DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/04/2025 has been entered.
Status of the Claims
This action is in response to papers filed 11/04/2025 which claims 1-10, 12, 15, and 18 were canceled; claim 17 was amended; and claims 26-33 were newly added. All the amendments have been thoroughly reviewed and entered.
Claims 11, 13-14, 16-17, and 19-33 are under examination.
Withdrawn Objections/Rejections
The Examiner has re-weighted all the evidence of record. Any rejections and/or objections not specifically addressed below is hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
New Rejection
Necessitated by Applicant’s Claim Amendments
Claim Rejections - 35 USC § 112
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 29-31 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.
Regarding claims 29-31, the recitation of “said step a) comprises slowly mixing 18 grams of Polysaccharide Polymer with 100 ml of water at 100 to 200 rpm to obtain said homogenous mixture and said step b) comprises adding 2 grams of glycerol, 0.2 grams of flavour extract, and 0.05 grams of food colouring agent to said homogenous mixture and stirring at 100 to 200 rpm to obtain said second homogenous mixture” render said claims 29-31 indefinite because claims 29-31 are dependent from independent claims 11, 16, and 20, respectively, and said claims 11, 16, and 20 recites “a) adding in a reaction vessel, a predetermined amount of cellulose based polymer and water under continuous stirring conditions to obtain a homogenous mixture” and “b) adding a predetermined amount of at least one plasticizer, a predetermined amount of at least one flavoring agent and a predetermined amount of at least one food coloring agent to said homogeneous mixture to obtain a second homogeneous mixture.” Thus, there is no “polysaccharide polymer” in step a) and no “glycerol,” or “flavour extract,” in step b) of method claims 11, 16, and 20. Thus, it is unclear how step a) in claims 29-31 can comprise “polysaccharide polymer” when step a) in claims 11, 16, and 20 does not contain “polysaccharide polymer” but rather contains “cellulose based polymer.” It is noted that “polysaccharide polymer” as recited in claims 29-31 is a much broader polymer than “cellulose based polymer” recited in claims 11, 16, and 20. As such, there is lack of antecedent basis for “polysaccharide polymer” in step a) of claims 11, 16, and 20, as there is no nexus between “polysaccharide polymer” recited in claims 29-31 and the “cellulose based polymer” recited in claims 11, 16, and 20.
Furthermore, it is also unclear how step b) in claims 29-31 can comprise adding glycerol and flavour extract when step b) in claims 11, 16, and 20 does not contain “glycerol” or “flavour extract” but rather contains “plasticizer” and “flavoring agent.” As such, there is lack of antecedent basis for “glycerol” and “flavour extract” in step b) of claims 11, 16, and 20, as there is no nexus between the “glycerol” and “flavour extract” recited in claims 29-31, and the “plasticizer” and “flavoring agent” recited in claims 11, 16, and 20.
As a result, claims 29-31 do not clearly set forth the metes and bounds of patent protection desired.
Modified Rejections
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(s) 11, 17, 26, 29, and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pearce (US 2005/0008735 A1), and as evidenced by Birketvedt (US 2016/0310552 A1).
Regarding claim 11, Pearce teaches an edible film that is used to encapsulate substances such as flavors, breath fresheners, and confectionary food product (Abstract; [0004]-[0178]). Pearce further teaches the substance is used in pre-measured amount ([0085], [0105], [0266], [0268], and [0269]). Pearce teaches the substance for encapsulation in the edible film is in granules form ([0064], [0067], [0076], and [0082]).
Pearce teaches the substances such as breath fresheners include mint or peppermint ([0045], [0105]). As evidenced by Birketvedt, mint or peppermint is known for its function both as a breath freshener (a flavoring agent) and a digestive aid (Birketvedt: [0045] and [0060]), thereby the breath freshener such as mint or peppermint of Pearce meets the claimed digestive aid.
Pearce teaches the edible film is produced by thoroughly blending an amount of a cellulose polymer, water, an amount of plasticizer such as glycerol (glycerin), an amount of flavoring agent, and an amount of coloring agent to form an uniformly homogeneous mixture ([0007]-[0030], [0103]-[0170]). Pearce teaches the uniformly homogenous mixture is de-aerated under vacuum until air bubbles are removed and then casting the uniform mixture on a suitable substrate such as polyethylene terephthalate film, and then drying the cast mixture to form a coated film ([0157]-[0170]). Pearce teaches the coated film is then peel to obtain the edible film ([0157]-[0170]). Pearce teaches the edible film is then used to encapsulate substances such as flavors, breath fresheners, and confectionary food product (Abstract; [0004]-[0178]). It is noted that selection of any order of preforming process steps or selection of any order of mixing ingredients is prima facie obvious, absence of new or unexpected results. See In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946); In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930).
