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 .
DETAILED ACTION
This office action is in reply to Applicant’s Arguments/Remarks filed 17 July 2026 for application 18/615,156 filed 25 March 2024. Claims 1-2 and 13-16 are amended. Claims 11 and 19 are canceled. Currently, claims 1-10, 12-18, and 20 are pending.
REJECTIONS WITHDRAWN
The status for each rejection and/or objection of the previous office action is set out below.
35 U.S.C. 102, 103, and Double Patenting
Applicant’s arguments to claims 1-4, 7-10, 12 and 14 were found persuasive and the rejection has been withdrawn.
REJECTIONS – MAINTAINED & NEW
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(New/Maintained) Claims 1-10, 12-14, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Badejo et al. (Aqueous-based compositions, US 2021/0162051 A1, 2021; entered into the IDS on 19 July 2024) in view of Wan et al. (Gelatin gummy composition and methods of making and using thereof, US 2020/0138704 A1, 2020).
Badejo discloses an aqueous-based composition containing multiple components, including some which can inhibit microbial growth, are safe for human use, can be in syrup form or contain syrups, and other pharmaceutical ingredients (para. 0003). A variety of active pharmaceutical ingredients are considered including those that are anti-inflammatory, decongestants, cough-suppressants, etc. (para. 0009). Badejo also discloses that polyols, such as glycerin or sorbitol, exhibit antimicrobial properties (para. 0005), where the glycerin amount in the composition can range from 50-70% w/v and sorbitol amount in the composition can range from 10-50% w/v (para. 0008).
They do not, however, disclose where the composition is substantially free of any ingredient having a fructose content greater than 15 percent.
Wan rectifies this deficiency by teaching gummies designed to deliver a composition dosage, which are described as advantageous over other delivery methods such as tablets, capsules, soft-gels, powders, liquid suspensions or solutions due to the ability to deliver more precisely the active ingredients of choice to the patient (para. 0003-0006). Wan exemplifies this by teaching an ibuprofen gummy in example 19, where the ingredients include 170 g. sucrose, 50 g. beta-cyclodextrin, 410 g. glucose syrup, 12 g. lysine, 62.5 g. gelatin, 20 g. mannitol, 120 g. fructose, 0.5 g. sodium benzoate and 0.5 g. potassium sorbate, giving 14.2% of the composition being fructose.
As such, it would be prima facie obvious, to a person of ordinary skill in the art, before the effective filing date, to consider the use of dietary or nutritional supplements, or related homeopathic active ingredients, in the use of any composition designed to deliver a therapeutic effect whether it is in the form of a gummy or an aqueous (liquid) composition.
(New/Maintained) Regarding the limitations of claim 2 are met as Badejo discloses the use of glycerin in the aqueous composition (para. 0008) and brown rice syrup (para. 0129).
(New/Maintained) Concerning the limitations of claim 3 are met as several sweeteners disclosed by Badejo, including stevia and monk fruit syrup, do not contain any fructose and therefore inherently would have less than 0.7 g/mL of total fructose (para. 0129).
(New/Maintained) Pertaining to the limitations of claim 4 are met as Badejo discloses the use of several possible active pharmaceutical ingredients such as phenylephrine, dextromethorphan, diphenhydramine, etc. (para. 0009).
(New/Maintained) With respect to the limitations of claim 5 are met as Wan teaches the use of dietary or nutritional supplements such as herbal extracts, herb powders, natural products, vitamins, amino acids, lipids, fatty acids, minerals, co-enzymes, hormones, or anti-oxidants, of which some are encompassed within the homeopathic active ingredient domain, such as herbal extracts, herb powders, and natural products (para. 0045).
(New/Maintained) With regards to the limitations of claim 6 are met as Wan teaches the use of dietary or nutritional supplements such as herbal extracts, herb powders, natural products, vitamins, amino acids, lipids, fatty acids, minerals, co-enzymes, hormones, or anti-oxidants, of which some are encompassed within the homeopathic active ingredient domain, such as herbal extracts, herb powders, and natural products (para. 0045).
(New/Maintained) With concern to the limitations of claim 7 are met as Badejo discloses that the aqueous-based composition can be in the form of a solution, syrup, suspension or gel (para. 0015).
(New/Maintained) Regarding the limitations of claim 8 are met as Badejo discloses that the aqueous-based composition can be in the form of a solution, syrup, suspension or gel (para. 0015).
(New/Maintained) Concerning the limitations of claim 9 are met as Badejo discloses the use of a variety of active pharmaceutical ingredients including diphenhydramine, dextromethorphan, guaifenesin, ibuprofen, cetirizine, acetaminophen and phenylephrine (para. 0009).
(New/Maintained) Pertaining to the limitations of claim 10 are met as the disclosed active pharmaceutical ingredients diphenhydramine and cetirizine are antihistamines (para. 0009).
