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
Claims 1-8, 10-26 are currently pending. Claims 11-26 are withdrawn from consideration. Claims 1-8 and 10 are currently pending.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 recites, “and stirred until its fully incorporated” on lines 22-23. It appears that the limitation intends to recite, “and stirred until it is fully incorporated.”
Claim 2 recites, “and and” on line 5. It appears that one recitation of “and” should be deleted.
Claim 2 recites, “at a temperature 30 +/- 3°C.” It appears that this should recite, “at a temperature of 30 +/- 3°C.”
Appropriate correction is required.
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.
Claim 10 is 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 10 recites, “laminar flow air velocity of 0.15 m/sec.” The specification only refers to “air velocity in laminar flow of 0.15 m3/sec.” There is no further guidance in Applicant’s original disclosure that the “air velocity in laminar flow” was intended to refer to 0.15 m/sec. Therefore to change the units to m/sec constitutes new matter. This rejection can overcome by amending the claim limitation to recite, “laminar air flow of 0.15 m3/sec.”
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 and 10 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, “where an amount of the active ingredient and optionally an amount of sweetener of between 7% and 10% of the total weight of the composition are previously mixed” on lines 19-22. This limitation is unclear because it appears to recite that there is a step of previous mixing between an active ingredient and a sweetener but the limitation also recites that the sweetener is optional (i.e. not required). Therefore the claim limitation is indefinite. This rejection can be overcome by amending the limitation to recite, “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…”
Claim 1 recites, “and subsequently added to the mixture of the second stage (ii)” on line 22 and “the mixture obtained in the third stage (iii)” on line 24. Both these limitations lack proper antecedent basis. This rejection can be overcome by amending line 18 to recite, “then stir until complete dissolution to obtain a mixture of the second stage” and amending line 23 to recite, “fully incorporated in said homogeneous mixture to obtain a mixture of the third stage.”
Claim 1 recites, “said homogeneous mixture” on line 23. This limitation lacks proper antecedent basis because it is not clear whether this is referring to “a homogeneous mixture” as recited on line 21 or the homogeneous mixture of the second stage. This rejection can be overcome by amending the claim limitation to recite, “stirred until fully incorporated in said homogeneous mixture obtained in the second stage.
Claim 2 recites the limitation, “the cooked paste mixture” on line 3. This limitation lacks proper antecedent basis. This rejection can be overcome by amending claim 1 to recite, that the fifth stage produces a flavored cooked paste and to then amend claim 2 to recite, “the flavored cooked paste.” The same amendment can be made for “said cooked paste on line 5 of claim 2.
Claim 2 recites the limitation, “the molded forms” on line 8. This limitation lacks proper antecedent basis. This rejection can be overcome by amending claim 2 to recite that the sixth stage produces molded forms.
Claim 3 recites the limitation, “the dry forms” on lines 3-4; “the sweetening equipment”, “the sweetener” and “the coating” on line 4; “the steam” on line 5. These limitations lack proper antecedent basis.
Claim 3 recites the limitation, “they” on line 7. This limitation is not clear as to what “they” is referring to.
Claim 4 recites the limitation, “the flavor” and claim 5 recites the limitation, “the flavors” both of which lacks proper antecedent basis. These limitations are not clear as to what flavor is being referred to.
Claim 4 recites the limitation, “the flavor is divided into combinations of flavors and aromas and a wax-based coating.” This limitation is not clear as to what are the recited combinations that the flavor is divided into. This limitation is further unclear as to what it means for the flavor to be “divided” into combinations. For example, it is not clear whether the limitation is referring to an active step of dividing “a flavor” into various combinations of flavors, combinations of aromas and combinations of wax-based coatings; or whether the limitation is referring to flavors being selected from the group consisting of flavors, aromas, wax-based coatings or combinations thereof; or whether the claim is referring to the flavor as being a combination of flavors and aromas and also being a combination of a wax-based coating. Clarification is required.
Claim 6 recites the limitation, “such as” on line 4. These limitations make the claim indefinite because it is not clear if the limitations following the term, “such as” are part of the claimed invention.
