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 statement referencing 18/598091, submitted on 6/6/2024, has been considered. Accordingly, US 2024/0307039 A1, the corresponding publication, has been cited on the Notice of References Cited, form PTO-892.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the container configured to store the hydrogel and its various components must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sanderson et al. (US 4647470 A).
Considering claim 1, Sanderson discloses a ultrasound phantom comprising a hydrogel, wherein the hydrogel contains water (Column 2, line 63 – Column 3, line 2; aqueous gels, 0.004M Ca++ used to cause gelations as listed throughout the examples and tables), a first polysaccharide containing a glucose residue in a main chain thereof, and a mannose residue and a glucuronic acid residue in a side chain thereof (xanthan; Column 2, lines 63-68), and a second polysaccharide containing a mannose residue in a main chain thereof and a galactose residue in a side chain thereof (galactomannan; Column 2, lines 63-68), and wherein the hydrogel has a Young's modulus of 0.1 kPa or more and 5.0 kPa or less (Modulus described in Column 2, lines 4-13; Claimed range equivalent in PSI ~ .015 to .72 PSI; Table 2-1 - #2, 0.28 PSI; #6, 0.51PSI; #7, 0.47 PSI; Table 3-1 - #4, 0.41 PSI; #5, 0.14 PSI; Table 4-1; #3, 0.71 PSI, #4, 0.41 PSI, #5, 0.16 PSI; Table 5-1 - #4 0.46 PSI, #5 0.16 PSI).
Considering claim 2, Sanderson disclose that the brittleness, which is considered “the first significant drop in the force-deformation curve during the first compression cycle” (Column 2, lines 20-22) and is “measured as the % strain required to break the gel” (Column 2, lines 25-26). Accordingly, for the specimens that meet the criteria of claim 1, above, the following first points of compressive deviations were found: Table 2-1 - #2, 69.79%; #6, 58.3%; #7, 61.18%; Table 3-1 - #4, 62.0%; #5, 0.14 PSI; Table 4-1; #3, 51.6%, #4, 60.3%, #5, 69.6%; Table 5-1 - #4 61.0%, #5 69.9%), which are all over 50%. As similarly stated in Table I and [0110] of the originally filed specification, the breakage (decrease in compressive strength with increased strain) doesn’t occur until after at least 50%.
Considering claim 3, Sanderson discloses that the first polysaccharide is Xanthan, and therefore it is inherent that the polysaccharide has a ratio of the number of the mannose residues to the number of the glucose residues of 0.8 or more and 1.2 or less, and a ratio of the number of the glucuronic acid residues to the number of the glucose residues of 0.4 or more and 0.6 or less (Xanthan is 2:2:1, D-glucose, D-mannose, and D-glucuronic acid).
Considering claim 4, Sanderson discloses that the second polysaccharide is Locust bean gum, which inherently has a ratio of the number of the galactose residues to the number of the mannose residues of 0.2 or more and 0.4 or less (Locust bean gum has a ratio of D-galactose to D-mannose of 1:4).
Considering claim 5, Sanderson discloses that the second polysaccharide is Locust bean gum, which inherently has a ratio of the number of the galactose residues to the number of the mannose residues of 0.2 or more and 0.3 or less (Locust bean gum has a ratio of D-galactose to D-mannose of 1:4).
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.
Claims 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over Sanderson et al. (US 4647470 A) in view of Madsen et al. (US 6238343 B1).
Considering claim 9, Sanderson fails to disclose a container.
However, Madsen teaches placing an ultrasound phantom 12 into a container 11 to store it, wherein the container has a holding portion (lower portion of container), which is brought into contact with the ultrasound phantom 12 and is configured to hold a shape thereof (Figures 1-3, Column 4, line 58 – Column 5, line 37).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize a container, as taught by Madsen, in the invention by Sanderson. The motivation for doing so is to provide the form factor of the desired phantom, as understood in the art.
Considering claim 10, Sanderson fails to disclose that the hydrogel has an acoustic coupling surface to be acoustically coupled to an acoustic probe, and the container has the holding portion at a position different from that of the acoustic coupling surface.
However, Madsen teaches that the hydrogel 12 has an acoustic coupling surface (portion just under window 24) to be acoustically coupled to an acoustic probe, and the container 11 has the holding portion (lower portion of the container) at a position different from that of the acoustic coupling surface (Figures 1 and 4; Column 5, lines 7-30, lines 56-64).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize an acoustically coupling surface of the hydrogel being positioned differently from the holding portion of the container, as taught by Madsen, in the invention by Sanderson. The motivation for doing so is to allow the transmission of ultrasound pulses through a portion of the container while providing sufficient rigidity to hold the hydrogel within the container, as suggested by Madsen (Column 5, line 38 – Column 6, line 2).
Considering claim 11, Sanderson fails to disclose the container.
However, Madsen teaches that at a position facing the acoustic coupling surface through the hydrogel, an acoustic wave-reducing portion 70,71,72,74 configured to reduce reflection of an acoustic wave from the acoustic coupling surface (Column 9, lines 28-58).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize an acoustic wave-reducing portion configured to reduce reflection of an acoustic wave from the acoustic coupling, as taught by Madsen, in the invention by Sanderson. The motivation for doing so is to “minimize return of unwanted echoes to the scan head”, as suggested by Madsen (Column 9, line 40).
