DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Notice to Applicant
2. This communication is in response to the communication filed 9/8/2026. Claims 2, 7, 10 and 15 are cancelled. Claim 20 is newly added. Claims 1, 9 and 18-19 are currently amended. Claims 1, 3-6, 8-9, 11-14, and 16-20 are currently pending.
Claim Rejections - 35 USC § 101
3. 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.
3.1. Claims 1, 3-6, 8-9, 11-14 and 16-20 are rejected under 35 U.S.C. § 101 because while the claims (1) are to a statutory category (i.e., process, machine, manufacture or composition of matter, the claims (2A1) recite an abstract idea (i.e., a law of nature, a natural phenomenon); (2A2) do not recite additional elements that integrate the abstract idea into a practical application; and (2B) are not directed to significantly more than the abstract idea itself.
In regard to (1), the claims are to a statutory category (i.e., statutory categories including a process, machine, manufacture or composition of matter). In particular, independent claims 1 and 9, and their respective dependent claims are directed, in part, to systems and methods for assessing gastrointestinal cleansing of a patient by a health professional.
In regard to (2A1), the claims, as a whole, recite and are directed to an abstract idea because the claims include one or more limitations that correspond to an abstract idea including mental processes, and/or mathematical concepts. For example, claims 3 and 11 recite formulas for calculating a cleansing measure. This is an abstract idea categorized under a mathematical concept.
Furthermore, the claims are also directed to a mental process because the claims, except for certain limitations (* identified below in bold), under the broadest reasonable interpretation, can be reasonably and practically performed in the human mind and/or with pen and paper using observation, evaluation, judgment and/or opinion. That is, other than reciting the certain additional elements, nothing in the claims precludes the limitations from being practically performed in the mind and/or with pen and paper. For example, a person can reasonably and practically access images and their cleansing scores, determine an estimate of how much a capsule device has advanced using images, determine a weight for the image, determine a cleansing score for the image, determine a cleansing measure, and provide a visual indication based on the cleansing measure in the human mind and/or with pen and paper using observation, evaluation, judgment and/or opinion.
CLAIM 1:
A system for assessing gastrointestinal tract cleansing, comprising:
one or more processors; and
at least one memory storing instructions which, when executed by the one or more processors, cause the system to:
access a plurality of images of at least a portion of a gastrointestinal tract (GIT) captured by a capsule endoscopy device;
access a cleansing score for each image of the plurality of images;
determining an estimate of how much the capsule endoscopy device has advanced from one of: a beginning of the at least the portion of the GIT, or a location where an immediate prior image was captured, to reach a location where the respective image was captured;
for each image of the plurality of images:
determine a weight for the respective image based on the respective estimate of how much the capsule endoscopy device has advanced from one of: the beginning of the at least the portion of the GIT, or the location where the immediate prior image was captured, to reach the location where the respective image was captured, and
determine a weighted cleansing score for the respective image based on the cleansing score for the respective image and the weight for the respective image;
determine a cleansing measure for at least the portion of the GIT based on the cleansing score for each image of the plurality of images; and
provide a visual indication based on at least one of: the cleansing measure for at least the portion of the GIT.
CLAIM 3:
The system of claim 1, wherein the cleansing measure for at least the portion of the GIT is computed as:
∑
i
=
1
n
s
c
o
r
e
i
∙
∆
i
∆
i
wherein:
n is a number of images in the plurality of images,
score; is the cleansing score for image i, and
Δi is the estimate of how much the capsule endoscopy device has advanced for image i, and
Δtotal =
∑
i
=
1
n
Δil, wherein the respective weight for each image i is:
Δil / Δtotal, wherein the respective weighted cleansing measure for each image i is:
scorei · Δil / Δtotal
CLAIM 4:
The system of any one of the preceding claims claim 1, wherein the instructions, when executed by the one or more processors, further cause the system to: access advancement information indicative of whether the capsule endoscopy device is static.
