DETAILED ACTION
This office action is in response to the communication received on 10/27/2025 concerning application no. 18/678,825 filed on 05/30/2024.
Claims 1-20 are pending (Claims 1-8 and 15-20 are withdrawn from consideration).
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 .
Election/Restrictions
Applicant's election with traverse of Invention II (Claims 9-14) in the reply filed on 10/27/2025 is acknowledged.1 The traversal is on the ground(s) that Inventions I and II overlap in scope in both structure and/or function. Applicant alleges that both comprise an ultrasound probe, holder, and a processor that determines operating state and probe cleanliness. Applicant alleges both overlap with regard to cleanliness bases on operating state. Applicant further argues that that there was no indication of search burden as the cited classifications are all within the subclass A61B8 and are “closely related.”
This is not found persuasive because Applicant’s reliance on the ultrasound probe, holder, and a processor that determines operating state and probe cleanliness are the broad recitation of nominal features. These inventions are not capable of use together and have a materially different mode of operation, function, or effect and do not overlap in scope. Invention I uses a PZT material with a damping block behind it and a matching layer in front of it and uses a sensor to detect its motion along with a sensor on a holder. Invention II has no such design. A CMUT-based or PMUT-based ultrasound probe would be compatible with the scope of Invention II but not with Invention I. Such a probe design is materially different and requires a different manner of design and operation. Furthermore, in terms of functionality, Invention I requires while a processor assess a non-active state to determine if the probe face is clean according to image analysis. No such functionality is present in Invention II. Rather, it is according to an operation that uses a timer to assess the cleanliness of a probe face and an operation in an active, idle, pre-exam, and exam state while using a cleaning delay to automatically determine if a probe face is clean.
With regards to the search burden, Applicant’s remarks that the cited classifications are all within the subclass A61B8 and are “closely related” are unpersuasive. Applicant fails to address the fact that the restriction, filed 08/27/2025, notes “there would be a serious search and/or examination burden” (emphasis added). Applicant completely neglects to consider the fact that the examination burden is present. As noted in the restriction, filed 08/27/2025, “the inventions have different scopes and may require different considerations under 35 U.S.C. 101 and 35 U.S.C. 112.” Applicant’s remarks that the inventions are “closely related” are conclusory and without support. MPEP 716.01(c) establishes “Arguments presented by the applicant cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965) and In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984).” Additionally, the allegation that they are all within A61B8 neglects that the restriction, filed 08/27/2025, establishes that they are in completely different particular classifications within A61B8.2 Additionally, Applicant is silent regarding the fact that “The inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries). Invention I requires the search of terms like “PZT”, “Piezo$1electric”, “damp$3”, and “match$3”. Invention II requires the search of terms like “active”, “idle”, “stand$1by”, and “$4exam”…” Inventions I and II require different search terms and thereby establish a serious search burden.
Finally, it is acknowledged that Applicant themselves admits “Applicant does not believe the inventions are obvious variants…” (emphasis added).3
The requirement is still deemed proper and is therefore made FINAL.
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 9-14 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.
Claim 9 is indefinite for the following reasons:
Recites “if a timer is exceeded”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art what the timer is exceeded with respect to. The timer is assessed in exceeding a threshold. Another interpretation is that the timer is assessed in exceeding a pre-determined time. Another interpretation is that the timer is exceeding prior historical times.
Applicant is encouraged to provide consistent and clear language.
Recites “in response to the ultrasound system in the idle state, automatically determining if the probe face is clean if a timer is exceeded; in response the ultrasound system in the active use state, setting the timer to zero and not automatically determining if the probe face is clean”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art when the timer is triggered and in what component the timer is present in. The alter recitation of the timer appears to establish that the timer is not set at zero initially. Given this, it would be unclear to one with ordinary skill in the art what prompts the timer and what temporal position the timer is within during the active state use.
Applicant is encouraged to provide consistent and clear language.
Recites “cleaning delay”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the cleaning delay is a delay in operation that allows for cleaning to be performed during it or a delay prior to the performance of the cleaning.
Applicant is encouraged to provide consistent and clear language.
Claim 11 is indefinite for the following reasons:
Recites “comparing a top portion of the near field image including bars caused by entrance echoes”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art what the comparison is with respect to. That is, it is unclear what the top portion of the near field image including bars caused by entrance echoes is being compared with. One interpretation is historic image data. Another interpretation is a template image. Another interpretation is that it is compared amongst the data set.
Applicant is encouraged to provide consistent and clear language.
Claim 14 is indefinite for the following reasons:
Recites “an ultrasound image”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the “ultrasound image” is the same as the “a near field image and/or cine sequence” established in claim 10 or is a separate and distinct feature.
Applicant is encouraged to provide consistent and clear language.
Recites “an ultrasound image”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the “ultrasound image” is the same as the “ultrasound image” established in the preceding claim element or is a separate and distinct feature.
Applicant is encouraged to provide consistent and clear language.
Claims that are not discussed above but are cited to be rejected under 35 U.S.C. 112(b) are also rejected because they inherit the indefiniteness of the claims they respectively depend upon.
