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 .
Status of Claims
This office action is in response to arguments and amendments entered on September 15, 2026 for the patent application 18/866,200 filed on November 15, 2024. Claims 1, 3-4, 12 and 14-15 are amended. Claims 1-15 are pending. The first office action of April 29, 2026 is fully incorporated by reference into this Final Office Action.
Drawings
Regarding FIG. 2, 37 CFR 1.84(b)(1), stated in part, indicates that black and white photographs, including photocopies of photographs and clip art, are not ordinarily permitted in utility and design patent applications. The Office will accept photographs in utility and design patent applications, however, if photographs are the only practicable medium for illustrating the claimed invention. The photographs must be of sufficient quality so that all details in the photographs are reproducible in the printed patent. In the present case, FIG. 2 contains screenshots/clip art that are not of sufficient quality so that all details in the screenshots are reproducible in the printed patent. Therefore, the use of screenshots/clip art lacking sufficient reproducible quality prevents FIG. 2 from complying with 37 CFR 1.84(b)(1).
Claim Rejections - 35 USC § 112
Claims rejected under 35 U.S.C. § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claim 15 is rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor at the time the application was filed, had possession of the claimed invention.
Claim 15 recites the following limitations: “A non-transitory computer readable medium comprising instructions, which in response to execution on a processor, to cause the processor to perform the computer- implemented method of claim 14.” These limitations are not adequately described in the specification as originally filed and forms the basis of the rejection. As such, the limitations are reasonably rejected under a theory of new matter. Therefore, claim 15 is rejected under 35 U.S.C. § 112(a), as failing to comply with the written description requirement.
Claims rejected under 35 U.S.C. § 112(b)
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.
Claim 15 is rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 15 recites “A non-transitory computer readable medium… to perform the computer- implemented method of claim 14.”
Per M.P.E.P. § 2173.05(p): A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303 (Fed. Cir. 2011). In Katz, a claim directed to “A system with an interface means for providing automated voice messages...to certain of said individual callers, wherein said certain of said individual callers digitally enter data” was determined to be indefinite because the italicized claim limitation is not directed to the system, but rather to actions of the individual callers, which creates confusion as to when direct infringement occurs. In re Katz, 639 F.3d at 1318 (citing IPXL Holdings v. Amazon.com, Inc., 430 F.2d 1377, 1384, 77 USPQ2d 1140, 1145 (Fed. Cir. 2005), in which a system claim that recited “an input means” and required a user to use the input means was found to be indefinite because it was unclear “whether infringement... occurs when one creates a system that allows the user [to use the input means], or whether infringement occurs when the user actually uses the input means.”); < Ex parte Lyell, 17 USPQ2d 1548 (Bd. Pat. App. & Inter. 1990) (claim directed to an automatic transmission workstand and the method of using it held ambiguous and properly rejected under 35 U.S.C. 112, second paragraph).
In Applicant’s case, claim 15 is reciting “a non-transitory computer readable medium” and “a method”. Because Applicant is claiming two separate statutory classes together in a single claim, claim 15 is deemed indefinite. Therefore, claim 15 is rejected under 35 U.S.C. § 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
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 1-15 are rejected under 35 U.S.C. § 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step 1 – “Statutory Category Identification”
Claim 1 is directed to “an apparatus” (i.e. a machine) and claim 14 is directed to “a computer-implemented method” (i.e. a process), hence the claims are directed to one of the four statutory categories (i.e. process, machine, manufacture, or composition of matter). In other words, Step 1 of the subject-matter eligibility analysis is “Yes.”
Step 2A, Prong 1 “Abstract Idea Identification”
However, the claims are drawn to an abstract idea of “providing guidance,” in the form of “certain methods of organizing human activity,” in terms of managing personal behavior or relationships or interactions between people (including social activities, teaching and following rules or instructions), or reasonably in the form of “mental processes,” in terms of processes that can be performed in the human mind (including an observation, evaluation, judgement or opinion). Regardless, the claims are reasonably understood as either “certain methods of organizing human activity” or “mental processes,” which require the following limitations:
Per claim 1:
“receive an ultrasound image acquired by the user with an ultrasound acquisition system;
determine a spatial relationship between the received ultrasound image and a target view, and compute at least one distance metric for the acquired ultrasound image based on said spatial relationship, and
generate guidance information based on said spatial relationship, indicative of a change in at least one of position or orientation of the ultrasound acquisition system for the acquisition of another ultrasound image; and
selectively toggle the user interface, between:
a guidance mode in which guidance information generated by the guidance module is provided on the user interface and the received ultrasound image is not provided on the user interface; and
an imaging mode in which the received ultrasound image is provided on the user interface; and
wherein is adapted to set the user interface to the guidance mode if the at least one distance metric exceeds a predefined threshold, and set the user interface to imaging mode otherwise.”
