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 .
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 Non-Final Office Action mailed 02/17/2026.
Response to Arguments
Applicant’s arguments filed 05/12/2026 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.
Given the amendments to claims 1 and 17, reference to Feng is being relied upon to teach dependent claims 2-6 and 18 more-consistently with the instant claim language, as shown below.
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 1-6, 10-11, 17-20, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Feng et al. (CN 109758180 A, published May 17, 2019) in view of in view of Slayton et al. (US 5175709 A, published December 29, 1992), Salgo et al. (US 20030060710 A1, published March 27, 2003), Eibl et al. (US 20170332995 A1, published November 23, 2017), hereinafter referred to as Feng, Slayton, Salgo, and Eibl, respectively.
Regarding claim 1, and similarly for claims 17 and 27, Feng teaches a portable ultrasound device for non-invasively imaging a selected sub-cutaneous structure in a subject, comprising:
(a) a housing (Fig. 2; see pg. 6, para. 3 – “As shown in FIG. 2, the flexible ultrasonic probe comprising: a flexible substrate 1 [housing] for sealing the ultrasonic transducer unit 2.”);
(b) a plurality of spaced arrays of transducer elements (Fig. 2; see pg. 6, para. 3 – “As shown in FIG. 2, the flexible ultrasonic probe comprising: a flexible substrate 1 for sealing the ultrasonic transducer unit 2 [spaced arrays of transducer elements].”),
each array being obliquely angled with respect to a surface of the subject and arranged in parallel (Fig. 3, each array 2 angled and arrange in parallel to each other) and
each transducer element comprising a transmitter transducer and a receiver transducer (see pg. 10, para. 1 – “wherein, when the flexible ultrasonic probe is a continuous Doppler ultrasonic probe, adjacent two ultrasonic transducer units 2, wherein an ultrasound transducer unit 2 for emitting ultrasonic wave, the other ultrasonic transducer unit 2 for receiving ultrasonic waves.”),
(transducer elements) located within said housing for continuously transmitting ultrasound energy in a predetermined frequency range at the same angle of insonation toward a body of the subject and continuously receiving echo signals in a predetermined frequency range from the body of the subject following reflection of ultrasound energy (see pg. 10, para. 1 – “wherein, when the flexible ultrasonic probe is a continuous Doppler ultrasonic probe, adjacent two ultrasonic transducer units 2, wherein an ultrasound transducer unit 2 for emitting ultrasonic wave, the other ultrasonic transducer unit 2 for receiving ultrasonic waves.”);
(c) a controller for operating said plurality of parallel 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 subject (see pg. 9, para. 6 – “The detected Doppler ultrasound frequency shift information of different positions of the subject to obtain the different position of the object and the depth of the blood speed.”; see pg. 11, para. 1 – “signal processing module 33 [controller] for performing image processing for the second ultrasonic electric signal, to obtain the image data of the second ultrasonic electric signal.”); and
(d) a screen 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 laterally reconstructed image of the sub-cutaneous structure of the subject (see pg. 9, para. 6 – “…using the ultrasonic wave echo signal strength, which can detect the grey scale image information of the two-dimensional structure of the different positions of the subject. the ultrasonic transducer unit 2 and set by tilting of the ultrasonic transducer unit 2 are used in combination, can obtain different position on the ultrasonic image of the subject, a blood flow speed information of different depths.”; see pg. 12, para. 5 – “display [screen] of the ultrasonic diagnostic device can display image information of Doppler ultrasound frequency shift by an ultrasound echo of the blood in the body of the subject for the medical staff to observe and make the corresponding diagnosis.”).
Feng 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.").
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 Feng, 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).
Feng in view of Slayton teaches a plurality of spaced parallel arrays enabling imaging of a sub-cutaneous structure along its length, but does not explicitly teach generating images in multiple transverse and lateral planes.
Whereas, Salgo, in an analogous field of endeavor, teaches said plurality of spaced parallel arrays enabling imaging of a sub-cutaneous structure in multiple transverse and lateral planes along its length (see para. 0025 – “The biplane images in the two image planes are acquired by transmitting and receiving beams of each image as exemplified by the acquisition of beams 504 and 505 in the respective image planes of FIG. 2A.”).
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 plurality of spaced parallel arrays enabling imaging of a sub-cutaneous structure along its length, as disclosed in Feng in view of Slayton, by also generating images in multiple transverse and lateral planes, as disclosed in Salgo. One of ordinary skill in the art would have been motivated to make this modification in order to create and display multiple planar images of a volumetric region of the body in real time, as taught in Salgo (see para. 0006).
