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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 March 31, 2026 has been entered.
Response to Amendment
Those objections and rejections that have not been repeated in this Office Action have been withdrawn.
Claims 1-8, 10-27 are currently pending.
Claims 11-26 are withdrawn from consideration. Claims 1-8, 10 and 27 are currently pending.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-8, 10 and 27 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites, “[a] process for manufacturing and shaping an active ingredient containing chewable oral form composition containing a gelling agent consisting of agar-agar and locust bean gum, wherein the composition is free of any additional gelling agents.” (lines 1-4). Applicant’s specification supports “a gelling agent consisting of agar-agar and locust bean gum,” however, since the claim is a comprising claim (i.e. “…composition containing a gelling agent…”) and since the specification does not specifically recite that no other gelling agents are part of the composition, the limitation of, “wherein the composition is free of any additional gelling agents” is not seen to have reasonable support in Applicant’s originally filed disclosure. That is, “[a]ny negative limitation or exclusionary proviso must have basis in the original disclosure,”; however the specification does not provide clarity that additional gelling agents cannot be part of the composition. Furthermore, there may be circumstances in which it can be established that a skilled artisan would understand a negative limitation to be necessarily be present in a disclosure, silence will not generally suffice to support a negative claim (see MPEP 2173.05(i)). In this instance, there does not appear to be any guidance in the disclosure for a composition comprising agar-agar and locust bean gum while excluding any other gelling agents. This rejection can be overcome by reciting that the composition, “consists of” the various ingredients recited in the claim.
Claims 2-8, 10 and 27 are rejected based on their dependence to a rejected claim.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-8, 10 and 27 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation, “and stirred until fully incorporated in said mixture to obtain a mixture of the third stage (iii).” (see lines 22-23). The limitation of, “said mixture” lacks proper antecedent basis.
Claims 2-8, 10 and 27 are rejected based on their dependence to a rejected claim.
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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Okuyama (JP2003-061592) in view of Cao (US 20140112982), Pandey (US 20090181145), Rowe (US 20160219901) and Fujii (JP 2004099558) and in further view of Davis (US 20120015075) and Fukui (US 20100239684) and in further view of Torgerson (US 20200154751) and Kojima (US 20030138938).
Regarding claim 1, Okuyama teaches a process of manufacturing and shaping an active ingredient containing chewable oral form (“jelly product”, which is cooled to produce a jelly product and is therefore shaped- see paragraph 13 of the machine translation) that contains gelling agents; said process comprising: (i) hydrating agar-agar and locust bean gum gelling agent in combination at between 0.1-4% (see paragraph 7 where a combination of agar and locust bean gum can be used at 1.5wt%; see paragraph 12, “dissolving the inulin, sugar alcohol, gelling agent and water”), with an amount of sweeteners in a range of between 6% and 10% (see paragraph 6 of the machine translation: 8-12%; see also paragraph 10 where additional sweetener can be added at 0.5-5%, where 5% is seen to be close to the claimed range of 6-10% and where it would have been obvious to one having ordinary skill in the art to have used added amounts of sweetener for achieving the desired flavor and sweetness to the composition) with water until a homogeneous mixture is obtained, and then adding a quantity of water to the homogeneous mixture and stir until complete dissolution of the homogeneous mixture (see paragraph 5, lines 51-52 where the components are mixed and dissolved thus teaching and suggesting a homogeneous mixture having complete dissolution; see also paragraph 9).
Okuyama further teaches that glycerin can be incorporated into the mixture (see paragraph 6) as well as inulin in an amount such as 20% (see paragraph 5, last sentence). Since Okuyama teaches that the inulin, glycerin and gelling agents are combined with water, heated and dissolved, Okuyama is teaching and suggesting complete dissolution of the glycerin and inulin and is therefore teaching and suggesting that the homogeneous mixture is a dissolved homogeneous mixture, as recited in the claimed second stage.
Okuyama also teaches the incorporation of an active ingredient, such as prune extract (see table 1, example 1; prune extract reads on “fruit extract” as recited in claim 7 and therefore can be construed as an active ingredient), thus suggesting a third stage of incorporating. The claimed third stage does not require sweetener mixed with the active ingredient since such mixing is claimed as being optional.
