DETAILED ACTION
Applicant’s amendment submitted 5/13/2026 is acknowledged. Claims 1-13, 16, and 19-20 are currently amended. Claims 14-15 are canceled. Claims 16-18 remain withdrawn pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention. Claims 1-13 and 16-20 are pending in the instant application.
Claims 1-13 and 19-20 are the subject of this office 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
The instant application claims the benefit of priority to foreign Application No. EP17203622.0 filed at the European Patent Office on 24 November 2017. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55 and the claim to the benefit of priority is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/20/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
Applicant’s amendment to claims 1-13 and 19-20 to recite “slurry or suspension” overcomes the 35 U.S.C. 112(b) rejection previously set forth in the Non-Final Rejection mailed 11/14/2025. Accordingly, the rejection is withdrawn.
Applicant’s amendment to claim 11 to delete the recitation of “having a Dextrose Equivalent (DE) between 6 and 52” overcomes the 35 U.S.C. 112(b) rejection previously set forth. Accordingly, the rejection is withdrawn.
Applicant’s amendment to claim 13 to now recite “wherein the enzyme particles are prepared by spray drying or absorption, followed by drying” overcomes the 35 U.S.C. 112(b) rejection previously set forth. Accordingly, the rejection is withdrawn.
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.
Maintained Rejection: Claims 1-13 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Macario et al. (Catalysis Today, 2013, Vol. 204, p.148-155; of record) in view of Negishi et al. (US2008/0102500; of record) and Mazeaud et al. (WO2009/010561; of record in IDS filed 5/21/2020) as evidenced by Etale et al. (Chem. Rev., 2023, Vol. 123, p.2016-2048; of record).
Regarding claims 1-7 and 9-12, Macario teaches a hybrid nanosphere that comprises an organic and inorganic phase (see Abstract, p.149, left column, 4th-5th paragraphs, and Figs. 1 and 6). The organic phase comprises liposomes formed by lecithin (fat), and Rhizomucor miehei lipase (lipolytic enzyme as recited in claim 12) (see Abstract, p.149, left column, last paragraph, and right column, 1st-2nd paragraphs). The inorganic phase is comprised of porous silica (siliceous material in claim 7) and covers and stabilizes the organic phase (see Abstract, p.149, right column, 3rd paragraph, and Fig. 1). The hybrid nanospheres are formed in a homogenized suspension and then dried (equivalent to a powder and suspension comprising a plurality of enzyme particles, wherein each of said particles comprise as a homogenous mixture) (see p.149, right column, 3rd paragraph). The hybrid nanospheres that Macario teaches necessarily have an average diameter that is below 100 μM (see p.151, right column, last paragraph, and Figs. 6-9). Macario discloses various ratios of lecithin (i.e. fat), lipase (i.e. lipolytic enzyme), and silica (i.e. siliceous material) used to form hybrid nanospheres in Table 1 (see p.149, right column, 1st-3rd paragraphs). LL1 of Table 1 discloses a 21.15% w/w of a lipolytic enzyme (21.15 = 100 * 0.236 g of lipase /1.116 g total), 39.43% w/w of a siliceous material (39.43 = 100 * 0.44 g silica/1.116 g total), and 39.43% w/w of fat (39.43 = 100 * 0.44 g lecithin/1.116 total), which are within the ranges recited in claims 1, 2, and 6. Macario further tests the hybrid nanoparticles in transesterification reactions of triolein with methanol to methyl esters, typical biodiesel mixture compounds (see Abstract, p.149, right column, 4th paragraph-p.150, left column, last passage, p.153, left column, 1st paragraph-p.154, left column, 3rd paragraph, and Figs. 10-14). Macario further teaches enzyme active compounds are encapsulated and retain their activity for at least 5 reaction cycles, reading on wherein said particles are encapsulated in said oil or fat (see Abstract, p.149, left column, 4th paragraph, right column, 1st paragraph, p.150, right column, 1st paragraph, p.151, left column, 2nd paragraph, right column, 2nd paragraph, paragraph bridging pp.154-155, Figs. 1 and 6, and Table 2).
Macario does not teach 10-80% w/w of an organic filter aid and 2-50% w/w of a water-soluble polyol selected from carbohydrates and sugar alcohols.
