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 Claims 11-26 are withdrawn from consideration.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 preparation to be soluble, stable and easier to disperse, which is not disclosed in Okuyama’s process. Applicant also urges that the amount of water added at each stage of the claimed process is limited and controlled so that after cooking the final solids are between 72-74° brix.
It is noted however, that the secondary teachings, as discussed above provide motivation for altering the particular order in which glycerin, inulin and an active ingredient have been added to a solution that is already a homogeneous mixture of agar and locust bean gum with sweeteners. The combination teaches that after cooking, it has been conventional to add additional flavoring agents as part of a fifth stage, with subsequent molding and gelling by cooling and where it would have been obvious to one having ordinary skill in the art to have demolded and dried the molded, gelled product for the purpose of reducing moisture of the product prior to packaging. There is not seen to be a sufficient showing of the unexpected results of the claimed order, compared to the teachings of the prior art. Regarding the amount of water added at each stage, Applicant’s arguments are not commensurate in scope with the claims, which do not recite any particular amounts of water.
On pages 19-20, regarding Muniz, Applicant urges that it is not possible to predict from Muniz the series of stages and process conditions in the claimed invention to reach the final preparation and is focused on a specific formula which is not part of the claimed invention.
These arguments are not persuasive because Okuyama already teaches and suggests the claimed conditions for the cooking stage but is not specific as to what is the brix value of the resulting paste. As such, Muniz teaches chewable oral forms, like Okuyama, where by design one can tailor the particular brix after heating the mixture. Cao is similar in this regard and therefore, it would have been obvious to one having ordinary skill in the art to have modified the Okuyama process to control the heating time and temperature for also achieving a brix within the range of 72-74° (and 70-80 as taught by Muniz and Cao) because these references teach that it has been conventional to arrive at a brix within the claimed range commensurate with the particular formulation that was desired.
Further on page 20 of the response, Applicant’s arguments with respect to the amount of water that has been used and the claimed process not requiring reducing sugar controllers has been considered but is not sufficient because as discussed above, the claims do not specify any particular amount of water or the exclusion of other ingredients as part of the composition.
On page 21, Applicant urges that Okuyama incorporates colorings, flavorings, and acidifying and pH regulating agents to control pH which is not required of the claimed process.
This argument is not persuasive because the claimed process does not exclude the use of additional ingredients.
On page 21-22 of the response, Applicant urges that Davis uses additional ingredients that are not used in the claimed process however this argument is not persuasive because the claimed process does not exclude the use of additional ingredients.
Further on page 22 of the response, Applicant urges that Davis uses amounts of acid that are below the claimed range and that the claimed process and product is not pH dependent. Applicant urges that the claimed process the acidifying agent is only used to adjust the flavor and not to adjust the pH.
It is noted however, that Davis has recognized the use of citric acid to balance the flavor of the product (see paragraph 86 and 93). While Davis might not specifically teach the claimed amount of acid, in view of Davis’s disclosure alone, it would have been obvious to one having ordinary skill in the art to have experimented with the amounts of citric acid for providing a particular flavor to the final product. Nonetheless, Fukui provides further evidence to what Davis suggests: that it would have been obvious to use citric acid as a taste adjusting agent in amounts of 0.1-5% which therefore overlap and encompass the claimed amounts, and therefore make the claimed amounts of citric acid prima facie obvious for achieving a desired flavor to the product.
On pages 22-23 of the response, Applicant urges that Fukui’s disclosure of a granular jelly beverage has a viscosity, volume, hardness and texture characteristics that are different from those required for a gummy bear, and thus implies that the beverage is not obtained through the inventive process that is used to prepare a gummy bear type product. Applicant urges that modifying the flavor of a beverage like that of Fukui requires a smaller amount of citric acid compared to a gummy which has a smaller proportion.
These arguments are not persuasive because the reference has only been relied on to evidence percentages of citric acid that can be incorporated into a gelled composition for the purpose of controlling the flavor of the composition. In view of this, it would have been obvious to one having ordinary skill in the art to have experimented with amounts of citric acid as taught by Davies and Fukui for the purpose of balancing the flavor of Okuyama’s chewable oral form.
