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 .
Request for Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant’s submission filed on 1/16/25 has been entered.
DETAILED ACTION
Claims 1-11, 13, 14, 16, 17, 20-22, 28 and 30 are pending in the Claim Set filed 12/16/2025.
Claims 1 and 21 have been amended.
Claims 6, 28 and 30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Claims 12, 15, 18, 19, 23-27 and 29 are canceled.
Applicants’ elected Group I: claims 1-11, 13, 14, 16, 17 and 20-22, in the reply filed 11/25/2024.
Applicants’ election of species without traverse: emulsifier: lecithin; co-emulsifier: sodium oleate; and isotonic agent: glycerol.
Herein, claims 1-5, 7-11, 13, 14, 16, 17 and 20-22 are for examination for prior art to the extent that they read on the elected species.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/2/2026 has been considered by the examiner and an initialed copy of the IDS is included with the mailing of this office action.
Withdrawn Objections/Rejections
The objection to the Abstract is withdrawn in view of the corrected version filed 7/28/2025.
The objection to the drawings is withdrawn in view of the corrected version filed 12/16/2025.
The objection to claim 21 is withdrawn in view of the amendments to claim set 12/16/2025.
Claim Objection
Claim 17 is objected to because of the following informalities:
Claim 17 recites ‘MCTs’. It appears that the term ‘MCTs’ is misrepresented. According to the Specification at pp. 24, 26 and 27, this oil should be ‘MCT oil’, not the plural form ‘MTCs’. In addition, when an abbreviation is first recited in a claim an explanation of what the abbreviation stands for should be provided, e.g. MCT oil (Medium-Chain Triglyceride oil).
In order to overcome this objection, claim 17 should be amended to recite: MCT oil (Medium-Chain Triglyceride oil).
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS- Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 7 and 9 are rejected 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.
Claims 7 and 9 depend from claim 1. Claims 7 and 9 recite (in part): isotonic agent. However, claim 1 already has an isotonic agent
Therefore, claims 7 and 9 do not further limit the subject matter of claim 1 upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
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 8 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 pre-AIA the applicant regards as the invention
Claim 8 recites (in part): isotonic agent is a polyol.
Claim 8 is dependent on claim 1.
However, claim 1 recites (in part): b) isotonic agent and e) isotonic agent
Thus, it is unclear as to which isotonic agent in Claim 1 that claim 8 refers to.
Therefore, the phrase: isotonic agent is a polyol, lacks antecedent basis.
Secondly, the recitation of “the pharmaceutically isotonic agent” lacks antecedent basis because both part b) and part e) recite “at least one pharmaceutically acceptable isotonic agent”. Therefore, it is unclear if the pharmaceutically acceptable isotonic agent is referring back to the one or more than one agents earlier recited.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS- Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 11 is rejected 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.
Claim 11 depends from claim 1. Claim 11 recites (in part): isotonic agent is exclusively added to step e).
So that the limitation: ‘isotonic agent is exclusively added to step e)’ excludes the isotonic agent from being present in 1b). However, isotonic agent was added to claim 1b).
Therefore, claim 11 does not further limit the subject matter of claim 1 upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
Claim Rejections - 35 USC § 103
(reformulated)
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention
Claims 1-5, 7-11, 13, 14, 16 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Sommermeyer et al (EP0298293, referenced English Translation: of record) [Sommermeyer] is maintained and made again.
Regarding claims 1-5, 7-11, 13, 14 and 16,
Sommermeyer teaches a process for manufacturing an oil-in-water emulsion (Abstract; See entire document).
