DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
In applicant’s reply on 04/27/2026, the claims were amended. Rejections under 35 U.S.C. 112 have been withdrawn, and new rejections under 35 U.S.C. 112 can be found below. Revised rejections under 35 U.S.C. 103 can be found below, as well as the rejections of the new claims under 35 USC 103.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2, 4-6, and 13-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 as amended recites “unhydrolyzed rice protein that is without chemical modification”. This is not supported by the disclosure as filed. Par. 0008 of the specification filed 07/15/2022 discloses the use of unhydrolyzed protein referring to a protein which has not been broken down partially or completely into smaller components by an acid, base, or enzyme. This is substantially more specific that a broad claim of “without chemical modification”. Many other chemical reactions exist aside from those listed, for example cross linking or oxidation. Claims 2, 4-6, and 13-17 are similarly rejected as they depend from claim 1.
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 1-2, 4-6, and 13-17 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.
Claim 1 recites “unhydrolyzed rice protein that is without chemical modification”. The specification does not define “chemical modification” and as such it is unclear what is meant by “without chemical modification”. It could be presumed to mean modification of the chemical (protein), or modification using a chemical such as a reactant. Further, as we are looking at the final product, it is unclear if it is claimed that the rice protein has never had any chemical modification. Presumably the protein has been processed to an extent to be extracted from the whole rice, so there is uncertainty surrounding what qualifies as an “unhydrolyzed rice protein that is without chemical modification”. For examination purposes the examiner is assuming chemical modification to be modification using chemicals as the provided examples in Par. 0008 of the specification filed 07/15/2022 describe modification methods using external chemicals.
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.
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.
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 1-2, 4-6 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Tran (US 2015/0313844 A1) in view of Popplewell (WO 2019/212896 A1), further in view of Marles (WO 2015/019307 A1) found in Applicant’s IDS filed 02/14/2023.
Regarding claim 1, Tran teaches an encapsulation particle (active partially or fully encapsulated within the protective matrix Par. 0137)
comprising: (a) an active material (probiotic Par 0010)
and (b) a matrix material encapsulating an oil phase including the active material (hydrophobic actives may be additionally added such as lipids or lipid as solvent Par. 0029-0035; hydrophobic active may be partially or fully encapsulated within the denatured protein of the protective matrix Par. 0137)
wherein the matrix material contains an unhydrolyzed rice protein that is without chemical modification (protective matrix precursor comprising denatured protein Par. 0010; rice protein may be used to have less allergic responses Par. 0105; protein is denatured so thiol groups can form disulfide bridges, effected by heat treatment Par. 0113-0114). It is noted that par. 0007 of applicant’s specification filed 07/15/2022 lists denatured rice protein as an unhydrolyzed protein. Further, understanding chemical modification to mean modification of the unhydrolyzed rice protein using chemical methods, the modification of the protein is enacted using heat, not external chemicals.
and a carrier (carrier Par. 0010)
the active material is dispersed within the matrix material (a microparticle precursor composition comprising blending together a probiotic, the protective matrix precursor composition and a cross-linkable reagent Par. 0012)
and the ratio between the active material and the unhydrolyzed rice protein is 10:1 to 1:10 (Example 1 Par. 0198-0202: 10% protein in WPI Mixture, 46% WPI Mixture in protective matrix precursor composition, 4.6% protein; Example 4 Par. 0209-0217: 25g probiotics, 130g protective matrix precursor, 6g protein, 4.2:1 ratio of probiotics to protein). It is noted that though the examples use whey protein, it would be obvious to replace it with one of Tran’s provided suitable alternative proteins, such as rice protein.
wherein the active material is in a discontinuous phase of inclusions of oil dispersed within a continuous phase of the matrix material (matrix surrounds dispersed droplets of active Par. 0177; blending an emulsion comprising a hydrophobic active with the probiotic-containing matrix precursor to form a probiotic-containing emulsion Par. 0012; lipids in the emulsion 0049; hydrophobic vitamins in combination with the probiotic and oil Par. 0042-0043; hydrophobic actives dissolved in lipid Par. 0048)
and wherein the unhydrolyzed rice protein is an emulsifier (components of the protein act as an emulsifier Par. 0136-0137)
and wherein the encapsulation particle is water-dispersible (alginate gels show dissolution and/or disintegration in weak alkaline conditions. This property enables alginate gels to be used effectively to deliver probiotics and other actives to the human intestine (pH above 6.7) Par. 0074)
and has a water activity of less than 0.5 (after forming the microparticle having the protective matrix, the solvent/carrier may be removed, water is often the preferred carrier Par. 0109). With no water, the water activity would be near 0.
Tran does not teach comprising a blue agave inulin and a chicory root inulin, or wherein the encapsulation particle has a diameter of 2 µm to 5000 µm.
Popplewell teaches a blue agave inulin and a chicory root inulin (carrier is inulin Par. 0015; inulins from chicory root and blue agave Par. 0079).
