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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d).
Information Disclosure Statement
The information disclosure statement (IDS) submitted on March 26, 2025 and June 06, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings filed on March 26, 2025 are accepted.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3, 5, 6 and 13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 3 recites that one glucose residue of the cellulose ether is modified with a derivative group at a proportion range that renders the scope of the claim indefinite. It is unclear (1) what it means by having a alkoxy substitute modification at a non-integer number, and (2) what it means by the modification being at a proportion of a range, i.e., it is unclear what the proportion refers to. Note that in the specification, PG Pub US 2025/0302450 A1, [0025] discloses that “as for an average number of the alkoxy groups contained in one glucose residue, it is preferable for methoxy group to be 0.4 to 2.4 groups….. Hence, to in-line with the disclosure, claim 3 is interpreted such that the claimed range refers to an average alkoxy group that one glucose residue is modified within the cellulose ether.
Claims 5, 6 and 13 recite the term “storage elastic modulus”. It is unclear whether it refers to the commonly used term “elastic storage modulus”. Clarification is required.
Claims 5 and 6 recite “a storage elastic modulus at a frequency…”. Claim 13 recites “frequency-storage elastic modulus” that renders the scope of the claims indefinite. The parameters of “frequency” and “storage elastic modulus” is not defined. In specific, it is unclear whose frequency it refers to. It is unclear whose storage elastic modulus it refers to. It is unclear which object the dynamic shear viscoelasticity measurement is performed upon.
The dependent claims of the above rejected claims are rejected due to their dependency.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 7-9 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Demitri et al., “Hydrogel Based Tissue Mimicking Phantom for IN-Vitro Ultrasound Contrast Agents Studies”. Journal of Biomedical Materials Research Part B: Applied Biomaterials, 2008, 87B: 338-345, hereinafter Demitri.
Claim 1. Demitri teaches a hydrosol to be applied to an ultrasound phantom (Title: hydrogel based tissue mimicking phantom for in-vitro ultrasound contrast agent studies), comprising:
water, cellulose ether, and a sound velocity adjusting agent (p.339, Col. Left, MATERIALS AND METHODS, Hydrogels Preparation, ¶-2: Cellulose-based hydrogel was obtained by crosslinking water-based mixture of carboxymethylcellulose sodium salt (CMCNa) and hydroxyethylcellulose (HEC), using divinylsulphone (DVS) as crosslinking agent. CMCNa is a cellulose ether, where substitutive groups are methyl carboxylic groups…HEC is a cellulose ether, where substitutive groups are oxyethylene chains (Figure 1)…First, liquid DVS has been added to the distilled water, stirring gently at room temperature till complete dissolution. The mixture of CMCNa and HEC has been added to the DVS water solution till a concentration of 2% by weight; and p.342, Col. Left, RESULTS: Table 1 presents a density values for cellulose-based hydrogel with varying CMCNa/HEC weight ratios (3/1, 2/1, 1.5/1, 1/1, and 1/1.5). Therefore, the corresponding values for the measured sound velocity are reported, Table 1. Column u shows different sound wave velocity for different cellulose sample numbers) – in the above taught composition, both CMCNa and HEC are cellulose ether, upon varying their weight ratios the sound velocity is adjusted, hence, one of them may be considered a base cellulose ether, and the other is the “sound velocity adjusting agent” as claimed.
Further, the composition of HEC in water makes it a hydrosol.
Claim 2. Demitri further teaches that
the cellulose ether has a hydroxy group derived from a glucose residue substituted with at least one selected from the group consisting of a methoxy group, a hydroxyethoxy group and a hydroxypropoxy group (HEC is a cellulose ether, where substitutive groups are oxyethylene chains (Figure 1); and FIG.1: the illustrated cellulose derivatives include R being CH2CH2O and/or CH2CH2OH).
Claim 7. Demitri further teaches
a container which has a retaining portion that is in contact with the hydrosol and retains a shape of the hydrosol, and accommodates the hydrosol (p.341, Col. Left, Phantom Preparation: the cellulose-based hydrogel solution was placed in the box for the crosslinking process; and FIG.3: the cellulose-based hydrogel set to the shape of the container where it is placed).
Claim 8. Demitri further teaches that
the hydrosol has an acoustic coupling surface for acoustically being coupled with an acoustic probe (p.342, Col. Left, ¶-1: The US transducer…was positioned using a coupling gel on the top of the phantom, so that the imaging plane resulted perpendicular to the vessels; FIG.4: the top surface of the phantom where the US probe is applied onto is the “acoustic coupling surface” as claimed), and
the container has the retaining portion at a position different from the acoustic coupling surface (p.341, Col. Left, Phantom Preparation: a Plexiglas’s box (opened on the top)…the cellulose-based hydrogel solution was placed in the box for the crosslinking process) – as the box has an opening on the top, it teaches that the top surface of the phantom is the coupling surface, and the remaining portion of the box is positioned around the rest of the surfaces of the phantom.
