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
Applicant’s election of Group (I) in the reply filed on 12/10/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicant’s election without traverse of DHA, EPA, phosphatidylcholine, oleic acid, glycerol, EDTA, and water in the reply filed on 12/10/2025 is acknowledged. However, it is noted that glycerol and EDTA are not recited in any claims. The fact that EDTA and glycerol are not recited in any of the present claims, the election of species is construed to be DHA, EPA, phosphatidylcholine, oleic acid and water.
Claims 62-65, 68, 83, and 96-98 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/species, there being no allowable generic or linking claim. The election of DHA, EPA, phosphatidylcholine, oleic acid, glycerol, EDTA, and water as the oil-in-water species does not include the species of claims 96-98.
Priority
This application claims priority to PCT Application No. PCT/US21/27411, filed April 15, 2021, which claims the benefit of United States Provisional Patent Application No. 63/010,364, filed April 15, 2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/10/2025 has been considered by the examiner.
Status of Claims
Claims 1-5, 8, 10-11, 13-15, 18, 20, 25, 36, 43, 62-65, 68, 83, and 96-98 are pending. Claims 6-7, 9, 12, 16-17, 19, 21-24, 26-35, 37-42, 44-61, 66-67, 69-82, and 84-95 are canceled. Claims 62-65, 68, 83, and 96-98 are withdrawn. Claims 1-5, 8, 10-11, 13-15, 18, 20, 25, 36, and 43 are examined in accordance to the elected species.
Claim Objections
Claims 2-4, 8, 15, and 18 are objected to because of the following informalities: the fact that some claims recite “comprising” including claim 1 and claims 1-4, 8, 15, and 18 recite “comprises.” For consistency and clarity, claims 1-4, 8, 15, and 18 should align with the transitional phrase as recited in claim 1, and thus, they need to be amended accordingly. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-5, 8, 10-11, 13-15, 18, 20, 25, 36, and 43 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In the instant case, independent claim 1 is directed to a stable injectable diglyceride (DG) oil-in-water emulsion having a mean particle size of 200 nm or less and a zeta potential (ZP) of about -30 mV or more negative than -40 mV. The dependent claims and the elected species recite DHA and EPA where DHA can be at least about 50%, or at least about 60%, or at least about 75%. That means the EPA can be at least about 50%, or at least about 40%, or at least about 25%. Similarly, Independent claim 43 is directed to a composition suitable for intravenous or intra-arterial injection, the composition comprising a stable diglyceride (DG) oil-in-water emulsion; wherein the emulsion comprises at least 10% by weight of a DG oil, the esterified fatty acids of the DG oil being at least about 90% n-3 fatty acids and comprising DHA and EPA; wherein the emulsion has a mean particle size of 200 nm or less with a polydispersity index of 0.3 or less and a zeta potential (ZP) of about -30 mV or more negative than -30 mV.
The (DG) oil-in-water emulsion of claim 1 is characterized by a mean particle size and by a zeta potential (ZP) without reciting the component or the make-up of the (DG) oil-in-water emulsion.
Similarly, the (DG) oil-in-water emulsion of claim 43 only contains 10% of DG oil comprising DHA and EPA and, the esterified fatty acids of the DG oil being at least about 90% n-3 fatty acids and comprising DHA and EPA and is characterized by a mean particle size, polydispersity index, and by a zeta potential (ZP) without reciting the component or the make-up of the (DG) oil-in-water emulsion. That means the 10% of DG oil contains at least about 90% of DHA and EPA. So, the ratio of EPA or DHA can be any amount as long at the total amount of 90% and other oil makes up the remaining at about 10%.
In fact, a typical oil-in-water emulsion contains an oil phase (the dispersed droplets), a water or aqueous phase (the continuous phase), and a surfactant, which stabilizes the interface between them. The oil-in-water emulsion also typically contains a co-surfactant that can help fine-tune the balance at the interface, stabilizers, like polymers or electrolytes to control the osmotic pressure or viscosity, a pH buffer or a salt to maintain the stability and control the charge. These components work together to control droplet size, surface charge, and over stability of the emulsion.