Per claim 14:
“receiving an ultrasound image acquired by the user with an ultrasound acquisition system;
determining a spatial relationship between the received ultrasound image and a target view, and computing at least one distance metric for the acquired ultrasound image based on said spatial relationship;
generating guidance information based on said spatial relationship, indicative of a change in at least one of position or orientation of the ultrasound acquisition system for the acquisition of another ultrasound image; and
toggling a user interface between:
a guidance mode in which guidance information is provided on the user interface and the received ultrasound image is not provided on the user interface; and
an imaging mode in which the received ultrasound image is provided on the user interface;
wherein the method further comprises setting the user interface to the guidance mode if the at least one distance metric exceeds a predefined threshold, and setting the user interface to imaging mode otherwise.”
These limitations simply describe a process of data gathering and manipulation, which is partially analogous to “collecting information, analyzing it, and displaying certain results of the collection analysis” (i.e. Electric Power Group, LLC, v. Alstom, 830 F.3d 1350, 119 U.S.P.Q.2d 1739 (Fed. Cir. 2016)). Hence, these limitations are akin to an abstract idea which has been identified among non-limiting examples to be an abstract idea. In other words, Step 2A, Prong 1 of the subject-matter eligibility analysis is “Yes.”
Step 2A, Prong 2 – “Practical Application”
Furthermore, the claims do not include additional elements that either alone or in combination are sufficient to claim a practical application because to the extent that, e.g., “a receiving unit,” “an ultrasound acquisition system,” “a processing unit,” and “a user interface,” are claimed, as these are merely claimed to generally link the use of a judicial exception to a particular technological environment or field of use. In other words, the claimed “providing guidance,” is not providing a practical application, thus Step 2A, Prong 2 of the subject-matter eligibility analysis is “No.”
Step 2B – “Significantly More”
Likewise, the claims do not include additional elements that either alone or in combination are sufficient to amount to significantly more than the judicial exception because to the extent that, e.g. “a receiving unit,” “an ultrasound acquisition system,” “a processing unit,” and “a user interface,” are claimed, these are generic, well-known, and conventional elements. As evidence that these are generic, well-known, and a conventional elements (or an equivalent term), as a commercially available product, or in a manner that indicates that the additional elements are sufficiently well-known, the Applicant’s specification discloses these in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a), per MPEP § 2106.07(a) III (a). As such, this satisfies the Examiner’s evidentiary burden requirement per the Berkheimer memo.
Moreover, the element of “a receiving unit,” is best described in para. [0048] as follows: “[0048] The apparatus 100 comprises a receiving unit 110 adapted to receive an ultrasound image acquired by the user with an ultrasound acquisition system 118. For example, the ultrasound acquisition system may include a probe, the position and orientation of which are freely adjustable by the user by hand. The receiving unit may in some cases receive a series of ultrasound images, e.g. a stream of ultrasound images. It may process each received image in turn.” This element is reasonably interpreted as an input device as part of a generic computer which provides no details of anything beyond ubiquitous standard off-the-shelf equipment.
Likewise, the element of “an ultrasound acquisition system,” is also best described in para. [0048] as follows: “[0048] The apparatus 100 comprises a receiving unit 110 adapted to receive an ultrasound image acquired by the user with an ultrasound acquisition system 118. For example, the ultrasound acquisition system may include a probe, the position and orientation of which are freely adjustable by the user by hand. The receiving unit may in some cases receive a series of ultrasound images, e.g. a stream of ultrasound images. It may process each received image in turn.” This element is reasonably interpreted as generic, well-known, and as a commercially available product.
Continuing, the element of “a processing unit,” is best described in para. [0049] as follows: “[0049] The apparatus 100 further comprises a processing unit 120, which itself further comprises a view analyzer module 122 and a guidance module 124. It is noted that these may be software modules or hardware modules. Furthermore, although they are shown as separate elements in FIG. 1, they may simply represent software functions or routines, and both may in practice be implemented by a same processing element and/or set of program instructions.” This element is reasonably interpreted as a generic computer component as part of a generic computer which provides no details of anything beyond ubiquitous standard off-the-shelf equipment.
Finally, the element of “a user interface,” is best described in para. [0055] as follows: “[0055] The apparatus further comprises an input/output 130 adapted to operably couple the processing unit 120 with a user interface 132. The input/output 130 can output guidance information and/or imaging information to the user interface 132. The user interface may comprise one or more display devices.” This element is also reasonably interpreted as a generic computer component as part of a generic computer which provides no details of anything beyond ubiquitous standard off-the-shelf equipment.
