DETAILED ACTION
Abstract
The abstract of the disclosure is objected to because it is unclear due to apparent syntax or antecedent errors. Going forward with examination, the abstract is interpreted to be (Note that in applicant’s response, where a change is requested in the abstract, a separate page of the abstract containing the change will be needed):
--A phantom has a structure that, when subject to [[a]] B-mode ultrasound, is configured to generate return waves that mimic return waves produced by muscle tissue when subjected to B-mode ultrasound. The phantom has a longitudinal axis. The structure includes a first material. The structure defines a plurality of regions free of the first material along a first transverse axis perpendicular to the longitudinal axis.--
Correction is required. See MPEP § 608.01(b).
Specification
The disclosure (specification) is objected to because it is unclear due to apparent syntax or antecedent errors. Going forward with examination, the following specification paragraphs are interpreted to be (Note that in applicant’s response, where a change is requested in the specification, an entire paragraph of the specification containing the change will be needed):
--[0005] Disclosed herein is phantom that has a structure that, when subject to [[a]] B-mode ultrasound, is configured to generate return waves that mimic return waves produced by muscle tissue when subjected to B-mode ultrasound. The phantom has a longitudinal axis. The structure includes a first material. The structure defines a plurality of regions free of the first material along a first transverse axis perpendicular to the longitudinal axis.--
--[0028] Disclosed herein, and with reference to FIGS. 1A-6, are phantoms 10 for generating outputs of an ultrasound scan that mimic return waves produced by muscle tissue when subjected to B-mode ultrasound. Accordingly, the phantom 10 can have a structure 12 that, when subject to [[a]] B-mode ultrasound, is configured to generate return waves that mimic return waves produced by muscle tissue when subjected to B-mode ultrasound.--
--[0035] Referring also to FIG. 6, the structure 12 can comprise walls 34 extending through the walls 34 of adjacent walls of adjacent passages can be axially offset from each other. Accordingly, the structure 12 can have a latticed profile.--
Appropriate correction is required.
Claim Objections
Claims 1 and 20 are objected to because they are unclear due to apparent syntax or antecedent errors. Going forward with examination, the claims are interpreted to be:
` --1. A phantom comprising:
a structure that, when subject to [[a]] B-mode ultrasound, is configured to generate return waves that mimic return waves produced by muscle tissue when subjected to B-mode ultrasound.--
--20. A method comprising:
immersing the phantom of claim 1 in water;
subjecting the phantom to [[a]] B-mode ultrasound; and
capturing return waves generated by the phantom.--
Appropriate correction is required.
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, 15-16 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Betrouni et al. (US 2014/0306126 A1; hereinafter “Betrouni”).
Betrouni teaches:
A phantom (3) comprising (See figs. 2, 6c, reproduced below):
a structure (3) that, when subject to B-mode ultrasound (Pars. 0054, 0120), is configured to generate return waves (to produce a 2D cross-sectional ultrasonic image shown in fig. 6c, for example) that mimic return waves produced by muscle tissue (e.g., of a prostate) when subjected to B-mode ultrasound (Abstract; Pars. 0015, 0050, 0054, 0120. Note that the phantom 3 mimics a human prostate and is used to validate and/or optimize new therapies, for example; Par. 0004).
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15. The phantom of claim 1, wherein the phantom 3 (made of thermoformable plastic ABS-M30; Par. 0073) does not have an internal structure that physically resembles muscle.
16. The phantom of claim 1, wherein the phantom (3) has a length from 20 mm to 100 mm (which may be a length of a prostate that the phantom 3 may mimic).
19. A method comprising:
forming the phantom (3) of claim 1 by 3D printing (Pars. 0064; 0073-0074).
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 1, 15-16 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Geiger et al. (US 10,481,234 B2; hereinafter “Geiger”).
Geiger teaches a phantom (18) comprising (See figs. 1, 2, reproduced below):
a structure (18) that
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Geiger doesn’t expressly teach that the structure (18) is subject to B-mode ultrasound to generate return waves that mimic return waves produced by the muscle tissue when subject to B-mode ultrasound.
