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 without traverse of Group I and species of soybean oil, glycerol, and polysorbate 80 in the reply filed on September 2, 2026 is acknowledged.
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, 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 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 1-9, 11-16, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Selbekk et al (WO 2013 167654; cited on IDS filed December 10, 2024) in view of Ceriani et al (Organic Process Research & Development, 2020).
Regarding claims 1-3, Selbekk discloses an aqueous ultrasound contact fluid comprising 50-110 g/L triglyceride, 2-10 g/L emulsifier, and humectant (claim 3). Regarding claims 1 and 6, Selbekk discloses that the emulsifier can be lecithin (phospholipid) or polysorbate 20 (non-ionic stabilizing agent) (claim 6). Regarding claim 4, the weight ratio between triglyceride and phospholipid can be 25:1 if the fluid comprises 50 g/L triglyceride and 2 g/L of phospholipid. Regarding claim 5, Selbekk discloses that the triglyceride can be vegetable oils (claim 4). Regarding claim 7, Selbekk discloses that the amount of humectant can be 5-15 g/L (claim 3). Regarding claim 8, Selbekk discloses that the humectant can be polyols (claim 7). Regarding claims 9, 11, and 12, Selbekk discloses that the polysorbate 20 (non-ionic stabilizing agent) can be present in an amount of 2-10 g/L as an emulsifier (claims 3 and 6). Regarding claim 13, Selbekk discloses that the fluid can comprise a pH adjusting additive (claim 8). Regarding claim 14, Selbekk discloses that the pH adjusting additive can be added in amount to set the pH in the range 6 to 8 in order to adjust the fluid to a pH level suitable for intended clinical use (claim 9; page 6, ¶ 4). Regarding claim 15, Selbekk discloses that the fluid can have an attenuation coefficient α > 0.066 dB/(MHz·cm) (claim 11). Regarding claim 16, Selbekk discloses that the fluid can comprise 50-110 g/L triglyceride such as soybean oil, 2-10 g/L emulsifier such as lecithin and polysorbate 20, and 5-15 g/L humectant such as glycerol (claims 3-7). Regarding claim 25, Selbekk discloses that the fluid comprising soybean oil (triglyceride), lecithin (phospholipid), glycerol (humectant), and physiological saline water (claim 10).
Selbekk does not disclose an aqueous ultrasound coupling agent or kit comprising both phospholipid such as lecithin and non-ionic stabilizing agent such as polysorbate 80.
Ceriani discloses that the use of a mixture of two commercially available, food-grade efficient emulsifiers lecithin and Tween 80 (polysorbate 80, non-ionic stabilizing agent; page 9, line 7 of instant specification as filed) can provide a finely dispersed emulsion of the most hostile hydrophobes (page 2605, column 1, ¶ 2; page 2608, column 2, ¶ 1).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the aqueous ultrasound contact fluid of Selbekk to comprise the mixture of lecithin and Tween 80 of Ceriani to prepare a more effective aqueous ultrasound coupling agent or kit. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Ceriani teaches that a mixture of lecithin and Tween 80 can be used for emulsifying hydrophobic molecules such as triglycerides. Further, a person of ordinary skill in the art would have been motivated to utilize the surfactant mixture of lecithin and Tween 80 in an aqueous triglyceride-based ultrasound agent in order to achieve a uniform and stable emulsion that is also a biocompatible agent. A person of ordinary skill in the art would have been motivated to utilize the fluid of Selbekk as an aqueous ultrasound coupling agent in order to expand the applications of the fluid. A person of ordinary skill in the art would have readily recognized that the aqueous ultrasound contact fluid disclosed in the prior art, having the same composition as the claimed aqueous ultrasound coupling agent, inherently functions as an aqueous ultrasound coupling agent. Utilizing or characterizing this fluid for ultrasound applications is nothing more than recognizing an inherent property or routine application within the skill of the art. A person of ordinary skill in the art would have been motivated to optimize the amount of compositions such as triglyceride, phospholipid, humectant, and non-ionic stabilizing agent in order to prepare an aqueous ultrasound coupling agent or kit according to specific requirement of the intended applications. The concentration ranges of triglyceride, phospholipid, humectant, and non-ionic stabilizing agent of the prior art encompass or overlap with those instantly claimed. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. Further, the concentrations of triglyceride, phospholipid, humectant, and non-ionic stabilizing agent are clearly result effective parameters that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the concentrations of the compositions in the agent in order to best achieve the desired aqueous ultrasound coupling agent as the amounts of such compositions determine the stability and homogeneity of the agents. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See MPEP § 2144.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Selbekk and Ceriani as applied to claims 1-9, 11-16, and 25 above, and further in view of Mahdi et al. (Drug design, development and therapy, 2011; cited on PTO-892).
