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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 September 15, 2026 has been entered.
Status of Claims
Claims 1, 5-11, 15-20 and 22-26 are pending in this application. Claims 2-4, 12-14 and 21 are canceled. Claims 1, 17 and 22 are amended.
Claim 6, 11, 15, 23 and 25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention or species, there being no allowable generic or linking claim.
Claims 1, 5, 7-10, 16-20, 22, 24 and 26 are examined in light of the elected species of gelatin and water.
Previous Rejections
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn as are those rejections and/or objections expressly stated to be withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Rejections Withdrawn
Claim Rejections - 35 USC § 101
In light of the amendments to the claims the rejection of claims 1, 5, 7-10, 16-20 and 24 under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more is withdrawn.
Claim Rejections - 35 USC § 103
Upon further consideration the rejection of claims 1, 2, 5, 7-10, 16, 19, 20, 22, 24 and 26 under 35 U.S.C. 103 as being unpatentable over Pan et al. (“Pan”, US 2006/0263412, cited by Applicant in the IDS filed 12 April 2022) in view of Arfsten et al. (“Arfsten”, US 2014/0154394), Chen et al. (“Chen”, US 2010/0062988), and Kulkarni et al. (“Kulkarni”, US 20080020024), as evidenced by Norwell (product information for MOI-STIR®) is withdrawn.
New Rejections
Claim Interpretation
Claim 22 recites, “plant-based oil.” No limiting definition is provided for “plant-based oil” in the specification as originally filed. The Examples in the specification incorporate the material “Wecobee M” by Stepan, described as “a triglyceride derived from fully hardened palm kernel oil” (as evidence, see Wecobee M Product Bulletin, page 1). Therefore, the phrase “plant-based oil” is construed according to its broadest reasonable interpretation, to include oils derived directly from a plant (e.g., coconut oil), as well as components thereof (e.g., triglycerides).
Claim Rejections - 35 USC § 103
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.
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, 5, 7-10, 16, 19, 20, 22, 24 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Pan et al. (“Pan”, US 2006/0263412, cited by Applicant in the IDS filed 12 April 2022) in view of Arfsten et al. (“Arfsten”, US 2014/0154394), Chen et al. (“Chen”, US 2010/0062988) and Capdepon et al. EP3570680 (1/19/2018) as evidenced by Norwell (product information for MOI-STIR®).
Pan teaches a confectionery product for delivering of at least one active for preventing, reducing or alleviating the symptoms of dry mouth comprising a water dissolvable or erodible shell comprising a saliva stimulating agent; and a core component comprising a saliva substitute and optionally, a saliva stimulating agent (e.g., see paragraphs [0006] - [0010]). The core may be in a solid state form (e.g., paragraph [0017]). The confectionary product can be in the form of a lozenge (e.g., paragraph [0039]), and therefore may be solid set (i.e., does not flow at room temperature).
The core and shell may also include fats and oils as a core fill component (e.g., paragraph [0018]), and/or as taste masking agents, such as hydrogenated coconut oils (e.g., paragraph [0035]). Pan expressly teaches that fats and oils such as medium chain triglycerides are useful as core fill components. (See [0018]). Triglycerides are called for in instant claim 1. Other materials that may be added to the core and/or shell include viscosity modifying agents and demulcents, (i.e., throat coating agents) (e.g., paragraph [0033]), such as pectin and gelatin (e.g., paragraph [0036]). Pan teaches that emulsifiers are an optional ingredient and are therefore not required. (See [0034]).
Pan teaches water can be present in the core fill components at levels from about 5% to about 95% by weight of the fill component (e.g., paragraph [0025]). The fill component is not the entire article but is present at an amount of up to 75% by weight. (See [0017]). Therefore, water may be present at an amount of from about 3.75% to about 71.25% (75% of 5% to 95%) of the entire article. 3.75% to about 71.25% overlaps with the not less than 12% but not greater than 35% called for in instant claims 1, 17 and 21. 3.75% to about 71.25% also overlaps with the not less than 20 wt% called for in instant claim 7.
Pan does not specifically teach wherein the article comprises an amount of triglycerides or plant-based oil of 32 wt-% to 57 wt-% (claims 1 and 21-22) or gelatin or a solid-set homogeneous composition. These deficiencies are made up for with the teachings of Arfsten, Chen and Capdepon.
However, Arfsten teaches a filling composition (e.g., abstract). The filling composition may be sweet, e.g. a confectionery filling (e.g., paragraph [0068]). Typical sweet filling composition may comprise solid fats (e.g., paragraph [0071]). Typical solid fats include hydrogenated oils (e.g., paragraph [0072]). Examples of hydrogenated oils include hydrogenated vegetable oil (e.g., paragraphs [0004] and [0005)). Hydrogenated oils are called for in instant claims 1.
Chen teaches a chewable composition comprising a wax-like agent (e.g., abstract). Suitable wax-like agents include hydrogenated vegetable oil (e.g., paragraph [0071]). The wax-like agent is present in the range of from about 1% to about 80% (e.g., paragraph [0075)). 1 to 80% overlaps with the 32 to 57% called for in instant claims 1, 21 and 22.