While Okuyama’s example on paragraph 16 uses Triorich and Omalty, Okuyama’s examples are not seen to teach away from the reference’s broader disclosure which discloses that such sugar alcohols are not required but that other sugar alcohols could be used, which would obviously have also been sweeteners (see paragraph 6; see MPEP 2123).
Okuyama teaches that the above combination of ingredients are heated at 75-92°C for 30-50 minutes and then allowed to form a jelly product (see paragraph 12), thus reading on the claimed fourth stage of cooking and sixth stage of allowing the cooked paste to gel.
Claim 1 differs from Okuyama in specifically reciting mixing agar-agar, locust bean gum and 6-10% sweeteners to form a homogeneous mixture and then adding a quantity of water to stir until complete dissolution of the mixture;
Claim 1 also differs from Okuyama in specifically reciting, “(ii) a second stage of incorporating additional components into the agar-agar locust bean gum homogeneous mixture of the first stage, said second stage comprising: adding glycerin in an amount between 1% and 3% of the total weight of the composition in combination with inulin liquid in an amount of between 7% and 12% of the total weight of the composition and inulin powder in an amount of between 5% and 10% of the total weight of the composition and optionally mixing with an amount of sweetener between 20% and 28% of the total weight of the composition, and then stir until complete dissolution to obtain a mixture of the second stage (ii); (iii) a third stage of incorporating the active ingredient, wherein the active ingredient is optionally mixed with an amount of sweetener of between 7% and 10% of the total weight of the composition and subsequently added to the mixture of the second stage (ii) and stirred until fully incorporated in said mixture to obtain a mixture of the third stage (iii).”
It is initially noted however that Okuyama teaches that the order of mixing of these components can be appropriately determined and therefore is open to any order of mixing (see paragraph 12, first sentence).
Further regarding the order of mixing, Cao (US 20140112982) teaches that it has been conventional to mix a combination of a gelling agent with sweeteners and water (paragraph 5 and 39-41) for producing a blended mixture. That is, paragraph 40 teaches homogeneous mixing of a combination of a sweetener at 9% (see paragraph 19) with a thickening agent which can be a combination of gelling agents (see paragraph 18) together with water. Since the mixture produces a transparent solution, Cao teaches homogeneous mixing and complete dissolution. To this mixture, Cao teaches adding a second mixture that can comprise glycerin (see paragraph 39, and also see paragraph 17 where the water retention agent can be glycerin, i.e Cao’s transparent solution A). Whether one of ordinary skill in the art first blended the gelling agents and the sweetener and then added the water, versus some other order of blending would have been prima facie obvious as a rearrangement of steps, since the purpose of Cao’s blending is to produce a homogeneous, dissolved mixture.
Pandey (US 20090181145) teaches mixing gelling agents with sweeteners and then with water (see paragraph 59 – “first dispersed in any carbohydrate or carbohydrate sweetener…Then they are mixed with water). This mixture is then combined with other ingredients (see figure 1, item 11 and 12), which can be sweeteners such as inulin and glycerin (see paragraph 58) and where this combination can also be combined with additional ingredients (see figure 1, item 30; paragraph 58 and 61). Pandey teaches that the liquid and powder ingredients can comprise inulin and glycerol as well as additional sweeteners (see paragraph 40 which discloses powdered inulin and paragraph 41 suggesting liquid inulin, thus suggesting the use of liquid and powder inulin). Pandey also teaches that the order of mixing can be changed (see paragraph 91) and where the purpose of the blending is to produce a homogeneous blend (see paragraphs 11-15).
Rowe (US 20160219901) teaches a hydrated gelling solution to which a sweetener has been mixed (see paragraph 10). Figure 1 and paragraph 63 of Rowe further teaches a gelling mixture that can further comprise agar and locust bean gum; and to which a sweetener can be added, with subsequent mixing with water (see figure 1, “liquid glucose composition” “heated honey” “mix (020)” “gelatin solution”; see paragraph 37; It is also noted that the subsequent solutions would also have added water to the mixture). Rowe further teaches that after combining the sweetener with the gelling agent and water, that there can be an additional mixing of another flavor, stabilizer and/or active ingredient (see figure 1, “Flavor, stabilizer and/or active ingredient”). Rowe also teaches elevated temperatures for the dissolution of the components of the mixture (see paragraph 30).
