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 .
Election/Restrictions
Applicant’s election without traverse of the gummy candy species in the reply filed on November 24, 2025 is acknowledged.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-7, 13, 15, 16, 20, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Warren et al (WO 2020/227130) in view of Vaman et al (US 2011/0217427).
Regarding claims 1, 2, and 20, Warren et al (Warren) teaches a method of delivering an active pharmaceutical ingredient (API) to an edible substrate comprising: positioning a fully prepared or nearly finished edible substrate, including a gummy or other candy, inline with a dosing head, and after positioning, delivering a volume of at least one API containing liquid into an internal location of the substrate (abstract and paragraphs 8, 9, 11, 35, 37, 40, 46, 50, 51, and 71). Warren teaches that energy is added to the edible product after dosing to increase adhesion of the API material (paragraph 61). Warren teaches that positioning includes moving at least one of the edible substrate or the dosing head (paragraphs 11, 67, and 86-88).
Warren is not specific to the edible substrate as comprising a preformed void that extends into the substrate, wherein the liquid is delivered therein as recited in claim 1, wherein the positioning includes alignment of the dosing head and the void as recited in claim 2, or wherein the void extends into but not through the substrate as recited in claim 4, wherein the method includes creating the pre-formed void as recited in claim 7, or closing the void after the delivering step as recited in claim 13, including through delivery of an edible material to an open end of the void for closure as recited in claim 15.
Vaman et al (Vaman) teaches extruded confections, including gummies, with one or more capillaries distributed around the body that may contain a fluid that is the same or different, which solves the problem of quick release and allows extended release over time (abstract, Figure 15A-27, and paragraphs 1, 3, 5, 10, 11, 13, 29, and 132). Vaman teaches that the capillaries may extend the entire length, or less than the entire length so that they are visible at one or more ends and may be of a width or diameter as desired (paragraphs 12, 26, and 52). Vaman teaches that the capillaries are filled after extrusion, i.e. preforming and filling by alignment of a dosing head(s) (paragraphs 47 and 93, and Figure 3). Vaman teaches that if desired the product may comprise a coating to envelope the body portion (paragraphs 22 and 50).
Regarding the edible substrate as comprising a preformed void that extends into the substrate, wherein the liquid is delivered therein as recited in claim 1, wherein the positioning includes alignment of the dosing head and the void as recited in claim 2, or wherein the void extends into but not through the substrate as recited in claim 4, wherein the method includes creating the pre-formed void as recited in claim 7, or closing the void after the delivering step as recited in claim 13, including through delivery of an edible material to an open end of the void as recited in claim 15, it would have been obvious for the method of forming the filled substrate of Warren to comprise making preformed voids that extend into, but not through the substrate, wherein the process includes aligning the dosage head with the void, as Vaman teaches it was a known and desirable method for forming filled confections because it allows for extended release. It is noted that as the fill material of Warren was liquid, it would have been particularly obvious for the void to not extend fully through the substrate in order to prevent leaking, and for a coating to be applied after filling to seal in the filled liquid. As both Warren and Varman teach the product may comprise a coating, to include the use of a coating after filling the void would have been obvious over the teachings of the prior art for inherent reasons, such as for providing an additional and/or desired confectionery flavor component.
Regarding claim 3, Warren teaches that the API is delivered through a plurality of microdroplets (paragraphs 8, 38, 39, and 40), thus at least making obvious the sequential delivery of one microdroplet before another. It is noted that as Warren teaches dosing a plurality of microdroplets, the method of the prior art must necessarily encompass the microdroplets delivered in simultaneously or sequentially manner, and thus, as the prior art necessarily encompasses a limited number of options, one of ordinary skill in the art would find the claimed limitations obvious in practicing the prior art method.
Regarding claims 5 and 6, as discussed above, it would have been obvious for the substrate of Warren to comprise one or more voids for delivery of the API. Warren teaches that the delivery can be performed with one or more applicators, i.e. dosing heads, and that a plurality of different liquids and active ingredients are delivered to the substrate (paragraph 34, 38, 43, 73, 77, 78, 86-88, and 105). Thus, the claimed limitations are considered obvious over the teachings of the prior art.
Regarding claim 16, as discussed above, it would have been obvious for the substrate of Warren to comprise one or more voids for delivery of the API. Warren teaches that the microdroplets can have any suitable size and shape, including a maximum horizontal cross-sectional dimension of 5 millionths of an inch to 100 thousandths of an inch (paragraph 91). Thus, it would have been obvious for the space containing the microdroplet, i.e. the void, to be a size overlapping the claimed range, including being perpendicular to the central axis and having a cross section of at least 5 millionths of an inch to 100 thousandths of an inch as taught by Warren.
