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 .
Claim Status
Claims 1-20 were filed on 8/9/2024 and are pending.
Priority
The instant application as filed 8/9/2024 and claims the benefit of priority to:
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See filing receipt dated 8/29/2024. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 17/607143, filed on 10/28/2021.
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 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 8-12, 14-17, and 19-27 of co-pending Application No. 17/607143 (‘143, reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims recite a species of the claimed process, wherein the demineralization limitations of instant claims 8 and 19 are in the independent claim. Therefore, the process in the claims of ‘143 anticipates the claimed process. Also see MPEP 2131.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. It is noted that the claims of ‘143 were indicated as being allowable in the NOA dated 6/16/2026.
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) 1-5, 9-12, 14-16, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Camero (US 2003/0040609, published on 2/27/2003).
Applicants claim a process for separating pinitol from a carob extract through chromatography.
Camero teaches a method of obtaining pinitol from carob extracts, employing stages of inversion of the saccharose contained in said extracts to fructose and glucose, then chromatographic separation of the pinitol by means of ion-exchange resins, to obtain a solution of pinitol in water, and separation of the pinitol from said solution. See abstract and claims. Camero teaches that the carob extracts from which the pinitol is obtained have the following composition:
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, wherein pinitol is interpreted to fall within the scope of the cyclitols. See [0030]. Camero teaches a few different embodiments of the isolation of pinitol from the carob extracts, which involve the same steps, but in different combinations. The basic steps are set forth in [0033-0049] and includes preparation of carob syrup [0040-0044], inversion of the saccharose contained in the syrup [0045-0046], demineralization and decoloring [0047-0048], and chromatographic separation of pinitol from the other components remaining in the extract (which depends on the exact order of steps carried out this point) [0030-0039 and 0049].
In example 1 in [0066-0070], Camero teaches that “a carob syrup obtained as indicated previously but with the saccharose inverted and with the concentration of approx. 60°C Brix, is used as the feed for an improved simulated moving bed (ISMB®) plant (claim 10) characterized by the following operating parameters:
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, wherein UBK 530® is a strong cationic resin. See [0035]. As previously mentioned, “a carob syrup obtained as indicated previously” corresponds to the process in [0040-0044] and comprises:
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. Thus Camero teaches that the “preparation of the carob syrup” step comprises a step of demineralization with a strong cationic resin to remove the greater part of calcium and magnesium thereof, followed by filtration, and concentration to provide a syrup of “approx. 60°Brix”, which overlaps with the Brix ranges in claims 1-2 of at least 60°.
The next step in example 1 is the inversion of the saccharose, which is disucssed in [0045-0046] and includes:
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. Thus, this step can include treatment of the prepared syrup with another cationic resin.
The inverted syrup is then treated to the pinitol chromatography separation conditions of [0066], comprising contact of the inverted syrup with a strong cationic exchange resin in an ISMB® to produce the mixture in [0067]:
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. Thus, an inverted syrup feed comprising fructose, glucose, pinitol, non-sugars (salts), dry solids, and water produces two extracts, a reducing sugars (R.S. fraction) and a pinitol fraction. In [0068], Camero teaches that the pinitol fraction contains 44.2% of salts and is subjected to be “demineralized and decolorized as indicated previously” to provide a composition comprising 90% pinitol, 5% glucose, and 5% fructose. The demineralization and decolorization conditions are discussed in [0047-0048] and comprises:
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. Thus, these steps require at least two more passes through ion exchange resins (through at least one strong cation exchange resin and then through at least one strong anion exchange resin).
Therefore, example 1 of Camero teaches filtering, demineralizing, and concentrating [0040-0044] the carob syrup to produce a syrup having a Brix value of “approx. 60”. This syrup is then treated to an inversion process to convert saccharose to glucose and fructose [0045-0046], to produce the “feed” mixture in the table of [0067], which comprises 17 wt% of pinitol, which falls within the claimed range of 5 to 25 wt% and also having a Brix value of “approx. 60” [0066], which also falls within the claimed range of “greater than 60”. The feed mixture undergoes ISMB® chromatography (chromatographic separation) with strong cation exchange resin (chromatographic resin) which is only eluted with demineralized water to produce the aqueous “pinitol fraction” of the Table in [0067], which comprises 50.61 wt% of pinitol, which falls within the claimed range of “from 35 to 70 wt%”. Camero then teaches that the syrup is modified to have a Brix concentration of 20-30° Brix and subjected to further demineralization and decolorizing conditions [0047-0048 and 0068] to produce the purified aqueous solution in [0068], comprising 90 wt% of pinitol, which falls within the range of claim 2.
