Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Status of claims
Claims 66-76 are pending and under examination in the instant office action.
Claim Rejections - 35 USC § 112 (d)
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 74 is rejected under 35 U.S.C. 112(d) or 35 U.S.C. 112 (pre-AIA ), 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 74 recites “The composition oxygen therapeutic composition of claim 73, further comprising maltitol”. However, claim 73 recites that “the composition is free of a viscogen” and the instant specification discloses maltitol as a viscogen (see [0024]). As such, claim 74 fails to further limit the subject matter of the claim 73 from which it depends.
Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 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.
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.
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.
Claims 66-67, 69-72, and 75 are rejected under 35 U.S.C. 103 as being unpatentable over US 2010/0267842 (hereafter, KIRAL) in view of WO2015/134735 (hereafter, UNGER) as evidenced by US 2014/0234224 (hereafter, GUPTE).
KIRAL teaches an emulsion comprising perfluorocarbon dispersed as particles within a continuous phase, wherein the perfluorocarbon includes perfluorohexane and dodecafluoropentane (abstract and [0021]). KIRAL further teaches that the emulsions typically include emulsifiers, buffers, osmotic agents, and electrolytes ([0194]) and the formulation may include tonicity imparting agents such as sorbitol, glycerin and dextrose (polyol) and other viscosity imparting agents (viscogen) such as sodium carboxymethylcellulose, microcrystalline cellulose, polyvinylpyrrolidone, and polyvinyl alcohol ([0206]).
KIRAL specifically disclose the perfluorocarbon emulsion is prepared by: a) mixing an emulsifier (surfactant) and aqueous medium (water) together; b) adding perfluorocarbon to the mixture of step a); c) mixing the mixture of step b) to form a coarse emulsion; d) obtaining a sample of the coarse emulsion of step c) and determining particle size distribution of the sample; e) if the sample of step d) has a monomodal particle size distribution, then homogenizing the coarse emulsion of step c); and f) obtaining the emulsion (claim 22).
KIRAL further teaches that the mean size of the dispersed particles is about 200-400 nm ([0019]). Thus, the particle size necessarily falls within the range of IWMD in claim 66 when IWMD is determined.
KIRAL specifically disclose exemplary emulsions comprising perfluoro(tert-butylcyclohexane) (FtBu) or dodecafluoropentane (DDFP) and the emulsion further contains the following ingredients: egg yolk phospholipid (emulsifier/surfactant), buffering agent, glycerin or NaCl as tonicity adjuster, water for injection (WFI) (Example 1A, 1D, and Table 1-3). KIRAL further discloses that the DDFP emulsion has D(0.9) value of about 600 nm; and the DDFP emulsion has D(0.5) value of about 200-300 nm ([0290] and [0291]). The composition is free of sucrose as recited in claim 69.
Also, KIRAL discloses that the emulsion is in an aqueous medium that is isotonic and mildly buffered to a neutral pH range ([0028] and [0146]). KIRAL further discloses that glycerin USP (viscogen) is used in the formulation to adjust the tonicity of the emulsion and for intravenous infusion, it is important that the tonicity of the emulsion be in the same physiological range as blood tonicity ([0151]).
KIRAL further discloses that the PFC compositions may also contain non-toxic emulsifying, preserving, wetting agents, bodying agents, as for example, polyethylene glycols 200, 300, 400 and 600 ([0203]).
As to claim 75, KIRAL teaches that the perfluorocarbon emulsion is effective for treating sickle cell disease by enhancing oxygen delivery to tissues wherein it is administered intravenously (IV) or intrathecally (abstract, [0021], [0029], [0074], [0157], and [0161]).
KIRAL does not specifically disclose PEG-Telomer B (PTB) as surfactant. Also, KIRAL does not specifically disclose the concentration of viscogen and polyethylene glycol (PEG) as a viscogen and is silent about claimed osmolarity.