Regarding claim 22, as Warren teaches a plurality of different APIs in the substrate delivered to the specific locations of the edible product desired and that at least one internal API is not brought into direct contact with the tongue and that the microdroplets of API can be coated (paragraphs 34, 38, 43, 45-48, 74, and 76), the teachings of Warren encompass or at least make obvious at least one API configured for gastrointestinal absorption, i.e. a coated API for absorption upon digestion, which is separated from the other API, i.e. the uncoated API in the substrate for absorption upon consumption.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Warren et al (WO 2020/227130) in view of Vaman et al (US 2011/0217427), further in view of Kreske Jr (US 4,229,482).
As discussed above, Warren teaches a method of delivering an active pharmaceutical ingredient (API) to an edible substrate comprising: positioning a fully prepared or nearly finished edible substrate inline with a dosing head, and after positioning, delivering a volume of at least one API containing liquid into an internal location of the substrate, wherein it would have been obvious for the substrate to comprise a preformed void for filling which is later closed in view of Vaman.
Warren and Vaman are not specific to the void as closed by displacing the edible substrate at the surface as recited in claim 14.
Warren teaches that the substrate can be filled with a heated needle, which can soft or melt locations of the substrate in contact with it (paragraph 92), thus suggesting displacing the edible substrate at least at the insertion surface so as to close any hole left when inserting the needle and forming the filled void.
Kreske Jr (KJ) teaches of a method of protecting an edible filling through forming an edible substrate comprising a void and then filling said void with fluids (abstract and column 1 lines 8-32). KJ teaches that after filling the liquid, the end of the void is sealed to retain the fluid material therein, wherein sealing can be with a cap, or heating and crimping, i.e. displacing the substrate to close it.
It would have been obvious to one of ordinary skill in the art for the filled void of Warren in view of Varman to be closed so that the fluid material was retrained as discussed above, and as taught by KJ. It would have been further obvious to seal the void with known means, including with heat so that the edible substrate would melt, i.e. deform, and close in view of Kreske and/or as suggested by Warren.
Claims 1-11, 13, 15, 16, 20, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Warren et al (WO 2020/227130) in view of Valender et al (WO 2020/221627) and Kaplan (US 2010/0104687).
Regarding claims 1, 2, and 20, Warren et al (Warren) teaches a method of delivering an active pharmaceutical ingredient (API) to an edible substrate comprising: positioning a fully prepared or nearly finished edible substrate, including a gummy candy, inline with a dosing head, and after positioning, delivering a volume of at least one API containing liquid into an internal location of the substrate (abstract and paragraphs 8, 9, 11, 35, 37, 40, 46, 50, 51, and 71). Warren teaches that energy is added to the edible product after dosing to increase adhesion of the API material (paragraph 61). Warren teaches that positioning includes moving at least one of the edible substrate or the dosing head (paragraphs 11, 67, and 86-88).
Warren is not specific to the edible substrate as comprising a preformed void that extends into the substrate, wherein the liquid is delivered therein as recited in claim 1, wherein the positioning includes alignment of the dosing head and the void as recited in claim 2, or wherein the void extends into but not through the substrate as recited in claim 4, wherein the method includes creating the pre-formed void as recited in claim 7, wherein creating comprises ablating the edible substrate as recited in claim 8, preferably with at least one laser as recited in claim 9, or with a driving shaft as recited in claim 10, which compresses the edible substrate to create the void as recited in claim 11, or wherein the voids are closed as recited in claim 13, with an edible material for closure as recited in claim 15.
Valender et al (Valender) teaches a confectionery product which has pre-formed void(s) which extend into but not through the substrate filled with a desired material(s) and then sealed with an edible material providing for areas of weakness and a more varied consumer experience (abstract and page 2 lines 5-23). Valender teaches that each shell, i.e. the preform including the void, is made in any suitable way, such as with a mold and press, i.e. mechanically with shaft that compresses the edible material to create the void (page 22 lines 25-28).
Kaplan teaches confectionery articles with voids (100) formed mechanically or by laser drilling (abstract, Figure 11, and paragraph 132).
