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 .
Election/Restrictions
To summarize, Applicant’s election without traverse of Group M: a critically ill patient for whom enteral nutrition is contraindicated, in the reply filed on October 14, 2025 is acknowledged.
Status of Application
Receipt of Applicant’s remarks and amended claims filed on January 26, 2026 is acknowledged.
Claims 1-8, 10-23, and 25-27 are pending in this application.
Claims 1, 4-6, 10-12, 14-23, and 25 have been amended.
Claims 9 and 24 have been cancelled.
Claims 26-27 are new.
All claims are under examination in this application.
Information Disclosure Statement
The Information Disclosure Statement filed on March 13, 2026 is acknowledged. A signed copy is attached to this office action.
Withdrawn Objections/Rejections
Claim Objections
The objection of claims 10, 12, 15, 18, 21, and 24 because:
Claim 10 does not read well and should read “…from 1 mm to 300 mm per liter of the reconstituted multi-chamber container” has been withdrawn in view of the amendment to the claim to recite “…from 1 mm to 300 mm per liter of amino acid formulation.”;
claim 12 should read “…inorganic acids consisting of sulfate or chloride” has been withdrawn in view of the amendment to the claim to remove the optional subject matter;
claim 15 recites “…optionally one or more electrolytes selected from the group of electrolytes consisting of…” is redundant is unnecessary has been withdrawn in view of the amendment to remove the optional subject matter;
claim 18 because there should be a space between “ascrobyl palmitate” and “and” in line 4 has been withdrawn in view of the correction of the typographical error;
claim 21 because the claim does not read well and it is suggested the claim be amended to recite “wherein the multi-chamber container further comprises at least one additional chamber containing a vitamin and/or trace element formulation” has been withdrawn in view of the amendment to the claim to recite “wherein the multi-chamber contain comprises at least one additional chamber…”;
Claim 24 is a substantial duplicate of claim 11 has been withdrawn in view of the cancellation of the claim.
Claim Rejections - 35 USC § 112
The rejection of claims 16-20 and 23-24 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 because:
Claim 16 recites the limitation "wherein the arginine butyrate is present in the lipid formulation of the third chamber" in lines 1-2 and there is insufficient antecedent basis for this limitation in the claim has been withdrawn in view of the amendment to claim 16 to be an independent claim;
Claims 17-18 and 23 recite the limitation "the lipid formulation" in line 1 and here is insufficient antecedent basis for this limitation in the claim has been withdrawn in view of the amendment to the dependency of the claims;
Claim 19 recites the limitation "the oil phase" in line 1 and there is insufficient antecedent basis for this limitation in the claim has been withdrawn in view of the amendment to the dependency of the claims;
Claim 20 recites the limitation "the third chamber" in line 2 and there is insufficient antecedent basis for this limitation in the claim has been withdrawn in view of the amendment to the dependency of the claims;
The rejection of claim 9 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends because claim 1, from which claim 9 depends, recites “wherein at least the first or the second chamber comprising arginine butyrate”, however, claim 9 recites “wherein at least one of the first, the second, or the third chamber comprises arginine butyrate”, which would allow for only chamber 3 to comprise arginine butyrate, contradictory to the limitation recited in claim 1 has been withdrawn in view of the cancellation of the claim.
Maintained Rejections
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 1-8, 10-23, and 25-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-39 of U.S. Patent No. 11,666,548. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims recite a method of using the multi-chamber container recited in the patented claims. Additionally, the patented claims recite a method of treating patients who require parenteral nutrition when oral and enteral nutrition is not possible, recited in instant claim 2. The specific patient populations recited in instant claim 1 are recited in patented claim 34. The patented claims additionally recite the concentration of the arginine butyrate. The patented claims and the instant claims merely recite different combinations of dependent claims.
Response to Arguments
Applicant has stated Applicant will consider Double Patenting Rejections after indication of allowable subject matter. The applicant’s acknowledgement of the rejections is noted. However, they will not be held in abeyance. As detailed in MPEP 714.02 “[t]he reply by the applicant or patent owner must be reduced to a writing which distinctly and specifically points out the supposed errors in the examiner’s action and must reply to every ground of objection and rejection in the prior Office action. The reply must present arguments pointing out the specific distinctions believed to render the claims, including any newly presented claims, patentable over any applied references. If the reply is with respect to an application, a request may be made that objections or requirements as to form not necessary to further consideration of the claims be held in abeyance until allowable subject matter is indicated. Double patenting rejections are not “objections or requirements as to form not necessary to further consideration of the claims” and are not eligible to be held in abeyance.
