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 .
This office action is in response to applicant’s submission dated August 17, 2026. Any objections and/or rejections made in previous actions and not repeated below are hereby withdrawn.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 August 17, 2026, has been entered.
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.
Claims 1, 3-6, 8-11, and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Marangoni (US 2019/0261644 A1).
With respect to claims 1, 8 and 9, Marangoni teaches a method for preparing a composition comprising ethylcellulose, that method comprising preparing a mixture of food-grade ethylcellulose in an edible oil, adding a surfactant, heating the mixture to a temperature above the glass transition temperature, and then adding to an excipient to the mixture at a ratio of 1:3 to 1:9 of the mixture:excipient. [0027-0035] In a specific embodiment, the mixture is heated to 140°C, mixed with chocolate, then poured into a mold and cooled. [0087] Additionally, Marangoni teaches the surfactant may be a polyoxyethylene sorbitan monooleate, [0068] also known as Tween 80 or Polysorbate 80.
Marangoni reads on the limitations of steps a, c, and d, and reads on the temperature limitation of step b, but does not teach the limitation of heating for at least 5 minutes. According to MPEP 2144.05, “where 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.” The instant invention recites no criticality for the time recited at the invention taught by Marangoni is heated at least for the amount of time required to bring the mixture up to temperature. One of ordinary skill in the art would have found it obvious to optimize the amount of time to heat the mixture in order to achieve the result of the polymer blend being completely dissolved in the oil phase, as taught by Marangoni. [0087]
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have used the teaching of Marangoni to form an edible, non-aqueous chew, comprising the steps of blending ethyl cellulose, an oleaginous composition, and polyoxyethylene sorbitan fatty acid ester (specifically polysorbate 80), heating the mixture to at least 140°C for at least 5 minutes, blending with an excipient to form a pourable liquid, and pouring said liquid into a mold in order to form a non-aqueous chew upon cooling, thereby rendering obvious claim 1, 8 and 9.
With respect to Claim 3, Marangoni teaches that the ethylcellulose may have a viscosity of 45 cP. [0087] Though this does not read on the limitation of an ethyl cellulose with a viscosity of exactly 50 cP-350cP, MPEP 2144.05 I states, “a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close”. 45cP is close to 50cP. Therefore, Marangoni renders obvious claim 3.
With respect to Claim 4, Marangoni teaches the ethylcellulose may have a final concentration of 3%. [0087], falling within the claimed range.
With respect to Claims 5, 6 and 14, Marangoni teaches the oil may be hydrogenated palm stearin, [0065] which is a fractionated portion of hydrogenated palm oil, and the use of an oleaginous composition comprising stearic acid. [0071] Therefore, Marangoni renders obvious claims 5, 6, and 14.
With respect to Claim 10, Marangoni teaches the surfactant may be present in the final composition at a concentration of 1%. [0087] Therefore, Marangoni renders obvious claim 10.
With respect to Claim 11, Marangoni teaches the excipient may be a chocolate, [0035] a composition known for comprising sugar and flavor. Therefore, Marangoni renders obvious claim 11.
With respect to Claim 15, Marangoni teaches a method for preparing a composition comprising ethylcellulose, that method comprising preparing a mixture of food-grade ethylcellulose in an edible oil, adding a surfactant, heating the mixture to a temperature above the glass transition temperature, and then adding to an excipient to the mixture at a ratio of 1:3 to 1:9 of the mixture:excipient. [0027-0035] In a specific embodiment, the mixture is heated to 140°C, mixed with chocolate, then poured into a mold and cooled. [0087]
Marangoni reads on the limitations of steps a, c, and d, and reads on the temperature limitation of step b, but does not teach the limitation of heating for at least 5 minutes. According to MPEP 2144.05, “where 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.” The instant invention recites no criticality for the time recited at the invention taught by Marangoni is heated at least for the amount of time required to bring the mixture up to temperature. One of ordinary skill in the art would have found it obvious to optimize the amount of time to heat the mixture in order to achieve the result of the polymer blend being completely dissolved in the oil phase, as taught by Marangoni. [0087]
Additionally, the instant claim uses the transitional phrase “consists of”, and MPEP 2111.03 II, states, “The transitional phrase "consisting of" excludes any element, step, or ingredient not specified in the claim”. The method taught by Marangoni as described above is taught to happen in the order recited in steps a through d and does not include any extraneous steps. [0033-36]
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have used the teaching of Marangoni to form an edible, non-aqueous chew, consisting of the steps of blending ethyl cellulose, an oleaginous composition, and polyoxyethylene sorbitan fatty acid ester, heating the mixture to at least 140°C for at least 5 minutes, blending with an excipient to form a pourable liquid, and pouring said liquid into a mold in order to form a non-aqueous chew upon cooling, thereby rendering obvious claim 15.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Marangoni (US 2019/0261644 A1) as applied to claim 1, as evidenced by Wasilewska (Ethylcellulose – a Pharmaceutical Excipient with Multidirectional Application in Drug Dosage Forms Development, www.mdpi.com).
