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Any rejection or objection not reiterated in this action is withdrawn.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 Response After Final Action filed 4/28/2026, amended claims filed 5/29/2026, and RCE filed on 5/29/2026, is acknowledged.
Claims 1-13 are cancelled.
Claim 14 is amended.
Claims 16-18 are newly added.
Claims 14-18 are included in the prosecution.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/29/2026 has been entered.
Response to Amendments/Arguments
Applicant cancelled claims 1-13, therefore the rejection under 35 USC 101 is withdrawn.
Applicant’s amendment to claim 14 is sufficient to overcome the rejections under 35 USC 112(b) which are withdrawn.
Applicant amended claim 14, “wherein the gummy dosage form comprises from 6 to 19%, based on the total weight of the gummy dosage form, of tricalcium phosphate and 10 mg to 100 mg of a relaxing ingredient comprising Lemon balm extract, and wherein the Lemon balm extract contains at least about 3% rosmarinic acid, in wt% of the Lemon balm extract”.
Applicant’s arguments (pages 4-5, filed 5/29/2026) regarding the previous rejections under 35 USC 103 have been fully considered and are persuasive in light of the claim amendment as the amended limitations where not previously examined together.
Therefore, the previous rejections have been withdrawn.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) and 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)).
Modified Rejection
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 14-18 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 and 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 claims 14 and 18, 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% (encompasses the range of 6 to 19%) [0032].
Appleton does not explicitly disclose wherein botanical extract is Lemon balm extract that contains at least about 3% rosmarinic acid, wherein Lemon balm extract is present in an amount from 10 mg to 100 mg, and does not explicitly disclose a method of treating a gastric disease or disorder, comprising administering the claimed gummy dosage form.
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]. 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 100mg.
Gerardi further discloses GABA [0006], 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.
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, as previously disclosed by Gerardi, 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, Gerardi, and Yurchak are both 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], 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.
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 claims 15-17, 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.
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/QUANGLONG N TRUONG/Examiner, Art Unit 1615
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