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 .
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-3, 10, 12, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Puder et al. (herein referred to as Puder, WO 2016040570 A2) in view of Konda et al. (herein referred to as Konda, US 20190008187 A1).
With regard to Claim 1, Puder teaches a formulation that can take the form of an emulsion which contains total enteral or parenteral nutrition for a recipient subject (abstract). Puder teaches the composition comprising medium chain triglycerides (MCTs) comprising 65-75% C8 fatty acid (caprylic acid) ([0033]-[0034] One with ordinary skill in the art would recognize caprylic acid is another name for Octanoic acid). See MPEP 2131.03(I) "If the prior art discloses a point within the claimed range, the prior art anticipates the claim." UCB, Inc. v. Actavis Labs. UT, Inc., 65 F.4th 679, 687, 2023 USPQ2d 448 (Fed. Cir. 2023). Puder teaches the pH of the composition is typically between about 6.0 and about 9.0 ([0079]). See MPEP 2144.05(I) In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Puder teaches the compositions can further contain therapeutic agents such as proteins ([0080]). Puder teaches "therapeutic agent" as the term is used herein refers to a physiologically or pharmacologically active substance that produces a localized or systemic therapeutic effect or effects in a subject ([0080]). In addition, Puder teaches different protein sources have different biological value of the protein ([0057]). Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to utilize protein in the amount that would achieve the desired therapeutic effect or effects in a subject. This includes optimizing the amount of protein used and can include the type of protein source with the desired biological value of protein. See MPEP 2144.05(II)(A) Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Puder teaches the composition comprises at least one gum ([0071]) but is silent to the gum being iota carrageenan and gellan gum.
Konda teaches a dispersion stabilizer that has an effect of improving or stabilizing the dispersibility of solids insoluble in aqueous media and/or liquid components immiscible therewith (abstract). Konda teaches utilizing iota carrageenan and gellan gum as stabilizers in fat containing liquids ([0391]). Konda teaches the stabilizer prevents the occurrence of creaming in fat-containing liquid foods during storage ([0085]). In addition, Konda teaches iota carrageenan and gellan gum can be used as thickeners ([0265])
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Puder in view of Konda to utilize iota carrageenan and gellan gum as stabilizer to prevent fat-containing liquid foods from creaming during storage or to utilize iota carrageenan and gellan gum as thickeners.
With regard to Claim 2, Puder teaches the composition comprises at least one gum ([0071]) but is silent to the gum being iota carrageenan and gellan gum.
Konda teaches a dispersion stabilizer that has an effect of improving or stabilizing the dispersibility of solids insoluble in aqueous media and/or liquid components immiscible therewith (abstract). Konda teaches utilizing iota carrageenan and gellan gum as stabilizers in fat containing liquids ([0391]). Konda teaches the stabilizer prevents the occurrence of creaming in fat-containing liquid foods during storage ([0085]). In addition, Konda teaches iota carrageenan and gellan gum can be used as thickeners ([0265])
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Puder in view of Konda to utilize iota carrageenan and gellan gum as stabilizer to prevent fat-containing liquid foods from creaming during storage or to utilize iota carrageenan and gellan gum as thickeners
With regard to Claim 3, Puder teaches the composition comprises at least one gum ([0071]) but is silent to the gum being carboxymethyl cellulose and or microcrystalline cellulose.
Konda teaches utilizing carboxymethyl cellulose as a thickener ([0265]) or as a stabilizer in fat containing liquids ([0391]). Konda teaches thickeners improve shape retention by adding viscosity ([0251]). In addition, Konda teaches utilizing iota carrageenan and gellan gum as stabilizers in fat containing liquids ([0391]). Konda teaches the stabilizer prevents the occurrence of creaming in fat-containing liquid foods during storage ([0085]). In addition, Konda teaches iota carrageenan and gellan gum can be used as thickeners ([0265])
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Puder in view of Konda to utilize carboxymethyl cellulose as a stabilizer to prevent fat-containing liquid foods from creaming during storage or as a thickener to improve shape retention by adding viscosity. In addition, it would have been obvious to one with ordinary skill in the art to utilize iota carrageenan and gellan gum as stabilizer to prevent fat-containing liquid foods from creaming during storage or to utilize iota carrageenan and gellan gum as thickeners.
With regard to Claims 10, Puder teaches the compositions can further contain therapeutic agents such as proteins ([0080]). Puder teaches "therapeutic agent" as the term is used herein refers to a physiologically or pharmacologically active substance that produces a localized or systemic therapeutic effect or effects in a subject ([0080]). In addition, Puder teaches different protein sources have different biological value of the protein ([0057]). Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to utilize protein in the amount that would achieve the desired therapeutic effect or effects in a subject. This includes optimizing the amount of protein used and can include the type of protein source with the desired biological value of protein. See MPEP 2144.05(II)(A) Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
With regard to Claim 12, Puder teaches the emulsion formulation can contain additional components required for the total nutrition (e.g., total daily nutrition) of the recipient ([0055]). Puder teaches non-limiting examples include carbohydrates ([0055]-[0058], [0061]). Puder teaches carbohydrates are useful ingredients that should be present in an amount which will not significantly affect the omega-3 or omega- 6 fatty acid levels of the recipient subject ([0050]). It would have been obvious to one with ordinary skill in the art to modify the amount of carbohydrates to still meet the total nutrition of the recipient while not significantly affect the omega-3 or omega- 6 fatty acid levels of the recipient subject.