Therefore, the claims encompass a genus of emulsions defined by its physicochemical properties, which is simply a wish to know the identity of such emulsion that will satisfy those physicochemical properties. Accordingly, there is insufficient written description encompassing just the (DG) oil-in-water emulsion as recited in claim 1 and just the the (DG) oil-in-water emulsion containing 10% of DG oil comprising DHA and EPA and, the esterified fatty acids of the DG oil being at least about 90% n-3 fatty acids and comprising DHA and EPA as recited in claim 53, wherein the DG emulsion of claim 1 is characterized by a mean particle size and by a zeta potential (ZP) and wherein the (DG) oil-in-water emulsion of claim 43 is characterized by a mean particle size, polydispersity index, and by a zeta potential (ZP) because the relevant identifying characteristics of the genus such as structure or other physical and/or chemical characteristics are not set forth in the specification as-filed, commensurate in scope with the claimed invention. Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed” (see page 1117). The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed” (see Vas-Cath at page 1116).
Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
One cannot describe what one has not conceived. See Fiddles v. Baird, 30 USPQ2d 1481, 1483. In Fiddles v. Baird, claims directed to mammalian FGF’s were found unpatentable due to lack of written description for the broad class. The specification provided only the bovine sequence. Thus, the specification fails to describe these DNA sequences. The Court further elaborated that generic statements are not adequate written description of the genus because it does not distinguish the claimed genus from others, except by function.
Per the Enzo court’s example, (Enzo Biochem., Inc. v. Gen-Probe Inc., 63 USPQ2d 1609 (CA FC 2002) at 1616) of a description of an anti-inflammatory steroid, i.e., a steroid (a generic structural term) couched “in terms of its function of lessening inflammation of tissues” which, the court stated, “fails to distinguish any steroid from others having the same activity or function” and the expression “an antibiotic penicillin” fails to distinguish a particular penicillin molecule from others possessing the same activity and which therefore, fails to satisfy the written description requirement. Similarly, “a mixture or composition comprising Deferasirox or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients” wherein the composition “has reduced release under gastric condition and fast release at near neutral pH or at neutral pH” ” or “when the composition is tested in-vitro by USP Apparatus II (Paddle) method of U.S. Pharmacopoeia at 50 rpm, at 37°C in pH 6.8 phosphate buffer with 0.25% Tween, the release rate of at least 70% by weight within 15 minutes,” does not distinguish any particular composition comprising Deferasirox and one or more pharmaceutically acceptable excipients from other compositions having the same activity or function and as such does not satisfy the written-description requirement. Applicant has not disclosed enough relevant, identifying characteristics, such as structure or other physical and/or chemical properties, sufficient to show possession of the claimed genus. Mere idea or function is insufficient for written description; isolation and characterization at a minimum are required. A description of what a material does, rather than what it is, usually does not suffice. Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
M.P.E.P. 2163 II-A-3-a ii) states: “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i) (C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure “indicates that the patentee has invented species sufficient to constitute the gen[us].” See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004) (“[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated.”). “A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed.” In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004) (Claims directed to PTFE dental floss with a friction-enhancing coating were not supported by a disclosure of a microcrystalline wax coating where there was no evidence in the disclosure or anywhere else in the record showing applicant conveyed that any other coating was suitable for a PTFE dental floss.)”.