Sommermeyer teaches a process for producing an oil-in-water emulsion comprising a water phase and about 40% of a fish oil in relation to the total weight of emulsion, wherein the process comprises the following steps:
First, 75 ml of distilled water (about 75 g) and 12 g of egg lecithin (i.e., a pharmaceutically acceptable emulsifier: elected species) were added together with constant stirring, wherein the mixture was continually while stirred 25 g of glycerol (elected species) and 0.3 g of sodium oleate (elected species) were added provided in 25 ml of distilled water and heated to 55 to 60oC with stirring. The solution that was obtained was then added to the prepared water-lecithin mixture under nitrogen pressure and 100 g of a highly refined fish oil was added to the mixture of lecithin, glycerol and sodium oleate with constant stirring, for example using a mechanical high-frequency device (Ultra-Turrax) for emulsification together with a stirrer. After the addition of the fish oil had ended, the crude emulsion formed was further emulsified for 25 minutes. During the preparation of the raw emulsion, it was kept at a temperature in the range from 60 to 65 °C. and was continuously blanketed with nitrogen.
After switching off the mechanical high-frequency device and thereby producing an emulsion by homogenizing to provide a raw emulsion suitable for the production of oil-in-water emulsions. Here the emulsion was allowed to rest with occasional slow stirring.
Sommermeyer teaches that the fish oil was steamed for 3 hours at 180 oC/I hPa with 5% water vapor (See Example 1, p.7) (i.e., fish oil is sterilized before added to the container). “Selection of any order of mixing ingredients is prima facie obvious." In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930)]. MPEP2144.04 IV. C. Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959) (Prior art reference disclosing a process of making a laminated sheet wherein a base sheet is first coated with a metallic film and thereafter impregnated with a thermosetting material was held to render prima facie obvious claims directed to a process of making a laminated sheet by reversing the order of the prior art process steps.). See also In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results); In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients is prima facie obvious.). See MPEP 2144.04 (IV).
Subsequently, the homogenized emulsion was treated with an aqueous solution to a specified target value (pH value from 8.7 to 8.8) by adding an appropriate amount of 1N sodium hydroxide solution. The emulsion was stored in glass containers, which were then closed (See Examples 1-5).
Accordingly, the produced oil-in-water emulsion comprises lecithin (elected species), glycerol (isotonic agent: elected species), sodium oleate (elected species) and fish oil (i.e., animal oil that is recited in 1a). Further, the manufactured oil-in-water emulsion comprises about 40% wt (i.e., about 43 %wt) of fish oil and Sommermeyer teaches about 30% wt of water contained in the emulsion and about 20% wt of glycerol (isotonic agent).
MPEP 2144.05: a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of O. 75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium.)."
Moreover, it would have been well within the purview of ordinary skill in the art to optimize the relative amounts of the constituents without undue experimentation. One skilled in the art would have been motivated to optimize the amounts of fish oil and water to best achieve a desired goal. Optimization of result effect parameters (e.g., ingredient ranges) is obvious as being within the skill of the artisan. The optimization of known effective amounts of known active ingredients is considered well in the competence level of an ordinary skilled artisan in formulation science, involving merely routine skill in the art. It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980). Moreover, Sommermeyer explicitly teaches the constituents mentioned can be present in very different proportions in the fat emulsion according to the invention (See page 6).
Regarding claim 2, Sommermeyer teaches parenterally administration (i.e., feeding intravenously: ‘through a vein’), of the emulsion, that is suitable for dietetic purposes, containing distilled water (See claim 1 at page 11). Accordingly, parenterally administration is directed to providing nutritional support directly into the bloodstream. Therefore, it would be prima facie obvious to one of ordinary skill in the art that the distilled water is water for injection purposes, since is provided to be delivered in an emulsion intravenously through a vein, i.e., via parenterally administration.
Regarding claim 3, Sommermeyer teaches the emulsion contains 12 g of lecithin (i.e., a pharmaceutically acceptable emulsifier: elected species, 75 ml of distilled water (about 75 g), 25 g of glycerol (elected species), 0.3 g of sodium oleate (elected species) were provided in 25 ml of distilled water (about 25 g) and 100 g of fish oil.
Therefore, the total weight of the emulsion is about 212 grams.