Selbekk and Ceriani are discussed above.
Neither Selbekk nor Ceriani discloses that the non-ionic stabilizing agent has a hydrophilic-lipophilic balance (HLB) value in the range of 8-14.
Mahdi discloses non-ionic surfactants having various HLB values (Tables 1 and 2). Mahdi discloses that Tween® 85 has an HLB value of 11.0 (Table 1). Mahdi discloses that the surfactants have different solubilization capacity with water for palm kernel oil esters and that selecting a surfactant with the proper HLB for specific oils is important (abstract, page 322, column 1, ¶ 3).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the aqueous ultrasound coupling agent of Selbekk and Ceriani to comprise non-ionic stabilizing agent having an HLB value in the range of 8-14 such as Tween® 85 for preparing a more effective agent. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Mahdi teaches that Tween® 85, having an HLB value of 11.0, can be used as a non-ionic surfactant. Further, a person of ordinary skill in the art would have been motivated to select a non-ionic stabilizing agent with proper HLB value according to the specific requirements of the intended applications, as taught by Mahdi. Selection of a non-ionic stabilizing agent with a specific HLB range is a matter of design choice and routine optimization well within the purview of a person of ordinary skill in the art in order to best achieve the desired stable oil-in-water emulsion (aqueous ultrasound coupling agent) as the non-ionic stabilizing agent determines the solubility and stability of the oil emulsion as taught by Mahdi.
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 1-16 and 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. US 9,770,521 in view of Ceriani et al (Organic Process Research & Development, 2020) and Mahdi et al. (Drug design, development and therapy, 2011; cited on PTO-892).
Regarding claims 1-3 and 7, claim 3 of the ‘521 recites an aqueous ultrasound contact fluid comprising 50-110 g/L triglyceride, 2-10 g/L emulsifier, and 5-15 g/L of humectant. Regarding claims 1 and 6, claim 6 of the ‘521 recites that the emulsifier can be lecithin (phospholipid) or polysorbate 20 (non-ionic stabilizing agent). Regarding claim 4, the weight ratio between triglyceride and phospholipid can be 25:1 if the fluid comprises 50 g/L triglyceride and 2 g/L of phospholipid. Regarding claim 5, claim 4 of the ‘521 recites that the triglyceride can be vegetable oils. Regarding claim 8, claim 7 of the ‘521 recites that the humectant can be polyols. Regarding claims 9, 11, and 12, claims 3 and 6 of the ‘521 recites that the polysorbate 20 (non-ionic stabilizing agent) can be present in an amount of 2-10 g/L as an emulsifier. Regarding claim 13, claim 8 of the ‘521 recites that the fluid can comprise a pH adjusting additive. Regarding claim 14, claim 9 of the ‘521 recites that the pH adjusting additive can be added in amount to set the pH in the range 6 to 8. (claim 9). Regarding claim 15, claim 12 of the ‘521 recites that the fluid can have an attenuation coefficient α > 0.066 dB/(MHz·cm). Regarding claim 16, claims 3-7 of the ‘521 recites that the fluid can comprise 50-110 g/L triglyceride such as soybean oil, 2-10 g/L emulsifier such as lecithin and polysorbate 20, and 5-15 g/L humectant such as glycerol. Regarding claim 25, claim 11 of the ‘521 recites that the agent (kit) comprising soybean oil (triglyceride), lecithin (phospholipid), glycerol (humectant), and physiological saline.
Claims of the ‘521 do not recite an aqueous ultrasound coupling agent or kit comprising both phospholipid such as lecithin and non-ionic stabilizing agent such as polysorbate 80.