Claim 9. Demitri further teaches
an acoustic wave reducing portion that reduces a reflection of an acoustic wave emitted from the acoustic coupling surface, at a position facing the acoustic coupling surface through the hydrosol (p.341, Col. Left, Phantom Preparation, ¶-2: To limit acoustic wave reflection into the box during the US analysis, a thin layer of polyurethane is placed on the bottom internal surface of the box) – the bottom internal surface is a surface that faces to the top, hence facing the acoustic coupling surface.
Claim 12. Demitri teaches a method for manufacturing an ultrasound phantom (Title: hydrogel based tissue mimicking phantom for in-vitro ultrasound contrast agent studies; p.339, Col. Left: Hydrogels Preparation) comprising:
producing a mixed liquid in which water, cellulose ether and a sound velocity adjusting agent are mixed; producing a hydrosol by stirring and mixing the mixed liquid (p.339, Col. Left, MATERIALS AND METHODS, Hydrogels Preparation, ¶-2: Cellulose-based hydrogel was obtained by crosslinking water-based mixture of carboxymethylcellulose sodium salt (CMCNa) and hydroxyethylcellulose (HEC), using divinylsulphone (DVS) as crosslinking agent. CMCNa is a cellulose ether, where substitutive groups are methyl carboxylic groups…HEC is a cellulose ether, where substitutive groups are oxyethylene chains (Figure 1)…First, liquid DVS has been added to the distilled water, stirring gently at room temperature till complete dissolution. The mixture of CMCNa and HEC has been added to the DVS water solution till a concentration of 2% by weight; and p.342, Col. Left, RESULTS: Table 1 presents a density values for cellulose-based hydrogel with varying CMCNa/HEC weight ratios (3/1, 2/1, 1.5/1, 1/1, and 1/1.5). Therefore, the corresponding values for the measured sound velocity are reported, Table 1. Column u shows different sound wave velocity for different cellulose sample numbers) – in the above taught composition, both CMCNa and HEC are cellulose ether, upon varying their weight ratios the sound velocity is adjusted, hence, one of them may be considered a base cellulose ether, and the other is the “sound velocity adjusting agent” as claimed; and
pouring the hydrosol into a container (p.341, Col. Left, Phantom Preparation: the cellulose-based hydrogel solution was placed in the box for the crosslinking process; and FIG.3: the cellulose-based hydrogel set to the shape of the container where it is placed).
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 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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Demitri et al., “Hydrogel Based Tissue Mimicking Phantom for In-Vitro Ultrasound Contrast Agents Studies”. Journal of Biomedical Materials Research Part B: Applied Biomaterials, 2008, 87B: 338-345, hereinafter Demitri.
Claim 3. Demitri further teaches that
one glucose residue of the cellulose ether is modified with a methoxy group at a proportion of 0.4 or larger and 2.4 or smaller, with a hydroxyethoxy group at a proportion of 0 or larger and 0.6 or smaller, and with a hydroxypropoxy group at a proportion of 0 or larger and 0.5 or smaller, on average (FIG.1: in any given glucose residue, the possible number of substitution is 0-3 (up to all three Rs are substituted), hence making the average number of substitution of the substitution in the cellulose ether to be 0-3 per glucose residue).
The range of 0-3 substantially overlaps with the range of 0.4-2.4 for the substitution of a methoxy group, and encompasses the range of 0 to 0.6 for a hydroxyethoxy group, and the range of 0 to 0.5 for a hydroxypropoxy group. 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) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms" considered prima facie obvious in view of prior art reference teaching that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." The court stated that "by stating that ‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range."). See also In re Bergen, 120 F.2d 329, 332, 49 USPQ 749, 751-52 (CCPA 1941) (The court found that the overlapping endpoint of the prior art and claimed range was sufficient to support an obviousness rejection, particularly when there was no showing of criticality of the claimed range). See MPEP 2144.05.I.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Demitri, further in view of Wilström et al., “Surface Treatment of cellulose ethers”. Institutionen Ingenjörshögskolan, 2014, hereinafter Wilström.
Claim 4. Demitri teaches all the limitations of claim 1, including the hydrosol that comprises cellulose ether (p.339, Col. Left, MATERIALS AND METHODS, Hydrogels Preparation, ¶-2).
Demitri does not teach that the cellulose ether is surface-treated with glyoxal.
However, in an analogous cellular ether preparation field of endeavor, Wilström teaches that
the cellulose ether is surface-treated with glyoxal (p.4, Abstract, ¶-1: in order for the cellulose ether to dissolve without forming lumps, some surface treatment is commonly required. In this work glyoxal has been used for this surface modification).
PP.6-34 of Wilström teaches further details in regard to the surface treatment methods for cellulose ether with glyoxal.
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the cellulose ether of Demitri employ such a feature of being surface treated with glyoxal as taught in Wilström as “a commonly required surface treatment” for the advantage of “for the cellulose ether to dissolve without forming lumps”, as suggested in Wilström, p.4, Abstract, ¶-1.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Demitri, further in view of Zhang et al., US 2022/0406222 A1, hereinafter Zhang.
Claim 10. Demitri teaches all the limitations in claim 1, including the ultrasound phantom being placed in a container (p.341, Col. Left, Phantom Preparation: the cellulose-based hydrogel solution was placed in the box for the crosslinking process).
