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
Response to Amendment
In view of Applicant’s response after-final filed 10/28/2025 regarding the Li reference being disqualified as prior art, all rejections have been withdrawn, and a new grounds of rejection has been issued herein.
Claims 18, 25, 33, 42, 47, 49-55, 57-61, 64-66 are currently pending in this Office Action. Claims 25 and 33 have been withdrawn due to being drawn to the non-elected invention.
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.
Claim(s) 18, 42, 47, 49, 50-55, 57-58, 64-66 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beck et al. (WO 2006/053761 A2 – cited in IDS filed 8/27/2020) in view of Holahan (WO 03/011051 A1).
Regarding Claims 18, 47 and 49-50, 64-66, Beck discloses a stable liquid composition (liquid compositions, stabilized oil-in water dispersions, page 6, last paragraph”), comprising:
(i) thickening agents (starch, component I, page 2 lines 20-24); and
(ii) a polysaccharide-based ingredient comprising Acacia tree polysaccharide gum (gum arabic, page 3, lines 14-22), wherein the polysaccharide-based source material has been subjected to protein hydrolysis (Page 4, first paragraph), wherein the polysaccharide-based ingredient has a protein content that is less than about 5 wt% thereof (0.5 to about 3 wt%, page 3, fourth paragraph). See Table on page 7 following line 7 which is a composition according to the invention of Beck comprising both a starch and a modified plant gum.
Since both starch and gum arabic are known thickening agents, it is construed that addition of the composition to an aqueous liquid foodstuff increases the viscosity of liquid foodstuff. Also see Page 21, last paragraph, where Beck recognizes that hydrocolloids provides “well adapted viscosity in aqueous solution”. Beck also discloses wherein the polysaccharide-based ingredient is present in an amount from about 0.5 to 60 wt% (page 5, ln. 17-21) which encompasses the claimed range of 10% to 25%, 10% to 20% (as required in Claim 47), 10% to 15% (as required by Claim 64), 15% to 25% (as required by Claim 65), and 12% to 20% (as required by Claim 66).
Beck is silent to wherein the stable liquid composition has a viscosity of less than 4000cP and specifically requiring both an Acacia tree polysaccharide extract or gum and a thickening agent comprising, consisting of, or consisting essentially of xanthan gum wherein the xanthan gum is present in an amount from 3% to 9.5% by weight of the stable liquid composition. However, Beck further discloses that the source for plant gums can also be xanthan gum (page 3, lines 14-22). Therefore, it would have been obvious to combine equivalents known for the same purpose (see MPEP 2144.06).
In any case, Holahan is relied on to teach a stable liquid composition (concentrate thickener paste, see abstract) comprising a mixture of xanthan gum and gum arabic (see Claim 2) to produce a thickening mixture for patients with dysphagia (). Therefore, it would have been obvious to use known combinations of gum arabic and xanthan gum to facilitate swallowing for patients with dysphagia.
As to the particular amount of xanthan gum, Holahan is further relied on to teach a liquid composition comprising xanthan gum in an amount of about 2% to about 5% (paragraph 50), which overlaps with the claimed range of 3 to 9.5% by weight (as required by Claim 18), about 3% to about 7% (as required by claim 49), 5% to 8% (as required by Claim 64), and 3 to 6wt% (as required by Claim 65). Also, the term “about 5%” is construed to overlap with the claimed range of 6% to 9% (as required by Claim 66) as the term “about” allows for one of ordinary skill in the art to include values above 5% and therefore construe “about 5%” to read on the claimed 6%. In the event that Applicant argues that the prior art “about 5%” does not read on the claimed 6%-9%, A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) Therefore, it would have been obvious to one of ordinary skill in the art to modify the thickening composition to have xanthan gum in an amount effective for patients with dysphagia.
As to the viscosity of the composition (as required by Claim 18 and 50), since the combination discloses a thickening composition having the combination of xanthan gum and gum acacia that encompasses the claimed range, there is a reasonable expectation that the overlapping ranges would exhibit similar viscosity as the claimed viscosity. "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Regarding Claim 42, Beck further teaches wherein the polysaccharide-based ingredient has a protein content that is less than about 2wt%, and 1wt% (0.5 to about 3 wt%, page 3, fourth paragraph).
Regarding Claims 51-55, and 57, the claims are all directed to product by process limitations. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Also see MPEP 2113. Since the prior art suggest a stable liquid composition having a viscosity that is less than 4000cP comprising xanthan gum, and an acacia tree polysaccharide gum that has been subjected to hydrolysis and wherein the polysaccharide-based ingredient has a protein content of less than 5%wt, the prior art is seen to suggest a product that is the same as or obvious from the claimed product.