However, it appears that anyone may (and ought to be allowed) to subject the structure (18) to any mode of ultrasound, including but not limited to B-mode ultrasound (if or whenever one wants to). Subjecting the structure (18) to B-mode ultrasound (or any other mode of ultrasound) appears to be just an intended use unpatentable. B-mode ultrasound is known to produce a 2D cross-sectional ultrasonic image.
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the present application to have the structure (18) subject to B-mode ultrasound to generate return waves that mimic return waves produced by the muscle tissue when subject to B-mode ultrasound, so as to produce a 2D cross-sectional image of the structure (18) mimicking or emulating the muscle tissue, for example.
15. Geiger as modified teaches the phantom of claim 1, wherein the phantom 18 (made of plastic, resin, metal, etc., with different shapes, etc., not naturally occurring in an organ; Col. 5, lines 4-12; Col. 6, lines 26-67) does not have an internal structure that physically resembles muscle.
16. Geiger as modified teaches the phantom of claim 1, wherein the phantom (18) has a length from 20 mm to 100 mm (which may be a length of a muscle that the phantom 18 may mimic).
19. Geiger as modified teaches a method comprising:
forming the phantom (18) of claim 1 by 3D printing (as shown at least in figs. 1, 2).
Claims 1-2, 9 and 11-18 are rejected under 35 U.S.C. 103 as being unpatentable over Keegan (US 7,255,565).
Keegan teaches a phantom (10) comprising (See figs. 1, 2, reproduced and annotated below below):
a structure (10) that
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Keegan doesn’t expressly teach that the structure (10) is subject to B-mode ultrasound to generate return waves that mimic return waves produced by the muscle tissue when subject to B-mode ultrasound.
However, it appears that anyone may (and ought to be allowed) to subject the structure (10) to any mode of ultrasound, including but not limited to B-mode ultrasound (if or whenever one wants to). Subjecting the structure (10) to B-mode ultrasound (or any other mode of ultrasound) appears to be just an intended use unpatentable. B-mode ultrasound is known to produce a 2D cross-sectional ultrasonic image.
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the present application to have the structure (10) subject to B-mode ultrasound to generate return waves that mimic return waves produced by the muscle tissue when subject to B-mode ultrasound, so as to produce a 2D cross-sectional image of the structure (10) mimicking or emulating the muscle tissue, for example.
Keegan as modified teaches the phantom of claim 1, wherein the phantom (10) has a longitudinal axis, wherein the structure (10) comprises a first material (11+25; Figs. 1, 2 above), and wherein the structure (10) defines a plurality of regions (inside hollow rods or conduits 27, 33, 33’) free of the first material (11+25) along a first transverse axis perpendicular to the longitudinal axis (Note that the plurality of regions inside the hollow rods or conduits 27, 33, 33’ may be empty, or may be filled with a liquid or material that simulates natural fluid or material, to simulate blood vessels, for example; Abstract; Col. 2, lines 35-45; Col. Col. 4, lines 54- 61; Col. 5, lines 36-37).
9. Keegan as modified teaches the phantom of claim 2, wherein the structure (10) comprises a body (27, 33, 33’) defining a plurality of longitudinally extending passages (27, 33, 33’) that define the plurality of regions free of the first material 11+25 (as is evident from the discussion above in claim 2; Abstract; Col. 2, lines 35-45; Col. 5, lines 36-37).
11. Keegan as modified teaches the phantom of claim 9, wherein the plurality of longitudinally extending passages (27, 33, 33’) have an inscribed diameter from about 1 mm to about 4 mm (which may be an inscribed diameter of a blood vessel to be mimicked. See discussion above in claim 2).
12. Keegan as modified teaches the phantom of claim 9, wherein the structure (10) comprises walls defining the longitudinally extending passages (27), wherein the structure (10) defines transverse openings (33, 33’) extending through the walls of the longitudinally extending passages 27 (as is evident from at least fig. 2).
