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 February 17, 2026. Any objections and/or rejections made in the previous action, and not repeated below are hereby withdrawn.
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 and 3-12 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, 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.
With respect to Claim 3, Marangoni teaches that the ethylcellulose may have a viscosity of 45 cP. [0087] This reads on the limitation of an ethyl cellulose with a viscosity of about 50 cP. 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 and 6, Marangoni teaches the oil may be hydrogenated palm stearin, [0065] which is a fractionated portion of hydrogenated palm oil. Therefore, Marangoni renders obvious claims 5 and 6.
With respect to Claim 7, 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.
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.” One of ordinary skill in the art would have found it obvious to modify the amount of oleaginous composition in the final product in order to produce a chew with desirable qualities of flavor and texture. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have modified the teaching of Marangoni of an edible, non-aqueous chew to have an oleaginous composition concentration of between 30-80%, thereby rendering claim 7 obvious.
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 12, Marangoni teaches the excipient may be 75% of the final composition. [0035]
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.” One of ordinary skill in the art would have found it obvious to modify the amount of excipient in the final product in order to produce a chew with desirable qualities of flavor and texture. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have modified the teaching of Marangoni of an edible, non-aqueous chew to have an excipient concentration of between 10-50%, thereby rendering claim 12 obvious.
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.
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 February 17, 2026 have been fully considered but they are not persuasive.
Applicant asserts on Page 8, lines 10-14, “Marangoni does not disclose any minimum heating duration, nor does it identify heating time as affecting polymer dissolution, texture, gel formation, or chew properties. Rather, Marangoni teaches heating until dissolution is achieved” and continues on lines 16-17, “there is no basis to conclude that extending heating to ‘at least 5 minutes’ would have been obvious”.
Applicant is directed to MPEP 2144.01, which states, “[I]n considering the disclosure of a reference, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom”. In absence of an explicit teaching of the amount of time required to dissolve the polymer blend in the oil phase, the time required for dissolution would have been optimized based on the polymer blend. It would be reasonable for one of ordinary skill in the art to have optimized the time required to heat the oil phase and dissolve the polymer blend to be a time between 5 minutes and infinity.
Applicant asserts on Page 9, lines 8-11, with respect to claim 2, “The shortcomings of the primary reference have been noted above. The addition of the Wasilewska et al. reference does not cure, or even address, those shortcomings. The cited references, either taken alone or in combination, do not disclose or suggest all of the limitations of the claims as amended herein”. Applicant also asserts, with respect to claim 13, on lines 19-21, “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. The cited references, either taken alone or in combination, do not disclose or suggest all of the limitations of the claims as amended herein”.
Applicant has not overcome the rejection of claim 1, and presents no specific arguments regarding the secondary references.
For this reason and those enumerated above, applicant’s assertions have been found to be unpersuasive and the rejections of claims 1-13 are maintained.
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.
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/J.C.M./Examiner, Art Unit 1791
/Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791