So that 12 g of lecithin (i.e., 12 g lecithin / 212 g total weight of emulsion) equal about 5 wt % of lecithin, of which lies within the claimed amount of 0.1 to 5 wt %. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257,191 USPQ 90 (CCPA 1976); In re Woodruff, 91 9 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05. Moreover, it would be well within the purview of one skilled in the art to optimize the weight percent of the emulsifier in light of the teachings of Sommermeyer to encompass arrange of 0.1 to 5 wt % to best achieve a desired goal having a reasonable expectation of success. Optimization of parameters is a routine practice that would be obvious to a person of ordinary skill in the art to employ and reasonably expect success. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233,235 (CCPA 1955) & MPEP 2144.05.
Regarding claim 22,
Sommermeyer teaches oil-in-water for parenterally administration comprises fish oil which is enriched with omega3- fatty acids (Abstract; See entire document), e.g., antilipemic lipid-regulating agents. Thus, Sommermeyer teaches adding a drug to the oil-in-water emulsion, at the same time that the fish oil is added in the process of making the emulsion, for instance, Sommermeyer teaches: solution that was obtained was then added to the prepared water-lecithin mixture under nitrogen pressure and 100 g of a fish oil was added to the mixture of lecithin, glycerol and sodium oleate with constant stirring, i.e., at least during the first through second step.
Selection of any order of mixing ingredients is prima facie obvious. In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930)]. See MPEP 2144.04 IV. CHANGES IN SIZE, SHAPE, OR SEQUENCE OF ADDING INGREDIENTS C. Changes in Sequence of Adding Ingredients.
The prior art discloses the individual elements of applicant's claimed composition including the elected species: emulsifier, e.g., lecithin; co-emulsifier, e.g., sodium oleate; and isotonic agent, e.g., glycerol, and furthermore an animal oil that is fish oil, but does not appear to disclose their combination with sufficient specificity.
Nevertheless, it would have been obvious to combine these individually known ingredients as Sommermeyer teaches their inclusion together in an oil-in-water emulsion. Since this modification of the prior art represents nothing more than “the predictable use of prior art elements according to their established functions” a prima facie case of obviousness exists. All the claimed elements herein are 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 would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Accordingly, it would have been obvious for one of ordinary skill in the art to provide instantly claimed invention and one of ordinary skill would have had a reasonable expectation of success in producing the claimed invention. Therefore, in the absence of evidence to the contrary, the invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by Sommermeyer.
Obviousness does not require absolute predictability, however, at least some degree of predictability is required. Evidence showing there was no reasonable expectation of success may support a conclusion of nonobviousness. In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976).
Response to Arguments
Applicants argue that Table 1 (Example 1 [0216]: Test number IV discloses that the "glycerin concentration" of water phase 1 is 14.3% (see, last row of Table 1). As can be seen in the table, the formation of emulsions was successful at glycerol (isotonic agent) concentrations in water phase 1 (last line) of 3.2 % (experiment I), 6.7 % (experiment II), 11.1 % (experiment III), 13 % (experiment VII) and 14. 3 % (experiment IV), but not at a concentration of 20 % (experiment V). Table 1 also shows that the glycerol concentration of water phase 1 is calculated solely on the basis of the amount of water (WFI) and glycerol. See, for example, experiment V, wherein the total mass of WFI and glycerol is 12.5 g. Of these, 2.5 g are glycerol and 10 g are WFI, and consequently the glycerol concentration is 20% (2.5 x 100/12.5). This test did not result in the formation of an emulsion. Applicants argue that this calculation notably does not take into account the mass of the emulsifier and coemulsifier. This results from their insolubility in water. Lecithin and sodium oleate merely form a disperse mixture with water, which means that they are not part of water phase 1, and thus they are excluded from the calculation. Example 1 demonstrates the considerable importance of the concentration of the isotonic agent in water phase 1 and also shows how a person of ordinary skill in the art would calculate it, that is, only with regards to the mass of WFI and glycerol. Since the concentration of the isotonic agent in water phase 1 was found to have a critical limit up to a maximum of 18%, beyond which emulsions would not successfully form, this criticality must not be ignored. Further, applicants argue that Sommermeyer thereby discloses a glycerol concentration in the water phase as 25 g glycerol / (100 g water + 25 g glycerol) = 0.2, or 20%. This lies outside of the range as encompassed in claim 1. Therefore, Sommermeyer does not disclose the method of claim 1 (as amended), comprising the step of providing a water phase 1, comprising at least one pharmaceutically acceptable isotonic agent, wherein said at least one pharmaceutically acceptable isotonic agent is present in a concentration of at most 18%, in relation to the total weight of the water phase. Sommermeyer also does not suggest the method of claim 1 (as amended). The present application gives explicit criticality to the amount of isotonic agent present in the water phase, providing both an upper limit and experimental evidence of failure beyond that limit. For example, paragraphs [0222]-[0223] of the present application state, "The emulsion formation failed with a glycerin concentration of 20% in the water phase 1 ... The emulsion formation succeeded with glycerin concentrations of up to 14.3% in the water phase 1 ... The polyol concentration in the emulsifying step should thus be below 18%".
