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 Claims
Receipt of Remarks/Amendments filed on 06/16/2026 is acknowledged. Claims 1, 3, 10, 12-13, and 15-17 are amended and claims 2, 5, 11, 14, and 18 are canceled. Claims 19-21 are new. Claims 6-9 and 15-17 remain withdrawn as being drawn to a non-elected invention. Claims 1, 3-4, 10, 12-13, and 19-21 are currently examined on the merits herein.
Priority
The instant application filed 11/08/2023, claims foreign priority to CN202311160919.2, filed 09/08/2023.
Withdrawn Objections/Rejections
Claim 3 was objected to for informalities. Applicants’ amendments to claim 3 have overcome the objection and the objection is withdrawn.
Claims 10-14 were rejected under 35 U.S.C. 101 for reciting a “use”. Applicants’ amendments to the claims have overcome the rejection and the rejection is withdrawn.
Claims 1, 5 and 10-14 were rejected under 35 U.S.C. 112(b) as being indefinite. Applicants’ amendments to the claims have overcome these rejections and the rejections are withdrawn.
Claims 1, 3-5, 10, and 12-14 were rejected under 35 U.S.C. 103 as being unpatentable over Guo. Applicants’ amendments to the claims have overcome the rejection and the rejection is withdrawn.
Claims 1-5 and 10-14 were rejected under 35 U.S.C. 103 as being unpatentable over Guo in view of Feng. Applicants’ amendments to the claims have overcome the rejection and the rejection is withdrawn.
The following grounds of rejection are new as necessitated by amendment:
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 and 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (2019). Controllable Fabrication of Inhomogeneous Microcapsules for Triggered Release by Osmotic Pressure. Small, 15, 1903087 (PTO-892), hereinafter Zhang, in view of Guo, J., et al. (2020). Generation of Ultra-Thin-Shell Microcapsules Using Osmolarity-Controlled Swelling Method. Micromachines, 11(4), 444 (on record), hereinafter Guo.
Zhang discloses inhomogeneous microcapsules that can encapsulate various cargo for controlled release triggered by osmotic shock (abstract).
Regarding claim 1: The microcapsules were fabricated using an oil-in-water (W/O/W) double emulsion template. The inner phase, reading on the core phase, consists of sucrose in 3 wt% poly(vinyl alcohol) (PVA) aqueous solution. Sucrose is used as an agent to increase the osmotic pressure of the inner phase (i.e., a density enhancer) (p. 2, left col., para. 3). Sucrose was added to the inner phase at concentrations of 0.6, 1.2, and 2 M (p. 6, left col., para. 2). The aqueous solution reads on the balance being water. Protease was used as a model biological molecule by coencapsulating protease with sucrose in microcapsules with a nonuniform shell thickness. Protease has great medical and pharmaceutical importance due to its key role in biological processes and in the life-cycle of many pathogens (p. 4-5, bridging paragraph), thereby reading on an active substance such as a pharmaceutical or physiological active. A glass capillary microfluidic device was used to fabricate microcapsules with inhomogeneous shell thickness based on water-in-oil-in-water (W/O/W) double emulsion templates. Fabrication of double emulsion droplets was followed by UV exposure to crosslink the monomers in the middle oil phase (p. 2, col. 1-2, bridging paragraph; Fig. 2; p. 6, Microcapsule Fabrication 2). Confocal microscopy was then used to visualize the swelling (i.e., inflating) and rupture of the microcapsules under hypotonic conditions (p. 2, right col. final paragraph; Fig. 1).
The teachings of Zhang differ from that of the instant invention in that Zhang does not explicitly teach a shell phase comprising the elastomer, curing agent, and silicone oil of claims 1 and 3-4, nor does Zhang explicitly teach the volume ratios, concentrations, and inflated degree of instant claim 1.