Claim 6 recites the limitation, “the level” on line 4. It is not clear as to what “the level of the digestive system…” means.
Claim 7 recites the limitation, “such as” on line 2, which makes the claim indefinite because it unclear whether the limitations following the phrase are part of the claimed invention.
Claim 7 recites the limitation, “or their combinations.” This limitation is not clear as to what the term “their combinations” modifies. That is, since the claim recites, “such as” and also recites fatty acids selected from EPA and DHA; folic acid, iodine, biotin, choline…and acerola or their combinations, it is not clear as to whether “or their combinations is only referring to the active ingredients after “DHA;” or is referring to vitamins; probiotics; fruit extracts; botanical extracts, minerals selected from…; omega 3 fatty acids; folic acid, iodine, biotin, choline, ginger…and acerola.”
Claim 8 is rejected based on its dependence to a rejected claim.
Claim 10 recites the limitation, “units of chewable oral forms.” This limitation is unclear as to whether this is referring to additional units of chewable oral forms or whether it is referring to “the chewable oral forms” as recited on line 7 of claim 1.
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).
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, “Triorich” and table 1 where this sugar alcohol is used at 9.67%; see also paragraph 10 where additional sweetener can be added at 0.5-5%) 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 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.
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).
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; (iii) a third stage of incorporating the active ingredient, where an amount of the active ingredient and optionally an amount of sweetener of between 7% and 10% of the total weight of the composition are previously mixed until a homogeneous mixture is obtained and subsequently added to the mixture of the second stage (ii) and stirred until its fully incorporated in said homogeneous mixture.”
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 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 the prior art teaches 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 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 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 the claim is not clear as to what flavor is being referred to and whether the claim is only referring to different forms of flavors or an active step of dividing “the flavor.” Nonetheless, as best understood, 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).
To therefore modify the combination and use combinations of flavors and aromas or a wax based coating, would have been obvious to one having ordinary skill in the art based on the desired flavor 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.
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.
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 Bunick (US 20090196907) and Hart (WO 2018107019).
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)).
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.
Further regarding the new limitation of the flow air velocity of 0.15 m/sec, while the above combination is not specific in this regard, Bunick teaches that it has been known in the art of manufacturing gelled compositions (see paragraph 161, “gelling substances”) that the drying can be optimized by controlling air velocity and air temperature (see paragraph 165:, “In this embodiment, the line speed…the air temperature, and velocity are controlled to optimize drying”). Hart also teaches gelled compositions (see paragraph 41, 48) that can be subsequently dried using an air velocity of about 0.15m/s (see the abstract, paragraph 72). Hart teaches a humidity such as between 30% relative humidity (see paragraph 64) with temperature of about 29°C (paragraph 65) for the purpose of controlling and accelerating the drying of the gel composition (paragraph 1-2) . It would therefore have been obvious to one having ordinary skill in the art to use air speeds such as 0.15m/s at the temperatures and humidity as already suggested by Rifkin and Cherukuri for the known purpose of achieving the desired degree of drying of the coated product.
Response to Arguments
On page 13 of the response, regarding Okuyama, Applicant urges that the claimed process uses only two gelling agents and does not use: TRIORICH which is a reduced pectin oxidized sugar alcohol, OMALTY MR-50 a reduced glucose oxidized sugar. Applicant further urges the claimed cooking process is controlled thus does not require the use of ingredients such as TRIORICH and OMALTY MR50 and therefore is a less expensive formula.
These arguments have been considered but are not sufficient to overcome the rejection. It is initially noted that while the claims require agar-agar and locust bean gum, the claims do not recite that these are the only two gelling agents. That is, the claims are open to other gelling agents and are also open to other ingredients as part of the homogeneous mixture. Furthermore, while Okuyama discloses the inclusion of sugar alcohols, this does not mean that TRIORICH and OMALTY MR50 are required sugar alcohols, but rather are just examples of sugar alcohols that can be used (see paragraph 6). Furthermore, sugar alcohols are not excluded from the claimed process and could also read on serving as a flavoring or sweetening component. It is also noted that the claims also add glycerin, which can be categorized as a sugar alcohol.