CLAIM 5:
The system of claim 4, wherein the plurality of images do not include images whose advancement information indicates that the capsule endoscopy device is static.
CLAIM 6:
The system of any one of the preceding claims claim 1, wherein the instructions, when executed by the one or more processors, further cause the system to: access wall assessment information indicating whether an image is an image of only a clean wall of the at least the portion of the GIT, wherein the plurality of images do not include images whose wall assessment information indicates that the image is an image of only a clean wall.
CLAIM 8:
system of any one of the preceding claims claim 1, wherein the cleansing score for each image of the plurality of images is based on a predetermined set of scores including:
a first score indicative of poor visualization of mucosa and indicative of at least one of: excessive content, excessive debris, excessive bubbles, excessive bile staining, excessive chyme staining, or excessive bleeding;
a second score indicative of moderate visualization of mucosa and indicative at least one of: moderate content, moderate debris, moderate bubbles, moderate bile staining, moderate chyme staining, or blurriness;
a third score indicative of good visualization of mucosa not through a big bubble and indicative at least one of: mild amount of debris, mild bubbles, mild bile staining, or mild chyme staining; and
a fourth score indicative of excellent visualization of mucosa not through a big bubble and indicative at least one of: minimal amount of debris, minimal bubbles, minimal bile staining, minimal chyme staining, no debris, no bubbles, no bile staining, or no chyme staining.
CLAIM 9:
A computer-implemented method for assessing gastrointestinal tract cleansing, the method comprising:
accessing a plurality of images of at least a portion of a gastrointestinal tract (GIT) captured by a capsule endoscopy device;
accessing a cleansing score for each image of the plurality of images;
for each image of the plurality of images:
determining an estimate of how much the capsule endoscopy device has advanced from one of: a beginning of the at least the portion of the GIT, or a location where an immediate prior image was captured, to reach a location where the respective image was captured;
determining a weight for the respective image based on the respective estimate of how much the capsule endoscopy device has advanced from one of: the beginning of the at least the portion of the GIT, or the location where the immediate prior image was captured, to reach the location where the respective image was captured, and
determine a weighted cleansing score for the respective image based on the cleansing score for the respective image and the weight for the respective image;
determining a cleansing measure for at least the portion of the GIT based on the weighted cleansing score for each image of the plurality of images; and
providing a visual indication based on at least one of: the cleansing measure for at least the portion of the GIT.
CLAIM 11:
The computer-implemented method of claim 9, wherein the cleansing measure for at least the portion of the GIT is computed as:
∑
i
=
1
n
(scorei · Δil / Δtotal)
wherein:
n is a number of images in the plurality of images,
score; is the cleansing score for image i, and
Δi is the estimate of how much the capsule endoscopy device has advanced for image i, and
Δtotal =
∑
i
=
1
n
Δil, wherein the respective weight for each image i is:
Δil / Δtotal, wherein the respective weighted cleansing measure for each image i is:
scorei · Δil / Δtotal.
CLAIM 12:
The computer-implemented method of any one of the preceding claims claim 9, further comprising: accessing advancement information indicative of whether the capsule endoscopy device is static.
CLAIM 13:
The computer-implemented method of claim 12, wherein the plurality of images do not include images whose advancement information indicates that the capsule endoscopy device is static.
CLAIM 14:
The computer-implemented method of any one of the preceding claims claim 9, further comprising: accessing wall assessment information indicating whether image is an image of only a clean wall of the at least the portion of the GIT, wherein the plurality of images do not include images whose wall assessment information indicates that the image is an image of only a clean wall.
CLAIM 16:
The system of claim 1, wherein the instructions, when executed by the one or more processors, further cause the system to: automatically reduce, based on the cleansing measure for at least the portion of the GIT, a number of images in a study to be reviewed by a healthcare professional, wherein images remaining in the study permit the healthcare professional to focus review time.
CLAIM 17:
The computer-implemented method of claim 9, further comprising: automatically reducing, based on the cleansing measure for at least the portion of the GIT, a number of images in a study to be reviewed by a healthcare professional, wherein images remaining in the study permit the healthcare professional to focus review time.
