6980
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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 12, 2026 has been entered.
Claim 37 is cancelled and claim 41 is new. Claims 20-24, 26-32, 34-36 and 38-41 are pending.
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 35, 36, 39 and 41 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.
Claim 35 was amended June 28, 2004 to recite conditions (i) “administering a thickened composition comprising 20-50% of xanthan gum and 0.05-5.0 wt% of guar gum to the dysphagia patient.” While there is support in the specification and claims as originally filed to claim preparing a thickened composition by adding a thickening agent comprising 20-50 wt% of xanthan gum and 0.05-5.0 wt% of guar gum and administering the thickened composition to the dysphagia patient”(page 3/L5-38).
New claim 41 recites “wherein the thickened composition has a viscosity of 70-1500 cP, as measured using cone-plant viscosimetry at 50 s-1 and 20°C.” There is no support in the specification or claims, as originally filed, for a viscosity with units of cP or for a method named “viscosimetry.” The present specification states “viscosity can be determined using cone-plate viscosity measurements at 50 s-1 and 20C” (page 5/L16-26). The specification reports viscosity using units of mPa·s (page 5/L16-26).
Claims 36 and 39 are rejected because they are dependent from a rejected base claim.
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 20-27, 29-32, 34-36 and 38-40 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 20-25, 34-36 and 38-40, 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 January 12, 2206 have been fully considered but they are not persuasive.
Applicant submits “[t]he specification demonstrates that compositions with a specific XG/GG weight ratio of about 60:1 to 100:1 achieve decreased LVC time and total duration of swallowing response in dysphagia patents, as show in Tables 1 and 2.” Applicant explains the specification states “[a]bsent such effects observed for similarly viscous, thickened composition comprising xanthan gum, these advantageous effects could not be attributed to viscosity only.”
Here, Applicant does not claim how much of the thickener is included in the thickened composition. Rather only the ratio of XG to GG is claimed. Seo et al. disclose a thickened composition made by adding 1% or 3% (w/w) of a food thickener, comprising both XG and GG, to water. The thickened compositions exhibit viscosities of 0.21 Pa·s (i.e., 210 mPa.s) at a 1% (w/w) concentration and a composition comprising a 0.99 Pa·s (i.e., 990 mPa.s) at a 3% (w/w) concentration. Given the viscosity measurements overlap with the claim viscosity of 20-3000 mPa.s, inherently the ratio of XG to GG must fall within the claimed range.
Note, while there may be a plurality of XG to GG ratios which will result in a thickened composition displaying a viscosity in the claimed range, Seo et al. must necessarily employ a commercial thickener with XG to GG ratio in the claimed range. If the claimed ratio is not inherent in the food thickener of Seo et al, the concentration of food thickener, and/or ingredients other than XG and GG must necessarily play a role in the resulting viscosity.
Applicant submits Seo discloses “sample A, which is based on XG and dextrin, and sample B, which is based on XG, GG, and dextrin.” Applicant submits “Seo does not specify any amounts or ratios of the different gums in Sample B” and “[a]t best, Seo provides only a generic disclosure of a combination of XG and GG without any specific ratio.”
Seo et al. disclose a thickened composition made by adding 1% or 3% (w/w) of a food thickener, comprising both XG and GG, to water. The thickened compositions exhibit viscosities of 0.21 Pa·s (i.e., 210 mPa.s) at a 1% (w/w) concentration and a composition comprising a 0.99 Pa·s (i.e., 990 mPa.s) at a 3% (w/w) concentration. Given the viscosity measurements overlap with the claim viscosity of 20-3000 mPa.s, inherently the ratio of XG to GG must fall within the claimed range. Again, Applicant does not claim how much of the thickener is included in the thickened composition. Rather only the ratio of XG to GG is claimed.
Applicant argues the Examiner’s inherency argument fails. Applicant explains that viscosity is primarily determined by the total amount of thickener used, not the ratio of XG to GG and the same viscosity range can be obtained with any XG/GG ratio through routine adjustments in concentration and processing conditions.
If the amount of the thickening agent used is the driver in determining viscosity, it is not clear how the ratio of XG to GG is critical. There is no evidence on the record demonstrating the criticality of the claimed ratio in decreasing LVC time and/or decreasing the duration of swallowing response in a dysphagia patent.
Applicant submits “viscosity is not the same as LVC time.” Applicant submits a peer reviewed article to show safe and unsafe swallowing is a problem for all viscosities, and the LVC time can and should be improved regardless of the viscosity.”
It is not clear how the results of Bolivar-Prados et al. are germane to Seo et al. Note, Bolivar-Prados et al. teach increasing shear bolus viscosity with xanthan gum-based thickener increases the safety of swallow in poststroke oropharyngeal dysphagia in a viscosity-dependent manner (Abstract). Bolivar-Prados et al. teach increasing viscosity shortened LVC time (Abstract). Here, Seo et al. disclose a method of using a thickener composition substantially similar to the claimed method. There is no evidence on the record demonstrating the criticality of the claimed XG to GG ratio, specific to LVC time.
Applicants argue “Examiner’s inherency argument that LVC time would decrease because Seo disclose a “substantially similar” method is unsupported by any evidence in Seo that specifically addresses the parameter.”
While Seo et al. does not disclose LVC time, 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. Here, Applicant has not demonstrated the criticality of the claimed XG to GG ratio or concentration of each component used in the thickening agent.
Applicant submits “Seo highlights negative effects associated with adding GG to XG.” Applicant notes that according to Seo et al., gums with high degree of shear thinning (low n value) do not feel slimy, whereas “sample B (XG +GG) exhibits more sliminess due to the higher n value contributed by guar gum.” Applicant goes on to say “[f]or patients with dysphagia, the ideal texture is usually smooth, cohesive, and easy to swallow without feeling slimy or watery.” Applicant argue “[s]ince guar gum produces a more slimy, less cohesive texture according to Seo, a skilled person would conclude from Seo’s teaching that GG can reduce bolus control and is less suitable for dysphagia management compared to the cohesive, elastic textures produced by xanthan gum alone.”
While Seo et al. discuss that the sliminess of sample B (XG + GG) seemed to be due to the addition of GG and higher viscosity, the reference does not discourage the use of the thickener. Moreover, Seo et al. does not disclose that the “slimy” character has any affect on the function of the thickener for use with or acceptability with Dysphagia patients.
Moreover, arguments presented by applicant cannot take the place of evidence in the record. See In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984); In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997) ("An assertion of what seems to follow from common experience is just attorney argument and not the kind of factual evidence that is required to rebut a prima facie case of obviousness."). See MPEP 716.01 (c) for examples of applicant statements which are not evidence and which must be supported by an appropriate affidavit or declaration.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
-Moret-Tatay et al., ("Commercial thickeners used by patients with dysphagia: Rheological and structural behavior in different food matrices", Food Hydrocolloids, Volume 51, October 2015, pp. 318-326) teaches thickened beverages for patients with dysphagia comprising a commercial thickener, Nutilis®.
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