On page 23 of the response, Applicant urges that the claimed process does not use a MOGUL molding to avoid cross-contamination and accumulation of active ingredients, and also uses a starchless process to allow obtaining a gum with a humidity of less than 20%, whereas Davies uses a mogul drying that uses starch and implies that the starch recirculates and therefore can contaminate the gum.
These arguments are not sufficient to overcome the rejection because the only specificity with respect to demoulding, degreasing and drying is to dry by spreading the molded forms on “stools or drying baskets” at 30+/5°C at 25+/-5% relative humidity.
That is, the claims do not exclude the presence of starch. Since Okuyama already teaches gelled pieces such as jellies and jelly candies, it would have been obvious to one having ordinary skill in the art to mold and then form a gel from Okuyama’s cooked paste for achieving a desired shape to the product and use temperatures such as 75°C as taught by Rowe and cooling as taught by Hornby because these have been the conventional steps used for shaping and subsequently demolding a cooked paste mixture to produce a chewable oral form.
On pages 23-24 of the response, Applicant urges that the cooling to reach 2-8°C after depositing the paste while maintaining the temperature between 75-89°C of the cooked paste in molds is required otherwise the network will not be formed for gelation. Applicant urges that while Rowe indicates that temperatures greater than 75°C are used to prevent gelling before molding, Rowe uses a different gelling composition with varying process conditions whereas the claimed process requires a molding temperature of 75-89°C and Row does not satisfy the maximum temperature during the molding process.
These arguments are not sufficient to overcome the rejection because Rowe teaches temperature conditions within the claimed range for ensuring that the cooked paste can be shaped within the mold prior to gelation. The reference need not teach the entirety of the claimed range to present a prima facie case of obviousness, and in this case, the reference teaches at minimum a temperature of 75°C, which is within the claimed range. It is noted that Rowe also encompasses agar and locust bean gum as gelling agents (paragraph 63). Regarding cooling, it would have been obvious to one having ordinary skill in the art that cooling would have been required for gelling of the product within the mold and in this regard, Hornby evidences that in order for the composition to set and retain its shape, it would have been obvious to have cooled the product to temperatures such as 4°C. While Okuyama does not specifically mention any particular cooling temperatures, the prior art evidences that it has been known for cooked pastes to be cooled in order to set. Nonetheless, Rowe and Hornby teach and suggest that in order to shape a mixture that comprises gelling agents into a particular form, it has been common and conventional to keep the temperatures of the mixture above a gelling temperature, such as 75°C, deposit into a mold and then cool to allow the mixture to subsequently set and therefore gel. In view of this, it would have been obvious to one having ordinary skill in the art to have modified Okuyama’s process to deposit Okuyama’s cooked paste at a temperature of 75°C to prevent gelling into a mold and then cool to 4°C for the purpose of allowing Okuyama’s composition to take a desired shape when gelling.
On pages 24-25 of the response, Applicant urges that to guarantee gelation the gelled gum must reach a temperature of 2-8° slowly.
These urgings are not seen to be sufficient to overcome the rejection because they are not commensurate in scope with the claims, which only recite cooling to a temperature range between 2-8°C. Applicant’s remarks with respect to the additional ingredients disclosed by Okuyama are not persuasive for the reasons already discussed above.
Applicant’s arguments on page 25-26 reiterate those arguments already presented on page 23-24 and therefore are not sufficient for the reasons already discussed above.
On page 27 of the response, regarding the Hornby reference, Applicant urges that the reference uses 10 minutes to cool to 4°C whereas the claims recite cooling at 2-8°C which done slowly to guarantee gellification and stability. Applicant also urges that the claimed process does not use buffer or buffer salts, maltodextrin, pasteurization or immersion of the gums in a thermostated bath.
