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 § 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, 4, 8, 10-26 are 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 – Claim 1 recites a method of vessel visualization and, therefore, is a process. Claim 14 recites a method of planning an embolization procedure for a patient, and is therefore a process. Claim 18 recites a non-transitory computer-readable medium and is therefore an apparatus.
Step 2A, Prong 1, Judicial Exception: YES - The claim recites the limitation of “determining diameters of the vessel tree along the vessel tree based on the digital image”. 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 “executed by a processor to cause the processor to perform” (claim 18) nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the “executed by a processor” language, the claim encompasses a user simply taking a digital image and manually measuring the diameters. This could be done manually with a ruler or in the mind’s eye based on the observed structures in the digital image. The mere nominal recitation of a “processor” in claim 18 does not take the claim limitation out of the mental processes grouping. Similarly, in claim 14, “outputting a digital representation” or claim 1 “presenting a visualization” does not take the claim limitation out of the mental processes grouping because a user can color code (e.g. highlight) with a pen or marker based on observed diameters. There are no structural components required in claims 1 and 14 at all; “capturing a 3D digital image” (claims 1, 14) can be data transfer or providing a generic image to a user and is pre-solution activity related to data collection. Thus, the claim recites a mental process.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites additional elements: “capturing a digital image” (claims 1, 14). The capturing step is recited at a high level of generality (i.e., as a general means of obtaining a digital image), and amounts to mere data gathering, which is a form of insignificant extra-solution activity. The processing circuitry that performs the “determining diameters” step is also recited at a high level of generality (claim 18), and merely automates the determining step. 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 processor, claim 18). 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, the initial image capturing step and determining 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 specification 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 capturing step is well-understood, routine, conventional activity is supported under Berkheimer Option 2. For these reasons, there is no inventive concept in the claim, and thus it is ineligible.
Evaluating additional elements in the dependent claims:
Claim 8, 19 recites “machine learning model” for determining the diameters. However, the “machine learning model” is recited at a high level of generality and only serves as a general recitation to apply the mental step on a computer. As such, it does not take the claim out of the mental processing grouping or amount to significantly more than the mental process.
Claim 10 recites a generic displaying step, but courts have ruled that “displaying” information is also part of abstract idea grouping (e.g. Elec. Power Grp., LLC v. Alstom S.A., 830 F.3d 1350 (Fed. Cir. 2016)).
Similarly, providing an overlay image can be performed by hand and when generally recited, does not take the invention out of the abstract idea grouping either (e.g. claims 12, 17).
Claims 21-24 present limitations directed towards color-coding the vessel diameters. These steps can be performed by hand (e.g. high-lighting with marker) and therefore do not take the claim out of the mental processing grouping or amount to significantly more than the mental process.
Claims 25-26 incorporate an additional parameter into the comparison step – compressibility parameter (claim 25) and expansion parameter (claim 26). The claim does not specify how these parameters are determined. They may just be provided to the user, which in case the user can do a mental comparison to compare the data values of diameter and compressibility (or expansion) parameters to determine if the microbead can pass or not. As such, they do not take the claim out of the mental process grouping or amount to significantly more than a mental process. If these steps could be clarified to include how the parameters are determined (e.g. complex modeling that cannot readily be performed in the mind?), it may make the claim patent eligible.
In conclusion, Claims 1, 4, 8, 10-26 are ineligible.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 4, 10-18, 20-24 are rejected under 35 U.S.C. 103 as being unpatentable over US 20090012382 to Dutta in view of NPL “Embolic Agents: Particles” to Lee.
Regarding Claim 1, Dutta teaches a method of vessel visualization comprising:
capturing a digital image of a vessel tree of a patient that has been contrast-enhanced (contrast agent is administered to the patient and vascular imaging is performed to produce CT images, 20, 122, Figure 4; the vascular image is a vascular tree due to naturally having the branching points, par. 0057); and
determining a respective plurality of diameters of a plurality of vessel segments (size parameters 172, Figure 6) of the vessel tree along the vessel tree based on the digital image (diameter decreases in size with each branching level, par. 0057 and are calculated and displayed as in Figure 9; detection module 128, Figure 4 determines size parameters such as diameters of the vessel segments, par. 0050);
presenting a visualization of the plurality of vessel segments based on the determined diameters (each of the vessel segments at a particular branching level are identified by a unique color, par. 0088, Figure 9; branching level indicates diameter, par. 0084).
