DETAILED ACTION
Status of Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Any rejection or objection not reiterated in this action is withdrawn.
Receipt of the Amendments to the Claims and Applicant’s arguments, filed on 9/29/2025, is acknowledged.
Claims 1, 4, 6, 13, and 14 are amended.
Claim 2 is cancelled.
Claims 1 and 3-15 are included in the prosecution.
Response to Amendments/Arguments
Applicants’ amendment to independent claims 1, 13, and 14 to remove the limitations “L-theanine” and “GABA”, and to add new limitations “from 6 to 19% of tricalcium phosphate” and “wherein the Lemon Balm extract contains at least about 3% rosmarinic acid”, which were not previously in the claim set, changes the scope of the claims.
Applicant’s arguments (pages 6-8, filed 9/29/2025) regarding the previous rejections under 35 USC 103 have been fully considered and are persuasive in light of the claim amendment.
Therefore, the previous rejections have been withdrawn.
However, Examiner makes a new ground of rejection by incorporating Appleton et al. (US 20180250225 A1) as the new primary reference in view of Gerardi et al. (US 20210177038 A1) as evidenced by Kittler et al. (“Content and composition of essential oil and content of rosmarinic acid in lemon balm and balm genotypes (Melissa officinalis)”, June 2018, Genetic Resources and Crop Evolution 65(2)) as well as Appleton et al. (US 20180250225 A1) in view of Yurchak et al. (US20030013639A1) as evidenced by Kittler et al. (“Content and composition of essential oil and content of rosmarinic acid in lemon balm and balm genotypes (Melissa officinalis)”, June 2018, Genetic Resources and Crop Evolution 65(2)).
The new grounds of rejection are necessitated by amendment; therefore, this action is made FINAL.
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 1 and 3-15 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 pre-AIA the applicant regards as the invention.
Claims 1, 13, and 14 are indefinite for reciting “gummy dosage form comprising from 6 to 19% of tricalcium phosphate”, which is unclear because examiner is unable to determine if the percentage is weight by weight or weight by volume, etc. For example, the instant specification states “a method of making the gummy dosage form according to the present disclosure, comprising the steps of: a) blending the tricalcium phosphate and the relaxing ingredient in an aqueous pectin solution” [0023], which makes it unclear whether the percentage of tricalcium phosphate is weight by weight based on the total weight of the gummy dosage form or if the percentage of tricalcium phosphate is weight by volume based on the volume of the aqueous pectin solution. In the interest of compact prosecution, examiner uses the broadest reasonable interpretation and interprets the % as w/w% in the final product of the amount of tricalcium phosphate in the final gummy dosage form.
Claims 1, 13, and 14 are indefinite for reciting “wherein the Lemon balm extract contains at least about 3% rosmarinic acid”, which is unclear because examiner is unable to determine if the percentage is weight by weight or weight by volume or volume by volume. The instant specification states “The Lemon balm extract can be incorporated in the form of a liquid extract or a powder.” [0048], thus it is unclear if the percentage of rosmarinic acid is weight by weight based on the weight of the lemon balm extract, if the percentage of rosmarinic acid is weight by volume based on volume of the lemon balm extract, or if the percentage of rosmarinic acid is volume by volume based on the volume of the lemon balm extract.
Claims 3-12 and 15 are included in the rejection because they do not correct for the defect of the claim from which they depend.
Appropriate correction is required.
Maintained and Modified Rejections
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1 and 3-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more, as evidenced by Kittler et al. (“Content and composition of essential oil and content of rosmarinic acid in lemon balm and balm genotypes (Melissa officinalis)”, June 2018, Genetic Resources and Crop Evolution 65(2)) hereinafter Kittler.
Claim 1 is drawn to a gummy dosage form comprising from 6 to 19% of tricalcium phosphate and a relaxing ingredient, wherein the relaxing ingredient comprises Lemon balm extract and wherein the Lemon balm extract contains at least about 3% rosmarinic acid.