In the instant case, Applicants disclose only a single species of a stable (DG) oil-in-water emulsion comprising
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. The (DG) emulsion was prepared by mixing egg yolk phosphatidylcholine (PC) with DG oils where the DG oils contain at least 90% DHA and/or EPA or pure DG-DHA, pure DG-EPA or a mixture of DHA and EPA. (See lines 27-32 of page 19 and Table 1.) Even said single species of DG oil-in-water emulsion does not make clear the exact components in the DG oil (whether or not a mixture of DHA and EPA, or just EPA, just DHA, just pure-DG-EPA, just pure-DG-DHA, or a mixture of pure-DG-EPA and pure-DG-DHA as each will affect the interfacial properties- like how the fatty acids arrange at droplet surface- and that can shift the zeta potential. Moreover, Pure DG (DHA or EPA) means only DHA/EPA attached-no mixing, just that singly fatty acid. But if the emulsion contains just DG- DHA/EPA, as in a blend or in a mixture that might contain other components-like free fatty acids, triglycerides, or a less pure form-then the emulsion is likely to be different. Impurities or other lipid species can in the non-pure forms can affect how the molecules arrange, so that mixture itself might give a different droplet size or zeta potential that the pure form. In short purity gives a more defined, predictable behavior, while a mixture introduces more variability.
Additionally, when DG with just DHA is the only component in the DG oil, it behaves differently that of a DG with just EPA. DHA and EPA have different chain lengths, flexibilities, and polarities, so they alter how the droplets form at the interface. However, when you combine them, the ratio changes the packing which affects droplet size, stability, and zeta potential. So, each form of the DG oil-in-water emulsion, i.e., just DG-EPA, Just DG-DHA, or a mixture of DG-EPA and DG-DHA will give a distinct profile in terms of how these emulsions behave. Similar situation applies for the pure forms.
The Examiner notes that the data provided in Figure does not make clear the exact components and ratio of DG oil that satisfies the zeta potential and the particle size.
Given the broad scope of the claimed subject matter (the large genus of DG oil-in-water emulsion that might satisfy the instantly claimed physicochemical properties), applicant has not provided sufficient written description that would allow the skilled artisan to recognize that applicant was in possession of the genus.
In the absence of structural characteristics that are shared by members of the genus, one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus. Thus, Applicant was not in possession of the claimed genus. See University of California v. Eli Lilly and Co. 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997).
In summary, the skilled in the art will not know which other components (if any) and in which proportion should be present in the claimed DG oil-in-water emulsion in order to satisfy the above zeta potential profile, the mean particle size, and the polydispersity index parameters.
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 1-5, 8, 10-11, 13-15, 18, 20, 25, and 36 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 1 and other dependent claims recites emulsions (plural) which render the claims indefinite. The plural form contemplates a broad, unclear range of emulsions and one cannot predict or distinguish which specific emulsion fall into the scope of the DG oil-in-water emulsion that satisfies the claimed mean particle size and the claimed zeta potential.
Claim 8 recites the composition comprises from about 10% to about 50% lipids by weight of the composition. However, it is not clear if the lipids recited in claim 8 are the DG oils from the DG oil-in-water emulsion or different lipids since the specification teaches the lipids can be n3 fatty acids such as EPA or DHA or phospholipids.
Claim 15 recites the composition of claim 1, wherein the emulsions comprise one or more phospholipid emulsifiers. However, claim 1 only recites an injectable composition comprising stable diglyceride (DG) oil-in-water emulsions, wherein the emulsions have a mean particle size of 200 nm or less and a zeta potential (ZP) of about -30 mV or more negative than -40 mV. Therefore, claim 15 is indefinite because it is unclear whether the emulsion of claim 1 includes or excludes the phospholipid emulsifier. In particular, it is not clear whether or not the phrase the emulsions in claim 2 refers to the exact composition of claim 1 or if it introduces a new limitation. This kind of language points out the ambiguity and requests clarification to avoid the lack of indefiniteness. Perhaps, claim 15 should recite, the composition of claim 1, the stable diglyceride DG) oil-in-water emulsion further comprising one or more phospholipids emulsifiers.
Claim 18 recites wherein the phospholipid emulsifiers comprise one or more phosphoglyceride emulsifiers. Claim 18 is indefinite because the phospholipid emulsifiers (plural) exclude the singular form of the phospholipid emulsifier recited in claim 15. As such, the phospholipid emulsifier recited in claim 18 lack antecedent basis for the one or more phospholipid emulsifiers of claim 15.