Therefore, the Applicant’s own specification discloses ubiquitous standard equipment that is (1) generic, routine, conventional, and/or commercially available; and (2) does not provide anything significantly more. Thus, Step 2B, of the subject-matter eligibility analysis is “No.”
In addition, dependent claims 2-13 and 15 do not provide a practical application and are insufficient to amount to significantly more than the judicial exception. As such, dependent claims 2-13 and 15 are also rejected under 35 U.S.C. § 101, based on their respective dependencies to claim 1 or 14. Therefore, claims 1-15 are rejected under 35 U.S.C. § 101 as being directed to non-statutory subject matter.
Response to Arguments
The Applicant’s remarks filed on September 15, 2026 related to claims 1-15 are fully considered, but are not persuasive.
Drawing Objection
The Applicant respectfully argues “In response to the Examiner's objection to the drawings, Applicant submits herewith a replacement sheet for Fig. 2.”
The Examiner respectfully disagrees. Fig. 2 continues to contain screenshots/clip art that is lacking sufficient reproducible quality and thus preventing FIG. 2 from complying with 37 CFR 1.84(b)(1). As such, the argument is not persuasive. Therefore, the drawing objection is not withdrawn.
Claim Objections
The Applicant respectfully argues “The Office Action objects to claims 1-15 for a perceived informality. The claims have been amended as set forth above in line with the indication by the Examiner. Based on these amendments, Applicant believes the objection is overcome.”
The Examiner respectfully agrees. As such, the argument is persuasive. Therefore, the claim objections are withdrawn.
Claim Interpretation
The Applicant respectfully argues “The Office Action interprets the recited language "view analyzer module" and "guidance module" in claim 1 under 35 U.S.C. § 112(f). Applicant thanks the Examiner for highlighting these issues and while the Applicant does not concede the Examiner's interpretation, for compact prosecution have amended the claims as set forth above to more fully recite structure.”
The Examiner respectfully agrees. As such, the argument is persuasive. Therefore, the invocation under 35 U.S.C. §112(f) is withdrawn.
Claim Rejection under 35 USC §112
The Applicant respectfully argues “Applicant respectfully request these rejections be withdrawn, and assert the claims are now in condition for allowance.”
The Examiner respectfully disagrees. The Applicant’s amendments have provided new grounds for rejection under 35 U.S.C. §112(a) and 35 U.S.C. §112(b). Please see above. As such, the argument is not persuasive. Therefore, the rejections under 35 U.S.C. §112(a) and 35 U.S.C. §112(b) are not withdrawn.
Claim Rejections - 35 U.S.C. § 101
Step 2A Prong One
The Applicant respectfully argues “Applicants respectfully disagree with the Examiner that the claims should be considered methods of organizing human activity or mental processes. Similarly, the recited subject matter is not merely collecting information, as analogized to the case Electric Power Group.
Notably however, the apparatus and methods impact the operation of a machine to elevate its purpose beyond just a selective display. Instead, the machine restricts overburdensome information responsive to the location of an ultrasound system's location on a patient. This responsiveness to the location of scanning changes this device from merely displaying certain results to a machine that actively guides a user towards a location with reduced distraction.”
The Examiner respectfully disagrees. First, it is worth noting in MPEP §2106 under “II. Certain Methods Of organizing Human Activity,” certain activity between a person and a computer (for example a method of anonymous loan shopping that a person conducts using a mobile phone) may fall within the "certain methods of organizing human activity" grouping. As applied in this case, a person interacting with a computer for “providing guidance,” reasonably constitutes identifying the Applicant’s claims as an abstract idea in the form of “certain methods of organizing human activity.”
Second, it is worth noting in MPEP §2106 under “III Mental Processes,” the courts do not distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer. As the Federal Circuit has explained, "[c]ourts have examined claims that required the use of a computer and still found that the underlying, patent-ineligible invention could be performed via pen and paper or in a person’s mind." Versata Dev. Group v. SAP Am., Inc., 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015). See also Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1318, 120 USPQ2d 1353, 1360 (Fed. Cir. 2016) (‘‘[W]ith the exception of generic computer-implemented steps, there is nothing in the claims themselves that foreclose them from being performed by a human, mentally or with pen and paper.’’); Mortgage Grader, Inc. v. First Choice Loan Servs. Inc., 811 F.3d 1314, 1324, 117 USPQ2d 1693, 1699 (Fed. Cir. 2016) (holding that computer-implemented method for "anonymous loan shopping" was an abstract idea because it could be "performed by humans without a computer"). Once again, as applied in this case, a person interacting with a computer for “providing guidance,” reasonably constitutes identifying the Applicant’s claims as an abstract idea in the form of “mental processes.”
