DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.114 has been timely paid, the finality of the previous Office Action has been withdrawn pursuant to 37 CFR 1.114.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 01/15/2026 has been entered.
Claim status
Claims 1-4, 10-11 and 14-15 filed 12/02/2024 are pending in the application and are hereby examined on the merits.
Examiner Note
Any objections and/or rejections that are made in the previous actions and are not repeated below, are hereby withdrawn.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-4, 10 and 14-15 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sannino WO 2009/021701 A2 (hereinafter referred to as Sannino) in view of Friesen WO 2006/056079 A1 (hereinafter referred to as Friesen), and evidenced by Eisenhardt US Patent Application Publication No. 2002/0187139 A1 (hereinafter referred to as Eisenhardt) and Moheno US Patent Application Publication No. 2008/0166355 A1 (hereinafter referred to as Moheno).
Regarding claims 1, 10 and 14, Sannino teaches a method for treating obesity, reducing food or calories intake or achieving or maintaining satiety (page 13, bottom para.). The method comprises administering an effective amount of a polymer hydrogel comprising a hydrophilic polymer crosslinked with a polycarboxylic acid, such as carboxymethylcellulose crosslinked with citric acid, to a mammal such as a human subject, wherein the hydrogel can be ingested alone or in a mixture with liquid or dry food (abstract; page 12, paragraph 2; page 13, bottom para.; example 2). Further, Sannino teaches that the polymer hydrogel can be used as a dietary supplement, for example, as the bulking agents in dietary supplement for hypocaloric diet capable of conferring a sensation of lasting satiety being retained into the stomach for a limited period of time, or as water and low molecular weight compounds supplement, such as mineral salts or vitamins, to be included into beverages (e.g., drinks) (page 16, para. 1-2). A mixture of the hydrogel and the food or hypocaloric diet reads on the modified food or foodstuff. Sannino teaches the polymer hydrogel can be milled to produce polymer hydrogel particles of a desired size (page 9, 2nd para.).
Sannino is silent regarding the polymer hydrogel (particles) being coated with a moisture barrier. What Sannino teaches is that the polymer hydrogel can take up volume and/or exert pressure on the wall of the small intestine by moving from the stomach into the small intestine and swelling, wherein preferably, the polymer hydrogel remains swollen in the small intestine for a period of time sufficient to inhibit the intake of food by the subject (page 14, paragraph 1). Sannino also teaches that preferred polymers exhibit pH-dependent swelling, with greater swelling observed at higher pH than at lower pH, such that it does not swell significantly in the stomach unless food and/or water is present to raise the pH, and when the stomach is emptied of food the pH drops and the polymer will actually shrink, but will swell in the higher pH environment of the small intestine (page 14, paragraph 1). Sannino also discloses that the polymer hydrogels can be used in the pharmaceutical field (page 15, paragraph 3).
Friesen teaches a pharmaceutical composition for oral administration, wherein the composition has an enteric coating placed on a tablet, wherein the enteric coating is made of pH-sensitive materials which are relatively insoluble and impermeable at the pH of the stomach, but are more soluble and permeable at the pH of the small intestine [00061]. Additionally, Friesen lists the pH-sensitive materials for preparing the coating include polymers of cellulose acetate phthalate, polyvinyl acetate phthalate, hydroxypropyl methylcellulose phthalate, hydroxypropyl methylcellulose acetate succinate, methylcellulose phthalate, Eudragit L and Eudragit S, etc. ((00061). Note that the coating materials as listed by Friesen are consistent with those recited in instant specification pages 39-40.
