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 .
Applicants amendment filed 5/21/2026 has been entered. Claims 17 and 27 were amended. Claims 21, 24-26 and 73 were cancelled. New claims 71-74 were added. Claims 17-19, 22, 27, 71, 72 and 74-76 are under examination.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6/24/2026 has been entered.
Withdrawn rejections
Applicant's amendments and arguments filed 5/21/2026 are acknowledged and have been fully considered. Any rejection and/or objection not specifically addressed below is herein withdrawn.
Applicants amendment has necessitated new rejections below.
New Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 17-19, 22, 27, 71, 72 and 74-76 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The limitation that the thickening agent comprises at least one of beta-glucan in claims 17 and 27 is not supported by the original disclosure. The specification does support okra gum, cactus mucilage, kiwi mucilage, psyllium mucilage, mallow mucilage, flax seed mucilage, marshmallow mucilage, ribwort mucilage, mullein mucilage and cetraria mucilage [0091]. The disclosure nowhere discloses beta-glucan, in fact, the only glucan mentioned is alpha-glucan which is used as a prebiotic [00129].
New 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 (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 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.
Claim(s) 17-19, 22, 27,71, 72 and 74-76 are rejected under 35 U.S.C. 103 as being unpatentable over Hausler (WO 2007/038979) in view of Michlig et al. (WO 2015/140124; published September 24, 2015) in further view of Burbidge et al. (US 2016/0081923; March 24, 2016).
Applicant claims a method of preventing, alleviating, and or compensating swallowing dysfunction in a patient comprising: providing an effervescent composition in a form of a powder or a tablet comprising an acid compound, an alkaline compound; a thickening agent selected from okra gum, cactus mucilage, kiwi mucilage, psyllium mucilage, mallow mucilage, flax seed mucilage, marshmallow mucilage, ribwort mucilage mullein mucilage, or cetraric mucilage; and cinnamaldehyde and zinc as a trigeminal ingredient; dissolving the effervescent composition in a liquid to provide a nutritional product; and orally administering the nutritional product to the patient. (Claim 17)
Applicant claims a method of promoting swallowing safety and/or efficiency in a patient comprising: providing an effervescent composition in a form of a powder or a tablet comprising an acid compound, an alkaline compound; a thickening agent selected from okra gum, cactus mucilage, kiwi mucilage, psyllium mucilage, mallow mucilage, flax seed mucilage, marshmallow mucilage, ribwort mucilage mullein mucilage, or cetraric mucilage; and cinnamaldehyde and zinc as a trigeminal ingredient; dissolving the effervescent composition in a liquid to provide a nutritional product; and orally administering the nutritional product to the patient. (Claim 27)
Claims 22 and 74 are drawn to inherent properties of the composition.
Hausler teach effervescent metformin tablets and granules (abstract; limitation of claims 17, 27, 75 and 76). Treating dysphagia in elderly patients with type 2 diabetes is implied (page 2, lines 3-6). The formulations are powders or granules that are dissolved in water prior to administration (page 19, lines 27-31). The effervescent acids are selected from citric acid, succinic acid, adipic acid, tartaric acid, fumaric acid, malic acid and anhydrides (page 6, lines 7-14; limitation of claims 18 and 71). The alkaline compound is selected from potassium carbonate, sodium carbonate, sodium bicarbonate, potassium bicarbonate, sodium glycine carbonate, calcium carbonate and arginine carbonate (page 10, lines 4-15; limitation of claims 19 and 72). Hausler et al. teach other flavorants include aldehydes and esters such as benzaldehyde, citral, neral, decanal and C8-aldehyde which reads on cinnamaldehyde (page 24, lines 8-21). Additional excipients used in the formulations include the thickener sodium carboxymethyl cellulose (page 25, lines 3-11).
Hausler et al. teach patients unable to swallow tablets, specifically elderly patients with type 2 diabetes, are prone to dysphagia. To overcome this issue the effervescent compositions allow for accurate dosing, high stability, easy to carry and easy to swallow formulations that disintegrate in water in less than 3 minutes with a palatable taste (page 3, lines 1-7).
