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
The amendment to the claims filed after non-final office action on June 22, 2026 is acknowledged. Claims 1-7 were canceled, claims 8, 10, 12 were amended, claims 13-14 were newly added and claims 8-14 are pending in the instant application.
The restriction was deemed proper and made final previous office action.
Claims 8-14 are examined on the merits of this office action. *Applicant’s arguments are moot in light of amendment of the claims and new rejections presented below.
Withdrawn Rejections/Objections
The rejection of claims 8 and 10 under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter is withdrawn in view of amendment of the claims filed June 22, 2026.
The rejection of claims 8, 10, 12 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in view of amendment of the claims filed June 22, 2026.
The rejection of claim(s) 8, 10-12 under 35 U.S.C. 102(a)(1) as being anticipated by Somekawa (US20110288012 A1, cited in Applicant’s IDS) is withdrawn in view of amendment of the claims filed June 22, 2026.
The rejection of claim(s) 8-10 under 35 U.S.C. 102(a)(1) as being anticipated by Wassner (The American Journal of Clinical Nutrition 32: JULY 1979, pp. 1497-1504) is withdrawn in view of amendment of the claims filed June 22, 2026.
New Rejections
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 8-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 8 claims “A method for suppressing symptoms of refeeding syndrome by providing nutritional support for a marasmus-kwashiorkor-type or kwashiorkor-type patient in an undernutrition state using a nutritional formulation, the method comprising administering to said patient the nutritional formulation comprises comprising 0 to 3.5 g of a protein or an amino acid per 100 kcal.” MPEP 2173.05 (b) states “The addition of the word "type" to an otherwise definite expression (e.g., Friedel-Crafts catalyst) extends the scope of the expression so as to render it indefinite. Ex parte Copenhaver, 109 USPQ 118 (Bd. Pat. App. & Inter. 1955). Likewise, the phrase "ZSM-5-type aluminosilicate zeolites" was held to be indefinite because it was unclear what "type" was intended to convey. The interpretation was made more difficult by the fact that the zeolites defined in the dependent claims were not within the genus of the type of zeolites defined in the independent claim. Ex parte Attig, 7 USPQ2d 1092 (Bd. Pat. App. & Inter. 1986). In the instant case, it is unclear what “type” following marasmus-kwashiorkor or kwashiorkor is intended to convey. Claims 9-14 are rejected due to dependence on claim 8 and not further clarifying this point of confusion.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 8, 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bandsma (PLOS medicine, 16(2):e1002747, published online 2/2019, cited in Applicant’s IDS).
Bandsma teaches treatment of severely malnourished children with a nutritional formulation (see “Methods and findings”), In particular, Bandsma teaches wherein 31% of the children treated had kwashiorkor (see Results, “Patient characteristics”). Bandsma teaches wherein the nutritional formulations containing protein were administered to malnourished children that fall within the claimed range (see Table 1). For example, Bandsma teaches protein at an amount of 9.9g/1000 mL and the text identifies that F75 is 75 kcal/100 mL. Thus, these amounts correspond to 1.32 g protein/100 kCal thus falling within the limitation of instant claim 8. Regarding suppressing refeeding syndrome, Bandsma specifically teaches “F75 was designed to meet the estimated nutritional requirements to restore physiological and metabolic functions and to prevent refeeding syndrome while medical conditions stabilize” (see page 3, first three lines). Bandsma teaches “We also hypothesized that a reduction in carbohydrate content of the modified F75 formula could lower the risk of refeeding syndrome. Together, reformulated F75 could plausibly improve early clinical outcomes among hospitalized children with SAM” (see page 3, second to last paragraph). The treatment is specifically designed to prevent refeeding syndrome while metabolic conditions stabilize, and the study reports low incidence of a biochemical indicator of refeeding syndrome during treatment (see page 14, paragraph 3).
Regarding claim 11, Bandsma teaches the children were fed a liquid diet thus meeting the limitations of oral administration (introduction, Paragraph 0002).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 9-10, 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Bandsma (PLOS medicine, 16(2):e1002747, published online 2/2019) in view of Prieto (Int. J. Environ. Res. Public Health 2011, 8, 4353-4366).