Both Sannino and Friesen teach orally administered compositions, which may be used for pharmaceutical purposes and wherein it is desirable for the composition to swell or dissolve in a higher pH such as the pH of small intestine. Given that Sannino suggests that it is preferred that the swelling of the edible polymer hydrogel occurs more in higher pH than in lower pH (note that the presence of food will increase the pH of the stomach, and small intestine registers a higher pH than the stomach, see the para. 1, page 14 of Sannino), and teaches the use of polymers that exhibit pH-dependent swelling, such that 1) the polymers do not swell significantly in the stomach unless food is present to raise the pH, but will shrink when the stomach is emptied of food and the pH drops, and 2) when the polymers move to small intestine, the higher pH of the small intestine will cause the polymer to swell, it would have been obvious to apply/administer an enteric coating as taught by Friesen to the edible polymer hydrogel particle of Sannino. This is because Friesen teaches that suitable enteric coatings are impermeable at the pH of the stomach which is known be 3 or less when the stomach is empty and are more permeable at the pH of the small intestine which is known be 4-5 (see Eisenhardt para. 0005 and Moheno para. 0046). Therefore, applying/administering an enteric coating the edible polymer hydrogel of Sannino as suggested by Friesen will help to the realize the goal of Sannino that the hydrogel polymer swells occurs more at higher pH than in lower pH (e.g., at a lower pH of the empty stomach, the enteric coating is relative intact thus the polymers are not exposed thus do not swell too much, however, when the food is present in the stomach, the higher pH in the stomach will result in the dissolving of the enteric coating and the exposed polymers will swell significantly; similarly, when the polymers with enteric coating move to the small intestine, the higher pH in the small intestine will also cause the coating to dissolve and the polymer to swell significantly). The coating as disclosed by Friesen reads on the limitation about “coated with a moisture barrier”, given that the coating materials as mentioned above are hydrophobic/polymeric in nature.
Regarding claims 2-3, Sannino teaches that the polymer hydrogel has a swelling ratio from about 50 to about 100 (page 12, paragraph 3). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. (MPEP 2144.05 I).
Regarding claim 4, Sannino teaches that the polymer hydrogel but does not explicitly teaches its elastic modulus value. However, it is observed that Example 2 of Sannino teaches exactly same method of making the polymer hydrogel comprising CMC crosslinked with citric acid as the Example 2 of the instant application, it thus logically follows that the polymer hydrogel as disclosed by Sannino has an elastic modulus value that either falls with or overlaps with the range as recited in the claim. See MPEP 2112.01 I, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Regarding claim 15, Sannino teaches that the weight ratio of citric acid to carboxymethylcellulose is 1% to 5% (claim 38).
Claim 11 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sannino in view of Friesen as applied to claim 1 above, and further in view of Sunvold US Patent No. 6,204,291 B1 (hereinafter referred to as Sunvold).
Regarding claim 11, Sannino as recited above teaches a method for treating obesity, reducing food or calories intake or achieving or maintaining satiety in a mammal comprising adding the polymer hydrogel comprising citric acid-crosslinked CMC to the food. Further, Sannino teaches that oral feeding the polymer hydrogel to a rat could induce satiety in the rat and lead to decrease in food intake (Example 4). Thus, given that Sannino also teaches that the polymer hydrogel could be ingested by the mammal subject as a mixture of the polymer hydrogel with food in both liquid or dry form (page 13, bottom para.), it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have combined the rat food (dry or wet) with the polymer hydrogel to form a food mixture with reasonable expectation of success, for the reason that prior art has established that the polymer hydrogel can be added to food for a mammal such as rat, and that the mixture of food and polymer hydrogel can be liquid or dry. Rat food reads on pet food.
Further, Sunvold teaches that substance (e.g., L-carnitine) that is capable of promoting weight loss, reducing food intake and enhancing the satiety could be mixed with a pet food and fed to the pet (e.g., canine) (abstract; column 1, line 51-61; column 2, line 35-37). Additionally, Sunvold teaches that the canine food is Eukanuba veterinary diet, which is known to be a dry dog food.
Both Sannino and Sunvold are directed to substances that could promote weight loss, reduce food intake and enhance the satiety for a mammal. It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified Sannino by including the hydrogel of crosslinked CMC in a dry canine food with reasonable expectation of success, for the reason that prior art has established that substance with aforementioned function could be added to a dog food for the substance to perform its intended function.
Response to Arguments
It is noted applicant’s arguments filed 01/15/2026 is no more than those filed 06/16/2025 in the after-final response, to which the examiner has responded (see the Advisory action issued 06/30/2025).
Conclusion
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/CHANGQING LI/Primary Examiner, Art Unit 1791
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