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 .
Claim Status
Claims 1-18, 20, and 23, are pending and under examination.
Claim Objections
Claim 4 is objected to because of the following informalities: “pectin or combination thereof” in ln 2 should read “pectin or a combination thereof”. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: “from animal source” in ln 2 should read “from an animal source”. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: in ln 2, “comprises antibacterial agent” should read “comprises an antibacterial agent”. Appropriate correction is required.
Claim 12 is also objected to because of the following informalities: in ln 3, “an analgesics” should read “an analgesic”. Appropriate correction is required.
Claim 12 is also objected to because of the following informalities: in ln 10, “a antidepressant” should read “an antidepressant”. Appropriate correction is required.
Claim 20 is objected to because of the following informalities: in ln 1-2, “said sugar alcohols comprises maltitol” should read “said sugar alcohols comprise maltitol,” as sugar alcohols is plural. Appropriate correction is required.
Claim Rejections - 35 USC § 101 / § 112- Hybrid Claim
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.
Claim 23 is rejected under 35 U.S.C. 101 because the claimed invention is not directed to a single statutory class. The claims are directed to neither a “process” nor a “machine”, but rather embraces or overlaps two different statutory categories of invention set forth under that statute, which is drafted so as to set forth the statutory classes of invention in the alternative only. See Ex parte Lyell, 17 USPQ2d 1548, 1551 (Bd. Pat. App. & Inter. 1990).
Applicants have amended the preamble to recite “a method of treating or preventing a disease in a subject,” however, the method is presented without any active steps. The claim simply recites the “use” of a chewable composition according to claim 1, which is neither a “process” nor a “machine”, where no active steps of using the chewable composition are claimed.
The following is a quotation of the second paragraph of 35 U.S.C. 112:
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.
Claim 23 is also rejected under 35 U.S.C. 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
A single claim which recites both a product and method steps of using that product is indefinite under 35 USC 112, second paragraph. See Ex parte Lyell, 17 USPQ2d 1548 (Bd. Pat. App. & Inter. 1990).
Note, for purposes of examination, the claimed limitations directed to active steps will be interpreted as intended use limitations or product by process limitations.
Claim Rejections - 35 USC § 112(b) or pre-AIA 2nd ¶
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 1-18, 20, and 23, 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.
Claims 1 and 2 recite a gel strength as measured by “pressing force test.” It is not clear to the examiner what particular processing conditions were used to determine the gel strength. For example, paragraph 24 of the instant specification recites that “the strength is a function of suspended solids, solid contents, temperature, chemical content, and time.” Where the steps and conditions used to determine the gel strength of the “pressing force test” are not defined, it is not clear what embodiments in the prior art may read on the gel strength recited in the instant claims. For purposes of examination, the examiner is interpreting any gel composition capable of being chewed, while having the components and the amounts instantly claimed, as meeting the gel strength limitation.
Claim 3 recites “wherein the composition comprises a gelling agent component in an amount of 1.2% w/w,” and it is unclear if the gelling agent is the gelling agent of claim 1, or if the gelling agent is an additional gelling agent. For purposes of examination, the claim is interpreted as “the gelling agent,” making clear that the gelling agent of claim 1 is being referred to.
Claim 20 recites “wherein the sugar alcohols comprises maltitol, sorbitol liquid, xylitol…,” which appears to allow for a single sugar alcohol to be selected. If a single sugar alcohol can be selected, it is unclear how the singular maltitol, for example, reads on the plural “sugar alcohols.” For purposes of examination, if any one of the sugar alcohols of claim 20 are present, the limitation is interpreted as being met.
Regarding claims 2-18, 20, and 23, the claims are also rejected for the same reasons for depending upon rejected claim 1.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 7, 8-12, 17, 20, and 23, are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Sirihorachai et al (US 20180263904 A1, hereinafter “Sirihorachai”), as evidenced by BenchChem (“comparative analysis of maltitol and sorbitol as sugar substitutes,” 2025, pp. 1-9) and Drugs.com (Lotoradine, retrieved 2026).