Fujii (JP2004099558) also teaches at paragraph 16 of the machine translation that a base of locust bean gum and agar can be prepared and into which additional components can be dissolved therein, either simultaneously or in any order (see paragraph 22).
Therefore, Cao, Pandey, Rowe and Fujii teach that it has been conventional to use an order of mixing of agar with locust bean gum and sweeteners which are then mixed with water for the purpose of producing a dissolved homogeneous blend that reads on the order as claimed.
To therefore modify Okuyama who already desires a homogeneous blend, and to first combine a sweetener and a mixture of agar-agar and locust bean gum to which water has been added, and then to add thereto, glycerin and inulin with a subsequent addition of an active ingredient, would have been obvious to one having ordinary skill in the art, based on known and conventional arrangements for combining similar ingredients for producing a similar chewable oral composition.
Regarding the limitation a fourth stage of cooking into a paste the mixture obtained in the third stage at a temperature range between 80-100°C for 30 +/- 5 minutes wherein the resulting solids concentration is in the range between 72-78° Brix, it is noted that while Okuyama teaches heating within the temperature range of between 80-100°C for 30 +/- 5 minutes, and therefore suggests cooking into a paste, the claim differs in reciting a brix of 72-78°.
However, Cao also teaches known brix values when heating a mixture comprising gelling agents, glycerin, and sweeteners can be between 70-80° or 75° (see paragraph 40).
Additionally, Muniz (US 20180207282) teaches chewable oral forms (see the abstract) where it has been conventional for the slurry to be homogeneously mixed and heating the mixture until the mixture achieves a brix of between 70-80 (see paragraph 48). Muniz teaches that such brix levels can be routinely achieved based on design (see paragraph 39).
Since Okuyama teaches the claimed heating time and temperature for producing a paste but is not specific as to a particular brix value, to modify Okuyama and to modify the ingredient composition so as to achieve a brix of between 70-80° when heating the mixture for 80-100°C for 30 minutes, would have been obvious to one having ordinary skill in the art, as a matter of engineering and/or design, based on known brix values for gummy, chewable oral forms and for providing a particular flavor to the oral forms.
Regarding the limitation of, “a fifth stage of flavoring that includes transferring the cooked paste from the fourth stage (iv) to a flavoring tank and adding black carrot in an amount of between 0.1% and 0.4%, in combination with flavoring in an amount between 0.1% and 1% of the total weight of the composition, and citric acid in an amount between 0.23% and 0.29% of the total weight of the composition,” it is noted that the claim differs from Okuyama and the above combination in this regard.
However, Davis (US 20120015075) teaches that it has been desirable, after cooking a gelling mixture to a brix of between 65-75° (see paragraph 64-65) to further add additional ingredients such as black carrot added at 0.5% (paragraph 86, 93) and flavoring at 1.5% and 1% (see paragraph 86, 93 and 69), as well as citric acid to balance the flavoring (see paragraph 86, 93). Davis’s teaching of a dosier reads on a flavoring tank (see paragraph 68) into which the cooked paste has been placed for adding additional flavoring. While Davis teaches 0.5% black carrot and the claim recites up to 0.4% black carrot, since the black carrot has been added as flavor and since 0.5wt% is close to 0.4wt%, it would have been prima facie obvious that the flavoring as a result of these two amounts would have performed similarly. Furthermore, since black carrot has been disclosed to be used as a flavoring, it would have been obvious to one having ordinary skill in the art to have modified the amounts of flavorings based on flavor desired from the produced chewable oral form.
To therefore modify the combination and to add black carrot, flavoring and citric acid after cooking of the composition would have been obvious to one having ordinary skill in the art, based on conventional expedients at which flavoring and citric acid can be added, for the purpose of balancing the flavor of the chewable oral form.
Further regarding the amount of citric acid being between 0.25-0.29%, Davis teaches that citric acid can be added in amounts such as 0.01-0.03% as disclosed at paragraph 69 but can also discloses that citric acid can be used at 1% (see Table B, below paragraph 82). Fukui (US 20100239684) teaches jelly compositions (see the abstract) where acids such as citric acid can be used as taste adjusting agents (paragraph 51) in amounts such as from 0.1-5% (see paragraph 54). Okuyama also teaches pH adjusters such as citric acid, used in amounts from 0.01-3% for consumption purposes (see paragraph 8).
