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 .
Status of the Claims
Claims 1-15 are pending. Claims 13-15 stand withdrawn without traverse.
Claims 1-12 are under current examination.
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 5 and 12 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 5, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 12, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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.
Claims 1-3, 5, and 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over Rozen et al. (US 2007/0281993; publication date: 12/06/2007; of record) in view of Bosley et al. (US 5,773,266; issue date 06/30/1998; of record) and further in view of Feng et al. (US 2003/0180780; publication date: 09/25/2003; of record).
In para 0118, Rozen discloses a method of immobilizing an enzyme, specifically lipase, by providing a slurry (i.e. providing a suspension per instant claim 1(a)) of support matrix (e.g. silica) followed by exposing the support matrix to the enzyme to immobilize (i.e. immobilizing a functional constituent on the solid carrier per instant claim 1(b)), then filtering (i.e. isolating per instant claim 1(d)) the immobilized enzyme. The immobilized enzyme is then either freeze dried or used wet and added to a biphasic system comprising olive oil and buffer solution, followed by filtration, and washing with cold acetone (per instant claim 1(e)). The immobilized enzyme is then dried in a desiccator. It would necessarily be isolated before or during this drying step (per instant claim 1(f)).
Rozen does not disclose, in this one example, a step of forming a protective layer on the surface of the solid carrier to protect the functional constituent immobilized on the solid carrier; however, Rozen discloses that the lipase can be immobilized on particulate hydrophobic support containing surfactant prepared according to US Pat No 5,773,266 (i.e. Bosley, noted in the rejection statement above).
Bosley discloses immobilizing lipase on a hydrophobic support with an aqueous solution of lipase and a non-ionic surfactant (abstract). The support can be silica (col 4, lines 12-14). The esterification activity (i.e. enzymatic activity of the lipase) was only observed when the surfactant was present (i.e. the surfactant protects the enzyme in the sense that the enzymatic activity is preserved after immobilization on the support). As the support is solid, the surfactant would form a layer over the solid support. In an example, Bosley discloses providing a solid support (Accurel EP10) in phosphate buffered saline containing surfactant followed by incubation for 16 hours then adding the lipase to immobilize it (col 7, Example VIII). Thus, Bosley discloses a method of immobilizing an enzyme on a solid carrier by providing a suspension of the carrier, and exposing the carrier suspension to the enzyme to immobilize it, and also discloses a step of forming a protective layer over the solid carrier (claim 1(c)). The examiner notes that Bosley discloses these steps (immobilizing the enzyme and exposing the solid support/enzyme to a surfactant) may happen in any sequence or simultaneously (col 1, lines 60-66).
It would have been prima facie obvious to use the particles of immobilized lipase on a solid support formed by Bosley’s method because Rozen discloses this to be included in their invention.
Thus, Rozen/Bosley render obvious a method of producing a composition, the composition comprising a solid carrier, a functional constituent and a protective layer to protect the functional constituent, the method comprising the following steps: (a) providing a suspension of a solid carrier; (b) immobilizing a functional constituent on the solid carrier; (c) forming a protective layer on the surface of the solid carrier to protect the functional constituent immobilized on the solid carrier; (d) isolating the solid carrier comprising the functional constituent protected by the protective layer from the suspension; (e) washing the solid carrier comprising the functional constituent protected by the protective layer in an organic solvent; and (f) isolating the solid carrier comprising the functional constituent protected by the protective layer from the organic solvent suspension.
Neither Rozen nor Bosley expressly describe “resuspending” the solid carrier particles in the organic solvent.
Feng discloses that resuspension was a known method to wash particles (0052).
It would have been prima facie obvious to wash the immobilized enzyme in Rozen’s method by resuspending in the acetone because this would have been applying a known technique to a known product to yield predictable results (see MPEP 2143(D)).
With respect to claim 2, as noted above, Rozen discloses drying the enzyme immobilized on the solid support after exposure to acetone (the organic solvent).
With regard to claim 3, the solid support is suspended in a phosphate buffer in both of Rozen’s and Bosley’s method (col 7, example VIII).
With regard to claim 5, as noted above, the functional component is the enzyme, lipase.
With regard to claims 8-10, as noted above, the solvent is acetone.
With regard to claim 11, as noted above, the particles are silica.