UNGER discloses an oxygen therapeutic composition comprising a perfluorocarbon emulsion in water for intravenous administration, wherein said fluorocarbon consists of perfluoropentane or said fluorocarbon comprises perfluoropentane and perfluorohexane (abstract and claims 11-15). UNGER teaches that lower molecular weight fluorocarbons (FC), most particularly with boiling points from about -4 degrees centigrade to about 100 degrees centigrade are far more effective than the higher molecular weight, higher boiling point PCs and most preferred are perfluoropentane and perfluorohexane ([00014]). UNGER specifically disclose that most preferably, the FC is prepared in an emulsion by using a variety of surfactants such as phospholipids including dioleoylphosphatidylcholine (DOPC) and fluorosurfactants such as PEG Telomer B ([00015] and claims 9-10). UNGER teaches that a viscogen is included in the formulation to increase the viscosity in the product to decrease settling of the nano-emulsion and suitable viscogens include sucrose, trehalose, starch, Hextend®, propylene glycol, glycerol (polyol) and polyethylene glycol ranging in molecular weight from about 400 to 8,000 MW ([00016]). UNGER specifically disclose emulsion for injection comprising dodecafluoropentane, sucrose (viscogen), PEG Telomer B (surfactant), and water, wherein the emulsion has mean particle size of emulsion about 250 nm ([00028]).
As to the use of PEG-Telomer B (PTB) as surfactant, while KIRAL teaches that the PFC compositions contain surfactants such as phospholipids, KIRAL does not specifically disclose PEG-Telomer B (PTB) as surfactant. However, UNGER teaches that a variety of surfactants such as phospholipids and fluorosurfactants such as PEG Telomer B (PTB) can be used for the perfluorocarbon emulsions comprising perfluoropentane and perfluorohexane. Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use PEG-Telomer B as a surfactant for perfluorocarbon emulsions of KIRAL because PEG-Telomer B was a known surfactant suitable for perfluorocarbon emulsions and could be used in place of phospholipid as evidenced by UNGER. One of ordinary skill in the art would have been able to carry out such a substitution, and the results were reasonably predictable.
As to claimed PEG, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use PEG as viscogen for the composition comprising perfluorocarbon because UNGER teaches and suggests PEG as suitable viscogen along with sucrose for the same perfluorocarbon emulsion as KIRAL. Also, KIRAL already teaches and suggest the addition of tonicity imparting agents such as sorbitol, glycerin and dextrose (polyol) and other viscosity imparting agents to the perfluorocarbon emulsions. Thus, the skilled artisan would have been motivated to use the PEG as a viscogen as taught by UNGER for the perfluorocarbon emulsions of KIRAL on the reasonable expectation that PEG as a viscogen would increase viscosity of the emulsion, thereby decreasing settling of the emulsion as evidenced by UNGER. Generally, it is prima facie obvious to select a known material for incorporation into a composition based on its recognized suitability for its intended use. See MPEP 2144.07. Also, the range of the molecular weight of PEG in UNGER overlaps the claimed range. 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, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
As claims 70 -71, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use sucrose in combination with other viscogens such as PEG for the composition comprising perfluorocarbon because UNGER teaches and suggests that sucrose is suitable viscogen along with PEG for the same perfluorocarbon emulsion as KIRAL. Also, KIRAL already teaches and suggest the addition of tonicity imparting agents such as sorbitol, glycerin and dextrose (polyol) and other viscosity imparting agents to the perfluorocarbon emulsions. In addition, it would have been prima facie obvious to one of ordinary skill in the art to optimize the concentration of sucrose in combination with the other viscogen to reach the physiological range (e.g., about 300 mOsm/L) and viscosity suitable for intravenous administration.
