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 . Claims 1-28 are pending; claims 1-16 and 23-28 are examined, claims 17-22 are withdrawn according to Applicant’s election of 09/11/2025.
Applicant’s arguments, filed 10 March 2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 112(b)
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 3 and 24 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.
Claims 3 recites “a low peroxide level oil, wherein the low peroxide level oil comprises a peroxide value of” in lines 2-3 of the claim. The claims are indefinite because the scope of the claims is unclear. It is not clear how an oil comprises a peroxide value, since the peroxide value appears to be a property of the oil and not a physical component of the oil. To obviate this issue, it is suggested for claim 3 to recite --- an oil with a peroxide value of --- as supported by para. [00197] of the instant Specification.
Claim 24 is rejected as it depends from claim 3 and also recites “low peroxide level oil” and “low peroxides” in lines 2-3.
Claim Rejections - 35 USC § 103 (maintained)
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-16 and 23-28 are rejected under 35 U.S.C. 103 as being unpatentable over Sumiyoshi et al. (US 2010/0092446 A1, 04/15/2010) (hereinafter Sumiyoshi).
Sumiyoshi discloses a drug solution having a reduced dissolved oxygen (DO) content and is less susceptible to oxidative degradation and highly stable over time, and a drug solution containing pack (i.e. container) which is capable of maintaining the dissolved oxygen content of the drug solution, such that the DO concentration of the drug solution is not higher than 2 ppm, after a sterilization process (abs). The drug solution includes a lipid-soluble vitamin containing solution ([0017]) and any of various known fat emulsions ([0132]), containing at least one lipid-soluble vitamin including Vitamin A, D, E, and K ([0020]). Exemplary fats and oils in the fat emulsion includes fish oil and safflower oil (i.e. low peroxide oil of claim 24) ([0133]). Example of vitamin A includes retinol palmitate (i.e. claimed retinyl palmitate); example of vitamin E includes tocopherol ([0055]). The amounts of vitamin A may be 400 to 6500 IU/L ([0109]). The lipid-soluble vitamin containing solution may further contain a water-soluble vitamin in the aqueous medium of the lipid-soluble vitamin containing solution ([0082], [0084]). The water-soluble vitamins include vitamin B2, B12, and a pantothenic compound ([0035]) such as pantothenic acid (i.e. vitamin B5) (i.e. claimed B vitamins of claims 9 and 27) ([0039]). The lipid-soluble vitamin solution may be adjusted to a pH of 6 to 6.5 ([0246]). The drug solution container is preferably a flexible or soft container ([0135]) and comprises an innermost layer comprising polyolefin resin ([0149]). An aluminum laminate film may be used as the outer package ([0201]).
Accordingly, Sumiyoshi discloses a sterilized product comprising a fat emulsion (i.e. claimed sterilized lipid emulsion of claim 14) comprising fat-soluble vitamin A and vitamin D, E, or K (abs, [0020]) adjusted to a pH of 6 to 6.5 ([0246]) in a flexible container ([0135]) that is able to maintain a dissolved oxygen (DO) content of no higher than 2 ppm (abs). Together these would provide a medical product as instantly claimed.
The prior art is not anticipatory insofar as this combination must be selected from various lists/locations in the reference. It would have been obvious, however, to make the combination since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. See MPEP § 2143 (I)(A).
Regarding the preamble of claim 1, the claim is directed to a product, therefore the “for” statements are interpreted as intended use. Where the same active agent (i.e. vitamin A) is present in the prior art as instantly claimed, the intended use is met.
Regarding claims 3 and 4, as noted by paras. [00197]-[00198] of the instant Specification, safflower oil is described as complying with the requirement of a lipid or oil with a low peroxide level, specifically having a peroxide value of no more than 1.5 milliequivalents (mEq) O2/kg. Thus the safflower oil of Sumiyoshi meets the limitations of a low peroxide level oil and an oil with a peroxide value of no more than 1.5 or 5 milliequivalents (mEq) O-2/kg, respectively, as instantly claimed.
