DETAILED ACTION
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 the Application
Receipt of the Request for Continued Examination (RCE under 37 CFR 1.114), the Response, and Amendment filed 11/03/2025 is acknowledged.
Applicant has overcome the following rejections by cancellation of the claims: (1) the warning to claim 24 has been withdrawn; (2) the 35 U.S.C. §112(a) rejection of claim 25 has been withdrawn; and (3) the 35 U.S.C. §103 rejection of claim 1 over Porzio, Chen, and Toth has been withdrawn.
The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 23-24
Withdrawn claims: None
Previously cancelled claims: 2-22
Newly cancelled claims: 1, 25
Amended claims: 23
New claims: None
Claims currently under consideration: 23-24
Currently rejected claims: 23-24
Allowed claims: None
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/03/2025 has been entered.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Porzio (Porzio, M., “Advances in Flavor Encapsulation”, 2012, Food Technology, vol. 66, no. 6; PDF page numbers relied on for citations; previously cited) in view of Chen (US 2002/0127303; previously cited) as evidenced by Uhlemann (Uhlemann et al., “Flavor Encapsulation Technologies: An Overview Including Recent Developments”, 2002, Perfumer & Flavorist, vol., 27, pages 52-61).
Regarding claim 23, Porzio teaches a carbohydrate-based, flavor-containing granule formulation (corresponding to spray dried encapsulated flavors containing polymers and mono- and disaccharides) containing maltodextrin, maltose, modified starch, and flavors (page 1, 1st column , paragraph under “Spray Drying”- page 1, 2nd column, 1st paragraph; page 3, 3rd column, 2nd paragraph). Porzio teaches that the formulation comprises flavors in an amount of 10-20 wt.% (page 3, Table 1, 1st row), which falls within the claimed concentration of flavors. Porzio teaches that the encapsulated flavor may be oil-soluble (page 3, Table 1, 1st row) and that the encapsulation technology is known in the flavor art as well as the pharmaceutical art (page 7, 1st column, 2nd paragraph). Flavor encapsulation provides stabilization of volatile (corresponding to labile) ingredients and protection against external influences such as oxidation as evidenced by Uhlemann (page 52, 2nd column, 4th paragraph -page 53, 1st column, 1st paragraph). Therefore, it is presumable that the encapsulated flavor granule formulation of Porzio provides oxidative/volatile flavor stability and structure as presently claimed.
Porzio does not disclose that the formulation comprises: the claimed amount of modified starch; lecithin in the claimed amount; or the combined amount of maltodextrin and maltose and their weight ratio.
However, Chen teaches a spray dried encapsulation granule formulation [0019] wherein the encapsulant is a fat-soluble substance [0001]; and the formulation contains the disaccharide maltose in an amount of about 30 wt.% to about 95 wt.% [0009]-[0010]; maltodextrin in an amount of about 5 wt.% to about 35 wt.% [0011]; modified starch in an amount of about 0.1 wt.% to about 30 wt.% [0013], [0016]; and lecithin in an amount of 0.1 wt.% to about 15 wt.% [0014], [0016]. Chen also teaches that weight ratios of maltose to maltodextrin in its formulation include 1:1 (corresponding to the weight ratio of maltose to Maltrin M100 in Example 2 of Table 1 on page 3), which falls within the claimed range. The disclosed amounts of modified starch and lecithin overlap the claimed concentrations. The disclosed amounts of maltose and maltodextrin provide a range of concentrations of maltose and maltodextrin which overlap the claimed combined concentration of maltose and maltodextrin. The selection of a value within the overlapping ranges renders the claimed concentrations obvious. MPEP §2144.05.