Since Davis teaches that the amount of citric acid can be varied to balance the flavor and since Fukui teaches amounts of citric acid that encompass the claimed range, to modify the combination and to use an amount of citric acid between 0.01-1% would have been obvious to one having ordinary skill in the art, as a result effective variable for the purpose of balancing the flavor of the chewable oral form.
Claim 1 newly recites the composition contains “a gelling agent consisting of agar-agar and locust bean gum, wherein the composition is free of any additional gelling agents.”
Okuyama already suggests using agar (see paragraph 7, line 100 and Table 1) and also suggests using locust bean gum (see paragraph 7, line 100).
Okuyama is not specific about specifically using only agar-agar and locust bean gum.
However, Torgerson teaches chewable oral forms (see at least, the abstract and paragraph 23) which can use a gelling agent consisting of agar and locust bean gum (see paragraph 16 and Table 2 which disclose using agar at 2% and a gum at 0.2% while being free of additional gelling agents). Torgerson teaches that the use of a gum, such as locust bean gum prevents the gelling agent and therefore composition from being rock solid by holding water within the matrix (see paragraph 16). Kojima further evidences that it has been conventional to make gummy jelly oral forms (see paragraph 40 for example) which use agar as the gelling agent in combination with locust bean gum (see the abstract and paragraph 23) and where the presence of locust bean gum can help to control the particular gel strength and rupture distance (see figure 2 and 4 and the line graph associated with locust bean gum). Kojima teaches that a combination of agar with locust bean gum provides excellent water retention, sufficient gelling ability and no pasty eating texture (see the abstract; paragraph 12). Kojima also teaches that such a combination is a desirable substitute to using gelatin (see paragraph 7).
Therefore, it would have been obvious to one having ordinary skill in the art to modify Okuyama, who already teaches and suggests using agar and locust bean gum, and to specifically use only agar and locust bean gum without additional gelling agents, because Torgerson teaches that this combination is a useful combination of gelling agents used for producing chewable oral forms, while retaining a sufficient amount elasticity by binding water and because Kojima teaches that such a combination is useful as a substitute for gelatin, while providing the requisite degree of water retention, gel strength, rupture distance and texture.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over the combination, as applied to claim 1, above, and in further view of Hornby (US 20220046971) and in further view of Rifkin (US 20130316053), Cherukuri (US 4317838), Taylor (US 2218592) and Sugii (JP H07196478).
Regarding claim 2, while Okuyama teaches gelling the cooked mixture and also teaches producing chewable oral forms (see paragraph 5, “jellies, jelly candies and similar products”), Okuyama does not specifically discuss molding, demolding, degreasing and drying. However, in view of Davis, the combination teaches that the oral composition is molded and then dried at 25% humidity for setting the product and to ensure packaging without breakage and proper yield (see Davis paragraph 75). To modify Okuyama and to therefore mold, demold and then dry the gelled composition would have been obvious to one having ordinary skill in the art for the purpose of providing the gelled composition in desired shapes and to ensure the product is desirably set while ensuring packaging without breakage and providing proper yield.
Claim 2 differs from the combination in specifically reciting, “gelling the cooked mixture from the fifth stage (v) by depositing while maintaining the temperature between 75-89°C of the cooked paste in molds and gelling by reducing the temperature to a range of between 2°C at 8°C.”
Rowe teaches that it has been conventional to pour a gelling composition into a mold at temperatures such as above 75°C and then to cool in order to gel the molded composition (see paragraph 117). These reads on depositing while maintaining the temperature of the mixture to between 75-89°C and then reducing the temperature to allow for gelling.
Since Okuyama teaches setting the heated composition for forming a chewable, gelled oral form by cooling, to therefore modify the Okuyama combination and to deposit into the mold while maintaining the temperature of the cooked paste between 75-89°C and then to cool the composition to set the chewable oral form, would have been obvious to one having ordinary skill in the art, based on conventional expedients of setting similar gelling compositions. Further regarding the temperature for gelling is reduced to a temperature of between 2-8°C, it is noted that while the above teachings are not specific as to this particular temperature range, Hornby teaches cooling shaped gelling composition to 4°C so as to set and retain their shape (see paragraph 84 and page 13, lines 5-25 of the foreign priority document GB18211573).
