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
Claims 77-94, 97 and 100 are pending.
Response to Amendment
Applicant amended claim 77-80 and 82-84. Applicant amended claim 81 and deleted the limitation in parentheses.
The rejection of claim 81 under 35 U.S.C. 112(b) is withdrawn in view of amendment.
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 77-88, 90-94, 97 and 100 remain rejected under 35 U.S.C. 103 as being unpatentable over Assegehegn (WO-2017167409-A1, of record in Office Correspondence mailed on 10/03/2023) ) in view of Kirk (US 20160309748 A1), Driscoll (US 20140274957) and as evidenced by Yang (Foods 8.8 (2019): 334, of record in Office Correspondence mailed on 10/03/2023)
Regarding claims 77-78, 80-84, 86-87, 94 and 100, Assegehegn teaches a multi-chamber container for parenteral administration comprising a first chamber with an oil in-water emulsion, second chamber with an amino acid solution and a third chamber with a carbohydrate solution (Abstract, claims 1 and 13). Assegehegn teaches that the emulsion comprises 5 wt. % to 30 wt.% of an oil phase based on the total weight of the emulsion (page 3 lines 26-27). Assegehegn teaches that the composition comprises 1.15 g of DHA in 100g of oil phase (10 g of extract containing 115mg DHA/g extract) (Table 1). Assegehegn teaches that the composition comprises 10g soybean oil in 100g of composition (Table 7). Evidentiary reference Yang shows that Soybean oil contains phytosterol (approximately 300 mg/100 g). Thus, the composition taught by Assegehegn contains about 30 mg of phytosterol in 100 g composition. Assegehegn does not teach the lipid formulation comprises water soluble forms of choline. Thus the limitation of “the lipid formulation is essentially free of water-soluble forms of choline” is met since the reference is silent to it.
Assegehegn does not teach that the DHA is from Schizochytrium and that the composition comprises arachidonic acid.
There is no evidence that the source of the DHA imparts any additional structure to the composition. However, Kirk teaches that microbial oil from Schizochytrium can be formulated for providing parenteral dosage form (Abstract, [0077], [0040])). Kirk teaches that the oil comprises docosahexaenoic acid (DHA) and arachidonic acid (ARA) (claim 15). Kirk teaches the weight ratio of DHA to EPA is about 20:1 ([0056]) and teaches the oil comprises a triglyceride fraction comprising DHA and EPA ([0012], [0062]). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition taught by Assegehegn by substituting a composition comprising DHA and ARA derived from Schizochytrium as suggested by Kirk, for Assegehegn’s fish and krill oil compositions, with a reasonable expectation of success. One of ordinary skill in the art would be motivated to do so in order to form a health composition comprising DHA which is beneficial for the maintenance of cognitive functions and has anti-inflammatory properties, as taught by Kirk ([0007]). Since Assegehegn and Kirk teach a composition for parenteral administration comprising DHA, there is a reasonable expectation of success.
Assegehegn and Kirk do not teach wherein the amino acid formulation comprises
glycerophosphocholine.
However, Driscoll teaches that a composition comprising glycerylphosphorylcholine at 30 mg to 2,400 mg ([0010]) can be used for parenteral administration ([0046]) and teaches a dose of 600 mg of GPC (Table 1). Driscoll teaches that water or aqueous dextrose (i.e., carbohydrate solution) are suitable carriers for parenteral solutions ([0053]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the composition taught by Assegehegn by adding glycerophosphocholine as suggested by Driscoll. One of ordinary skill in the art would be motivated to do so in order to increase the dietary choline in a patient as suggested by Driscoll ([0081]). MPEP 2131.02 III states that a generic disclosure will anticipate a claimed species covered by that disclosure when the species can be "at once envisaged" from the disclosure. MPEP 2144.08 addresses the obviousness of species when prior art teaches genus. Driscoll does not specify the glycerylphosphorylcholine is added to the amino acid formulation Assegeheg teaches the composition has three chambers and the amino acid solution is an aqueous amino acid solution (page 14 line 20). One skilled in the art would envision using the glycerophosphocholine in the amino acid or carbohydrate formulation as these are aqueous solutions and suitable carriers for glycerophosphocholine. Since Assegehegn and Driscoll teach a desire to form a health composition for parenteral administration comprising choline, there is a reasonable expectation of success.
