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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/30/2025 has been entered.
Claim Status
Claims 37-40, 42-43, 47-50, and 52 are withdrawn.
Claims 1, 4-5, 8-14, 16-19, 23, 26, 29-32, and 36 are rejected.
No claims are allowable.
Modified 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, 4-5, 8-14, 16-19, 23, 26, 29-32, and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Kaplan et al. (WO 2014/012099 A1, 2014) (hereinafter Kaplan) (cited by applicant on IDS 09/29/2023).
Kaplan discloses methods for encapsulation and/or stabilization of odor-releasing substances (e.g., fragrances) and/or flavoring substances in a silk-based material (Abstract) including an emulsion of an oil phase dispersed in an aqueous phase comprising a silk-based material ([0006-0007]). Compositions may comprise a plurality of (e.g., at least two or more) one or more embodiments of the silk particles, including an emulsion, a colloid, a gel, a film, powder, or any combinations thereof ([0019]). Silk particle compositions are produced, in general, by a process comprising forming an emulsion of the oil phase (e.g., oil or oil droplets) (i.e., colloid) dispersed in a silk-based material ([00195]). The silk-based material encapsulating the oil phase can be a solution ([00245]) and may comprise an active agent is in the form of a gel (i.e., comprising a gel phase, a colloidal phase, and a solution phase) ([00264]). The method of production of silk particle compositions comprises (a) providing an emulsion of oil droplets dispersed in a silk solution undergoing a sol-gel transition (where the silk solution remains in a mixable state); and (b) adding a pre-determined volume of the emulsion into a non-aqueous phase ([00197]). The silk solution can be treated to induce a sol-gel transition prior to addition of the oil phase into the silk solution. In other embodiments, the oil phase can be added into the silk solution before treating the mixture to induce a sol-gel transition ([00198]). The emulsion can be added into the nonaqueous phase, e.g., dropwise via an extrusion-like process, so the size of the resulting silk particle can be controlled. An extrusion-like process can be characterized by precise control of particle size and composition loading. For example, an extrusion-like process can include pipetting (i.e., applying pressure and shear force) or injecting controlled volumes of a known composition into a continuous phase ([00211]). In some embodiments, the emulsion can be added to an aqueous solution comprising a surfactant to form a silk particle encapsulating at least one oil droplet, such as in a salt solution comprising a surfactant. In this embodiment, not only can a silk particle form in the salt solution but a beta-sheet can also form in silk fibroin in the presence of the salt (i.e., to form an aqueous extrudate suspension) ([00212]). The silk particle compositions may be emulsions (e.g., oil- in- water and water-in-oil, as well as multiple emulsions) and multilaminar gels, and can be formulated as emulsions of one or more oil phases in an aqueous continuous phase (or an aqueous phase in an oil phase) ([0165]). The sol-gel transition refers to the silk solution remaining in solution state long enough to perform the double emulsion (i.e. colloid), and can remain separate for at least about 5 seconds to about 2 days or more before changing into a gel (i.e. separating gel phase) and encapsulating the oil droplets within ([00204]). The sol-gel transition of the silk solution can be induced by any method that is known to induce a conformation change in silk fibroin, including, water annealing (i.e., heating) and/or any other silk gelation methods ([00205]). The silk-based material comprises from 10-100% of silk fibroin ([0078]) and the silk fibroin can be recombinant spider silk ([00265]), including genetically engineered polypeptides (00272]). Additives include silk powder ([0086]) and plasticizers such as glycerol ([0015]) and are integrated homogenously ([0082]). The silk-based material can be present in any shape or form, including a sheet, gel, or hydrogel, and can be present in a dried state by drying under an ambient condition and/or by lyophilization ([00113]). The silk particles can be a part of a network or aggregate ([00251]), and aggregation of fragrance-loaded silk particles coated with higher silk concentrations can be due to the newly applied silk on separate particles fusing together as they crystallize ([00367]). Beta sheet content in silk fibroin is increased in the silk coating layer with treatments (e.g., but not limited to water annealing (i.e., heating) and ethanol immersion) known to induce crystallinity ([0062]). Beta-sheets (i.e. aggregates) can be induced by methanol ([00225]). The composition can comprise additives such as beta-sheet inducing agents to provide strength, flexibility, solubility, or surface morphology ([0082-0083]). Stable oil in water emulsions can be produced by manual mixing (gentle shaking for approx. 10 minutes) of oil and silk solution ([00325]).