With regard to Claim 14, Puder teaches the composition is in a form of a liquid emulsion ([0012], [0053], [0061]) Puder describes the emulsion formulation in mL and being administered via tube feeding or oral administration. One with ordinary skill in the art can deduce that to be utilized in a tube feeding application the emulsion would be liquid.
Response to Arguments
Applicant's arguments filed 22 May 2026 have been fully considered but they are not persuasive.
Applicant’s arguments filed 22 May 2026, with respect to the rejection(s) of claim(s) 1 under 102(a)(2) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection over Puder, WO 2016040570 A2) in view of Konda et al. (herein referred to as Konda, US 20190008187 A1).
First, Applicant argues that Puder does not disclose a blend of (i) gellan gum and iota carrageenan; or (ii) carboxymethyl cellulose (CMC) and microcrystalline cellulose (MCC). This argument is not found persuasive in light of the new grounds of rejection. In this case Konda is relied upon to teach the claimed blend of gellan gum and iota carrageenan. Konda teaches utilizing iota carrageenan and gellan gum as stabilizers in fat containing liquids ([0391]). Konda teaches the stabilizer prevents the occurrence of creaming in fat-containing liquid foods during storage ([0085]). In addition, Konda teaches iota carrageenan and gellan gum can be used as thickeners ([0265]). Thus, Konda provides ample motivation to utilize the blend of gellan gum and iota carrageenan because it is a stabilizer. This motivation aligns with applicant’s discussion on the benefits of the blend of gellan gum and iota carrageenan on page 7 of applicant’s remarks. Therefore, applicant’s argument is not found to be persuasive.
However, on page 8 of applicant’s remarks, applicant argues that Konda does not remedy the deficiencies of Puder because Konda is not concerned with MCT compositions. In response, the examiner would like to highlight that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, as discussed above, Konda provides ample motivation to combine because it is a stabilizer used in emulsions. Thus, applicant’s argument is not found to be persuasive.
Applicant continues to argues that Konda that because Konda teaches 53 different options for use as stabilizers one with ordinary skill in the art would not arrive at the specifically claimed blends from the choice of that many alternatives. This argument is not found to be persuasive because the number of different options is not relevant to the fact that Konda teaches the claimed combination of Gellan Gum and iota carrageenan and provides ample motivation to combine. Therefore, applicant’s argument is not found to be persuasive.
Lastly with regard to Konda, applicant argues that Konda “champions” the use of wellan gum and states that the desired effects could not be obtained other than by use of this specific polysaccharide “without adversely affecting the characteristics of the food”. The teachings of Konda referred to polysaccharide thickeners separate to Wellan gum. Konda teaches, “In addition to wellan gum, the burst inhibitor for deep-fried foods of the present invention may contain components used for general deep-fried foods, as long as the effects of the present invention are not significantly adversely affected. Specifically, such other components can be one or more components selected from the group consisting of starch, polysaccharide thickeners, bread crumbs, oil and fat, wheat flour, emulsifiers, seasonings, flavors, colorants, sweeteners, acidulants, baking powder, shelf life-improving agents, preservatives, antioxidants, etc.” ([0263]). Therefore, applicant’s argument is not found to be persuasive.
Next, applicant argues that the recite pH of the composition also makes a significant contribution to an improved stability, applicant points to paragraph [00156] of the specification. This argument is not found to be persuasive because Puder teaches the pH of the composition is typically between about 6.0 and about 9.0 ([0079]) which overlaps with the claimed pH range. Therefore this argument is not found to be persuasive.
With regard to the protein concentration, Puder teaches the compositions can further contain therapeutic agents such as proteins (Puder [0080]). Puder teaches "therapeutic agent" as the term is used herein refers to a physiologically or pharmacologically active substance that produces a localized or systemic therapeutic effect or effects in a subject ([0080]). Applicant argues that the claimed protein concentration can improve the stability of the composition without the need for an additional emulsifier. However, per MPEP 716.02(b)(I) The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) (Mere conclusions in appellants’ brief that the claimed polymer had an unexpectedly increased impact strength "are not entitled to the weight of conclusions accompanying the evidence, either in the specification or in a declaration."); Thus, the applicants argument that the protein concentration as claimed improves stability is not found to be persuasive because there is no supporting data and merely a conclusion the applicant stated.
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.
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/K.I.D./Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792
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