To therefore modify the combination and to use cooling temperatures such as 4°C would have been obvious to one having ordinary skill in the art, based on conventional temperatures for setting a gelling composition that comprises similar types of gelling agents.
Claim 2 differs from the above combination in specifically reciting, “ a seventh stage of demolding, degreasing and drying, which includes demolding followed by degreasing, and then drying by spreading the molded forms on stools or drying baskets at a temperature of 30° +/- 3°C and 25 +/- 5 % relative humidity.”
However, Rifkin (US 20130316053) teaches gelled, chewable oral compositions (see paragraph 49) which after molding are conditioned (see figure 4, item 460) by drying at 60-140°F (i.e. 15-60°C) at a relative humidity of 20-30% (see paragraph 132) for the purpose of reducing the moisture of the molded product, and where the conditioning also includes cleaning for being able to form a glaze coating on the surface of the dried product (see paragraph 131).
Cherukuri (US 4317838) teaches conventional drying conditions for chewable oral forms including jellified products (see column 5, lines 55-60) is to use drying temperatures such as 78°F (25.5°C) with a relative humidity of 30% (see column 7, lines 8-12).
It is further noted that Taylor (US 2218592) evidences that it has been conventional to mold jelly products (see page 3, left column, lines 29-32) and where the mold itself can be oiled for facilitating removal of the molded product, such that oil would also require removal from the surface of the molded product, with subsequent drying (see page 3, right column, lines 53-70).
Similarly, Sugii (JP H07-196478) teaches oral chewable compositions that comprise agar as well as other gelling agents such as locust bean gum (see the abstract and paragraph 13) that are molded, deoiled and dried (see paragraph 46), thus teaching that it has been conventional to degrease and dry oral chewable compositions.
Therefore, the prior art teaches that it has been conventional to remove the molded product, clean and remove oil on the surface of the product and use a drying temperature and relative humidity that falls within the claimed range. To modify the combination and to thus degrease and dry the demolded product using temperatures within the range of 27-33°C and a relative humidity of 20-30% would have been obvious to one having ordinary skill in the art, for removing any oil used as a mold release agent and based on conventional drying conditions for gelled molded products.
Regarding the limitation of spreading the chewable oral forms on stools or drying baskets, it would have been obvious to one having ordinary skill in the art that the demolded oral forms would have required to be placed on some type of surface for drying and therefore encompasses what can be construed as a stool for drying. Nonetheless, Rifkin teaches using a cooling tunnel for moisture removal, which therefore encompasses spreading on stools (see paragraph 131) and to therefore similarly dry the product in a cooling tunnel would for removing moisture would have been obvious to one having ordinary skill in the art, based on known expedients for performing a drying function. It is further noted that on page 36 of the response filed on July 28, 2025, the steps of unmolding, degreasing, drying and finishing are indicated as being normal processes in confectionery.
Claims 3-8 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over the combination as applied to claim 2 above, and in further view of Eden (US 4874628), Plociak (US 20190373912), Perry (US 20090130251) and in further view of Hsu (EP 0207384) and James (US 20150296847).
Claim 3 differs from the combination, as applied to claim 2, in specifically reciting, an eighth stage of sweetening and packaging the molded dried forms, where the dry forms are introduced to the sweetening equipment and the sweetener is added until the coating is complete and for this the steam is adjusted at a pressure range between 275 Pa to 413 Pa and an amount of sweetener between 6% and 10%, where once sweetened, they are inspected and packed.”
Regarding inspecting and packing, it is noted that Davis teaches that chewable oral gummy forms are first inspected for food safety and organoleptic effects and then packaged (see Davis, ‘075; paragraph 78) and to therefore modify the combination for this same purpose would have been obvious to one having ordinary skill in the art.
Regarding the sweetener added until the coating is complete by adjusting steam between 275-413 Pa and an amount of sweetener between 6-10%, it is noted that Eden (US 4874628) teaches the desirability of steam treating a molded jelly product so that a sweetener can be coated on the surface thereof (see column 3, lines 42-62).
While Eden does not specifically teach the pressure and the amount of sweetener, Plociak (US 20190373912) teaches using steam for tackifying the surface of a chewable oral composition which can be a gummy product (see paragraph 49 and 40) for the purpose of applying a particulate coating to the surface thereof (see paragraph 49). Plociak teaches that the coating can comprise a sweetener at 6% (see paragraph 75).
