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 (IDS) submitted on 12/02/2025 and 01/08/2026 has been considered by the examiner.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/08/2026 has been entered. Claims 1-27 remain pending in the application.
Response to Amendment
Claims 1-27 remain pending in the application in response to the applicant’s amendments to the rejections previously set forth in the Final Office Action mailed 08/13/2025.
Response to Arguments
Applicant’s arguments filed 01/08/2026 with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 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.
Claims 1-11, 17-20, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Vilkomerson (US 6346081 B1, published February 12, 2002) in view of Slayton et al. (US 5175709 A, published December 29, 1992) and Eibl et al. (US 20170332995 A1, published November 23, 2017), hereinafter referred to as Vilkomerson, Slayton, and Eibl, respectively.
Regarding claim 1, and similarly for claims 17 and 27, Vilkomerson teaches a portable ultrasound device for non-invasively imaging a selected sub-cutaneous structure in a subject, comprising:
(a) a housing (transducer elements within the housing of a probe for imaging is inherent and known in the art);
(b) a plurality of arrays of transducer elements, each array being obliquely angled with respect to a surface of the skin of the subject and arranged in parallel and each transducer element comprising a transmitter transducer and a receiver transducer (see col. 4, lines 34-38 – “As shown in FIG. 3A-3D, by using four conventional CW transducers, each pair with a small dihedral angle α and a larger angle B in the Orthogonal direction, two sets of CW measurement with different insonation angles can be obtained.”),
located within said housing for continuously transmitting ultrasound energy in a predetermined frequency range toward a body of a subject and continuously receiving echo signals in a predetermined frequency range from the body of the subject following reflection of ultrasound energy (see col. 7, lines 38-43 – “For example, in FIG. 3A-D, if transducer 1 is driven at frequency f1 and transducer 2 receives the blood-Scattered signal from the Overlap region 25 shown, and the Doppler-shift is measured, and then transducer 3 used for transmitting f1 and transducer 4 as receiving, another Doppler-shift frequency is obtained.”);
(c) a controller for operating said plurality of arrays of transducer elements in a continuous wave doppler mode and communicable with a processor for processing said echo signals from said plurality of arrays of transducer elements to determine at least one of a position of the sub-cutaneous structure, a depth of the sub-cutaneous structure and a dimension of the sub-cutaneous structure below the surface of the skin of the subject (see col. 5, lines 13-16 – “Referring now to FIGS. 2A and 2B, there is shown a CW angle-independent Probe 10 according to the present invention. It consists of two diffraction-grating transducers, 1 and 2, one Sending the one receiving, as in a conventional CW [continuous wave] Doppler structure.”; see col. 7, lines 29-31 – “This electronic control of the location of the Sensitive area can be useful in ensuring that a vessel of a particular depth is measured [position/depth of sub-cutaneous structure].”).
Vilkomerson teaches pairs of transmitters and receivers, but does not explicitly teach a transmitter transducer and a receiver transducer separated by a septum with acoustic insulation properties.
Whereas, Slayton, in an analogous field of endeavor, teaches a transmitter transducer and a receiver transducer separated by a septum with acoustic insulation properties (see col. 4, lines 54-56 – “e Doppler transducers, as illustrated in FIGS 4 and 5. In FIG. 4., the transducer has a diametrical separation layer 39 that acoustically and electrically isolates the transmitter from the receiver.”); and
displaying an image of said sub-cutaneous structure wherein said processor is configured to process said echo signals returning from the sub-cutaneous structure to selectively produce an image of the sub-cutaneous structure of the subject (Fig. 7; see col. 5, lines 35-41 – “An oscillator 44, which generates continuous waves, is connected to transmitter 44 for conversion to an ultrasonic signal and is connected to receiver 46 to detect the Doppler frequency shift. The receiver 46 is connected to a suitable display 50, such as a CRT, to display a representation of the Doppler frequency shift.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified pairs of transmitters and receivers, as disclosed in Vilkomerson, by also having a transmitter transducer and a receiver transducer separated by a septum with acoustic insulation properties, as disclosed in Slayton. One of ordinary skill in the art would have been motivated to make this modification in order to have cross coupling between the transmitter and the receiver significantly reduced in total, thereby improving the efficiency of the transducer, as taught in Slayton (see col. 6, lines 1-6).
Vilkomerson in view of Slayton teaches a probe and displaying an image of the subcutaneous structure, but does not explicitly teach a screen on the probe displaying an image of the subcutaneous structure.