However, Dutta is silent with respect to comparing the respective plurality of diameters of the plurality of vessel segments to a diameter of a selected microbead type to use for an embolization procedure.
Lee teaches embolization particles. Lee further teaches how the embolization particle size (i.e. diameter) is selected based on vessel diameter (page 19, second column, third paragraph).
As such, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to combine Dutta with Lee for teaching determining diameter of the blood vessels (Dutta) and selecting the embolization particle diameter based on the diameter of the blood vessels (Lee) via a comparison step. One of ordinary skill in the art before the effective filing date of the claimed invention would have expected only predictable results to occur, that being to select the optimal particles for a subsequent embolization procedure, as taught by Lee. Dutta teaches color-coding the vessel diameters which implicitly provides a visualization relating to diameter of the microbeads that can pass or not pass based on diameter size. For example, if the colors red, blue, green are used to indicate small, medium, large vessel segments respectively, then a medium microbead can flow in the blue (medium) and green (large) areas but not the red (small) areas.
Regarding Claim 4, Dutta further teaches wherein the digital image is a 3D reconstruction of the vessel tree (display 28, Figure 4 displays the vessel tree image as in Figure 9).
Regarding Claim 10, Dutta further teaches displaying a 3D graphical representation of the vessel tree on a monitor viewable by a clinician (display 28, Figure 4 displays the vessel tree image as in Figure 9).
Regarding Claim 11, Dutta further teaches wherein presenting the visualization of the plurality of vessel segments comprises presenting a plurality of colors corresponding to the comparison of the respective plurality of diameters of the plurality of vessel segments to the diameter of the selected microbead type (each of the vessel segments at a particular branching level are identified by a unique color, par. 0088, Figure 9; branching level indicates diameter, par. 0084).
Regarding Claim 12, Dutta further teaches wherein the 3D graphical representation of the vessel tree is overlaid on an image of an embolization target site (as shown in Figure 8).
Regarding Claim 13, Lee teaches how the embolization particle size (i.e. diameter) is selected based on vessel diameter (page 19, second column, third paragraph), which implicitly requires determining the diameter of the selected microbead type to use for the embolization procedure in the patient.
Claim 14 is rejected for the same reasoning as for Claim 1 above.
Claim 15 is rejected for the same reasoning as for Claim 1+13 above.
Claim 16 is rejected for the same reasoning as for Claim 1+11 above.
Claim 17 is rejected for the same reasoning as for Claim 12 above.
Claim 18 is rejected for the same reasoning as for claim 1 above. Additionally, the method is performed by a computer processor (processing system 22, Figure 4).
Claim 20 is rejected for the same reasoning as for claim 1+11 above.
Regarding Claims 21-24, Dutta teaches color-coding the vessel diameters. As such, the areas where correspondingly sized microbeads can and cannot flow are color-coded, since they correspond to diameter as well. (each of the vessel segments at a particular branching level are identified by a unique color, par. 0088, Figure 9; branching level indicates diameter, par. 0084). For example, if the colors red, blue, green are used to indicate small, medium, large, respectively, then a medium microbead can flow in the blue (medium) and green (large) areas but not the red (small) areas.
Claims 8 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over US 20090012382 to Dutta in view of NPL “Embolic Agents: Particles” to Lee, as applied to claims 1 and 14 above, in further view of US 20210174523 to Kaethner.
Regarding Claim 8, Dutta does not teach wherein the diameters of the vessel tree are determined based on a machine learning model.
