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 § 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 1-9 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In re claims 1-9, it is unclear if an ultrasound imaging device is a required apparatus at all. It is unclear if the ultrasound echo associated with an ultrasound pulse transmitted by the ultrasound imaging device is a required function by a required apparatus. The claim can be read as the processor operable to receive an ultrasound signal ONLY because an ultrasound signal is an inherent feature or representation of an ultrasound echo which is inherently associated with an ultrasound pulse transmitted by the ultrasound imaging device toward any target that the imaging device intended to.
So it is not clear if clam 1 requires any ultrasound imaging device, and if claim 1 requires the ultrasound imaging device transmitted an ultrasound pulse to the blood clot first before the processor starts to receive… determine .. and output.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 3-7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) determine an acuteness of the blood clot.
Step 1: Statutory Category: YES - The claim recites a method for evaluating deep vein thrombosis and, therefore, is a method.
Step 2A, Prong 1, Judicial Exception: YES - The claim recites the limitation of receiving … and determining, an acuteness of the blood clot based on a strength of the ultrasound signal; and outputting, to a display …” This limitation, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting “a computing device,” nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the “a computing device” language, the claim encompasses a user simply looking at an ultrasound image, which is based on a strength of the ultrasound signal, to determine an acuteness of a blood clot in his/her mind. The mere nominal recitation of a processor and a display does not take the claim limitation out of the mental processes grouping. Thus, the claim recites a mental process.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites additional elements: the computing device … receives … output, to a display. Such step is recited at a high level of generality (i.e., as a general means of receiving data, and displaying data), and amounts to mere data gathering, which is a form of insignificant extra-solution activity. The function of claim 11 of using ultrasound device to send and receive is also at a high level of generality of operating any ultrasound system. The processor that performs the comparison step of claim 12 is also recited at a high level of generality, and merely automates the comparison step. And the displaying of a grey scale of claim 13 is also recited at a high level of generality and that of which is fundamental operation of all ultrasound in B-mode. Displaying based on a threshold and overly features of different color or text of claims 14-16 are also recited at a high level of generality. Each of the additional limitations is no more than mere instructions to apply the exception using a generic computer component (the processor).
The combination of these additional elements is no more than mere instructions to apply the exception using a generic computer component (the processing circuitry). Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to the abstract idea.
Step 2B, Inventive Concept: No - As discussed with respect to Step 2A Prong Two, the additional elements in the claim amount to no more than mere instructions to apply the exception using a generic computer component. The same analysis applies here in 2B, i.e., mere instructions to apply an exception on a generic computer cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B. Under the 2019 PEG, a conclusion that an additional element is insignificant extra-solution activity in Step 2A should be re-evaluated in Step 2B. Here, transmitting step, receiving step, displaying step, and comparing steps were considered to be extra-solution activity in Step 2A, and thus it is re-evaluated in Step 2B to determine if it is more than what is well-understood, routine, conventional activity in the field. The background of the example does not provide any indication that the processor is anything other than a generic, off-the-shelf computer component, and the Symantec, TLI, and OIP Techs. court decisions cited in MPEP 2106.05(d)(II) indicate that mere collection or receipt of data over a network is a well‐understood, routine, and conventional function when it is claimed in a merely generic manner (as it is here). Accordingly, a conclusion that the transmitting, receiving, displaying, and comparing step is well-understood, routine, conventional activity is supported under Berkheimer Option 2. See Rubin et al. (Sonographic Elasticity Imaging of Acute and Chronic Deep Venous Thrombosis in Humans, J Ultrasound Med 2006; 25:1179–1186.) For these reasons, there is no inventive concept in the claim, and thus it is ineligible.
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.
Claim(s) 1-7, 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rubin et al. (Sonographic Elasticity Imaging of Acute and Chronic Deep Venous Thrombosis in Humans, J Ultrasound Med 2006; 25:1179–1186, from IDS filed on September 06, 2024, hereinafter Rubin ‘2006)
In re claim 1, Rubin ‘2006 teaches a method for evaluating deep vein thrombosis (DVT) caused by a blood clot formed in a deep vein of a patient (abstract, title), comprising: receiving, at a computing device to (page 1181, Scanning technique and Data Acquisition section, note that all ultrasounds scans will have a computing device) in communication with an ultrasound imaging device, an ultrasound signal representative of an ultrasound echo reflected from the blood clot (page 1181, Scanning technique and Data Acquisition section, Signal Processing, page 1181, Thrombus Echogenicity), the ultrasound echo associated with an ultrasound pulse transmitted by the ultrasound imaging device (page 1181, Scanning technique and Data Acquisition section, Signal Processing, page 1181, Thrombus Echogenicity, fig. 4, B Scan requires echo and ultrasound pulse); determining, by the computing device, an acuteness of the blood clot based on a strength of the ultrasound signal (page 1181, Results, note that all echogenicity must be depend on the strength of ultrasound signal, or else nothing is received or displayed like fig. 2 or 4); and outputting, to a display in communication with the computing device, a graphical indication of the determined acuteness (fig. 1, fig. 4 and 5, page 1184, last para to page 1185, first and second para).
