Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 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.
DETAILED ACTION
Claims 16-35 are pending, claims 1-15 are canceled in this application. This application is a continuation of 18/146,306, filed on 12/23/2022, now abandoned, which is a continuation of 16/863,918, filed on 04/30/2020, now abandoned, which is a continuation of 16/259,037, filed on 01/28/2019, now abandoned, which is a continuation of 15/491,521, filed on 04/19/2017, now abandoned, which is a continuation of 13/978,334, filed on 09/18/2013, now abandoned, which is a national stage entry of PCT/EP2012/050043, filled on 01/03/2012, which claims foreign priority to EP 11150064.1, filed on 01/04/2011 in Europe.
Election/Restrictions
Applicants’ election without traverse of Group IV, claims 33 and 34, filed on 04/02/2026 is acknowledged.
Applicants have changed the dependency of claims 18-28 to be dependent claims of claim 34. Therefore, the election of group IV now encompasses claims 18-28, 33, and 34.
Claims 16, 17, 29-32 and 35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group or species, there being no allowable generic or linking claim.
Claims 18-28, 33, and 34 will presently be examined to the extent they read on the elected subject matter of record.
Priority
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Claim Rejections - 35 USC § 112/Second paragraph
The following is a quotation of the second paragraph 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 19-21, 26, 27 are rejected under 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 applicant regards as the invention.
The recitation of “after diluting the preconcentrate emulsion prior to use with an aqueous liquid” in the claims is not consistent with the disclosure in the instant specification page 14, line 15-16. The examiner suggests applicants changing the recitation as: “after diluting the preconcentrate emulsion with an aqueous liquid prior to use” according to the disclosure in the instant specification page 14, line 15-16.
Claim 27 is rejected under 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 applicant regards as the invention.
The recitation of osmotic pressure with mOsmol/kg as its unit renders the claim indefinite. The unit of osmotic pressure is Pa, atm, etc., while mOsmol/kg is the unit of osmolality. Thus, it is unclear and indefinite as to how osmotic pressure with mOsmol/kg as unit herein is encompassed.
Claim 27 is rejected under 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 applicant regards as the invention.
The recitation of “The emulsion of claim 26, wherein the aqueous continuous phase comprises excipients selected from sodium chloride, sugars, and sugar alcohols, and has an osmotic pressure of 250 to 400 mOsmol/kg” renders the claim indefinite. It is not clear whether “the emulsion of claim 26” “has an osmotic pressure of 250 to 400 mOsmol/kg” or “the aqueous continuous phase” “has an osmotic pressure of 250 to 400 mOsmol/kg”.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
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(a) 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 18-24, 27, 28, 33, 34 are rejected under 35 U.S.C. 103(a) as being unpatentable over Meinert (US 6,489,367 B1) in view of Long, Jr. (US 5,077,036).
Meinert teaches a stable oil-in-water emulsion (oil dispersed phase and aqueous continuous phase, the instant claim 33) (column 7, line 7-10 and claims 1-4) with emulsion particle size of 100-300 nm (the instant claim 20) (column 2, line 36) being formulated as aqueous emulsion (column 7, line 7-23 and claims 1-4), i.e., the claimed preconcentrate before being formulated as aqueous emulsion and a s, or alternatively, water being incorporated into the formulation in two separate steps (the claimed preconcentrate before the 2nd step of adding water) comprising
semifluorinated alkane RFRH (F3-20H3-20) including F6H10, F6H8 (soluble in oil, i.e., in dispersed phase, the instant claims 33, 18, and 34) (column 8, line 6) with oxygen (40 mg/L water solubility) dissolved within (the claimed active in the instant claims 19, 33, and 34) (column 5, line 40-43) as dermatological application (the instant claim 21) (column 3, line 55-65 and column 7, line 8-24), and
the aqueous emulsion further comprising lecithin (the claimed ionic surfactant in the instant claims 33, 23, 24, and 28), Pluronic (poloxamer, nonionic surfactant, the instant claim 33, 23, 24, and 28), etc., (column 7, line 8-24) and
exemplified concentration of 0.1-10% by weight of RFRH (both as dispersed phase and concentration of RFRH) (column 9, line 57-60) → > 0.1-10% by weight of dispersed phase relative to the emulsion with oxygen dissolve in RFRH.
No perfluorinated compound is taught by Meinert (the instant claim 22).
No preservative is taught by Meinert (the instant claim 22).
The limitation of “heat sterilizable” in the instant claim 22; please note that the claim element that uses capable of-type language does not impose any requirement that the device or composition actually perform the function. A claim that uses “capable of”-type language covers devices/compositions that have the recited components and which are capable of performing the recited functions. Furthermore, Meinert teaches semifluorinated alkane F6Hx being heat resistant and having boiling point above 100 °C (column 8, line 5-14 and figure 1) and thus would be heat-resistant, i.e., “heat sterilizable”. MPEP 2114.IV.
Meinert does not specify: i) the emulsion comprising non-ionic osmotic agent sugar in the instant claims 24 and 27 (the osmotic pressure in the instant claim 27 is not addressed due to its being indefinite as discussed above); and ii) the weight percentage of the dispersed phase in the instant claims 33.
