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 .
Claims 1-16 are presented for examination.
Applicants’ drawings filed July 3, 2023 have been received and entered.
Applicants’ information disclosure statement filed January 16, 2026 has been received and entered.
Applicants’ election filed November 25, 2025 in response to the restriction requirement of October 27, 2025 has been received and entered. The applicants elected the invention described in claims 1-12 (Group I) without traverse.
Claims 13-16 are withdrawn from consideration as being drawn to the non-elected invention (37 CFR 1.142(b)).
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-12 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-12 of copending Application No. 18/884,836 (reference application).
This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Claims 1-12 are not allowed.
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, 3, 4 and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10 and 11 of U.S. Patent No. 12,171,866 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the present application teaches a lipid emulsion for parenteral nutrition comprising an aqueous phase and about 5% to about 35% by weight of an oil phase based on the total weight of the lipid emulsion (w/w), wherein the lipid emulsion comprises from about 2.0 g/L to about 15.0 g/L of DHA; from about 0 g/L to about 1.2 g/L of EPA; and from about 5.0 g/L to about 20.0 g/L of ARA and further comprising choline in an amount of from 0.5 g/L to 5.0 g/L and a multi-chamber bag containing lipid emulsion; and the patented application teaches a lipid emulsion for parenteral administration comprising glycerophosphocholine in a concentration of from 0.1 g to 15.0 g/L, DHA, and ARA wherein the lipid emulsion comprises an aqueous phase and about 5% to about 35% by weight of an oil phase based on the total weight of the lipid emulsion comprising DHA of from 0.1 g to 5.0 g/L and ARA of from 0.1 g to 100 g, wherein EPA is no more than 0.001%, and further containing a multi-chamber container containing the lipid emulsion
Note in the present application, the choline is selected from glycerophosphocholine. Also note in the present application, the EPA is from about 0 g/L to 1.2 g/L and the patented application the EPA is no more than 0.001% at converted to 0.01 g/L.
Claims 1, 3, 4 and 12 are not allowed.
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, 3-6, 9 and 12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 77 and 92 of copending Application No. 17/059,932 (reference application); and claims 1 and 16 of copending Application No. 19/318,846 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the present application teaches a lipid emulsion for parenteral nutrition comprising an aqueous phase and about 5% to about 35% by weight of an oil phase based on the total weight of the lipid emulsion (w/w), wherein the lipid emulsion comprises from about 2.0 g/L to about 15.0 g/L of DHA; from about 0 g/L to about 1.2 g/L of EPA; and from about 5.0 g/L to about 20.0 g/L of ARA and further comprising choline in an amount of from 0.5 g/L to 5.0 g/L and a multi-chamber bag containing lipid emulsion, and the copending applications teach a multi-chamber container for parenteral administration comprising (i) a carbohydrate formulation present in a first chamber; (ii) an amino acid formulation present in a second chamber; and (iii) a lipid formulation present in a third chamber; wherein: the lipid formulation comprises an aqueous phase and about 5% to about 35% by weight of an oil phase based on the total weight of the lipid formulation; the lipid formulation is present in the form of an oil-in-water emulsion; the oil phase comprises docosahexaenoic acid (DHA) obtained from a single cell source, wherein the single cell source is an extract of microalgae and wherein DHA is present in a concentration of from 0.1 g to 5.0 g per 100 g of oil phase; the oil phase comprises arachidonic acid (ARA); the lipid formulation includes about 70 mg phytosterols or less per 100 g of oil phase; and the lipid formulation is essentially free of water soluble forms of choline, wherein the carbohydrate formulation and/or the amino acid formulation comprises glycerophosphocholine.
Note the only difference between the copending applications’ claims and the present application’s claims lies in that the copending applications’ claims have additional agent, a carbohydrate, combined with presently claimed active agents, DAH, EPA, ARA, a choline selected from glycerophosphocholine, phytosterol, and tocopherol.
The copending applications’ claims would anticipate the present application’s claims because the present application’s claims recite “comprising” and thus opens the claims to the inclusion of additional agents.
Claims 1, 3-6, 9 and 12 are not allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN E WEDDINGTON whose telephone number is (571)272-0587. The examiner can normally be reached M-F 1:30-10:00.
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, Jeff Lundgren can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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KEVIN E. WEDDINGTON
Primary Examiner
Art Unit 1629
/KEVIN E WEDDINGTON/Primary Examiner, Art Unit 1629