As discussed above, Ceriani discloses that the use of a mixture of two commercially available, food-grade efficient emulsifiers lecithin and Tween 80 (polysorbate 80, non-ionic stabilizing agent; page 9, line 7 of instant specification as filed) can provide a finely dispersed emulsion of the most hostile hydrophobes (page 2605, column 1, ¶ 2; page 2608, column 2, ¶ 1).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the aqueous ultrasound contact fluid of the ‘521 to comprise the mixture of lecithin and Tween 80 of Ceriani to prepare more effective aqueous ultrasound coupling agent or kit. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Ceriani teaches that a mixture of lecithin and Tween 80 can be used for emulsifying hydrophobic molecules such as triglycerides. Further, a person of ordinary skill in the art would have been motivated to utilize the surfactant mixture of lecithin and Tween 80 in an aqueous triglyceride-based ultrasound agent in order to achieve a uniform and stable emulsion that is also a biocompatible agent. A person of ordinary skill in the art would have been motivated to utilize the fluid of the ‘521 as an aqueous ultrasound coupling agent in order to expand the applications of the fluid. A person of ordinary skill in the art would have readily recognized that the aqueous ultrasound contact fluid of the ‘801 in view of prior art, having the same composition as the claimed aqueous ultrasound coupling agent, inherently functions as an aqueous ultrasound coupling agent. Utilizing or characterizing this fluid for ultrasound applications is nothing more than recognizing an inherent property or routine application within the skill of the art. A person of ordinary skill in the art would have been motivated to optimize the amount of compositions such as triglyceride, phospholipid, humectant, and non-ionic stabilizing agent in order to prepare aqueous ultrasound coupling agent or kit according to specific requirement of the intended applications. The concentration ranges of triglyceride, phospholipid, humectant, and non-ionic stabilizing agent of the prior art encompass or overlap with those instantly claimed. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. Further, the concentrations of triglyceride, phospholipid, humectant, and non-ionic stabilizing agent are clearly result effective parameters that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the concentrations of the compositions in the agent in order to best achieve the desired aqueous ultrasound coupling agent as the amounts of such compositions determine the stability and homogeneity of the agents. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See MPEP § 2144.
Regarding claim 10, claims of the ‘521 do not recite that the non-ionic stabilizing agent has an HLB value in the range of 8-14.
As discussed above, Mahdi discloses non-ionic surfactants having various HLB values (Tables 1 and 2). Mahdi discloses that Tween® 85 has an HLB value of 11.0 (Table 1). Mahdi discloses that the surfactants have different solubilization capacity with water for palm kernel oil esters and that selecting a surfactant with the proper HLB for specific oils is important (abstract, page 322, column 1, ¶ 3).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the aqueous ultrasound coupling agent of the ‘521 and Ceriani to comprise a non-ionic stabilizing agent having an HLB value in the range of 8-14 such as Tween® 85 for preparing a more effective agent. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Mahdi teaches that Tween® 85, having an HLB value of 11.0, can be used as a non-ionic surfactant. Further, a person of ordinary skill in the art would have been motivated to select a non-ionic stabilizing agent with proper HLB value according to the specific requirements of the intended applications, as taught by Mahdi. Selection of a non-ionic stabilizing agent with a specific HLB range is a matter of design choice and routine optimization well within the purview of a person of ordinary skill in the art in order to best achieve the desired stable oil-in-water emulsion (aqueous ultrasound coupling agent) as the non-ionic stabilizing agent determines the solubility and stability of the oil emulsion as taught by Mahdi.
Claims 1-16 and 25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims of copending Application No. 19/485,156 in view of Selbekk et al (WO 2013 167654; cited on IDS filed December 10, 2024), Ceriani et al (Organic Process Research & Development, 2020), and Mahdi et al. (Drug design, development and therapy, 2011; cited on PTO-892).
