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 .
Election/Restrictions
Applicant’s election without traverse of claims 31-33 and 47 in the reply filed on 4/16/2026 is acknowledged.
Applicant’s election of the following species is acknowledged:
For the tetraalkoxysilane monomer recited in claim 31 having the general formula Si(OR)4 or (OR)3Si(OSi(OR)2)nOSi(OR)3
n = 0; and R is ethyl.
For the organo-alkoxysiloxane monomer recited in claim 31 having the general formula Si(OR)4-xR'x
x= 1;
R is methyl; and
R' is methyl.
For the enzyme component recited in claim 47, SEQ ID NO: 3.
Claims 1-4, 17, 20-21, 23, 27, and 51-55 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/16/2026.
In view of the prior art search, the species election is expanded to include SEQ ID NO: 5 in claim 47.
Priority
This application is a 371 of PCT/US2021/060583 (3/28/2024) which claims benefit of 63/117,648 (11/23/2021).
Information Disclosure Statement
The information disclosure statement (IDS) filed on 12/7/2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to for the following reasons:
37 CFR 1.84 states “Character of lines, numbers and letters. All drawings must be made by a process that will give them satisfactory reproduction characteristics. Every line, number, and letter must be durable, clean, black (except for color drawings), sufficiently dense and dark, and uniformly thick and well-defined.”
In the current case, the text in Figure 1 is illegible.
The drawings are objected to for the following reasons:
37 CFR 1.84(u)(1) states “View numbers must be preceded by the abbreviation “FIG.”.
In the current case, the view numbers for Figure 1 is preceded by the word “Figure” instead of the abbreviation “FIG.”. View numbers should be updated to recite the abbreviation “FIG.”. Any changes to the drawings should also be reflected in the specification.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
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 31-33 and 47 are rejected under 35 U.S.C. 103 as being unpatentable over Rambo et al., US 2013/0267004 A1 in view of Bergonzi et al., WO 2020/185861, and as evidenced by Duan et al., Langmuir; 29(20):6156-65.
Regarding claim 31, Rambo teaches a stabilized and immobilized enzyme product comprising an enzyme entrapped in a sol-gel (Rambo p. 8 para. 140, 145). The sol comprises an alkoxy silane, and/or organotrialkoxysilane, and/or a metasilicate, a poly(silicone), and an enzyme dispersed in an aqueous medium (Rambo p. 8 para. 145). Rambo teaches that the enzyme/monomer/water ratio for the sol formulation is 1:15:5, based on mass, or 0.04 wt% enzyme component (Rambo p. 20 para. 362). Rambo teaches that sol-gel derived coatings have a surface area of at least about 300 m2/g (Rambo p. 6 para. 122).
Si(OR)4 wherein R is ethyl is also known as tetraethylorthosilicate. Si(OR)4-xR'x wherein x= 1, R is methyl, and R' is methyl is also known as trimethoxymethylsilane. Rambo teaches that the sol-gel is derived from an alkoxysilane and/or organotrialkoxysilane (Rambo p. 8 para. 146). Alkoxysilanes include tetraethylorthosilicate, and organotrialkoxysilane is trimethoxymethylsilane (Rambo pp. 4-5 para. 92-93).
Rambo does not teach that the enzyme component is capable of hydrolyzing one or more acyl-homoserine lactones, that the composite particles have a density in a range of about 0.02 g/cm3 to about 0.5 g/cm3 and fractal three-dimensional structures, or that the one or more organo-alkoxysiloxane monomers are at an amount that is greater than 0 mol% and no more than about 30 mol% of the siloxane monomer component on a silicon mol basis (claim 31), or that the enzyme has a sequence as set forth in claim 47.
Regarding the limitation in claim 31 that the enzyme component is capable of hydrolyzing one or more acyl-homoserine lactones, Bergonzi teaches lactonases which degrade acyl-homoserine lactones (Bergonzi p. 73 para. 1; Table 9). Bergonzi teaches that disruption of bacterial signaling via quorum quenching using AHL-degrading enzymes, dubbed lactonases, has been shown to drastically reduce bacterial biofilms and virulence for numerous pathogens (Bergonzi p. 73 para. 1). Bergonzi teaches a silica gel matrix (silicon alkoxide cross-linked silica nanoparticle gels), made by a condensation process (polymerization) of TM40 silica nanoparticles and tetraethoxysilane (Bergonzi p. 75 para. 3). Bergonzi teaches that synthetic silica coatings are effective for encapsulating biologically active materials and the bioactivity of biochemicals and enzymes can last for as long as several months (Bergonzi p. 75 para. 2). Bergonzi teaches encapsulating the SsoPox lactonase enzyme and variants thereof in silica gel coating (Bergonzi Table 10). The lactonase-containing silica coating significantly reduced biocorrosion due to disruption of bacterial AHL-based quorum sensing (Bergonzi pp. 82-83 “Conclusions”).