Whereas, Eibl, in an analogous field of endeavor, teaches said plurality of parallel arrays enabling imaging of a sub-cutaneous structure in multiple transverse and lateral planes (see para. 0152 — “The array may be oriented obliquely (as shown by the line indicative of plane 406) to pass through the CCA [common carotid artery, subcutaneous structure] such that the array can read anatomical information in the transverse plane, and Doppler signal processing information in the longitudinal [lateral] plane.”); and
(d) a screen forming part of said housing for displaying an image of said sub-cutaneous structure wherein said processor is configured to process said echo signals returning from the sub-cutaneous structure to selectively produce an image of the sub-cutaneous structure of the subject (Fig. 1; see para. 0104 — “In such an embodiment, the output of the device 102 may be indicative of reflected hypersonic waves transmitted by transponders forming part of the device 102, and reflecting off of a vessel of interest (in this example, the carotid artery)...The device 102 may output through the user interface 110, for example, as various readings that can be interpreted by a machine and/or a healthcare practitioner.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified a probe and displaying an image of the subcutaneous structure, as disclosed in Vilkomerson in view of Slayton, by including a screen on the probe displaying an image of the subcutaneous structure, as disclosed in Eibl. One of ordinary skill in the art would have been motivated to make this modification in order to further compact the ultrasound device.
Furthermore, regarding claims 2 and 18, Vilkomerson further teaches wherein each array of transducer elements comprises a plurality of transducer elements, with the transmitter transducer and the receiver transducer in each transducer element being interleaved with the transmitter transducer and the receiver transducer in adjacent transducer elements (see col. 7, lines 38-43 – “For example, in FIG. 3A-D, if transducer 1 is driven at frequency f1 and transducer 2 receives the blood-Scattered signal from the Overlap region 25 shown, and the Doppler-shift is measured, and then transducer 3 used for transmitting f1 and transducer 4 as receiving, another Doppler-shift frequency is obtained.”).
Furthermore, regarding claim 3, Vilkomerson further teaches wherein said sub-cutaneous structure is a vascular structure (see col. 7, lines 29-31 – “This electronic control of the location of the Sensitive area can be useful in ensuring that a vessel [vascular structure] of a particular depth is measured [position/depth of sub-cutaneous structure].”).
Furthermore, regarding claim 4, Vilkomerson further teaches wherein said plurality of arrays of transducer elements are spaced apart from each other by a distance along a horizontal axis selected to minimise interference and maximise a scanning window (see col. 8, lines 4-8 – “Each pair or Set represents an orthogonal Set which detects blood motion that would be perpendicular to their grating Structure, or equivalently, parallel to the Space between the two transducers set at the dihedral angle.”).
Furthermore, regarding claim 5, Eibl further teaches wherein the distance is between 5 and 30 mm (Fig. 19; see para. 0249 – “In an illustrative example, the geometry of an array may include the following: element (10mm)-gap (1-5mm)-element (10mm)-gap (1-5mm)-element, etc.”).
Furthermore, regarding claim 6, Volkomerson further teaches wherein said parallel arrays are angled at an angle of insonation Φ where 10 degrees < Φ < 60 degrees (see col. 6, lines 31-34 – “…diffraction grating transducers 1 and 2 Separated Via distance d from one another and positioned at a given dihedral angle α. Preferably, the dihedral angle is 12 or 24 degrees, however, it is contemplated that the range of dihedrals may be between 1 and 89 degrees depending on the desired application and the Volume to be generated.”).
Furthermore, regarding claims 10 and 19, Eibl further teaches wherein said processor is programmed with instructions to discriminate between arterial and venous vascular sub- cutaneous structures (see para. 0101 – “For example, in some embodiments in order to differentiate target blood vessels from other blood vessels, forward and reverse flow signals may be classified as venous or arterial by application of a flow profile (e.g., pulsatile positive direction against non-pulsatile +opposite of positive direction).”).
One of ordinary skill in the art would have been motivated to make this modification in order to capture the entirety of both arterial and venous signals at a particular monitored cross-section, as taught in Eibl (see para. 0101).
Furthermore, regarding claims 11 and 20, Eibl further teaches wherein said processor discriminates between the arterial and venous sub-cutaneous structures based on measurement of pulsatility (see para. 0101 – “For example, in some embodiments in order to differentiate target blood vessels from other blood vessels, forward and reverse flow signals may be classified as venous or arterial by application of a flow profile (e.g., pulsatile positive direction against non-pulsatile +opposite of positive direction).”).
The motivation for claims 11 and 20 was shown previously in claims 10 and 19.
Claims 7-8 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Vilkomerson in view of Slayton and Eibl, as applied to claim 6 above, and in further view of Southard et al. (US 20200237403 A1, published July 30, 2020), hereinafter referred to as Southard.
Regarding claim 7, Vilkomerson in view of Slayton and Eibl teaches all of the elements disclosed in claim 6 above.
Vilkomerson in view of Slayton and Eibl teaches a screen displaying a subcutaneous structure, but does not explicitly teach where the screen provides an indication of the correct location for insertion of a cannula into the sub-cutaneous structure.