Regarding the edible substrate as comprising a preformed void that extends into the substrate, wherein the liquid is delivered therein as recited in claim 1, wherein the positioning includes alignment of the dosing head and the void as recited in claim 2, or wherein the void extends into but not through the substrate as recited in claim 4, wherein the method includes creating the pre-formed void as recited in claim 7, wherein creating comprises ablating the edible substrate as recited in claim 8, preferably with at least one laser as recited in claim 9, or with a driving shaft as recited in claim 10, which compresses the edible substrate to create the void as recited in claim 11, as discussed above Warren teaches of fluid filled confections. Valender teaches center filled confections can be formed by any known means, including mechanical means. It would have been obvious for the filled confection of Warren to be formed by known means, including by first preforming a cavity(s) with a closed end void(s) for filling as taught by Valender, including with known tools for doing so, such as mechanically with a compression shaft as taught by Valender or with a laser which would ablate the material as taught by Kaplan and then to align the dosing head with the space for the filling, i.e. the void, and deliver said filling in view of Warren. To use one known forming means or another would have been obvious to one of ordinary skill in the art. This position is supported as Valender teaches any known means for forming a confectionery cavity can be used, and as Kaplan teaches that voids can be formed mechanically or with laser drilling.
Regarding the voids as closed as recited in claim 13, with an edible material as recited in claim 15, it would have been further obvious to seal the voids with an edible material in an area of weakness in order to provide a more varied consumer experience as taught by Valender.
Regarding claim 3, Warren teaches that the API is delivered through a plurality of microdroplets (paragraphs 8, 38, 39, and 40), thus at least making obvious the sequential delivery of one microdroplet before another. It is noted that as Warren teaches dosing a plurality of microdroplets, the method of the prior art must necessarily encompass the microdroplets delivered in simultaneously or sequentially manner, and thus, as the prior art necessarily encompasses a limited number of options, one of ordinary skill in the art would find the claimed limitations obvious in practicing the prior art method.
Regarding claims 5 and 6, as discussed above, it would have been obvious for the substrate of Warren to comprise one or more voids for delivery of the API. Warren teaches that the delivery can be performed with one or more applicators, i.e. dosing heads, and that a plurality of different liquids and active ingredients are delivered to the substrate (paragraph 34, 38, 43, 73, 77, 78, 86-88, and 105). Thus, the claimed limitations are considered obvious over the teachings of the prior art.
Regarding claim 16, as discussed above, it would have been obvious for the substrate of Warren to comprise one or more voids for delivery of the API. Warren teaches that the microdroplets can have any suitable size and shape, including a maximum horizontal cross-sectional dimension of 5 millionths of an inch to 100 thousandths of an inch (paragraph 91). Thus, it would have been obvious for the space containing the microdroplet, i.e. the void, to be a size overlapping the claimed range, including being perpendicular to the central axis and having a cross section of at least 5 millionths of an inch to 100 thousandths of an inch as taught by Warren.
Regarding claim 22, as Warren teaches a plurality of different APIs in the substrate delivered to the specific locations of the edible product desired and that at least one internal API is not brought into direct contact with the tongue and that the microdroplets of API can be coated (paragraphs 34, 38, 43, 45-48, 74, and 76), the teachings of Warren encompass or at least make obvious at least one API configured for gastrointestinal absorption, i.e. a coated API for absorption upon digestion, which is separated from the other API, i.e. the uncoated API in the substrate for absorption upon consumption.
Claims 1-7, 10-16, 20, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Warren et al (WO 2020/227130) in view of Valender et al (WO 2020/221627) and Martin et al (WO 01/35758).
Regarding claims 1, 2, and 20, Warren et al (Warren) teaches a method of delivering an active pharmaceutical ingredient (API) to an edible substrate comprising: positioning a fully prepared or nearly finished edible substrate, including a gummy candy, inline with a dosing head, and after positioning, delivering a volume of at least one API containing liquid into an internal location of the substrate (abstract and paragraphs 8, 9, 11, 35, 37, 40, 46, 50, 51, and 71). Warren teaches that energy is added to the edible product after dosing to increase adhesion of the API material (paragraph 61). Warren teaches that positioning includes moving at least one of the edible substrate or the dosing head (paragraphs 11, 67, and 86-88).
Warren is not specific to the edible substrate as comprising a preformed void that extends into the substrate, wherein the liquid is delivered therein as recited in claim 1, wherein the positioning includes alignment of the dosing head and the void as recited in claim 2, or wherein the void extends into but not through the substrate as recited in claim 4, wherein the method includes creating the pre-formed void as recited in claim 7, which includes driving a shaft into the edible substrate as recited in claim 10, wherein the shaft compresses the substrate to create the void as recited in claim 11, or wherein the shaft is heated to at least partially melt the substrate and create the void as recited in claim 12, or wherein the voids are closed as recited in claim 13, by displacing an edible material of the substrate surface as recited in claim 14, or with an edible material for closure as recited in claim 15.