The broadest reasonable interpretation of the claimed compositions would be the material that is named, that is: a component that forms a gummy dosage form, tricalcium phosphate, and a relaxing ingredient comprising Lemon balm extract. A component that can form gummies such as pectin is a naturally occurring product unless otherwise specified. Tricalcium phosphate is a naturally occurring product. And Lemon balm extract is a naturally occurring product.
Thus, the compositions claimed in claim 1 are not markedly different from how the individual components in nature. The amount of 6 to 19% of tricalcium phosphate does not change the function or properties of tricalcium phosphate that is markedly different from how tricalcium phosphate is in nature. Lemon balm extract containing at least about 3% rosmarinic acid is found in nature, as evidenced by Kittler, “Lemon balm (Melissa officinalis L.) is used since ancient times because of its sedative, spasmolytic and antiviral effects. Its therapeutic impact is due to the content of essential oil and rosmarinic acid. A set of 68 M. officinalis genotypes was evaluated for content and composition of essential oil and the content of rosmarinic acid. The rosmarinic acid content ranged in the year 2010 from 3.67 to 7.55% and in the year 2011 from 4.92 to 8.07%.” (abstract). It is not integrated into a practical application because nothing in claim 1 relies on or uses the exception. There is nothing significantly more than the judicial exception because there are no additional elements in the claim. With regard to claims 3-12 the enumeration of the amounts or additional products of nature do not make the combination of the products of nature markedly different from how they occur in nature.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception, because the formulation at the broadest interpretation of the claim language is a mixture of products of nature comprising: a gummy dosage form comprising tricalcium phosphate and Lemon balm extract, which does not appear to change the biological/pharmacological functions, chemical/physical properties, or the structure/form of said ingredients. Because the claimed formulation does not have markedly different characteristics, it is a product of nature.
Response to Amendments/Arguments
Applicants’ amendment to independent claims 1, 13, and 14 to remove the limitations “L-theanine” and “GABA”, and to add new limitations “from 6 to 19% of tricalcium phosphate” and “wherein the Lemon Balm extract contains at least about 3% rosmarinic acid” changes the scope of the claims.
Applicant’s arguments (pages 5-6, filed 9/29/2025) regarding the rejection under 35 USC 101 have been fully considered but are not persuasive.
The previous rejection under 35 USC 101 has been modified, as necessitated by amendment, to address the further limitations of “from 6 to 19% of tricalcium phosphate” and “wherein the Lemon Balm extract contains at least about 3% rosmarinic acid”.
Applicant argues that since claim 1, “has been amended to include a specific weight percentage of tricalcium phosphate. Relaxing ingredients have been limited to lemon balm extract comprising more than about 3% of rosmarinic acid. The claimed formulation, as amended, is not a product found in nature.”
However, the amount of tricalcium phosphate does not appear to change the biological/pharmacological functions, chemical/physical properties, or the structure/form of the tricalcium phosphate in the gummy dosage form. Since the claimed formulation does not have markedly different characteristics, it is a product of nature. Further, lemon balm extract containing at least about 3% rosmarinic acid is not different from how it exists in nature, as evidenced by Kittler, who teaches “A set of 68 M. officinalis genotypes was evaluated for content and composition of essential oil and the content of rosmarinic acid. The rosmarinic acid content ranged in the year 2010 from 3.67 to 7.55% and in the year 2011 from 4.92 to 8.07%.” and is therefore a product of nature. Since the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception, the formulation at the broadest interpretation of the claim language is a mixture of products of nature comprising: a gummy dosage form comprising tricalcium phosphate and Lemon balm extract, which does not appear to change the biological/pharmacological functions, chemical/physical properties, or the structure/form of said ingredients. Therefore, since the claimed formulation does not have markedly different characteristics, it is a product of nature.
New Grounds of Rejection Necessitated by Amendment
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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-7, and 9-13 are rejected under 35 U.S.C. 103 as being unpatentable over Appleton et al. (US 20180250225 A1) hereinafter Appleton in view of Gerardi et al. (US 20210177038 A1) hereinafter Gerardi as evidenced by Kittler et al. (“Content and composition of essential oil and content of rosmarinic acid in lemon balm and balm genotypes (Melissa officinalis)”, June 2018, Genetic Resources and Crop Evolution 65(2)) hereinafter Kittler.