Applicants’ arguments have been fully considered but they are not persuasive, because claim 1b) recites: providing a water phase 1, comprising water, at least one pharmaceutically acceptable the isotonic agent, and optionally at least one pharmaceutically acceptable co-emulsifier and/or at least one substance for setting the pH value and/or at least one pharmaceutically acceptable preservative, wherein said at least one pharmaceutically acceptable the isotonic agent is present in a concentration of at most 18%, in relation to the total weight of the water phase (water phase 1).
Thus, it clear from claimed subject matter recited in claim 1 b): said at least one pharmaceutically acceptable the isotonic agent is present in a concentration of at most 18%, in relation to the total weight of the water phase, depends on the total weight of the water phase 1, of which would when given its broadest reasonable interpretation would include water, at least one pharmaceutically acceptable the isotonic agent, and at least one pharmaceutically acceptable co-emulsifier and at least one substance for setting the pH value and/or at least one pharmaceutically acceptable preservative. Moreover, total weight of the water phase does not require that all ingredients are solubilized and/or suspended in the water phase 1. Particularly, Sommermeyer teaches sodium oleate (elected species: co-emulsifier: 0.3 g of sodium oleate) that is water soluble (e.g., about 100 mg/mL), so that sodium oleate would necessarily be present in the water phase and contribute mass (weight) to the total weight of the water phase I. Moreover, claim 1b) fails to limit the amount of water that must be contained in the water phase and/or fails to further limit the amounts of an acceptable co-emulsifier and/or at least one substance for setting the pH value and/or at least one pharmaceutically acceptable preservative, if present. Furthermore, Applicants examples in Table 1 are limited a single isotonic agent: glycerin, whereas instant claim 1b) recites ‘at least one pharmaceutically acceptable isotonic agent’, which when given claim 1b) it’s broadest reasonable interpretation would necessarily encompass multiple varied isotonic agents and combination thereof. Table 1 is directed to a single isotonic agent: glycerin, so that the results provided in Table 1 are not commensurate with the full scope of the claims. Noteworthy, Table 1 is directed to the Glycerol concentration water phase 1. In contrast, claimed 1 b) requires ‘the total weight of the water phase 1, i.e., thus, ‘total weight of the water phase’ requires all of ingredients in the water phase 1, and not just the water and isotonic agent. Therefore, Applicants arguments that the inventors surprisingly discovered that the formation of the emulsions as encompassed by the claimed invention only succeeds up to a certain concentration of the isotonic agent in water phase 1 is not persuasive. Therefore, the results provided in Table 1 are not commensurate with the full scope of the claims.
Applicants admit on page 15 (second paragraph) of the reply filed 12/16/2026: Table 1 also shows that the glycerol concentration of water phase 1 is calculated solely on the basis of the amount of water (WFI) and glycerol.
Therefore, the alleged unexpected results do not presently overcome the rejections of record.
MPEP 716.02(d) Unexpected Results Commensurate in Scope with Claimed Invention [R-08.2012]
Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range, not just the elected species. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980). Thus, in the instant case, the unexpected results are not commensurate in scope with what is instantly claimed, because the scope of Instant Claim 1b) recites (in part): ‘the total weight of the water phase (water phase 1).
