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
Applicant's amendment and argument filed 04/25/2025 in response to the non-final rejection, are acknowledged and have been fully considered. Any previous rejection or objection not mentioned herein is withdrawn.
Claims 1, 5-15, 17-26 are pending and being examined on the merits.
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.
Claims 1, 2, 5-10, 13-15, 17-20 and 22-26 are rejected under 35 U.S.C. 103 as being unpatentable over Chen (CN111803439A), Harunobu (JP2011234654A), Romanoschi (US20160296474A1), Prasad (US11938100B2) and with supporting evidence by Norihiro et. al. (JP3630900B2). This rejection is maintained with slight modifications due to the amendments and arguments filed on 04/25/2025.
Chen’s general composition is to a chewable edible oil-in-water gel composition and preparation method (see abstract and title).
Chen teaches that “fish oil jellies” tend to suffer from relatively low oil content (e.g., less than 50 wt%) such that the delivery of the active is inefficient. When the content of oil is relatively high (for example, more than 50 wt%), oil-water separation is liable to occur, and therefore there is a problem that oil is precipitated on the surface of the product during storage. This results in a low storage stability of the oleogel product, accompanied by problems of loose texture, poor chewiness, etc. (see page 2, background).
Regarding claim 1, 2 and 14-15, Chen teaches a chewable edible oil-in-water gel emulsion composition which comprises fish oil (see page 3, 3rd and 5th para. and Fig.1) and can be in an amount up to 50% wt or greater than 55%-70% wt (see page 4, para 8 or page 2, Summary of the invention). Chen also teaches wherein upon administration of the gummy that the greasy feeling can be improved (see disclosure of invention).
Chen also teaches wherein the sweetener can be in amounts of 10-30% (see page 5, para. 5).
Regarding claims 5-6, Chen teaches the term “grease” also has the conventional meaning for drugs such as the triglycerides and esters form (see page 4, para 6).
Regarding claim 7 and 17, Chen also teaches an antioxidant such as vitamin E may be in the composition (see page 3, para 4).
Regarding claim 8 and 18, Chen teaches gelatin as the gelling agent (see page 2, last para) which is also known as a structurant (structuring agent).
Regarding claim 9 and 19, Chen teaches locust bean gum and agar as gelling agents (see page 3, 1st para).
Regarding claim 10 and 20, Chen teaches the composition to comprise minerals (see page 3, para 5).
Regarding the hardness of the gummy having a strength of 150 gForce, Chen teaches that the composition has improved texture such as hardness, elasticity and firmness (see page 4, para 8) and shows that the hardness score of the claimed composition had the highest rating score of 5 when a first (gelatin) and second gelling agent (xanthan gum) are used (see page 8, last para). Also, the hardness of the gummy is something a person having ordinary skill in the art could control and optimize for based on the water activity and gelling agents used.
Chen does not specifically teach the water activity being below 0.73 of the gummy composition or the hardness being at 150 gForce to 600 gForce measured as a peak force using aTA-8A probe to push through the gummy composition from a top surface for 5mm at a rate of 0.5 millimeters per second or glycerin being added to the composition. Chen also does not specifically teach wherein the oil phase comprises at least one of (1) at least one mineral in an amount of 20 percent by weight to 40 percent by weight of the gummy composition and (2) at least one herb in an amount of 15 percent by weight or more.
Harunobu’s general disclosure is to a gummy candy-structure which has a smooth texture, melts in the mouth and is suitable for long-term distribution at room temperature, and a method for producing the same (see abstract).
Regarding claims 1 and 14, Harunobu teaches that a water activity of 0.6 or less does not deteriorate or allow for the growth of microorganisms (see page 6, para 9).
Harunobu also teaches that “In gummy candy, saccharides have a role as an excipient that gives elasticity to gummy candy, in addition to serving as a mere sweetener”, and that “as long as sugar alcohol is used, unnatural sweetness and shape retention problems cannot be completely eliminated” (see page 3, 3rd para.).