Regarding claim 1, Appleton is drawn to a gummy dosage form including honey in an amount of 20% by dry weight or greater; fruit juice concentrate in an amount of 2% by dry weight or greater; a calcium source; one or more hydrating materials; and a hydrophilic long-chain polymer. The gummy dosage forms can further include additives such as flavorants, fiber, and pH-adjusters. The disclosure further comprises methods for preparing such gummy dosage forms (abstract).
Appleton discloses the “active ingredient” included within the gummy dosage forms disclosed herein can be any compound, composition, or like material that may be included in a dosage form for delivery to an individual to achieve any one or more of a desired nutritional purpose, medicinal purpose, and therapeutic purpose. An active ingredient can include any plant-derived material that is safe for human consumption, including herbal extracts, botanical extracts, and the like [0014].
Appleton discloses the disclosed gummy dosage forms also typically comprise a calcium source, e.g., tricalcium phosphate (TCP). In some embodiments, tricalcium phosphate is employed, and is present within the disclosed gummy dosage forms in an amount of about 10% to about 15% [0032].
Appleton does not explicitly disclose wherein the botanical extract is Lemon balm extract that contains at least about 3% rosmarinic acid.
However, Gerardi is drawn to compositions configured for oral use, the compositions including at least one active ingredient selected from GABA, theanine, lemon balm extract, or combinations thereof, are provided. The compositions may be in chewable forms (abstract).
Gerardi discloses a composition in chewable form, configured for oral use, the composition comprising: at least one active ingredient selected from the group consisting of GABA, theanine, lemon balm extract, and combinations thereof; pectin; wherein the composition is a homogenous mixture [0006]. Gerardi discloses the at least one active ingredient comprises lemon balm extract [0017].
As evidenced by Kittler, “Lemon balm (Melissa officinalis L.) is used since ancient times because of its sedative, spasmolytic and antiviral effects. Its therapeutic impact is due to the content of essential oil and rosmarinic acid. A set of 68 M. officinalis genotypes was evaluated for content and composition of essential oil and the content of rosmarinic acid. The rosmarinic acid content ranged in the year 2010 from 3.67 to 7.55% and in the year 2011 from 4.92 to 8.07%” (abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Appleton wherein the botanical extract of Appleton, comprises Lemon balm extract, as previously disclosed by Gerardi, and arrive at the instant invention.
One of ordinary skill in the art would have been motivated to do so because Appleton and Gerardi are in the field of oral chewable compositions, and Gerardi expressly embodies “a composition in chewable form, configured for oral use, the composition comprising: at least one active ingredient selected from lemon balm extract,” [0082], and recognizes lemon balm extract as a botanical extract “The botanical materials useful in the present disclosure may comprise, certain botanicals, as the plant material or an extract thereof, have found use in traditional herbal medicine, and are described further herein. Non-limiting examples of botanical-derived materials include lemon balm” [0177]. Further, one having ordinary still in the art would reasonably expect success in combining prior art elements according to known methods to yield predictable results, see MPEP 2141.
The Supreme Court has acknowledged:
When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation... 103 likely bars its patentability...if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions......the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) (emphasis added).
From the teachings of the references, 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 at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Regarding claim 3, Appleton in view of Gerardi as evidenced by Kittler disclose the gummy dosage form of claim 1, and Gerardi further discloses .5-1.5 w/w% lemon balm extract in a 2600mg chewable form [0268], which calculates to 13-39 mg and is encompassed by the claimed range of 10mg to 2g.
Regarding claim 4, Appleton in view of Gerardi as evidenced by Kittler disclose the gummy dosage form of claim 1, and Gerardi further discloses theanine [0006].
Regarding claim 5, Appleton in view of Gerardi as evidenced by Kittler disclose the gummy dosage form of claim 1, and Gerardi further discloses 1.2-1.8 w/w% theanine in a 2600mg chewable form [0268], which calculates to 31.2-46.8 mg and is encompassed by the claimed range of 10mg to 2g.