Bandsma teaches treatment of severely malnourished children with a nutritional formulation (see “Methods and findings”), In particular, Bandsma teaches wherein 31% of the children treated had kwashiorkor (see Results, “Patient characteristics”). Bandsma teaches wherein the nutritional formulations containing protein were administered to malnourished children that fall within the claimed range (see Table 1). For example, Bandsma teaches protein at an amount of 9.9g/1000 mL and the text identifies that F75 is 75 kcal/100 mL. Thus, these amounts correspond to 1.32 g protein/100 kCal thus falling within the limitation of instant claim 8. Regarding suppressing refeeding syndrome, Bandsma specifically teaches “F75 was designed to meet the estimated nutritional requirements to restore physiological and metabolic functions and to prevent refeeding syndrome while medical conditions stabilize” (see page 3, first three lines). Bandsma teaches “We also hypothesized that a reduction in carbohydrate content of the modified F75 formula could lower the risk of refeeding syndrome. Together, reformulated F75 could plausibly improve early clinical outcomes among hospitalized children with SAM” (see page 3, second to last paragraph). The treatment is specifically designed to prevent refeeding syndrome while metabolic conditions stabilize, and the study reports low incidence of a biochemical indicator of refeeding syndrome during treatment (see page 14, paragraph 3).
Regarding claim 11, Bandsma teaches the children were fed a liquid diet thus meeting the limitations of oral administration (introduction, Paragraph 0002).
Bandsma is silent to in enteral infusion or intravenous administration of the nutritional formulation.
Prieto teaches enteral nutrition for critically ill and malnourished children, recommending that enteral nutrition be started “within the first 24 to 48 hours after adminission, when oral feeding is not possible”, and that parenteral nutrition be used when enteral nutrition is contraindicated or not tolerated (see Abstract). Prieto also describes tube based enteral feeding, including interruptions when “the tube becomes obstructed or falls out” (see paragraph 0012).
It would have been obvious to modify Bandsma to administer the nutritional formulation by enteral infusion, as taught by Prieto, because enteral feeding was a known method for providing nutritional support to malnourished pediatric patients when oral feeding was not possible. Such modification represents the application of a known technique to a similar method to obtain predictable results (KSR Int’l Co. v. Teleflex Inc., 550 US 398, 417 (2007). A skilled artisan would have had a reasonable expectation of success because Prieto teaches enteral feeding as an established method of delivering nutrition to pediatric patients, and Bandsma’s F75 is a liquid nutritional formulation intended for GI nutritional support.
Furthermore, it would have been obvious to one of ordinary skill in the art to modify Bandsma to provide nutritional support intravenously, as taught by Prieto, when enteral nutrition was contraindicated or not tolerated. Prieto teaches parenteral nutrition as a known alternative for providing nutritional support under such circumstances. Selecting IV/parenteral administration would have constituted the use of a known technique to achieve a predictable result, delivery of nutritional support when enteral feeding could not be used (KSR Int’l Co. v. Teleflex Inc., 550 US 398, 417 (2007). A skilled artisan would have had a reasonable expectation of success because IV/parenteral nutrition was an established method of providing nutritional support to critically ill patients.
Regarding claims 10, 12, Bandsma teaches sugar and a saccharide (see Table 1, Lactose).
Regarding claims 13-14, Bandsma teaches wherein the formulation comprises lipid (see Table 1).