Demitri does not teach that the container comprises: a lid portion facing the acoustic coupling surface; the retaining portion; and a main body portion fastened to the lid portion.
However, in an analogous imaging phantom setting configuration field of endeavor, Zhang teaches
a lid portion facing the acoustic coupling surface; the retaining portion; and a main body portion fastened to the lid portion ([0042]: the chamber 102, the tissue phantom 100, the cover 106; the silicon-based sealant…During testing, the cover 106 will be coupled to the chamber by the removable sealant; and FIG.1) – in FIG.1, the chamber 102 is the main body that is fastened to the cover 106 via the layer of silicon-based sealant 112. The space that holds the tissue phantom 100 is the retaining portion.
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the container of Demitri employ such a feature of comprising a lid portion facing the acoustic coupling surface; the retaining portion; and a main body portion fastened to the lid portion, as taught in Zhang for providing a detailed configuration of the container that holds the tissue phantom, as suggested in Zhang, FIG.1.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Demitri, further in view of Oraevsky et al., US 9,655,594 B2, hereinafter Oraevsky.
Claim 11. Demitri teaches all the limitations of claims 1 and 7.
Demitri further teaches a first cellulose either and a second cellulose ether that have different average molecular weights, i.e., a second ultrasound phantom that comprises a second cellulose ether having an average molecular weight different from the average molecular weight of the cellulose ether, water, a sound velocity adjusting agent (p.342, Col. Left, RESULTS: Table 1 presents a density values for cellulose-based hydrogel with varying CMCNa/HEC weight ratios (3/1, 2/1, 1.5/1, 1/1, and 1/1.5). Therefore, the corresponding values for the measured sound velocity are reported, Table 1. Column r shows different density, hence different average MW for different cellulose sample numbers).
Demitri does not teach that these different cellulose material are configured as a first and a second ultrasound phantom.
However, in an analogous hydrogel-based tissue imaging phantom configuration field of endeavor, Oraevsky teaches such a feature in Claim 19: a phantom for medical imaging, comprising: a first hydrogel with a first predefined proportion of gelatin to water ad at least one first additive…a second hydrogel with a second predefined proportion of gelatin to water and at least one second additive; and FIG.23A, Panel A: the phantoms are retained in a container - Different proportion of gelatin to water results in different average molecular weight.
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the phantom of Demitri employ such a feature of comprising a second ultrasound phantom that comprises a second cellulose ether having an average molecular weight different from the average molecular weight of the cellulose ether, water, a sound velocity adjusting agent, as taught in Oraevsky for the advantage of having the properties of each hydrogel to match with different tissue types/portions as needed, as suggested in Oraevsky, Claim 19.
Both Demitri and Oraevsky teach that the tissue phantom is placed in a container. Whether both the first and the second tissue phantoms are placed in the same container, as taught by Oraevsky, or in different containers, i.e., the first container and the second container as recited in the claim, is considered among various common practices that normally requires only ordinary skill in the art and hence are considered routine expedients. Such an alternate configuration is considered merely duplication of parts, which the court has held normally require only ordinary skill in the art and hence is considered routine expedients. It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to arrive such a configuration through routine experimentation with reasonable expectation of success. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) (Claims at issue were directed to a water-tight masonry structure wherein a water seal of flexible material fills the joints which form between adjacent pours of concrete. The claimed water seal has a "web" which lies in the joint, and a plurality of "ribs" projecting outwardly from each side of the web into one of the adjacent concrete slabs. The prior art disclosed a flexible water stop for preventing passage of water between masses of concrete in the shape of a plus sign (+). Although the reference did not disclose a plurality of ribs, the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced.). MPEP 2144.04.VI.B.
Allowable Subject Matter
Claims 5, 6 and 13 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include 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:
The limitation recited in claim 5 in regard to the features of “in dynamic shear viscoelasticity measurement at 25*C, when a storage elastic modulus at a frequency of 2.5 Hz is represented by G'2.5 and a storage elastic modulus at a frequency of 0.25 Hz is represented by G'o.25, G'2.5/G'o.25 is 2.0 or larger and 15 or smaller", in combination with the other claimed elements, is not taught or disclosed in the prior arts.
The limitation recited in claim 5 in regard to the features of “in dynamic shear viscoelasticity measurement at 25*C, when a storage elastic modulus at a frequency of 2.5 Hz is represented by G'2.5 and a storage elastic modulus at a frequency of 0.25 Hz is represented by G'o.25, G'2.5/G'o.25 is 2.0 or larger and 10 or smaller", in combination with the other claimed elements, is not taught or disclosed in the prior arts.
The limitation recited in claim 5 in regard to the features of “measuring a dynamic shear viscoelasticity of the hydrosol after the stirring, and thereby acquiring a curve of frequency-storage elastic modulus”, in combination with the other claimed elements, is not taught or disclosed in the prior arts.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YI-SHAN YANG whose telephone number is (408)918-7628. The examiner can normally be reached Monday-Friday 8am-4pm PST.
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, Pascal M Bui-Pho can be reached at 571-272-2714. 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.
/YI-SHAN YANG/Primary Examiner, Art Unit 3798