Regarding claim 17, Pearce teaches the substance for encapsulation is encapsulated in one layer of edible film ([0004], [0005], [0041], [0089], [0104]). Pearce teaches the edible film is thin to encourage rapid dissolution or disintegration, wherein the edible film thickness can be any desired thickness of from about 0.0005 inches (12.7 micrometer) to 0.002 inches (50.8 micrometer) ([0177]; claims 46-47). Pearce teaches the edible film is thin to encourage rapid dissolution or disintegration, wherein the edible film thickness can vary between 5 and 200 micrometers ([0163], [0226], [0266]). It is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). As such, it would have been customary for an artisan of ordinary skill to determine the film thickness to achieve the desired thin film thin to encourage rapid dissolution or disintegration. Absent some demonstration of unexpected results showing criticality from the claimed parameters, the optimization of the thickness of the edible film would have been obvious before the effective filing date of Applicant’s invention. See MPEP §2144.05 (I)-(II).
Regarding claim 26, Pearce teaches edible film contains up to about 20% of plasticizer by dry weight of the film composition, about 0.1 to about 30 wt% of flavoring agent, and an up to about 5 wt% of coloring agent ([0026]-[0027], [0046], [0119]). It is noted that the amounts of plasticizer, flavoring agent, and coloring agent disclosed in Pearce overlap the claimed amount ranges for plasticizer, flavoring agent, and food coloring agent as recited in claim 26. It is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). As such, it would have been customary for an artisan of ordinary skill to determine the film thickness to achieve the desired thin film thin to encourage rapid dissolution or disintegration. Absent some demonstration of unexpected results showing criticality from the claimed parameters, the optimization of the amounts of plasticizer, flavoring agent, and food coloring agent in the edible film composition would have been obvious before the effective filing date of Applicant’s invention. See MPEP §2144.05 (I)-(II).
Regarding claim 29, as discussed above, Pearce teaches the edible film is produced by thoroughly blending an amount of a cellulose polymer, water, an amount of plasticizer such as glycerol (glycerin), an amount of flavoring agent, and an amount of coloring agent to form an uniformly homogenous mixture ([0007]-[0030], [0103]-[0170]). Pearce teaches cellulose polymer as a film-forming agent is used in amount ranging from about 0.01 to about 99 wt% ([0010]). Pearce teaches edible film contains up to about 20% of plasticizer by dry weight of the film composition, about 0.1 to about 30 wt% of flavoring agent, and an up to about 5 wt% of coloring agent ([0026]-[0027], [0046], [0119]). Thus, it would have been obvious to one of ordinary skill in the art to optimize the weight in grams of cellulose polymer in water, plasticizer (glycerol), flavoring agent, and coloring agent used during preparation of the mixture, as well as, optimize the condition during preparation by adjusting the rotational speed of the mixer so as to achieve the desired uniformly homogenous mixture. Absence objective evidence showing criticality of amounts of cellulose polymer in water, plasticizer (glycerol), flavoring agent, and coloring agent used in step a), as well as, the criticality of mixing at 100 to 200 rpm, in achieving an edible film composition that is unexpectedly superior from the prior art, the optimization of the weight in grams of cellulose polymer in water, plasticizer (glycerol), flavoring agent, and coloring agent used during preparation of the mixture, as well as, optimization of the condition during preparation by adjusting the rotational speed of the mixer so as to achieve the desired homogenous mixture, would have been obvious by routine optimization and experimentation. It is noted that “Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP §2144.05 (I)-(II).
Regarding claim 32, as discussed above, Pearce teaches the substance for encapsulation in the edible film can be made into granules forms, thereby the substance of Pearce is not in a powdered form.
From the teachings of the reference, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed 11/04/2025 have been fully considered but they are not persuasive.
Below is the Examiner’s response to Applicant’s arguments as they pertain to the pending 103 rejection.
Applicant argues that Pearce does not teach peeling (Remarks, page 8).
In response, the Examiner disagrees. Pearce at paragraph [0160] teaches removing the film from the carrier material. Thus, Pearce does not fact teach peeling.
Applicant argues that Pearce does not teach a granular composition (Remarks, pages 9-10).
In response, the Examiner disagrees. As discussed above in the pending 103 rejection, Pearce teaches the substance for encapsulation in the edible film is in granules form ([0064], [0067], [0076], and [0082]), thereby meeting the claimed “said edible composition is in granular form.”
Applicant argues that Pearce does not teach first de-aerating the solution prior to coating the mixture on the TP substrate and then drying the film afterwards (Remarks, page 11).