13. Keegan as modified teaches the phantom of claim 2, wherein the plurality of regions free of the first material are full of a gas or liquid (as is evident from the discussion above in claim 2; Abstract; Col. 2, lines 35-45; Col. Col. 4, lines 54- 61; Col. 5, lines 36-37).
14. Keegan as modified teaches the phantom of claim 2, wherein the plurality of regions free of the first material are full of a second solid material that is different from the first material (as is obvious from the discussion above in claim 2; Abstract; Col. 2, lines 35-45; Col. Col. 4, lines 54- 61; Col. 5, lines 36-37).
15. Geiger as modified teaches the phantom of claim 1, wherein the phantom 18 (made of plastic, resin, metal, etc., with different shapes, etc., not naturally occurring in an organ; Col. 5, lines 4-12; Col. 6, lines 26-67) does not have an internal structure that physically resembles muscle.
16. Geiger as modified teaches the phantom of claim 1, wherein the phantom (18) has a length from 20 mm to 100 mm (which may be a length of a muscle to be mimicked).
17. Geiger as modified teaches the phantom of claim 2, wherein the first material (11+25) comprises photocured elastic resin (or an equivalent “thermoplastic elastomer;” Abstract; Col. 2, lines 15-21; Col. 3, lines 33-35).
18. Keegan as modified teaches the phantom of claim 2, wherein the first material has a hardness from about 40 to about 60 on the shore A durometer scale (which may be determined or optimized through routine experimentation to mimic, emulate, or simulate the muscle tissue. Note that it has been held that optimization within prior art conditions or through routine experimentation is an obvious variation of a known structure, thus uninventive and unpatentable. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over either Betrouni, Geiger, or Keegan, as applied to claim 1 above, and further in view of Parker et al. (US 6,720,766 B2; hereinafter “Parker”).
Betrouni, Geiger, or Keegan, teaches a method comprising:
subjecting the phantom of claim 1 to B-mode ultrasound; and
capturing return waves generated by the phantom (See discussion above in respective claim 1).
Betrouni, Geiger, or Keegan, is silent about: immersing the phantom in water.
Parker teaches immersing a phantom (24) in water, for assessing performance of an ultrasound imaging system (See fig. 1, reproduced below; Col. 1, lines 15-23).
The phantom (24) mimics a human tissue of which ultrasonic images are made in a medical ultrasound operation (Col. 5, lines 27-31).
The ultrasonic system comprises an ultrasound transducer (14) for generating return waves produced by the phantom (24) mimicking the human tissue. The bottom of the ultrasound transducer (14) is located at and in the plane of the water line (12), much in the same way as the ultrasonic transducer (14) would be located on a surface of a skin of a patient during a medical ultrasound operation (Col. 4, lines 41-59).
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It would have been obvious to one ordinarily skilled in the art before the effective filing date of the present application to apply Parker teaching to Betrouni, Geiger, or Keegan method by immersing the phantom in water. The bottom of an ultrasound transducer in Betrouni, Geiger, or Keegan would be located at and in the plane of the water line, much in the same way as the ultrasonic transducer would be located on a surface of a skin of a patient during a medical ultrasound operation, so as to assess performance of a respective ultrasound imaging system.
Allowable Subject Matter
Claims 3-8 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 would be a statement for indication of an allowable subject matter:
With respect to claim 3, prior art of record doesn’t teach, suggest, or render obvious the total combination of the recited features, including the following allowable subject matter: “…wherein the plurality of regions (16) free of the first material (14) are defined by spaces between the plurality of rods (20).”
(Claims 4-8 are dependent on claim 3.)
With respect to claim 10, prior art of record doesn’t teach, suggest, or render obvious the total combination of the recited features, including the following allowable subject matter: “…wherein the plurality of longitudinally extending passages (32) are hexagonal in cross sections perpendicular to the longitudinal axis (4).”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nguyen (Wyn) Q. Ha whose telephone number is (571) 272-2863, email: nguyenq.ha@uspto.gov. The examiner can normally be reached Monday - Friday 8 am - 4:30 pm (Eastern Time).
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/Nguyen Q. Ha/Primary Examiner, Art Unit 2853 September 15, 2026
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