With respect to Claim 2, Marangoni teaches the process of preparing an edible non-aqueous chew that renders obvious claim 1, as described above, but is silent to the ethoxyl concentration of the ethyl cellulose. Wasilewska teaches the physiochemical characteristics of ethyl cellulose, [Pg. 2, Sec. 2] specifically that ethyl cellulose contains 44-51% ethoxyl groups. [Pg. 2, Sec. 2, Par. 2] Therefore, Marangoni renders obvious claim 2.
Claims and 7 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Marangoni (US 2019/0261644 A1) as applied to claim 1, in view of Ergun et al. (US 2016/0081374 A1).
With respect to Claim 7, Marangoni teaches the invention recited in claim 1, as described above. Additionally, Marangoni teaches that the mixture of ethyl cellulose, polyoxyethyl sorbitan fatty acid esters, and oil comprises 76% oil, [0033] and the mixture is about 25% of the final product, [0035] resulting in 19% oleaginous composition. Marangoni is silent to a composition comprising between 30-80% by weight.
Ergun et al. teaches a process for making an oleogel that can be used in an invention, and specifically with ethyl cellulose. [0018] Ergun et al. teaches that the oleaginous material can be edible in the form of an oily feed, [0024] and can be mixed with Tween 80 to form a stable composition. [0049] Ergun et al. teaches that the composition comprising ethylcellulose and the oily feed composition comprises between 99-75% of the oleaginous material. [0031] Additionally, Ergun et al. teaches that the oleogel composition can serve as a healthy alternative to solid fats in food. [0018]
Marangoni and Ergun et al. exist within the same field of endeavor in that they teach compositions comprising polyester polymers and oleaginous components. Where Marangoni teaches a composition for use in chocolate compositions, Ergun et al. teaches an oleogel composition comprising oily feed and ethylcellulose. One would have been motivated to combine Ergun et al. with Marangoni in order to develop a healthier fat composition.
Using the teaching of both Marangoni and Ergun et al., one of ordinary skill in the art would have been able to conceive of a composition that incorporates the mixture of Marangoni between the primary 25% taught in the reference and the 99% taught in Ergun et al. MPEP 2144.05 I states, “A range can be disclosed in multiple prior art references instead of in a single prior art reference”. The range described above would incorporate a composition comprising 76% of an oleaginous composition between 25-99% by weight, resulting in a final composition of between 19-75.2% oleaginous composition. This amount overlaps with the range recited in the instant claim, and MPEP 2144.05 I states, “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists”.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant invention, to have used the teaching of Marangoni in view of Ergun et al. to have developed the invention according to claim 1, wherein the composition comprises between 30-80% by weight of an oleaginous composition, thereby rendering claim 7 obvious.
With respect to Claim 12, Marangoni teaches the invention recited in claim 1, as described above. Marangoni teaches the excipient may be 75% of the final composition, [0035] but is silent to the total composition comprising between 10-50% of excipients by weight.