Regarding claims 1, 2, 8, and 16, claim 33 of the ‘156 recites an aqueous ultrasound coupling agent comprising 5-9% w/v (50-90 g/L) triglyceride, 7.4-9.4 (g/L) phospholipid, and glycerol (humectant). Regarding claims 5 and 16, claim 60 of the ‘156 recites that the triglyceride can be soybean oil. Regarding claims 6 and 16, claim 66 of the ‘156 recites that the phospholipid can be lecithin. Regarding claims 13 and 14, claims 33 and 95 of the ‘156 recites that the agent can comprise a pH buffer and that the agent can have a pH in the range of 6.5 to 8.5. Regarding claim 25, claim 33 of the ‘156 recites that the agent can comprise triglyceride, phospholipid, humectant, and water.
Claims of the ‘156 do not recite non-ionic stabilizing agent such as polysorbate 80. Claims of the ‘156 do not recite the specific concentration of the compositions such as phospholipid, humectant, and non-ionic stabilizing agent and specific weight ratio between triglyceride and phospholipid in claimed ranges. Claims of the ‘156 do not recite that an attenuation coefficient (α) is greater than 0.066 dB/(MHz·cm). Claims of the ‘156 do not recite a pH-adjusting additive.
As discussed above, Selbekk discloses an aqueous ultrasound contact fluid comprising 50-110 g/L triglyceride, 2-10 g/L emulsifier, and humectant (claim 3). Selbekk discloses that the emulsifier can be lecithin (phospholipid) or polysorbate 20 (non-ionic stabilizing agent) (claim 6). The weight ratio between triglyceride and phospholipid can be 25:1 if the fluid comprises 50 g/L triglyceride and 2 g/L of phospholipid. Selbekk discloses that the amount of humectant can be 5-15 g/L (claim 3). Selbekk discloses that the polysorbate 20 (non-ionic stabilizing agent) can be present in an amount of 2-10 g/L as an emulsifier (claims 3 and 6). Selbekk discloses that the pH adjusting additive can be added in amount to set the pH in the range 6 to 8 in order to adjust the fluid to a pH level suitable for intended clinical use. (claim 9; page 6, ¶ 4). Selbekk discloses that the fluid can have an attenuation coefficient α > 0.066 dB(MHz·cm) (claim 11). Selbekk discloses that the agent can comprise 50-110 g/L triglyceride such as soybean oil, 2-10 g/L emulsifier such as lecithin and polysorbate 20, and 5-15 g/L humectant such as glycerol (claims 3-7).
As discussed above, Ceriani discloses that the use of a mixture of two commercially available, food-grade efficient emulsifiers lecithin and Tween 80 (polysorbate 80, non-ionic stabilizing agent; page 9, line 7 of instant specification as filed) can provide finely dispersed emulsion of the most hostile hydrophobes (page 2605, column 1, ¶ 2; page 2608, column 2, ¶ 1).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the aqueous ultrasound coupling agent of the ‘156 to comprise a non-ionic stabilizing agent such as polysorbate 80 and pH-adjusting additive for preparing more stable agent or kit. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Selbekk and Ceriani teach that a non-ionic stabilizing agent such as polysorbate 80 and a pH-adjusting additive can be used for improving the agent. Selbekk teaches the concentration ranges of the composition which encompass or overlap with those instantly claimed. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. A person of ordinary skill in the art would have been motivated to optimize the amount of compositions such as triglyceride, phospholipid, humectant, and non-ionic stabilizing agent in order to prepare more effective aqueous ultrasound coupling agent according to specific requirement of the intended applications. The concentrations of triglyceride, phospholipid, humectant, and non-ionic stabilizing agent are clearly result effective parameters that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the concentrations of the compositions in the agent in order to best achieve the desired aqueous ultrasound coupling agent or kit as the amounts of such compositions determine the stability and homogeneity of the agents. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See MPEP § 2144. Similarly, Selbekk teaches the weight ratio between triglyceride and phospholipid which is within the claimed range and attenuation coefficient which is the same as instantly claimed. A person of ordinary skill in the art would have been motivated to optimize the weight ratio and attenuation coefficient in order to prepare a more effective aqueous ultrasound coupling agent according to specific requirements of the intended applications. A weight ratio and an attenuation coefficient are inherent properties depending on the amount of compositions in the agent. Adjusting the amount of the composition, the weight ratio, and the attenuation coefficient is a matter of design selection and routine optimization well within the purview of a person of ordinary skill in the art in order to best achieve the desired agent.