In response, the Examiner disagrees. Pearce at paragraph [0170] teach the deaerating the uniform mixture before casting and drying the mixture on the substrate. The recitation of “the film” after deaerating in Pearce appeared to be a typographical error as the following steps are “casting the unform mixture on a suitable substrate” and drying the cast mixture to form a film. Thus, the deaerating in Pearce is performed on the uniform mixture as the last step was to drying the cast mixture to form “a film.”
Applicant argues that Pearce does not each or suggest wrapping (Remarks, pages 12-13).
In response, the Examiner disagrees. Pearce at paragraphs [0092] and [0103]-[0105] teach the film is used for encapsulating an edible material. Thus, Pearce does not in fact teach wrapping.
Applicant argues “just because Birketvedt teaches one example in which mint could be a digestive aid or a breath freshener, the Examiner cannot rely on this for the proposition that all breath fresheners are digestive aids or vice versa and then reject a claim directed to a digestive aid based on a reference directed to a breath freshener.” Thus, Applicant alleges the claimed digestive aid is distinguished from the breath freshener of Pearce (Remarks, pages 13-14).
In response, the Examiner disagrees. The claimed “digestive aid” is generic. Thus, under broadest reasonable interpretation (BRI) consistent with the specification, breath freshener (in other words, mouth freshener) as taught by Pearce reads on the generically claimed “digestive aid.” As discussed above in the pending 103 rejection, Pearce teaches the substances such as breath fresheners include mint or peppermint ([0045], [0105]). As evidenced by Birketvedt, mint or peppermint is known for its function both as a breath freshener (a flavoring agent) and a digestive aid (Birketvedt: [0045] and [0060]), thereby the breath freshener such as mint or peppermint of Pearce meets the claimed digestive aid. The specification on page 1, particularly defines “mouth freshener” under “Definitions” as synonymous to “digestive aid.” Accordingly, Birketvedt is sufficiently used as extrinsic evidence to establish that the breath freshener such as mint or peppermint of Pearce meets the claimed digestive aid in light of the preponderance of evidence from Applicant’s instant specification.
As a result for at least the reasons discussed above, claims 11, 17, 26, 29, and 32 remain rejected as being obvious and unpatentable over the teachings from Pearce (and as evidenced by Birketvedt) in the pending 103 rejection as set forth in this office action.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pearce (US 2005/0008735 A1), and as evidenced by Birketvedt (US 2016/0310552 A1), as applied to claim 11 above, and further in view of Lee et al (US 2014/0199460 A1).
The process of claim 11 is discussed above, said discussion being incorporated herein in its entirety.
Regarding claim 13, Lee teaches an edible water-soluble film comprising carboxymethyl cellulose or a salt thereof such as sodium carboxymethylcellulose, wherein the edible water-soluble film is transparent (Abstract; [0017], [0026]-[0035], and [0042]-[0043]).
It would have been obvious to one of ordinary skill in the art to incorporate sodium carboxymethylcellulose as the carboxymethyl cellulose in the edible film of Pearce, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Lee provided the guidance to do so because teaching that a salt thereof such as sodium carboxymethylcellulose is a suitable carboxymethyl cellulose for use as a material in forming an edible water-soluble film, where carboxymethyl cellulose or a salt thereof such as sodium carboxymethylcellulose can aid in providing a resultant edible film that is transparent. Thus, an ordinary artisan would have looked to known a salt of carboxymethyl cellulose such as sodium carboxymethylcellulose suitable for use in forming an edible film and use said sodium carboxymethylcellulose as the carboxymethyl cellulose in the edible film of Pearce with an reasonable expectation of obtaining an edible film that is transparent, and achieve Applicant’s claimed invention with reasonable expectation of success.
From the teachings of the reference, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed 11/04/2025 have been fully considered but they are not persuasive.
Applicant argues Lee does not make up for the deficiencies of Pearce as evidence by Birketvedt. (Remarks, page 15).
In response, the Examiner disagrees. As discussed above, Pearce as evidenced by Birketvedt. remained to render obvious independent claim 11. See pages 5-12 of this office action, said pages being incorporated therein its entirety.
As a result, claim 13 remained to be rejected as obvious and unpatentable over the combined teachings of Pearce (as evidenced by Birketvedt) and Lee in the pending 103 rejection as set forth in this office action.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pearce (US 2005/0008735 A1), and as evidenced by Birketvedt (US 2016/0310552 A1), as applied to claim 11 above, and further in view of Chang (US 2014/0212453 A1).
The process of claim 11 is discussed above, said discussion being incorporated herein in its entirety.
Regarding claim 14, Chang teaches an edible composition (a snack) comprising flavoring ingredients such as betel nut (areca nut) and peppermint, wherein the flavoring ingredients are in powder form (Abstract; [0014], [0036], [0038], [0040], [0043]-[0044]; claims 29 and 31).