Considering claim 12, Sanderson fails to disclose the container.
However, Madsen teaches that the container 11 has a lid portion facing the acoustic coupling surface and a main body portion 14-18, which has the holding portion and is fastened to the lid portion (Column 6, lines 15-23).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize a container having a lid, as taught by Madsen, in the invention by Sanderson. The motivation for doing so is to protect the acoustic coupling surface, the window covers and the hydrogel, as suggested by Madsen (Column 6, lines 15-23).
Claims 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Madsen et al. (US 4277367 A), hereafter Madsen ‘367, in view of Sanderson et al. (US 4647470 A).
Considering claim 13 Madsen ‘367 discloses a method of producing an ultrasound phantom (Abstract), the method comprising:
- producing a dispersion liquid by mixing water, a first polysaccharide, and an ultrasonic scatterer (Column 3, line 61 – Column 4, line 35; Column 8, lines 1-19);
- causing the dispersion liquid to solate by increasing a temperature thereof (Column 3, lines 64-66); and
- causing the dispersion liquid that has solated to gelate by reducing a temperature thereof (Column 4, lines 4-9).
The invention by Madsen ‘367 discloses the use of at least one polysaccariade, but fails to explicitly disclose that the dispersion liquid includes a first polysaccharide containing a glucose residue in a main chain thereof, and a mannose residue and a glucuronic acid residue in a side chain thereof, and a second polysaccharide containing a mannose residue in a main chain thereof and a galactose residue in a side chain thereof.
However, Sanderson teaches the formation of a congealed gelatin having a first polysaccharide containing a glucose residue in a main chain thereof, and a mannose residue and a glucuronic acid residue in a side chain thereof (xanthan; Column 2, lines 63-68), and a second polysaccharide containing a mannose residue in a main chain thereof and a galactose residue in a side chain thereof (galactomannan; Column 2, lines 63-68).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize a first and second polysaccharide, as taught by Sanderson, in the invention by Madsen ‘367. The motivation for doing so is to provide a desired amount of elasticity and brittleness to the phantom of Madsen to mimic different parts of the body.
Considering claim 14, Madsen ‘367 discloses determining the speed of sound through the gelation and attenuation coefficients thereof, but fails to disclose during the causing the dispersion liquid to gelate, or after the causing the dispersion liquid to gelate, obtaining a stress-strain curve by subjecting the dispersion liquid that has gelated to a compression test.
However, Sanderson teaches during the causing the dispersion liquid to gelate, or after the causing the dispersion liquid to gelate, obtaining a stress-strain curve by subjecting the dispersion liquid that has gelated to a compression test (Column 1, line 64 – Column 2, line 44; Column 3, line 52 – Column 4, lines 30, gelation occurs to make the sample gels which are then tested for hardness, modulus, brittleness and elasticity).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to obtain a stress-strain curve by subjecting the dispersion liquid that has gelated to a compression test, as taught by Sanderson, in the invention by Madsen ‘367. The motivation for doing so is to provide a quantitative measure that correlates closely with a sensory perception of the sample’s firmness, as suggested by Sanderson (Column 2, lines 8-9).
Considering claim 15, the claimed rationale for obtaining the stress-strain curve, specifically that it is “performed so that information on whether or not a compressive stress monotonically increases at a compressive strain of 0% or more and 50% or less is obtained”, amounts to merely an intended use. There is no additional structural or functional limitation added by this clause.
A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Given that Madsen ‘367, as modified by Sanderson, has already shown the step of obtaining the stress-strain curve, then the combination is capable of providing the intended use, and the claim is rejected under the same rationale as claim 14, above.
Allowable Subject Matter
Claims 6-8 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Considering claim 6, the prior art made of record fails to disclose, suggest or otherwise render obvious the subject matter of a hydrogel containing 0.3 part by mass or more of the first polysaccharide and 0.3 part by mass or more of the second polysaccharide with respect to 94 parts by mass of the water, and a total of the first polysaccharide and the second polysaccharide is between 0.6-3.0 parts by mass.
The invention by Sanderson is the closest art of record, but fails to disclose the corresponding parts ratio of polysaccharides and water by mass.
Considering claim 8, the prior art made of record fails to disclose, suggest or otherwise render obvious the subject matter of a viscosity of a sol liquid of a mixture obtained by increasing a temperature of a hydrogel to a temperature equal to or more than a solation temperature is measured with a rotational viscometer at 700C, a viscosity thereof at a rotational speed of 0.1 sec-1 is between 3-300 Pa∙s, and the viscosity at a rotational speed of 0.1 sec-1 is 3.0 or more times as high as a viscosity thereof at a rotational speed of 1.0 sec-1.
The invention by Sanderson is the closest art of record, but fails to discuss the viscosity measurements.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Jacobs et al. (US 20150140113 A1) discloses a gelling agent containing water with at least 40 wt%, xanthan gum in 0.1 to 1.0 wt%, and locust bean gum in 0.1 to 1.0 wt%, wherein the Young’s modulus is between .01-.095 kPa.
Ogata et al. (JP 2004105031 A) discloses a jelly-like agent made with xanthan gum, locust bean gum and water, at least, whereby the storage elastic modulus is 0.005-.150 kPa.
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/JONATHAN M DUNLAP/Primary Examiner, Art Unit 2855 March 19, 2026