Regarding claim 6, Appleton in view of Gerardi as evidenced by Kittler disclose the gummy dosage form of claim 1, and Gerardi further discloses GABA [0006].
Regarding claim 7, Appleton in view of Gerardi as evidenced by Kittler disclose the gummy dosage form of claim 1, and Gerardi further discloses 1.5-2.5 w/w% GABA in a 2600mg chewable form [0268], which calculates to 39-65 mg and is encompassed by the claimed range of 10 mg to 800 mg.
Regarding claim 9, Appleton in view of Gerardi as evidenced by Kittler disclose the gummy dosage form of claim 1, and Appleton further discloses the gummy dosage form further comprises sucrose [0010].
Regarding claim 10, Appleton in view of Gerardi as evidenced by Kittler disclose the gummy dosage form of claim 1, and Appleton does not require the presence of high fructose corn syrup, therefore the gummy dosage form is substantially free of high fructose corn syrup.
Regarding claims 11-12, Appleton in view of Gerardi as evidenced by Kittler disclose the gummy dosage form of claim 1, and Appleton further discloses gummy dosage forms can be provided with masses including masses in the range of about 1 g to about 6 g (encompassed by the claimed range of 0.5 gram to 10 grams, and overlaps with the claimed range of 4 grams to 6 grams) [0035].
Regarding claim 13, Appleton is drawn to a gummy dosage form including honey in an amount of 20% by dry weight or greater; fruit juice concentrate in an amount of 2% by dry weight or greater; a calcium source; one or more hydrating materials; and a hydrophilic long-chain polymer. The gummy dosage forms can further include additives such as flavorants, fiber, and pH-adjusters. The disclosure further comprises methods for preparing such gummy dosage forms (abstract).
Appleton discloses the “active ingredient” included within the gummy dosage forms disclosed herein can be any compound, composition, or like material that may be included in a dosage form for delivery to an individual to achieve any one or more of a desired nutritional purpose, medicinal purpose, and therapeutic purpose. An active ingredient can include any plant-derived material that is safe for human consumption, including herbal extracts, botanical extracts, and the like [0014].
Appleton discloses the disclosed gummy dosage forms also typically comprise a calcium source, e.g., tricalcium phosphate (TCP). In some embodiments, tricalcium phosphate is employed, and is present within the disclosed gummy dosage forms in an amount of about 10% to about 15% [0032].
Gerardi is drawn to compositions configured for oral use, the compositions including at least one active ingredient selected from GABA, theanine, lemon balm extract, or combinations thereof, are provided. The compositions may be in chewable forms (abstract).
Gerardi discloses a composition in chewable form, configured for oral use, the composition comprising: at least one active ingredient selected from the group consisting of GABA, theanine, lemon balm extract, and combinations thereof; pectin; wherein the composition is a homogenous mixture [0006]. Gerardi discloses the at least one active ingredient comprises lemon balm extract [0017].
As evidenced by Kittler, “Lemon balm (Melissa officinalis L.) is used since ancient times because of its sedative, spasmolytic and antiviral effects. Its therapeutic impact is due to the content of essential oil and rosmarinic acid. A set of 68 M. officinalis genotypes was evaluated for content and composition of essential oil and the content of rosmarinic acid. The rosmarinic acid content ranged in the year 2010 from 3.67 to 7.55% and in the year 2011 from 4.92 to 8.07%” (abstract).
Appleton further discloses a slurry comprising the hydrocolloid system is prepared. The components can be combined in various orders. In one particular embodiment, hot water is heated to 180° F., and pectin, water, and gelatin are added thereto (giving a first mixture). To this first mixture, tricalcium phosphate, is then added. Advantageously, such components can be pre-combined and heated at elevated temperature (e.g., 180° F.) and this second mixture is added to the first mixture. Subsequently, the sugar and certain active ingredients are then added [0045].