It would have been obvious to one of ordinary skill in the art to betel nut (areca nut) as one of the substances in the edible composition of Pearce, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Chang teaches that betel nut (areca nut) can be used an ingredient in an edible composition to improve flavor, as it is used as a flavoring ingredient. One of ordinary skill in the art would have reasonable expectation of success in including betel nut (areca nut) as one of the substances in the edible composition of Pearce because flavoring agents are taught in Pearce as part of the edible composition (Pearce: [0104]-[0105]). Thus, ordinary artisan seeking to provide an edible composition with areca nut flavor would have looked to including betel nut (areca nut) as one of the substances in the edible composition of Pearce, and achieve Applicant’s claimed invention with reasonable expectation of success.
From the teachings of the reference, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed 11/04/2025 have been fully considered but they are not persuasive.
Applicant argues Chang does not make up for the deficiencies of Pearce as evidence by Birketvedt. (Remarks, page 16).
In response, the Examiner disagrees. As discussed above, Pearce as evidenced by Birketvedt remained to render obvious independent claim 11. See pages 5-12 of this office action, said pages being incorporated therein its entirety.
As a result, claim 14 remained to be rejected as obvious and unpatentable over the combined teachings of Pearce (as evidenced by Birketvedt) and Lee in the pending 103 rejection as set forth in this office action.
Claim(s) 16, 27, 30, and 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pearce (US 2005/0008735 A1) in view of Albert (US 2004/0033293 A1), and as evidenced by Birketvedt (US 2016/0310552 A1).
Regarding claim 16, Pearce teaches an edible film that is used to encapsulate substances such as flavors, breath fresheners, and confectionary food product (Abstract; [0004]-[0178]). Pearce further teaches the substance is used in pre-measured amount ([0085], [0105], [0266], [0268], and [0269]). Pearce teaches the substance for encapsulation in the edible film is in granules form ([0064], [0067], [0076], and [0082]).
Pearce teaches the substances such as breath fresheners include mint or peppermint ([0045], [0105]). As evidenced by Birketvedt, mint or peppermint is known for its function both as a breath freshener (a flavoring agent) and a digestive aid (Birketvedt: [0045] and [0060]), thereby the breath freshener such as mint or peppermint of Pearce meets the claimed digestive aid.
Pearce teaches the edible film is produced by thoroughly blending an amount of a cellulose polymer, water, an amount of plasticizer, an amount of flavoring agent, and an amount of coloring agent to form an uniform mixture ([0007]-[0030], [0103]-[0170]). Pearce teaches the uniform mixture is de-aerated under vacuum until air bubbles are removed and then casting the uniform mixture on a suitable substrate such as polyethylene terephthalate film, and then drying the cast mixture to form a coated film ([0157]-[0170]). Pearce teaches the coated film is then peel to obtain the edible film ([0157]-[0170]). Pearce teaches the edible film is then used to encapsulate substances such as flavors, breath fresheners, and confectionary food product (Abstract; [0004]-[0178]). It is noted that selection of any order of preforming process steps or selection of any order of mixing ingredients is prima facie obvious, absence of new or unexpected results. See In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946); In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930).
However, Pearce does not expressly teach applying a sugar coating to the edible composition before wrapping of claim 16.
Regarding the application of a sugar coating to the edible composition before wrapping of claim 16, Albert teaches an edible product comprising edible composition coated with an sugar shell and said sugar coated edible composition is wrapped within an edible adhesive film (Abstract; [0011]-[0026]; claims 1-31).
It would have been obvious to one of ordinary skill in the art to coat the edible composition of Pearce with a sugar shell before wrapping the edible composition with an edible film, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Albert provided the guidance do so by teaching that an edible composition can first be coated with a sugar shell before it is encapsulated within edible film so as colorants/glitter can be added to the edible film, and obtain an edible product that has a colorful decorative appearance (Albert: [0011]-[0012], [0017], [0023]-[0026]). Thus, ordinary artisan seeking to produce a colorful decorative edible product would have looked to first coat the edible composition of Pearce with a sugar shell before wrapping with the edible film, and achieve applicant’s claimed invention with reasonable expectation of success.
Regarding claim 27, Pearce teaches edible film contains up to about 20% of plasticizer by dry weight of the film composition, about 0.1 to about 30 wt% of flavoring agent, and an up to about 5 wt% of coloring agent ([0026]-[0027], [0046], [0119]). It is noted that the amounts of plasticizer, flavoring agent, and coloring agent disclosed in Pearce overlap the claimed amount ranges for plasticizer, flavoring agent, and food coloring agent as recited in claim 26. It is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). As such, it would have been customary for an artisan of ordinary skill to determine the film thickness to achieve the desired thin film thin to encourage rapid dissolution or disintegration. Absent some demonstration of unexpected results showing criticality from the claimed parameters, the optimization of the amounts of plasticizer, flavoring agent, and food coloring agent in the edible film composition would have been obvious before the effective filing date of Applicant’s invention. See MPEP §2144.05 (I)-(II).
