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 .
Information Disclosure Statement
The information disclosure statement filed 03/07/2024 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. It has been placed in the application file, but the information referred to therein has not been considered.
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.
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, 3-5, 9, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Sanderson et al. (US 4,647,470, March 3, 1987, applicant submitted prior art via the IDS) and evidenced by Kuntz, L. (2009, August). “Locust Bean Gum: Good as gold”.
Regarding claim 1, Sanderson discloses an ultrasound phantom (“aqueous gels” col. 2, l. 63- col. 3, l. 2, 0.004 M Ca++ used to cause gelations as listed throughout the examples and tables) comprising:
water (“aqueous gels” col. 2, l. 63- col. 3, l. 2);
a polysaccharide (A) having a sol-gel phase transition point of 30°C or more and 95°C or less (“low-acetyl gellan gum” Abstract; examiner notes that applicant discloses that polysaccharide (A) may be gellan gum in paragraph [0018] of the pre-grant publication of the instant application); and
a polysaccharide thickener (B) whose 1 mass% aqueous solution has a viscosity at room temperature of 300 mPa∙s or more (“locust bean gum” Abstract; examiner notes that polysaccharide thickener (B) may be locust bean gum as disclosed in paragraph [0039] of the pre-grant publication of the instant application; examiner further notes that as evidenced by Kuntz on page 1, “Locust bean gum viscosities typically fall within a range of 2,500 to 3,500 cps” which is equivalent to 2,500 to 3,500 mPa∙s).
Although Sanderson suggests wherein the ultrasound phantom is configured to show a tanδ of 0.2 or more under a gel state, which is obtained by dynamic viscoelasticity measurement at 1 Hz and room temperature (“The texture profile of a gel can be evaluated in terms of four parameters: modulus, hardness, brittleness, and elasticity. These are standard gel properties that are determined, for example, on an Instron 4201 Universal Testing Machine, which compresses the sample to about 1/4 of its original height two times in succession. The sample is compressed twice so that the amount of structure breakdown can be determined [...] It has been found that varying the ratio of xanthan:galactomannan has an effect on three of these parameters: hardness, modulus, and brittleness.” col. 1, l. 64- col. 2, l. 55; examiner also notes that applicant discloses in e.g., paragraph [0034] of the pre-grant publication, that it is the use of the claimed polysaccharide thickener, which is the locust bean gum disclosed by Sanderson, that provides the claimed high tan d value), Sanderson fails to explicitly disclose wherein the ultrasound phantom is configured to show a tanδ of 0.2 or more under a gel state, which is obtained by dynamic viscoelasticity measurement at 1 Hz and room temperature.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide the ultrasound phantom with a tanδ of 0.2 or more under a gel state, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05(II)(A).
Regarding claim 3, Sanderson further discloses wherein the polysaccharide thickener (B) is a polysaccharide thickener having a mannose residue in a main chain thereof, and having a galactose residue in a side chain thereof, and wherein a ratio of the number of the galactose residues present in the side chain to the number of the mannose residues present in the main chain is 0.2 or more and 0.4 or less (“Locust bean gum (lbg) is an extract of the locust bean or carob, Ceratonia siligua. It is commercially available and used as a stabilizer in foods such as ice cream, sausages, and cheese. Chemically, lbg is a galactomannan.” col. 1, ll. 55-60; examiner notes that Locust bean gum has a ratio of D-galactose to D-mannose of 1:4).
Regarding claim 4, Sanderson further discloses wherein the polysaccharide thickener (B) has a molecular weight of 90,000 or more (“Locust bean gum (lbg) is an extract of the locust bean or carob, Ceratonia siligua. It is commercially available and used as a stabilizer in foods such as ice cream, sausages, and cheese. Chemically, lbg is a galactomannan.” col. 1, ll. 55-60; examiner notes that Locust bean gum has am approximate molecular weight of 310,000 Da).
Regarding claim 5, Sanderson further discloses wherein the polysaccharide thickener (B) contains a polysaccharide thickener selected from a guar gum, a locust bean gum, and a tamarind seed gum (“Locust bean gum (lbg) is an extract of the locust bean or carob, Ceratonia siligua. It is commercially available and used as a stabilizer in foods such as ice cream, sausages, and cheese. Chemically, lbg is a galactomannan.” col. 1, ll. 55-60).
Regarding claim 9, Sanderson discloses a method of producing an ultrasound phantom (“aqueous gels” col. 2, l. 63- col. 3, l. 2, 0.004 M Ca++ used to cause gelations as listed throughout the examples and tables), the method comprising:
preparing a solution A (“The dry ingredients are blended and added to boiling water with stirring until all the dry ingredients are dissolved.” col. 9, ll. 25-30) containing a polysaccharide (A) having a sol-gel phase transition point of 30°C or more and 95°C or less (“low-acetyl gellan gum” Abstract; examiner notes that applicant discloses that polysaccharide (A) may be gellan gum in paragraph [0018] of the pre-grant publication of the instant application);
preparing a solution B (“The dry ingredients are blended and added to boiling water with stirring until all the dry ingredients are dissolved.” col. 9, ll. 25-30) containing a polysaccharide thickener (B) whose 1 mass% aqueous solution has a viscosity at room temperature of 300 mPa∙s or more (“locust bean gum” Abstract; examiner notes that polysaccharide thickener (B) may be locust bean gum as disclosed in e.g., claim 5 of the instant application);
preparing a preparation liquid C by mixing the solution A and the solution B (“The dry ingredients are blended and added to boiling water with stirring until all the dry ingredients are dissolved.” col. 9, ll. 25-30); and
preparing a hydrogel D by causing the preparation liquid C to gelate (“The invention also comprises aqueous gels comprising 0.1 to 1.5% (wt.) of the gum blends.” col. 2, l. 65- col. 3, l. 2),
wherein the hydrogel D in a gel state shows a tanδ of 0.2 or more, which is obtained by performing dynamic viscoelasticity measurement at 1 Hz and room temperature.