Regarding claim 79, Assegehegn teaches the composition comprises 1.15 g of DHA in 100g of oil phase (Table 1). Kirk teaches the triglyceride fraction comprises at least about 40% to about 80% by weight DHA. It would be obvious to one of ordinary skill in the art to optimize the concentration of DHA. Differences in concentration do not support the patentability of subject matter encompassed by the prior art. One of ordinary skill in the art would be motivated to optimize the concentration of DHA in order to form a parenteral composition with beneficial effect, e.g. on the cardiovascular system, on cerebral function, as well as in combatting inflammatory conditions as suggested by Assegehegn (page 1 lines 9-11).
Regarding claim 85, Kirk teaches that the microbial oil and/or one or more fractions thereof is substantially free of EPA ([0061]).
Regarding claim 88, Assegehegn teaches that the emulsion may further comprise a pharmaceutically acceptable co-surfactant (page 5 lines 27-28) and suggests using sodium oleate (page 6 line 17).
Regarding claims 90 and 91, Assegehegn teaches that the composition comprises glycerol (Table 1).
Regarding claim 92, Assegehegn teaches that the composition comprises tocopherols (Table 1).
Regarding claim 93, Assegehegn teaches that the composition has a pH 8.6-9 (Table 1).
Regarding claim 97, the limitations of the composition are discussed in the claim 77 analysis. Assegehegn teaches the multi-chambers are separated by leak tight seals that are peelable and rupture upon application of external pressure for mixing of the contents of the container only prior to use of the container (claim 12, page 14 line 10).
Claim 89 remains rejected under 35 U.S.C. 103 as being unpatentable over Assegehegn, Kirk and Driscoll as applied to claim 88 above, and as evidenced by Wu (Soybean lecithin composition, fractionation, and functionality." (2002). Thesis, Iowa state University)
Regarding claim 89, Assegehegn teaches the composition comprises soybean oil (Tables 3 and 7). Evidentiary reference Wu reports soybean oil comprises soy lecithin (page 2 “Soybean Lecithin Composition”).
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 77-93 and 97 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 10-12 and 25 of US 11,666,548 in view of Assegehegn and Kirk and as evidenced by Yang.
Regarding instant claims 77-84 and 86-89, patent claim 1 recites a multi-chamber container for parenteral administration, comprising a carbohydrate formulation present in a first chamber, an amino acid formulation present in a second chamber. Patent claim 2 recites the multi-chamber container according to claim 1, additionally comprising a lipid formulation present in a third chamber. Patent claim 10 recites wherein the lipid formulation comprises an aqueous phase and oil phase in an amount of from 1 g to 40 g of oil per 100 ml of lipid formulation. Patent claim 25 recites the amino acid formulation comprises glycerophosphocholine. Patent claim 12 recites the oil phase comprises one or more oils selected from the group consisting of olive oil, soybean oil, safflower oil, coconut oil, fish oil, fish oil extract, krill oil, medium chain triglycerides (MCTs), algae oil, fungi oil, com oil, sunflower oil, palm kernel oil, and rapeseed oil. Evidentiary reference Yang shows Soybean oil contains phytosterol (approximately 300 mg/100 g). Soybean oil contains comprises lecithin. Patent claim 25 recites the amino acid formulation comprises glycerophosphocholine. Patent claims 1-2, 10 and 12 do not recite an amount of DHA.
However, Assegehegn teaches a multi-chamber container for parenteral administration comprising a first chamber with an oil in-water emulsion, second chamber with an amino acid solution and a third chamber with a carbohydrate solution (Abstract, claims 1 and 13). Assegehegn teaches that the emulsion comprises 5 wt. % to 30 wt.% of an oil phase based on the total weight of the emulsion (page 3 lines 26-27). Assegehegn teaches that the composition comprises 1.15 g of DHA in 100g of oil phase (10 g of extract containing 115mg DHA/g extract) (Table 1).
Kirk teaches that microbial oil from Schizochytrium can be formulated for providing parenteral dosage form (Abstract, [0077], [0040])). Kirk teaches the oil comprises docosahexaenoic acid (DHA) and arachidonic acid (ARA) (claim 15). Kirk teaches the weight ratio of DHA to EPA is about 20:1 ([0056]) and teaches the oil comprises a triglyceride fraction comprising DHA and EPA ([0012], [0062]). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition recited in patent claims 1-2, 10 and 12 by adding DHA and optimizing its concentration as suggested by Assegehegn and Kirk. One of ordinary skill in the art would be motivated to do so in order to increase the amount of DHA in the composition and form a parenteral composition with beneficial effect, e.g. on the cardiovascular system, on cerebral function, as well as in combatting inflammatory conditions as suggested by Assegehegn (page 1 lines 9-11).