Valender et al (Valender) teaches a confectionery product which has pre-formed void(s) which extend into but not through the substrate filled with a desired material(s) and then sealed with an edible material providing for areas of weakness and a more varied consumer experience (abstract and page 2 lines 5-23). Valender teaches that each shell, i.e. the preform including the void, is made in any suitable way, such as with a mold and press, i.e. mechanically (page 22 lines 25-28).
Martin et al (Martin) teaches of a confectionery centerfill with a frangible break away portion (abstract). Martin teaches that a hinge is made to access the center, wherein the hinge is able to withstand a certain amount of force, but break away when a desired amount of frangible force is applied; and that the hinge may provide an element of play, such as to mimic the opening of doors in a house (abstract, page 2 lines 28-30, page 7 lines 26-28, page 8 lines 4-19, and page 9 lines 17-25). Martin teaches that the confectionary center fill has a void which is formed by any convenient method, including molding and then compression with a cold or hot press, i.e. shaft, to form the void (page 10 line 20 through page 11 line 34).
Regarding the edible substrate as comprising a preformed void that extends into the substrate, wherein the liquid is delivered therein as recited in claim 1, wherein the positioning includes alignment of the dosing head and the void as recited in claim 2, or wherein the void extends into but not through the substrate as recited in claim 4, wherein the method includes creating the pre-formed void as recited in claim 7, which includes driving a shaft into the edible substrate as recited in claim 10, wherein the shaft compresses the substrate to create the void as recited in claim 11, or wherein the shaft is heated to at least partially melt the substrate and create the void as recited in claim 12, as discussed above Warren teaches of fluid filled confections. Valender and Martin teach that center filled confections can be formed by any known means. It would have been obvious for the filled confection of Warren to be formed by known means, including by first preforming a cavity(s) with a closed end void(s) for filling as taught by Valender and/or Martin, including with known tools for doing so, such as mechanically through compression with a heated shaft, which would melt the material for molding as suggested by Martin and then to align the dosing head with the space for the filling, i.e. the void, and deliver said filling in view of Warren. To use one known forming means or another would have been obvious to one of ordinary skill in the art. This position is supported as Valender and/or Martin teach any known means for forming a confectionery cavity can be used.
Regarding the voids as closed as recited in claim 13, by displacing an edible material of the substrate surface as recited in claim 14, or with an edible material as recited in claim 15, it would have been further obvious to seal the voids with an edible material with a hinge, which would displace the edible surface of the substrate as taught by Martin in order to provide for mimicking of a door hinge and an element of play for the consumer in view of Martin. Thus, the claimed limitations are considered obvious over the teachings of the prior art.
Regarding claim 3, Warren teaches that the API is delivered through a plurality of microdroplets (paragraphs 8, 38, 39, and 40), thus at least making obvious the sequential delivery of one microdroplet before another. It is noted that as Warren teaches dosing a plurality of microdroplets, the method of the prior art must necessarily encompass the microdroplets delivered in simultaneously or sequentially manner, and thus, as the prior art necessarily encompasses a limited number of options, one of ordinary skill in the art would find the claimed limitations obvious in practicing the prior art method.
Regarding claims 5 and 6, as discussed above, it would have been obvious for the substrate of Warren to comprise one or more voids for delivery of the API. Warren teaches that the delivery can be performed with one or more applicators, i.e. dosing heads, and that a plurality of different liquids and active ingredients are delivered to the substrate (paragraph 34, 38, 43, 73, 77, 78, 86-88, and 105). Thus, the claimed limitations are considered obvious over the teachings of the prior art.
Regarding claim 16, as discussed above, it would have been obvious for the substrate of Warren to comprise one or more voids for delivery of the API. Warren teaches that the microdroplets can have any suitable size and shape, including a maximum horizontal cross-sectional dimension of 5 millionths of an inch to 100 thousandths of an inch (paragraph 91). Thus, it would have been obvious for the space containing the microdroplet, i.e. the void, to be a size overlapping the claimed range, including being perpendicular to the central axis and having a cross section of at least 5 millionths of an inch to 100 thousandths of an inch as taught by Warren.
Regarding claim 22, as Warren teaches a plurality of different APIs in the substrate delivered to the specific locations of the edible product desired and that at least one internal API is not brought into direct contact with the tongue and that the microdroplets of API can be coated (paragraphs 34, 38, 43, 45-48, 74, and 76), the teachings of Warren encompass or at least make obvious at least one API configured for gastrointestinal absorption, i.e. a coated API for absorption upon digestion, which is separated from the other API, i.e. the uncoated API in the substrate for absorption upon consumption.