Although Sanderson suggests wherein the hydrogel D in a gel state shows a tanδ of 0.2 or more, which is obtained by performing dynamic viscoelasticity measurement at 1 Hz and room temperature (“The texture profile of a gel can be evaluated in terms of four parameters: modulus, hardness, brittleness, and elasticity. These are standard gel properties that are determined, for example, on an Instron 4201 Universal Testing Machine, which compresses the sample to about 1/4 of its original height two times in succession. The sample is compressed twice so that the amount of structure breakdown can be determined [...] It has been found that varying the ratio of xanthan:galactomannan has an effect on three of these parameters: hardness, modulus, and brittleness.” col. 1, l. 64- col. 2, l. 55; examiner also notes that applicant discloses in e.g., paragraph [0034] of the pre-grant publication, that it is the use of the claimed polysaccharide thickener, which is the locust bean gum disclosed by Sanderson, that provides the claimed high tan d value), Sanderson fails to explicitly disclose wherein the hydrogel D in a gel state shows a tanδ of 0.2 or more, which is obtained by performing dynamic viscoelasticity measurement at 1 Hz and room temperature.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide the hydrogel D in a gel state that shows a tanδ of 0.2 or more, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05(II)(A).
Regarding claim 10, Sanderson further discloses wherein the preparing the hydrogel D includes cooling the preparation liquid C (“The mixture is then poured into jars and cooled to room temperature or under refrigeration.” col. 7, ll. 9-10).
Claims 2, 7, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Sanderson as applied to claim 1 above and further in view of Fatemi et al. (US 2019/0175140, June 13, 2019).
Regarding claim 2, Sanderson discloses the limitations of claim 1 as stated above but fails to disclose wherein the polysaccharide (A) is agar.
However, Fatemi teaches, in the same field of endeavor, wherein the polysaccharide (A) is agar (“Creep tests, discussed above, were performed on a homogenous tissue-mimicking phantom. To construct phantom, 13.7 grams gelatin (Sigma-Aldrich, St. Louis, Mo.), 60 mL Vanicream Lite (Pharmaceutical Specialties, Inc., Rochester, Minn.), 0.3 grams of agar (A5306, Sigma-Aldrich), 3 grams cellulose (Sigma-Aldrich) for ultrasound scattering and 3 grams potassium sorbate (Sigma-Aldrich) as a preservative, were dissolved in enough water to make the total solution volume equal 300 mL.” [0126])
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Sanderson by substituting the polysaccharide used in Sanderson with agar as taught by Fatemi, since such polysaccharides were routinely used in ultrasound phantoms and since one of ordinary skill in the art would have recognized routine engineering techniques for switching the polysaccharides. The rationale would have been the simple substitution of one known, equivalent element for another to obtain predictable results (obvious to substitute elements, devices, etc.). See MPEP 2143 1B.
Regarding claim 7, Sanderson discloses the limitations of claim 1 as stated above. Sanderson fails to disclose further comprising an ultrasonic scattering agent.
However, Fatemi teaches, in the same field of endeavor, further comprising an ultrasonic scattering agent (“cellulose (Sigma-Aldrich) for ultrasound scattering” [0083]).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Sanderson with further comprising an ultrasonic scattering agent as taught by Fatemi in order to improve ultrasound contrast.
Regarding claim 8, Sanderson discloses the limitations of claim 1 as stated above but fails to disclose further comprising an antiseptic.
However, Fatemi teaches, in the same field of endeavor, further comprising an antiseptic (“potassium sorbate (Sigma-Aldrich) as a preservative” [0083]).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Sanderson with further comprising an antiseptic as taught by Fatemi in order to preserve the ultrasound phantom.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Sanderson as applied to claim 1 above and further in view of Steffensen et al. (US 2022/0304922, September 29, 2022).
Regarding claim 6, Sanderson discloses the limitations of claim 1 as stated above but fails to disclose further comprising a sound speed-adjusting agent.
However, Steffensen teaches, in the same field of endeavor, further comprising a sound speed-adjusting agent (“Adjustment of the speed of sound within the phantom can be altered by changing the amount of inorganic powder present in the hydrocarbon gel layer and/or silicone sleeve.” [0070]).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Sanderson with further comprising a sound speed-adjusting agent as taught by Steffensen in order to improve echogenicity ([0026] of Steffensen).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMINAH ASGHAR whose telephone number is (571)272-0527. The examiner can normally be reached M-W, F 9am-5pm EST.
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/A.A./Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797
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