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 the Claims
The status of the claims as of the response filed 10/28/2025 is as follows: Claims 1, 5, 6, 8, 9, 10, 14, 15, 17, 18, and 19 are amended. Claims 2, 3, 4, 7, 11, 12, 13, 16, and 20 are original. Claims 21, 22, 23, 24, 25, 26, 27, 28, 29, and 30 are new. Claims None are canceled.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 11/03/2025 are in accordance with the provisions of 37 CFR 1.97 and are considered by the Examiner.
Claim Objections
Objections Claims 10, 21, 23, 24, 25 and 26
Claim 10 objected to because of the following informalities, concludes with the phrase "; and.". This construction is contradictory and grammatically incorrect. To resolve this objection, the applicant should amend the claim to remove the extraneous conjunction and conclude with a single terminal period.
Dependent claims 21, 23, 24, 25, and 26 are objected to as being improperly labeled as "system" claims while depending from claim 1, which is a "method" claim.
Appropriate correction is required.
Response to Arguments
35 U.S.C. § 101
Applicant’s arguments, see page 7-8 filed date 10-28-25 , with respect to Claims 1-30 have been fully considered and are not persuasive. The 35 U.S.C. § 101rejections is sustained.
The applicant argues that the amended claims recite a "measurement technique" that "generates new data" (historical trends and risk determinations), which qualifies as an improvement in technology and provides "significantly more" than an abstract idea per MPEP 2106.05(a)(II) and Electric Power Group.
The Examiner respectfully disagrees because the generation of "new data" in the form of diagnostic trends and risk profiles represents an improvement to the abstract idea rather than a technical improvement to a computer or another technology (MPEP 2106.05(a); Stanford II).
Double Patenting
Applicant's arguments, see page 8, filed 10/28/2025, with respect Claims 1-30 have been fully considered and are not persuasive. Claims continuous rejected under 35 U.S.C. § 101 and/or nonstatutory double patenting, have been fully considered and are not persuasive.
Applicant wishes to "defer responding to this rejection until all of the pending claims are otherwise deemed allowable
The Examiner respectfully disagrees because a request to defer a response does not constitute a "complete reply". Consequently, the rejections are maintained as the applicant has failed to provide a terminal disclaimer or demonstrate that the claims are patentably distinct.
35 U.S.C. § 102
Applicant's arguments, see page 8-9, filed 10/28/2025, with respect to amended Claims 1, 10, and 19 have been fully considered and are smoot.
Applicant argues Bachwich fails to disclose "generating a historical trend... based on the two or more images... showing a progression of the health or disease state." Applicant asserts that Bachwich is limited to assessing "colon preparation" status and does not record or compare trend data for a disease state.
The Examiner withdraws the rejection over Bachwich but now the claims 1-9, 21, 23, 25-26 and 10-18, 22, 27-30 are anticipated by Karlin (US 2020/0395124).
35 U.S.C. § 103
Applicant's arguments, see page 9-11, filed 10/28/2025, with respect to amended Claims 3-4, 9, 12-13, and 18-20 have been fully considered and are not persuasive.
Applicant argues that Karlin is limited to "real-time monitoring" and does not teach comparing multiple images or analyzing historical trends. Regarding Kim, applicant asserts the reference is directed to general image manipulation and "message history data" that is not used to develop a health trend, nor does it disclose stool characteristics.
The Examiner respectfully disagrees because Karlin explicitly discloses the sequential analysis of multiple stool images (e.g., "1.jpg, 2.jpg, 3.jpg" in Fig. 3) to track a patient's "progression rate" over months or years (Karlin [0027], [0086]). Karlin’s extraction of specific stool characteristics, color, size, and texture (Fig. 5)—when integrated with a "timeline" engine to detect "relapse" ([0098], [0099]) is the functional equivalent of the claimed health trend.
The "historical trend" of the claims is functionally identical to Karlin’s system because both convert discrete, timestamped image data into a temporal progression of a disease state. Specifically:
Karlin's Fig. 5 identifies the markers (color/texture/size) while 0098 plots these markers on a "timeline." The function of "generating a trend" is satisfied by Karlin's "visualization engine," which maps these sequential changes to identify a medical "relapse" ( 0099).