Guo, in the same field, discloses the generation of ultra-thin-shell microcapsules using osmolarity-controlled swelling method (title). A classic capillary microfluidic device is used to fabricate monodisperse W/O/W double-emulsion drops (Intro, para. 4). The inner phase comprises an aqueous solution of PVA. KCl is added into the inner phase and suspending medium to adjust the osmotic pressure between the inner and outer phase of the shell (p. 3, section 2.1). The middle oil phase comprises a mixture of PDMS (i.e., an elastomer precursor) and silicone oil, to which a curing agent is added for solidifying the double-emulsion drops into microcapsules (p. 3, section 2.1), thereby reading on the shell phase components of instant claim 1. A thermal curing method is used to solidify the PDMS shell phase (p. 2, para. 2; Fig. 1). The polydimethylsiloxane (PDMS) further reads on the elastomer precursor of claim 3 and the curing agent is capable of curing the PDMS shell as evidenced by Guo (p. 3, section 2.1; p. 7, section 3.3), thereby reading on claim 4.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to replace the shell of Zhang with the PDMS shell of Guo, since PDMS shells are known and routine in the art of osmotic-controlled double emulsion microcapsules as taught by Guo. One of ordinary skill in the art could have encapsulated the inner/core phase of Zhang with the middle/shell phase of Guo according to the known W/O/W double emulsion and thermal curing method taught by Guo, to predictably yield the instant invention. The substitution of one known shell phase for another known shell phase to obtain predictable results is considered prima facie obvious. One of ordinary skill in the art would have had a reasonable expectation of success in making such a modification since Zhang and Guo teach both teach microcapsules formed via W/O/W double-emulsion drops using a capillary microfluidic device, wherein the middle phase is a curable polymer precursor that forms a water-permeable shell.
Regarding the mass ratio of each agent in the shell phase as defined in claim 1, Guo teaches that PDMS (i.e., elastomer precursor) and silicone oil are provided at a volume ratio of 3:1, into which the curing agent is added at 10 wt% (p. 3, section 2.1). While such amounts do not directly align with the instantly claimed ratio, which is a mass ratio between all three components, it is well within the abilities of an ordinary artisan to optimize the amount of each component in the shell phase depending on the desired properties (i.e., shell hardness) of the final product. As such, one of ordinary skill in the art would have arrived at the instantly claimed ratio of elastomer to curing agent to silicone oil through no more than routine experimentation. Generally, differences in concentration or temperature 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).
As such, the shell phase of instant claims 1 and 3-4 is obvious in view of the combined teachings of Zhang and Guo.
Regarding the volume ratio of the core phase to the shell phase as defined in claim 1, both Zhang and Guo teach osmolarity-controlled swelling. Specially, Zhang teaches when the osmotic pressure of the inner core is higher than that of the external solution (i.e., hypotonic conditions), the osmotic pressure difference across the shell causes water to diffuse into the microcapsules and makes them begin to swell. During the expansion, the thickness of the polymeric shell membrane decreases, leading to an enhancement of the inward diffusion of water. Eventually, this part is unable to withstand deformation and mechanically cracks to release its cargo (p. 2-3, bridging paragraph). Guo similarly teaches that the core volume of the microcapsules can be controlled by changing the salt concentration of the suspending medium and therefore inducing osmolarity-controlled swelling. Along with the swelling of the inner core, the oil shell becomes sufficiently thinner and thinner (p. 5, Section 3.1). Thus, it would have been prima facie obvious to one of ordinary skill in the art to selectively adjust the volume ratio of the core phase to the shell phase depending on the desired structure of the final microcapsule (i.e., shell thickness or rupture/release profile). As such, one of ordinary skill in the art would have arrived at the instantly claimed ratio through no more than routine experimentation by adjusting the osmotic difference between the inner phase and the suspending medium as taught by Zhang and Guo (i.e., by changing the sucrose concentration in the core or changing the salt concentration in the suspending medium). "[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).
