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 .
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 (i.e., changing from AIA to pre-AIA ) 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.
Claim(s) 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Suetoshi et al (Pub. No.: US 2015/0164467).
Regarding claims 1, 3, Suetoshi et al disclose an apparatus for producing sonographic images of tissue below a patient’s intact skin, comprising:
an emitter (wave transmission oscillator 21/22) configured to emit sound waves at an intermediate frequency of about 10 MHz [see 0059] when activated [see 0080-0081, 0089] by disclosing the ultrasonic waves are sent out by the dedicated wave transmission oscillator 21 until the oscillators 24 receive the surface propagation waves [see 0080-0081];
a receiver (oscillators 24) configured to received returned sound waves vibrations, and convert the vibrations into electrical pulses [see 0080-0081, 0092] the reflected waves thereof are received by the oscillators 24 [see 0080];
processor (computer 35) coupled to the receiver (24) [see 0092] by disclosing waveform signals corresponding to the ultrasonic waves received by the oscillators 24 are sent to the computer 35 [see 0092] and configured to:
receive electrical pulses from the receiver [see 0092] by disclosing waveform signals corresponding to the ultrasonic waves received by the oscillators 24 are sent to the computer 35 [see 0092] and computer 35 functions as the waveform tracker 36, and tracks the echoes of surface reflected waves from the cortical bone 10 in these waveform signals, and thereby finds the timing at which the reflected waves from the surface of the cortical bone 10 were received [see 0092];
and configured to:
determine the length of time for the sound waves to return [see 0080-0081, 0083, 0092, 0150] by disclosing the resulting waveform signals are analyzed, which gives the timing at which the ultrasonic waves reflected at the surface of the cortical bone 10 was received by the oscillators 24 (S101, S102) [see 0080] and computer 35 functions as the waveform tracker 36, and tracks the echoes of surface reflected waves from the cortical bone 10 in these waveform signals, and thereby finds the timing at which the reflected waves from the surface of the cortical bone 10 were received [see 0092];
determine the intensity (amplitude) of the returned sound waves [see 0071, 0150-0153];
generate a sonography image [see 0023, 0047, 0157-0160].
Regarding claim 2, Suetoshi et al disclose a display configured to receive the sonography image and provide the sonography image on the display [see 0023, 0047, 0157-0160].
Regarding claim 4, Suetoshi et al disclose wherein the one or more sonographic characteristics is selected from the group consisting of unclear layered structure, hypoechoic lesion, discontinuous fascia, and heterogeneous hypoechoic area [see 0092] by disclosing waveform signals may include not only surface reflected waves from the cortical bone 10, but also other reflected waves (such as echoes from a fascia, defects in the soft tissue, etc.) [see 0092].
Claim(s) 16-17, 19-20, 23, 34-35, 37-39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mendlein et al (US Pat: 6, 013, 031)
Regarding claims 16, 34, Mendlein et al disclose a method of stratifying a plurality of patients in a care facility based on care levels, the method comprising the steps of:
obtaining a sonography image of a patient in the plurality of patients at one or more body locations selected for monitoring [see column 27 lines 36-45; column 23 lines 56-58] by disclosing place the probe to transmit a series of pulses to measure layer thickness accurately by generating an image [see column 27 lines 36-45] and two-dimensional gray-scale images of the heel are obtained at the measurement site. The distance from the probe/skin interface to the soft tissue/bore interface, i.e. the soft tissue thickness, is measured on the medial and the lateral side of the heel at the measurement site [see column 32 lines 41-43];
determining whether a sonographic characteristic of tissue damage is present in the sonography image [see column 15 lines 38-40] by disclosing the absence or change in signals will be indicative of the presence of structures in the path that remove or alter the transmitted ultrasonic signal [see column 15 lines 38-40];
determining a care level of N care levels that corresponds to the number and type of sonographic characteristic present [see column 21 lines 49-55] by disclosing identify population with an increased or decreased risk of bone fracture, particularly the fracture of the hip, spine, or long bones [see column 21 lines 49-55];
assigning the care level to the patient based on step (c) [see column 21 lines 49-55] by disclosing identify population with an increased or decreased risk of bone fracture, particularly the fracture of the hip, spine, or long bones [see column 21 lines 49-55];
arranging the patient of the plurality of patients into groups based on the patient’s assigned care levels [see column 21 lines 5-20]
Regarding claims 17, 35, Mendlein et al disclose wherein the sonographic characteristic is selected from the group consisting of unclear layered structure, hypoechoic lesion, discontinuous fascia, and heterogeneous hypoechoic area [see column 31 lines 45-48] by disclosing a representative image displaying the various tissue layers, e.g. skin, subcutaneous fat and bone, on the display monitor [see column 31 lines 45-48].
Regarding claims 19, 38, Mendlein et al disclose wherein the one or more body locations is selected from the group consisting of a sternum, a sacrum, a heel, a scapula (os latum scapularum), an elbow, an ear, and other fleshy tissues over a bony prominence of a patient [see column 32 lines 41-43 and figs 5A-6B].
Regarding claim 20, 39, Mendlein et al disclose wherein the one or more body locations comprises an anatomical site in long-term contact with a medical device [see figs 5A-6B, see column 43 lines 30-31].
Regarding claim 23, 37, Mendlein et al disclose wherein assigning a care level to the patient is based on a change in the presence of unclear layered structure over a period of two weeks [see column 43 lines 30-31].
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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 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.
Claim(s) 21, 40 are rejected under 35 U.S.C. 103 as being unpatentable over Mendlein et al (US Pat: 6, 013, 031) in view of Rico et al (Pub. No.: US 2010/0158332).
Regarding claims 21, 40, Mendlein et al don’t disclose the one or more body locations is selected from the group consisting of a cheek, a nose, a chest, a stomach, and a lower abdomen area.
Nonetheless, Rico et al disclose one or more body locations is selected from the group consisting of a cheek, a nose, a chest [see 0067], a stomach, and a lower abdomen area
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Mendlein et al and Rico et al by interrogating the chest area; so that regions this area can be assessed,
Claim(s) 18, 22, 36 are rejected under 35 U.S.C. 103 as being unpatentable over Mendlein et al (US Pat: 6, 013, 031) in view of Takagi (Pub. No.: US 2020/0104997).
Regarding claims 18, 22, 36, Mendlein et al don’t disclose wherein assigning a care level to the patient is based on the presence or absence of discontinuous fascia.
Nonetheless, Takagi discloses assigning a care level to the patient is based on the presence or absence of discontinuous fascia [see 0012, 0025, 0034, 0041, 0107, 0109, 0118].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Mendlein et al and Takagi by assigning a care level to the patient is based on the presence or absence of discontinuous fascia; for accuracy purposes.
Conclusion
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/JOEL F BRUTUS/ Primary Examiner, Art Unit 3798