Whereas, Southard, in an analogous field of endeavor, teaches wherein said screen, with the assistance of the processor, provides an indication of the correct location for insertion of a cannula into the sub-cutaneous structure and representation on the screen displaying information including one or more of: a depth of an imaged sub-cutaneous structure based on the determined depth of the sub-cutaneous structure below the surface of the skin of the subject; and a position of a needle tip being inserted into the sub-cutaneous structure (Fig. 8-10, depth of vessel and position of needle; see para. 0107 – “…displaying a visual indicator on the display 1130 (see, for example, FIG. 9) such as over an ultrasound image to indicate the proper insertion angle θ [correct location for insertion] for inserting the medical device [needle 1234] into the skin surface 1220 and subsequently into the blood vessel 1226 [subcutaneous structure].”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified a screen displaying a subcutaneous structure, as disclosed in Vilkomerson in view of Slayton and Eibl, by having the screen provide an indication of the correct location for insertion of a cannula into the sub-cutaneous structure, as disclosed in Southard. One of ordinary skill in the art would have been motivated to make this modification in order to provide visual feedback to the user, and to reduce difficulties or complications of inserting a needle into a vessel, as taught in Southard (see para. 0109).
Furthermore, regarding claims 8 and 26, Southard further teaches wherein said processor is programmed to calculate at least one of an optimal needle gauge and an insertion angle recommended for access to the imaged sub-cutaneous structure (see para. 0107 – “…displaying a visual indicator on the display 1130 (see, for example, FIG. 9) such as over an ultrasound image to indicate the proper insertion angle θ [correct location for insertion] for inserting the medical device [needle 1234] into the skin surface 1220 and subsequently into the blood vessel 1226 [subcutaneous structure].”).
The motivation for claims 8 and 26 was shown previously in claim 7.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Vilkomerson in view of Slayton, Eibl, and Southard, as applied to claim 7 above, and in further view of Yamazaki (US 6336899 B1, published January 8, 2002), hereinafter referred to as Yamazaki.
Regarding claim 9, Vilkomerson in view of Slayton, Eibl, and Southard teaches all of the elements disclosed in claim 7 above, and
Southard further teaches wherein the representation on the screen is provided in 3D for both a vascular structure (see para. 0076 – “Fig. 9 shows that… the screenshot 1230 can be configured such that the ultrasound image 1232 [which includes blood vessel 1226 as vascular structure0 an the needle image 1234 are oriented so as to be displayed in a three-dimensional aspect.”).
Vilkomerson in view of Slayton, Eibl, and Southard teaches a vascular structure in 3D, but does not explicitly teach a vascular structure and haemodynamic fields in 3D.
Whereas, Yamazaki, in an analogous field of endeavor, teaches wherein the representation on the screen is provided in 3D for both a vascular structure and haemodynamic fields including one or more of: velocity, pressure, shear stress, turbulence, stagnation, pulsatility or stenosis (Fig. 17A, 3D image IM2 includes blood vessels; see col. 7, lines 31-39 – “… a Doppler processor 15 for obtaining 3D data with respect to information on the blood flow rate or the like of the object from the frequency analysis by extracting a Doppler signal from the echo signal, a 3D processor 16 for constructing a 3D image (which includes at least one of the two-dimensional tomographic image and the three-dimensional projection image of an arbitrary cross section) on the basis of these items of 3D data…”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified a vascular structure in 3D, as disclosed in Vilkomerson in view of Slayton, Eibl, and Southard, by having both a vascular structure and haemodynamic fields in 3D, as disclosed in Yamazaki. One of ordinary skill in the art would have been motivated to make this modification in order to generate structure information and blood flow information for navigating a needle in real time, as taught in Yamazaki (see Abstract).
Claims 12-15 and 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Vilkomerson in view of Slayton and Eibl, as applied to claims 10 and 17 above, respectively, and in further view of Lange et al. (US 20200093378 A1, published March 26, 2020), hereinafter referred to as Lange.
Regarding claims 12 and 21, Vilkomerson in view of Slayton and Eibl teaches all of the elements disclosed in claims 10 and 17 above, respectively.
Vilkomerson in view of Slayton and Eibl teaches discriminating between arteries and veins based on an ultrasound signal, but does not explicitly teach discriminating between arteries and veins based on a FFT signal.
Whereas, Lange, in an analogous field of endeavor, teaches wherein said processor is programmed with instructions to discriminate between the arterial and venous sub- cutaneous structures based on processing of an energy signal determined from a Fast Fourier Transform (FFT) of a sampled ultrasound signal (see para. 0096 – “…the signal Sf is processed by vibratory analysis integrating a fast Fourier transformation (FFT), from which the spectral power density PSDi for each frequency group is extracted, that is to say on frequency bands each corresponding to a separate physiological parameter, such as for example the frequencies of the venous system and of the arterial system and the respiratory frequencies.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified discriminating between arteries and veins based on an ultrasound signal, as disclosed in Vilkomerson in view of Slayton and Eibl , by discriminating between arteries and veins based on a FFT signal, as disclosed in Lange. One of ordinary skill in the art would have been motivated to make this modification in order for each physiological function to be associated with a set of frequencies that make it possible to characterize it in its cycle, its energy and its dynamics, as taught in Lange (see para. 0096).