Capdepon et al. (Capdepon) teaches gelatin based solid gummy candies. (See Abstract and [0004]). Capdepon teaches that the liquid candy composition comprises most preferably 7-9 wt% gelatin. (See claim 7). 7-9 wt% gelatin overlaps with the from 6 to 10% gelatin called for in instant claims 1 and 22. Capdepon teaches that this amount of gelatin in the liquid composition causes the liquid composition to set and to become a solid gummy. (See [0022]). A solid-set homogeneous composition is called for in instant claims 1 and 22.
With respect to the plant-based oil to gelatin weight ratio (called for in claims 22 and 24), Capdepon teaches 7-9% gelatin and Chen teaches about 1% to about 80% hydrogenated vegetable oil. 1/7 = 0.14 which is less than 7.5 as called for in instant claims 1 and 17. 1/7 = 0.14 which is less than 15 as called for in instant claim 22.
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Pan teaches wherein the product comprises fats and oils. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated hydrogenated vegetable oil into the product since it is a known and effective oil for confectionery compositions as taught by Arfsten.
It would have been prima facie obvious to one of ordinary skill in the art before the earliest effective filing date making the Pan article to have incorporated about 1% to about 80% hydrogenated vegetable oil into the product since this is a known and effective amount of hydrogenated vegetable oil for edible compositions as taught by Chen.
It would have been obvious to a person having ordinary skill in the art before the earliest effective filing date to include 7-9% gelatin as taught by Capdepon in order to allow for the ideal gelling of gelatin containing compositions as taught by Capdepon.
Regarding claims 8 and 9, Pan teaches optional ingredients include sweeteners such as sugar alcohols such as sorbitol, xylitol, and mannitol (polyol sweeteners), and vitamins such as E and B12 (e.g., paragraph [0031]).
Regarding claim 10, it is noted the claim recites intended uses of the article, and does not impart any additional structural limitations apart from what is already claimed. Since Pan already teaches its compositions delivers at least one active for preventing, reducing or alleviating the symptoms of dry mouth (e.g., paragraph [0006]), the compositions are capable of at least one of the recited uses.
Regarding claim 16, Pan teaches other optional but compatible materials that may be added to the core and/or shell include viscosity modifying agents (i.e., thickeners) and emulsifiers (e.g., paragraphs [0018], [0034]).
Regarding claims 19 and 20, Pan teaches ingredients may include polyol sweeteners (e.g., paragraph [0031]), mineral elements including magnesium, which can be supplied as dibasic potassium phosphate (e.g., paragraph [0031]). While Pan does not specifically recite “magnesium chloride”, Pan teaches magnesium as a useful mineral element, and also teaches suitable saliva substitutes include MOI-STIR®, which includes magnesium chloride (as evidence, see Norwell product information for Moi-stir®, page 1), and thus the skilled artisan would find it obvious to include magnesium in the composition of the prior art.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Pan in view of Arfsten, Chen, and Capdepon as applied to claims 1, 5, 7-10, 16, 19, 20, 22, 24 and 26 above, and further in view of Lorenzi et al. (“Lorenzi”, 2006/0188612).
The inventions of Pan, Arfsten, Chen, and Capdepon are delineated supra.
Specifically regarding claim 17 (and more generally regarding the remaining claims), the combined prior art of Pan, Arfsten, Chen, and Capdepon do not specifically teach a thickener which is fumed silica.
However, Lorenzi teaches centre-filled hard boiled candies, wherein the filling comprises a thickener (e.g., abstract). Suitable thickeners include fumed silica (e.g., paragraph [0018]). Pan teaches wherein the product comprises viscosity modifying agents. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art before the earliest effective filing date to have incorporated fumed silica into the product of Pan since this is a known and effective viscosity modifying agent for a confectionery composition, as taught by Lorenzi.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Pan in view of Arfsten, Chen, and Capdepon as applied to claims 1, 5, 7-10, 16, 19, 20, 22, 24 and 26 above, and further in view of Piatko et al. (“Piatko”, US 2014/0170289).
The inventions of Pan, Arfsten, Chen, and Capdepon are delineated supra.
Specifically regarding claim 18 (and more generally regarding the remaining claims), the combined prior art of Pan, Arfsten, Chen, and Capdepon do not specifically teach an emulsifier such as polyglyceryl-6 distearate.
However, Piatko teaches edible compositions comprising fats including hydrogenated vegetable oils (e.g., abstract; paragraph [0009]) in amounts of 5-40% (e.g., paragraph [0032]). The compositions further comprise an emulsifier (e.g., paragraph [0008]) including Polyaldo HGDS, i.e. polyglyceryl-6 distearate (e.g., paragraph [0032]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the earliest effective filng date to have incorporated polyglyceryl-6 distearate into the product of Pan since this is a known and effective emulsifier for an edible composition containing hydrogenated vegetable oil, as taught by Piatko.
Response to Remarks
Applicants’ arguments of September 15, 2026 have been fully considered and are found to be persuasive or moot as described further below.
Applicants note the amendments to the claims and where support can be found for the amendments.