The active ingredient(s) to be incorporated within a gummy dosage form can be added to the slurry prior to cooking to ensure homogeneity of the resulting product or can be added after cooking the slurry to form a thickened slurry [0047]. Appleton discloses the active ingredient-containing, thickened slurry is deposited into molds and cooled therein to set the final, desired shape when released from the molds to provide gummy dosage forms. Advantageously, the gummy dosage forms exhibit sufficient integrity to remain in the desired form (without flowing) after removal from the molds [0048].
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Appleton et al. (US 20180250225 A1) hereinafter Appleton in view of Gerardi et al. (US 20210177038 A1) hereinafter Gerardi as evidenced by Kittler et al. (“Content and composition of essential oil and content of rosmarinic acid in lemon balm and balm genotypes (Melissa officinalis)”, June 2018, Genetic Resources and Crop Evolution 65(2)) hereinafter Kittler as applied to claims 1, 3-7, and 9-13 above, and further in view of Harunani (US20220110837A1).
The teachings of Appleton in view of Gerardi as evidenced by Kittler are discussed above.
Regarding claim 8, Appleton in view of Gerardi as evidenced by Kittler discloses the gummy dosage form of claim 1 comprising tricalcium phosphate, but does not explicitly disclose wherein the tricalcium phosphate is in an amount of about 100 mg to about 2 g in the gummy dosage form.
However, Harunani discloses a composition that comprises any combination of a calcium-based compound, a bicarbonate compound, a fluoride compound, an active ingredient, a therapeutic agent based on need, a non-cariogenic sweetener, a hydrating agent, at least one additive, and water. The composition is a candy that has a non-acidic-based composition which neutralizes acids while delivering necessary ions in a pH optimized environment to create the best possible conditions needed to arrest and/or reverse disease processes in the oral cavity and beyond (abstract).
Harunani discloses the composition comprises β-tricalcium phosphate in a range of about 0.5 g to about 5 g. The composition can be made in the form of a gummy candy (overlaps with the claimed range of from about 100 mg to about 2 g) [0024].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Appleton in view of Gerardi as evidenced by Kittler, wherein the amount of tricalcium phosphate in the gummy composition, selected from the range of about 0.5 g to about 5 g, as previously disclosed by Harunani, such that it overlaps with the claimed range of from about 100 mg to about 2 g, and arrive at the instant invention.
One of ordinary skill in the art would have been motivated to do so because Appleton in view of Gerardi, and Harunani are in the field of oral chewable compositions, and Harunani expressly teaches the desired ingredient, in an amount that overlaps the desired range, and in a gummy candy dosage form see [0024]. Further, one having ordinary still in the art would reasonably expect success in combining prior art elements according to known methods to yield predictable results, see MPEP 2141.
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Appleton et al. (US 20180250225 A1) hereinafter Appleton in view of Yurchak et al. (US20030013639A1) hereinafter Yurchak as evidenced by Kittler et al. (“Content and composition of essential oil and content of rosmarinic acid in lemon balm and balm genotypes (Melissa officinalis)”, June 2018, Genetic Resources and Crop Evolution 65(2)) hereinafter Kittler.
Regarding claim 14, Appleton is drawn to a gummy dosage form including honey in an amount of 20% by dry weight or greater; fruit juice concentrate in an amount of 2% by dry weight or greater; a calcium source; one or more hydrating materials; and a hydrophilic long-chain polymer. The gummy dosage forms can further include additives such as flavorants, fiber, and pH-adjusters. The disclosure further comprises methods for preparing such gummy dosage forms (abstract).
Appleton discloses the “active ingredient” included within the gummy dosage forms disclosed herein can be any compound, composition, or like material that may be included in a dosage form for delivery to an individual to achieve any one or more of a desired nutritional purpose, medicinal purpose, and therapeutic purpose. An active ingredient can include any plant-derived material that is safe for human consumption, including herbal extracts, botanical extracts, and the like [0014].
Appleton discloses the disclosed gummy dosage forms also typically comprise a calcium source, e.g., tricalcium phosphate (TCP). In some embodiments, tricalcium phosphate is employed, and is present within the disclosed gummy dosage forms in an amount of about 10% to about 15% [0032].