Claims 17-19 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Warren et al (WO 2020/227130) in view of Vaman et al (US 2011/0217427), or alternatively in view of Valender et al (WO 2020/221627) and Kaplan (US 2010/0104687), or alternatively in view of Valender et al (WO 2020/221627) and Martin et al (WO 01/35758), each respectively, further in view of Li et al (US 2003/0232082). It is noted that the rejection of claim 20 is an alternative to the one as presented above.
As discussed above, Warren teaches a method of delivering an active pharmaceutical ingredient(s) (API) to an edible substrate, wherein the API is a liquid material within a void(s) in the substrate.
Warren is silent to the API as remaining in the void after delivery as recited in claim 17, or the edible substrate as porous, wherein the liquid travels into a surrounding region of the edible substrate as recited in claim 18, or the method as further comprising a non-porous barrier to at least one internal surface and a base to define the void and prevent the API from traveling through the edible substrate as recited in claim 19.
Li teaches confectionery dosage forms, including center filled dosage mediums with liquid dosage forms, i.e. APIs, within a core(s), i.e. void(s) (abstract, and paragraphs 1, 12, 23, 33, 50, 51, and 61). Li teaches modified release of pharmaceuticals has been used to optimize drug delivery and enhance patient compliance (paragraph 5). Li teaches that at least a portion of the shell is semipermeable to gastrointestinal (gi) fluids (paragraph 3), thus teaching at least one API configured for transmucosal absorption and a second one configured for gi absorption (paragraphs 3, 5, and 50). Li teaches that the core comprises multiple active ingredients which may have different release modifying properties (paragraphs 1 and 86), and that the core may be formed through any suitable method including compression and molding (paragraphs 87, 103-104, 109, and 210). Li teaches that known mechanisms for dosage delivery include diffusion and osmosis (paragraphs 13, 24, 33, 34, 61-65, 83, 99, 100, 213, and 214), and thus encompasses the liquid as traveling through a porous edible substrate to the surrounding region(s). Li teaches that the core contains a passage way, i.e. a void, which extends to the surface of the shell (Figure 1 and paragraphs 61, 62, and 225), and thus encompasses a dosage delivery API configured for transmucosal absorption. Also see paragraph 80 wherein Li teaches that the active ingredient is absorbed by water, gastric fluid, intestinal fluid, or the like. Li teaches that the product may have a 3rd barrier portion between the void and shell to prevent the passage of the active ingredient (paragraph 211).
Regarding the edible substrate as substantially non-porous and the API as remaining in the void after delivery as recited in claim 17, or the edible substrate as porous, wherein the liquid travels into a surrounding region of the edible substrate as recited in claim 18, or the method as further comprising a non-porous barrier to at least one internal surface and a base to define the void and prevent the API from traveling through the edible substrate as recited in claim 19, it would have been obvious to one of ordinary skill in the art for the one or more APIs of Warren to have any known modified release method, including the edible substrate as substantially non-porous and the API as remaining in the void after delivery, or the edible substrate as porous, wherein the liquid travels into a surrounding region of the edible substrate, or the method as further comprising applying a non-porous barrier to at least one internal surface and a base to define the void and prevent the API from traveling through the edible substrate in order to control the release of the active(s) in view of Li.
Regarding claim 22, as discussed above, as Warren teaches a plurality of different APIs in the substrate delivered to the specific locations of the edible product desired and that at least one internal API is not brought into direct contact with the tongue and that the microdroplets of API can be coated (paragraphs 34, 38, 43, 45-48, 74, 76,), the teachings of Warren encompass or at least make obvious at least one API configured for gastrointestinal absorption, i.e. a coated API for absorption upon digestion, which is separated from the other API, i.e. the uncoated API in the substrate for absorption upon consumption. Alternatively, it would have been obvious for the APIs as taught by Warren to be configured for absorption and release at different parts, such as transmucosal or gi absorption, to optimize drug delivery in view of Li.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Machado et al (US 2016/0360768) teaches confections with a center fill can leave an open top for visual appeal or close to prevent spilling.
Sowden et al (US 2003/0235616) teaches of modified release dosage forms, wherein release can be controlled for immediate or delayed release.
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KELLY BEKKER
Primary Patent Examiner
Art Unit 1792
/KELLY J BEKKER/Primary Patent Examiner, Art Unit 1792