Regarding claim 30, as discussed above, Pearce teaches the edible film is produced by thoroughly blending an amount of a cellulose polymer, water, an amount of plasticizer such as glycerol (glycerin), an amount of flavoring agent, and an amount of coloring agent to form an uniformly homogenous mixture ([0007]-[0030], [0103]-[0170]). Pearce teaches cellulose polymer as a film-forming agent is used in amount ranging from about 0.01 to about 99 wt% ([0010]). Pearce teaches edible film contains up to about 20% of plasticizer by dry weight of the film composition, about 0.1 to about 30 wt% of flavoring agent, and an up to about 5 wt% of coloring agent ([0026]-[0027], [0046], [0119]). Thus, it would have been obvious to one of ordinary skill in the art to optimize the weight in grams of cellulose polymer in water, plasticizer (glycerol), flavoring agent, and coloring agent used during preparation of the mixture, as well as, optimize the condition during preparation by adjusting the rotational speed of the mixer so as to achieve the desired uniformly homogenous mixture. Absence objective evidence showing criticality of amounts of cellulose polymer in water, plasticizer (glycerol), flavoring agent, and coloring agent used in step a), as well as, the criticality of mixing at 100 to 200 rpm, in achieving an edible film composition that is unexpectedly superior from the prior art, the optimization of the weight in grams of cellulose polymer in water, plasticizer (glycerol), flavoring agent, and coloring agent used during preparation of the mixture, as well as, optimization of the condition during preparation by adjusting the rotational speed of the mixer so as to achieve the desired homogenous mixture, would have been obvious by routine optimization and experimentation. It is noted that “Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP §2144.05 (I)-(II).
Regarding claim 33, as discussed above, Pearce teaches the substance for encapsulation in the edible film can be made into granules forms, thereby the substance of Pearce is not in a powdered form.
From the teachings of the reference, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed 11/04/2025 have been fully considered but they are not persuasive.
Below is the Examiner’s response to Applicant’s arguments as they pertain to the pending 103 rejection.
Applicant argues that Pearce does not teach peeling (Remarks, page 16).
In response, the Examiner disagrees. Pearce at paragraph [0160] teaches removing the film from the carrier material. Thus, Pearce does not fact teach peeling.
Applicant argues that Pearce does not teach a granular composition (Remarks, page 16).
In response, the Examiner disagrees. As discussed above in the pending 103 rejection, Pearce teaches the substance for encapsulation in the edible film is in granules form ([0064], [0067], [0076], and [0082]), thereby meeting the claimed “said edible composition is in granular form.”
Applicant argues that Pearce does not teach first de-aerating the solution prior to coating the mixture on the TP substrate and then drying the film afterwards (Remarks, page 16).
In response, the Examiner disagrees. Pearce at paragraph [0170] teach the deaerating the uniform mixture before casting and drying the mixture on the substrate. The recitation of “the film” after deaerating in Pearce appeared to be a typographical error as the following steps are “casting the unform mixture on a suitable substrate” and drying the cast mixture to form a film. Thus, the deaerating in Pearce is performed on the uniform mixture as the last step was to drying the cast mixture to form “a film.”
Applicant argues that Pearce does not each or suggest wrapping (Remarks, page 16).
In response, the Examiner disagrees. Pearce at paragraphs [0092] and [0103]-[0105] teach the film is used for encapsulating an edible material. Thus, Pearce does not in fact teach wrapping.
Applicant argues “Albert does not teach a sugar shell and an edible film composition film composition wrapped around the sugar shell as in claim 16” (Remarks, page 17).
In response, the Examiner disagrees. The method of claim 16 recites “f) applying a sugar coating to said at least one edible composition; and g) wrapping said edible film composition around a predetermined amount of at least one edible composition to form a packaged dosage form after said sugar coating is applied.”
Claim 16 was rejected over the combined teachings of Pearce and Albert. As discussed above, in the pending 103 rejection, Albert provided the guidance for coating the edible composition of Pearce with a sugar shell before wrapping the edible composition with an edible film, in which Albert teaches that an edible composition can first be coated with a sugar shell before it is encapsulated within edible film so as colorants/glitter can be added to the edible film, and obtain an edible product that has a colorful decorative appearance (Albert: [0011]-[0012], [0017], [0023]-[0026]).
It is noted that the edible adhesive as disclosed in Albert that is applied around (“overcoated”) or in other word, wrapped, on the sugar shell, is the edible film. See particularly paragraph [0026] of Albert.