That is, the water phase 1 formulation that generated said alleged unexpected results are not commensurate in scope with water phase 1 formulation which is presently claimed (i.e., results generated in Table 1 are not commensurate in scope with claimed subject matter as described in claim 1 b).
The scope of the showing must be commensurate with the scope of claims to consider evidence probative of unexpected results, for example. In re Dill, 202 USPQ 805 (CCPA, 1979), In re Lindner 173 USPQ 356 (CCPA 1972), In re Hyson, 172 USPQ 399 (CCPA 1972), In re Boesch, 205 USPQ 215, (CCPA 1980), In re Grasselli, 218 USPQ 769 (Fed. Cir. 1983), In re Clemens, 206 USPQ 289 (CCPA 1980). It should be clear that the probative value of the data is not commensurate in scope with the degree of protection sought by the claim(s). Evidence as to any unexpected benefits must be "clear and convincing" In re Lohr, 137 USPQ 548 (CCPA 1963), and be of a scope reasonably commensurate with the scope of the subject matter claimed, In re Linder, 173 USPQ 356 (CCPA 1972).
Further Applicants argue that the Office Action further asserts that: "the emulsion was then subjected to further homogenization steps at 80 °C (i.e., sterilized before added to container)". In this, it appears that the Office is equating Sommermeyer's homogenization step with a sterilizing step. There is, however, no suggestion during this phase of Sommermeyer's homogenization that any level of sterilizing would occur, or that would be interpreted as sterilization by a person or ordinary skill in the art. A fresh look at the teachings of Sommermeyer disclose that ‘Sommermeyer teaches that the fish oil was steamed for 3 hours at 180 oC with 5% water vapor’ (See Example 1, p.7) (i.e., Sommermeyer teaches that fish oil is sterilized; See discussion above). Thus, one skilled it the art would have had reasonable expectation before the effective filing date of the claimed invention that heating fish oil to 180 0C for 3 hours would be more than enough to sterilize the fish oil, absence evidence to the contrary. Therefore, Applicants argument that Sommermeyer does not teach sterilization is not persuasive.
Further, Applicants argue that the person of ordinary skill in the art would reasonably infer, when reviewing the contents of Table 1, and with the context of the entire specification, that other isotonic agents would have behaved similarly under the conditions of Table 1 (See reply at page 20).
Applicant’s arguments have been fully considered but they are not persuasive, because Table 1 provides test results for a single isotonic agent, that is glycerol (glycerin). Moreover, the limitation as recited in the claims: at least one pharmaceutically acceptable the isotonic agent, does not set any obvious boundaries on how may isotonic agents and combinations thereof would necessarily achieve the identical test results in Table 1. The language of a claim must make it clear what subject matter the claim encompasses to adequately delineate its ‘metes and bounds.’ Furthermore, the arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965). Examples of attorney statements which are not evidence and which must be supported by an appropriate affidavit or declaration include statements regarding unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the applicant.
Claim 17 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sommer Meyer et al (EP0298293, referenced English Translation: attached) [Sommerer] as applied to claim Claims 1-11, 13, 14, and 16 20-22 are above and further in view of Edmundo Brito De La Fuente et al (US 20160338987) [Fuente] is maintained and made again.
Regarding claim 17,
Fuente teaches commercially available parenteral emulsions comprising a physical mixture of oils: soybean oil (30%), MCT oil (30%), olive oil (25%) and fish oil (15%) (Tradename: SMOFlipid), of which provides % amounts based on the total weight of the oil, wherein these % amounts overlap with claimed wt % amounts. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257,191 USPQ 90 (CCPA 1976); In re Woodruff, 91 9 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05. One skilled in the art would have been motivated to provide SMOFlipid in the oil-in-water emulsion as instantly claimed because it is well known to be used in oil-in-water emulsions for parenteral administration (i.e., intravenous administration) to treat varied diseases and features the added advantage of being conveniently commercially available {0002- 0007]; See entire document).