Regarding the inflated degree of the microcapsule as recited in claim 1, it is discussed above that Zhang and Guo teach that the osmotic pressure difference across the shell causes water to diffuse into the core, resulting in swelling of the microcapsule which can be used to modulate the inner volume, the shell thickness, and the rupture and release profile of the microcapsule. As such, it would have been prima facie obvious to one of ordinary skill in the art to selectively adjust the degree of swelling (i.e., inflated degree) depending on the desired deformation and release profile of the final microcapsule. As such, one of ordinary skill in the art would have arrived at the instantly claimed inflated degree (alpha) of 1.34 through no more than routine experimentation by adjusting the osmotic difference between the inner phase and the suspending medium as taught by Zhang and Guo (i.e., by changing the sucrose concentration in the core or changing the salt concentration in the suspending medium). The optimization of a result effective parameter is considered within the skill of the artisan. See, In re Boesch and Slaney (CCPA) 204 USPQ 215. This is what research chemists do, optimization of result-effective variables through routine experimentation (MPEP 2144.05 IIA and B).
Regarding the amount of PVA, sucrose, and active in the core phase as defined in claim 1: The inner phase of Zhang comprises in 3 wt% PVA and sucrose at varying concentrations of 0.6, 1.2, and 2 M (p. 2, left col., para. 3; p. 6, left col., para. 2). The concentration of encapsulated protease (i.e., active) was calculated according to the volume of inner phase and the total volume collected as well as the initial concentration of protease in inner phase (p. 6, left col. para. 4). While Zhang does not define the specific concentrations of claim 1, it is well within the abilities of an ordinary artisan to optimize the amount of these components in the core phase depending on the desired properties and structure of the final product. As such, one of ordinary skill in the art would have arrived at the instantly claimed ranges of PVA, sucrose, and protease (i.e., active substance) through no more than routine experimentation. Generally, differences in concentration or temperature 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).
Regarding the product-by-process limitation of claim 1, "even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In the instant case, every structural limitation of the instantly claimed microcapsule is made obvious above. Thus, the claimed product is obvious over the combined prior art product, regardless of if the prior art uses a different process. In any case, it is discussed above that Zhang teaches preparing the microcapsules using a microfluidic device to form double emulsion droplets. Fabrication of double emulsion droplets is followed by curing of the middle oil phase (UV in the case of Zhang). However, following the substitution of the middle phase with the PDMS solution of Guo, as made obvious above, it would have also been prima facie obvious to one of ordinary skill in the art to use a thermal curing step in place of the UV curing step of Zhang, since the PDMS shell of Guo is cured via heat. Such a modification requires no more than simple substitution of one known curing step for another to predictably yield the instantly claimed microcapsule. The microcapsules then undergo swelling (i.e., inflating treatment) after the curing step as taught by Zhang, until the desired microcapsule is reached as discussed above (i.e., shell thickness, rupture profile, etc). Thus, the product and process of the instant claims are obvious in view of Zhang and Guo.
2. Claims 1, 3-4, 10, and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang and Guo as applied to claims 1 and 3-4 above, and further in view of Bhargava et al. (2013). Controlled-release Mechanism of Fragrances. Cosmetic and Toiletries (PTO-892), hereinafter Bhargava.
The combined teachings of Zhang and Guo are discussed above.
Zhang further teaches that stimuli-responsive microcapsules have been widely used to encapsulate various valuable cargoes, including nanomaterials, essential oils, colorings, flavorings, bioactive molecules, and living cells, for long term storage without any deterioration (p. 1, right col., para. 1).
Guo further teaches that microcapsules can serve as model systems in various applications such as drug delivery controlled release, and food (p. 1, intro., para. 1).
The combined teachings of Zhang and Guo differ from that of the instant invention in that neither explicitly teach a cosmetic product as recited in claims 10 and 12-13.