In re claim 2, Rubin ‘2006 teaches transmitting, by use of the ultrasound imaging device, the ultrasound pulse into the deep vein where the blood clot is positioned (title, objective, DVT throughout the paper in addition to Scanning Technique and Data Acquisition of page 1181).
In re claim 3, Rubin ‘2006 teaches comparing a strength of the ultrasound signal to a threshold signal strength; determining that the blood clot is acute if the ultrasound signal is below the threshold signal strength page 1182, Thrombus Echogenicity, note that magnitude of the IQ signal is signal strength; page 1182, Results, strain magnitude is also a strength of an ultrasound signal; Applicant has not indicated a specific type of ultrasound signal; page 1182, Results to page 1182, para 1, threshold for acute is 1.17-1.54, and threshold for chronic is 2.5-7.5); and determining that the blood clot is chronic if the ultrasound signal is equal to or above the threshold signal strength (page 1182, Thrombus Echogenicity, note that magnitude of the IQ signal is signal strength; page 1182, Results, strain magnitude is also a strength of an ultrasound signal; Applicant has not indicated a specific type of ultrasound signal; page 1182, Results to page 1182, para 1, threshold for acute is 1.17-1.54, and threshold for chronic is 2.5-7.5, note that all echogenicity must be depend on the strength of ultrasound signal, or else nothing is received or displayed like fig. 2 or 4); and output, to a display, a graphical indication of the determined acuteness (fig. 1, fig. 4 and 5, page 1184, last para to page 1185, first and second para).
In re claim 4, Rubin ‘2006 teaches further comprising: displaying a grey scale image of the ultrasound signal on the display (fig. 4, A, page 1184).
In re claim 5, Rubin ‘2006 teaches wherein displaying the grey scale image of the ultrasound signal comprises: displaying the grey scale image of the ultrasound signal with a first graphical overlay if the ultrasound signal is below the threshold signal strength; and displaying the grey scale image of the ultrasound signal with a second graphical overlay if the ultrasound signal is equal to or above the threshold signal strength (page 1184, fig. 4, B and C, note that the scale below has different colors for different range; and that acute is 1.17-1.54, and chronic is 2.5-7.5).
In re claim 6, Rubin ‘2006 teaches wherein the first graphical overlay comprises a first color and the second graphical overlay comprises a second color different from the first color (page 1184, fig. 4, B and C, note that the scale below has different colors for different range; and that acute is 1.17-1.54, and chronic is 2.5-7.5).
In re claim 7, Rubin ‘2006 teaches where the first graphical overlay comprises a first text and the second graphical overlay comprises a second text different from the first text (page 1184, fig. 4A).
In re claim 9, Rubin ‘2006 teaches wherein the ultrasound imaging device is an external ultrasound probe (page 1181, note that Sonoline Elegra sonographic scanner (Siemens Medical Solutions, Mountain View, CA) uses external ultrasound probes).
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 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.
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.
Claim 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rubin ‘2006 in view of Spencer et al. (US 2016/0007947, hereinafter Spencer ‘947).
In re claim 8, Rubin ‘2006 fails to teach wherein the ultrasound imaging device is an intravascular ultrasound catheter.
Spencer ‘947 teaches wherein the ultrasound imaging device is an intravascular ultrasound catheter (0020, 0024, 0028).
It would have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of Rubin ‘2006 to include the features of Spencer ‘947 in order to generate a model of the anatomy of the vessel.
Response to Arguments
Applicant's arguments filed on December 08, 2025 have been fully considered but they are not persuasive.
In response to Applicant’s argument that:
“receiving, ... , an ultrasound signal representative of an ultrasound echo reflected from the blood clot, the ultrasound echo associated with an ultrasound pulse transmitted by the ultrasound imaging device; determining, ..., an acuteness of the blood clot based on a strength of the ultrasound signal; and outputting, ..., a graphical indication of the determined acuteness. Accordingly, the above claim limitations do not meet the "mental processes" or concepts relating to data comparisons that can be performed mentally or are analogous to mental work without significantly more.
The Examiner disagrees. As shown above, receiving is merely a data collection of an echo reflected by an ultrasound wave. The determining step is merely a high level of generalization of determining something by looking at a “strength” of the collected data/signal. A human can visually look at a reflected data, i.e. a graph of wave form, a graph of pixel of different contrast to determine if something is acute or not. There is NO requirement to further narrow or improve the detection of acuteness of the blood clot. There is not additional processing on the strength of the ultrasound signal. Any signal is going have some strength. Applicant does not claim any additional signal processing for such strength. The outputting step is also merely showing the result with a graph, i.e. can be done with a pen and paper to write a check mark, or words, or draw the same thing the user saw. These are mental processes that can be done on the paper after reading the data collected.