These deficiencies are cured by Long, Jr. who teaches heat sterilization stable emulsions with continuous aqueous phase (o/w emulsion), for intravascular use and/or topical application for burns, comprising 75-125% w/v a fluorocarbon including a mean particle size of less than 250 nm (RFRH, a semifluorinated alkane including F6H2) and 6% w/v lecithin as emulsifier with fluorocarbon-hydrocarbon and emulsifier in the dispersed phase for delivery of oxygen (40 mg/L solubility in water) dissolved in fluorocarbon, phosphate buffer, and osmotic agent such as mannitol (the claimed nonionic osmotic agent and sugar alcohol) and osmotic agent being in the aqueous phase, wherein the emulsion for topical application further comprising medicines for treating burns, and exemplified in example IV a composition having an osmolality of 258 (abstract, column 2, line 25-35, column 3, line 5-6, column 5, line 25-27, column 7, line 3-6, line 26-66, example IV, and claims 1, 4-7, 9, 14, 16, and 17). Given the density of semifluorinated alkane of 1.1-1.7 g/mL (Meinert, column 2, line 63-65) (the medium value used in calculation as 1.4 g/mL) and the percentages of fluorocarbon-hydrocarbon and lecithin being 75-125% w/v and 6% w/v, respectively, the weights of fluorocarbon-hydrocarbon and lecithin are 75-125 g and 6 g, respectively, in 100 mL of the emulsion (50-89.3 mL of fluorocarbon-hydrocarbon and thus about 50-10.7 ml of water with a density of about 1 g/mL) and the total weight is about 125-135.7 g and the w/w percentages of fluorocarbon-hydrocarbon in the emulsion is calculated as about 60-92.1% by weight.
It would have been prima facie obvious at the time of the invention to a person of ordinary skill in the art to combine the teachings in Meinert and Long, Jr. to add mannitol osmotic agent in the composition taught by Meinert. Incorporating osmotic agent in an o/w emulsion, for intravascular use, comprising a fluorocarbon including fluorocarbon-hydrocarbon (RFRH, a semifluorinated alkane) and lecithin as emulsifier for intravascular use was well known to a person of ordinary skill in the art at the time of the invention. The motivation for adding it flows from its having been used in the prior art, and from its being recognized in the prior art as useful for the same purpose.
A prima facie case of obviousness typically exists when the range of a claimed composition lies inside the range disclosed in the prior art, such as in the instant rejection. The claimed range of the amount of the dispersed phase relative to the emulsion is about 60 to 80% by weight and the range of the amount of the dispersed phase relative to the emulsion taught in the prior art is about 60-92.1% by weight and therefor, includes the claimed range.
Claims 18-28, 33, and 34 are rejected under 35 U.S.C. 103(a) as being unpatentable over Meinert (US 6,489,367 B1), Long, Jr. (US 5,077,036), Lanza et al. (US 2005/0175541 A1), and Chen (US 2007/0207173 A1) as evidenced by Georgieff (US 6,197,323 B1).
The teachings of Meinert and Long, Jr. are discussed above and applied in the same manner.
Meinert and Long, Jr. do not specify the medicaments including propofol (the instant claim 25) and the weight percentage of it (the instant claim 26).
This deficiency is cured by Lanza et al. who teach oil-in-water emulsions containing hydrophobic constituent such as fluorocarbon disclosed by Long, Jr. being used for intravenous delivery of therapeutic agent including anesthetic and sedative such as propofol with agent being embedded in lipid coating (abstract, paragraph 35-37, 92, 93, 115, and 134, and claims 1 and 2) according to Georgieff 2,6-diisopropylohenol (propofol) in a perflourocarbon emulsion for intravenous administration comprising perfluorohexyloctane (F6H8) is presented (dissolved) in the fatty or aqueous phase depend on the solubility (abstract, column 8, line 17-35 and column 10, line 21 through column 11, line 24, and claims 1, 7, and 8-11) and Chen who teaches o/w emulsion for intravenous injection comprising active including anesthetic such as propofol and derivative of hydrocarbon as oil phase with greater than 99% of substantially water insoluble active being dissolved in oil (dispersed phase) and the ratio between the active and oil being about 1:5 → about 16.7% by weight (1/(1+5)=0.167) active relative to oil phase (abstract, paragraph 72, 81, and 101), i.e., while there are both aqueous continues phase and lipid dispersed phase with agent (water-insoluble propofol) being embedded in lipid coating, propofol is dissolved in lipid phase, not aqueous phase.
It would have been prima facie obvious at the time of the invention to a person of ordinary skill in the art to combine the teachings in Meinert, Long, Jr., and Lanza et al. as evidenced by Georgieff to specify the medicaments in the composition taught by Meinert including propofol in the dispersed phase. Propofol being intravenous delivered in oil-in-water emulsions containing hydrophobic constituent such as fluorocarbon was well known to a person of ordinary skill in the art at the time of the invention. The motivation for specifying it flows from its having been used in the prior art, and from its being recognized in the prior art as useful for the same purpose.
It would have been prima facie obvious at the time of the invention to a person of ordinary skill in the art to combine the teachings in Meinert, Long, Jr., Lanza et al., and Chen to specify the amount of propofol in the composition taught by Lanza et al. being about 16.7% by weight relative to the total of oil (within the claimed 10-50%). About 16.7% by weight of propofol relative to the oil phase being incorporating in an intravenous injection o/w emulsion was well known to a person of ordinary skill in the art at the time of the invention. The motivation for specifying it flows from its having been used in the prior art, and from its being recognized in the prior art as useful for the same purpose.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 18-28, 33, and 34 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 8,986,738 B2, claims 1-4 of U.S. Patent No. 6,489,367 B2, claims 1-13 of U.S. Patent No. 9,308,262 B2, claims 1-3 of U.S. Patent No. 10,813,999 B2 in view of Long, Jr. (US 5,077,036).
The subject matter claimed in the instant application is fully disclosed in the patent and is covered by the patent since the patent and the application are claiming common subject matter in view of Long, Jr.
Although the patent and instant claims are not identical, they are not patentably distinct from each other because claims in both applications are drawn to the same o/w emulsion.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HONG YU whose telephone number is (571)270-1328. The examiner can normally be reached on 9 am - 5:30 pm.
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/HONG YU/
Primary Examiner, Art Unit 1614
Prosecution Insights