Regarding the limitations of claims 29 and 30 reciting wherein said applied shear force is at least 1.5 Newton meters and wherein said applied pressure is at least 1 MPa, as discussed above, Kaplan teaches that the size of the resulting silk particle can be controlled through an extrusion-like process such as pipetting (i.e., applying pressure and shear force). Thus, one of ordinary skill in the art would have arrived at the claimed shear force and pressure through routine experimentation depending to achieve a desired silk particle size. "[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), see MPEP 2144.05.
Response to Applicant’s Arguments
Applicant argues that Kaplan does not disclose or suggest the combination of steps recited in the claims and does not disclose or suggest an aqueous extrudate suspension as claimed.
Applicant’s argument has been fully considered but found not to be persuasive. A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art. See MPEP 2123. As discussed above, Kaplan teaches a method of making a silk-based gel composition formed from a solution of silk materials that encapsulate an oil forming an emulsion (i.e., a colloid) wherein the solution comprises an active material gel, glycerol, and recombinant spider silk. In the method of making the silk-based gel composition, the emulsion of oil droplets dispersed in a silk solution that is undergoing a sol-gel transition and comprises an active agent in gel form is pipetted via an extrusion-like process into an aqueous solution comprising a surfactant to form a silk particle encapsulating at least one oil droplet, such as in a salt solution comprising a surfactant wherein a silk particle forms encapsulating at least one oil droplet in the salt solution (i.e., to form an aqueous extrudate suspension). The sol-gel transition of the silk solution can be induced by water annealing (i.e., heating) and the sol-gel transition refers to the silk solution remaining in solution state long enough to perform the double emulsion (i.e. colloid), and can remain separate for at least about 5 seconds to about 2 days or more before changing into a gel (i.e. separating gel phase) and encapsulating the oil droplets within. Thus, it would have been obvious to one of ordinary skill in the art to have combined the steps of Kaplan to arrive at the instantly claimed method. Further, it is obvious that an aqueous extrudate suspension is formed when the emulsion is pipetted into an aqueous solution comprising a surfactant since Kaplan discloses that a silk particle forms encapsulating at least one oil droplet. Because a silk particle forms in the solution and the silk encapsulates the oil, it is obvious that the emulsion is not miscible in the aqueous solution.
Applicant argues that Kaplan does not provide motivation to a person of ordinary skill in the art to apply pressure and shear force to a silk-containing composition as claimed since the Office cites Example 3 of Kaplan to necessarily describe applying pressure and shear force but Example 3 describes formation of silk spheres, in the form of tapioca-like "pearls," via extrusion of a silk solution into an oil bath, which does not suggest applying pressure and shear force to a silk-containing composition or suspending such an extrudate in aqueous solvent to form an aqueous extrudate suspension, as claimed.