Claims 20 and 21 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sommermeyer et al (EP0298293, referenced English Translation: attached) [Sommermeyer] as applied to claim Claims 1-11, 13, 14, and 16 20-22 are above and further in view of Ottoboni et al (US 2016/0082013) [Ottoboni] is maintained and made again.
Ottoboni teaches stable oil-in-water emulsions suitable for parenteral administration (Abstract). Particularly, Ottoboni teaches intravenous emulsions should have a very small droplet size to circulate in the bloodstream without causing capillary blockage and embolization. Ottoboni teaches that these size limits are typified by USP33-NF28 General Chapter <729> for Globule Size Distribution in Lipid Injectable Emulsions, hereinafter referred to as USP <729>, which defines universal limits for (1) mean droplet size not exceeding 500 nm or 0.5 μm and (2) the population of large-diameter fat globules, expressed as the volume-weighted percentage of fat greater than 5 μm (PFAT5) not exceeding 0.05%, irrespective of the final lipid concentration [0006]; [0068]; See entire document).
Sommermeyer teaches that the emulsion is passed through a membrane filter having a pore diameter of about 2-8 µm (See pages 6, 9), i.e., average of about 5 µm. Thus, one of ordinary skill would have recognized that an emulsion as taught by Sommermeyer would be expected to have an average droplet size of about less than 5 µm. Moreover, it would have been obvious to one of ordinary skill in the art that the emulsion as taught by Sommermeyer would have PFAT5 values that do not exceed 0.05% in light of the teachings of Ottoboni.
Accordingly, it would have been obvious to one of ordinary skill in the art that the emulsion as taught by Sommermeyer would be expected to have average PFAT5 values that do not exceed 0.05% in light of the teachings of Ottoboni.
Moreover, one skilled in the art would have been motivated to provide an emulsion that is suitable for parenteral administration having a droplet size not exceeding 500 nm or 0.5 μm in order to provide an emulsion with having a very small droplet size that can circulate in the bloodstream without causing capillary blockage and embolization that is suitable for parenteral administration in accordance with the teachings of the prior art.
All the claimed elements herein are 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 would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to provide instantly claimed emulsion having a PFAT5 of less than about 0.05 %, i.e., PFAT5 below 0.035%, having a reasonable expectation of success, wherein the emulsion (i.e., obtained as a final product in the final step) would have a droplet size of less than about 5 µm and be expected to have a PFAT5 less than 0.05, wherein it would have been well within the purview of one of ordinary skill to follow the teaching of Sommermeyer to obtain in the final step of making an emulsion having a PFAT5 of less than 0.035% having a reasonable expectation of success that would be especially suitable for parenteral administration.
Response to Arguments
Applicants argue that for at least the same reasons as claim 1, claims 17, 20 and 21 are patentable over Sommermeyer, and therefore are also patentable over Sommermeyer in view of Fuente and Sommermeyer in view of Ottoboni.
Applicants’ arguments have been fully considered but they are not persuasive, because the rejection of claims 1-5, 7-11, 13, 14, 16 and 22 under 35 U.S.C. 103 as being unpatentable over Sommermeyer et al (EP0298293) is maintained and made again for at least the reasons as set forth above.
Similarly, the rejection of claim 17 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sommermeyer et al (EP0298293, referenced English Translation: attached) [Sommermeyer] as applied to claim Claims 1-11, 13, 14, and 16 20-22 are above and further in view of Edmundo Brito De La Fuente et al (US 20160338987) [Fuente] is maintained and made again.
Similarly, the rejection of claims 20 and 21 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sommermeyer et al (EP0298293, referenced English Translation: attached) [Sommermeyer] as applied to claim Claims 1-11, 13, 14, and 16 20-22 are above and further in view of Ottoboni et al (US 2016/0082013) [Ottoboni] is maintained and made again.
Conclusions
No claim is allowed.
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/T.W./ Examiner, Art Unit 1619
/SARAH ALAWADI/Primary Examiner, Art Unit 1619
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