As to the claimed osmolarity, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to arrive at perfluorocarbon emulsions having the claimed osmolality because of the following reasons. KIRAL teaches that perfluorocarbon emulsions may further include osmotic agents and for intravenous infusion, it is important that the tonicity of the emulsion be in the same physiological range as blood tonicity. Also, KIRAL discloses the use of the isotonic aqueous medium. The osmolarity of the isotonic solution is about 300 mOsm/L (mOsm/kg) as evidenced by GUPTE ([0057]). GUPTE discloses an emulsion containing a perfluorcarbon compound such as perfluorohexane as oxygen carrier ([0016]). GUPTE further discloses the emulsion may contain an isotonic agent, to adjust the osmotic pressure of the emulsion to about that of blood and exemplary agents include glycerol and sodium chloride (NaCl) ([0057]). GUPTE further discloses that isotonic agents may be added to the emulsion to adjust osmolarity to the approximate physiological value of about 300 mOsm/l with a range of from about 290-600 mOsm/l and amounts may be added as needed to reach target osmolarity ([0057]). Thus, the skilled artisan would have been motivated to prepare the emulsion having an osmolality similar or close to the physiological range of blood osmolality (e.g., 300 mOsmol per kg) so that it would be suitable for intravenous injection of the emulsion composition in the treatment of sickle cell disease as taught by KIRAL. Also, it would have been prima facie obvious to one of ordinary skill in the art to optimize the concentration of tonicity imparting agent/viscogen to reach the target osmolarity (e.g., about 300 mOsm/L) and viscosity suitable for intravenous administration. Through routine optimization, the skilled artisan would have arrived at the claimed range.
One having ordinary skill in the art would have been motivated before the effective filing date of the claimed invention to combine these references and make the modification because they are drawn to the same technical fields (the use of perfluorocaron for oxygen delivery), and pertinent to the problem which applicant concerns about. MPEP 2141.01(a).
Claims 66 and 68 are rejected under 35 U.S.C. 103 as being unpatentable over US 2010/0267842 (hereafter, KIRAL) in view of WO2015/134735 (hereafter, UNGER) as evidenced by US 2014/0234224 (hereafter, GUPTE), and in further view of US 2012/0156251 (hereafter, BRITO) as evidenced by Rowe et al. (Handbook of Pharmaceutical Excipients, 6th edition, p414-417, 2009).
KIRAL, UNGER and GUPTE as applied supra are herein applied for the same teachings in their entirety.
They do not specifically disclose maltitol as viscogen.
However, it was well known in the art that the osmolarity of the aqueous phase in emulsions is determined by nonionic tonicity adjusting agents and suitable tonicity adjusting agents include sugars, sugar alcohols such as mannitol, sorbitol, xylitol, erythritol, lactitol, and maltitol, and glycerol as evidenced by BRITO (abstract, [0201], and [0271). BRITO further teaches that the tonicity adjusting agents are added in a sufficient quantity to make the emulsion isotonic ([0019]). Thus, the skilled artisan would have recognized that the sugar alcohols (polyol) such as maltitol as tonicity imparting agents (osmotic agents) are functional equivalent to glycerin and sorbitol taught by KIRAL and could be alternatively used in place of glycerin ([0332]).
Also, it was known in the art that maltitol solution is a viscous, syrupy, liquid, the osmolarity of an aqueous maltitol solution is similar to that of a sucrose solution of the same concentration and a 10% v/v aqueous solution of maltitol is iso-osmotic with serum as evidenced by Rowe et al. (p416, section 10). Rowe et al. further teach that maltitol exhibits a low glycemic index and can therefore, under medical supervision, have a place in the diet of diabetic patients (p415, section 14).