These arguments are not sufficient to overcome the rejection because the claims only require cooling to gel, by reducing the temperature to a range of between 2-8°C and since the prior art teaches known cooling temperatures for gellification, such as 4°C, the prior art teaches and suggests the claimed gelling conditions. Regarding cooling slowly, the argument is not commensurate in scope with the claims. Regarding the remainder of the arguments with respect to Hornby, it is noted that the reference has only been relied on to teach and suggest known temperatures for cooling a solution such that the gelling agents can subsequently gel upon cooling.
On page 28 of the response, regarding Rifkin, Taylor, Sugii, Applicant urges that these references disclose a different product because Rifkin uses oils and emulsifiers which are not claimed; Taylor uses gelatin and sorbitol, molasses and honey and castor oil to condition the molds, which are not in the claimed process; and Sugii is directed to a different pharmaceutical composition that the claimed product which is a gum. Applicant also urges that Sugii uses a drying tunnel which is also not claimed.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). It is further noted that the claims recite a chewable oral form, and in this regard, Rifkin also teaches a chewable oral form that is gelled (paragraph 49) and after molding are dried at 15-60°C and 20-30% humidity for reducing the moisture of the product. Therefore, while Rifkin’s composition as a whole might differ from that of Okuyama and the claimed composition, the reference teaches the conditions useful for drying a gelled composition after molding. Cherukuri has been similarly relied on in this regard. Taylor further teaches demoulding, degreasing via the use of oils for facilitating removal of the product from the mold and Sugii teaches molding, deoiling and drying of gelled products. Since the combination already teaches depositing a paste that has a temperature of 75°C into a mold, and then cooling to 4°C to gel the paste, it would have been obvious to one having ordinary skill in the art to demold the shaped product and to degrease and dry because some form of grease has been commonly used in molds for preventing sticking and drying has been conventional to reduce the moisture content of the gelled product. While Sugii teaches using a drying tunnel, the claims do not exclude a drying tunnel. Furthermore, the claims do not limit what constitutes stools for drying and since the prior art teaches drying at temperatures of 30+/-3°C and 25+/-5% relative humidity, it is not seen that patentability can be predicated on the specific use of a “stool” versus any other support surface on which drying can be performed absent a showing of criticality of the use of a stool.
Applicant’s remarks on page 29 with respect to Davies reiterate those remarks presented on pages 21-22 and are not sufficient for the reasons already discussed above.
On page 30 of the response, Applicant urges that Plociak uses a generalized process where more combination options are evidence to allow the particulate sweetener to adhere, while the claimed invention focuses on steam and pressure and uses between 6-10% sweetener whereas Plociak teaches 0.01-6%. Applicant also urges that the claimed process does not impart surface stickiness.
These urgings are not sufficient because while Plociak might teach other options, Plociak clearly teaches that a known expedient for applying a particulate to a gummy composition is to use steam to tackily the surface and then to coat with a sweetener. Plociak’s sweetener amounts overlap with the claimed ranges and therefore a prima facie case of obviousness is presented. It is further noted however, that since the purpose of the sweetener is to add additional flavor, it would have been obvious to one having ordinary skill in the art to have used other known amounts of sweetener as part of the particulate coating, based on the desired sweetness of the final packaged product. Furthermore, the claims refer to the application of steam at a particular pressure for applying a sweetener but does not recite any particular interaction of the steam with the formed product and therefore allows for the steam to also create a degree of tack for helping to coat the chewable oral forms with additional ingredients. The fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Applicant’s arguments on pages 30-31 regarding Perry have been considered but are not persuasive because the reference has only been further relied on to teach known amounts of a sweetener coating applied to a gummy oral form using steam.
On page 31 of the response, regarding the rejection of claim 10, Applicant urges that the claimed products are not dried in drying tunnels but are dried in baskets of specific dimensions and a known capacity to avoid problems such as deformation, non-uniform drying.
It is noted however, that claim 10 recites drying in drying tunnels, therefore the arguments is not seen to be commensurate in scope with the claims. It is further noted that the claims do not specifically require the use of baskets, as the claim recite the use of “stools or drying baskets” without any particular dimensions.
On page 32 of the response, Applicant urges that Cherukuri is directed to the drying of a dragee which is different from the drying of a gum.