Camero teaches in Example 2 that 70 mL of a carob extract, inverted, demineralized, and decolorized, with a 25°C Brix value and comprising 35 wt% of pinitol is subjected to treatment with an anionic resin to separate the pinitol from the glucose, fructose, and non-sugars present in the feed. See [0071-0074]. The purity of the pinitol recovered from example 2 is lower than that of example 1. Thus, example 2 of Camero teaches that the demineralization and decolorization steps occur before the chromatographic pinitol separation and teaches the use of a strong anionic exchange column instead of a strong cationic exchange column.
In example 3, Camero uses a commercial carob syrup and after inversion, comprises 15.73 wt% of pinitol. See [0075]. This feed is fed to an ISMB® chromatographic separation process with a strong cationic exchange resin to produce a P-fraction and an R-fraction, wherein the R-fraction comprises 78.9 wt% of pinitol which when concentrated and atomized provides pinitol in 95% purity. See [0077]. No further demineralization or decolorization steps appear to be required in this example.
Thus, Camero teaches that pinitol can be predictably separated from inverted carob extracts comprising other sugars and salts by treatment with cationic or anionic exchange resins, both before and after demineralization and decolorization steps. Example 1 of Camero appears to teach all of the limitations of instant claims 1-2 except that the pinitol containing aqueous solution obtained from the chromatographically separating step has a Brix value of “20 or lower” in claims 1-2.
It would have been prima facie obvious to arrive at the claimed process based on the teachings of Camero with a reasonable expectation of success before the effective filing date of the claimed invention. A person of ordinary skill would have been motivated to adjust the Brix value of the aqueous solution obtained from the chromatographically separating step (the pinitol separation step of Camero) to within the claimed range of 20 or lower, because Camero teaches a range which overlaps with that claimed of 20-30. Brix values are measures of the concentration of dissolved solids in liquids (see p. 8, final paragraph of the specification as filed), therefore it is obvious that they could be adjusted to the desired concentration by adding or removing liquid. Also see MPEP 2144.05.
Regarding claims 3-5 and 14-16, Camero teaches that demineralization and decoloring can occur before (examples 2 and 3) or after (example 1) the chromatographic separation. Camero further teaches that the demineralization and decolorization comprises contacting a syrup with a concentration of 20-30° Brix by passing it successively through strong cationic resins (H form) and then through strong anionic resins (OH form). See [0047-0048].
Regarding claims 9 and 20, the pinitol in the first carob extract in example 1 is 17 wt% [0067] and in example 3 is 15.73 wt% [0075-0077]. Both of these values fall within the claimed range. See MPEP 2144.05.
Regarding claims 11-12, Camero teaches that the purified extract of example 1 comprises 90 wt% of pinitol, and that the fraction is further concentrated and crystallized to produce 95% pure pinitol. See [0068-0069]. Also see MPEP 2144.05.
Claim(s) 6-8 and 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Camero (US 2003/0040609, published on 2/27/2003), as applied to claims 1-5, 9-12, 14-16, and 20 above, and further in view of Foraci (US2011/0048413, published on 3/3/2011).
Camero teaches that the demineralization step comprises passing a carob syrup having a Brix value of 20-30 successively through a strong cationic resin and then through a strong anionic resin. See [0047-0048]. Camero is silent regarding the use of weak anionic resins in the demineralization process.
Foraci is directed toward a process and plant for producing sugar products from grapes comprising a first step of demineralizing and decolorizing a fruit juice so as to bring its solid content to comprise from 99 wt% to 99.99 wt% of a mixture of saccharides, alcohols, and flavonoids. See abstract. The decoloration and demineralization step is shown in Fig. 5:
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. In figure 5, columns (21), (23), (25), and (27) are each treating columns comprising a solid bed of ion-exchange resins and which are fluidly connected by ducts (29), (31), (33), and (35) through which the fruit juice flows during treatment. See [0027-0038]. “Preferably each treating columns containing anion exchange resins is alternated with a treating column containing cation exchange resins along the fluidic path of the fruit juice to be treated, as shown in Fig. 5, wherein columns 21 and 25 contain anion exchange resins and columns 23 and 27 contain cation exchange resins”. See [0029-0031]. Foraci further teaches “preferably the first treating column of the series contains an anion exchange resin, more preferably a weak anion exchange resin. Preferably the last treating column of the series contains cation exchange resins. Preferably the last treating column but one 25 contains a first bed 25A of a weak anion exchange resin in its upper part, and a second bed 25B of strong anionic resins in its lower part”. See [0032].