It would have been obvious for a person of ordinary skill in the art to have modified the formulation of Porzio by providing maltose, maltodextrin, modified starch, and lecithin in the amounts taught by Chen. Since Porzio teaches that its formulation contains maltodextrin, maltose, modified starch, and oil-soluble flavors (page 1, 1st column , paragraph under “Spray Drying”- page 1, 2nd column, 1st paragraph; page 3, 3rd column, 2nd paragraph), but does not disclose an amount of maltodextrin, maltose, or modified starch in the formulation, a skilled practitioner would have been motivated to consult an additional reference such as Chen in order to determine suitable amounts of maltose, maltodextrin, and modified starch to include in the formulation, thereby rendering the claimed amount of modified starch, the claimed combined amount of maltose and maltodextrin, and the claimed weight ratio of maltose and maltodextrin obvious. In consulting Chen, the skilled practitioner would also find that the inclusion of lecithin in the disclosed amount is beneficial for use with fat-soluble substances in encapsulation formulations [0007], thereby rendering the claimed lecithin and its concentration obvious.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Porzio (Porzio, M., “Advances in Flavor Encapsulation”, 2012, Food Technology, vol. 66, no. 6; PDF page numbers relied on for citations; previously cited) in view of Chen (US 2002/0127303; previously cited) as applied to claim 23 above, in further view of Toth (US 2007/0184163; previously cited; previously cited) as evidenced by Uhlemann (Uhlemann et al., “Flavor Encapsulation Technologies: An Overview Including Recent Developments”, 2002, Perfumer & Flavorist, vol., 27, pages 52-61).
Regarding claim 24, modified Porzio teaches the invention as described above in claim 23, including that its encapsulation technology is known in the flavor art as well as the pharmaceutical art (Porzio, page 7, 1st column, 2nd paragraph).
Porzio does not teach that the formulation contains derivatized cellulose or a salt thereof in the claimed amount as an anti-caking agent.
However, Toth teaches that anti-caking agents which improve flow properties by absorbing moisture from the environment are known in the pharmaceutical art. Toth demonstrates this disclosure by referencing a patented invention comprising a powder containing 2-60 wt.% of a derivatized cellulose or salt thereof (corresponding to methylcellulose or an alkali metal salt of carboxymethylcellulose) as an anti-caking agent [0003], which overlaps the claimed concentration. The selection of a value within the overlapping range renders the claimed concentration obvious. MPEP §2144.05.
It would have been obvious for a person of ordinary skill to have modified the formulation of Porzio by including 2-60 wt.% of modified cellulose or salt thereof as the anti-caking agent as taught by Toth. Since Porzio discloses that its encapsulation technology is known in the flavor art as well as the pharmaceutical art (page 7, 1st column, 2nd paragraph) and Toth discloses that anti-caking agents which improve flow properties by absorbing moisture from the environment are known in the pharmaceutical art [0063], a skilled practitioner would have readily recognized that anti-caking agents may be used in the encapsulation formulation of Porzio as well, thereby rendering the claimed anti-caking agent and its concentration obvious.
Response to Amendment
The Declaration under 37 CFR 1.132 filed 11/03/2025 is insufficient to overcome the rejection of claims 23-24 based upon the combination of Porzio and Chen or the combination of Porzio, Chen, and Toth as set forth in the last Office action.
Applicant stated that extrusion of formulations comprising the claimed weight ratios of maltose to maltodextrin and extrusion of formulations comprising weight ratios of maltose to maltodextrin outside of the claimed range were performed to demonstrate the criticality of the claimed ratios. Applicant stated that formulations comprising weight ratios of maltose to maltodextrin outside of the claimed range could not be processed in the extruder as the formulations resulted in an inconsistent flow through the die of the extruder and a clear separation of flavor oil from the other ingredients in the formulation. Applicant stated that formulations comprising the claimed weight ratios of maltose to maltodextrin could be processed well in the extruder. Applicant argued that the results provided by the claimed weight ratio of maltose to maltodextrin represented surprising and unexpected results that overcome the obviousness rejections (Declaration, paragraphs 3-14).
However, as pointed out during the interview on 10/16/2025, the present claims are directed toward a composition, not a method; and extrusion is not mentioned in the claims. Therefore, the claimed formulation may be made by any process (e.g., spray drying) so that the asserted surprising and unexpected results may not be observed in the formulation. Therefore, Applicant’s arguments are moot and the Declaration is insufficient to overcome the obviousness rejections.
Response to Arguments
Claim Warning: Applicant canceled claim 1; therefore, the claim warning is withdrawn.
Claim Rejections – 35 U.S.C. §112(a) of claim 25: Applicant canceled claim 25; therefore, the rejection is withdrawn.
Claim Rejections - 35 U.S.C. §103 of claim 1 over Porzio, Chen, and Toth: Applicant canceled claim 1; therefore the rejection of claim 1 is withdrawn.