Negishi teaches lipase powder compositions comprising a filter aid and in which the lipase is immobilized to a silica carrier (see Abstract and paragraphs [0012-[0016]). Negishi teaches the inclusion of filter aids with pulverized lipase in the lipase powder improves the lipase activity and operability in methods for exchanging esters of fats and oils and for esterification (see Abstract and paragraphs [0016], [0030]-[0031], Examples 1-8 and Tables 1-2). Negishi further teaches cellulose is the most preferrable organic filter aid and demonstrates its use in the lipase powders tested in the Examples, reading on claim 9 (see paragraph [0022]). Negishi further teaches the mass ratio of the lipase pulverized product (i.e. lipase immobilized to silica carrier) to the filter aid(s) is preferably 1/10 to 10/1 and more preferably 1/7 to 2/1 (see paragraph [0023]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have further included cellulose filter aid, as taught by Negishi, in the hybrid nanosphere of Macario, to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to include a cellulose filter aid to improve the lipase activity and operability in ester exchange and esterification reactions as taught by Negishi. One of ordinary skill in the art would have had a reasonable expectation of success because each of Macario and Negishi are drawn to lipase-silica powder compositions for esterification reactions. It would have further been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have routinely optimized the amount of cellulose filter aid in the modified hybrid nanosphere of Macario based on the recommended mass ratios suggested by Negishi and to arrive within the mass ratios of claims 1, 3, and 4.
Macario and Negishi do not teach a water-soluble polyol selected from carbohydrates and sugar alcohols.
Mazeaud teaches the addition of a soluble polyol such as a carbohydrate or sugar alcohol significantly improves the performance of immobilized lipolytic enzyme product with regard to initial enzyme activity, enzyme stability, i.e., half-life, and/or enzyme productivity (see Abstract, p.2, 2nd paragraph, p.3, 1st paragraph, p.16, 3rd paragraph, p.17, last paragraph, p.19, p.20, and p.22, 1st paragraph). Mazeaud discloses suitable polyols that include dextrin, maltodextrin, trisaccharides, disaccharides, monosaccharides, and combinations of the exemplified polyols, reading on claim 10 (see p.3, 3rd-7th paragraphs). Mazeaud further teaches the polyol is used in the particles of the invention in an amount of 2% to 75% by weight, which overlaps the ranges recited in claims 1 and 5 (see p.3, 5th paragraph). Mazeaud specifically demonstrates the use of maltodextrin (Maltrin® M200) having a DE of 20-23 in combination with a lipase immobilized on a silica-based carrier in Examples 2, 4-7, and 9-14, reading on claim 11.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have further included the maltodextrin polyol, Maltrin® M200, at a mass ratio of 2 to 75% as taught by Mazeaud, in the modified hybrid nanosphere comprising liposome, lipase, cellulose, and silica, as taught by Macario in view of Negishi, to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to include a maltodextrin polyol in an immobilized lipase composition as taught by Macario in view of Negishi since Mazeaud teaches the addition of a soluble polyol significantly improves the performance of immobilized lipolytic enzymes, including lipases, with regards to initial enzyme activity, enzyme stability, i.e., half-life, and/or enzyme productivity, yielding predictable results. One of ordinary skill in the art would have had a reasonable expectation of success because each of Macario, Negishi, and Mazeaud are drawn to immobilized lipase-silica carrier compositions.
Regarding claims 8 and 19, Negishi teaches a cellulose filter aid as set forth in the rejection of claim 1 above. Cellulose is a water-insoluble polysaccharide comprising β(1→4) glycosidic bonds, as evidenced by Etale et al. (see Abstract and p.2017, left column, 1st passage).
Regarding claim 13, the limitations “prepared by spray drying or absorption, followed by drying” recited render claim 13 as a product-by-process claim as set forth in MPEP § 2113(I). The hybrid nanospheres powder and suspension of Macario in view of Negishi and Mazeaud render obvious the product of claim 1 as set forth in the rejection above, and thereby read on the product produced by the process of claim 13. Moreover, Mazeaud discloses an embodiment in which lipase, water, and maltodextrin were stirred, applied uniformly onto a carrier using continuous mixing, reading on a homogenous suspension (see Example 2, p.14, lines 30-p.15, line 8). An atomizing nozzle was used to distribute the liquid over the carrier, reading on spray drying. The moist carrier particles were then dried in a fluidized bed. Thus, one of ordinary skill in the art would have found it obvious to produce dried carrier-immobilized lipase compositions by spray drying a homogenous mixture of the lipase composition followed by drying, as it was a recognized technical practice in the relevant field, yielding predictable results.
Thus, claims 1-13 and 19 are prima facie obvious over Macario in view of Negishi and Mazeaud as evidenced by Etale.
Maintained Rejection: Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Macario et al. (Catalysis Today, 2013, Vol. 204, p.148-155; of record) in view of Negishi et al. (US2008/0102500; of record) and Mazeaud et al. (WO2009/010561; of record in IDS filed 5/21/2020) as evidenced by Etale et al. (Chem. Rev., 2023, Vol. 123, p.2016-2048; of record), as applied to claims 1-13 and 19 above, and further in view of Tan et al. (Molecul. Pharmac., 2010, Vol. 7(2), p.522-532; of record).
Macario in view of Negishi and Mazeaud teach the invention of claim 1 as outlined in the rejection above.