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 9-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 9 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite an ultrasound system and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “automatically identify an operating state of the ultrasound system, wherein the operating state is one of active use, idle, pre-exam, or exam finished; in response to the ultrasound system in the pre-exam state or exam finished state automatically determining if a probe face of an ultrasound probe of the ultrasound system is clean; in response to the ultrasound system in the idle state, automatically determining if the probe face is clean if a timer is exceeded; in response the ultrasound system in the active use state, setting the timer to zero and not automatically determining if the probe face is clean; if the probe face is determined to not be clean, perform a processor operation to…, wait for a cleaning delay and then automatically determine if the probe face is clean; and when the probe face is determined to be clean, not performing the processor operation”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the determination of the operational state of a probe to be active, idle, pre or post examination, in some states due to a timer. This determination then prompting further determination of the cleanliness of a probe. In cases of uncleanliness waiting and then reassessing the cleanliness over a delay. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements: “an ultrasound probe; a holder, wherein the ultrasound probe is positioned inside the holder when the ultrasound system is not in an active use state; and a processor communicatively coupled to a display and a user interface, wherein the processor includes instructions stored on non-volatile memory that when executed cause the processor to: indicate that the probe face of the ultrasound probe is not clean”. Indication of the uncleanliness is a display step that merely amounts to a post-solution insignificant activity. The use of a processor and memory does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 9 is ineligible.
Claim 10 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite an ultrasound system and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “wherein automatically determining if the probe face is clean”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the assessment of the cleanliness of the probe phase according to image data. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements: “acquiring a near field image and/or cine sequence using the ultrasound probe in air and automatically analyzing the near field image and/or cine sequence”. Acquisition of the image data is a data gathering step that is a form of a pre-solution insignificant activity.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 10 is ineligible.
Claim 11 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite an ultrasound system and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “wherein automatically analyzing the near field image includes comparing a top portion of the near field image including bars caused by entrance echoes”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to assessing cleanliness of a probe according to the image echo information. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No - Similar to Step 2A Prong 2, the claim does not contain additional elements. For these reasons, there is no inventive concept in the claim. In light of the above, claim 11 is ineligible.
Claim 12 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite an ultrasound system and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “wherein automatically analyzing the cine sequence includes determining a rate of motion in the cine sequence is present and the rate of motion is slower than a rate of motion of the cine sequence when the ultrasound system is in the active use state”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to analysis and comparison of motion to the cine sequence motion for determination of cleanliness of the probe face. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No - Similar to Step 2A Prong 2, the claim does not contain additional elements. For these reasons, there is no inventive concept in the claim. In light of the above, claim 12 is ineligible.
Claim 13 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite an ultrasound system and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “further comprising not displaying the acquired near field image and/or cine sequence on the display of the ultrasound system”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to analysis of the probe face without image display. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No - Similar to Step 2A Prong 2, the claim does not contain additional elements. For these reasons, there is no inventive concept in the claim. In light of the above, claim 13 is ineligible.
Claim 14 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 and Step 2A, Prong 1, Judicial Exception are discussed above in the claim 10 rejection.
Claim 14 recites the following elements: “wherein the processor operation includes one or more of generating a warning at the display of the ultrasound system, replacing an ultrasound image with video instructions for cleaning the ultrasound probe, and saving an ultrasound image with a label indicating the ultrasound probe was not clean when the ultrasound image was acquired”. This claim element is a mere storage and display step which amounts to a post-solution insignificant activity. This post-solution insignificant activity does not integrate the judicial exception into a practical application nor does it contain an inventive step. In light of above, claim 14 is ineligible.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Shine et al. (PGPUB No. US 2015/0245810): Teaches a gel dispensation and probe cleaning station. Teaches holding the probe for cleaning. UV is used in probe sterilization.
Wodecki et al. (PGPUB No. US 2017/0296142): Teaches a probe holder and cleaner. UV is used in probe sterilization.
Kuroshima et al. (PGPUB No. US 2007/0193605): Teaches a cleaning station for ultrasound endoscopic devices after examination.
Yang et al. (PGPUB No. US 2023/0033190): Teaches a probe sterilization device that holds and cleans the probe.
Ye (US Patent No. 12,247,696): Teaches UV is used in probe sterilization.
Jacobs et al. (US Patent No. 7,246,627): Teaches a medical device cleaning station that cleans and removes acoustic gels.
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/ADIL PARTAP S VIRK/Primary Examiner, Art Unit 3798
1 Page 8 of Applicant’s remarks, filed 10/27/2025, notes “Applicant elects Invention II, claims 9-14, with traverse. Applicant traverses the restriction only between Inventions I and II, which errs for the reasons described below.” (emphasis added).
2 Page 4 of the restriction, filed 08/27/2025, “The inventions have acquired a separate status on their art in view of their classification. Invention I is classified A61B8/4483 (Contains 10,115 references). Invention II is classified A61B8/4422 (Contains 1,281 references). Invention III is classified A61B8/4472 (Contains 4,922 references).”
3 Page 9 of Applicant’s remarks, filed 10/27/2025.
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