Claim Rejections – 35 U.S.C. §103 of claim 23 over Porzio and Chen; claim 24 over Porzio, Chen, and Toth: Applicant’s arguments have been fully considered and are considered unpersuasive.
Applicant canceled claim 1. Applicant amended claim 23 to recite that the formulation is “for providing oxidative/volatile flavor stability and structure”. Applicant argued that the uses of Chen’s formulation are different from the use of the presently claimed formulation as the formulations of Chen can be used for “multivitamin tablets, hard gelatin capsules and dry food and feed compositions” and that the formulations of Chen “can be mixed directly without using any adhesive with sugar”. Applicant argued that the problem addressed by Chen was to improve the stability of fat soluble substances under regular storage conditions while the problem addressed by the present invention is to provide oxidative/volatile flavor stability and structure. For this reason, Applicant argued that skilled practitioner would not have had reason to select Chen to modify Porzio because Chen deals with a different problem than the presently claimed invention (Applicant’s Remarks, page 5, 1st paragraph under section II – page 6, 4th paragraph).
However, the Examiner points out that the goal of Chen is to encapsulate volatile substances (i.e., fat-soluble substances) in a matrix to improve stability of that volatile substance during storage [0001], [0004]-[0005] while the present invention also seeks to provide stability for volatile substances. Therefore, the goal of Chen is not dissimilar from the purpose of the presently claimed invention.
Furthermore, the primary reference Porzio discloses the encapsulation of oil-soluble substances such as flavor oils (page 1, column 1, paragraph under “Spray Drying”; page 4, columns 2-3; page 6, column 1, paragraph under “Complex Coacervation”). Flavor encapsulation provides stabilization of volatile (corresponding to labile) ingredients and protection against external influences such as oxidation as evidenced by Uhlemann (page 52, 2nd column, 4th paragraph -page 53, 1st column, 1st paragraph). Therefore, it is presumable that the encapsulated flavor granule formulation of Porzio provides oxidative/volatile flavor stability and structure as presently claimed.
Since Porzio teaches that its formulation contains maltodextrin, maltose, modified starch, and oil-soluble flavors (page 1, 1st column, paragraph under “Spray Drying”- page 1, 2nd column, 1st paragraph; page 3, 3rd column, 2nd paragraph), but does not disclose an amount of maltodextrin, maltose, or modified starch in the formulation, a skilled practitioner would have been motivated to consult an additional reference such as Chen in order to determine suitable amounts of maltose, maltodextrin, and modified starch to include in the formulation, thereby rendering the claimed amount of modified starch, the claimed combined amount of maltose and maltodextrin, and the claimed weight ratio of maltose and maltodextrin obvious.
Applicant then argued that the Examiner used impermissible hindsight to arrive at the present invention as the Examiner has not explained how Chen is modified to arrive at the presently claimed weight ratio of maltose to maltodextrin. Applicant argued that Chen discloses a realm of possibilities comprising an undisclosed amount of low-molecular weight carbohydrates such as maltose optionally combined with high-molecular weight carbohydrates such as maltodextrin, but that Chen does not specifically disclose a combination of maltose and maltodextrin. Applicant provides three options of Chen’s formulations (as best interpreted by the Examiner): (1) a formulation containing 1-40 wt.% fat-soluble substance, 0.1 wt.% to about 30 wt.% emulsifier, and a carbohydrate matrix composed of maltose or maltose syrup or a mixture of low-molecular weight carbohydrates; (2) a formulation containing 1-40 wt.% fat-soluble substance, 0.1 wt.% to about 30 wt.% emulsifier, and a carbohydrate matrix composed of 0.1 wt.% to about 50 wt.% high-molecular weight carbohydrates only; and (3) a formulation containing 1-40 wt.% fat-soluble substance, 0.1 wt.% to about 30 wt.% emulsifier, a carbohydrate matrix composed of 0.1 wt.% to about 50 wt.% high-molecular weight carbohydrates only, and about 0.1 wt.% to about 15 wt.% antioxidants. Applicant argued that these three options do not represent “a finite number of identified, predictable solutions with a reasonable expectation of success” as Chen discloses (a) an optional inclusion of high-molecular weight carbohydrates in a broad weight range wherein maltodextrin is only one option for the high-molecular weight carbohydrate amongst a list of options; and (b) a third option which optionally includes antioxidants wherein lecithin is only one option for antioxidants amongst a list of options (Applicant’s Remarks, page 6, 5th paragraph – page 9, 4th paragraph).