Kaethner, solving a similar problem of segmenting small vessels from contrast-enhanced blood vessel images (par. 0006), teaches using machine learning to find size parameters of the vascular tree (neural network, par. 0107 is utilized to find and segment the vascular tree).
As such, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to provide machine learning in the method of Dutta to improve the detection of small blood vessels as shown to be advantageous for such purpose in Kaethner.
Claim 19 is rejected for the same reasoning as for claim 8 above.
Allowable Subject Matter
Claims 25 and 26 avoid the prior art but are rejected under USC 101.
Response to Arguments
Applicant's arguments filed March 31, 2026 have been fully considered but they are not entirely persuasive.
Applicant argues the objections and rejections under 35 USC 112(b) are overcome by the amendments. Examiner agrees.
Regarding the prior art, Applicant argues Dutta and Lee fail to teach or suggest “comparing the respective plurality of diameters of the plurality of vessel segments to a diameter of a selected microbead type to use for an embolization procedure, and presenting a visualization of the plurality of vessel segments based on the comparison of the respective plurality of diameters of the plurality of vessel segments to the diameter of the selected microbead type” as required by claim 1 and analogously in claims 14 and 18. While the step is not anticipated, when considered in combination of the teachings of Dutta and Lee, one of ordinary skill in the art would arrive at the claimed invention, as Lee teaches microbead size selection is related to vessel diameter and Dutta teaches color-coding vessel diameter. As such, the color-coded display of Dutta implicitly teaches where a microbead of a certain diameter can and cannot flow, based on the color coding and known diameter size of the microbead. Applicant further argues that modifying Dutta to include microbead determination undermines the purpose of Dutta. However, Dutta is related to displaying vessel diameters. The teachings related to the treatment method are not relied upon. As such, the display method of Dutta is not undermined by using it for another purpose, in this case, to aid in determining where microbeads can and cannot flow.
Examiner agrees that claims 25-26 avoid the prior art. However, all claims are rejected under USC 101 as being directed towards a mental process without significantly more. While Applicant argues eligibility under Step 2A Prong Two because the claimed visualization would provide more precise planning and allow the clinician to focus on affected vessels during embolization by providing an intuitive graphics display for aiding the user in selection of appropriately sized microbeads to use for subsequent embolization. However, simple visual aids that can be drawn by hand using mental comparisons of data have been determined by the courts to be patent ineligible. Claiming only the functions of such a comparison and visualization are not sufficient to take the claimed invention out of the mental process grouping. Regarding Step 2B, Applicant argues the determination of diameters, comparing of diameters, and visualization are unconventional. However, these features are directed to the mental processes and cannot serve to amount to significantly more unless additional elements are introduced. Examiner discussed the patent eligibility of the claims with the Technology Center Quality Assurance Specialist (QAS) who also indicated the claims broadly recite capabilities of performing functions and can be considered extra solution activity that does not integrate into any practical application.
Examiner notes that Claims 25-26 incorporate an additional parameter into the comparison step – compressibility parameter (claim 25) and expansion parameter (claim 26). The claim does not specify how these parameters are determined. They may just be provided to the user, which in case the user can do a mental comparison to compare the data values of diameter and compressibility (or expansion) parameters to determine if the microbead can pass or not. As such, they do not take the claim out of the mental process grouping or amount to significantly more than a mental process. If these steps could be clarified to include how the parameters are determined (e.g. complex modeling that cannot readily be performed in the mind?), it may make the claim patent eligible.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 20210361257 and US 11986342 to Eimer teaches visualization of microbeads based on relative diameter size between the blood vessel and microbeads, e.g. the microbeads cannot pass when the vessel diameter is small (Figure 3C) but can pass when the vessel diameter is larger (Figure 3A).
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 ANGELA MARIE HOFFA whose telephone number is (571)270-7408. The examiner can normally be reached Monday - Friday 9:30 am - 6:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached at (571)270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
ANGELA M. HOFFA
Primary Examiner
Art Unit 3799
/Angela M Hoffa/Primary Examiner, Art Unit 3799
Prosecution Insights