Section 101 Rejections
Applicants address the section 101 rejections by asserting that claim 1 should be evaluated as a whole and asserting that the analysis does not meaningfully address the recited article as whole.
Applicants assert that pending claim 1 does not merely recite plant-based oil or gelatin in isolation. Amended claim 1 recites a resultant article defined by a formulation window and by physical features of the article. Applicants submits that the recited article is not a plant, not an unmodified oil as found in nature and not gelatin as found in nature. Applicants reassert that combinations of naturally-occurring products are not precluded from patentability under Sec. 101, and a homogenized solid-set oral article of oil, water and gelatin in the specified amounts has a distinct physical form than any of the naturally occurring components.
Applicants assert that Examples 11 and 12 compared to Comparative Examples 8 and 9, each having 6% gelatin, differ by the oil-to-gelatin ratio. There is too much oil within Comparative Examples 8 and 9 to form a homogenous article. The application thus describes successful articles within the claimed formulation window and unsuccessful articles outside the useful window.
Applicants submit that claim 1 integrates any alleged judicial exception into a practical application, namely a specific manufactured oral article having concrete structural and physical features and assert that the Office does not explain why this article fails to qualify as a practical application.
However, Applicants note that claim 2 was not included in the Sec 101 rejection and further note that the limitations of claim 2 have been included in claim 1 and claim 2 has been canceled.
Response
In light of the amendments to the claims the 101 rejections are withdrawn above. In light of the amendments and the withdrawal of the the 101 rejections Applicants arguments are moot.
Obviousness Rejections
Applicants assert that the combination of the cited documents does not teach or suggest all of the claimed features, specifically gelatin present in an amount from 6 wt% to 10 wt%. Applicants argue that the maximum disclosed amount is 5% in the cited prior art of Kulkarni and there is no disclosure or suggestion of any benefit from increasing that amount. Applicants assert that the Office Action’s stated rationale does not support an assertion of results-effective variable with respect to the oil-to-gelatin weight ratio called for in the claims.
Applicants argue that Pan’s shell-and-core product does not teach the solid-set and homogeneous article recited in the claims. Applicants also argue that there is no teaching identified in Pan that gelatin can cause the core and shell to form a homogenous article. Therfore Pan does not teach the feature wherein the article is solid set and homogeous.
Applicants argue that nothing in the Pan disclosure would have led a skilled artisan to select fats/oil, gelatin and water for use in combination with any expectation of achieving a solid-set homogeneous article at the claimed oil-to-gelatin or oil-to-agar weight ratios. Nothing in the Pan disclosure suggests that oils/fats and water will emulsify in the presence of gelatin/agar, in the absence of emulsifier, nor remain stable. None of Arfsen, Chen or Kularni cure the deficiencies of Pan.
Arfsen teaches an oil encapsulated with a protein shell and is silent about the incorporation of water and homogenizing oil and water with specific weight ratios of gelatin or agar. Arfsen does not teach the amended water feature. Nothing in the Chen disclosure would motivate a skilled artisan to select fats/oil, gelatin and water to incorporate within the confectionary product with any expectation of achieving a solid-set homogeneous article.
Kulkarin is directed to fast dissolving orally consumable films and is silent regarding mixing fats/oil and water together and homogenizing oil and water with specific weight ratios of gelatin or agar. Nothing in Kulkarin teaches that gelatin can homogenize fats/oils to achieve a solid-set homogeneous article. Norwell is cited only to show that magnesium chloride is used within saliva substitutes and is not reflective of claim 1. Lorenzi and Piatko do not cure the deficiencies of Arfsten, Chen, Kulkarno and Lorenzi.
Response
Pan’s examples are not limiting of the disclosure which is much broader and described the embodiment in which the water amount of the fill can range from 5% to 95% of the fill and the fill can be up to 75% of the entire article.
Applicants argument that Pan is made differently than the claimed invention is not found to be persuasive since the claims are directed to an article and are not directed to how the article is made.
Applicants’ argument that nothing in the prior art teaches or would motivate a skilled artisan to select fats/oil, gelatin and water to incorporate within the confectionary product with any expectation of achieving a solid-set homogeneous article is not found to be persuasive for the reasons that Capdepon teaches that 7-9% is the most preferred amount of gelatin that can gel a composition into a solid-set homogeneous composition.
Specifically, Capdepon teaches that this amount of gelatin in the liquid composition causes the liquid composition to set and to become a solid gummy. (See [0022]). Capdepon teaches that the homogeneity can be achieved through 7-9% gelatins effect as an emulsifier and can also be achieved through the use of a well-known emulsifier, whose use is taught by the art such as Pan and Piatko. The solid set is already achieved in Pan in the confectionary product in the form of a lozenge (e.g., paragraph [0039]), and therefore may be solid set (i.e., does not flow at room temperature). The teachings of Arfsten teach solid compositions as well. Therefore, these limitations are taught by several and the combination of these teachings are motivated by the prior art as described above.
The remaining arguments are moot in view of the new rejections applied above.
Conclusion
No claim is allowed.
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/SARAH CHICKOS/
Examiner, Art Unit 1619
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619