Ergun et al. teaches a process for making an oleogel that can be used in an invention, and specifically with ethyl cellulose. [0018] Ergun et al. teaches that the oleaginous material can be edible in the form of an oily feed, [0024] and can be mixed with Tween 80 to form a stable composition. [0049] Ergun et al. also teaches that the oleogel composition can be incorporated into greater food products and can comprise between 1-95% by weight of the total composition. [0053] Additionally, Ergun et al. teaches that the oleogel composition can serve as a healthy alternative to solid fats in food. [0018]
Marangoni and Ergun et al. exist within the same field of endeavor in that they teach compositions comprising polyester polymers and oleaginous components. Where Marangoni teaches a composition for use in chocolate compositions, Ergun et al. teaches an oleogel composition comprising oily feed and ethylcellulose. One would have been motivated to combine Ergun et al. with Marangoni in order to develop a healthier fat composition
The range taught by Ergun et al. teaches a composition comprising between 1-99% excipients with relation to the base comprising an oleaginous material, ethyl cellulose, and a surfactant. MPEP 2144.05 I states, “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists”.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant invention, to have used the teaching of Marangoni in view of Ergun et al. to have developed the invention according to claim 1, wherein the excipients comprise between 10-50% by weight, thereby rendering claim 12 obvious.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Marangoni (US 2019/0261644 A1) as applied to claim 1, in view of Ruheena et al. (Soft Chewable Drug Delivery System: Oral Medicated Jelly and Soft Chew, Journal of Drug Delivery and Therapeutics).
With respect to claim 13, Marangoni teaches the process of preparing an edible non-aqueous chew that renders obvious claim 1, as described above, but is silent to the additional of pharmaceutical or nutritionally functional ingredients.
Ruheena et al. teaches that oral medications are advantageous for the administration of medicants due to the high patient acceptance, aesthetic appearance, and good texture. [Abstract] Additionally, Ruheena et al. specifically teaches that soft chews are advantages for the same reasons and can be used for localized and systemic treatment. [Pg. 69, Col. 1, Par. 4-5] Ruheena et al. teaches a method of formulating soft chews comprising heating components comprising fat and surfactants, mixing with a pharmaceutical ingredient, then cooling in a mold. [Pg. 71, Col. 2, Par. 4]
Marangoni and Ruheena et al. exist within the same field of endeavor in that they teach soft chews and the method of production. Where Marangoni teaches a chocolate flavored soft chew, Ruheena et al. teaches that soft chews can be used as pharmaceutical delivery mechanisms.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have combined the teaching of Marangoni with the teaching of Ruheena et al. to produce a soft chew according to the method recited in claim 1 with the incorporation of a pharmaceutical ingredient, thereby rendering obvious claim 13.
Response to Arguments
Applicant's arguments filed August 17, 2026, have been fully considered but they are not persuasive.
Applicant asserts on Page 6, Lines 19-20, that “The cited reference does not disclose or suggest heating the blend to a temperature not less than 140°C for at least 5 minutes, as is required by the current Applicant’s claims”, continuing on Page 7, Lines 4-5, that “The Marangoni reference does not teach, or suggest, that the duration of heating affects any relevant property of the process or product”.
Examiner respectfully disagrees with the assessment made by applicant that Marangoni does not trach a relevant effect of the heating duration of the method taught. On the contrary, Marangoni teaches that the duration of time is related to the amount of solids dissolved in the oleaginous composition and that undissolved solids results in an unappealing composition. [0012] Therefore, one of ordinary skill in the art would have been motivated to optimize the amount of time it would take to dissolve all the solids into the fat phase.
Additionally, the recitation of “at least 5 minutes” allows for 5 minutes and any amount of time greater than 5 minutes. In the interest of dissolving all the solids in the fat phase, it would be conducive to the success of the endeavor to increase the amount of time the composition remains heated. Therefore, it would also be obvious to one of ordinary skill in the art to have optimized toward a higher end of the amount of time required.
For these reasons, applicant’s assertion is found to be unpersuasive.
Applicant’s assertions with respect to claims 7 and 12 have been considered but are moot because the new ground of rejection relies on a new reference not applied in the prior rejection of record for the relevant teaching or matter specifically challenged in the assertion.
Applicant asserts on Page 8, Lines 24-25, with respect to claim 2, “The shortcomings of the primary reference have been noted above. The addition of the Wasilewska reference does not cure, or even address, those shortcomings”. Applicant also asserts, with respect to claim 13, on Page 9, Lines 5-6, “The shortcomings of the primary reference have been noted above. The addition of the Ruheena et al. reference does not cure, or even address, those shortcomings”.
Applicant has not overcome the rejection of claim 1 and presents no specific arguments regarding the secondary references.
Conclusion
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 JOSEPH CULLEN MERCHLINSKY whose telephone number is (571)272-2260. The examiner can normally be reached Monday - Friday 9:00am - 5:00pm.
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/J.C.M./Examiner, Art Unit 1791
/Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791
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