Claims 4, 6, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Rozen et al. (US 2007/0281993; publication date: 12/06/2007; of record), Bosley et al. (US 5,773,266; issue date 06/30/1998; of record) and Feng et al. (US 2003/0180780; publication date: 09/25/2003; of record) as applied to claims 1-3, 5, and 8-11 above, and further in view of Shahgaldian et al. (US20160168559; publication date: 06/16/2016).
The relevant disclosures of Rozen, Bosley, and Feng are set forth above. None of these references disclose that the protective layer is formed from both structural and protective building blocks, wherein the structural building blocks are precursors of inorganic silica capable of forming 4 covalent bonds in the layer formed and the protective building blocks are organosilanes; embedding from 50 to 100% of the functional constituent; or modifying the polarity of the solid carrier prior to instant step (e), as required by instant claims 4, 6, and 7, respectively.
Shahgaldian discloses a method of immobilizing an enzyme on the surface of silica particles followed by coating the particles and enzymes with a protective layer formed from mixtures such as structural building blocks (e.g. tetraethylorthosilicate (TEOS)) and protective building blocks including 3-Aminopropyltriethoxysilane (APTES) (0111). These substances are the same structural and protective building blocks employed in the instant invention (see instant specification, page 9 and TEOS is capable of forming 4 covalent bonds as required by the instant claims). The protective layer can coat 100% of the enzyme (Figures 1A&B, drawing sheet 1). More specifically, as the thickness of the layer may be one of the properties controlled more precisely, burying large amounts of functional components (constituents) too deep within the layer to be reached by target molecules can be avoided hence making better use of the functional constituents used in the production of the composition. The control over thickness thus gives the possibility of obtaining a final protective layer that has about the size of the larger enzyme axis (0054). Shahgaldian discloses further that a main disadvantages of the enzyme immobilization on silicate materials is the low porosity of the silica-gel or the molecules/enzyme packing within the mesopore channels, thereby resulting in a catalytic activity lower than that of free enzymes (0033). Shahgaldian discloses that their invention provides for a polymer building reaction and so a polymer is created around the functional constituent the monomers are closely arranged around the functional constituent [i.e. the enzyme] due to the additional interaction therewith (0049), resulting in superior protection and enzymatic activity to enzymes immobilized on solid particles without the additional protective layer.
It would have been prima facie obvious to form a protective coating over Rozen’s enzyme immobilized onto silica particles according to the method disclosed by Shahgaldian. The skilled artisan would have been motivated to do so in order to further improve enzyme stability and activity and had reasonable expectation of success because Shahgaldian provides step by step instructions on how to do so for a very similar system.
With regard to instant claim 7, Shahgaldian method includes incubating the particles with the building block n-octyltriethoxysilane (0108) by polycondensation of silane building-blocks around both immobilized enzymes and free surface of the SNPs to yield a protective layer (0255), which modifies the polarity of the silica particle in the instant invention (see e.g. pages 5 and 9 of the instant specification).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Rozen et al. (US 2007/0281993; publication date: 12/06/2007; of record), Bosley et al. (US 5,773,266; issue date 06/30/1998; of record) Feng et al. (US 2003/0180780; publication date: 09/25/2003; of record), and Shahgaldian et al. (US20160168559; publication date: 06/16/2016) as applied to claims 1-11 above, and further in view of Rashid et al. (Food Sci Biotechnol (2018) 27(6):1701-1718).
The relevant disclosures of Rozen, Bosley, Feng, and Shahgaldian are set forth above. None of these references disclose incubating the suspension obtained in step (e) for 5 to 48 hours.
Rashid, in the analogous art of lipase immobilization on solid supports, discloses that precipitating lipase onto the support is a simple and effective method to immobilize lipase resulting in higher loading capacity and that this is accomplished by incubating a lipase solution with the support in the presence of acetone (page 1710, para bridging left and right columns).
It would have been prima facie obvious to extend the duration by which the lipase and support are exposed to acetone in Rozen’s method. The skilled artisan would have been motivated to do so in order to increase precipitation onto the support. The artisan of ordinary skill would have had reasonable expectation of success because this had been disclosed as an effective method to improve lipase adherence to the support by Rashid. With regard to the duration of time that the precipitation is allowed to proceed, the examiner considers this limitation to have been a matter of routine optimization for one of ordinary skill. See MPEP 214.05(II)(A).
Response to Arguments
Applicant's arguments filed 11/11/2025 have been fully considered but they are not persuasive.
