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 .
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.
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Claims 1, 3-5, 7-9 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-8 of copending Application No. 18/546,865 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 1 is not patentably distinct from claim 1 of 18/546,865 because both claims are directed to the same overall process for reducing MOSH and/or MOAH in lauric oil. In both claims, the process begins by breaking down lauric oil into a glycerol-derived fraction and a fatty-acid-derived fraction, then purifying the fatty-acid-derived portion by distillation, and then reacting the purified intermediate with glycerol to obtain a MOSH- and/or MOAH-reduced lauric oil. In 868_cm (1), the process proceeds through a fatty acid fraction followed by esterification with glycerol. In 865-CLM_2023, the process proceeds through a fatty acid alkyl ester fraction followed by transesterification with glycerol.
These differences amount to no more than a closely related process variation in the form of the intermediate and the chemistry used to re-form the oil. The claimed subject matter therefore is not patentably distinct.
Claim 3 is not patentably distinct from claim 3 of 865-CLM_2023. Both claims recite pretreatment of the lauric oil before step a, and both cover degummed, bleached and/or deodorized lauric oil. The additional reference to neutralization in 868_cm (1) is only a further conventional oil pretreatment step and does not render the claim patentably distinct from the corresponding claim in 865-CLM_2023.
Claim 4 is not patentably distinct from claim 4 of 865-CLM_2023. Both claims are directed to lauric oil that has been degummed and bleached before step a. The added neutralization language in 868_cm (1) merely identifies another conventional pretreatment step and does not define a separate invention.
Claim 5 is not patentably distinct from claim 5 of 18/546,865 because both claims limit the lauric oil to coconut oil.
Claim 7 is not patentably distinct from claim 6 of 18/546,865 because both claims require deodorization of the oil obtained after the glycerol reaction step.
Claim 8 is not patentably distinct from claim 7 of 18/546,865 because both claims require a bleaching step before deodorization.
Claim 9 is not patentably distinct from claim 8 of 18/546,865 because both claims require that the fatty acid profile of the final MOSH- and/or MOAH-reduced lauric oil substantially match that of the starting lauric oil within recited deviation limits. Although the wording differs slightly, the claimed requirement is the same in substance.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 112
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.
Claim 9 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 claim(s) 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 9 reads for each selected fatty acid, the percentage difference between the amount of that fatty acid in the MOSH- and/or MOAH-reduced lauric oil and the amount of the corresponding fatty acid bound as an acyl group in glycerides in the starting lauric oil is less than the stated limit.
However, the specification does not describe that broader comparison. The disclosure describes a narrower comparison, namely, the amount of the fatty acid bound as an acyl group in glycerides in the final MOSH- and/or MOAH-reduced lauric oil versus the amount of the corresponding fatty acid bound as an acyl group in glycerides in the starting lauric oil. Claim 9 omits that limitation on the final oil and therefore reaches subject matter not described in the application as filed.
Hence, the specification does not show possession of the full scope of claim 9.
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 4 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 4 refers to “the fat-splitting step a).” Claim 1, however, does not define step a) as a fat-splitting step. Step a) in claim 1 is defined as transesterifying a lauric oil in the presence of an alcohol to obtain a fatty acid alkyl ester fraction and a glycerol fraction.
As claim 4 uses a different label for step a), it is unclear whether claim 4 is referring to the transesterification step set out in claim 1 or to some different step. As a result, the scope of claim 4 is unclear.
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.
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) 1-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yukio et al. (US Pat 4,303,590, hereafter US’590) in view of Busch et al. (US Pat 6,127,561, hereafter US’561) and further in view of Stage (US Pat. 4,599,143, hereafter US’143).
Claim 1 disclose a process for reducing MOSH and/or MOAH in lauric oil comprising: (a) transesterifying a lauric oil with an alcohol to obtain a fatty acid alkyl ester fraction and a glycerol fraction; (b) purifying the ester fraction into whole distilled lauric oil fatty acid alkyl esters; and (c) transesterifying the distilled ester fraction with glycerol to obtain a MOSH- and/or MOAH-reduced lauric oil.
US’590 discloses the preparation of lower alkyl esters of fatty acids by alcoholysis of naturally occurring fats and oils with a lower alcohol. The alcoholysis reaction produces lower alkyl esters and glycerine (col. 1, lines 50–60; col. 3, lines 1–10). Also disclosed are suitable naturally occurring oils include coconut oil and palm kernel oil (col. 3, lines 11–18), which are recognized lauric oils, and that lower alcohols such as methyl alcohol and ethyl alcohol are suitable for the reaction (col. 3, lines 25–30). Additionally, US’590 discloses that the ester product obtained from the alcoholysis reaction may be purified and that purification may include rectification distillation of the ester fraction (col. 1, lines 63–68; col. 4, lines 5–15).
This reads on step (a) of claim 1, namely transesterifying a lauric oil in the presence of an alcohol to obtain fatty acid alkyl esters and glycerol, and also teach purification of the ester fraction by distillation as required by step (b).
US’561 discloses glycerolysis of fatty acid methyl esters derived from vegetable or animal fats and oils. US’561 explains that methyl esters may be reacted with glycerol to form glycerides, including mono-, di-, and triglycerides (col. 1, lines 20–30; col. 2, lines 10–20). Furthermore, that suitable starting materials for the process include methyl esters derived from vegetable oils (col. 2, lines 30–35). Thus, US’561 discloses reacting fatty acid alkyl esters with glycerol to regenerate glyceride oil, corresponding to step (c) of claim 1.