Harunobu also teaches preferably using sugar alcohols such as malitol, reduced
palatinose, xylitol, erythritol, sorbitol, lactitol, mannitol (see page 6, para. 11).
Harunobu also teaches that “Since the gelatin is a major factor for adjusting the hardness of the gummy candy-like structure, it needs to be 100 to 350 bloom and that bloom indicates jelly strength and “Moreover, it is preferable that a bloom is 250 or more in order to adjust hardness” (see page 5, para 3).
Regarding claims 13 and 22, Harunobu also teaches that glycerin is used as a step to dissolve and swell the gelatin instead of hot water, thereby suppressing the water activity (see abstract and page 4, 1st and 3rd para.).
Regarding claims 25-26, Harunobu teaches using molds and cooling and drying (see abstract).
Prasad’s general disclosure is to gummy formulations for nutritional supplementation (see abstract).
Prasad teaches gummy compositions which include at least one mineral and at least one plant-based nutrient (see claim 1 and abstract).
Prasad teaches wherein the gummy composition can comprise of a mineral in the formulation from about 0.001 to about 500 mg (see claim 4) and teaches wherein the composition can have said plant-based nutrient in formulation at 1 to about 1000 mg (see claim 5) and with the broadest reasonable interpretation a plant-based nutrient can also be considered an herb as broadly claimed.
Norihiro’s general disclosure is to gummy candy compositions. Norihiro teaches:
“Most gummy candy is adjusted to 78 to 82, pH 4 or less, and water activity value 0.7 or less, which is an index representing sugar concentration. In particular, BX% affects the texture, and if it is higher than this reference value, it becomes a gummy candy having a hard texture, and if it is lower, it tends to be a gummy candy having a soft texture. Further, solidifying with a corn starch mold is called corn starch mold or aging, which is characteristic of gummy candy production.
Most gummy candy often contains 30 to 40% by weight of sugar in addition to starch syrup, in order to give a sense of sweetness. In addition, there are many products that contain fruit juice extract, flavor, etc., and are conscious of consumer preference.
Examples of the sugar alcohol include sorbitol, reduced starch saccharified solution, and reduced maltose starch syrup. However, these sugar alcohols have the following disadvantages as sweeteners for gummy candy.
In the case of sorbitol, the osmotic pressure is high, which promotes the water separation of the gummy candy and after aging it becomes a tightly gummy candy with a low water content, or the whole gummy candy becomes loose and soft jelly due to low viscosity. And the texture is completely different from the original gummy candy. Moreover, since the reduced starch saccharified solution has a high viscosity, it tends to form a hard gummy candy having no elasticity, and the texture is remarkably impaired. In addition, due to the high viscosity, it is difficult to perform the sugar concentration process sufficiently, and the water transfer during corn starch mold is significantly impaired, so that the water content and water activity value of gummy candy are increased, and the product properties are reduced. Significantly damaged.
Among sugar alcohols, the one with the best processability is said to be reduced maltose starch syrup. However, as a sweetener, only the reduced maltose starch syrup is used, and the gummy candy manufactured at a general blending ratio such as 1% citric acid and 8% 250 bloom gelatin is different from the conventional gummy candy using starch syrup. Compared with its extremely firm elasticity, it loses the soft and unique elasticity that consumers prefer, and it cannot be a product. In order to solve this, attempts have been made to focus on gelatin, such as using gelatin with low gel strength or lowering the blending ratio of gelatin. Since the change in gel strength has a great influence on the texture of gummy candy, the manufacture of products that satisfy consumer preferences has not been achieved. In addition, it has been proposed to reduce the gel strength by acid hydrolysis of a part of the crosslinked structure of gelatin by extending the heating time in the acidity after citric acid blending in the process. It is not realistic because it involves significant improvements in equipment such as a transfer pump and resetting of production conditions.