Regarding claim 47, Bergonzi teaches that the wild-type SsoPox lactonase enzyme has a sequence according to SEQ ID NO: 11, which is 100% identical to instant SEQ ID NO: 5 (Bergonzi pp. 66-67 Ex. 3; see sequence alignment in OA appendix).
It would have been obvious for a skilled artisan to combine the teachings of Rambo and Bergonzi and utilize an enzyme capable of hydrolyzing acyl-homoserine lactones, such as the SsoPox enzyme having a sequence according to SEQ ID NO: 5, in a stabilized enzyme product as taught by Rambo. Both Rambo and Bergonzi teach encapsulating enzymes in silica-based gel coating products. It would have been obvious that the enzyme used by Bergonzi could be substituted as the enzyme component in the organopolysiloxane matrix as taught by Rambo.
A person of ordinary skill in the art would have been motivated to make this substitution because lactonases such as SsoPox are quorum quenching enzymes, which are useful in breaking down bacterial biofilms and reducing biocorrosion, as taught by Bergonzi. Further, Bergonzi teaches that silica coatings are effective for encapsulating quorum quenching enzymes and the encapsulation of these enzymes allows for extended bioactivity and stability. The polysilicate-polysilicone copolymeric materials of Rambo provide a versatile platform for the
immobilization of enzymes due to the high degree to which the properties of the particles and coatings can be modified based on selection of the component substituents, for example, the pore size, hydrophilicity/hydrophobicity, transport properties, and enzymatic functionality
of the coating can be controlled by the appropriate selection of the component substituents (Rambo p. 2 para. 44). Thus, an ordinary artisan would have been motivated to use the organopolysiloxane matrix as taught by Rambo, which has a variety of benefits in improving the stability and efficiency of enzymes for use in the catalysis of industrial processes, for encapsulating an industrially relevant enzyme such as the lactonase taught by Bergonzi.
A skilled artisan would have had a reasonable expectation of success in making this substitution because Bergonzi teaches that SsoPox and other quorum quenching enzymes that hydrolyze acyl-homoserine lactones can be successfully incorporated in silica coatings, which can then be applied for industrial purposes such as reducing biocorrosion through the AHL-degrading action of the enzyme. Thus, a skilled artisan could reasonably expect success in incorporating such an enzyme in a different polysilicate-based coating as taught by Rambo, which is also used for stabilizing and immobilizing enzymes.
Regarding the limitation in claim 31 that the composite particles have a density in a range of about 0.02 g/cm3 to about 0.5 g/cm3 and fractal three-dimensional structures, it is known in the art that silica aerogels produced by sol-gel processes have extremely low density (3–350 mg/cm3), large surface area (500–1200 m2/g), and fractal structures (see Duan p. 6156 para. 1; p. 6161 Section 3.3). Additionally, the instant specification states that the water is at an amount selected or regulated such that the resulting oligomers have a low-density, a highly accessible surface area, and fractal three-dimensional structure; and that these properties at least in part result from the amount of water relative to amount of siloxane monomer. The specification additionally states that the mol ratio of water to silicon preferable for providing low-density, a highly accessible surface area, and fractal three-dimensional structure is in a range of about 0.2:1 to about 100:1. (see instant specification para. 52). Rambo teaches that the enzyme/monomer/water ratio for the sol formulation is 1:15:5 based on mass (Rambo p. 20 para. 362).
The amount of monomer and water would have been routinely optimized by a skilled artisan. Rambo teaches that the enzyme/monomer/water ratio for the sol formulation can be easily altered by increasing or decreasing the amount of monomers or volume of enzyme stock (Rambo p. 20 para. 362). Thus, a skilled artisan would have found it obvious to modify these parameters as necessary through routine experimentation, resulting in the claimed characteristics of density and a fractal three-dimensional structure.