It would have been obvious to one having ordinary skill, at the time of filing, to modify the invention of tran with the carrier of Popplewell. As Popplewell teaches the use of inulins as carriers (Par. 0015), the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See MPEP 2144.07.
Marles, in the same field of endeavor, teaches an encapsulation particle which has a diameter of 2 µm to 5000 µm (between about 20 and about 100 µm in diameter Par. 0046).
It would have been obvious to one having ordinary skill in the art, at the time of filing, to modify the invention of modified Tran with the particle size of Marles. One would have been motivated to make this modification to provide a product that carry probiotics through gastric pH (Marles Par 0046).
Regarding claim 2, Tran further teaches the carrier is present in an amount of 1% to 99% by weight of the encapsulation particle (Example 1: 30.7% glycerol in protective precursor composition; protective matrix precursor may be 10% by weight of microparticle precursor composition Par. 0099; 3.07% glycerol in microparticle). It is noted that as seen below in claim 3, applicant lists polyol as a potential carrier.
Regarding claim 4, Tran further teaches the active material is selected from the group consisting of a fragrance, pro-fragrance, flavor, malodor counteractive agent, vitamin or derivative thereof, anti-inflammatory agent, fungicide, anesthetic, analgesic, antimicrobial active, anti-viral agent, anti-infectious agent, anti-acne agent, skin lightening agent, insect repellant, animal repellent, vermin repellent, emollient, skin moisturizing agent, wrinkle control agent, UV protection agent, fabric softener active, hard surface cleaning active, skin or hair conditioning agent, flame retardant, antistatic agent, taste modulator, cell, probiotic, colorant, vegetable oil, and combinations thereof (probiotic Par 0010)
Regarding claim 5, Tran further teaches the active material is present in an amount of 0.1% to 60% by weight of the encapsulation particle (probiotic 2.5-5% of microparticle weight Par. 0028)
Regarding claim 6, Tran further teaches the unhydrolyzed rice protein is present in an amount of 0.1% to 99% by weight of the encapsulation particle (Example 1: 10% protein in WPI Mixture, 46% WPI Mixture in protective precursor composition, 4.6% protein; protective matrix precursor may be 10% by weight of microparticle precursor composition Par. 0099; 0.46% protein in microparticle). It is noted that though the examples use whey protein, it would be obvious to replace it with one of Tran’s provided suitable alternative proteins, such as rice protein.
Regarding claim 13, Tran, Popplewell, and Marles do not teach the ratio of the blue agave inulin to the chicory root inulin is 2.25:1 on a weight-to-weight basis. However, it would have been obvious to choose the ratio to achieve desired taste.
Attention is invited to In re Levin, 84 USPQ 232 and the cases cited therein, which are considered in point in the situation of the instant case, and wherein the Court stated on page 234 as follows:
This court has taken the position that new recipes or formulas for cooking food which involve the addition or elimination of common ingredients, or for treating them in ways which differ from the former practice, do not amount to invention, merely because it is not disclosed that, in the constantly developing art of preparing food, no one else ever did the particular thing upon which the applicant asserts his right to a patent. In all such cases, there is nothing patentable unless the applicant by a proper showing further establishes a coaction or cooperative relationship between the selected ingredients which produces a new, unexpected, and useful function. In re Benjamin D. White, 17 C.C.P.A (Patents) 956, 39 F.2d 974, 5 USPQ 267; In re Mason et al., 33 C.C.P.A. (Patents) 1144, 156 F.2d 189, 70 USPQ 221.
Regarding claim 14, Tran, Popplewell, and Marles do not teach the ratio of the blue agave inulin to the chicory root inulin is 3:1 on a weight-to-weight basis. However, it would have been obvious to choose the ratio to achieve desired taste.
Attention is invited to In re Levin, 84 USPQ 232 and the cases cited therein, which are considered in point in the situation of the instant case, and wherein the Court stated on page 234 as follows:
This court has taken the position that new recipes or formulas for cooking food which involve the addition or elimination of common ingredients, or for treating them in ways which differ from the former practice, do not amount to invention, merely because it is not disclosed that, in the constantly developing art of preparing food, no one else ever did the particular thing upon which the applicant asserts his right to a patent. In all such cases, there is nothing patentable unless the applicant by a proper showing further establishes a coaction or cooperative relationship between the selected ingredients which produces a new, unexpected, and useful function. In re Benjamin D. White, 17 C.C.P.A (Patents) 956, 39 F.2d 974, 5 USPQ 267; In re Mason et al., 33 C.C.P.A. (Patents) 1144, 156 F.2d 189, 70 USPQ 221.