Bhargava discloses various controlled release mechanisms for fragrances in a cosmetic preparation, specifically osmotic controlled release. Osmotic controlled delivery systems utilize the principles of osmotic pressure to drive the controlled delivery of active agents. The active agent (core) is enclosed in a selectively water-permeable polymeric membrane with a small orifice; this membrane is impermeable to the active agent. In an aqueous environment, water permeates through the membrane into the core. If the active agent has high solubility in water, a large osmotic pressure is created inside the capsule. The active agent is then released when the osmotic pressure exceeds the maximum force that the walls of the capsule can tolerate (p. 5-6, bridging paragraph). When osmotic pressure exceeds the surrounding pressure, capsules swell until the membrane or some other part of the enclosure wall reaches the point of ultimate elongation and a portion of the wall yields and ruptures, releasing the contents of the enclosure to the environment. Osmotic fragrance delivery systems have been developed that release the active core either in a sustained manner or via osmotic bursting. These delivery systems rely upon semipermeable coatings to control the influx of the water and to control the active core within the matrix (p. 6, para. 2)
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to encapsulate an active such as a fragrance in the combined microcapsules of Zhang and Guo and incorporate such microcapsules in a cosmetic product, since this is a known and routine application of osmotic delivery systems as taught by Bhargava. One of ordinary skill in the art could have combined the known microcapsule of Zhang and Guo with a fragrance active and a cosmetic product via known methods to predictably yield the instant invention. One of ordinary skill in the art would have had a reasonable expectation of success in making such a modification since Zhang teaches that stimuli-responsive microcapsules have been widely used to encapsulate various valuable cargoes and Bhargava teaches that these systems are known and routine in the field of cosmetics.
3. Claims 1, 3-4, and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang and Guo as applied to claims 1 and 3-4 above, and further in view of Jeyakumari A, et al. (2016). Microencapsulation of bioactive food ingredients and controlled release-a review. MOJ Food Process Technol. 2(6):214-224 (PTO-892), hereinafter Jeyakumari.
The combined teachings of Zhang and Guo are discussed above.
Zhang further teaches that stimuli-responsive microcapsules have been widely used to encapsulate various valuable cargoes, including nanomaterials, essential oils, colorings, flavorings, bioactive molecules, and living cells, for long term storage without any deterioration (p. 1, right col., para. 1).
Guo further teaches that microcapsules can serve as model systems in various applications such as drug delivery controlled release, and food (p. 1, intro., para. 1).
The combined teachings of Zhang and Guo differ from that of the instant invention in that neither explicitly teach a food product as recited in claims 19-21.
Jeyakumari teaches various microencapsulation methods and its application in the encapsulation of bioactive food ingredients and controlled release mechanisms. (abstract). Bioactives in food are physiologically active components that provide health benefits beyond their nutritional role. Bioactive ingredients include proteins, vitamins, minerals, lipids, antioxidants, phytochemicals and probiotic bacteria. These bioactives are very sensitive and their application in food is a great challenge to the industry without affecting their properties. Encapsulation technology has proven to be an excellent method to protect the sensitive food ingredients and to develop the novel foods formulations with improved properties (Intro, para. 1). Controlled release has been defined as a method by which one or more active agents are occurs at the target site and at the desirable rate and time. The major objectives of controlled release are to decrease the loss of target compound such as vitamins and minerals during the processing and storage, to optimize the absorption and to increase of effective use. The advantages of controlled release are; the active ingredients are released at controlled rates over prolonged periods of time. The most commonly used methods for controlled release includes osmotic pressure activated release (p. 6, controlled release mechanism).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to encapsulate a bioactive agent having a nutritional benefit in the combined microcapsules of Zhang and Guo and incorporate such microcapsules in a food product, since this is a known and routine application of osmotic controlled microcapsules as taught by Jeyakumari. One of ordinary skill in the art could have combined the known microcapsule of Zhang and Guo with a nutritional bioactive and a food product via known methods to predictably yield the instant invention. One of ordinary skill in the art would have had a reasonable expectation of success in making such a modification since Zhang teaches that stimuli-responsive microcapsules have been widely used to encapsulate various valuable cargoes, while Guo teaches that microcapsules can serve as model systems in various applications such as food.