On page 8, Applicant argues that Rozen is primarily concerned with the composition and use of structured triglycerides, which incorporate medium, long, and very long chain fatty acids in defined positions on the glycerol backbone for parenteral nutrition emulsions and does not disclose the formation of a protective layer on the surface of the solid carrier to protect the functional constituent immobilized on the solid carrier, as recited in step (c) of the present application and also cannot teach step (e) because step (e) requires the presence protective layer.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The prior art in combination renders obvious adding a step of forming a protective layer.
On page 9, Applicant summarizes findings of Bosley with regard to the benefits of a surfactant coating layer (which falls within the scope of the instant protective layer in the instant invention, as claimed). Applicant argues that the specific non-ionic surfactants are essential for enabling proper immobilization and functional loading of lipases onto the described supports. Applicant argues that the surfactants facilitate enzyme immobilization rather than as a protective agent therefore Bosley does not disclose, teach, or suggest a "protective layer on the surface of the solid carrier to protect the functional constituent immobilized on the solid carrier", as recited by claim 1.
The examiner respectfully disagrees with Applicant’s interpretation of the scope of the term “protective”. As the activity of the enzyme is improved when surfactant is present, the activity is protected.
On page 9, Applicant argues that the Examiner fails to identity any adequate rationale or motivation in the art to combine the cited references to arrive at the presently claimed invention. The mere fact that references can be combined or modified does not render the resultant combination obvious unless the prior art also suggests the desirability of the combination, citing In re Mills. On pages 9-10, Applicant argues that one of ordinary skill would not have been motivated to perform a subsequent washing step in an organic solvent, such as acetone, as described by Rozen. This is because Bosley clearly describes that the presence of the non-ionic surfactant is essential for achieving and maintaining lipase activity on hydrophobic supports. A person of ordinary skill in the art would reasonably expect that washing the surfactant-coated particles in an organic solvent could remove the surfactant, potentially leading to a loss of enzyme activity. Consequently, there would be no incentive, motivation, or reason to apply an organic solvent washing step to the immobilized enzymes of Bosley.
The examiner respectfully disagrees with the statement that no motivation to combine references was supplied in the rejection. The reasoning is laid out in the rejection: Bosley is specifically cited by Rosen as a method to make the immobilized enzyme particles for their invention. Thus, the artisan of ordinary skill is expressly directed to Bosley. With regard to the assertion that one having ordinary skill would have expected the acetone washing step to be incompatible with adding a surfactant according to Bosley’s method, no evidence has been supplied to support this position. The examiner maintains the opinion that one having ordinary skill would have expected the method expressly called out by Rosen to be compatible with their invention.
On page 10, Applicant argues that in Rozen, the acetone washing step is performed primarily to remove residual components of the biphasic system and other impurities, as well as to dry the immobilized enzyme and support. Rozen does not teach or suggest that this step influences enzyme activity or imparts any functional benefit beyond purification and drying. Therefore, a person of ordinary skill in the art would have had no reason or motivation to expect that washing the immobilized enzymes of Bosley in an organic solvent would have any effect other than drying the particles. This is in contrast to the presently claimed invention, which unexpectedly demonstrates that resuspending carriers comprising an enzyme protected by a protective layer in an organic solvent significantly increases enzyme activity. As shown in Examples 1 and 2, incubating protected particles in organic solvent results in a multifold improvement in enzymatic activity compared to incubation in buffer.
Insomuch as this may be an assertion of unexpected results, please refer to MPEP 716.02(b) which details the burden on Applicant to establish that results in a side-by-side comparison to the closest prior art are unexpected and significant. Specifically, Applicant must establish that differences in results are in fact unexpected and unobvious and are of both practical and statistical significance. Additionally, evidence of unexpected properties must be commensurate in scope with the claims.
As an initial matter, the examiner notes that the data provided in examples 1 and 2 of the instant specification are not commensurate in scope with the claims at least in terms of the requirement for a 12 hour incubation in solvent after step (e) and in terms of the identity of the solvent, the enzyme, and the substances used to form the coating material. The examiner notes that the comparison in the instant specification is between an enzyme immobilized on a core and protected by a coating that has been incubated in buffer for 12 hours relative to the same immobilized enzyme that has been incubated in acetone or heptane for 12 hours. Also there is no nexus between the allegedly unexpected results reported in the specification (i.e. greatly improved enzyme activity in immobilized enzymes with a protective coating that have been washed with acetone or heptane vs. those that have been washed with water) and the difference between the cited prior art and the instant invention (i.e. the presence of absence of a protective coating). As Rozen discloses washing with acetone, the associated benefit is considered inherent, absent evidence to the contrary. This position is further supported by the state of the art in general, where it appears to have been recognized that precipitating with solvent, particularly acetone, can improve enzymatic activity (see Hambarliiska et al. Bulgarian Chemical Communications 51(special issue D), pp184-188, publication year: 2019, abstract only). As such, it is unclear at this point in prosecution whether the claimed invention represents an unexpected improvement over methods of the prior art.