Newly Applied Objections/Rejections
Claim Objections
Claims 13, 15, and 17 are objected to because of the following informalities:
Regarding claim 13, the claim recites “wherein the amino acid formulation comprises from 1 g to 100 g of amino acids per 100 mL of the amino acid formulation.” However, the recitation of “of the amino acid formulation” is redundant and unnecessary.
Regarding claim 15, the claim recites “wherein the carbohydrate formulation comprises from 1 g to 100 g of at least one of glucose, maltose, or trehalose per 100 mL of the carbohydrate formulation.” However, the recitation of “of the carbohydrate formulation” is redundant and unnecessary.
Regarding claim 17, the claim recites “wherein the lipid formulation comprises an aqueous phase and an oil phase in an amount of from 1 g to 40 g of oil per 100mL of the lipid formulation.” However, the recitation of “of the lipid formulation” is redundant and unnecessary.
Appropriate correction is required.
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.
Claim 12 is 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.
Regarding claim 12, the claim recites “wherein the amino acid formulation comprises an aqueous solution of one or more amino acids,…”. The recitation of amino acid formulation indicates that an amino acid is already present in the formulation, therefore, it is unclear if the formulation further comprises and additional amino acid. Clarification is requested.
Allowable Subject Matter
The claims are free of the prior art.
The closest prior art is that of Trouilly et al. (US 2007/0092579) which discloses a sterilized medical product for a pediatric patient population comprising: a) a polymeric containing having a first and second chambers positioned at opposing lateral ends of the container and at least one additional chamber positioned between the first and second chambers, a first frangible barrier separating the first chamber from the at least one additional chamber and a second frangible barrier separating the second chamber from the at least one additional chamber; b) a carbohydrate formulation housed in the first chamber; c) an amino acid formulation housed in the at least one additional chamber and having cysteine at a level appropriate for pediatric nutrition; d) a lipid formulation housed in the second chamber; and e) electrolytes included in one or both of the carbohydrate and amino acid formulations, wherein activation of all the frangible barriers produces a total nutritional formulation (claim 1 of Trouilly et al.).
Trouilly does not teach the use arginine butyrate in either chamber of the container.
As discussed in the parent application, 16/893,807, reasons for allowance, the claims invention is directed to methods of utilizing a multi-chamber container for parenteral administration comprising: (i) a carbohydrate formulation present in a first chamber; and (ii) an amino acid formulation present in a second chamber; wherein at least the first or the second chamber comprises arginine butyrate. Applicant has found that arginine butyrate can improve the intestinal health of parenteral nutrition patients, such as, for example, maintaining or ameliorating local immunity, reducing local inflammation and maintaining or improving intestinal barrier function. As shown in Table 2 of the instant specification, surprisingly, a significant difference has been found for formulations comprising arginine butyrate, a butyric acid derivative which so far has not been used in parenteral nutrition compositions. Arginine butyrate proved to be especially beneficial (as compared with tributyrin and dipalmitoyl butyryl glycerol) regarding gut architecture, as evidenced by villus height, crypt depth and tight junctions (duodena mucosal resistance) analysis; local and systemic inflammation as shown by determination of pro- inflammatory and anti-inflammatory cytokines, and an improved local immunity as evidenced by sIgA (See specification, paragraph [00147]). Thus, the experimental results set forth in Table 2 demonstrate that arginine butyrate is surprisingly superior, Additionally, as shown in Table 3 the instant specification, an immediate high-level comparison of the results in Intervention Group C, which received arginine butyrate, and the results intervention groups A and B, which received tributyrin and which is known as potentially having positive effects on gut health, versus standard parenteral and enteral feeding, supports the finding that arginine butyrate containing formulations have an unexpected superior effect on the tested markers for gut barrier functionality, local inflammation, local immunity, gut architecture and systemic inflammation (See specification, paragraph [00148]). Thus, the experimental results set forth in Table 3 demonstrate that arginine butyrate has an unexpected superior effect on the tested markers for gut barrier functionality, local inflammation, local immunity, gut architecture and systemic inflammation to other butyric acid derivatives such as tributyrin. for gut health to other butyric acid derivatives such as sodium butyrate and tributyrin.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA S MERCIER whose telephone number is (571)272-9039. The examiner can normally be reached M-F 6:30 am to 4 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A Wax can be reached at 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MELISSA S MERCIER/Primary Examiner, Art Unit 1615
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