However, the Examiner points out that Chen does not disclose any formulation wherein only high-molecular weight carbohydrates are used in the carbohydrate matrix, but instead discloses a formulation comprising maltose/maltose syrup/a mixture of low-molecular weight carbohydrates in combination with high-molecular weight carbohydrates (i.e., “maltose or maltose syrup, or a mixture of low-molecular weight carbohydrates, optionally in combination with 0.1 wt% to about 50 wt% of a high-molecular weight carbohydrate”). Therefore, formulation (2) as asserted by the Applicant and as understood by the Examiner is not disclosed by Chen.
The Examiner also points out that Chen states that the carbohydrate matrix of its formulation may comprise the low-molecular weight carbohydrate in an amount of about 30 wt.% to about 95 wt.%; and further comprise the high-molecular weight carbohydrate in an amount of about 5 wt.% to about 35 wt.% and an antioxidant in an amount of about 0.1 wt.% to about 15 wt.% , wherein the low-molecular weight carbohydrate may be maltose, the high-molecular weight carbohydrate may be maltodextrin, and the antioxidant may be lecithin [0006], [0009]-[0011], [0014]. Since Chen exemplifies maltose, maltodextrin, and lecithin in specific amounts, Chen at least suggests that its formulation may comprise a combination of lecithin, maltose, and maltodextrin in amounts and weight ratios which overlap the presently claimed amounts and weight ratio such as a weight ratio of maltose to maltodextrin of 1:1 (which falls within the claimed weight ratio range), even if Chen does not specifically disclose a combination of lecithin, maltose, and maltodextrin. Since Chen exemplifies lecithin, maltose, and maltodextrin, not only does Chen provide a finite number of identified, predictable solutions with a reasonable expectation of success, but Chen discloses species. When the species is clearly named, the species claim is anticipated no matter how many other species are additionally named. MPEP §2143.I.E and §2131.02.II.
The Examiner also points out that Chen does disclose formulations which comprise combinations of maltose and maltodextrin (i.e., Maltrin M100); therefore, Chen does specifically disclose maltose as being used in combination with maltodextrin. Chen also discloses a weight ratio of maltose to maltodextrin of 1:1 in Example 2 which does fall within the claimed weight ratio range. Therefore, Chen discloses a weight ratio of maltose to maltodextrin which falls within the claimed range, which supports the Examiner’s stance that Chen discloses the claimed weight ratio, thereby rendering the claimed ratio obvious.
Applicant stated that most of the examples in Chen include amounts of maltose and maltodextrin which lie outside of the claimed ranges and that Chen provides only one example wherein the weight ratio of maltose to maltodextrin falls within the claimed range (i.e., weight ratio of 1:1). Applicant argued that a skilled practitioner would not be guided by the teachings of Chen to arrive at the claimed ratio in view of the surprising and unexpected results demonstrated by ratio when Chen does not disclose maltose and maltodextrin being combined together (Applicant’s Remarks, page 9, 5th paragraph – page 11, 2nd paragraph).
However, it is unclear as to why a skilled practitioner would not be motivated to use the weight ratio of maltose to maltodextrin of 1:1 when Chen specifically discloses such a weight ratio. If such a ratio provided a benefit to the formulation, as is asserted by the Applicant, a skilled practitioner would be further motivated to use a ratio of 1:1 in order to provide the asserted benefit to the resulting formulation.
Applicant then pointed to the Declaration filed 11/03/2025 to demonstrate the surprising and unexpected results provided by the claimed weight ratio of maltose to maltodextrin (Applicant’s Remarks, page 11, 3rd paragraph – page 15, 3rd paragraph).
See the section above labeled “Response to amendment”.
Since the prior art has been shown to render the present claims obvious and Applicant’s arguments have been shown to be unpersuasive, the rejections of claims 23-24 are maintained as written herein. The rejection of claim 1 is withdrawn due to the cancelation of the claim.
Conclusion
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/KELLY P KERSHAW/Examiner, Art Unit 1791
/Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791