Under the Broadest Reasonable Interpretation (MPEP 2111), "generating a historical trend" is the act of representing data points over time to show a direction of change. By recording "1.jpg, 2.jpg, 3.jpg" (Fig. 3) and noting "physiological changes" on a timeline (0099), Karlin performs the exact same diagnostic tracking of a disease state progression as recited in the claims.
Karlin is not limited to "real-time" individual image analysis; it specifically illustrates a system receiving and storing a plurality of images per patient (Fig. 3 showing "1.jpg, 2.jpg, 3.jpg") for "long-term monitoring" ([0027]).
The rejection over Bachwich is withdrawn. A new rejection under 35 U.S.C. § 103 is submitted over the combination of Karlin, Kim, and Clark.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4, 7, 10-18, 20 and 27-30, rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Antecedent Basis Rejections
Claim 4 and 7, (and by extension 13 and 16) recite the limitation "the client device" in the first occurrence of the term in each claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the health or disease state" in the operation of "generating a historical trend." There is insufficient antecedent basis for this limitation in the claim.
Claim 19 recites the limitation "the health or disease state" in the operation of "generating a historical trend." There is insufficient antecedent basis for this limitation in the claim.
Note: Claims 11-18, 20, 22, and 27-30 are also rejected on this basis because of their dependence on claim 10.
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 1-30 are rejected under 35 U.S.C. § 101 because the claimed subject matter is directed to a judicial exception (an abstract idea) without reciting elements that integrate the exception into a practical application or provide an inventive concept amounting to significantly more than the exception itself.
Step 1
Step 1 of the subject matter eligibility analysis determines if the claims fall into one of the four statutory categories defined in 35 U.S.C. § 101 (Process, Machine, Manufacture, or Composition of Matter).
Process (Claims 1-9, 21, 23- 26): These claims are directed to a "method" for managing disease states. Under the Broadest Reasonable Interpretation (MPEP § 2111), the claims recite a series of acts or steps (receiving images, determining characteristics, generating trends, and providing information). The dependent claims 21, 23- 26, were included for compact prosecution and in view on future amendments.
Machine (Claims 10-20, 22, and 27-30): These claims recite a "system" or a "non-transitory computer-readable storage medium." They specifically include structural hardware elements such as "one or more data processors." This identifies a "machine" as a concrete thing consisting of parts or devices.
Step 2A, Prong One: Judicial Exception Analysis
The claims are directed to the judicial exceptions of Mental Processes, Certain Methods of Organizing Human Activity, and Mathematical Relationships.
Under the Broadest Reasonable Interpretation (MPEP § 2111), the invention is directed to the abstract idea of collecting visual data of stool, analyzing that data to observe medical trends, and providing notifications based on those observations. The core logic of the claims involves cognitive steps that can be performed in the human mind or with the aid of pen and paper.
Independent Claim Analysis
The bold text represents additional elements, while non-bold text represents the abstract idea.
Claim 1.
A method for managing one or more of irritable bowel disease, ulcerative colitis or Crohn's disease, the method comprising:
receiving two or more images from one or more user devices, wherein a
first of the two or more images is captured prior to the second of the two or more images;
determining, from stool in the two or more images, one or more stool
characteristics;
generating a historical trend of a health or disease state of a user based on the two or
more images, wherein the historical trend shows a progression of the health or disease state over time based on the one or more stool characteristics;
determining a risk of the health or disease state based at least in part on the historical
trend;
and generating and providing information associated with the determined risk
of the health or disease state to at least one of the one or more user devices.
Claim 19.