As stated above, KIRAL teaches that perfluorocarbon emulsions may further include osmotic agents for intravenous infusion and for intravenous infusion, it is important that the tonicity of the emulsion be in the same physiological range as blood tonicity. KIRAL also teaches and suggest the addition of tonicity imparting agents such as sorbitol, glycerin and dextrose (polyol). Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a known polyol such as maltitol as tonicity imparting agent for perfluorocarbon emulsions of KIRAL. Also, UNGER teaches that a viscogen is included in an oxygen therapeutic composition comprising perfluoropentane or perfluorohexane emulsion to increase the viscosity in the product for decreasing settling of the nano-emulsion and suitable viscogens include polyols such as sucrose, trehalose, starch, Hextend®, propylene glycol, and glycerol (glycerin). Thus, the skilled artisan would have reasonably expected that maltitol would function as tonicity imparting agent and viscogen to increase viscosity of the emulsion similar to sugar (sucrose) and the other polyols such as glycerin as evidenced by Rowe et al. Generally, it is prima facie obvious to select a known material for incorporation into a composition based on its recognized suitability for its intended use. See MPEP 2144.07. Also, it would have been prima facie obvious to one of ordinary skill in the art to optimize the amount of tonicity imparting agent/viscogen such as maltitol to reach the target osmolarity (e.g., about 300 mOsm/L) and viscosity. Based on the concertation disclosed in Rowe et al., the skilled artisan would have arrived at the claimed range through routine optimization.
Claims 73 and 76 are rejected under 35 U.S.C. 103 as being unpatentable over US 2010/0267842 (hereafter, KIRAL) in view of WO2015/134735 (hereafter, UNGER) as evidenced by US 2014/0234224 (hereafter, GUPTE) and Rowe et al. (Handbook of Pharmaceutical Excipients, 6th edition, p637-640, 2009).
KIRAL teaches an emulsion comprising perfluorocarbon dispersed as particles within a continuous phase, wherein the perfluorocarbon includes perfluorohexane and dodecafluoropentane (abstract and [0021]). KIRAL further teaches that the emulsions typically include emulsifiers, buffers, osmotic agents, and electrolytes ([0194]) and the formulation may include tonicity imparting agents such as sorbitol, glycerin and dextrose (polyol) and other viscosity imparting agents such as sodium carboxymethylcellulose, microcrystalline cellulose, polyvinylpyrrolidone, and polyvinyl alcohol ([0206]).
KIRAL specifically disclose the perfluorocarbon emulsion is prepared by: a) mixing an emulsifier (surfactant) and aqueous medium (water) together; b) adding perfluorocarbon to the mixture of step a); c) mixing the mixture of step b) to form a coarse emulsion; d) obtaining a sample of the coarse emulsion of step c) and determining particle size distribution of the sample; e) if the sample of step d) has a monomodal particle size distribution, then homogenizing the coarse emulsion of step c); and f) obtaining the emulsion (claim 22).
KIRAL further teaches that the mean size of the dispersed particles is about 200-400 nm ([0019]). Thus, the particle size necessarily overlaps the range of IWMD as claimed when IWMD is determined.
KIRAL specifically disclose exemplary emulsions comprising perfluoro(tert-butylcyclohexane) (FtBu) or dodecafluoropentane (DDFP) and the emulsion further contains the following ingredients: egg yolk phospholipid (emulsifier/surfactant), buffering agent, glycerin or NaCl as tonicity adjuster, water for injection (WFI) (Example 1A, 1D, and Table 1-3). KIRAL further discloses that the DDFP emulsion has D(0.9) value of about 600 nm; and the DDFP emulsion has D(0.5) value of about 200-300 nm ([0290] and [0291]). The composition is free of a viscogen such as sucrose.
Also, KIRAL discloses that the emulsion is in an aqueous medium which is isotonic and mildly buffered to a neutral pH range ([0028] and [0146]).
KIRAL further discloses that for intravenous infusion, it is important that the tonicity of the emulsion be in the same physiological range as blood tonicity ([0151]). KIRAL further discloses that the PFC compositions may also contain non-toxic emulsifying, preserving, wetting agents, bodying agents, as for example, polyethylene glycols 200, 300, 400 and 600 ([0203]).
As to claim 76, KIRAL teaches that the perfluorocarbon emulsion is effective for treating sickle cell disease by enhancing oxygen delivery to tissues wherein it is administered intravenously (IV) or intrathecally (abstract, [0021], [0029], [0074], [0157], and [0161]).