Response to Arguments
Applicant's arguments filed 06/16/2026 have been fully considered but they are not persuasive:
(1) Applicant argues that the instantly claimed order of preparing the microcapsule (curing-then-inflating) creates an accumulation of elastic potential energy in the microcapsules which is not provided by the preparation steps of Guo (inflating-then-curing). Applicant asserts that one of ordinary skill in the art would have no motivation to refer to Guo when faced with the technical problem of “how to stretch an elastic shell to store elastic potential energy” or “how to generate a powerful mechanical stimulus to the surrounding environment” (p. 13-14 of Remarks).
In response to this argument, it is discussed above that "even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In the instant case, every structural limitation of the instantly claimed microcapsule is made obvious. Thus, the claimed product is obvious over the combined prior art product, regardless of if the prior art uses a different process. In any case, the rejection is now based on a combination of Zhang and Guo which yield the instantly claimed process obvious. The difference in elastic potential that occurs from the difference in preparation, as argued by the Applicant, is not recited in the claims and it is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See MPEP 2144 IV.
(2) Applicant argues that the instantly claimed inflated degree (≥ 1.34) enables the complete release of actives within a matter of milliseconds. The fast release profile in the instant invention constitutes an unexpected result that could not have been predicated by people having ordinary skill in the art. Applicant asserts that one of ordinary skill in the art would have no motivation to refer to Guo or Feng when faced with the technical problem of “how to achieve complete release of active ingredients from a microcapsule within milliseconds” (p. 14 of Remarks).
It is noted that the above rejection now relies on Zhang, which explicitly teaches that swelling degree affects rupture and release. The instantly claimed “inflated degree” refers to a volume ratio of an inflated microcapsule to a microcapsule before inflation, and is simply a measure of a microcapsules swelling, which can be controlled by an osmotic mechanism as taught by both Zhang and Guo. One of ordinary skill in the art would recognize that the degree of swelling (i.e., inflated degree) directly correlates to the thinness of the shell and the subsequent rupture of the microcapsule to release its cargo. As such, one of ordinary skill in the art would have expected a higher inflated degree or higher swelling to achieve a faster release profile as achieved by the Applicant. In any case, the microcapsule release profile is not a claimed limitation and it is not necessary that the prior art suggest [a modification] to achieve the same advantage or result discovered by applicant. See MPEP 2144 IV.
(3) Applicant argues that it would not have been obvious to perform routine optimization of the inflated degree since Guo only teaches methodology for adjusting a swelling ratio, not a critical impact of swelling on the mechanical behavior and release kinetics of the microcapsules. Applicant points to Test Embodiment 3 of the instant specification to prove that “ultra-fast release” is not an inherent property achieved by any arbitrary inflated degree, rather it is a critical phenomenon unlocked only within a specific optimized range of inflated degree (p. 15-16 of Remarks).
It is noted that the above rejection now relies on Zhang, which explicitly teaches that swelling degree affects rupture and release. One of ordinary skill in the art would recognize that the degree of swelling (i.e., inflated degree) directly correlates to the thinness of the shell and the subsequent rupture of the microcapsule to release its cargo. As such, one of ordinary skill in the art would have expected a higher inflated degree or higher swelling to achieve a faster release profile as disclosed by the Applicant. In any case, “ultra-fast release” is not a claimed feature of the invention. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
(4) Applicant argues that sucrose is utilized as the density enhancer, whereas Feng utilizes glycerol (p. 16 of Remarks).
In response to this argument, it is noted that Feng is no longer relied upon and Zhang, the instantly applied reference, explicitly teaches sucrose in the microcapsule core.
Conclusion
No claims 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.
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/SUSANNAH S ARMSTRONG/Examiner, Art Unit 1616
/ERIN E HIRT/Primary Examiner, Art Unit 1616