US’143 discloses deodorizing and physically refining edible oils, fats, and esters by steam distillation under elevated temperature and reduced pressure (col. 1, lines 10–20; col. 2, lines 40–50). US’143 further discloses that this distillation refining process removes undesirable volatile materials from edible oils, fats, and esters (col. 3, lines 5–15). These teachings demonstrate that distillation of edible ester streams was a known purification technique used to remove unwanted impurities.
It would have been obvious to a person of ordinary skill in the art at the time of the invention to combine these teachings. US’590 discloses converting lauric oil feedstocks such as coconut oil into fatty acid alkyl esters and separating glycerine from the product stream (col. 3, lines 11–18; col. 1, lines 50–60). US’561 discloses reacting such fatty acid alkyl esters with glycerol to form glycerides (col. 1, lines 20–30). US’143 discloses purification of edible ester streams by distillation to remove undesired volatile impurities (col. 3, lines 5–15). In view of these teachings, it would have been obvious to convert lauric oil into alkyl esters, purify the ester fraction by distillation, and then react the purified ester fraction with glycerol to regenerate glyceride oil. This combination merely applies known processing steps for their established purposes.
As to the recited reduction of MOSH and/or MOAH, these materials are considered hydrocarbon contaminants. US’143 discloses that distillation refining removes undesirable volatile materials from edible oils and esters (col. 3, lines 5–15). A person of ordinary skill in the art would reasonably have expected that distillation purification of the ester fraction prior to glycerolysis would remove distillable hydrocarbon contaminants from the ester stream before the oil was reconstituted. The regenerated oil would therefore have been expected to contain reduced levels of such impurities.
Claim 2 requires that the glycerol used in step (c) is obtained from the glycerol fraction of step (a) after further treatment with an adsorbent. US’590 discloses separation and recovery of glycerine from the esterification product (col. 1, lines 50–60), while US’561 discloses use of glycerol in the downstream glycerolysis reaction (col. 1, lines 20–30). Purifying recovered glycerol prior to reuse would have been an obvious matter of routine process optimization.
Claim 3 requires that the lauric oil used in step (a) is degummed, neutralized, bleached, and/or deodorized. US’143 discloses refining and deodorizing edible oils and esters to improve purity (col. 1, lines 10–20; col. 2, lines 40–50). Use of a conventionally refined lauric oil feedstock would therefore have been obvious.
Claim 4 recites use of degummed, neutralized, and bleached lauric oil. Such pretreatments represent standard edible-oil refining steps and would have been obvious to employ before alcoholysis.
Claim 5 recites that the lauric oil is coconut oil. US’590 expressly discloses coconut oil as a suitable starting oil for alcoholysis (col. 3, lines 11–18).
Claim 6 recites that the alcohol in step (a) is methanol, ethanol, or a mixture thereof. US’590 expressly discloses lower alcohols including methyl alcohol and ethyl alcohol for the alcoholysis reaction (col. 3, lines 25–30).
Claim 7 adds a deodorization step after step (c). US’143 expressly discloses deodorization of edible oils, fats, and esters by distillation refining (col. 1, lines 10–20; col. 2, lines 40–50).
Claim 8 requires bleaching before the deodorization step of claim 7. Bleaching and deodorization are well-known sequential refining operations in edible oil processing, as reflected in the refining teachings of US’143 (col. 1, lines 10–20).
Claim 9 requires that, for selected fatty acids, the percentual difference between the amount present in the final lauric oil and the amount bound as acyl groups in the starting lauric oil is less than 10%, less than 5%, or less than 2%. US’590 converts the fatty acid glycerides of the starting oil into lower alkyl esters (col. 1, lines 50–60), and US’561converts such esters back into glycerides through reaction with glycerol (col. 1, lines 20–30). Because the same fatty acid moieties are carried through the esterification and glycerolysis sequence, preservation of fatty acid distribution would have been expected absent significant side reactions. The claimed deviation therefore represents an inherent result of the combined process or, at most, routine optimization of known processing conditions.
It would have been obvious to combine the teachings of US’590, US’561, and US’143 to arrive at the claimed process. US’590 teaches transesterifying lauric oils with lower alcohols to form fatty acid alkyl esters and glycerol and further teaches purification of the ester product by distillation. US’561teaches reacting fatty acid alkyl esters with glycerol to form glycerides. US’143 teaches refining edible esters by distillation to remove volatile impurities. A skilled artisan would therefore have found it obvious to distill the ester fraction produced from lauric oil and then convert the purified esters back to glycerides using glycerol.
This combination represents the predictable use of known processing steps according to their established functions. As explained in KSR Int’l Co. v. Teleflex Inc., when a claimed invention simply arranges familiar elements using known methods to yield predictable results, the claim is unpatentable under §103. The claimed process merely applies known esterification, purification, and glycerolysis steps in sequence, with the expected result of obtaining a purified regenerated oil.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEBORAH D CARR whose telephone number is (571)272-0637. The examiner can normally be reached Monday-Friday (10:30 am -6:30 pm).
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/DEBORAH D CARR/ Primary Examiner, Art Unit 1691