Hausler et al. do not specify cinnamaldehyde and zinc as a trigeminal ingredient. It is for this reason that Michlig is joined.
Michlig teach a compositions comprising cinnamaldehyde supplemented with zinc to improve swallowing reflex (abstract). Michlig teach treating dysphagia and for preventing aspiration pneumonia [0018-21]. The combination of cinnamaldehyde and zinc unexpectedly have a synergistic effect and reduces the amount of cinnamaldehyde that is needed to be effective [0044].
Hausler et al. and Michlig do not teach the thickener is selected from okra gum, cactus mucilage, kiwi mucilage, psyllium mucilage, mallow mucilage, flax seed mucilage, marshmallow mucilage, ribwort mucilage mullein mucilage, or cetraric mucilage. It is for this reason that Burbidge et al. is joined.
Burbidge et al. teach a method for treating swallowing disorder in a patient suffering from aspiration and a bolus for use in the treatment of a swallowing disorder (abstract). The bolus is selected from cohesive thin liquids having a shear viscosity of less than about 50 mPas when measured at shear rate of 50s-1 and a relaxation time of more than 10 ms at 20 degrees Celsius as determined by a capillary breakup extensional rheometry (CaBer) and cohesive thickened liquids having a shear viscosity of more than about 50 mPas, preferably 55-350, when measured at shear rate of 50s-1 and a relaxation time of more than 10 ms at 20 degrees Celsius as determined by a capillary breakup extensional rheometry (CaBer) [0010-11; limitation of claim 22]. The bolus comprises plant derived gums and mucilages selected from okra gum, cactus mucilage, kiwi mucilage, psyllium mucilage, mallow mucilage, flax seed mucilage, marshmallow mucilage, ribwort mucilage mullein mucilage, or cetraric mucilage in an amount ranging from at least 0.01-25 wt% [0015-16]. The administrable form is selected from a nutritional supplement, a full meal, a pharmaceutical formulation or beverage [0017]. The severity of dysphagia may vary from minimal difficulty in safely swallowing liquid to the inability to swallow without significant risk of aspiration and therefore classifying the patient into a specific group is used [0036-38]. This is done by using a standard videofluoroscopy technique which determines whether aspiration occurs before, during or after the swallowing reflex [0039]. Therefore, Burbidge teach selecting and administering a bolus that is specifically suited for the type of aspiration occurring in the patient by using either the thin liquids or the thickened liquids [0040].
Hausler, Michlig and Burbidge et al. are drawn to methods of treating dysphagia. Therefore, it would have been prima facie obvious for one of ordinary skill in the art to combine the teachings of Hausler, Michlig and Burbidge to administer effervescent compositions comprising an acid component, an alkaline component and cinnamaldehyde and zinc to alleviate swallowing dysfunction in a patient unable to swallow tablets with a reasonable expectation of success. One of ordinary skill in the art would have been motivated at the time of filing to combine the teachings of Hausler, Michlig and Burbidge to treat swallowing dysfunction with the dissolved compositions comprising cinnamaldehyde and zinc because Hausler et al. teach the effervescent tablet compositions allow for accurate dosing and easy to swallow formulations that disintegrate in water in less than 3 minutes and Michlig teach that the combination of cinnamaldehyde and zinc unexpectedly has a synergistic effect a of improving swallowing reflex.
It would have been prima facie obvious for one of ordinary skill in the art to combine the teachings of Hausler, Michlig and Burbidge et al. to include thickener selected from okra gum, cactus mucilage, kiwi mucilage, psyllium mucilage, mallow mucilage, flax seed mucilage, marshmallow mucilage, ribwort mucilage mullein mucilage, or cetraric mucilage with a reasonable expectation of success. One of ordinary skill in the art would have been motivated at the time of filing to combine the teachings of Hausler, Michlig and Burbidge et al. and include these thickeners because Burbidge et al. teach they are food grade biopolymers that aid in treating swallowing disorders in a patients suffering from aspiration.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIELLE D JOHNSON whose telephone number is (571)270-3285. The examiner can normally be reached Monday-Friday 9:00 am-5:30 pm.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
DANIELLE D. JOHNSON
Examiner
Art Unit 1617
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