In response to Applicant’s argument that “the claimed invention improves the field of evaluating deep vein thrombosis by providing a method of determining whether a DVT is acute or chronic based on ultrasound signal strength,” the Examiner disagrees. Every ultrasound wave has a signal strength. That’s inherent and natural in all ultrasound waves. Applicant has not improved the ultrasound wave or the strength of ultrasound wave during any of the data collection steps. The natural reflection of a signal is NOT improving the signal or the determination of the signal for the field of evaluating deep vein thrombosis.
In response to Applicant’s argument that:
With respect to step 2B, even if a claim is directed to an abstract idea under step 2A, the claim is still subject matter eligibility if it amounts to "significantly more" than the abstract idea. As explained in MPEP§2106.05, claims constitute "significantly more" if the additional limitations of the claim contribute an inventive concept. For example, if the additional limitations recite a specific limitation other than what is well-understood, routine, conventional activity in the field. As discussed in more detail below, claim 1 and its dependent claims are directed to significantly more than an abstract idea and are directed to inventive concepts.
The Examiner disagrees. Applicant has failed to indicate what element is offering something significantly more. Applicant’s current argument is merely an opinion. The Examiner has explained above that nothing in the claim is significantly more. Applicant fail to rebut this with evidence.
In response to Applicant’s argument that: “Rubin teaches a method of sonographic elasticity imaging as opposed to receiving, ..., an ultrasound signal representative of an ultrasound echo reflected from the blood clot, and determining, . . ., an acuteness of the blood clot based on a strength of the ultrasound signal as set forth in claim 1. Rubin merely discloses a method of sonographic elasticity for measuring median normalized strain magnitude for acute and chronic cases.” The Examiner disagrees. Applicant has failed to explain what claim elements Rubin fail to teach.
Does Rubin fail to teach:
1. receiving, at a computing device to (page 1181, Scanning technique and Data Acquisition section, note that all ultrasounds scans will have a computing device) in communication with an ultrasound imaging device, an ultrasound signal representative of an ultrasound echo reflected from the blood clot (page 1181, Scanning technique and Data Acquisition section, Signal Processing, page 1181, Thrombus Echogenicity),
2. the ultrasound echo associated with an ultrasound pulse transmitted by the ultrasound imaging device (page 1181, Scanning technique and Data Acquisition section, Signal Processing, page 1181, Thrombus Echogenicity, fig. 4, B Scan requires echo and ultrasound pulse);
3. determining, by the computing device, an acuteness of the blood clot based on a strength of the ultrasound signal (page 1181, Results, note that all echogenicity must be depend on the strength of ultrasound signal, or else nothing is received or displayed like fig. 2 or 4); and
4. outputting, to a display in communication with the computing device, a graphical indication of the determined acuteness (fig. 1, fig. 4 and 5, page 1184, last para to page 1185, first and second para)?
Which one Rubin fails to teach?
Applicant has failed to identify any of these specifically. Applicant merely rebut the teaching with a generalization but without specific identification of any element of the claims.
The Examiner has indicated as above that Rubin teaches all the limitation of the claims.
Again, Rubin teaches an ultrasound signal representative of an ultrasound echo reflected from the blood clot in at least fig 4. B-scan is an ultrasound scan and the display b-mode image is intensity of the pixel of ultrasound signal which representative of an ultrasound echo, and thrombus is formation of blood clots. Note that Applicant describes in para 0044 “The strength of the ultrasound signal representative the ultrasound echo reflected from a blood clot is proportional to the brightness of the grey scale image.” B-mode is display with brightness in gray scale ultrasound image.
Rubin also teaches “determining, . . ., an acuteness of the blood clot based on a strength of the ultrasound signal” in at least fig 4. in which thrombus area (blood clot) is determined with an arrow and showing in dark area.
Applicant has not limited any scope of determining to be any different than visual determination of an ultrasound image with a knowledge of what an acuteness might look like.
Applicant’s claim does not exclude the additional or any further calculation/processing of signals to obtain additional strain or normalized strain value which can probably lead to additional improvement in detection of blood clot/thrombus area.
Applicant also describes that “When the strength of the ultrasound signal is below the threshold signal strength, the computer system 520 would determine that the blood clot is acute… The threshold value may be expressed as the intensity of the pixels in the region of interest for a blood clot to be qualified in an ultrasound image, with respect to the intensity of the pixels of a region representing blood speckle at the ultrasound imaging frequency. The threshold value in dB can be converted to a threshold value in intensity of pixels.”
The intensity of pixel values in strain area show in color in fig 4 of Rubin would also read on the threshold value.
Hence, Rubin teaches the claim as shown above.
Conclusion
THIS ACTION IS MADE FINAL. 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 BO JOSEPH PENG whose telephone number is (571)270-1792. The examiner can normally be reached Monday thru Friday: 8:00 AM-5:00 PM EST.
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/BO JOSEPH PENG/Primary Examiner, Art Unit 3797