Thus, in order to satisfy the conditions of low calorie, low touch and sugar, gummy candy with starch syrup, sugar free and sugar alcohol is desired, but due to the above, sugar alcohol is used to the extent that it replaces a portion of syrup and sugar” (see 0003 to 0009).
Norihiro also teaches: “when the sugar content is adjusted to BX% 78-82 only with sugar alcohol, the moisture content inside the gummy candy moves to the surface due to the passage of time and temperature when the gelatin content is general, and the surface of the gummy candy tends to get wet. There is. This phenomenon can be solved by increasing the gel strength of the gelatin used or increasing the blending amount of gelatin, but the texture is remarkably impaired. Therefore, maltose, trehalose or lactose is added in order to reduce the water content of the entire sugar and increase the solid content. Maltose is particularly preferable. Maltose has high solubility, low crystallinity, and extremely low moisture absorption and release, so that the sugar solid content of gummy candy, which is based on the balance of moisture and gel, is accompanied by a concentration process. Is an optimal saccharide.
The ratios of saccharides in the present invention are as follows. Reduced maltose starch syrup is 70 to 17% by weight, preferably 54 to 37% by weight, and sorbitol is 13 to 27% by weight, preferably 18 to 23% by weight. 18% by weight, preferably 9-14% by weight. The total amount of maltose, trehalose and lactose is 13 to 38% by weight, preferably 19 to 26% by weight of the total carbohydrate content. If the amount of sorbitol is less than 13% by weight, the hardness of the gummy candy does not change much, and if it exceeds 27% by weight, the entire gummy candy becomes soft and inelastic, resulting in a jelly-like texture. If the branched oligosaccharide alcohol is less than 4% by weight, it tends to become sticky with time, and if it is added in an amount of more than 18% by weight, it tends to lose its softness and elasticity, resulting in a jelly-like texture and damage to the product properties. When the total amount of maltose, trehalose, and lactose is less than 13% by weight, the effect is small. (see 0014 and 0015).
Romanoschi’s general disclosure is to multicomponent gummy compositions (see abstract).
Regarding claims 10-12 and 23-24, Romanoschi teaches gummy compositions to comprise of both minerals and herbs (see claim 6 and 0070), minerals such as calcium carbonate (table 5 and example 11).
Regarding claims 11-12 and 21, Romanoschi teaches the compositions to include lecithin as an emulsifier (see 0145) and magnesium stearate as a processing aid (see 0105).
Regarding claims 25-26, Romanoschi teaches using molds (see 0007, 0076, 0146, 0176 etc.).
Therefore, it would have been obvious at the effective filing date to a person having ordinary skill in the art to create a chewable edible oil-in-water composition containing fish oil as taught by Chen, that also has a water activity level of less than 0.6 as described by Harunobu because the composition would not deteriorate or allow for the growth of microorganisms at that water activity level and that level is less than the instantly claimed activity.
It would have also been obvious to have sugar and sugar alcohols in the composition in the amount of greater than 34% because Harunobu teaches saccharides have a role as an excipient that gives elasticity to gummy candy, in addition to serving as a mere sweetener and that as long as sugar alcohol is used, unnatural sweetness and shape retention problems cannot be completely eliminated. Thus, it would be understood to use both sugar and sugar alcohols in the composition. Sugar to assist in controlling for elasticity of the gummy and to also assist with the flavor profile from the use of sugar alcohols, and sugar alcohols to reduce the use of natural sugars which can increase calories and blood sugars of the person ingesting the gummy. Furthermore, Chen teaches adding sweeteners in amounts up to 30% and optimizing the amount to be right outside the taught range would have been prima facie obvious.
Additionally, Norishiro teaches including sugar alcohols and sugars in amounts that would equate to the instantly claimed amount and gives additional motivation as to why one might want to control these sugars and amounts. Norishiro teaches adding sorbitol in amounts of 13-27 % and preferably at 18-23% by weight and teaches adding maltose and lactose in amounts of 13-38% more preferably 19-26% by weight. When considered these amounts of sugars and alcohol sugars would amount to greater than 34% by weight of the gummy composition.