Regarding claim 5, although Sumiyoshi does not explicitly disclose the amount of fat/lipid in the fat emulsion, it would appear to have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed concentration of lipid (i.e. 2-40% w/w) through routine experimentation based on conventional fat emulsion amounts desired. "[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." See MPEP § 2144.05(II)(A).
Regarding claims 6 and 25, as noted by para. [0051] of the instant Specification, tocopherol is an antioxidant agent. Thus the tocopherol of Sumiyoshi meets the limitation of an antioxidant as instantly claimed.
Regarding claim 7 reciting an amount of vitamin A, the claimed amounts (i.e. 2000-4000 IU) would have been obvious to one of ordinary skill in the art since they overlap with the ranges of the prior art (i.e. 400 to 6500 IU/L). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP § 2144.05(I).
Regarding claims 8 and 26 reciting amounts of vitamin A per gram of lipid, although Sumiyoshi does not explicitly disclose amounts of vitamin A per gram of lipid, Sumiyoshi discloses wherein any conventional fat emulsion may be used and 400 to 6500 IU/L of vitamin A. Accordingly, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed amount of vitamin A per gram of lipid (i.e. at least 20 IU/gram, or 20-80.000 IU/gram, respectively) through routine experimentation based on the amounts of conventional fat emulsions desired. "[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." See MPEP § 2144.05(II)(A).
Regarding claim 10, as discussed above, Sumiyoshi discloses an aluminum laminate film as the outer package. Thus a light protective outer wrapping would have also been obvious.
Regarding claim 11, as noted by para. [0014] of the instant Specification, polyolefin is free of PVC, plasticizers, adhesives or latex. Accordingly, one of ordinary skill in the art would reasonably conclude the polyolefin resin of Sumiyoshi would be free of PVC, plasticizer, adhesives and latex as instantly claimed.
Regarding claims 12 and 13, Sumiyoshi does not explicitly disclose the claimed stability conditions of vitamin A in the lipid emulsion. However, Sumiyoshi discloses wherein the dissolved oxygen content of the drug solution of the drug solution containing pack can be maintain at a very low level for a long period of time by reducing the dissolved oxygen content of the drug solution of the drug containing pack to not higher than 2ppm, thus preventing the oxidative degradation of the drug solution ([0027]). Accordingly, since Sumiyoshi discloses a lipid emulsion comprising vitamin A at substantially the same pH, with substantially the same restrictions on dissolved oxygen content, one of ordinary skill in the art would reasonably conclude the product of Sumiyoshi to reasonably possess the same properties as the claimed invention, such as wherein the vitamin A in the lipid emulsion is stable for at least three months when stored at a temperature between 1 and 50 °C, or for at least 6 months at a temperature of from 1 °C to 32 °C, respectively.
Regarding claims 15 and 28, Sumiyoshi does not disclose wherein carbohydrates or proteins are required components of the drug solution, or wherein the fat emulsion must comprise additional nutrients besides lipids and vitamins. Therefore it would have been obvious to one of ordinary skill in the art that the product of Sumiyoshi does not comprise carbohydrates and proteins, or does not comprise any nutrients besides lipids and vitamins, respectively.
Regarding claim 16, Sumiyoshi further discloses wherein the drug solution is intended as nutrition for a patient achieved by intravenous administration ([0002]).
Response to Arguments
Applicant mainly asserts on p. 9 of the Remarks of 03/10/2026 that contrary to the claims as amended, ¶ 122 of Sumiyoshi discloses vitamin C, and Sumiyoshi provides no teaching or motivation for a skilled artisan to be motivated to modify the composition of Sumiyoshi to remove vitamin C with a reasonable expectation of success, and that removing the vitamin C from the primary reference would improperly change its principle of operation based on ¶ 246-247 and ¶ 301. Applicant further asserts removing ascorbic acid would require restructuring the composition’s formulation, thereby departing from the reference’s disclosed operation.