Regarding claim 10, claims of the ‘156 do not recite that the non-ionic stabilizing agent has an HLB value in the range of 8-14.
As discussed above, Mahdi discloses non-ionic surfactants having various (HLB) values (Tables 1 and 2). Mahdi discloses that Tween® 85 has an HLB value of 11.0 (Table 1). Mahdi discloses that the surfactants have different solubilization capacity with water for palm kernel oil esters and that selecting a surfactant with the proper HLB for specific oils is important (abstract, page 322, column 1, ¶ 3).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the aqueous ultrasound coupling agent of the ‘156, Selbekk and Ceriani to comprise a non-ionic stabilizing agent having an HLB value in the range of 8-14 such as Tween® 85 for preparing a more effective agent. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Mahdi teaches that Tween® 85, having an HLB value of 11.0 can be used as a non-ionic stabilizing agent. Further, a person of ordinary skill in the art would have been motivated to select a non-ionic stabilizing agent with proper HLB value according to the specific requirements of the intended applications, as taught by Mahdi. Selection of a non-ionic stabilizing agent with a specific HLB range is a matter of design choice and routine optimization well within the purview of a person of ordinary skill in the art in order to best achieve the stable oil-in-water emulsion (aqueous ultrasound coupling agent) as the non-ionic stabilizing agent determines the solubility and stability of the oil emulsion as taught by Mahdi.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-16 and 25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims of copending Application No. 19/503,801 in view of Selbekk et al (WO 2013 167654; cited on IDS filed December 10, 2024), Ceriani et al (Organic Process Research & Development, 2020), and Mahdi et al. (Drug design, development and therapy, 2011; cited on PTO-892).
Regarding claims 1, 6, and 16, claim 2 of the ‘801 recites a composition comprising triglyceride, phospholipid (lecithin), and humectant. Regarding claims 1, 2, and 16, claim 13 of the ‘801 recites that the concentration of the triglyceride is about 7% w/v (70 g/L). Regarding claims 5 and 16, claim 16 of the ‘801 recites that the triglyceride can be soybean oil. Regarding claims 1, 3, and 16, claim 26 of the ‘801 recites that the concentration of the phospholipid can be 3.2 to 5.2 g/L. Regarding claim 4, the weight ratio between triglyceride and phospholipid can be about 13:1 if the agent of the ‘801 comprises 70 g/L triglyceride and 5.2 g/L of phospholipid. Regarding claims 8 and 16, claim 49 of the ‘801 recites that the humectant can be glycerol. Regarding claims 11, 12, and 16, claim 67 of the ‘801 recites that the composition can comprise polysorbate 80. Regarding claims 13 and 14, claims 1 and 73 recite that the composition can comprise pH buffer and that the pH of the composition can be 6.5 to 8.5. Regarding claim 15, claim 91 of the ‘801 recites that an attenuation coefficient can be about 0.1 to 1.5 dB/(MHz·cm). Regarding claim 25, claims 1 and 188 of the ‘801 recite a kit comprising the composition comprising triglyceride, phospholipid, humectant, and water.
Claims of the ‘801 do not recite non-ionic stabilizing agent such as polysorbate 80. Claims of the ‘801 do not recite the specific concentration of the compositions such as humectant and non-ionic stabilizing agent in claimed ranges. Claims of the ‘801 do not recite pH-adjusting additive.
As discussed above, Selbekk discloses an aqueous ultrasound contact fluid (aqueous ultrasound coupling agent) comprising 50-110 g/L triglyceride, 2-10 g/L emulsifier, and humectant (claim 3). Selbekk discloses that the emulsifier can be lecithin (phospholipid) or polysorbate 20 (non-ionic stabilizing agent) (claim 6). Selbekk discloses that the amount of humectant can be 5-15 g/L (claim 3). Selbekk discloses that the polysorbate 20 (non-ionic stabilizing agent) can be present in an amount of 2-10 g/L as an emulsifier (claims 3 and 6). Selbekk discloses that the pH adjusting additive can be added in amount to set the pH in the range 6 to 8 in order to adjust the fluid to a pH level suitable for intended clinical use. (claim 9; page 6, ¶ 4).