It would further have been obvious to control the bloom strength by controlling the gelatins utilized in the composition to adjust for the particular hardness of the gummy composition to the desired end product, which would also have a gForce strength of 150 or greater, because Harunobu also teaches that this is how to control for the composition’s hardness. It would have also been obvious to use glycerin to control for the water activity as taught by Harunobu. Although Chen’s composition may possibly be physically harder than the instant applications, the methods of controlling for the composition’s hardness are known in the art and those particular parameters would have been obvious adjustments to persons skilled in the art for subjective and objective endpoints of how hard the composition would be as a desired confectionery. A person skilled in the art would include each of the ingredients listed of the prior art to create the instant invention and the only difference is controlling the bloom strength for creating a composition that has a specific mouth feel and hardness.
Harunobu teaches methods for controlling hardness for gummy compositions by controlling bloom strength and teaches the strength of 250 to adjust for hardness, which is what the instant applicant teaches in their examples (see table 1-5, 7, 9, 11, 13, 18-20). Harunobu also teaches controlling the water content at below 0.6 to control for the composition’s deterioration. Harunobu gives working examples of gummies with gel strength of 19.4 × 10 5 kg / m 2 and water activity of 0.526 and another example of gel strength of 29.3 × 10 5 kg / m 2, the water activity was 0.511 and wherein the size of the gummy is set in a 2 cm mold (see example 1) which is the same size as the instantly claimed. Therefore, the combined art along with the broadest reasonable interpretation of the instant invention’s parameters would have been made obvious, because the broadest reasonable interpretation is to an oil-in water phase gummy composition with improved hardness and water activity below a specific parameter. The prior art describes how and why one of skill would control for these parameters and gives working examples which are shown to be similar in nature to the applicants.
Finally it would have also been obvious to add minerals and herbs to be within the claimed amounts and in the oil phase because minerals and herbs can have hydrophobic properties and including them in the oil phase would allow for those ingredients to not separate out of solution. Minerals and herbs, depending on the types used are known to impart health benefits and this would be reasons to include them and reasons to optimize their amounts to be included in the gummy. Additionally, Prasan teaches including minerals in gummy compositions at 500mg and plant-based nutrients (herbs) at up to 1,000 mg. These amounts, depending on the weight of additional components can equate to the instantly claimed 20%-40% of mineral and 15% of herb. The optimization to include these components at the instantly claimed range is a matter of judicious selection. Also, it is obvious to set the gummies into a mold to control for shape and to remove them once they have had enough time to set into the mold formation.
Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient concentration would have been obvious before the effective filing date of applicant’s claimed invention.
There would be a reasonable expectation of success in arriving at the instantly taught invention because gummies containing fish oil, minerals, herbs and having improved firmness and water activity have been previously described as discussed above.
Claims 11-12 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over as applied Chen (CN110478312A), Harunobu (JP2011234654A), Romanoschi (US20160296474A1), Prasad (US11938100B2) and Norihiro et. al. (JP3630900B2) as applied to claims 1, 5-10, 13-15, 17-20 and 22-26 above, and further in view of Yang (US5928664A). This rejection is maintained with slight modifications due to the amendments and arguments filed on 04/25/2025.
Although Romanoschi teaches the instantly claimed gummy composition to comprise lecithin, calcium and magnesium salt, those purposes may only be specific to tablet formation and thus Yang is relied upon for support of those ingredients.
Yang’s general disclosure is to a consumable gummy delivery system (see abstract and title).
Yang teaches that mineral supplements such as calcium carbonates and magnesium oxide and other alkali metals are useful in gummy delivery systems and are conventional additives (see 36 and 64).
Yang also teaches wherein lecithin can be useful as an emulsifier (see 65).