Thus, Pearce in view of Albert does teach and render obvious the claimed “wrapping said edible film composition around a predetermined amount of at least one edible composition to form a packaged dosage form after said sugar coating is applied.”
Applicant argues the claimed digestive aid is distinguished from the breath freshener of Pearce (Remarks, page 18).
In response, the Examiner disagrees. The claimed “digestive aid” is generic. Thus, under broadest reasonable interpretation (BRI) consistent with the specification, breath freshener (in other words, mouth freshener) as taught by Pearce reads on the generically claimed “digestive aid.” As discussed above in the pending 103 rejection, Pearce teaches the substances such as breath fresheners include mint or peppermint ([0045], [0105]). As evidenced by Birketvedt, mint or peppermint is known for its function both as a breath freshener (a flavoring agent) and a digestive aid (Birketvedt: [0045] and [0060]), thereby the breath freshener such as mint or peppermint of Pearce meets the claimed digestive aid. The specification on page 1, particularly defines “mouth freshener” under “Definitions” as synonymous to “digestive aid.” Accordingly, Birketvedt is sufficiently used as extrinsic evidence to establish that the breath freshener such as mint or peppermint of Pearce meets the claimed digestive aid in light of the preponderance of evidence from Applicant’s instant specification.
As a result for at least the reasons discussed above, claims 16, 27, 30, and 33 remain rejected as being obvious and unpatentable over the combined teachings of Pearce and Albert (and as evidenced by Birketvedt) in the pending 103 rejection as set forth in this office action.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pearce (US 2005/0008735 A1), and as evidenced by Birketvedt (US 2016/0310552 A1), as applied to claim 11 above, and further in view of Kumar et al (WO 2016/005930 A1).
The process of claim 11 is discussed above, said discussion being incorporated herein in its entirety.
Regarding claim 19, Kumar teaches an edible film used as an edible packaging material for wrapping food products therein, the edible film comprises carboxymethyl cellulose, glycerol or sodium oleate or potassium oleate (a plasticizer), and edible silver or gold (a coloring agent) (Abstract; [00032]-[00064]; claims 1-14).
It would have been obvious to one of ordinary skill in the art to incorporate sodium oleate or potassium oleate (a metal salt of a fatty acid) in place of glycerol as the plasticizer of Pearce, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Pearce and Kumar are commonly drawn to edible film used as an edible packaging material for wrapping food products (snacks), and Kumar provided the guidance to use sodium oleate or potassium oleate in place of glycerol in the formation of the edible film. Thus, an ordinary artisan would have looked other known plasticizers in the prior art including a metal salt of a fatty acid such as sodium oleate or potassium oleate to be used as the plasticizer in Pearce so as to form an edible film with a desired flexibility, which is one of the desired properties of the edible film of Kumar and Pearce, and achieve Applicant’s claimed invention with reasonable expectation of success.
From the teachings of the reference, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed 11/04/2025 have been fully considered but they are not persuasive.
Applicant argues Kumar does not make up for the deficiencies of Pearce as evidence by Birketvedt. (Remarks, page 18).
In response, the Examiner disagrees. As discussed above, Pearce as evidenced by Birketvedt remained to render obvious independent claim 11. See pages 5-12 of this office action, said pages being incorporated therein its entirety.
As a result, claim 19 remained to be rejected as obvious and unpatentable over the combined teachings of Pearce (as evidenced by Birketvedt) and Kumar in the pending 103 rejection as set forth in this office action.
Claim(s) 20-25, 28, and 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pearce (US 2005/0008735 A1) in view of Kumar et al (WO 2016/005930 A1), and as evidenced by Birketvedt (US 2016/0310552 A1).
Regarding claim 20, Pearce teaches an edible film that is used to encapsulate substances such as flavors, breath fresheners, and confectionary food product (Abstract; [0004]-[0178]). Pearce further teaches the substance is used in pre-measured amount ([0085], [0105], [0266], [0268], and [0269]).
Pearce teaches the substances such as breath fresheners include mint or peppermint ([0045], [0105]). As evidenced by Birketvedt, mint or peppermint is known for its function both as a breath freshener (a flavoring agent) and a digestive aid (Birketvedt: [0045] and [0060]), thereby the breath freshener such as mint or peppermint of Pearce meets the claimed digestive aid.