A system for managing one or more of irritable bowel disease, ulcerative colitis or Crohn's disease, comprising:
one or more data processors;
and
a non-transitory computer-readable storage medium containing instructions which, when
executed on the one or more data processors, cause the one or more data processors to perform operations including:
receiving a plurality of images from each user device of a plurality of user
devices, wherein a first of the plurality of images is captured prior to at least a second of the plurality of images from the each user device;
determining, from stool in the plurality of images, one or more stool characteristics
associated with the each user device;
generating a historical trend of the health or disease state of a user based on the plurality
of images, wherein the historical trend shows a progression of the health or disease state over time based on the one or more stool characteristics;
determining a risk of the health or disease state based at least in part on the historical
trend;
generating and providing information associated with the
determined risk of the health or disease state to at least some of the plurality of user devices;
generating a corresponding report associated with a corresponding user device of at
least some of the plurality of user devices, wherein a corresponding file size associated with the corresponding report is proportional to a number of images associated with the corresponding user device;
and based on the corresponding file size exceeding a threshold, generating an alert to a
caregiver device.
Note: applicant language is from US20240366193A1 application number.
Claim Abstract Classification Rationale
The independent claims 1, 10 and 19 recite abstract ideas falling into the following MPEP categories:
Mental Processes (MPEP § 2106.04(a)(2)(III)): The steps of "determining... characteristics," "generating a historical trend," and "determining a risk" are cognitive tasks. These limitations describe the evaluation of data to reach a diagnostic conclusion. This is a process that can be performed in the human mind. The specification supports this by stating: "Patients with ulcerative colitis (UC) are often asked to visually assess stool characteristics as a measure of disease activity" (Spec., para. [0017]).
Certain Methods of Organizing Human Activity (MPEP § 2106.04(a)(2)(II)): The steps of "providing information" and "generating an alert to a caregiver device" (Claim 19) fall into the sub-category of managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions). These steps describe the management of interactions between patients and healthcare providers, facilitating medical clinical workflows and professional communication. The specification provides evidentiary support for this being an organizational/behavioral management tool: "In some implementations, a doctor or caregiver at a hospital can be alerted to a change in disease activity information for a subset of patients associated with the doctor or caregiver... an alert can be provided to the doctor or caregiver to check reports associated with the subset of patients" (Spec., para. [0048]). Paragraph [0048] explicitly describes a protocol for alerting medical professionals based on specific patient data patterns, thereby illustrating a rule-based management of professional interactions and clinical workflows between healthcare providers and their patients.
Mathematical Relationship (MPEP § 2106.04(a)(2)(I)): Claim 19 recites that "a corresponding file size... is proportional to a number of images." This is a mathematical relationship (e.g., y=kx) expressing a correlation between two variables, which is a fundamental mathematical concept.
Manual Replication Scenario (Human Equivalence)
The abstract nature of the claims is reinforced because the entire process is analogous to fundamental human activities that a physician or patient could perform:
Receiving Images (Claim 1, 10, 19): A patient hands a doctor two printed photographs of their stool, one taken on Monday and one taken on Friday.
Determining Characteristics (Claim 1, 10, 19): The doctor looks at the photographs and mentally identifies that "blood" or "mucous" is present in the Friday photo but was absent in the Monday photo.
Generating a Trend/Progression (Claim 1, 10, 19): The doctor compares the two photos and concludes that the patient's condition is worsening over the five-day period.
Determining Risk (Claim 1, 10, 19): Based on the observation of blood and the worsening trend, the doctor concludes there is a high "risk" of a flare-up.
Providing Information/Alerting Caregiver (Claim 1, 10, 19): The doctor tells the patient about the risk and then writes a note to the patient’s nurse (the caregiver) to alert them.
File Size Threshold (Claim 19): A medical clerk notices that a patient's physical file folder is becoming very thick (proportional to the number of photo-reports inside). The clerk observes that the thickness exceeds a 2-inch "threshold" and, following a rule, alerts the doctor that the patient has had an unusually high number of incidents requiring review.
Dependent Claims Analysis
The dependent claims are also directed to an abstract idea as they merely narrow the specific data points or the environment of the mental process without moving away from the judicial exception.