Regarding claim 14, Bandsma teaches various ratios of lipid to saccharide depending on how the calculation is done. For total lipid to saccharide the ration is .45:1 and .77:1 (see table 1, assuming lipids are 9 kcal/g and saccharides as 4 kcal/g). For maltodextrin individually, the ratio is 2.2:1 or 1.12/1. Thus, clearly the amount of lipid and saccharide are result-effective variables. Therefore, it would be obvious to one of ordinary skill in the art to optimize the concentration of each component to achieve optimal nutrition. The MPEP states the following: 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) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997). Therefore, it would have been obvious to optimize dosing and the concentration of each component to achieve optimal activity and therapeutic effectiveness in patients. There is a motivation to optimize since it is normal desire of scientists or artisans to improve upon what is already generally known with a reasonable expectation that optimization would at least work the same.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 8-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of copending Application No. 18/576582 (reference application) in view of Bandsma and Prieto. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant application claims “method for suppressing symptoms of refeeding syndrome by providing nutritional support for a marasmus-kwashiorkor-type or kwashiorkor- type patient in an undernutrition state using a nutritional formulation, the method comprising administering to said patient wherein the nutritional formulation comprises comprising 0 to 3.5 g of a protein or an amino acid per 100 kcal” (claim 8); IV or enteral administration (claims 9, 11-12); a lipid (claim 13); a sugar or saccharide (claims 10, 12); and a 1:1 ratio of lipid to saccharide caloric ratio.
Co-pending Application claims “A method for providing nutritional supplementation to a subject in poor nutrition state using an enteral nutrient preparation, the enteral nutrient preparation comprising protein and a lipid, and an amino acid as necessary, wherein 90 wt% or more of the protein is not milk-derived protein, and(a) an amino acid score of a mixture of the protein and the amino acid is 100, and a lipid calorie ratio is 40% or more, or (b) an amino acid score of a mixture of the protein and the amino acid is less than 100, and a lipid calorie ratio is 15% or more” (see claim 8). Co-pending Application further claims preventing or suppressing refeeding syndrome (claim 5); comprising more than 3.5 g of the protein and/or the amino acid per 100 kcal in total (claim 3); which is used for administration to a subject in poor nutrition state (claim 7); further comprising glucide (claim 4). Co-pending Application is silent to wherein the subject is kwashiorkor type patient; IV administration and a 1:1 ratio.
Bandsma teaches treatment of severely malnourished children with a nutritional formulation (see “Methods and findings”), In particular, Bandsma teaches wherein 31% of the children treated had kwashiorkor (see Results, “Patient characteristics”). Bandsma teaches wherein the nutritional formulations containing protein were administered to malnourished children that fall within the claimed range (see Table 1).
Prieto teaches enteral nutrition for critically ill and malnourished children, recommending that enteral nutrition be started “within the first 24 to 48 hours after adminission, when oral feeding is not possible”, and that parenteral nutrition be used when enteral nutrition is contraindicated or not tolerated (see Abstract). Prieto also describes tube based enteral feeding, including interruptions when “the tube becomes obstructed or falls out” (see paragraph 0012).
Furthermore, it would have been obvious to one of ordinary skill in the art to modify AN18/576582 to provide nutritional support intravenously, as taught by Prieto, when enteral nutrition was contraindicated or not tolerated. Prieto teaches parenteral nutrition as a known alternative for providing nutritional support under such circumstances. Selecting IV/parenteral administration would have constituted the use of a known technique to achieve a predictable result, delivery of nutritional support when enteral feeding could not be used (KSR Int’l Co. v. Teleflex Inc., 550 US 398, 417 (2007). A skilled artisan would have had a reasonable expectation of success because IV/parenteral nutrition was an established method of providing nutritional support to critically ill patients.
it would be obvious to one of ordinary skill in the art to optimize the concentration of each component to achieve optimal nutrition. The MPEP states the following: 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) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997). Therefore, it would have been obvious to optimize dosing and the concentration of each component to achieve optimal activity and therapeutic effectiveness in patients. There is a motivation to optimize since it is normal desire of scientists or artisans to improve upon what is already generally known with a reasonable expectation that optimization would at least work the same.
It would have been obvious to treat kwashiorkor type malnutritioned children as taught by Bandsma. One of ordinary skill int eh art would have been motivated to do so because refeeding syndrome is a complication with kwashiorkor type malnutritioned children and formulations aimed at providing nutrition with the range of protein, lipid and saccharides would be therapeutically beneficial in this patient population.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERINNE R DABKOWSKI whose telephone number is (571)272-1829. The examiner can normally be reached Monday-Friday 7:30-5:30 Est.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko Garyu can be reached at 571-270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERINNE R DABKOWSKI/Primary Examiner, Art Unit 1654
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