Regarding instant claim 85, patent claim 1 does not recite EPA. Thus, the limitation of “the lipid formulation is essentially free of EPA” is met since the reference is silent to it (i.e. 0%).
Regarding claim 90 and 91, kirk teaches the composition may comprise glycerol ([0078]).
Regarding instant claim 92, patent claim 11 recites the lipid formulation comprises at least one pharmaceutically acceptable antioxidant selected from the group consisting of alpha-tocopherol, beta-tocopherol, gammatocopherol, delta-tocopherol, and ascorbyl palmitate.
Regarding claim 93, Assegehegn teaches that the composition has a pH 8.6-9 (Table 1).
Regarding claim 97, patent claims 1-2, 10-12, 25 do not recite openable seals among the first chamber, the second chamber and the third chamber. However, Assegehegn teaches a multi-chamber container for parenteral administration comprising a first chamber with an oil in-water emulsion, second chamber with an amino acid solution and a third chamber with a carbohydrate solution (Abstract, claims 1 and 13). Assegehegn teaches the multi-chambers are separated by leak tight seals that are peelable and rupture upon application of external pressure for mixing of the contents of the container only prior to use of the container (claim 12, page 14 line 10).
Claims 94 and 100 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 10-12, 25 of US 11,666,548 in view of Assegehegn, Kirk and Driscoll.
Regarding claim 94, patent claims 1-2, 10-12, 25 do not recite a concentration of glycerophosphocholine. However, Driscoll teaches a composition comprising glycerylphosphorylcholine at 30 mg to 2,400 mg ([0010]) can be used for parenteral administration ([0046]) and a dose of 600 mg of GPC (Table 1). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition recited in patent claims 1-2, 10-12, 25 by adding 600 mg of GPC as suggested by Driscoll. One of ordinary skill in the art would be motivated to do so in order to use an effective and safe dose of GPC.
Regarding claim 100, Driscoll teaches aqueous dextrose (i.e., carbohydrate solution) is a suitable carrier for GPC for parenteral solutions ([0053]).
Claims 77-79, 85-94, 97 and 100 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claim 18 of US 12,171,866 in view of Driscoll and Assegehegn, as evidenced by Yang
Regarding claims 77-79, 85-87, 94, and 100, patent claim 18 recites a parenteral nutrition composition reconstituted from a multi-chamber container comprising an amino acid formulation, a carbohydrate formulation, and a lipid formulation, wherein glycerophosphocholine is present in the lipid formulation of the composition in a concentration of from 0.01 g to 6.0 g per liter, wherein the lipid formulation further comprises docosahexaenoic acid (DHA) in a concentration of from 0.1 g to 5.0 g per 100 g of the oil phase and arachidonic acid (ARA) in a concentration of from 0.1 g to 15.0 g per 100 g of the oil phase for use in the treatment of choline deficiency and liver damage by parenteral administration, and wherein the lipid formulation is essentially free of eicosapentaenoic acid (EPA). There is no evidence that the source of the DHA imparts any additional structure to the composition. Patent claim 18 does not recite the lipid formulation comprises 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 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 amino acid formulation comprises glycerophosphocholine.
However, Assegehegn teaches a multi-chamber container for parenteral administration comprising a first chamber with an oil in-water emulsion, second chamber with an amino acid solution and a third chamber with a carbohydrate solution (Abstract, claims 1 and 13). Assegehegn teaches the emulsion comprises 5 wt. % to 30 wt.% of an oil phase based on the total weight of the emulsion (page 3 lines 26-27). Assegehegn teaches the composition comprises 10g soybean oil in 100g of composition (Table 7). Evidentiary reference Yang shows Soybean oil contains phytosterol (approximately 300 mg/100 g). Thus, the composition taught by Assegehegn contains about 30 mg of phytosterol in 100 g composition. Assegehegn teaches the composition comprises soybean oil (Tables 3 and 7). Soybean oil comprises soy lecithin. Assegehegn teaches a multi-chamber container for parenteral administration comprising a first chamber with an oil in-water emulsion, second chamber with an amino acid solution and a third chamber with a carbohydrate solution (Abstract, claims 1 and 13). Assegehegn teaches the multi-chambers are separated by leak tight seals that are peelable and rupture upon application of external pressure for mixing of the contents of the container only prior to use of the container (claim 12, page 14 line 10).