Regarding claim 20, Macario does not teach an average diameter of 1-60 μM.
Negishi teaches an average particle diameter of 1-300 μM (see Abstract and paragraph [0016] and [0021]).
Mazeaud teaches the particle of their disclosed invention may have a size of 50-2000 μM (see p.3, 2nd paragraph).
Tan teaches silica-lipid hybrid microcapsules having an average size of 2-5 μM and no larger than 10 μM produced by spray-drying an emulsion composition comprising silica and lipid (see Abstract and p.526, left column, 1st-2nd paragraph, and Fig. 1).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have produced a powder of homogenous in lipase, silica, cellulose, maltodextrin, and liposome, as taught by Macario in view of Negishi and Mazeaud, with an average size of 2-5 μM and no larger than 10 μM by using the spray-drying method of producing silica-lipid hybrid microparticles, as taught by Tan, to arrive at the claimed invention. One of ordinary skill in the art would have recognized that Negishi, Mazeaud, and Tan demonstrate the variability in particle sizes that can be achieved through routine experimentation. One of ordinary skill in the art looking specifically to Tan would recognize that silica-lipid hybrid particles, like those of Macario, can be altered in size according to production technique, yielding predictable results and a reasonable expectation of success within the relevant field.
Thus, claim 20 is prima facie obvious over Macario in view of Negishi, Mazeaud, and Tan.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Maintained Rejection: Claims 1-13 and 19-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 18-30 and 32-33 of copending Application No. 17/614,837 in view of Mazeaud et al. (WO2009//010561; of record in IDS filed 5/21/2020) and Macario et al. (Catalysis Today, 2013, Vol. 204, p.148-155; of record).
Claim 18 of the copending application recites a plurality of enzyme particles, wherein said particles comprise as a homogenous composition: 1-50% w/w of an immobilized lipolytic enzyme, 10-80% w/w of a hydrophobic polymer, 10-80% w/w of an organic filter aid, and 2-50% w/w of a water-soluble polyol selected from carbohydrates and sugar alcohols, wherein the particles comprise the hydrophobic polymer, and the organic filter aid in a total amount of 40-95% w/w. Claim 20 recites the plurality of enzyme particles of claim 18, wherein the organic filter aid is in an amount of 20-60% w/w. Claim 22 recites the plurality of enzyme particles of claim 18, wherein the polyol is in an amount of 5-25% w/w. Claim 23 recites the plurality of enzyme particles of claim 18, wherein the lipolytic enzyme in an amount of 2-25% w/w. Claim 25 recites the plurality of enzyme particles of claim 18, wherein the organic filter aid is a water-insoluble polysaccharide. Claim 26 recites the plurality of enzyme particles of claim 25, wherein the water-insoluble polysaccharide comprises beta(1-4) glycosidic bonds. Claim 27 recites the plurality of enzyme particles of claim 18, wherein the organic filter aid is cellulose. Claim 28 recites the plurality of enzyme particles of claim 18, wherein the polyol is selected from the group consisting of dextrin, maltodextrin, trisaccharides, disaccharides, monosaccharides, and mixtures thereof. Claim 29 recites the plurality of enzyme particles of claim 18, wherein the polyol is maltodextrin or glucose syrup having a DE between 6 and 52. Claim 30 recites the plurality of enzyme particles of claim 18, wherein the lipolytic enzyme is a lipase. Claim 32 recites the plurality of enzyme particles of claim 18, wherein said particles have an average diameter below 100 μM. Claim 33 recites the plurality of enzyme particles of claim 18, wherein said particles have an average diameter of 1-60 μM.
The copending claims do not recite the enzyme particles comprise a siliceous material as recited in instant claim 1, the weight concentration of the siliceous material as recited in instant claims 1-2, at least 10% w/w oil or fat as recited in instant claim 1, the combined weight concentration of the siliceous material and the organic filter aid as recited in instant claim 4, or wherein said particles are encapsulated in said oil or fat.
Mazeaud discloses enzymes are generally immobilized onto a particle. Immobilization facilitates re-use of the enzymes, and may affect the selectivity and stability of the enzyme (see p.1, lines 16-18). Mazeaud further discloses the particle carrier is silica (see Claim 3). The silica carrier was suspended in the solution and the carrier to liquid ratio of 1:5 (w/w) was used (see p.20, lines 1-5).
