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 .
Continued Examination Under 37 CFR 1.114
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/24/2025 has been entered.
Notice to Applicant
3. This communication is in response to the communication filed 12/24/2025. Claims 2, 7, 10 and 15 are cancelled. Claims 3, 6, 8, and 11-14 are currently amended. Claims 18-19 are new. Claims 1, 3-6, 8-9, 11-14, and 16-19 are currently pending.
Claim Rejections - 35 USC § 101
4. 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.
4.1. Claims 1, 3-6, 8-9, 11-14 and 16-19 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 regards 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 regards 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, and/or certain methods of organizing human activity which encompasses both certain activity of a single person, certain activity that involves multiple people, and certain activity between a person and a computer. For example, claims 3 and 11 recite formulas for calculating a cleansing measure, this is a mathematical concept. As a further example, independent claims 1 and 9, as a whole, are directed to assessing gastrointestinal cleansing of a patient by a health professional by, inter alia, accessing images, accessing cleansing scores, accessing advancement information, determining a cleansing measure, and providing a visual indication of the cleansing measure or score which are human activities and/or interactions and therefore, certain methods of organizing human activity which encompasses both certain activity of a single person, certain activity that involves multiple people, and certain activity between a person and a computer. The dependent claims include all of the limitations of their respective independent claims and thus are directed to the same abstract idea identified for the independent claims but further describe the elements and/or recite field of use limitations.
Furthermore, assuming arguendo, the claims are not directed to certain methods of organizing human activities, the claims, nevertheless, are directed to an abstract idea 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. Moreover, claims 3 and 11 recite mathematical equations and calculating cleansing measures using the equations and thus, are categorized as abstract ideas under the grouping of mathematical concepts.
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;
for each image of the plurality of images:
determine a weight for the respective image based on 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, 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 or at least one of the cleansing scores.
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:
determine a weight for the respective image based on 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, 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 or at least one of the cleansing scores.
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 the instructions, when executed by the one or more processors, further cause the system to: for each image of the plurality of images, determine the 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, 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, further comprising: for each image of the plurality of images, determining the 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, wherein a number of the plurality of images to be processed is on an order of tens of thousands of images.
* 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 regards 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
5. Applicant's arguments filed 12/24/2025 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 12/24/2025.
5.1. Applicant argues, on pages 8-11 of the response, that (1) the subject matter of the pending claims do not recite any abstract idea of managing personal behavior or interactions between people; (2) even if the claims could be characterized as reciting an abstract idea, the pending claims are patent-eligible because the pending claims recite a technological improvement; and (3) the claims involve significantly more than an abstract idea.
In regard to (1), the claims are directed to assessing gastrointestinal tract (GIT) cleansing by using a capsule endoscopy device that is swallowed by a patient and captures images that are analyzed to determine a cleansing score and measure for the patient. This is a human activity and/or interaction and thus, a certain method of organizing human activity which encompasses both certain activity of a single person, certain activity that involves multiple people, and certain activity between a person and a computer. It is further noted that the number of people involved in the activity is not dispositive as to whether a claim limitation falls within this grouping. Instead, the determination should be based on whether the activity itself falls within one of the sub-groupings. Therefore, as a further example, providing a visual indication of the cleansing score or measure to a user, such as a provider or patient, via a computer is properly categorized as an abstract idea under the grouping of certain methods of organizing human activity. It is also reiterated that even if the claims are not directed to certain methods of organizing human activity, the claims are nonetheless directed to and recite an abstract idea because the steps of the claims can be reasonably and practically performed in the human mind and/or with pen and paper, as detailed in section 4, supra.
In regard to (2) and (3), it is 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
6. 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