DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The amendment filed July 27, 2026 has been entered. Claims 20-24, 26-32, 34-36 and 38-41 are pending examination.
The previous rejection of claims 35, 36, 39 and 41 under 35 U.S.C. 112 (a) has been withdrawn in light of Applicant’s amendment filed July 27, 2026.
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 20-24, 26, 27, 29-32, 34-36 and 38-41 are rejected under 35 U.S.C. 103 as being unpatentable over Seo et al. (“Steady and Dynamic Shear Rheological Properties of Gum-Based Food Thickeners Used for Diet Modification of Patients with Dysphagia: Effect of Concentration”, Dysphagia, 28, (2013), pp. 205-211).
Regarding claims 20-24, 34-36 and 38-41, Seo et al. disclose a method of decreasing the swallowing response (i.e., increasing transit times during swallowing) in a dysphagia patient comprising administering a thickened fluid composition (i.e., nutrition) to the dysphagia patient (i.e., oropharyngeal dysphagia patient). Seo et al. disclose a thickened composition comprising a commercial food thickener and water wherein the commercial food thickener comprises xanthan gum, guar gum and dextrin. Seo et al. disclose the apparent viscosity of a thickened composition comprising a 1.0% concentration of the food thickener is 0.21 Pa·s and a composition comprising a 3.0% concentration of the food thickener is 0.99 Pa·s.
Seo et al. is silent with respect to the ratio or concentration of xanthan gum and guar gum in the food thickener. Given Seo et al. disclose a thickened composition comprising xanthan gum and guar gum as presently claimed wherein the thickened composition exhibits a viscosity of 0.21 Pa·s (i.e., 210 m Pa·s ) when the food thickeners are at a concentration of 1.0% (w/w) and a viscosity of 0.99 Pa·s (i.e., 990 m Pa·s) when the food thickeners are at a concentration of 3.0% (w/w), inherently the ratio of xanthan gum to guar gum in the food thickener would fall within the claimed range of 6:1 –100:1.
In the alternative, given both xanthan gum and guar gum are food thickeners with known physical and chemical properties, the skilled artisan would have been motivated to adjust, in routine processing, the ratio or concentration of xanthan gum to guar gum to achieve a desired thickness or viscosity.
Given Seo et al. disclose a method substantially similar to that of the claimed invention, inherently LVC time in the dysphagia patent would also decrease.
Regarding claim 26, Seo et al. disclose all of the claim limitations as set forth above. Seo et al. disclose preparing the thickened composition by mixing the food thickener comprising xanthan gum and guar gum with filtered water to obtain a thickener dispersion (p. 206/Materials and Sample Preparation). Given Seo et al. disclose a dispersion, it necessarily follows that the food thickener composition was added as a composition of fine solid particles (i.e., powder).
Regarding claim 27, Seo et al. disclose all of the claim limitations as set forth above. Seo et al. disclose the food thickener comprises dextrin. Given maltodextrin is a type of dextrin, absent evidence to the contrary, it would have been obvious to have used any dextrin in the thickened composition of Seo et al. with a reasonable expectation of success.
Regarding claim 29, Seo et al. disclose all of the claim limitations as set forth above. Given Seo et al. disclose a thickened composition comprising 1% , 1.5%, 2%, 2.5% or 3 % (w/w) of a food thickener comprising xanthan gum, guar gum and dextrin in water (p. 206/Materials and Sample Preparation), since xanthan gum, guar gum and dextrin only have calories associated with carbohydrates (wherein each has an energy density of 3-4 kcal/g), it is clear Seo et al. disclose a composition having an energy density in the claimed range. When a thickened composition of Seo et al. comprises 3 g/100 ml of the food thickener, the composition would have an energy density within the claimed range.
Regarding claim 30, Seo et al. disclose all of the claim limitations as set forth above. Seo et al. disclose preparing the thickened composition by mixing the food thickener comprising xanthan gum and guar gum with filtered water to obtain a thickener dispersion (p. 206/Materials and Sample Preparation).
Regarding claim 31, Seo et al. disclose all of the claim limitations as set forth above. Given Seo et al. disclose a thickened composition as presently claimed inherently the composition would exhibit the same appearance, i.e. transparency as a composition not comprising the xanthan gum and guar gum combination.
Regarding claim 32, Seo et al. disclose all of the claim limitations as set forth above. Given Seo et al. disclose a composition of matter (i.e., water, xanthan gum, guar gum, dextrin), inherently the composition would be opaque, transparent and/or translucent.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Seo et al. (“Steady and Dynamic Shear Rheological Properties of Gum-Based Food Thickeners Used for Diet Modification of Patients with Dysphagia: Effect of Concentration”, Dysphagia, 28, (2013), pp. 205-211) as applied to claim 20, and further in view of Burbidge et al. (US 2016/0081923).