Applicant’s argument has been fully considered but found not to be persuasive. The Office does not rely on Example 3 to teach applying pressure and shear force to a silk-containing composition or suspending such an extrudate in aqueous solvent to form an aqueous extrudate suspension, as claimed. As discussed above, Kaplan teaches that the emulsion, which comprises silk, can be added into the nonaqueous phase, e.g., dropwise via an extrusion-like process, so the size of the resulting silk particle can be controlled. An extrusion-like process can be characterized by precise control of particle size and composition loading and includes pipetting. It is known in the art that during the process of pipetting, a substance is aspirated into the pipette by lifting a plunger and then dispensed out of the pipette when the plunger is pressed. Pressing the plunger down creates a positive pressure that forces the substance out of the pipette. Shear force is created when the substance is being dispensed because the substance near the walls of the pipette tip moves slower than the substance at the center of the tip, due to friction. The difference in speeds of the liquid exiting the tip of the pipette creates shear stress. Thus, one of ordinary skill in the art would have been motivated to pipette (i.e., apply pressure and shear force) an emulsion comprising silk particles into a non-aqueous phase in order to control the particle size of the resulting silk particle as taught by Kaplan.
Applicant argues that Kaplan does not disclose or suggest suspending such an extrudate in aqueous solvent to form an aqueous extrudate suspension.
Applicant’s argument has been fully considered but found not to be persuasive. As discussed above, Kaplan teaches that in the method of making the silk-based gel composition, the emulsion of oil droplets dispersed in a silk solution comprising an active agent in gel form is pipetted via an extrusion-like process into an aqueous solution comprising a surfactant to form a silk particle encapsulating at least one oil droplet, such as in a salt solution comprising a surfactant wherein a silk particle forms in the salt solution encapsulating at least one oil droplet (i.e., to form an aqueous extrudate suspension). It is obvious that an aqueous extrudate suspension is formed when the emulsion is pipetted into an aqueous solution comprising a surfactant since Kaplan discloses that a silk particle forms and encapsulates at least one oil droplet. Because a silk particle forms in the solution and the silk encapsulates the oil, it is obvious that the emulsion is not miscible in the aqueous solution and the silk particle remains suspended in the aqueous solution.
Applicant argues that even if Kaplan did disclose or suggest suspending such an extrudate in aqueous solvent to form an aqueous extrudate suspension, the addition would not form a multi-phase aqueous extrudate suspension as claimed.
Applicant’s argument has been fully considered but found not to be persuasive. As discussed above, Kaplan teaches that in the method of making the silk-based gel composition, the emulsion of oil droplets dispersed in a silk solution comprising an active agent in gel form is pipetted into an aqueous solution comprising a surfactant to form a silk particle encapsulating at least one oil droplet. Accordingly, the emulsion that is being pipetted into the aqueous solution is a colloid itself. The emulsion is made of oil droplets dispersed in a silk solution. This silk solution comprises an active ingredient which is a gel. Thus, at the time of being pipetted into an aqueous solution, the emulsion comprises a colloid phase (i.e., dispersed oil droplets), a solution phase (i.e., silk material solution) and a gel phase (i.e., active agent), which is a multi-phase aqueous extrudate suspension.
Applicant argues that Kaplan does not disclose an aqueous extrudate suspension comprising the combination of a gel phase, a colloidal phase, and a solution phase as claimed because Kaplan at [00204] describes the transition of a solution to a double emulsion and then to a gel that can encapsulate oil phase droplets, rather than a single suspension comprising gel, colloidal, and solution phases as demonstrated in the formation of an aqueous extrudate suspension of the instant claims.
Applicant’s argument has been fully considered but found not to be persuasive for reasons discussed above. Additionally, while the silk solution comprising the oil droplets and active agent gel can then further undergo a sol-gel transition as disclosed in Kaplan at [00204], at the time of being pipetted into an aqueous solution, the emulsion comprises a colloid phase (i.e., dispersed oil droplets), a solution phase (i.e., silk material solution) and a gel phase (i.e., active agent).
Applicant argues that it appears the Office has impermissibly used hindsight
reasoning, using Applicant's disclosure as a template to pick and choose elements of Kaplan that assertedly correspond to elements of the claimed methods.
Applicant’s argument has been fully considered but found not to be persuasive. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Conclusion
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/S.J.K./Examiner, Art Unit 1614
/TRACY LIU/Primary Examiner, Art Unit 1614