Perry (US 20090130251) also teaches a steam treatment prior to applying a coating (see paragraph 137) onto the surface of a gummy oral form (paragraph 95) and where the steam treatment is used to apply a sweetener coating at 5-15% (See paragraph 32).
Therefore, to accordingly modify the combination so as to use steam to apply a sweetener at 6% or within the range of 5-15% would have been obvious to one having ordinary skill in the art to tackify the surface of the chewable oral form so as to provide a desirable flavor coating thereon.
Furthermore, it is noted that the pressure as claimed has been construed as gauge pressure. Therefore, the absolute pressure would have been 101325 Pa + 275 to 413 Pa or, 101600 Pa to 101738 Pa (i.e. 1.002 to 1.004atm) – which is construed to be close to atmospheric pressure.
Nonetheless, it is noted that Hsu (EP 0207384) teaches using steam at a pressure of close to atmospheric or more preferably less than 4kPa above atmospheric (see page 12, lines 9-22) for the purpose of moistening the surface of a food to allow a coating to be applied thereon (see page 1, lines 5-15). Similarly, James (US 20150296847) teaches steam which is at or slightly above atmospheric (paragraph 89) can be used for improving the coating thereon (see paragraph 36). These limitation are seen to suggest steam being adjusted to between 275-413 Pa, because the prior art encompasses gauge pressures that are close to atmospheric pressure, for the purpose of tackifying a surface so that a coating can be applied therein. To therefore modify the combination and use steam that is applied at an absolute pressure that is close to atmospheric pressure would have been obvious to one having ordinary skill in the art, as a matter of engineering and/or design so as to achieve a tackified surface to which a coating can be adhered thereon.
Regarding claim 4, it is noted that Davis teaches combinations of flavors and aromas for application to a gummy chewable oral form (see Davis’075; paragraph 68). Davis also teaches that wax coating can be applied to the finished product depending on whether the product was to be polished or not (see Davis’075; paragraph 76) and therefore teaches it would have been obvious to one having ordinary skill in the art to divide the composition based on whether to coat with a wax coating or not.
To therefore modify the combination and to divide the composition would have been obvious to one having ordinary skill in the art based on whether it was desirable to provide a wax coating or not. Furthermore, it would have been obvious to one having ordinary skill in the art that providing different flavoring would have required different batches of compositions such that it would have been obvious to one having ordinary skill in the art to have divided the composition based on flavor as a matter of design preference.
Regarding claim 5, in view of Davis, the combination teaches flavors such as strawberry (see Davis’075; paragraph 81).
Regarding claim 6, it is noted that prune extract, as taught by Okuyama, as discussed above with respect to claim 1, can be construed as a natural product and therefore can be construed as an active ingredient. Additionally, Davis teaches the inclusion of vitamins and minerals (see the abstract) such that it would have been obvious to one having ordinary skill in the art to have included vitamins or minerals for providing added nutrition to Okuyama’s chewable oral forms.
Regarding claim 7, Okuyama teaches the incorporation of an active ingredient, such as prune extract, which can be construed as a “fruit extract.” (see table 1, example 1), and therefore can be construed as an active ingredient. Nonetheless, in view of Davis, the combination further teaches adding vitamins such as vitamin B1 and D (see paragraph 44 and 57).
To therefore modify the combination and include a vitamin such as B1 or D would have been obvious to one having ordinary skill in the art for providing the desired nutrition to the oral form.
Regarding claim 8, it is noted that Cao teaches sweeteners that can be used in combination including white granulated sugar and sugar alcohol (see paragraph 20). It would have been obvious to one having ordinary skill in the art that white granulated sugar is a sugar based on cane sugar. By teaching a combination of sweeteners, Cao teaches sweeteners comprise sweeteners.
Since Okuyama also teaches using combinations of sweeteners, to therefore modify Okuyama and use a combination of sweeteners as taught by Cao would have been obvious to one having ordinary skill in the art, for the purpose of achieving the desired flavor profile to the chewable oral form.
Regarding claim 27, it is noted that the claim only further limits the particular active pharmaceutical ingredients but does not positively recite that the active ingredient is an active pharmaceutical ingredient. Therefore, claim 27 is rejected based on its dependence to claim 6.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over the combination as applied to claim 3 above, and in further view of Chan (US 20190200638) and in further view of Brandt (US 20090092752) and Silva (US 4753790).