Sirihorachai discloses chewable gel products containing a gel carrier and an active pharmaceutical ingredient (API) (abs). In one embodiment, the chewable gel formulation comprises loratadine (API), pectin at 1.2-2.0 wt%, maltitol at 77.460 wt%, sucralose at 0.300 wt%, colorant FD&C Red 40, artificial berry flavor, etc. (table 8A). As evidenced by BenchChem, maltitol has a glycemic index of about 35 (pg. 2). As evidenced by Drugs.com, lotoradine is an antihistamine.
Regarding the amount of pectin of claim 1, the skilled artisan would at once envisage an embodiment comprising 1.2 wt% pectin, thereby anticipating the claimed range. A generic disclosure will anticipate a claimed species covered by that disclosure when the species can be at once envisaged from the disclosure. A reference disclosure can anticipate a claim when the reference describes the limitations but does not expressly spell out the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination.
Regarding the API of claim 1, loratadine is an API.
Regarding the gel strength of claims 1 and 2, while the reference does not appear to disclose the gel strength as measured by “pressing force test,” where the reference discloses the gels as chewable, and comprise the same components and their amounts as instantly claimed, it appears that the gel strength is inherent to the compositions themselves. See MPEP 2112(II) and (III).
Regarding claim 3, the skilled artisan would at once envisage an embodiment comprising 1.2 wt% pectin, for the same reasons discussed above.
Regarding claims 4 and 7, pectin is disclosed above, thereby meeting the claimed limitation.
Regarding claim 8, maltitol has a glycemic index of about 35, as evidenced by BenchChem, thereby meeting the claimed limitation.
Regarding claim 9, the embodiment disclosed by Sirihorachai does not comprise gelatin, and therefore necessarily does not comprise a gelatin from an animal source.
Regarding claim 10, the embodiment disclosed above does not comprise any of D-glycose, D-fructose, or D-sucrose, thereby meeting the claimed limitation.
Regarding claim 11, maltitol (i.e., a sugar alcohol) is included at 77.460 wt%, thereby meeting the claimed limitation of not less than 50 wt% sugar alcohols.
Regarding claim 12, lotoradine is an antihistamine, as evidenced by Drugs.com above.
Regarding claim 17, the embodiment disclosed above comprises colorants and flavoring agents, thereby meeting the claimed limitation.
Regarding claim 20, the embodiment disclosed above comprise maltitol, thereby meeting the claimed limitation.
Regarding claim 23, where the chewable compositions comprise a pharmaceutically active ingredient and the same components instantly claimed, and in the same amounts, it appears the composition would be capable of meeting the intended use limitation of treating or preventing a disease in a subject.
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.
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 1-14, 17, 18, 20, and 23, are rejected under 35 U.S.C. 103 as being unpatentable over Sirihorachai et al (US 20180263904 A1, hereinafter “Sirihorachai”).
Sirihorachai is discussed above and further teaches suitable gel carriers include pectin, carrageenan, etc., including kappa carrageenan (¶¶ 5, 26). The active pharmaceutical ingredient is selected from an anti-inflammatory, an antirheumatic, an antipyretic, an antiemetic, an analgesic, an antiepileptic, an antipsychotic, an antidepressant, a hypnotic, an anti-ulceric, a prokinetic, an anti-asthmatic, an antiparkinsonic, a cardiovascular, a vasodilator, a urologic, a diuretic, an erectile dysfunction medication, a hypolipidemic, an anti-diabetic, and an antihistaminic active ingredient (¶ 5). Examples include acetaminophen (¶ 5). The chewable gel product has a total weight from about 100 mg to about 10,000 mg, including from about 1,000 mg to about 4,000 mg, from about 1,000 mg to about 3,000 mg (¶ 99). The compositions provide a convenient and easy way to self-administer medications (¶ 4).
Sirihorachai is discussed above but does not teach a particular embodiment comprising carrageenan in the amounts as instantly claimed, an embodiment as instantly claimed comprising acetaminophen, nor an embodiment as instantly claimed comprising the composition weight of claim 18. Further, purely arguendo, if somehow the embodiment disclosed by Sirihorachai does not anticipate the amount of gelling agent and if the method is not intended use, the following also applies.
Regarding the amount of gelling agent of claim 1, if somehow the amount of gel carrier does not anticipate the claimed range, it would have been obvious to formulate the chewable gel composition with 1.2 wt% gel carrier, as taught by the reference. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding claims 4-6, it would have been obvious to substitute pectin for carrageenan or kappa carrageenan, where both are situatable gel carriers as taught by Sirihorachai.