Feng in view of Slayton and Salgo 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 a controller within the housing (Fig. 6, CPU 604 as controller within housing), and a screen forming part of said housing (Figs. 6 and 12-13; see para. 0199 – “For example, the embodiment may include a probe 1204 for use with a patient 1202/1310, a base 1206, a display 1208/1306 [screen], and an adjustable neck 1210/1305.”).
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 Feng in view of Slayton and Salgo, 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, Feng 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 pg. 10, para. 1 – “wherein, when the flexible ultrasonic probe is a continuous Doppler ultrasonic probe, adjacent two ultrasonic transducer units 2, wherein an ultrasound transducer unit 2 for emitting ultrasonic wave, the other ultrasonic transducer unit 2 for receiving ultrasonic waves.”).
Furthermore, regarding claim 3, Feng further teaches wherein said sub-cutaneous structure is a vascular structure (see pg. 7, para. 2 – “…ultrasonic transducer unit emitting ultrasonic and/or ultrasonic wave received by the receiving surface to the surface of the object is a certain included angle, according to the Doppler ultrasonic frequency shift measuring method measuring blood flow speed [vascular].”).
Furthermore, regarding claim 4, Feng 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 for providing said laterally reconstructed image of the sub-cutaneous structure (Fig. 3, each arrays 2 are spaced apart from each by a distance along a horizontal axis).
Furthermore, regarding claim 5, Feng further teaches wherein the distance is between 5 and 30 mm (Fig. 3, each arrays 2 are spaced apart from each by a distance along a horizontal axis).
Furthermore, regarding claim 6, Feng further teaches wherein said parallel arrays are angled at an angle of insonation C where 10 degrees < θ <60 degrees (see pg. 7, para. 5 – “As shown in FIG. 2, the direction of the emitted ultrasonic transducer with the flexible substrate 1 of the first plane of the included angle is less than 90 degrees, preferably 45 degrees to 60 degrees.”).
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 Feng in view of Slayton, Salgo, 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, Feng in view of Slayton, Salgo, and Eibl teaches all of the elements disclosed in claim 6 above.
Feng in view of Slayton, Salgo, 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 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 e [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 Feng in view of Slayton, Salgo, 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 Feng in view of Slayton, Salgo, 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, Feng in view of Slayton, Salgo, 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 vascularstructure0 an the needle image 1234 are oriented so as to be displayed in a three-dimensional aspect.").
Feng in view of Slayton, Salgo, 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 Feng in view of Slayton, Salgo, 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 Feng in view of Slayton, Salgo, and Eibl, as applied to claims 10 and 17 above, respectively, and in further view of Lange et al. (US 20200093378A1, published March 26,2020), hereinafter referred to as Lange.
Regarding claims 12 and 21, Feng in view of Slayton, Salgo, and Eibl teaches all of the elements disclosed in claims 10 and 17 above.
Feng in view of Slayton, Salgo, 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 Doppler frequencies 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 Feng in view of Slayton, Salgo, 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 for Doppler frequencies of
Furthermore, regarding claims 14 and 23, Feng 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 pg. 9, para. 6 – “The detected Doppler ultrasound frequency shift information of different positions of the subject to obtain the different position of the object and the depth of the blood speed.”).
Furthermore, regarding claims 15 and 24, Feng 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 pg. 9, para. 6 – “The detected Doppler ultrasound frequency shift information of different positions of the subject to obtain the different position of the object and the depth of the blood speed.”).
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 Feng in view of Slayton, Salgo, 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, Feng in view of Slayton, Salgo, Eibl, and Lange teaches all ofthe elements disclosed in claims 14 and 23 above.
Feng in view of Slayton, Salgo, 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 Feng in view of Slayton, Salgo, 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:
Dirksen et al. (US 20210321981 A1, published October 21, 2021 with a priority date of August 16, 2019) discloses a bi-plane imaging system adapted to acquire image data in a first imaging plane having a first orientation and a second imaging plane having a second orientation, wherein the first orientation is different from the second orientation by a way of a first ultrasonic transducer array.
Haim et al. (US 20060184029 A1, published August 17, 2006) discloses perpendicular transducer arrays and parallel transducer arrays configured to generate 2D images of a blood vessel, where the 2D images are orthogonal to each other (Fig. 5-6).
Stringer (US 20070016030 A1, published January 18, 2007) discloses a sensor assembly including two linear transducer arrays oriented perpendicular to each other to form a “T” shape to provide ultrasound images of at least one blood vessel in a portion of a patient’s body in two perpendicular planes.
Choi et al. (US 20190099160 A1, published April 4, 2019) discloses while trying to find a target vessel for needle insertion using automatic toggling between two orthogonal B-mode images, the user may select to turn Doppler on or off to find the target vessel more efficiently.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nyrobi Celestine whose telephone number is 571-272-0129. The examiner can normally be reached on Monday - Thursday, 7:00AM - 5:00PM EST.
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/N.C./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
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