Foraci further teaches that “the above arrangements of the decoloration and demineralization plant 20 increases the amount of exchange resins effectively involved during treatment, reduces of about 50% the consumption of regenerants—such as hydrogen chloride and caustic soda—and water for regenerating the ion exchange resins, and reduces the time for diluting the fruit juice to be treated, thereby reducing the electric consumption of the next concentration stage”. See [0038]. Foraci further teaches that the “particularly low content of anions, cations and other non-sugars, non polyhydric alcohols, and non flavonoids of the liquid decolorized and demineralized fruit juice fed to the chromatographic separation plant (1-of Fig. 1-4) increases the efficient of the chromatographic plant itself, which can produce for long times –such as several years – high purity fructose- and glucose-enriched fractions, with high yields and substantially no need of regenerating or replacing the ion exchange resins”. See [0099-0100].
Therefore, the embodiment of Figure 5 of Foraci teaches the limitations of the demineralization step in claims 6 and 17 and the use of the five columns of claims 7-8 and 18-19 in the order of i) weak anion exchange resin (21); ii) strong cation exchange resin (23); iii) strong anion exchange resin (25B); iv) weak anion exchange resin (25A); and v) strong cation exchange resin (27). Foraci does not explicitly teach reversing the order of iii) and iv) such that the fruit juice contacts the second weak anion exchange resin (25A) before the strong anion exchange resin (25B).
It would have been prima facie obvious to combine the teachings of Camero and Foraci to arrive at the claimed process with a reasonable expectation of success before the effective filing date of the claimed invention. A person of ordinary skill would have been motivated to replace the demineralization and decoloration process of Camero with that of Foraci because replacing one known process for demineralizing and decolorizing extract comprising sugars with another is prima facie obvious. Further, Foraci teaches that the disclosed process reduces the consumption of regenerants and can produce high purity sugar fractions with high yields and substantially no need of regenerating or replacing the ion exchange resins. Therefore, replacing the demineralization process of Camero with that of Foraci will predictably result in a more efficient process for obtaining pinitol from carob. Also see MPEP 2143(I)(B). A person of ordinary skill would have been motivated to modify the order of the weak and strong anion exchange resins in the demineralization process because Foraci teaches that as long as the basic resins are used as the first in a series with strong cation exchange columns, that the process will predictably demineralize and decolorize extracts comprising sugars to provide a high quality product for use in further sugar separation processes. Also see MPEP 2144.04(IV)(C).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Camero (US 2003/0040609, published on 2/27/2003), as applied to claims 1-5, 9-12, 14-16, and 20 above, and further in view of Johnson (US 2002/0023877, published on 2/28/2002) as evidenced by Amberlite® MB (downloaded from https://www.sigmaaldrich.com/US/en/product/sigma/d2572?srsltid=AfmBOootF3CtWzCJhoGNq92oB-RVTIFi3QymBekkwjXOysrd3-yTA58B on 9/4/2026).
Camero does not explicitly teach acid hydrolyzing the aqueous solution to obtain a hydrolyzed solution comprising D-chiro-inositol and purifying the solution by at least one passage on a strong anionic exchange resin.
Johnson teaches methods for the production of D-chiro-inositol (DCI). See abstract. Johnson teaches that DCI supplements can improve insulin sensitivity in insulin resistant individuals. See [0005]. Johnson teaches the method comprises hydrolyzing a DCI precursor, including pinitol, with 5N to 12N HCl (acid) to produce DCI. See claims. Johnson further teaches that the DCI is purified by passing through one or more ion exchange resins, preferably first through a basic anion exchange resin and then through an acid cationic exchange resin. See [0036-0040]. Examples 1-2 in [0083-0093] teach the HCl hydrolysis of pinitol to provide DCI and then passed through a mixed-bed resin for purification. As evidenced by Amberlite® MB, the resin of example 2 comprises a strong anionic exchange resin.
It would have been prima facie obvious to combine the teachings of Camero and Johnson to arrive at the instantly claimed process with a reasonable expectation of success before the effective filing date of the claimed invention. A person of ordinary skill would have been motivated to hydrolyze the purified pinitol obtained from Camero using the claimed process to produce DCI, because such is known from Johnson. Johnson further teaches that the skilled artisan would be motivated to obtain DCI because it is a known supplement to treat insulin resistance. Therefore, the combination of Camero and Johnson will predictably result in process for producing DCI from carob extracts, via hydrolysis of pinitol, using two known and predictable processes. Also see MPEP 2143(I)(A).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY C BONAPARTE whose telephone number is (571)272-7307. The examiner can normally be reached 11-7.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Goon can be reached at 571-270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMY C BONAPARTE/Primary Examiner, Art Unit 1692
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