(New/Maintained) With respect to the limitations of claim 13, wherein the first natural bulk sweetener is glycerin and the second natural bulk sweetener is tapioca syrup, is met as Badejo discloses the use of one or more natural sweeteners, and may be any suitable natural sweeteners (para. 0129). This is reinforced by Wan who teaches a gummy composition of the same purpose can use glucose syrups including corn syrup, tapioca syrup, rice syrup, barley syrup, cassava syrup, or potato syrup (para. 0025). A genus may be so small that, when considered in light of the totality of the circumstances, it would anticipate the claimed species or subgenus. For example, it has been held that a prior art genus containing only 20 compounds and a limited number of variations in the generic chemical formula inherently anticipated a claimed species within the genus because “one skilled in [the] art would… envisage each member” of the genus. In re Petering, 301 F.2d 676, 681, 133 USPQ 275, 280 (CCPA 1962).
(New/Maintained) With regards to the limitations of claim 14 are met as Badejo discloses the use of one or more natural sweeteners, may be any suitable natural sweetener, and gives the example of brown rice syrup (para. 0129).
(New/Maintained) With concern to the limitations of claim 18 are met as Wan teaches an ibuprofen gummy in example 19, where the ingredients include 170 g. sucrose, 50 g. beta-cyclodextrin, 410 g. glucose syrup, 12 g. lysine, 62.5 g. gelatin, 20 g. mannitol, 120 g. fructose, 0.5 g. sodium benzoate, and 0.5 g. potassium sorbate, thus giving a composition that is substantially free of agave syrup.
(New/Maintained) Regarding the limitations of claim 20 are met as the active pharmaceutical ingredients disclosed by Badejo are known to treat several symptoms including pain (ibuprofen, acetaminophen), fever (acetaminophen), cough (dextromethorphan), nasal congestion (phenylephrine), allergic rhinitis (diphenhydramine, cetirizine), and sore throat (ibuprofen, acetaminophen) (para. 0009). Wan further teaches use of the active agent in their composition, where the dosage will differ depending on the user and use. This is exemplified in cases such as gastrointestinal disorders such as bloating, discomfort, or pain, where 0.1-1.0 mg. of the active agent would be contained in dose (para. 0118). Other examples are given such as phenylephrine hydrochloride used for treating nasal congestion, where an adult dose is 10 mg every 4-6 hours and a child dose is 5 mg within the same time period (para. 0119). Aspirin is taught to be administered for treating symptoms of fever, pain, or for cardiovascular health, with a typical adult dose of 81 mg for cardiovascular health and 325 mg for pain or fever relief (para. 0120). Naproxen is taught to be administered for pain relief, with a typical adult dose of 275-500 mg (para. 0121). Acetaminophen is taught to be administered for reliving pain or fever, with an adult dose of 325-650 mg (para. 0122), Guaifenesin being administered for congestion in the chest or throat with an adult dose being 200-400 mg (para. 0124). Dextromethorphan hydrobromide can be administered to treat symptoms of cough, with a typical adult dose of 10-30 mg (para. 0124). Several other examples of active ingredients and their use in treating varied symptoms are also provided.
(New/Maintained) Claims 11 is rejected under 35 U.S.C. 103 as being unpatentable over Badejo and Wan as applied to claims 1-10, 12-14 and 18-20 above, and further in view of Naughton et al. (Medication with improved taste and sensory experience, US 2018/0055938 A1, 2018).
Badejo discloses an aqueous-based composition with multiple components including active pharmaceutical ingredients and natural sweeteners.
Badejo does not, however, teach the use of a sensate.
Naughton addresses this obstacle by teaching the use of menthol as a means to address the unpleasant taste and/or after taste that many liquid medications possess (para. 0008). This is exemplified where guaifenesin, described as one of the most bitter active pharmaceutical agents, is combined with menthol as a cooling sensate, to try to mitigate the negative aesthetics of liquid medications (para. 0009). This is further combined with WS-5, another cooling agent, and flavoring agents to help cover the bitterness of the pharmaceutical actives and allow the cooling sensation of menthol to be elevated without causing burning (para. 0010).
As such, it would have been prima facie obvious, to a person of ordinary skill in the art, before the effective filing date, to consider the use of menthol as one possible sensate, as taught by Naughton as they exemplified its use to counteract the bitterness of guaifenesin, one of the active pharmaceutical ingredients considered in the instant application.
(New/Maintained) Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Badejo and Wan as applied to claims 1-10, 12-14 and 18-20 above, and further in view of K. Vessels (Tertiary separation of allulose from corn syrup using chromatography, US 2023/0058087 A1, 2023).
Badejo discloses an aqueous-based composition with multiple components including active pharmaceutical ingredients and natural sweeteners.
Badejo does not disclose wherein the first natural bulk sweetener is glycerin and the second natural bulk sweetener is allulose syrup.
Vessels addresses this oversight by teaching that allulose syrup is a low caloric sweetener and an isomer of fructose, derived from isomerizing fructose using an epimerase enzyme, using fructose sources such as high fructose corn syrup (para. 0003, 0011). High fructose corn syrup, sourced from corn syrup falls under the genus of plant derived sweeteners.