KIRAL does not specifically teach a PFC emulsion comprising PEG-telomer B (PTB) as surfactant and the specific concentration of NaCl. Also, KIRAL is silent about claimed osmolarity.
UNGER discloses an oxygen therapeutic composition comprising a perfluorocarbon emulsion in water for intravenous administration, wherein said fluorocarbon consists of perfluoropentane or said fluorocarbon comprises perfluoropentane and perfluorohexane (abstract and claims 11-15). UNGER teaches that lower molecular weight fluorocarbons (FC), most particularly with boiling points from about -4 degrees centigrade to about 100 degrees centigrade are far more effective than the higher molecular weight, higher boiling point PCs and most preferred are perfluoropentane and perfluorohexane ([00014]). UNGER specifically disclose that most preferably, the FC is prepared in an emulsion by using a variety of surfactants such as phospholipids including dioleoylphosphatidylcholine (DOPC) and fluorosurfactants such as PEG Telomer B ([00015] and claims 9-10). UNGER specifically disclose emulsion for injection comprising dodecafluoropentane, sucrose (polyol), PEG Telomer B (surfactant), and water, wherein the emulsion has mean particle size of emulsion about 250 nm ([00028]).
As to the use of PEG-Telomer B (PTB) as surfactant, while KIRAL teaches that the PFC compositions contain surfactants such as phospholipids, KIRAL does not specifically disclose PEG-Telomer B (PTB) as surfactant. However, UNGER teaches that a variety of surfactants such as phospholipids and fluorosurfactants such as PEG Telomer B (PTB) can be used for the perfluorocarbon emulsions comprising perfluoropentane and perfluorohexane. Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use PEG-Telomer B as a surfactant for perfluorocarbon emulsions of KIRAL because PEG-Telomer B was a known surfactant suitable for perfluorocarbon emulsions and could be used in place of phospholipid as evidenced by UNGER. One of ordinary skill in the art would have been able to carry out such a substitution, and the results were reasonably predictable.
As to NaCl and its concentration, KIRAL already teaches the use of isotonic aqueous medium for the emulsion and discloses that the perfluorocarbon emulsion can comprise NaCl in place of glycerin as tonicity imparting agent. Also, it was known in the art that the primary use for sodium chloride is to produce isotonic solutions and about 0.9% w/v sodium chloride solution produces isotonic solution for intravenous preparations as evidenced by Rowe et al. (p637, section 7 and Table 1). Thus, it would have been prima facie obvious to add NaCl in a concentration close to isotonic saline (e.g., about 0.9% w/v) for making the emulsion an isotonic composition on the reasonable expectation that the resulting emulsion would have an osmolality similar or close to the physiological range of blood osmolality. The skilled artisan would have been motivated to prepare the emulsion of KIRAL to have physiologically acceptable tonicity/osmolality for making it suitable for intravenous injection in the treatment of sickle disease.
As to the claimed osmolarity, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to arrive at perfluorocarbon emulsions having the claimed osmolality because KIRAL teaches that perfluorocarbon emulsions may further include osmotic agents and for intravenous infusion, it is important that the tonicity of the emulsion be in the same physiological range as blood tonicity. Also, KIRAL discloses the use of the isotonic aqueous medium. The osmolarity of the isotonic solution is about 300 mOsm/L (mOsm/kg) as evidenced by GUPTE ([0057]). GUPTE discloses an emulsion containing a perfluorcarbon compound such as perfluorohexane as oxygen carrier ([0016]). GUPTE further discloses the emulsion may contain an isotonic agent, to adjust the osmotic pressure of the emulsion to about that of blood and exemplary agents include glycerol and sodium chloride (NaCl) ([0057]). GUPTE further discloses isotonic agents may be added to the emulsion to adjust osmolarity to the approximate physiological value of about 300 mOsm/l with a range of from about 290-600 mOsm/l and amounts may be added as needed to reach target osmolarity ([0057]). Thus, the skilled artisan would have been motivated to prepare the emulsion having an osmolality similar or close to the physiological range of osmolality of blood (e.g., 300 mOsmol per kg) so that it would be suitable for intravenous injection of the emulsion composition in the treatment of sickle cell disease as taught by KIRAL.