Appleton does not explicitly disclose wherein the botanical extract is Lemon balm extract that contains at least about 3% rosmarinic acid and does not explicitly disclose a method of treating a gastric disease or disorder, comprising administering the claimed gummy dosage form.
However, Yurchak discloses sleep inducing antacid composition are orally administered to humans or animals in solid form. The sleep inducing antacid composition are not harmful and generally recognized as safe (GRAS) and may be administered to children including babies. Suitable solid and semi-solid forms include soft chewable forms [0006].
Yurchak discloses the sleep inducing antacid composition contains an antacid and a sleep inducing compound [0007]. Yurchak discloses the sleep inducing compound is selected from herbal compounds and nonherbal compounds which exhibit anxiety reducing activity. The herbal compound may be in the form of ground plant or parts of plant, liquid extract of plant part, a semi-solid of plant part, and/or a powder extract of plant part. Examples of sleep inducing compounds include Melissa Officinalis (lemon balm) [0009].
Yurchak discloses the sleep inducing antacid composition was administered to three people experiencing excess gastrointestinal acidity. Prior to ingesting the sleep inducing antacid composition and approximately 15 to 20 minutes after ingesting the sleep inducing antacid composition, each person recorded (1) the amount of excess gastrointestinal acidity on a scale of 1 to 5 wherein 5 represented a high level of excess gastrointestinal acidity and 1 represented no excess gastrointestinal acidity; and (2) their level of drowsiness on a scale of 1 to 5 wherein 5 represented extreme alertness and 1 represented lethargy [0026].
Yurchak discloses the advantage of the sleep inducing antacid compositions are that they promote drowsiness and provide relief from excess gastrointestinal acidity [0033].
As evidenced by Kittler, “Lemon balm (Melissa officinalis L.) is used since ancient times because of its sedative, spasmolytic and antiviral effects. Its therapeutic impact is due to the content of essential oil and rosmarinic acid. A set of 68 M. officinalis genotypes was evaluated for content and composition of essential oil and the content of rosmarinic acid. The rosmarinic acid content ranged in the year 2010 from 3.67 to 7.55% and in the year 2011 from 4.92 to 8.07%” (abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Appleton wherein the botanical extract of Appleton, comprises Lemon balm extract, and wherein the dosage form is administered to treat a gastric disease or disorder, as previously disclosed by Yurchak, and arrive at the instant invention.
One of ordinary skill in the art would have been motivated to do so because Appleton and Yurchak are both in the field of oral chewable compositions, and Yurchak discloses “sleep inducing antacid composition are orally administered to humans or animals in solid form. The sleep inducing antacid composition are not harmful and generally recognized as safe (GRAS) and may be administered to children including babies. Suitable solid and semi-solid forms include soft chewable forms; sleep inducing compound is selected from herbal compounds which exhibit anxiety reducing activity; the advantage of the sleep inducing antacid compositions are that they promote drowsiness and provide relief from excess gastrointestinal acidity (Yurchak: [0006]; [0009]; [0033]). Further, one having ordinary still in the art would reasonably expect success in combining prior art elements according to known methods to yield predictable results, see MPEP 2141.
Regarding claim 15, Appleton in view of Yurchak as evidenced by Kittler disclose the method of claim 14, and Yurchak further discloses the test results in Table II clearly show that the sleep inducing antacid composition reduced excess gastrointestinal acidity in each of the three people within about 15 minutes and increased the level of drowsiness in each of the three people within about 15 minutes after ingesting the sleep inducing antacid composition [0032]; the advantage of the sleep inducing antacid compositions are that they promote drowsiness and provide relief from excess gastrointestinal acidity (wherein difficulty of sleeping related to a gastric disease or disorder is treated) [0033].
Conclusion
No claims are allowed.
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 extension fee 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Quanglong Truong whose telephone number is 571-270-0719. The examiner can normally be reached on Monday to Friday from 8:00 am – 5:00 pm.
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/QUANGLONG N TRUONG/Examiner, Art Unit 1615