Furthermore, regarding claims 13 and 22, Lange further teaches wherein said processor discriminates between the arterial and venous sub-cutaneous structures based on a power spectral density (PSD) computed from a sampled ultrasound signal (see para. 0096 – “…the signal Sf is processed by vibratory analysis integrating a fast Fourier transformation (FFT), from which the spectral power density PSDi for each frequency group is extracted, that is to say on frequency bands each corresponding to a separate physiological parameter, such as for example the frequencies of the venous system and of the arterial system and the respiratory frequencies.”).
Furthermore, regarding claims 14 and 23, Vilkomerson further teaches wherein said processor is programmed with instructions to determine the position of the sub-cutaneous structure below a contacting area of the ultrasound device along the skin of the subject within the body of the subject based on the processing of the sampled ultrasound signal (see col. 5, lines 13-16 – “Referring now to FIGS. 2A and 2B, there is shown a CW angle-independent Probe 10 according to the present invention. It consists of two diffraction-grating transducers, 1 and 2, one Sending the one receiving, as in a conventional CW [continuous wave] Doppler structure.”; see col. 7, lines 29-31 – “This electronic control of the location of the Sensitive area can be useful in ensuring that a vessel of a particular depth is measured [position/depth of sub-cutaneous structure].”).
Furthermore, regarding claims 15 and 24, Vilkomerson further teaches wherein the processor determines at least one of the depth and the dimension of the sub-cutaneous structure below said contacting area based on processing of the sampled ultrasound signal (see col. 5, lines 13-16 – “Referring now to FIGS. 2A and 2B, there is shown a CW angle-independent Probe 10 according to the present invention. It consists of two diffraction-grating transducers, 1 and 2, one Sending the one receiving, as in a conventional CW [continuous wave] Doppler structure.”; see col. 7, lines 29-31 – “This electronic control of the location of the Sensitive area can be useful in ensuring that a vessel of a particular depth is measured [position/depth of sub-cutaneous structure].”).
The motivation for claims 13 and 22 was shown previously in claims 12 and 21.
Claims 16 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Vilkomerson in view of Slayton, Eibl, and Lange, as applied to claim 14 and 23 above, respectively, and in further view of Blaivas et al. (US 20130131502 A1, published May 23, 2013), hereinafter referred to as Blaivas.
Regarding claims 16 and 25, Vilkomerson in view of Slayton, Eibl, and Lange teaches all of the elements disclosed in claims 14 and 23 above.
Vilkomerson in view of Slayton, Eibl, and Lange teaches processing an ultrasound signal of a subcutaneous structure, and inherently teaches a subcutaneous structure undergoing compression when an ultrasound probe is in contact with the skin of a patient, but does not explicitly teach processing a signal of a subcutaneous structure undergoing compression.
Whereas, Blaivas, in an analogous field of endeavor, teaches wherein the processor processes the sampled ultrasound signal with compression of the sub-cutaneous structure (see para. 0086 – “FIGS. 23 and 24 schematically depict the differential compressibility of veins and arteries as presented on screen images on touch screen 208 under the “Locate vessel” procedure of the access menu 280.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified processing a signal of a subcutaneous structure, as disclosed in Vilkomerson in view of Slayton, Eibl, and Lange, by processing a signal of the subcutaneous structure undergoing compression, as disclosed in Blaivas. One of ordinary skill in the art would have been motivated to make this modification in order to further differentiate between an artery and a vein in an ultrasound image, as taught in Blaivas (see para. 0086).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Walker et al. (US 20150011884 A1, published January 8, 2015) discloses a hand held ultrasonic instrument is provided in a portable unit that performs C-Mode imaging and collects 3D image data, and the displayed image could readily indicate the location where an inserted needle or the like would enter the tissue or other target.
Erkamp et al. (US 20100076315 A1, published March 25, 2010) discloses where an ultrasound sensor includes a piezoelectric transducer including an array of piezoelectric modules, and each piezoelectric module includes a transmitter and a receiver mounted at an angle.
Hunt (US 6155982 A, published December 5, 2000) discloses a plurality of acoustically and electrically independent Sub-arrays, wherein each Sub-array includes a plurality of transmitting and receiving elements and a backing assembly.
Tian et al. (US 20200187981 A1, published June 18, 2020) discloses the probe includes a left transducer and a right transducer with the transmissive surfaces facing at an angle towards each other and around a tool guiding channel.
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/Nyrobi Celestine/Examiner, Art Unit 3798