Claim 20 recites wherein the phospholipid emulsifiers comprise one or more phosphoglyceride emulsifiers. However, claim 20 is indefinite because it is unclear whether the phosphatidylcholine emulsifier in claim 20 includes or excludes the one or more phosphoglyceride emulsifiers. In particular, it is not clear whether or not the phrase the phosphatidylcholine emulsifier in claim 20 refers to the exact composition of claim 18 or if it introduces a new limitation. This kind of language points out the ambiguity and requests clarification to avoid the lack of indefiniteness. Perhaps, claim 20 should recite, the composition of claim 18, the one or more phosphoglyceride emulsifiers comprising phosphatidylcholine.
Claim 36 which depends from claim 1 recites the ratio of emulsifier to DG by weight is less than about 1:8, or less than about 1:10, or less than about 1:12, or less than about 1:15. Emulsifier is not recited in claim 1. Therefore, there is insufficient antecedent basis for this limitation in the claim.
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.
Claims 1-5, 8, 10-11, 13, 15, 18, and 36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Deckelbaum et al (US8,633,253 B2).
Deckelbaum teaches an omega-3 lipid-based oil-in-water emulsion Suitable for administration to a Subject, wherein
(a) the emulsion comprises at least about 7% to about 35% omega-3 oil by weight in grams per 100 ml of emulsion,
(b) the omega 3 oil comprises at least about 40%-to about 97% omega-3 diglyceride by weight per total weight of the omega-3 oil, and at least about 70 wt.-% of the acyl-groups of the omega-3 diglycerides comprise EPA, DHA or a mixture thereof,
(c) the omega-3 oil comprises less than about 10% omega 6 fatty acids, and
(d) the mean diameter of lipid droplets in the emulsion is less than about 1 micron. (See claim 1.) The less than about 1 micron reads on claims 1 and 10. Moreover, Deckelbaum teaches the most preferred emulsion contains 20g of DG, which is emulsified by 1.2 g of egg yolk lecithin, and 2.5g of glycerol/100 ml. The emulsion lipids are mixed in doubly distilled water (30 g of water and 20 g of oil) and dispersed. (See lines 62-67 of column 13 bridging lines 1-2 of column 14.) Egg yolk lecithin is a phosphoglyceride. The ratio of emulsifier (egg yolk lecithin) and DG, i.e., 2.5 g to 20 g equals to 1:16, meeting the limitation of less than about 1:15 of claim 36 because 1:16 reads on the about 1:15 of claim 36. Deckelbaum the emulsion is an oil-in-water emulsion. This emulsion contains 20% omega-3 diglyceride by weight fatty acid-based formula greater or equal than 70% of total omega-3 diglyceride fatty acids as EPA and DHA. (See lines 64-67 of column 14.)
Accordingly, with regard to the zeta potential (ZP) claimed, said limitation is the intended physicochemical properties of DG oil-in-water emulsion claimed. Since Deckelbaum does not teach the claimed DG oil-in-water emulsion, said physicochemical properties claimed is necessarily present. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed method is different from that taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
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.
Claims 14 and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Deckelbaum et al (US8,633,253 B2) as applied to claims 1-5, 8, 10-11, 13, 15, 18, and 36 as set forth in the rejection above.
The teachings of Deckelbaum have been discussed supra.