Macario further teaches a hybrid nanosphere that comprises an organic and inorganic phase (see Abstract, p.149, left column, 4th-5th paragraphs, and Figs. 1 and 6). The organic phase comprises liposomes formed by lecithin, reading on fat, and Rhizomucor miehei lipase, reading on lipolytic enzyme and claim 12 (see Abstract, p.149, left column, last paragraph, and right column, 1st-2nd paragraphs). The inorganic phase is comprised of porous silica and covers and stabilizes the organic phase, reading on a siliceous material and claim 7 (see Abstract, p.149, right column, 3rd paragraph, and Fig. 1). The hybrid nanospheres are formed in a homogenized suspension and then dried, reading on both a powder and suspension comprising a plurality of enzyme particles, wherein each of said particles comprise as a homogenous mixture (see p.149, right column, 3rd paragraph). The hybrid nanospheres that Macario teaches necessarily have an average diameter that is below 100 μM (see p.151, right column, last paragraph, and Figs. 6-9). Macario discloses various ratios of lecithin (i.e. fat), lipase (i.e. lipolytic enzyme), and silica (i.e. siliceous material) used to form hybrid nanospheres in Table 1 (see p.149, right column, 1st-3rd paragraphs). LL1 of Table 1 discloses a 21.15% w/w of a lipolytic enzyme (21.15 = 100 * 0.236 g of lipase /1.116 g total), 39.43% w/w of a siliceous material (39.43 = 100 * 0.44 g silica/1.116 g total), and 39.43% w/w of fat (39.43 = 100 * 0.44 g lecithin/1.116 total), which are within the ranges recited in claims 1, 2, and 6. Macario further tests the hybrid nanoparticles in transesterification reactions of triolein with methanol to methyl esters, typical biodiesel mixture compounds (see Abstract, p.149, right column, 4th paragraph-p.150, left column, last passage, p.153, left column, 1st paragraph-p.154, left column, 3rd paragraph, and Figs. 10-14). Macario further teaches enzyme active compounds are encapsulated and retain their activity for at least 5 reaction cycles, reading on wherein said particles are encapsulated in said oil or fat (see Abstract, p.149, left column, 4th paragraph, right column, 1st paragraph, p.150, right column, 1st paragraph, p.151, left column, 2nd paragraph, right column, 2nd paragraph, paragraph bridging pp.154-155, Figs. 1 and 6, and Table 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the plurality of enzyme particles recited in the copending claims to further comprise silica and liposome, because Mazeaud discloses immobilization of enzymes onto particles, such as silica, facilitate re-use of the enzymes, and may affect the selectivity and stability of the enzyme by encapsulating in the liposomes and hybrid silica particles, as taught by Macario, were a known technical practice in the relevant field. It would have been further obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the weight concentrations of the siliceous material, the combined weight concentration of the siliceous material and the organic filter aid by routine experimentation based on the ranges recited in Macario and Mazeaud, to arrive at the claimed invention.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 5/13/2026 have been fully considered but they are not persuasive.
In Applicant’s Remarks, see p.6, 2nd paragraph, Applicant argues the office reconstructs the invention by selecting elements form the cited references directed to materially different particle architectures and uses. Applicant submits that Macario identifies a liposome/silica hybrid, while the cited passages from Negishi identify a powder composition made by combining a pulverized immobilized lipase with a filter aid. Applicant argues the combination of Mazeaud, Negishi, and Maas, fails to teach or suggest the amended claims. This is not found persuasive. The rejection combines Macario, Mazeaud, and Negishi as evidenced by Etale. Maas is not relied upon in the rejection. Applicant has not specifically pointed to why the combination of cited art fails to teach or suggest the claimed invention as amended. Encapsulation in the liposomes is specifically taught by Macario, which teaches enzyme active compounds are encapsulated and retain their activity for at least 5 reaction cycles, reading on wherein said particles are encapsulated in said oil or fat (see Abstract, p.149, left column, 4th paragraph, right column, 1st paragraph, p.150, right column, 1st paragraph, p.151, left column, 2nd paragraph, right column, 2nd paragraph, paragraph bridging pp.154-155, Figs. 1 and 6, and Table 2). Furthermore, one of ordinary skill in the art would have had a reasonable expectation of success combining the cited art because each of Macario, Negishi, and Mazeaud are drawn to immobilized lipase-silica carrier compositions. Thus, each of the cited art are considered to be directed to the same technical field.
Applicant essentially requests that the double patenting rejection over co-pending application 17/614,837 be held in abeyance (Remarks p.7, 3rd-4th paragraphs). A request to hold a rejection in abeyance is not a proper response to a rejection. Rather, a request to hold a matter in abeyance may only be made in response to an OBJECTION or REQUIREMENTS AS TO FORM (see 37 CFR 1.111(b) and MPEP § 714.02). Thus, the double patenting rejections of record are still applicable as no response to these rejections has been filed by Applicant at this time. Claims 1-13 and 19-20 are provisionally rejected on the ground of nonstatutory double patenting.
Conclusion
THIS ACTION IS MADE FINAL. 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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/J.P.S./Examiner, Art Unit 1651
/MELENIE L GORDON/Supervisory Patent Examiner, Art Unit 1651
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