As to the limitation, “free of a viscogen and sucrose”, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare perfluorocarbon emulsions without a viscogen such as sucrose because KIRAL teaches that viscosity imparting agents are optional ingredients for the perfluorocarbon emulsions. Thus, it would have been prima facie obvious to arrive at perfluorocarbon emulsions with or without a viscogen. Also, KIRAL teaches either glycerin or NaCl can be used as tonicity adjusting agent. Thus, one of ordinary skill in the art would have at once envisaged a composition comprising NaCl in place of glycerin and the resulting composition would be free of viscogen. In addition, the skilled artisan would have been motivated to prepare the oxygen therapeutic composition without sucrose, particularly for diabetic patients because sucrose is well-known to increase blood glucose level.
Claim 74 is rejected under 35 U.S.C. 103 as being unpatentable over US 2010/0267842 (hereafter, KIRAL) in view of WO2015/134735 (hereafter, UNGER) in further view of US 2012/0156251 (hereafter, BRITO) as evidenced by US 2014/0234224 (hereafter, GUPTE) and Rowe et al. (Handbook of Pharmaceutical Excipients, 6th edition, p414-417 and p637-640, 2009).
KIRAL, UNGER, GUPTE, and Rowe et al. as applied supra are herein applied for the same teachings in their entirety.
They do not specifically disclose maltitol.
However, it was well known in the art that the osmolarity of the aqueous phase in emulsions is determined by nonionic tonicity adjusting agents and suitable tonicity adjusting agents include sugars, sugar alcohols such as mannitol, sorbitol, xylitol, erythritol, lactitol, and maltitol, and glycerol as evidenced by BRITO (abstract, [0201], and [0271). BRITO further teaches that the tonicity adjusting agents are added in a sufficient quantity to make the emulsion isotonic ([0019]). Thus, the skilled artisan would have recognized that the sugar alcohols (polyol) such as maltitol as tonicity imparting agents (osmotic agents) are functional equivalent to glycerin and sorbitol taught by KIRAL and could be alternatively used in place of glycerin ([0332]).
Also, it was known in the art that maltitol solution is a viscous, syrupy, liquid, the osmolarity of an aqueous maltitol solution is similar to that of a sucrose solution of the same concentration and a 10% v/v aqueous solution of maltitol is iso-osmotic with serum as evidenced by Rowe et al. (p416, section 10). Rowe et al. further teach that maltitol exhibits a low glycemic index and can therefore, under medical supervision, have a place in the diet of diabetic patients (p415, section 14).
As stated above, KIRAL teaches that perfluorocarbon emulsions may further include osmotic agents and for intravenous infusion, it is important that the tonicity of the emulsion be in the same physiological range as blood tonicity. KIRAL also teaches and suggest the addition of tonicity imparting agents such as sorbitol, glycerin and dextrose (polyol). Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a known polyol such as maltitol as tonicity imparting agent for perfluorocarbon emulsions of KIRAL. Generally, it is prima facie obvious to select a known material for incorporation into a composition based on its recognized suitability for its intended use. See MPEP 2144.07. Also, it would have been prima facie obvious to one of ordinary skill in the art to optimize the amount of tonicity imparting agent such as maltitol to reach the target osmolarity (e.g., about 300 mOsm/L). Based on the concertation disclosed in Rowe et al., the skilled artisan would have arrived at the claimed range through routine optimization.
Conclusion
No claims are allowed.
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/BONG-SOOK BAEK/Primary Examiner, Art Unit 1611