Claims 2-3, 11-12, 21-25, 27-29: Recite specific characteristics (Bristol scale, CRP levels, blood, mucous). These are simply more specific parameters for the same Mental Process of evaluating stool.
Claims 4-9, 13-18, 20: Recite providing alerts to caregivers or adjustments to therapy. These are further Methods of Organizing Human Activity (managing medical care).
Claims 26, 30: Recite using a "machine learning model" to determine inflammatory markers. While this mentions a specific software tool, under the BRI, "determining a level... based on stool characteristics" using a model is a functional recitation of a mental task (pattern recognition) that is itself an abstract idea. These claims inherit the abstract nature of the independent claims.
because the independent and dependent claims recite mental processes for diagnostic evaluation, mathematical correlations for data management, and methods for managing professional interactions, they are directed to judicial exceptions under Step 2A, Prong One. The analysis now proceeds to Step 2A, Prong Two to determine if the additional elements integrate these judicial exceptions into a practical application.
Step 2A, Prong Two: Integration into a Practical Application
The current claims fail to overcome Step 2A, Prong Two because they do not integrate the identified abstract ideas into a practical application; instead, they merely recite generic computer components as a platform for cognitive diagnostic logic without imposing a meaningful limit on the exception, such as by improving another technology or implementing a particular treatment.
Evaluation of Additional Elements
The independent claims recite additional elements (the bolded terms from Prong One) including user devices, data processors, and non-transitory computer-readable storage media containing instructions. These elements fail to integrate the abstract idea because they represent generic computer functionality and field-of-use limitations.
Mere Instructions (MPEP § 2106.05(f)) The recitation of the data processor and storage medium fails to integrate the abstract idea because these elements are used merely as tools to execute the mental steps of the exception. The instructions cause the processor to perform the operations of "receiving," "determining," and "generating." This amounts to "mere instructions to apply an exception" using a computer. The specification confirms that the hardware is used in its most basic capacity: "Each of these components can be realized by one or more computer devices and/or networked computer devices" (Spec., para. 0022). Consequently, the computer is not integrated into the process in any way other than as a vessel for the abstract logic.
No Improvement to Computer Functionality (MPEP § 2106.05(a)) The claims do not improve the functioning of the computer itself or another technology. Instead, the "improvement" described is the accuracy or convenience of a medical assessment (the abstract idea). The specification admits the system utilizes standard AI models: "In some implementations, the AI model is a convolutional neural network, deep learning model, large language model, machine learning model, etc." (Spec., para. 0027). Merely applying these off-the-shelf models to a specific type of data (stool images) does not constitute a technical improvement.
Linking the Exception to a Technological environment (MPEP § 2106.05(h)) The recitation of a "user device" and "caregiver device" (Claim 19) acts as a "field-of-use" or "technological environment" limitation. Restricting the abstract mental process of evaluating stool characteristics to the environment of a smartphone or a clinical alerting system does not provide a practical application. These elements simply provide the data sources and delivery mechanisms for the results of the abstract analysis.
Synthesis Analysis
When viewed as a whole, the combination of these elements does not integrate the abstract idea. The claims describe a system where data is collected (receiving), analyzed (determining characteristics/trends), and reported (providing information/alerts). Each step remains squarely within the realm of cognitive diagnostic reasoning and rule-based organizational management.
Dependent Claims Analysis (Prong Two)
The dependent claims generally narrow the scope of the abstract medical analysis or provide additional hardware that remains generic in function, failing to integrate the exception into a practical application.
Additional Hardware Elements (Claims 4 and 13): These claims specify that the client device includes a first device and a second device (e.g., patient and caregiver smartphones). This recitation of additional hardware fails to integrate the abstract idea because it merely adds a specific communication path for the data (MPEP § 2106.05(h)) without providing a technical improvement to the devices or implementing a treatment.
Software Tools (Claims 26 and 30): These claims introduce the use of a machine learning model trained on stool images. While this identifies a specific analytical tool, it serves only to automate the abstract mental process of pattern recognition. Applying a generic machine learning model to a specific clinical data set does not provide a technical improvement to computer functionality (MPEP § 2106.05(a)).