Regarding claims 12-14, it would have been obvious to substitute loratadine with acetaminophen, where both are suitable APIs as taught by Sirihorachai.
Regarding claim 18, it would have been obvious to formulate the total weight of the chewable gel product from about 100 mg to about 10,000 mg (i.e., about 0.1 g to about 10 g), including from about 1,000 mg to about 4,000 mg (i.e., about 1 g to about 4 g), from about 1,000 mg to about 3,000 mg (i.e., from about 1 g to about 3 g), as taught by Sirihorachai. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding claim 23, purely arguendo, if the method is not intended use as interpreted above for being “use” claim, where the chewable compositions comprise an active pharmaceutical ingredient in a dosage form for administering the active to a subject, it would have been obvious to treat or prevent any condition associated with the active pharmaceutical ingredient, which would be expected to include diseases, etc.
Regarding claims 1-14, 17, 18, 20, and 23, the claims are rejected for the same reasons discussed above as applied to each and every claimed limitation.
Claims 1-14, 17, 18, 20, and 23, are rejected under 35 U.S.C. 103 as being unpatentable over Sirihorachai et al (US 20180263904 A1, hereinafter “Sirihorachai”), as applied to claims 1-14, 17, 18, 20, and 23, above, and further in view of Simpson et al (US 20190388341 A1, hereinafter “Simpson”).
Sirihorachai is discussed above, and purely arguendo, if the gel strength is somehow not inherent to the components of the composition and their amounts, the following applies.
Simpson teaches a chewable gel dosage form that contains at least one active agent, one or more polyols, and at least one gelling agent, where it was known to formulate the dosage form with a firmness of from about 100 g to about 300 g (¶¶ 265, 267, claim 20). The firmness of the gels may be determined, for example, by measuring the resistance to deformation of the chewable gel dosage form as a function of weight, e.g., in grams, applied to a surface thereof, e.g., by squeezing the dosage form between two plates (¶ 265).
Regarding the gel strength of claim 1, it would have been obvious to formulate the chewable dosage form of Sirihorachai with known gel strength suitable for chewable gel dosage forms, such as from about 100 g to about 300 g, as taught by the Simpson. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Further, where the firmness of Simpson is measured as a function of weight applied to the surface (i.e., a force pressing on the chewable gel dosage form), it appears the limitation of a “pressing force test” is met.
Regarding claims 1-14, 17, 18, 20, and 23, the claims are rejected for the same reasons above as applied to each and every claimed limitation.
Claims 12, 15, and 16, are rejected under 35 U.S.C. 103 as being unpatentable over Sirihorachai et al (US 20180263904 A1, hereinafter “Sirihorachai”), as applied to claims 1-14, 17, 18, 20, and 23 above, and further in view of Wan et al (WO 2019241146 A1, hereinafter “Wan”).
Sirihorachai is discussed above but does not specifically teach an antibacterial agent.
Wan teaches low glycemic gummy compositions comprising not less than 50 wt% of a low glycemic index sugar component, and an active pharmaceutical ingredient, including antibacterial agents, such as azithromycin (abs, pg. 6 2nd and 3rd ¶).
It would have been obvious to modify the composition of Sirihorachai above, by including other known active agents suitable for chewable gel compositions, such as an antibacterial agent azithromycin, depending on desired treatments, etc.
Claims 12, 15, and 16, are rejected under 35 U.S.C. 103 as being unpatentable over Sirihorachai et al (US 20180263904 A1, hereinafter “Sirihorachai”) and Simpson et al (US 20190388341 A1, hereinafter “Simpson”), as applied to claims 1-14, 17, 18, 20, and 23, above, and further in view of Wan et al (WO 2019241146 A1, hereinafter “Wan”).
Sirihorachai and Simpson are discussed above but does not specifically teach an antibacterial agent.
Wan is discussed above.
It would have been obvious to modify the composition of Sirihorachai above, by including other known active agents suitable for chewable gel compositions, such as an antibacterial agent azithromycin, depending on desired treatments, etc.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA A ATKINSON whose telephone number is (571)270-0877. The examiner can normally be reached M-F: 9:00 AM - 5:00 PM + Flex.
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/JOSHUA A ATKINSON/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612