The Examiner disagrees. The disclosure of Sumiyoshi does not require the presence of vitamin C as an essential ingredient. A prior art reference is evaluated for all that it reasonably suggests and is not limited to preferred embodiments and working examples. See MPEP § 2123 (I). in this instant case, the disclosure of Sumiyoshi is not limited to Formulation 3 of ¶ 246-247. Moreover, ¶ 122 does not describe essential ingredients required to be in the product of Sumiyoshi. Finally, the rejection as discussed above does not rely on inclusion of vitamin C. As such, Applicant’s assertion is unpersuasive.
Claims 1-16 and 23-28 are rejected under 35 U.S.C. 103 as being unpatentable over Sumiyoshi et al. (US 2010/0092446 A1, 04/15/2010) (hereinafter Sumiyoshi) in view of Betz et al. (WO 2016/188876 A1, 12/01/2016, IDS reference) (hereinafter Betz).
The disclosure of Sumiyoshi is discussed in detail in the rejection supra. While Sumiyoshi is believed to support a finding of obviousness regarding claims 1-16 and 23-28, purely arguendo, for the purposes of complete prosecution, and for the purposes of this ground of rejection only, Sumiyoshi will be interpreted as though it does not explicitly disclose a concentration of lipid as instantly claimed in claim 5.
However, Betz discloses emulsions for parenteral administration comprising 1000 to 65000 IU of vitamin A (abs), sterile (p. 5, lns. 5-7), and have a pH preferably in the range of 6 to 9 (p. 8, lns. 24-25). The vitamin A includes the form of retinyl palmitate (p. 4, lns. 17-18). The oil phase is preferably 2-30% wt. of the emulsion (p. 4, lns. 25-26), comprising a variety of lipids including safflower oil and fish oil (p. 5, lns. 20-22). The emulsion may comprise at least one pharmaceutically acceptable antioxidant, including butylated hydroxytoluene (BHT) and soluble forms of vitamin E (p. 7, lns. 13-20). The emulsions are stabile for at least 12 weeks upon storage at 25 and 40 degrees Celsius respectively.
Sumiyoshi discloses wherein the drug solution comprises a conventional fat emulsion. Accordingly, it would have been obvious to one of ordinary skill in the art to have included 2-30% wt. of fats and oils (i.e. lipids) since it is a known and effective amount of oil phase for fat emulsions intended for parenteral administration as taught by Betz. As such, deriving the claimed amount of international unit (IU) of vitamin A per gram of lipid (IU/gram) would have also been obvious.
Response to Arguments
Applicant does not present specific arguments with regards to Sumiyoshi and Betz.
Since the Examiner has discussed Sumiyoshi above, this rejection is maintained.
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 1-28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-7, 9-23, and 25-29 of copending Application No. 18/246,239 and claims 1-2, 5-13, 15-39 of copending Application No. 17/330,076 (now 1-29 of U.S. Patent No. 12,507,721) (reference applications). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending applications each recite a more specific embodiment of the pending claims (i.e. a formulation comprising a lipid emulsion comprising retinyl palmitate and vitamin E in the lipid phase, vitamin b12, with dissolved oxygen of no more than 1 ppm and a pH value of 5-9, and a formulation comprising a lipid emulsion comprising vitamin A and vitamin E, vitamin b12, with dissolved oxygen of no more than 1.5 ppm, respectively) and thus read on the pending claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant asserts this stage is examination is premature for a terminal disclaimer, and that the double patenting rejection be withdrawn or held in abeyance until the claims are otherwise allowable.
Since Applicant has not addressed these rejections yet, the rejections are maintained.
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Brito De La Fuente et al. (US 2018/0147174 A1, 05/31/2018), directed to emulsions for parenteral administration comprising retinyl palmitate, soybean oil, and antioxidant.
Kido et al. (US 5,728,681, 03/17/1998), directed to an infusion liquid comprising a fat emulsion comprising vitamin A, glycerol, vitamin A, B12, and vitamin E.
Schweikert et al. (US 5.925,684, 07/20/1999) (hereinafter Schweikert), directed emulsions for parenteral administration, comprising antioxidants to increase stability of an oily vehicle.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUCY TIEN whose telephone number is (571)272-8267. The examiner can normally be reached Monday - Thursday 8:30 AM - 6:30 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, SAHANA KAUP can be reached at (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LUCY M TIEN/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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