As discussed above, Ceriani discloses that the use of a mixture of two commercially available, food-grade efficient emulsifiers lecithin and Tween 80 (polysorbate 80, non-ionic stabilizing agent; page 9, line 7 of instant specification as filed) can provide finely dispersed emulsion of the most hostile hydrophobes (page 2605, column 1, ¶ 2; page 2608, column 2, ¶ 1).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of the ‘801 to comprise a non-ionic stabilizing agent such as polysorbate 80 and pH-adjusting additive for preparing a stable aqueous ultrasound coupling agent or kit. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Selbekk and Ceriani teach that a non-ionic stabilizing agent such as polysorbate 80 and pH-adjusting additive can be used for improving the agent. A person of ordinary skill in the art would have been motivated to utilize the composition of the ‘801 as an aqueous ultrasound coupling agent in order to expand the applications of the composition. A person of ordinary skill in the art would have readily recognized that the composition of the ‘801 in view of prior art, having the same composition as the claimed aqueous ultrasound coupling agent, inherently functions as an aqueous ultrasound coupling agent. Utilizing or characterizing this composition for ultrasound applications is nothing more than recognizing an inherent property or routine application within the skill of the art. The ‘801 and Selbekk teaches the concentration ranges of the composition and attenuation coefficient which encompass or overlap with those instantly claimed. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. A person of ordinary skill in the art would have been motivated to optimize the amount of compositions such as triglyceride, phospholipid, humectant, and non-ionic stabilizing agent in order to prepare a more effective aqueous ultrasound coupling agent according to specific requirements of the intended applications. The concentrations of triglyceride, phospholipid, humectant, and non-ionic stabilizing agent are clearly result effective parameters that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the concentrations of the compositions in the agent in order to best achieve the desired aqueous ultrasound coupling agent as the amounts of such compositions determine the stability and homogeneity of the agents. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See MPEP § 2144. Similarly, the ‘801 teaches the weight ratio between triglyceride and phospholipid, and the attenuation coefficient which are within the claimed range. A person of ordinary skill in the art would have been motivated to optimize the weight ratio and attenuation coefficient in order to prepare a more effective aqueous ultrasound coupling agent according to specific requirements of the intended applications. A weight ratio and an attenuation coefficient are inherent properties depending on the amount of compositions in the agent. Adjusting the amount of the composition, the weight ratio, and the attenuation coefficient is a matter of design selection and routine optimization well within the purview of a person of ordinary skill in the art in order to best achieve the desired agent.
Regarding claim 10, claims of the ‘801 do not recite that the non-ionic stabilizing agent has an HLB value in the range of 8-14.
As discussed above, Mahdi discloses non-ionic surfactants having various HLB values (Tables 1 and 2). Mahdi discloses that Tween® 85 has an HLB value of 11.0 (Table 1). Mahdi discloses that the surfactants have different solubilization capacity with water for palm kernel oil esters and that selecting a surfactant with the proper HLB for specific oils is important (abstract, page 322, column 1, ¶ 3).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the aqueous ultrasound coupling agent of the ‘801, Selbekk and Ceriani to comprise a non-ionic stabilizing agent having an HLB value in the range of 8-14 such as Tween® 85 for preparing a more effective agent. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Mahdi teaches that Tween® 85, having an HLB value of 11.0, can be used as a non-ionic stabilizing agent. Further, a person of ordinary skill in the art would have been motivated to select a non-ionic stabilizing agent with proper HLB value according to the specific requirements of the intended applications, as taught by Mahdi. Selection of a non-ionic stabilizing agent with a specific HLB range is a matter of design choice and routine optimization well within the purview of a person of ordinary skill in the art in order to best achieve the stable oil-in-water emulsion (aqueous ultrasound coupling agent) as the non-ionic stabilizing agent determines the solubility and stability of the oil emulsion as taught by Mahdi.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONG HWAN BAEK whose telephone number is (571)272-0670. The examiner can normally be reached Mon - Thu, 9 am - 3 pm ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael G Hartley can be reached at 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JONG HWAN BAEK/Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
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