Pearce teaches the edible film is produced by thoroughly blending an amount of a cellulose polymer, water, an amount of plasticizer such as glycerol (glycerin), an amount of flavoring agent, and an amount of coloring agent to form an uniform mixture ([0007]-[0030], [0103]-[0170]). Pearce teaches the uniform mixture is de-aerated under vacuum until air bubbles are removed and then casting the uniform mixture on a suitable substrate such as polyethylene terephthalate film, and then drying the cast mixture to form a coated film ([0157]-[0170]). Pearce teaches the coated film is then peel to obtain the edible film ([0157]-[0170]). Pearce teaches the edible film is then used to encapsulate substances such as flavors, breath fresheners, and confectionary food product (Abstract; [0004]-[0178]). Pearce teaches the edible film contains colors and flavors, and is cut into small pieces for use as a breath freshener or as an oral care film ([0002]-[0046], [0151]-[0152]). It is noted that selection of any order of preforming process steps or selection of any order of mixing ingredients is prima facie obvious, absence of new or unexpected results. See In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946); In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930).
While Pearce teaches that the edible films contains colors and flavor and is cut into small pieces, Pearce does not expressly mentioned that the edible film is shredded into small pieces to make edible glitters. However, it would have been obvious to shred or cut the edible film of Pearce into small pieces to make edible glitters in view of the guidance from Kumar.
Kumar teaches an edible film used as an edible packaging material for wrapping food products therein, the edible film comprises carboxymethyl cellulose, glycerol or sodium oleate or potassium oleate (a plasticizer), and edible silver or gold (a coloring agent) (Abstract; [00032]-[00064]; claims 1-14). Kumar teaches the edible film is prepared by mixing a composition comprising sodium carboxy methyl cellulose, sodium oleate or potassium oleate, and edible silver or gold to form a mixture, and then applying the mixture on a substrate such as PET to be dried into edible thin film, and peeling said film from the substrate and shredding or cutting said film into desired small pieces to produce edible flakes/shreds with silver/gold appearance (Abstract; [00032]-[00064]).
It would have been obvious to one of ordinary skill in the art to include edible silver or gold in the method of preparing the edible film of Pearce such that upon shredding or cutting the formed edible film, the resultant edible film that is shredded or cutted into small pieces would produce edible flakes/shreds with silver/gold appearance (edible glitters), and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Pearce and Kumar are commonly drawn to edible film used as an edible packaging material for wrapping food products (snacks), and Kumar provided the guidance for producing the edible film of Pearce such that edible silver or gold can be included in the method of the method of preparing the edible film of Pearce so as upon shredding or cutting the formed edible film, the resultant edible film that is shredded or cutted into small pieces would produce edible flakes/shreds with silver/gold appearance. Thus, an ordinary artisan seeking to product edible film flakes/shreds with silver/gold appearance (edible glitter), would have looked to including edible silver or gold in the method of preparing the edible film of Pearce and shredding or cutting the resultant edible film into small pieces would to produce edible flakes/shreds with silver/gold appearance, and achieve Applicant’s claimed invention with reasonable expectation of success.
Regarding claim 21, Kumar provides the guidance for using sodium carboxymethyl cellulose as the cellulose film forming polymer in the method of preparing the edible film, as the use of sodium carboxymethyl cellulose keeps the film sturdy with a high level of uniformity in the thickness of the film (Kumar: [00033]-[00034] and [00046]-[00064]).
Regarding claim 22, Pearce teaches the edible film is thin to encourage rapid dissolution or disintegration, wherein the edible film thickness can be any desired thickness of from about 0.0005 inches (12.7 micrometer) to 0.002 inches (50.8 micrometer) ([0177]; claims 46-47). Pearce teaches the edible film is thin to encourage rapid dissolution or disintegration, wherein the edible film thickness can vary between 5 and 200 micrometers ([0163], [0226], [0266]). It is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). As such, it would have been customary for an artisan of ordinary skill to determine the film thickness to achieve the desired thin film thin to encourage rapid dissolution or disintegration. Absent some demonstration of unexpected results showing criticality from the claimed parameters, the optimization of the thickness of the edible film would have been obvious before the effective filing date of Applicant’s invention. See MPEP §2144.05 (I)-(II).
Regarding claim 23, Kumar teaches and provide guidance for using sodium oleate or potassium oleate in place of glycerol in the formation of the edible film of Pearce (Kumar: [00034], [00044], [00066], [00050], [00054], [00062], [00063]). Thus, it would have been obvious for an ordinary artisan to look to other known plasticizers in the prior art including a metal salt of a fatty acid such as sodium oleate or potassium oleate to be used as the plasticizer in Pearce so as to form an edible film with a desired flexibility.
Regarding claim 24, Pearce teaches cellulose polymer as a film forming polymer ([0010]-[0013]).
Regarding claim 25, as discussed above, Pearce teaches the edible film contains colors and flavors.