Regarding claim 15, Tran further teaches the encapsulation particle is obtained by spray drying a homogeneous aqueous slurry obtained by emulsifying the active material, the unhydrolyzed rice protein and the carrier (blending an emulsion comprising a hydrophobic active with the probiotic-containing matrix precursor to form a probiotic-containing emulsion, expose to cross linking reagent to form microparticle Par. 0012-0013; microparticles may be spray dried with or without the presence of carrier Par. 0192; microparticle slurry Par. 0234)
Regarding claim 16, Tran further teaches the unhydrolyzed rice protein has a protein content of 25-80% by weight (Par. 0106)
As Tran discloses a range which overlaps with the claimed amount, it would have been obvious to one having an ordinary skill in the art to modify Tran to have at least 70% protein by weight in the unhydrolyzed rice protein. It would have been prima facie case of obviousness to have selected the overlapping portion of the range (i.e. 70-80%) from the taught range of 25-80% (as seen above). In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); See MPEP 2144.05 (I)
Regarding claim 17, Tran does not teach the unhydrolyzed rice protein is present in an amount of 5% to 20% by weight of the encapsulation particle. Tran does teach the protein has value in the invention as it creates chain interactions which contribute to the cohesion of the protective matrix (Par. 0111-0114) to better protect the active (Par. 0123). As such, one having ordinary skill in the art to modify the amount of unhydrolyzed rice protein in the matrix to suit diffusion preferences.
Response to Arguments
Applicant’s arguments, see Pg. 6-8, filed 04/27/2025, with respect to the rejection of claims 13 and 14 under 35 U.S.C. 112 have been fully considered and are persuasive. The rejections of claims 13 and 14 have been withdrawn.
Applicant's arguments filed 04/27/2025 have been fully considered but they are not persuasive.
Applicant argues Tran does not teach a discontinuous oil phase. As seen above, Tran teaches the matrix surrounds dispersed droplets of active, in which the active may be dissolved in lipid Par. 0177, 0048). Therefore, Tran does teach a discontinuous oil phase dispersed within the matrix.
Applicant argues Tran does not teach inulin. The examiner agrees Tran does not teach inulin, rather it is modified with Popplewell to teach the aspect of blue agave inulin and a chicory root inulin as the carrier (Par. 0015, 0079, see above rejection).
Applicant argues the cross linkable reagent of Tran distinguishes it from the presently claimed invention. The claimed invention does not prohibit the use of a cross linkable reagent. Further, the flavor delivery or flavor masking aspect is not claimed. Tran’s flavor masking is an optional characteristic in an embodiment. The invention of the prior art as seen above has the same encapsulation structure and water-dispersion properties as the claimed invention and therefore one would assume similar flavor masking.
Applicant argues the unhydrolyzed rice protein of Tran has undergone chemical modification, contrary to the claimed invention. As seen above, the protein of Tran undergoes denaturation so thiol groups can form disulfide cross-linkages which is effected by heat treatment (Par. 0113-0114). Therefore the cross linking of the proteins merely uses heat rather than an external chemical. The cross-linking reagent of Tran’s Par. 95-97 is used to create linkages with Ca2+(Par. 0073) as applicant noted on page 9 of arguments. Therefore, the cross linkable reagent is not taught to interact with the protein.
Applicant argues the present invention is water dispersible and has a water activity of less than 0.5. The rejection of claim 1 above has been modified to reject these newly added elements.
Applicant argues Tran teaches away from the claimed invention of allowing easier release of active materials in an aqueous solution. Tran teaches the same encapsulation structure and water-dispersion properties as the claimed invention. Tran teaches an invention which shows dissolution and/or disintegration in weak alkaline conditions such as pH above 6.7 (Par. 0074). This supports Tran teaching the claimed invention, not teaching away. The provided data of solubility using cross linking agents is not persuasive. The solubility is not claimed, just the ability to be water-dispersible, which Tran teaches.
Applicant argues Marles teaches crosslinking and does not teach rice protein. Marles is merely relied on for particle size, not particle structure, water-dissolution ability, or protein type.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Popplewell discloses a blue agave inulin and a chicory root inulin as suitable carriers (Par. 0015, Par. 0079). It would have been obvious to one having ordinary skill, at the time of filing, to modify the invention of Tran with the carrier of Popplewell as Popplewell teaches the use of inulins as carriers (Par. 0015). The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See MPEP 2144.07.
In response to applicant's argument that Popplewell is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Popplewell teaches a process of encapsulating a microparticle (Par. 0006) and therefore one would look to Popplewell for suitable carriers to try in the encapsulation product of Tran.
Applicant argues the invention of the prior art fails to disclose inulin as the sole carbohydrate matrix. The invention as claimed does not discount the use of additional carbohydrates such as trehalose or polyol. Further, modification with Popplewell renders obvious for one having ordinary skill in the art to use of inulin as the carrier of the invention.
Applicant argues Popplewell teaches away from spray drying. Tran teaches spray drying (Par. 0192), and therefore Popplewell is not relied on for this aspect.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Zasypkin (US 2019/0307156 A1) discloses encapsulated flavor products in which the flavor is encapsulated in a glassy matrix.
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 ARIEL M RODGERS whose telephone number is (571)272-7857. The examiner can normally be reached Monday - Friday 9:00 am - 6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Erik Kashnikow can be reached at 5712703475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.M.R./ Examiner, Art Unit 1792 /ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792