Further on page 13 of the response, Applicant urges that the invention claims a specific process that includes a series of steps and gelling agents within which gelatin, pectin, starch, carrageenan, xanthan gum, as used by Okuyama, are not used but rather, uses agar-agar and locust bean gum.
These arguments are not seen to be sufficient to overcome the rejection because Okuyama teaches that the process can hydrate a combination of agar-agar and locust bean gum. While reference also discloses other gelling agents, Okuyama also teaches that one example includes a combination of gelling agents (see table 1, example 1), including agar-agar and locust bean gum. Okymama is also open to other combinations of gelling agents, as suggested at paragraph 7.
On page 14 of the response, Applicant urges that page 2 paragraph 4 of the specification as filed discloses that active ingredients are defined to include among others vitamins, minerals, natural products, botanicals and herbs, as well as active pharmaceutical ingredients, analgesics and antipyretics, whereas Okuyama’s disclosure of prune juice could have laxative action and alter intestinal motility and could cause diarrhea.
These arguments are not sufficient to overcome the rejection because while page 2, paragraph 4 of Applicant’s disclosure discusses examples of active nutritional ingredients, the disclosure also states that “natural products” can be active nutritional ingredients. Claim 7 discloses that the active ingredient can be “fruit extracts.” Therefore, Okuyama’s disclosure of prune extract falls within the bounds of what the claims define as an active ingredient.
Further on page 14 of the response, Applicant urges that the claimed cooking process is carried out at conditions different than those of Okuyama because the claimed process requires a temperature of above 92°C to activate the agar-agar and increase the solids to 72-74° Brix to have a good gel.
These arguments are not persuasive because they are not commensurate in scope with the claims, which recite a heating temperature of 80-100°C for 30 +/- 5 minutes to achieve a solids concentration of 72-74° Brix. Therefore, Okuyama is teaching cooking conditions of the fourth stage of cooking that are within the range as recited in claim 1 of 80-100°C for 30 +/- 5 minutes. Furthermore, at paragraph 12, Okuyama also discloses temperatures such as 95°C which is therefore above Applicant’s urged temperature threshold of 92°C, which Okuyama discloses is specifically for the purpose of dissolving all the components of the mixture. Okuyama also specifically discloses agar as one of the gelling agents (see paragraph 17).
On page 15 of the response, Applicant urges that the claimed process does not need sugar alcohol compounds as disclosed by Okuyama.
These arguments are not sufficient to overcome the rejection because the claims do not exclude the use of sugar alcohols. It is noted however, that Applicant is advised against the introduction of new matter.
On page 15 of the response, Applicant urges that Okuyama does not disclose the claimed order or sequence of steps, which ensures product stability and Okuyama’s use of inulin is not used as a filling agent but rather is used for providing intestinal health.
Regarding the order of steps, it is initially noted that Okuyama teaches that it has been desirable to provide a dissolved, homogeneous mixture that comprises gelling agents including agar-agar, locust bean gum, as well as inulin. During the mixing, another active ingredient has been taught by Okuyama to be added to the homogeneous mixture and subsequently Okuyama’s mixture is cooked and cooled for gelling. Okuyama is also open to any order of mixing (paragraph 12), such that it would have been prima facie obvious to add an active ingredient, such as Okuyama’s prune extract as part of a third step, instead of simultaneously with Okuyama’s disclosed mixing stage. Cao provides further evidence that prior to cooking a mixture for producing chewable oral form, that it has been desirable to provide a first, dissolved homogeneous mixture of a gelling agent with water and to then add glycerin and to the homogeneous mixture, thus teaching and suggesting the claimed steps of a first hydration stage and a second and third incorporation stage. This is further supported by Pandey, Rowe, Fujii who teach that it has been conventional to form a first hydrated gelling solution to which additional ingredients and water can be added.
Regarding the functionality of Okuyama’s inulin, it is noted while Okuyama might teach the use of inulin for health purposes, this is not seen to teach away from inulin providing multiple functionality, especially as Okuyama teaches inulin used in amounts such as 1-20% of the product, which overlaps with the claimed amount of inulin.
