10 nm” in the specification) step; or a sub-step of concentration and of diafiltration (or a demineralization step by ion exchange)” (claims 18, 19, 21, 25-27, 30-32, and 34):
Jennewein ‘800 disclosed purification of 3-fucosyllactose from fermentation broth. The cells were separated from the culture medium by ultrafiltration (0.05 μm cut-off) followed by a cross-flow filter with a MWCO of 150 kDa. The cell-free fermentation medium containing about 30 g/L 3-fucosyllactose, was passed over a strong cationic ion exchanger in H+ form to remove positive charged contaminants. Afterwards the solution was set to pH 7.0 using sodium hydroxide and applied to an anionic ion exchanger in the chloride form. Both ion exchangers were used in 200 L volume. After a second filtration (150 kDa) the particle free solution was concentrated 5-fold by nanofiltration using a Filmtech NF270 membrane (Dow, Midland, USA) and 2.5-fold by vacuum evaporation. The concentrated solution was filtrated (10 kDa), clarified by activated carbon charcoal and deionized by electrodialysis. A PC-Cell BED 1-3 electrodialysis apparatus with a PC-Cell E200 membrane stack was used containing the following membranes: cation exchange membrane CEM:PC SK and anion membrane AEM:PCAcid60. For reduction of brownish coloring originating from the fermentation process, a second round of ion exchange chromatography was performed using the same ion exchange material. Purification of lacto-N-tetraose from fermentation broth. For the fermentative production of Lacto-N-tetraose the E. coli BL21 (DE3) ∆lacZ strain was grown in a defined mineral salts medium, pH 6.5. The pH was controlled using a 25% ammonia solution. Nanofiltration membranes usually have a molecular weight cutoff in the range 150 - 1000 Daltons. Diafiltration using nanofiltration membranes was found to be efficient as a pretreatment to remove significant amounts of contaminants prior to electrodialysis. (page 29/45, lines 1-21; page 30/45, lines 3-12; page 15/45, lines 2-10).
Thus, these teachings of Jennewein ‘800 anticipate Applicant’s claims 18, 19, 21-27, 30-32, and 34 because the ion exchange of acidic and cell-free fermentation medium is equivalent to the claimed steps of adjusting pH below 7 and decolorization by adding an adsorbing agent, and thus would achieve the same intended results, including “the concentration factor is at least 3 or more”, “diafiltration factor is from 2.5 to 3.5”, “the nanofiltration membrane has a NaCl retention between 5 to 30 % of initial amount”, and “the throughput of the demineralisation step is increased by a factor of at least 2 or more compared to the throughput of an identical ion exchange step without the one or more nanofiltrations”, required by claims 22-24 and 27.
Applicant’s Arguments/Remarks filed on 10/15/2025 have been fully considered. Applicant argued “Jennewein fails to teach or suggest adjusting the pH below 7 by the addition of acid, as required. In Applicant's process the pH adjustment is expressly performed by adding at least one acid to the solution” (p. 8, para. 4) and “Jennewein fails to disclose "a first nanofiltration step; with a sub-step of concentration and a sub-step of diafiltration" as specifically recited” (p. 9, para. 2).
In response, these arguments are found not persuasive because of the following reasons. First, the argued “acid” is not specifically defined and would encompass the acidic and cell-free fermentation medium of Jennewein ‘800. Second, the step (h) is now interpretated as “a first nanofiltration step; or a sub-step of concentration and a sub-step of diafiltration” because dependent claim 21 recites only “a sub-step of concentration and a sub-step of diafiltration is carried out”. See also Claim Objections section above. Furthermore, the “nanofiltration” is defined as “the term "nanofiltration" refers to a type of physical filtration process. It uses membranes with smaller pores than ultrafiltration membranes. An example of nanofiltration membranes are those having pore sizes from 1-10 nm” in the Specification “p. 15, lines 14-18). The molecular weight cutoff of 150 - 1000 Daltons as taught by Jennewein ‘800 is encompassed by 1 to 10 nm, evidenced by Lenntech (https://www.lenntech.com/services/mwco.htm). The nanofiltration filtration functions as a concentration step. The diafiltration is not specifically defined and would encompass any diafiltration. To overcome the current 102 rejection, additional structural limitation that is not taught by the reference can be included. Any amendment after Final may not be entered if new issue arises or extensive search is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 18-22, 24-26, and 28-34 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17, 19, 22, and 25-30 of copending Application No. 17/414,703 (Applicant: BASF SE, the claim set of 05/27/2025). Although the claims at issue are not identical, they are not patentably distinct from each other because Appl ‘703 claims “A method for separating biomass from a solution comprising biomass and at least one oligosaccharide, comprising: providing the solution comprising biomass and oligosaccharides; setting the pH value of the solution below 7 (or a pH value in the range of 3.0 to 5.5) by adding at least one acid to the solution comprising biomass and the at least one oligosaccharide (or said at least one oligosaccharide comprises human milk oligosaccharide); adding at least one adsorbing agent (or in an amount in the range of 0.5 % to 3 % by weight) to the solution comprising biomass and oligosaccharides; and carrying out a first membrane filtration (or as cross-flow microfiltration or cross-flow ultrafiltration; or at a temperature of the solution in the range of 8 °C to 55 °C; or by means of a ceramic microfiltration or ultrafiltration membrane having a pore size in the range of 20 nm to 800 nm, or by means of a polymeric microfiltration membrane or polymeric ultrafiltration membrane having a cut-off in the range of 10 kDa to 200 kDa), so as to separate the biomass from the solution comprising at least one oligosaccharide, further comprising carrying out a second membrane filtration with the solution comprising oligosaccharides obtained by the first membrane filtration (or said second membrane filtration is an ultrafiltration and is carried out by means of an ultrafiltration membrane having a cut-off in the range of 1. 5 kDa to 10 kDa; or at a temperature of the solution being in the range of 5 °C to 15 °C)” (claims 27-30, 17, 19, 22, 25, and 26), reading on claims 18-22, 24-26, and 28-34 of this Application because the “cut-off in the range of 1. 5 kDa to 10 kDa” of Appl ‘703 is encompassed by the claimed “nanofiltration”, and thus would achieve the same intended results, including “the concentration factor is at least 3 or more”, and “the nanofiltration membrane has a NaCl retention between 5 to 30 % of initial amount”, required by claims 22 and 24. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant’s Arguments/Remarks filed on 10/15/2025 have been fully considered. Applicant argued “Applicants will address these provisional rejections once the rejections below have been withdrawn and the pending claims are otherwise allowable” (p. 12, para. 1).
In response, the double patenting is thus maintained.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/YIH-HORNG SHIAO/Primary Examiner, Art Unit 1691