Deckelbaum does not teach the DG oil is from 23% to 30% of the composition by weight. However, Deckelbaum teaches the emulsion comprises at least about 7% to about 35% omega-3 oil by weight in grams per 100 ml of emulsion and the omega 3 oil comprises at least about 40%-to about 97% omega-3 diglyceride by weight per total weight of the omega-3 oil, and at least about 70 wt.-% of the acyl-groups of the omega-3 diglycerides comprise EPA, DHA or a mixture thereof. (See claim 1.) Deckelbaum does not teach specifically teach phosphatidylcholine in the exemplified emulsion. However, Deckelbaum teaches emulsifiers may include physiologically acceptable emulsifiers (Surfactants) Such as phospholipids of animal or Vegetable origin. Examples of phospholipids are egg yolk lecithin, a biologic phospholipid, a phosphatidylcholine with fixed fatty acyl chain composition, a glycophospholipid or a phosphatidylethanolamine (See lines 15-19 of column 10.) Lastly, Deckelbaum does not each
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to modify the DG oil-in-water emulsion taught by Deckelbaum by substituting the egg yolk lecithin with the phosphatidylcholine and by including at least 10% by weight of the DG oil and at least about 90 wt.-% of the acyl-groups of the omega-3 diglycerides comprise EPA and DHA to give Applicants’ claimed invention. One would have been motivated do so, because not only Deckelbaum teaches egg yolk lecithin and phosphatidylcholine are interchangeable, but also because Deckelbaum teaches the oil-in-water DG emulsion can have at least about 70 wt.-% of the acyl-groups of the omega-3 diglycerides comprise EPA, DHA or a mixture thereof. One would reasonably expect the modified DG oil-in-water emulsion to achieve similar purpose as the exemplified DG oil-in-water emulsion taught by Deckelbaum with success.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Deckelbaum et al (US8,633,253 B2) as applied to claims 1-5, 8, 10-11, 13, 15, 18, and 36 as set forth in the rejection above in view of Motheram et al (US 8,658,676 B2).
The teachings of Deckelbaum have been discussed supra.
Deckelbaum does not teach the co-emulsifier is oleic acid.
Motheram teaches an oil-in-water emulsion wherein clevidipine is dis persed or dissolved in a lipid, such as Soybean oil, which in turn is emulsified with egg yolk phospholipids in water, and wherein the emulsion is further stabilized by the co-emulsi fier oleic acid. The tonicity of emulsion is adjusted with glycerin and further comprises an amount of EDTA sufficient to inhibit growth of microorganisms in the formulation. (See lines 22-29 of column 2.)
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to include oleic acid as the co-emulsifier to give Applicant’s claimed invention. On would have been motivated to do so, because not only because Deckelbaum teaches a co-emulsifier can be included in the DG oil-in-water emulsion, but also because Motheram teaches oleic acid is an effective co-emulsifier that can further stabilize the emulsion. As such, one would reasonably expect the inclusion of oleic acid as a co-emulsifier to successfully stabilize the DG oil-in-water emulsion.
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 1-5, 8, 10-11, 13, 14, and 43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 8,410,191B2; over claims 1-15 of U.S. Patent No. 8,536,232B2; over claims 1-7 of U.S. Patent No. 9,144,562B2; over claims 1-9 of U.S. Patent No. 8,533,253B2; over claims 1-8 of U.S. Patent No. 10,070,643B2, and over claims 1-10 of U.S. Patent No. 11,076,593B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
The U.S. patent claims teach an omega-3 lipid-based oil-in-water emulsion suitable for administration to a patient, wherein
(a) the emulsion comprises at least about 7% to about 35% omega-3 oil by weight in grams per 100 ml of emulsion,
(b) the omega 3 oil comprises at least about 40% omega-3 diglyceride by weight per total weight of the omega-3 oil, and at least about 70 wt.-% of the acyl-groups of the omega-3 diglycerides comprise EPA, DHA or a mixture thereof,
c) the omega-3 oil comprises less than about 10% omega 6 fatty acids, and
d) the mean diameter of lipid droplets in the emulsion is less than about 5 microns. (See claim 1.) he U.S. patent claims teach
Although the U.S. patent claims anticipate claims 1, The U.S. patent claims render obvious the other claims because the U.S. patent claims teach overlapping diglyceride oil, overlapping n-3 fatty acids and a mixture of DHA and EPA.
Accordingly, with regard to the zeta potential (ZP) claimed, said limitation is the intended physicochemical properties of DG oil-in-water emulsion claimed. Since the U.S. patent claims do not teach the claimed DG oil-in-water emulsion, said physicochemical properties claimed is necessarily present. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed method is different from that taught by the prior art and to establish patentable differences. See in re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Conclusion
Claims 1-5, 8, 10-11, 13-15, 18, 20, 25, 36, and 43 are not allowed.
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/JEAN P CORNET/Primary Examiner, Art Unit 1628