Regarding claim 28, Seo et al. disclose all of the claim limitations as set forth above. Seo et al. is silent with respect to a thickened composition comprising energy contributed by fat, carbohydrate and protein.
Burbidge et al. teach a method of treating a swallowing disorder by administering a thickened cohesive bolus to the patient (Abstract, [0027]). Burbidge et al. disclose the bolus is in administrable form selected form the group consisting of a nutritional supplement, a full meal, a nutritionally complete formula, a pharmaceutical formulation, a functional food or a beverage product ([0017]). Burbidge et al. disclose the bolus may comprise a source of dietary protein, carbohydrates and fat ([0064]-[0068]).
Seo et al. and Burbidge et al. are combinable because they are concerned with the same field of endeavor, namely compositions intended for treating swallowing disorders, i.e., dysphagia. Given Burbidge et al. teach it was known to make thickened compositions for treating swallowing disorders in the form a nutritionally complete formula wherein the composition comprises sources of protein, carbohydrate and fat, it would have been obvious to one of ordinary skill in the art the art to have added protein, carbohydrate and fat as part of the thickened composition in Seo et al. to obtain a composition suitable for dysphagia patients but also serves as a nutritionally complete formula or full meal. One of ordinary skill in the art would have been motivated to adjust, in routine processing, the amount of protein, carbohydrate and fat to add to the thickened composition with the goal of achieving a desired nutritional profile.
Response to Arguments
Applicant's arguments filed July 27, 2026 have been fully considered but they are not persuasive.
Applicant submit “the overlap in viscosity does not establish the claimed xanthan-gum to guar-gum ratio” Applicant find “[a] given viscosity is a function of the total amount of thickener, not the xanthan gum-to-guar gum ratio.”
There is no evidence on the record to demonstrate that the xanthan gum to guar gum ratio does not affect viscosity. As evidenced by Casas et al. (“Viscosity of guar gum and xanthan/guar gum mixture solutions”, Journal of the Science of Food and Agriculture, Volume 80, Issue 12, September 2020, pp. 1722-1727), solutions (at a fixed polymer concentration) having different xanthan/guar gum ratios have been shown to have different viscosities (p. 1725/Figure 7).
Applicant submits “increasing viscosity does not necessarily decrease LVC time, so the functional limitation of claims 20, 35 and 40 is not inherent in Seo.” Applicant provides three pieces of published literature to show increasing bolus viscosity does not reliably affect laryngeal vestibule closure time.
The evidence presented by Applicant generally shows LVC time is not reliably predicted by bolus viscosity. The evidence does not show how different ratios of xanthan gum to guar gum influences LVC time.
Regardless, the Examiner does not suggest that by merely increasing viscosity, LVC duration or the duration of swallowing response is decreased in a dysphagia patient. Instead, Given Seo et al. disclose a thickened composition comprising xanthan gum and guar gum as presently claimed wherein the thickened composition exhibits a viscosity of 0.21 Pa·s (i.e., 210 m Pa·s ) when the food thickeners are at a concentration of 1.0% (w/w) and a viscosity of 0.99 Pa·s (i.e., 990 m Pa·s) when the food thickeners are at a concentration of 3.0% (w/w), inherently the ratio of xanthan gum to guar gum in the food thickener would fall within the claimed range of 6:1 –100:1. Therefore, when the composition of Sao et al. is administered to a dysphagia patent, their LVC would be expected to decrease. Claim 1 only requires administering a composition comprising xanthan gum and guar gum wherein the ratio of xanthan gum to guar gum is in the range of 6:1-100:1. The content of thickening agent is not claimed. There is no evidence on the record demonstrating the criticality of the claimed XG to GG ratio.
Applicant submit “Bolivar-Prados et al. does not support the rejection and does not establish inherency.” Applicant submits “to the extent Bolivar-Prados is read to suggest that increasing viscosity shortens LVC time, it stands in direct conflict with Rofes et al, Clave et al. and Steele et al. (discussed above), which found LVC time and closure duration unaffected by increased viscosity.”
Note, Applicant inserted the Bolivar-Prados et al. reference into the record in the response filed January 12, 2026. As discussed above, the Examiner does not suggest that by merely increasing viscosity, LVC duration or the duration of swallowing response is decreased in a dysphagia patient.
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 ELIZABETH A GWARTNEY whose telephone number is (571)270-3874. The examiner can normally be reached M-F: 9 a.m. - 5 p.m. EST.
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ELIZABETH A. GWARTNEY
Primary Examiner
Art Unit 1759
/ELIZABETH GWARTNEY/Primary Examiner, Art Unit 1759