CLAIM 18:
The system of claim 1, wherein a number of the plurality of images to be processed is on an order of tens of thousands of images.
CLAIM 19:
The computer-implemented method of claim 9, wherein a number of the plurality of images to be processed is on an order of tens of thousands of images.
CLAIM 20
The system of claim 1, further comprising: the capsule endoscopy device configured to capture the plurality of images of at least the portion of the GIT.
* The limitations that are in bold are considered “additional elements” that are further analyzed below in subsequent steps of the 101 analysis. The limitations that are not in bold are abstract and/or can be reasonably and practically performed in the human mind and/or with pen paper.
In regard to (2A2), the claims do not recite additional elements that integrate the abstract idea into a practical application. The additional elements in the claims (i.e., * identified above in bold) do not integrate the abstract idea into a practical application because the additional elements merely add insignificant extra-solution activity to the abstract idea; merely link the use of the judicial exception to a particular technological environment or field of use; and/or simply append technologies and functions, specified at a high level of generality, to the abstract idea (i.e., the additional elements do not amount to more than a recitation of the words “apply it” (or an equivalent) or are more than mere instructions to implement an abstract idea or other exception on a computer).
Here, the additional elements (e.g., computer, one or more processors, memory, capsule endoscopy device, etc.) are recited at a high-level of generality such that it amounts to no more than mere instructions to apply the abstract idea using generic computer technologies. Moreover, the claims recite “cause the system to”, etc. devoid of any meaningful technological improvement details and thus, further evidence the additional elements are merely being used to leverage generic technologies to automate what otherwise could be done manually. Accordingly, the 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.
Furthermore, the additional elements do not recite improvements to the functioning of a computer, or to any other technology or technical field—the additional elements merely recite general purpose computer technology; the additional elements do not recite applying or using a judicial exception to effect a particular treatment or prophylaxis for disease or medical condition—there is no actual administration of a particular treatment; the additional elements do not recite applying the judicial exception with, or by use of, a particular machine—the additional elements merely recite general purpose computer technology; the additional elements do not recite limitations effecting a transformation or reduction of a particular article to a different state or thing—the additional elements do not recite transformation such as a rubber mold process; the additional elements do not recite 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—the additional elements merely leverage general purpose computer technology to link the abstract idea to a technological environment.
In regards to (2B), the claims, individually, as a whole and in combination with one another, do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements or combination of elements in the claims, other than the abstract idea per se, amount to no more than a recitation of (A) a generic computer structure(s) that serves to perform computer functions that serve to merely link the abstract idea to a particular technological environment (i.e., computers); and/or (B) functions that are well-understood, routine, and conventional activities previously known to the pertinent industry.
Here, as discussed above with respect to integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply the exception using generic computer technologies. Mere instructions to apply an exception using generic computer technologies cannot provide an inventive concept.
Moreover, paragraphs [0047] and [0068] of applicant's specification (US 2024/0249829) recites that the system/method is implemented using a workstation or computer, computing platform, computing system or other electronic computing device which are well-known general purpose or generic-type computers and/or technologies. The use of generic computer components recited at a high level of generality to process information through an unspecified processor/computer does not impose any meaningful limit on the computer implementation of the abstract idea. Thus, taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception (the abstract idea). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Furthermore, the additional elements are merely well-known general purpose computers, components and/or technologies that receive, transmit, store, display, generate and otherwise process information which are akin to functions that courts consider well-understood, routine, and conventional activities previously known to the pertinent industry, such as, performing repetitive calculations; receiving or transmitting data over a network; electronic recordkeeping; retrieving and storing information in memory; and sorting information (See, for example, MPEP § 2106).
Therefore, the claims are not patent-eligible under 35 U.S.C. § 101.
Response to Arguments
4. Applicant's arguments filed 9/8/2026 have been fully considered but they are not persuasive. Applicant’s arguments will be addressed hereinbelow in the order in which they appear in the response filed 9/8/2026.