It is noted however, that on column 5, lines 55-60, Cherukuri teaches that the product can be any edible product, including jelly products and coated jelly products. Therefore, Cherukuri is pertinent because the reference teaches known drying conditions for drying formed, jellified chewable oral forms.
Applicant’s remarks on page 32 with respect to Pandey have been considered but reiterate those remarks already presented above on page 16 and therefore are not sufficient for the reasons discussed above.
On pages 32-33 of the response, Applicant points to the combinations of Muniz and Davis compared to the exclusion of these components in the claimed process.
These arguments are not sufficient for the reasons already discussed above with respect to Muniz and Davis.
Applicant’s response on pages 33-34 with respect to Okuyama’s disclosure of prune extract and the particular active ingredient in the claimed process and Cao’s active ingredient as part of a fill, reiterate those remarks already presented above and therefore have been considered but are not sufficient for the reasons already discussed above.
On pages 35-36 of the response, Applicant urges that while it is well known that sweeteners are used as a filling agent, it should not be found obvious because each sweetener can be used in different proportions and in different order of addition. Applicant urges that the sweeteners are limited in the claimed process to facilitate making the chewable oral form guaranteeing stability, avoiding degradation and without the use of compounds such as TRIORICH and OMALTY MR-50.
It is noted however, that the prior art teaches including an amount of sweetener in the range of 6-10% as part of the first stage gelling solution and subsequently applies a sweetener composition to the demoulded and dried, gelled chewable form. That is, the prior art is providing a reason for including a sweetener in the claimed amount and at the claimed point in the process. The steps of adding 20-28% sweetener as part of the second stage is optional and therefore not required as is the inclusion of a sweetener as part of the third stage and active ingredient.
On pages 36-37 of the response, regarding Rifkin Applicant urges that Rifkin’s composition is different from the claimed composition, Rifkin requires the use of a cooling tunnel and the claimed flow and pressure does not require additional cooling by a tunnel or adjustment equipment, which Rifkin requires.
These arguments are not seen to be sufficient because while Rifkin teaches using a cooling tunnel the claims do not exclude the use of a cooling tunnel or any additional cooling equipment for the purpose of reducing the moisture of the formed product. Because Rifkin is teaching cooling to remove moisture, the reference is teaching a drying process.
On page 37, Applicant urgings regarding the claimed process not using oils or emulsifiers is not persuasive as the claims do not exclude the use of oils and emulsifiers and the prior art is teaching oils as helping to demold the formed product, and which therefore would have required degreasing after demoulding.
Applicant’s arguments on page 38 regarding Hsu and James have been considered but are not sufficient because there references teach common and conventional steam processing conditions for the purpose of facilitating application of a coating onto the surface of a chewable / edible product.
Applicant’s remarks on pages 38-39 with respect to the particular type of drying used by Davies and the claimed process being starchless reiterate those remarks presented above and are not sufficient for the reasons discussed above.
Applicant’s arguments on page 39 with respect to the use of polycarbonate molds is not commensurate in scope with the claims, which do not discuss any particular material of construction for the molds.
Applicant’s arguments on page 39 with respect to the claimed process using purely natural flavorings whereas Davis uses artificial and natural flavorings with added acid to regulate flavor have been considered but are not commensurate in scope with the claims, which do not limit the particular type of flavorings that can be used as part fo the process.
Applicant’s remarks on page 39 with respect to a wax-based coating, Applicant urges that the glossy appearance can be guaranteed from the molding of the gummy bear using the wax-based material as a release agent in the molds and not as a step of applying a wax-based finish.
It is noted however, that claim 4 is maintained to be indefinite in light of the rejection under 35 U.S.C. 112b. Furthermore, as the claim is not clear as to what “the flavor” of claim 4 is referring to, it can refer to any type of flavor such that application of a wax-based coating can read on “the flavor.” That is, the claim does not recite that the wax-based material is part of one of the components added during the first, second or third stage of the process, for example.
The remainder of Applicant’s remarks on page 40 are not seen to be sufficient for the reasons already presented above.
Conclusion
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.
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/VIREN A THAKUR/Primary Examiner, Art Unit 1792
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