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 1-7 and 11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over
claims 1-15 of copending Application No. 18221195
claim 1-18 of copending Application No. 18282361
claims 1-13 and 15-17 of copending Application No. 18556287
claims 1-17of copending Application No. 18729752
claims 1-15 of copending Application No. 19113222
in view of Jiang et al (Biochemical Engineering Journal 144, pages 125-134; publication year: 2019; cited in the IDS filed 12/01/2022) and further in view of Feng et al. (US 2003/0180780; publication date: 09/25/2003; of record).
Inter alia, the claims of the copending applications embrace a method of producing a composition, the composition comprising a solid carrier, a functional constituent and a protective layer to protect the functional constituent, the method comprising the following steps: (a) providing a suspension of a solid carrier; (b) immobilizing a functional constituent on the solid carrier; (c) forming a protective layer on the surface of the solid carrier to protect the functional constituent immobilized on the solid carrier.
The claims of the applications do not recite steps of (d) isolating the solid carrier comprising the functional constituent protected by the protective layer from the suspension; (e) re-suspending the solid carrier comprising the functional constituent protected by the protective layer in an organic solvent; and (f) isolating the solid carrier comprising the functional constituent protected by the protective layer from the organic solvent suspension.
Jiang discloses that Candida antarctica lipase B (CALB) that has been immobilized on virus-like organosilica particles (abstract, page 127, left col) is more tolerant after washing with organic solvent (page 103, paragraph bridging the left and right col).
Feng discloses that resuspension was a known method to wash particles (0052).
It would have been prima facie obvious to wash the immobilized lipase of the copending applications in organic solvent. The skilled artisan would have been motivated to do so because this increases tolerance of the enzyme. The skilled artisan would have had reasonable expectation of success because Jiang demonstrates that this is possible in a comparable method of immobilizing lipase to solid supports. Additionally, it would have been prima facie obvious to wash the immobilized enzyme by resuspending in organic solvent because this would have been applying a known technique to a known product to yield predictable results (see MPEP 2143(D)). One having ordinary skill in the art would have understood that in order to resuspend a particulate composition in a different medium (e.g. aqueous medium followed by resuspension in an organic solvent), it would necessarily have been isolated, as in claim 1(d).
This is a provisional nonstatutory double patenting rejection.
Claims 8-10 and 12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over
claims 1-15 of copending Application No. 18221195
claim 1-18 of copending Application No. 18282361
claims 1-13 and 15-17 of copending Application No. 18556287
claims 1-17of copending Application No. 18729752
claims 1-15 of copending Application No. 19113222
Jiang et al (Biochemical Engineering Journal 144, pages 125-134; publication year: 2019; cited in the IDS filed 12/01/2022) and Feng et al. (US 2003/0180780; publication date: 09/25/2003; of record) as applied to claims 1-7 and 11 above, and further in view of Rashid et al. (Food Sci Biotechnol (2018) 27(6):1701-1718).
The relevant limitations of the copending applications are set forth above and do not recite a limitation on the solvent.
Rashid, in the analogous art of lipase immobilization on solid supports, discloses that precipitating lipase onto the support is a simple and effective method to immobilize lipase resulting in higher loading capacity and that this is accomplished by incubating a lipase solution with the support in the presence of acetone (page 1710, para bridging left and right columns).
It would have been prima facie obvious to incubate the particles of the copending application in acetone. The skilled artisan would have been motivated to do so in order to increase precipitation onto the support. The artisan of ordinary skill would have had reasonable expectation of success because this had been disclosed as an effective method to improve lipase adherence to the support by Rashid. With regard to the duration of time that the precipitation is allowed to proceed, the examiner considers this limitation to have been a matter of routine optimization for one of ordinary skill. See MPEP 214.05(II)(A).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-7 and 11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of copending Application No. 18709228 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims render obvious the instant claims.
