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 .
Response to Amendment
This action is written in response to applicant’s amendments received on 12/15/25.
The rejection of claim 29 under 35 USC 112(b) is overcome by amendment.
Any objections or rejections not reiterated herein have been overcome by amendment.
Amended claims 18-30, and 32-33 are under examination herein.
Specification
The use of the term Lanxess ([0154]) and Lédige ([0155-0156]), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 USC § 103
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.
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 Rejections - 35 USC § 103
Claims 18, 20-23, 25-29, 30 and 32-33 are rejected under 35 U.S.C. 103 as being unpatentable over Macario ("Pure silica nanoparticles for liposome/lipase system encapsulation: Application in biodiesel production." Catalysis Today 204 (2013): 148-155), Mazeaud (of record) and Negishi (of record).
Regarding claims 18, 20-23, 27, and 30 Macario teaches immobilized lipase nanospheres (plurality of particles) (abstract). Macario teaches the nanoparticles are homogenous (2.2. Synthesis of hybrid nanospheres). Macario teaches LL1 of Table 1 discloses 21.15% w/w of a lipolytic enzyme (21.15 = 100 * 0.236 g of lipase /1.116 g).
Marcario does not explicitly teach the hydrophobic polymer, organic filter aid, or water soluble polyol.
Mazeaud teaches an immobilized enzyme product (p1 lines 1-4). Mazeaud teaches the immobilized enzyme product can be particles (abstract). Mazeaud teaches multiple particles (plurality) (p2 lines16-19). Mazeaud teaches that the enzyme product comprises a lipolytic enzyme and a soluble polyol selected from carbohydrates and sugar alcohols (claim 1). Mazeaud further teaches that the polyol can be maltodextrin (claim 7). Mazeaud further teaches the product can comprise a hydrophobic polymer including divinylbenzene (p5 lines 1-11). Mazeaud teaches the lipolytic enzyme can be lipase (p5 line 27). Mazeaud teaches their product results in increased enzyme stability during application (p2 lines 22-23). Mazeaud teaches that these additives significantly improve enzyme performance (abstract). Mazeaud teaches that the polyol by weight can be present in the range of 2-75% of the particle (p3 lines 22-24). This fully encompasses the claimed range and thus is prima facia obvious.
Macario and Mazeaud do not teach the organic filter aid.
Negishi teaches powdered, immobilized lipase compositions (abstract). This composition comprises a filter aid ([0015]). Negishi teaches that the addition of the filter aid improves the activity of the lipase ([0012 and 0015]). Negishi teaches the filter aid can be an organic filter aid, namely cellulose ([0022]). Negishi teaches the lipase- organic filter aid mass ratio can be in the range of 1/10 to 10/1 (~9%-~90%) ([0023]). The range of Negishi fully encompasses the claimed range and thus is prima facia obvious. Negishi teaches the lipase- organic filter aid mass ratio can be in the range of 1/10 to 10/1 (~9%-~90%) ([0023]). The range of Negishi overlaps the claimed range and thus is prima facia obvious.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the hydrophobic polymer and water soluble polyol as taught by Mazeaud and the cellulose as taught by Negishi in the product of Macario. One of ordinary skill in the art would be motivated to do so because Mazeaud teaches the additives improve enzyme performance and Negishi teaches that the filter aid improves the activity of the immobilized lipase. Further, one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. There would be a reasonable expectation of success as Macario, Mazeaud and Negishi are in the same field of endeavor of immobilized lipase particles.
Regarding claims 25-26: Negishi does not explicitly teach that the organic filter aid comprising water-insoluble polysaccharides or beta 1-4 glyosidic bonds. As evidenced by Proteopedia, cellulose is a water insoluble polysaccharide comprising beta 1-4 glyosidic bonds (p1 first full paragraph).
Regarding claim 28, Mazeaud teaches the polyol can be maltodextrin (p3 lines 11-12).
Regarding claim 29, Mazeaud teaches the maltodextrin can have a DE between 20-23 (p3 lines 18-20). The range of Mazeaud overlaps the claimed range and thus is prima facia obvious.
Regarding claims 32-33, Negishi teaches that their composition has a particle diameter of 1-300 µm (abstract). The range of Negishi fully encompasses the claimed range and thus is prima facia obvious.
Claims 19, 21, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Macario ("Pure silica nanoparticles for liposome/lipase system encapsulation: Application in biodiesel production." Catalysis Today 204 (2013): 148-155), Mazeaud (of record) and Negishi (of record) as applied to claims 18, 20, 22-23, and 25-33 above, and further in view of Schroers (of record).
Regarding claims 19 and 24, Macario, Mazeaud and Negishi do not teach methacrylic acid and the weight range of the hydrophobic polymer.
Schroers teaches a process for creating microparticles comprising enzymes (abstract). Schroers teaches that immobilized lipases can be utilized in their invention ([0013-0014 and 0180]). Schroers teaches that the microparticle can comprise a wall ([0140], claim 15). Schroers teaches the wall is preferentially made from ethylenically unsaturated monomers ([0140]). Schroers teaches that methacrylic acid is a preferred ethylenically unsaturated monomers ([0141], claim 29). Schroers teaches that the weight of the wall to the polyester is 1:5-10:1 (~16%-~90%) ([0154]). The range of Schroers overlaps with the claimed range and thus is prima facia obvious. Schroers teaches that the inclusion of a wall component is advantageous in slowing the release rate of the contents of the microparticle in addition to increasing the stability of the microparticle ([0177]).
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 composition of Mazeaud and Negishi as discussed above and incorporate a wall component of methacrylic acid as taught by Schroers. One of ordinary skill in the art would be motivated to do so because Schroers teaches that wall components increase stability and slow the release rate of the particles. Further, Schroers teaches methacrylic acid is a preferred component in the wall. There would be a reasonable expectation of success as Mazeaud, Negishi and Schroers are in the same field of endeavor of immobilized enzymes.
Regarding claim 21, Negishi teaches that the organic filter aid can be in the range of (~9%-~90%) ([0023]). Schroers teaches wall in the ratio of (~16%-~90%) ([0154]). When the two ranges are combined, the range could be 25%-100% for the organic filter range and the hydrophobic polymer given the teachings of both Negishi and Schroers. This fully encompasses the claimed range and this is prima facia obvious. Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05).
Response to Arguments
Applicant’s arguments with respect to claims 18-30 and 32-33 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TREVOR L KANE whose telephone number is (571)272-0265. The examiner can normally be reached M-F 7:00 am-4:00pm.
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/TREVOR KANE/Examiner, Art Unit 1657
/ROBERT J YAMASAKI/Primary Examiner, Art Unit 1657