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 Objections
Claim 1 and 2 are objected to because of the following informalities: in claim 1 the phrase “carrageenan (iota)” is used while in claim 2 the phrasing “iota carrageenan” is used. The examiner asks for the spelling and presentation to be consistent through the claims. Appropriate correction is required.
Election/Restrictions
Applicant’s election without traverse of Group I (Claims 1-3 and 10-14) in the reply filed on 17 November 2025 is acknowledged.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by Puder et al. (herein referred to as Puder, WO 2016040570 A2).
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 composition comprises at least one gum such as xanthan gum ([0071]).
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.
Claims 2-3 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 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 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]).
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.
Claims 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Puder et al. (herein referred to as Puder, WO 2016040570 A2)
With regard to Claims 10 and 11, 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 13, 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).
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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARLA I DIVIESTI whose telephone number is (571)270-0787. The examiner can normally be reached Monday-Friday 7am-3pm (MST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Erik Kashnikow can be reached at (571) 270-3475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/K.I.D./Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792