On pages 15-16 of the response, regarding Cao, Applicant urges that the reference is for a chewable soft capsule with filling while the claimed product is a chewable gum without filling. Applicant also urges that Cao agar and locust bean gum, not as gelling agents but as viscosity agents and not in the amounts claimed. Applicant also urges that Cao incorporates the active ingredients in the filling and not in the gum.
It is initially noted that the claims do not recite that the product is a gum, but rather, recites that the product is a chewable oral form. Furthermore, Cao has not been relied on for the particulars of the active ingredients or the specific product produced from Cao’s process but rather, has been relied on to teach that it has been conventional to provide a homogeneous solution of gelling agents together with water, to which can be added additional ingredients such as glycerin so as to form a homogeneous mixture and as such, it would have been prima facie obvious to one having ordinary skill in the art to have rearranged the order of Okuyama’s steps of first hydrating agar, locust bean gum and sweeteners, and then adding water for ensuring dissolution while subsequently adding glycerin and inulin and then adding an active ingredient, while still achieving a homogeneous mixture, which Okuyama already desires.
On page 16 of the response, Applicant urges that Pandey uses high shear agitation that is not required in the claimed process and homogeneity and hydration is not performed in Pandey
These arguments are not sufficient because the reference has not been relied on to teach the use of high-shear agitation, but rather, has been used as further evidence that the concept of providing a first solution of gelling agents with water, and then a subsequent step of adding additional ingredients such as inulin and glycerin while providing a homogeneous blend. That is, like Cao, the reference teaches and suggests that the order of mixing can be varied provided that there is a homogeneous solution after the mixing steps have been performed.
On page 17 of the response, regarding Rowe, Applicant urges that the reference uses honey and gelatin, both of which are not in the claimed preparation.
These urgings are not persuasive because the claims do not exclude the use of these ingredients. Additionally, it would have been obvious to one having ordinary skill in the art that Rowe also clearly envisioned using gelling agents including agar and locust bean gum. Nonetheless, the reference has not been relied on for its specific composition, but rather has been relied in a similar light to Cao and Pandey to teach that it has been conventional to provide a hydrated gelling solution to which has been added additional components such as sweeteners, and then to add additional water with subsequent addition of additional ingredients, all of which are dissolved as part of the solution.
Further on page 17, Applicant urges that Rowe’s manufacturing process is different from that of the claimed process because the claimed process does not require two or more evaporations, adds hydrocolloids before cooking and does not add flavor before cooking because it could degrade and produce a burnt taste. Applicant also urges that the claimed process allows for temperatures of 75-92°C due to the use of agar while gelatin as taught by Rowe must be used within a temperature of 70-85°C.
These arguments are not sufficient to overcome the rejections, because like Cao, Pandey, Rowe further evidences that it has been conventional to modify the order of the addition of subsequent ingredients to a gelling agent solution, provided that the formed mixture is homogeneous and dissolved. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Additionally, Applicant’s urging regarding flavor degradation and a burnt taste are not sufficient as the claimed process also includes sweeteners prior to the cooking step and because Davis teaches adding heat sensitive ingredients after a cooking step (see Davis figure 1). Furthermore, the claimed process allows for temperature such as 80-100°C and does not provide any further specificity as to additional temperatures for the first three stages of the process.
Further on pages 17-18 of the response, Applicant urges that Fujii requires the use of additives that are not within Applicants’ process, which process guarantees the stability of the product without the use of additives such as polyacrylic acid or its salts while not requiring the control of pH.
These arguments are not sufficient to overcome the rejection because, the reference has not been relied on for the specific ingredient to be added as part of the gelled composition, but rather, has been relied on to teach that it has been conventional to provide a dissolved, homogeneous solution that comprises locust bean gum and agar, into which additional ingredients can be added, in any order, provided that the mixture is a homogeneous mixture. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
On further on page 18 of the response, Applicant’s urgings with respect to Okuyama have been considered but are not seen to be sufficient in view of the responses as already presented above.
Further on page 18-19 of the response, Applicant urges that the claimed order is required for the prep