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 08/05/2025, 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 Rejections under 35 U.S.C. 112 have been withdrawn, and new rejections under 35 U.S.C. 112 can be found below.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 13-14 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 13 recites “the ratio of the blue agave inulin to the chicory root inulin in 2.25:1 on a weight-to-weight basis”. There is not support for this limitation in the disclosure as originally filed. Applicant points to Table 4 for support of this new claim, yet Table 4 supports amounts of blue agave inulin and chicory root of 2700g and 1200g respectively. This cannot support a claim of a 2.25:1 ratio outside of these disclosed amounts. For example, the Table 4 does not support an invention with 2.25g of blue agave inulin and 1g of chicory root inulin.
Similarly, claim 14 recites “the ratio of the blue agave inulin to the chicory root inulin in 3:1 on a weight-to-weight basis”. There is not support for this limitation in the disclosure as originally filed. Applicant points to Table 4 for support of this new claim (examiner believes they intended to point to Table 1), yet Table 1 supports amounts of blue agave inulin and chicory root of 3986g and 1340g respectively. This cannot support a claim of a 3:1 ratio outside of these disclosed amounts. For example, the Table 4 does not support an invention with 3g of blue agave inulin and 1g of chicory root inulin.
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 and a carrier (protective matrix precursor comprising denatured protein, polyol plasticizer, trehalose, and a carrier Par. 0010; rice protein may be used to have less allergic responses Par. 0105). It is noted that par. 0007 of applicant’s specification filed 07/15/2022 lists denatured rice protein as an unhydrolyzed protein.
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.
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.
Response to Arguments
Applicant's arguments filed 08/05/2025 have been fully considered but they are not persuasive.
Applicant argues Tran and Marles fail to teach the newly added limitations. Examiner agrees and Popplewell has been applied to teach these aspects.
Applicant argues Tran and Marles fail to teach the ratios of active material to unhydrolyzed rice protein. As seen above, Tran does teach the ratio between the active material and the unhydrolyzed rice protein is 4.2:1 (Par. 0198-0202, Par. 0209-0217). A specific example in the prior art which is within a claimed range anticipates the range. Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985). See MPEP 2131.03.
Applicant argues Tran and Marles require their matrices to be cross linked, unlike the claimed invention. As claimed, the present invention does not discount the use of cross linking, and the examiner asserts the final product of Tran modified by Marles (and now Popplewell as amended above) is the same as the present invention as claimed. The examiner urges applicant to amend the claims to reflect any structural differences in the final product as a result of the lack of cross linking.
Applicant argues Tran teaches a core/shell structure, contrary to the dispersed core structure of the present invention. Examiner notes that the core structure as claimed is “a matrix material encapsulating an oil phase including the active material” and “the active material is dispersed within the matrix material”. Tran teaches hydrophobic active may be partially or fully encapsulated within the denatured protein of the protective matrix (Par. 0137), which renders obvious “a matrix material encapsulating an oil phase including the active material”. Tran further teaches blending together a probiotic, the protective matrix precursor composition and a cross-linkable reagent (Par. 0012), which renders obvious “the active material is dispersed within the matrix material”. If the active material is blended with the matrix material, the active material is then dispersed within the matrix material. Further, Tran teaches the probiotic is distributed within the matrix. The terms disperse and distribute can reasonably both be taken to mean to spread out. As such, the teachings of Tran render the structure as claimed obvious.
Conclusion
THIS ACTION IS MADE FINAL. 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