Narrowing of Abstract Idea (Claims 2-3, 5-9, 11-12, 14-18, 20-25, 27-29): The remaining dependent claims merely narrow the types of data analyzed (e.g., Bristol scale, CRP levels, inflammatory markers) or describe subsequent cognitive actions (e.g., adjustments to therapy, alerts). These limitations provide more detail to the abstract diagnostic process but do not transform the logic into a practical application.
Because the additional elements, alone or in combination, do not integrate the judicial exceptions into a practical application, the claims are directed to an abstract idea. The analysis now proceeds to Step 2B to determine if the claims provide an inventive concept amounting to significantly more than the exception.
Step 2B: Inventive Concept Analysis
Step 2B determines whether the claim as a whole amounts to significantly more than the judicial exception. This involves evaluating the additional elements to see if they provide an "inventive concept"—a specific implementation that is not well-understood, routine, or conventional in the field.
Evaluation of Additional Elements regarding WRC
The additional elements in the independent and dependent claims, both individually and as an ordered combination, fail to provide an inventive concept because the specification describes these components and operations in generic, functional terms without identifying any non-conventional technical implementation.
Generic Computer Components (MPEP § 2106.05(f)/a/h) The independent claims recite a data processor, a storage medium, and user/caregiver devices. These elements do not add an inventive concept because the specification indicates they are used for their basic functions: processing data, storing instructions, and communicating over a network. The specification admits these components are generic and off-the-shelf: "Each of these components can be realized by one or more computer devices and/or networked computer devices... the client device 104 is a smartphone with a camera" (Spec., para. [0022]). Automating an abstract mental process using the standard processing power of a smartphone as described by the applicant does not constitute an inventive concept.
Standard AI and Machine Learning (Claims 26 and 30)
While the applicant recites a "machine learning model" in Claims 26 and 30, this does not supply an inventive concept. The claims recite the model at a high level of generality (as a functional "black box" for determining levels of inflammatory markers) without specifying any non-conventional mathematical architecture or specialized training algorithm. The specification acknowledges the generic nature of the models: "In some implementations, the AI model is a convolutional neural network, deep learning model, large language model, machine learning model, etc." (Spec., para. [0027]). The applicant's description provides for the use of any existing machine learning model to perform the diagnostic task, which indicates the use of standard, available technology rather than a technical improvement to the model itself.
When the elements are viewed as an ordered combination, they fail to amount to significantly more than the exceptions. The combination describes a generic computer system configured to perform the abstract steps of receiving diagnostic images, analyzing them via a functional model, and providing a report. As described in the specification, there is no non-conventional arrangement of the hardware or software that improves the computer's operation; rather, the "utility" resides in the clinical discovery of the correlations. An inventive concept cannot reside in the exception; it must be found in the additional elements as described in the application.
Dependent Claims Analysis for Step 2B
The dependent claims generally narrow the scope of the abstract medical analysis or provide additional hardware that the specification describes in generic terms, failing to supply an inventive concept.
Additional Hardware Elements (Claims 4 and 13): These claims specify a first device and a second device (e.g., patient and caregiver devices). This recitation fails to provide an inventive concept because the specification describes this as a standard arrangement for sharing data: "The first smartphone captures the stool images and shares the stool images with the second smartphone" (Spec., para. [0024]). This describes a high-level data transmission path between standard devices.
Software Tools (Claims 26 and 30): As noted above, the use of a machine learning model is described by the applicant in functional terms to automate the mental process of pattern recognition. The specification does not describe any technical modification to the machine learning architecture, instead relying on standard model types (Spec., para. [0027]).
Narrowing of Abstract Idea (Claims 2-3, 5-9, 11-12, 14-18, 20-25, 27-29): The remaining dependent claims merely narrow the types of data analyzed (e.g., Bristol scale, CRP levels, inflammatory markers) or describe subsequent cognitive actions and professional interactions (e.g., adjustments to therapy, alerts). These limitations provide more detail to the abstract diagnostic and organizational processes but do not contribute to a technical inventive concept as they are characterized in the specification as patient-reported or physician-scored observations (Spec., para. [0041]).