In any case, Beck discloses a process of manufacturing modified gums by performing a heat treatment at temperatures of about 5°C to about 120°C and an acid treatment at a pH of 2-10 (see pages 10-11, Step B) which encompasses the claimed range of about 55°C to about 90°C (as required by Claim 51), or about 70°C to about 80°C (as required by Claim 55), and pH of about 3 to about 5 (as required by Claim 51), or pH of about 3.5 to about 4.5 (as required by Claim 53), or pH of about 3.9 to 4.4 (as required by Claim 54), wherein the acid treatment comprises contacting the polysaccharide-based source material with citric acid (as required by claim 52), and wherein the protein hydrolysis is carried out for a few seconds to about 300 minutes (see page 12, last paragraph), which encompasses the claimed range of 15 minutes to about 30 minutes (as required by Claim 56), or about 30 minutes to about 3 hours (as required by Claim 57).
Regarding Claim 58, Beck further teaches comprising a food grade preservative (antioxidants, page 5, ln. 25-29).
Claim(s) 59-60 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combination as applied to Claim 58, further in view of Sato et al. (WO 2017/047803 A1 - see machine translations).
Regarding Claims 59-60, the combination is silent to wherein the food-grade preservative is selected from the group consisting of gellan gum, vitamin E, potassium sorbate, sodium benzoate, sodium metabisulphite, methyl paraben, EDTA, sulphur dioxide, nisin, propionic acid and any combination thereof. However, Beck further discloses that the source for plant gums can also be gellan gum (page 3, lines 14-22). Therefore, it would have been obvious to combine equivalents known for the same purpose (see MPEP 2144.06). In any case, Sato is relied on to teach a polysaccharide thickener that is added to liquid having excellent viscosity imparting and gelling functions (see abstract). Specifically, Sato discloses a thickening polysaccharide comprising gum arabic (page 2, third to last paragraph) and further comprising a thickening polysaccharide selected from gellan gum, xanthan gum, or a combination thereof (Page 2, last paragraph). Therefore, since Sato similarly suggest a thickening agent comprising gum arabic, and suggest combinations encompassing gum arabic and both xanthan and gellan gum, it would have been obvious to one of ordinary skill in the art to combine xanthan gum and gellan gum with gum arabic to achieve a thickening agent having the desired viscosity imparting and gelling functions.
Claim(s) 61 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combination as applied to Claim 18, further in view of Buffo et al. (NPL Reference-Factors affecting the emulsifying and rheological properties of gum acacia in beverage emulsions).
Regarding Claim 61, the combination is silent to wherein the pH of the stable liquid composition is between about 3.5 and about 5.5. Buffo is relied on to teach factors affecting the emulsifying and rheological properties of gum acacia in low pH environments. Buffo found that between a pH level of 2.5, 4.5, and 5.5, the emulsifying properties of gum acacia were less stable than at higher pH (4.5 and 5.5, see Abstract). Therefore, since Beck discloses a thickening agent comprising gum acacia, it would have been obvious to one of ordinary skill in the art adjust the pH of the liquid composition to 4.5 or 5.5 to maintain the emulsifying properties of gum acacia.
Response to Arguments
Applicant’s argument in the remarks filed 5 May 2025 has been considered, but is found not persuasive in view of the new grounds of rejections.
Applicant’s response in the remarks and the Declaration filed 5 May 2025 has been considered, but is found not persuasive over the prior art.
Applicant argues on the basis that the combination of xanthan gum and gum acacia provides unexpected results over the prior art. Specifically, Applicant notes that the combination is advantageous in inhibiting the viscosity level exerted by the Xanthan gum compared to a mixture without the polysaccharide-based ingredient. However, the evidence does not clearly convey that a mixture being under 4000cP constitutes “unexpected results”, as there are no clear comparison that a mixture without gum acacia would exhibit a viscosity above 4000cP. As to the U-shape curve achieved by using both xanthan gum and Acacia gum (Fig. 1 and 2 of Appendix A), there is no showing that Xanthan gum, or Acacia gum, when used alone, would not produce a similar curve, and therefore the evidence is not sufficient to show that the U-shaped curve is unexpected. Additionally, Applicant has not sufficiently shown that the ranges are critical in comparison to the closest prior art. In this case, since Holahan also teach a stable thickening composition for patients with dysphagia, the evidence submitted does not sufficiently show how the claimed composition achieves unexpected result over the prior art.
For these reasons, evidence is not sufficient to overcome obviousness.
Conclusion
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/T.H.N/Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792