Finally, with regard to Electric Power Group, LLC, v. Alstom, the claimed step of “receive an ultrasound image acquired by the user with an ultrasound acquisition system,” clearly reads on “collecting data.” The claimed step of “determine a spatial relationship between the received ultrasound image and a target view, and compute at least one distance metric for the acquired ultrasound image based on said spatial relationship,” clearly reads on “analyzing data.” Lastly, the claimed step of “generate guidance information based on said spatial relationship, indicative of a change in at least one of position or orientation of the ultrasound acquisition system for the acquisition of another ultrasound image,” clearly reads on “displaying certain results of the collection analysis.” As such, the Applicant’s claims are reasonably being analogized with Electric Power Group, LLC, v. Alstom. Therefore, the argument is not persuasive.
Step 2A Prong Two
The Applicant respectfully argues “Applicant respectfully disagrees with the Examiner's interpretation as the improvement is not only in the enhanced guidance for the user, but also is reflected in the speed with which the machine can operate. When processing resources are solely dedicated to guidance information rather than the display of ultrasound images, the generation of this guidance information occurs much more quickly than if the same machine had to produce both simultaneously. Accordingly, the mode switching enabled here is not only assistive to new/inexperienced users to reduce their distractions when adjusting image scanning location, but furthermore, improves the speed at which the machine can focus on generating this guidance information.
Furthermore, increase is in speed is not the only potential improvement - instead of optimizing for speed savings, there could also be a power savings from the reduced processor utilization as no ultrasound image information needs to be generated in a guidance mode. For at least these reasons, Step 2A, Prong 2 should be answered Yes as these are practical applications in the operation of the machine, system, or device contemplated in these claims.”
The Examiner respectfully disagrees. The Applicant’s argument is misguided as to the proper analysis of a “Practical Application” as required under Step 2A, Prong 2. Specifically, the Applicant’s argument appears to describe claimed utility, which is not the test. Instead, the Applicant’s claims are not considered a “Practical Application,” because the claims do not provide any of the following:
An improvement in the functioning of a computer, or an improvement to other technology or technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a);
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2);
Implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b);
Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP § 2106.05(c); and
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP § 2106.05(e).
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Furthermore, there are also several factors that reasonably explain that the Applicant’s claims are not indicative of integration into a practical application, which include:
Merely reciting the words "apply it" (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea, as discussed in MPEP § 2106.05(f);
Adding insignificant extra-solution activity to the judicial exception, as discussed in MPEP § 2106.05(g); and
Generally linking the use of a judicial exception to a particular technological environment or field of use, as discussed in MPEP § 2106.05(h).
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Here, the Applicant’s claims are not providing any technological advancement as described in the first five bulleted factors and, as described above in the rejection, the Applicant’s claims are merely claimed to use a computer as a tool to perform an abstract idea and to generally link the use of a judicial exception to a particular technological environment or field of use. As such, the argument is not persuasive.
Step 2B
The Applicant respectfully argues “Applicants again respectfully disagree with Examiner's interpretation. The effects of the specific implementation recited in the claims results in improved navigation by counter-intuitively suppressing information - this enables finer location information generated to be provided to the user as all resources in the system can be dedicated to the purpose of navigation feedback. While this improves not only the user's ability to use the device, it saves significant device resources in the form of reduced operation time and even reduced re-scans due to incorrect navigation. Furthermore, with repeat scans, this fine navigation control leads to improved reproducibility of scans. This not only improves the device but the resulting data generated for clinical analysis either by a medical professional or for use in further analysis by other devices. Reconsideration and withdrawal of these rejections is respectfully requested.”
The Examiner respectfully disagrees. The Applicant is misconstruing the analysis at Step 2B. Specifically, the claimed elements of “a receiving unit,” “an ultrasound acquisition system,” “a processing unit,” and “a user interface,” are generic, well-known, and conventional elements, as evidenced above in the rejection by citing the Applicant’s own written description of the specification as originally filed.
Finally, claims defining a desirable information-based result which are not limited to an inventive means of achieving the result, fail under § 101. Here, the Applicant is merely “generating guidance information,” which is reasonably understood as a desirable information-based result. As such, the arguments are not persuasive. Therefore, for the reasons stated here and above, the rejection of claims 1-15 under 35 U.S.C. §101 are not withdrawn.
Conclusion
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT P BULLINGTON whose telephone number is (313)446-4841. The examiner can normally be reached Mon.-Fri. 8:00-4:00.
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/Robert P Bullington, Esq./
Primary Examiner, Art Unit 3715