Driscoll teaches a composition comprising glycerylphosphorylcholine for parenteral administration ([0046]) and teaches water or aqueous dextrose (i.e., carbohydrate solution) are suitable carriers for parenteral solutions ([0053]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition recited in patent claim 18 by adding oil in-water emulsion comprising 5 wt. % to 30 wt.% of an oil phase based on the total weight of the emulsion (page 3 lines 26-27) and soybean oil, and by adding glycerophosphocholine in the carbohydrate and/or amino acid formulation instead of the lipid formulation as suggested by Driscoll. One of ordinary skill in the art would be motivated to do so in order to form an effective and stable parenteral composition and increase dietary choline in a patient as suggested by Driscoll ([0081]). MPEP 2131.02 III states that a generic disclosure will anticipate a claimed species covered by that disclosure when the species can be "at once envisaged" from the disclosure. MPEP 2144.08 discusses the obviousness of species when prior art teaches genus. One skilled in the art would envision using the glycerophosphocholine in the amino acid or carbohydrate formulation as these are aqueous solutions and suitable carriers for glycerophosphocholine. Since Assegehegn and Driscoll teach a desire to form a health composition for parenteral administration comprising choline, there is a reasonable expectation of success.
Regarding claim 88, Assegehegn teaches the emulsion may further comprise a pharmaceutically acceptable co-surfactant (page 5 lines 27-28) and suggests using sodium oleate (page 6 line 17).
Regarding claims 90 and 91, Assegehegn teaches the composition comprises glycerol (Table 1).
Regarding claim 92, Assegehegn teaches the composition comprises tocopherols (Table 1).
Regarding claim 93, Assegehegn teaches the composition has a pH 8.6-9 (Table 1).
Regarding claim 97, Assegehegn teaches the multi-chambers are separated by leak tight seals that are peelable and rupture upon application of external pressure for mixing of the contents of the container only prior to use of the container (claim 12, page 14 line 10).
Regarding claim 100, Driscoll teaches a dose of 600 mg of GPC (Table 1) and teaches that aqueous dextrose (i.e., carbohydrate solution) is suitable carrier for parenteral solutions ([0053]).
Response to Arguments
Applicant's arguments filed 01/29/2026 have been fully considered but they are not persuasive.
Applicant argues that there is no motivation to combine Driscoll and Assegehegn, the reliance on MPEP 2131.02 III is improper, and the subject obviousness rejection relies on four different references and is not a single reference obviousness challenge.
In response to argument, MPEP 2131.02 III and 2144.08 address the genus-species situation. Driscoll teaches a composition comprising glycerylphosphorylcholine used for parenteral administration ([0046]) and teaches that water or aqueous dextrose (i.e., carbohydrate solution) are suitable carriers for parenteral solutions ([0053]). Assegehegn teaches a three-chamber container for parenteral administration comprising a first chamber with an oil in-water emulsion, second chamber with an aqueous amino acid solution and a third chamber with a carbohydrate solution (Abstract, claims 1 and 13, page 14 line 20). One skilled in the art having a choice between the three chambers would be motivated to add the glycerophosphocholine in the amino acid or the carbohydrate formulation as these are aqueous solutions and suitable carriers for glycerophosphocholine.
Applicant argues a skilled artisan, looking at Driscoll would not specifically choose to include GPC in its composition and administer the composition parenterally but rather in a tablet or capsule.
In response to the argument, claims 77 and 97 recite “the amino acid formulation comprises glycerophosphocholine”. The claim does not exclude the presence of other components. Driscoll teaches a composition comprising glycerylphosphorylcholine used for parenteral administration ([0046]). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. See MPEP 2123.
Applicant argues Assegehegn does not disclose or suggest any benefit or desire to include any form of choline in any of its solutions.
In response to the argument, Assegehegn teaches the composition comprises krill oil which contains phosphatidylcholine (page 3 line 10). One of ordinary skill in the art would be motivated to combine the teachings of Assegehegn and Driscoll and to add glycerylphosphorylcholine to the parenteral composition in order to increase the dietary choline in a patient as suggested by Driscoll ([0081]).
Applicant requests that the double patenting rejection over US 11,666,548 and US 12,171,866 be held in abeyance. A request to hold a rejection in abeyance is not a proper response to a rejection. Rather, a request to hold a matter in abeyance may only be made in response to an OBJECTION or REQUIREMENTS AS TO FORM (see 37 CFR 1.111(b) and MPEP §714.02). Thus, the double patenting rejections of record have been maintained as no response to these rejections has been filled by applicant at this time.
Conclusion
THIS ACTION IS MADE FINAL. 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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/MARY A CRUM/Examiner, Art Unit 1657
/THANE UNDERDAHL/Primary Examiner, Art Unit 1699