Regarding claim 10, in view of Rifkin as applied to claim 2, the combination teaches gelled, chewable oral compositions (see paragraph 49) which after molding are conditioned (see figure 4, item 460) which includes drying at 60-140°F (i.e. 15-60°C) at a relative humidity of 20-30% (see paragraph 132) and where the conditioning also includes cleaning and glazing (see paragraph 131). Rifkin teaches that the drying further reduces moisture of the molded product, then cleaning the surface of the product and also forming a coating on the surface of the dried product. Cherukuri teaches conventional drying conditions for chewable oral forms including jellified products (see column 5, lines 55-60) is to use drying temperatures such as 78°F (25.5°C) with a relative humidity of 30% (see column 7, lines 8-12) and a flow rate of about 400 cfm (column 4, lines 23-25 and column 7, lines 11-12), where about 400cfm equates to about 0.18 cubic meters per second which is seen to slightly overlap with the 0.15 cubic meters per second as disclosed. Additionally, about 0.18 cubic meters per second this is seen to be reasonably close to the claimed velocity for the similar purpose of drying the composition, such that a prima face case of obviousness exists (see MPEP 2144.05(I)).
Further regarding the laminar flow air velocity, it is noted that Brandt teaches edible products such as gummies (see paragraph 14) that can be dried using air with a velocity of between 0.01-100 cubic meters per second at temperatures between -10°C to 250°C (see paragraph 51). Silva teaches jellies (column 3, line 24) that can be dried using air at 80-95°F (i.e. 26-35°C) and at 250-500 cfm (i.e.0.11 to 0.23 cubic meters per second) (see column 5, lines 65-68). This overlaps with the claimed 30 +/- 3°C temperature and 0.15cubic meters per second.
Therefore it would have been obvious to one having ordinary skill in the art to have modified the combination and to have dried the demolded forms, using known air velocities for drying to ensure the requisite moisture removal and coating on the surface of the dried product.
Regarding the use of a drying tunnel on which the oral forms are dispersed in a single layer, it is noted that Rifkin teaches the use of tunnels for moisture removal, thus suggesting a drying tunnel. While not specific as to a single layer Chan (US 20190200638) teaches formed molded gummy products (see paragraph 2) where the formed products (see figure 1 and 2, item 34H, 46) are then dropped onto a conveyor belt to be transferred through a tunnel (see figure 1, item 50; figure 2, Zone D; figure 4, item 50) which is temperature and humidity controlled and onto which a single layer of oral forms can be dispersed.
To therefore modify the prior art and use known types of equipment for the purpose of drying the oral forms to a desired moisture would have been obvious to one having ordinary skill in the art, as an obvious matter of engineering and/or design.
Response to Arguments
On page 10-1 of the response, Applicant urges that the combination does not teach or suggest a chewable oral form composition containing a gelling agent consisting of agar-agar and locust bean gum, wherein the composition is free of any additional gelling agents. Applicant further urges that Okuyama’s disclosure of the genus of gelling agents by itself is not sufficient to establish a primary facie case of obviousness to specifically use only agar-agar and locust ben gum.
These arguments have been considered but are moot in view of the new grounds of rejection as necessitated by the amendment to the claims
Further on page 11 of the response, Applicant urges that the prior art is silent on the effect of increasing the concentration of active ingredients such as using 20% magnesium which would normally have generated a high instability of the matrix due to volume and due to the low solubility of magnesium citrate.
These arguments have been considered but are not sufficient in light of the prior art combination as presented herein, teaching and suggesting using only a combination of agar-agar and locust bean gum as a gelling agent used for oral form compositions. It is further noted however, that the arguments are not supported by sufficient evidence and also are not commensurate in scope with the claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Magana (US 20160242450) discloses that combining agar with locust bean gum can make a gel more elastic (see paragraph 38).
Baker (US 2466146) discloses a gelling composition that can use agar in combination with locust bean gum (see column 2, lines 18-26, 27-32, and 38-43).
Barabash (US 20180321249) discloses using solely a gelling agent of agar and locust bean gum (paragraph 21).
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/VIREN A THAKUR/Primary Examiner, Art Unit 1792
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