Therefore, it would have been obvious at the effective filing date to a person having ordinary skill in the art to include the minerals calcium and magnesium in the gummy composition taught by Chen and Harunobu because these are conventional additives which can be used as mineral supplements in gummy delivery systems. It would have also been obvious at the effective filing date to include lecithin to the oil-in- water composition because Yang teaches that this component can be used as an emulsifier.
There would be a reasonable expectation of success in adding these components into gummy compositions and arriving at the instant invention because these components have previously been used in gummy delivery systems and are conventional in use.
Response to Arguments
Applicant's arguments filed 04/25/2025 have been fully considered but they are not persuasive. The applicant makes arguments reciting only the elements that each individual piece of art lacks in teaching. The Office combines these pieces of art together to make an obvious type rejection. The applicant argues against each piece of art for not anticipating the instant claims, however the Office is not making anticipatory type rejections. For instance, the applicant argues wherein Chen does not describe or predict any amount of any mineral in its combination, or predict including at least one herb in its combination, or wherein the oil phase comprises minerals and/or herbs. The applicant also argues that Harunobu and Norihiro do not describe the gummy containing a mineral and/or herb.
The applicant then argues that although the Office relies on Romanoschi to teach the mineral and herb components, Romanoschi does not describe that the mineral and oil components being in an oil phase of a set emulsification of an oil phase. The claims are directed to a composition and not a method. Although Romanoschi may not describe including the herb and mineral components in the oil phase, the Office articulated why a person having ordinary skill in the art would do so. Additionally, it is the composition that is being examined and not the process of getting to the end composition. Persons having skill in the art would know how to formulate components to arrive at the instantly claimed gummy composition especially given the relied upon pieces of art.
The applicant argues that Prasad’s teachings are to capsules and not gummy formulations because they describe in an embodiment wherein capsules are being administered. This may be one teaching of Prasad, however Prasad’s general disclosure is to gummy formulations (see title and summary of the invention). The applicant argues that Prasad does not teach any amount to include the mineral and herb components in either the capsule or gummy formulation. This is simply untrue as Prasad claims specific amounts of minerals at 0.001 to about 500 mg (see claim 4) and plant-based nutrients interpreted as an herb in amounts from about 1 to 1000 mg (see claim 5).
The applicant argues that Yang describes active ingredients in a shear form matrix which can include MCTs and emulsifiers, but Yang does not describe the active material in the oils and states that any oils present in the shear form matrix are primarily related to the texture and do not detract from the appearance or utility of the matrix as a delivery system for an active ingredient. Even if Yang does not describe including these components in the oil phase and the use of emulsifiers the instant claims are broad and allow for additional components because the claims use the “comprising” claim language and it is the end product being examined, not the method of making the product.
The applicant argues that that Chen describes a composition that includes up to 50 weight percent oil which is at least twice the oil than a gummy composition with minerals as instantly described and this would allow for a longer set/release time than instantly claimed. Reducing the amount of oil in a gummy composition is also well within the purview of any artisan. For instance Harunobu teaches gummy structures with 5 to 10% by weight of fats and oils (see abstract). The art is relied upon for its teachings and does not need to be a step-by-step instruction manual for creating/inventing the gummy candy. Instead the art can act as guidelines for knowledge to persons having skill in the art. Additionally, those having ordinary skill would have knowledge of how to optimize the instantly claimed components for many reasons as described in the above rejection. Optimizing oils to be lower than the 50% described by Chen would be obvious for simple reasons of creating gummies that are less oily and containing fewer greasy/fatty components. Harunobu teaches using much lower oils than Chen and combining this knowledge is well within the purview of any skilled artisan.
Conclusion
Currently no claims are allowed.
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 JACOB ANDREW BOECKELMAN whose telephone number is (571)272-0043. The examiner can normally be reached Monday-Friday 8am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Terry McKelevey can be reached at 571-272-0775. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
JACOB A BOECKELMAN Examiner, Art Unit 1655
/TERRY A MCKELVEY/ Supervisory Patent Examiner, Art Unit 1655