As such, it would be prima facie obvious, to a person of ordinary skill in the art, before the effective filing date, to consider the use of allulose syrup as an alternative low caloric sweetener that is derived from a plant source with regards to Petering as above.
(New/Maintained) Claims 16-17 is rejected under 35 U.S.C. 103 as being unpatentable over Badejo and Wan as applied to claims 1-10, 12-14 and 18-20 above, and further in view of Elements for life (Information about sweet freedom).
Badejo discloses an aqueous-based composition with multiple components including active pharmaceutical ingredients and natural sweeteners, which can be a combination of two to five or more sweeteners.
They do not, however, teach wherein the natural bulk sweetener is glycerin and the second natural bulk sweetener is a combination of apple syrup and carob syrup nor a ratio of the combination of apple syrup and carob syrup to glycerin being about 3:30:1.
Elements for life teaches the use of a similar mixture as a sweetener, including apple and carob syrup, that are plant derived sweeteners with inherently low fructose content, 23 g. per 100 g. and more importantly appropriate for individuals with diabetes.
As such, it would have been prima facie obvious, to a person of ordinary skill in the art, to consider the use of apple and carob syrup when considering Petering as above.
(New/Maintained) Regarding the limitations of claim 17 are met as optimizing the fructose content, as precursor to glucose in glucose metabolism, would be an obvious consideration as part of a research process that a person of ordinary skill in the art would necessarily be motivated to do as to obtain a desired clinical outcome or improved clinical outcome. The limitation of claim 17 can be construed as a conclusion from the optimization process.
Response to Arguments
The office kindly thanks the Applicant for their consideration and arguments to the previous office action. Responses are detailed below.
Applicant’s arguments, see Claim Rejections – 35 USC § 112, filed 17 July 2026, with respect to claims 1-20 have been fully considered and are persuasive. The rejection of claims 1-20 has been withdrawn.
Applicant’s arguments, see Claims Rejections – 35 USC § 102, filed 17 July 2026, with respect to the rejections of claims 1-4, 7-10, 12 and 14 under 35 U.S.C. 102(a)(2) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Wan et al. (Gelatin gummy composition and methods of making and using thereof, US 2020/0138704 A1, 2020) as a rejection of the amended limitation by Wan was already made in the previous office action.
On pg. 7 - Claims Rejections – 35 USC § 102 filed 17 July 2026, the Applicant argues:
… inherency requires that a claimed characteristic necessarily be present in the prior-art disclosure… the inquiry is whether Badejo necessarily discloses the claimed composition… encompasses numerous sweetener systems and numerous possible formulations that do not satisfy the presently claimed fructose restrictions, the examiner has not established inherency…
In response to applicant's argument that Badejo discloses numerous systems and formulations that do not satisfy the restrictions, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. As Badejo discloses/teaches the claimed limitations, a person of ordinary skill in the art, due to the limited size of the genus and as a creative entity, would be able to imagine combinations that satisfy the limitations with a reasonable expectation of success. To claim that the presentation of elements which do not satisfy the limitations would confound the person of ordinary skill in the art is disingenuous.
On pg. 8 – Claim Rejections – 35 U.S.C. § 103 filed 17 July 2026, the Applicant argues:
… As amended, independent claim 1 now requires a liquid composition comprising… Badejo is directed primarily to aqueous compositions achieve antimicrobial effectiveness through the use of natural polyols… the present invention is directed to therapeutic liquid compositions employing a specifically selected natural bulk sweetener system that controls fructose exposure… Wan is directed to gelatin gummy dosages… Wan does not address (several bullet points).
In response to applicant's arguments against the references individually, one cannot show non-obviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The Applicant is correct in the stated purpose of Badejo and similarly for Wan. However, the taught composition elements do not appear to significantly differ from one another, with the purpose of the composition to be defining characteristic. In this respect, there is not a significant difference either as the instant invention and the prior art all purport a composition that is therapeutic in nature and can be administered to a patient via oral means. Wan does exemplify several compositions that, as calculated, the exclusion of ingredients having fructose contents greater than 15% of the total composition. The new limitations amended into claim 1 were previously rejected in the prior office action and as such, the rejection is maintained.
On pgs. 11-12 – Claim Rejections – 35 U.S.C. § 103 filed 17 July 2026, the Applicant argues:
… A critical distinction between the presently claimed invention and the cited art is Applicant’s deliberate formulation strategy directed toward controlling fructose content… the cited references provide no teaching that would have promoted a skilled artisan to (bullet points) … the only apparent source for these selections is Applicant’s own disclosure…. The Examiner’s reliance on broad genera does not establish obviousness…No reasonable expectation of success…
In response to applicant's argument that the critical distinction of the presently claimed invention is a strategy directed toward controlling fructose content, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Allen Chao whose telephone number is (571)272-7001. The examiner can normally be reached Monday - Friday 0700-1300.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James H Alstrum-Acevedo can be reached at 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALLEN CHAO/Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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