Inter alia, the claims of the ‘228 application embrace a composition comprising a solid carrier wherein the surface of the solid carrier comprises an organosilane, a functional constituent, and a protective layer to protect the functional constituent. The composition is formed by the following steps: (a) providing a suspension of a solid carrier; (b) immobilizing a functional constituent on the solid carrier; (c) forming a protective layer on the surface of the solid carrier to protect the functional constituent immobilized on the solid carrier; (d) isolating the solid carrier comprising the functional constituent protected by the protective layer from the suspension; (e) re-suspending the solid carrier comprising the functional constituent protected by the protective layer in an organic solvent; and (f) isolating the solid carrier comprising the functional constituent protected by the protective layer from the organic solvent suspension. It would have been obvious to dry the immobilized functional constituent if it were not to be used immediately and to provide the suspension of carrier in an aqueous solution as this is comparable to the biological fluids in which functional constituents according to the invention are typically found.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 8-10 and 12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of copending Application No. 18709228 (reference application) as applied to claims 1-7 and 11 above, and further in view of Rashid et al. (Food Sci Biotechnol (2018) 27(6):1701-1718).
The relevant limitations of the ‘228 application are set forth above and do not recite a limitation on the solvent.
Rashid, in the analogous art of lipase immobilization on solid supports, discloses that precipitating lipase onto the support is a simple and effective method to immobilize lipase resulting in higher loading capacity and that this is accomplished by incubating a lipase solution with the support in the presence of acetone (page 1710, para bridging left and right columns).
It would have been prima facie obvious to incubate the particles of the copending application in acetone. The skilled artisan would have been motivated to do so in order to increase precipitation onto the support. The artisan of ordinary skill would have had reasonable expectation of success because this had been disclosed as an effective method to improve lipase adherence to the support by Rashid. With regard to the duration of time that the precipitation is allowed to proceed, the examiner considers this limitation to have been a matter of routine optimization for one of ordinary skill. See MPEP 214.05(II)(A).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 11/11/2025 have been fully considered but they are not persuasive.
On pages 11-12 in traversal of the double patenting rejections over the ‘195, ‘361, ‘287, ‘752, and ‘222 applications in view of Jiang and Feng, Applicant argues that Jiang demonstrates that immobilized lipases on hydrophobic virus-like organosilica nanoparticles show greater tolerance to organic solvents compared to free enzyme and in figure 7 observed improvement was typically less than 20%. Applicant argues further that there would have been no reasonable expectation of success that such systems would exhibit the dramatic enhancement in enzyme activity, 5 to 6 fold increase as demonstrated in examples 1 and 2 of the instant application.
Insomuch as this may be an assertion of unexpected results, please refer to MPEP 716.02(b) which details the burden on Applicant to establish that results in a side-by-side comparison to the closest prior art are unexpected and significant. Specifically, Applicant must establish that differences in results are in fact unexpected and unobvious and are of both practical and statistical significance. Additionally, evidence of unexpected properties must be commensurate in scope with the claims.
As an initial matter, the examiner notes that the data provided in examples 1 and 2 of the instant specification are not commensurate in scope with the claims at least in terms of the requirement for a 12 hour incubation in solvent after step (e) and in terms of the identity of the solvent, the enzyme, and the substances used to form the coating material. The examiner notes that the comparison in the instant specification is between an enzyme immobilized on a core and protected by a coating that has been incubated in buffer for 12 hours relative to the same immobilized enzyme that has been incubated in acetone or heptane. Jiang, in contrast compares the tolerance of free enzyme to that of enzyme that has been immobilized, showing improved tolerance to solvent on immobilization vs. free enzyme. The examiner does not consider the information in Jiang to address the expectedness of the results described in instant examples 1 and 2 because the questions are not related. That is to say, Jiang does not address whether incubating immobilized enzyme in an organic solvent improves enzyme activity over incubating an immobilized enzyme in buffer. As such, it is unclear at this point in prosecution whether the claimed invention represents an unexpected improvement over methods of the prior art.
On page 12, Applicant traverses the rejection over the ‘228 application by pointing out that this application is later filed than the instant application. Applicant cites MPEP 804(I)(B)(1)(b), which states that if a provisional nonstatutory double patenting rejection is the only rejection remaining in an application having the earliest effective filing date, the examiner should withdraw the rejection in the application having the earliest effective US filing date.
This comment is noted. As the nonstatutory double patenting rejection over the ‘228 application is not the only remaining rejection at this point in prosecution, the rejection is 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE PEEBLES whose telephone number is (571)272-6247. The examiner can normally be reached Monday through Friday: 9 am to 3 pm.
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/KATHERINE PEEBLES/Primary Examiner, Art Unit 1617