4.1. Applicant argues, on pages 8-15 of the response, that (1) the claims are not directed to an abstract idea of certain methods of organizing human activity, mathematical concepts, or mental processes; and (2) the claims integrate any abstract idea into a practical application citing the Peleg Declaration.
In response, the categorization of the claims under certain methods of organizing human activity has been withdrawn. It is respectfully submitted, however, that the claims are still directed to an abstract idea under the abstract categories of mental processes and/or mathematical concepts, as set forth in section 3, supra. Applicant asserts that at least the claim element “for each image of the plurality of images: determining an estimate how much the capsule endoscopy device has advanced from one of: a beginning of the at least the portion of the GIT, or a location where an immediate prior image was captured, to reach a location where the respective image was captured” cannot be practically performed in the human mind. Examiner respectfully disagrees and submits that, under a broad and reasonable interpretation, nothing in the claim precludes a person from performing this element in their mind and/or with pen and paper. For example, a person can review GIT images and estimate how much a capsule has advanced by comparing subsequent image locations in their mind using observation, evaluation, judgment and/or opinion. While Applicant argues the complexity of the capsule endoscopy device and computer vision technology to support their assertion that the claims cannot be practically performed by person, Examiner notes that the claims do not recite sufficient limitations regarding these specific details.
Furthermore, notes MPEP § 2106.04(a)(2)(c), which states the following:
A claim that recites a mathematical calculation, when the claim is given its broadest reasonable interpretation in light of the specification, will be considered as falling within the “mathematical concepts” grouping. A mathematical calculation is a mathematical operation (such as multiplication) or an act of calculating using mathematical methods to determine a variable or number, e.g., performing an arithmetic operation such as exponentiation. There is no particular word or set of words that indicates a claim recites a mathematical calculation. That is, a claim does not have to recite the word “calculating” in order to be considered a mathematical calculation. For example, a step of “determining” a variable or number using mathematical methods or “performing” a mathematical operation may also be considered mathematical calculations when the broadest reasonable interpretation of the claim in light of the specification encompasses a mathematical calculation.
Here, claims 1 and 9 recite determining an estimate of how much the capsule device has advanced, determining a weighted cleansing score, and determining a cleansing measure. Examiner submits these limitations are mathematical calculations because mathematical methods are used to determine a number. Moreover, claims 3 and 11 recite mathematical equations used to calculate a cleansing measure. As such, it is respectfully submitted that the claims, under a broad and reasonable interpretation, also fall under the abstract category of mathematical concepts.
In regard to (2), it is respectfully reiterated that the additional elements (e.g., computer, one or more processors, memory, capsule endoscopy device, etc.) are recited at a high-level of generality such that it amounts to no more than mere instructions to apply the abstract idea using generic computer technologies. Furthermore, it is submitted that the pending claims are not directed to any technological improvement per se, such as an improvement in computers as tools. Rather, the claimed invention is merely being linked to a technological environment by using well-known general purpose computer technology (e.g., a processor) as a tool to perform an abstract idea; and the alleged improvements of the claims pertain to the abstract idea itself, rather than improvements to the technology (i.e., computer/processor, capsule endoscopy device, etc.). In other words, the focus of the claims is not on an improvement in computers as tools, but on certain abstract ideas that use computers as tools. As such, the additional elements neither integrate the abstract idea into a practical application nor amount to significantly more than the abstract idea itself.
In short, the claims are directed to and recite an abstract idea; and the additional elements do not integrate the abstract idea into a practical application or amount to significantly more than the abstract idea. Accordingly, the claims are not patent-eligible subject matter under 35 U.S.C. § 101.
Conclusion
5. 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 Michael Tomaszewski whose telephone number is (313)446-4863. The examiner can normally be reached M-F 5:30 am - 2:30 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, Peter H Choi can be reached at (469) 295-9171. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL TOMASZEWSKI/Primary Examiner, Art Unit 3681
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