Regarding the limitation in claim 31 that one or more organo-alkoxysiloxane monomers are at an amount that is greater than 0 mol% and no more than about 30 mol% of the siloxane monomer component, Rambo does not teach this amount of organo-alkoxysiloxane monomers in the siloxane monomer component. However, the concentration of organo-alkoxysiloxane would have been routinely optimized by a skilled artisan based on the other assay conditions. Rambo clearly teaches that the organo-alkoxysiloxane monomers are provided in a concentration effective to achieve the result of sol gel formation enzyme immobilization, and are therefore result-effective variables. Result-effective variables would be optimized through routine experimentation by one having ordinary skill in the art. Furthermore, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. See MPEP 2144.05(II)(A).
Additionally, Rambo teaches that hydrophobic components, such as alkylsilanes, e.g., trimethoxymethylsilane, can be used, but in amounts that provide a polysilicate-polysilicone copolymer that has acceptable hydrophobicity (Rambo p. 5 para. 102). Thus, it is clear that based on the hydrophobic properties of the organo-alkoxysiloxane monomer, trimethoxymethylsilane, the amounts used would have been optimized to ensure an acceptable level of hydrophobicity that does not interfere with gel formation and enzyme activity.
Regarding claim 32, Rambo teaches that for the one or more tetraalkoxysilane monomers, R is ethyl, i.e. tetraethylorthosilicate, and that for the organo-alkoxysiloxane monomers, R is methyl and R’ is methyl, i.e. trimethoxymethylsilane (Rambo pp. 4-5 para. 92-93). In the response to the species election requirement on 4/16/2026, applicant elected organo-alkoxysiloxane monomers wherein R is methyl, R’ is methyl, and x=1. Organo-alkoxysiloxane monomers wherein x=2 or 3 were not elected. Thus, it is considered that the organo-alkoxysiloxane monomer wherein R is methyl and R’ is methyl as taught by Rambo reads on claim 32.
Regarding claim 33, as discussed above, the amount of the organo-alkoxysiloxanes in the siloxane monomer component is a result-effective variable. Result-effective variables would be optimized through routine experimentation by one having ordinary skill in the art. Furthermore, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. See MPEP 2144.05(II)(A). Further, as Rambo teaches that amounts of hydrophobic components would be chosen to ensure acceptable hydrophobicity (Rambo p. 5 para. 102), a skilled artisan would have found it obvious to modify the amounts of organo-alkoxysiloxanes to achieve this desired outcome, resulting in a ratio of organo-alkoxysiloxanes as claimed.
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 31-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12364739. Although the claims at issue are not identical, they are not patentably distinct from each other because both are directed to products comprising enzymes within an organopolysiloxane matrix.
Regarding claim 31, claim 1 of ‘739 recites one or more quorum silencing enzymes entrapped in an organopolysiloxane matrix, wherein the quorum silencing enzymes are an acyl-homoserine lactone hydrolase; and the organopolysiloxane matrix comprises tetra-alkoxy siloxane moieties, trialkoxy-organosiloxane moieties, or a combination thereof, wherein the organopolysiloxane matrix is obtained by gelating a hydrolyzed siloxane pre-polymer mixture having a ratio of 60-70 mol % of one or more tetraalkoxysilane monomers having the general formula Si(OR)4 to 40-30 mol % of one or more trialkoxy-organosiloxane monomers having the general formula Si(OR)3R′, wherein each R group is independently selected from the group consisting of methyl or ethyl.
Regarding the limitations directed to the wt% of enzyme component, density, surface area, and three-dimensional structure, these components would be routinely optimized by a skilled artisan during routine experimentation. See instant specification para. 52 which states that the water is at an amount a selected or regulated such that the resulting oligomers have a low-density, a highly accessible surface area, and fractal three-dimensional structure; and that these properties at least in part result from the amount of water relative to amount of siloxane monomer. The amount of water, as well as concentration of enzyme used, would have been routinely optimized by a skilled artisan, and is therefore considered obvious.
The limitations of dependent claims 32-33 are recited in claim 1 of ‘739.
Conclusion
Claims 31-33 and 47 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY F EIX whose telephone number is (571)270-0808. The examiner can normally be reached M-F 8am-5pm ET.
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/EMILY F EIX/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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