Regarding claim 28, Pearce teaches edible film contains up to about 20% of plasticizer by dry weight of the film composition, about 0.1 to about 30 wt% of flavoring agent, and an up to about 5 wt% of coloring agent ([0026]-[0027], [0046], [0119]). It is noted that the amounts of plasticizer, flavoring agent, and coloring agent disclosed in Pearce overlap the claimed amount ranges for plasticizer, flavoring agent, and food coloring agent as recited in claim 26. It is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). As such, it would have been customary for an artisan of ordinary skill to determine the film thickness to achieve the desired thin film thin to encourage rapid dissolution or disintegration. Absent some demonstration of unexpected results showing criticality from the claimed parameters, the optimization of the amounts of plasticizer, flavoring agent, and food coloring agent in the edible film composition would have been obvious before the effective filing date of Applicant’s invention. See MPEP §2144.05 (I)-(II).
Regarding claim 31, as discussed above, Pearce teaches the edible film is produced by thoroughly blending an amount of a cellulose polymer, water, an amount of plasticizer such as glycerol (glycerin), an amount of flavoring agent, and an amount of coloring agent to form an uniformly homogenous mixture ([0007]-[0030], [0103]-[0170]). Pearce teaches cellulose polymer as a film-forming agent is used in amount ranging from about 0.01 to about 99 wt% ([0010]). Pearce teaches edible film contains up to about 20% of plasticizer by dry weight of the film composition, about 0.1 to about 30 wt% of flavoring agent, and an up to about 5 wt% of coloring agent ([0026]-[0027], [0046], [0119]). Thus, it would have been obvious to one of ordinary skill in the art to optimize the weight in grams of cellulose polymer in water, plasticizer (glycerol), flavoring agent, and coloring agent used during preparation of the mixture, as well as, optimize the condition during preparation by adjusting the rotational speed of the mixer so as to achieve the desired uniformly homogenous mixture. Absence objective evidence showing criticality of amounts of cellulose polymer in water, plasticizer (glycerol), flavoring agent, and coloring agent used in step a), as well as, the criticality of mixing at 100 to 200 rpm, in achieving an edible film composition that is unexpectedly superior from the prior art, the optimization of the weight in grams of cellulose polymer in water, plasticizer (glycerol), flavoring agent, and coloring agent used during preparation of the mixture, as well as, optimization of the condition during preparation by adjusting the rotational speed of the mixer so as to achieve the desired homogenous mixture, would have been obvious by routine optimization and experimentation. It is noted that “Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP §2144.05 (I)-(II).
From the teachings of the reference, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed 11/04/2025 have been fully considered but they are not persuasive.
Applicant argues that Pearce does not teach peeling (Remarks, page 19).
In response, the Examiner disagrees. Pearce at paragraph [0160] teaches removing the film from the carrier material. Thus, Pearce does not fact teach peeling.
Applicant argues that Pearce does not teach first de-aerating the solution prior to coating the mixture on the TP substrate and then drying the film afterwards (Remarks, page 19).
In response, the Examiner disagrees. Pearce at paragraph [0170] teach the deaerating the uniform mixture before casting and drying the mixture on the substrate. The recitation of “the film” after deaerating in Pearce appeared to be a typographical error as the following steps are “casting the unform mixture on a suitable substrate” and drying the cast mixture to form a film. Thus, the deaerating in Pearce is performed on the uniform mixture as the last step was to drying the cast mixture to form “a film.”
Applicant argues “[t]here is no motivation to modify Pearce and Birketvedt to provide a metalized film, much less a metalized film that is removed for final packaging” (Remarks, page 20).
In response, the Examiner disagrees. The obviousness analysis in the 103 rejection for claim 20 is not to “modify[ing] Pearce and Birketvedt to provide a metalized film,” but rather, it would have been obvious to one of ordinary skill in the art to include edible silver or gold in the method of preparing the edible film of Pearce such that upon shredding or cutting the formed edible film, the resultant edible film that is shredded or cutted into small pieces would produce edible flakes/shreds with silver/gold appearance (edible glitters), per guidance from Kumar. See 103 rejection, pages 26-27 of this office action. Thus, Applicant’s argument focusing on how “[t]here is no motivation to modify Pearce and Birketvedt to provide a metalized film” is misplaced and not pertinent to the obviousness analysis in the 103 rejection for claim 20. Applicant is noted that "[t]he test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference.... Rather, the test is what the combined teachings of those references would have suggested to those of ordinary skill in the art." See In re Keller, 642 F.2d 413, 425, 208 USPQ 871, 881 (CCPA 1981).
As a result, for at least the reason discussed above, claims 20-25, 28, and 31 remain rejected as being obvious and unpatentable over the combined teachings of Pearce and Kumar (and as evidenced by Birketvedt) in the pending 103 rejection as set forth in this office action.
Conclusion
No claim is allowed.
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/DOAN T PHAN/Primary Examiner, Art Unit 1613