Conclusion
The claims are directed to an abstract idea and lack an inventive concept. Therefore, Claims 1-30 are rejected under 35 U.S.C. § 101.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-18 and 22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over copending Application No. 18/572,148 (the Kraus reference). While the claims are not identical, the differences are obvious variations.
Claim 1:
A method for managing one or more of irritable bowel disease, ulcerative colitis or Crohn's disease, the method comprising:
receiving two or more images from one or more user devices, wherein a
first of the two or more images is captured prior to the second of the two or more images; (References application, Claim 30)
determining, from stool in the two or more images, one or more stool
characteristics; (References application, claim 30)
generating a historical trend of a health or disease state of a user based on the two or
more images, wherein the historical trend shows a progression of the health or disease state over time based on the one or more stool characteristics; (References application, claim 30)
determining a risk of the health or disease state based at least in part on the historical
trend; (References application, claim 30)
and generating and providing information associated with the determined risk
of the health or disease state to at least one of the one or more user devices. (References application, claim 30)
Claim 2:
The method of claim 1, wherein the one or more stool characteristics include stool form, fuzziness, fragmentation, volume, stool color, blood, mucous, or any combination thereof. (References application, claim 31)
Claim 5.
The method of claim 1, wherein the health or disease state information is referenced to a specific time period. (References application, claim 30)
Claim 6.
The method of claim 5, wherein the health or disease state information indicates a flare up over the time period. (References application, claim 30, 32)
Claim 7.
The method of claim 6, further comprising:
providing to the client device an adjustment to a therapy associated with managing the
flare up. (References application, claim 30)
Claim 9.
The method of claim 1, wherein the health or disease state information indicates ulcerative colitis or Crohn's disease state information. (Reference application, claim 33)
Claim 21.
The system of claim 1, wherein the health or disease state comprises a gastrointestinal health or disease state. (References application, claim 33)
Note: Claims 10-11, 14-16, 18 and 22 are rejected with the same analysis above from being very similar to claims 1-2, 5-7, 9 and 21.
Claim 3.
The method of claim 2, wherein the stool form is determined as the . (references application, claim 30-31, paragraph 0036, 0057-0060, 0069)
The references application claim 30 describe “images of stool… determining one or more characteristics associated with the stool”, then claim 31 describe “one or more characteristics comprises one or more of a shape, texture, consistency, fragmentation, fuzziness, or volume of the stool “. However does not disclosed in the claims that the method used is “Bristol Stool Scale”.
Even when is not in the claim, the references specification describe “wherein the shape and texture characteristic is provided according to the Bristol Stool Score “ .
The instance application missing limitation is an obvious variation, because an ordinary person with skill in the art would substitute the broad claim 31 limitation, to specify method as a Bristol Stool Score to provides a standardized way to assess digestive health.
Claim 4.
The method of claim 1, wherein the client device includes a first device and a second device, (References application, claim 42-47, par. 0049, 0065, 0074, 0111)
References application in the claims describe “wherein the computing device comprises at least one of a mobile device…wherein the computing device further comprises a camera…wherein receiving the plurality of images of the stool comprises using a camera in operative communication with the processor and configured to capture the plurality of images “.
However does not explicitly describe in the references application claims who are associated with the devices patient and caregiver, and that the caregiver could receive stool images.
References application describe in the specification “systems and methods for determining and/or monitoring a stool condition for a subject….receives one or more images of a stool 104 from an image capturing device that is then used by a stool evaluation…captured by a first party (for example, the subject 102, a medical professional, or any other person…provided to a second party (for example, the subject 102, a medical professional, or any other person different from the individual operating the image capture device),”.
The missing elements in references claims are obvious variations, because a ordinary skilled person in the art, would find obvious because references describe in the claims the “device” more broad just to clarify that uses a camara and is in communication with the processor and configured to capture images, add that devices could be used to receive images to the caregiver as is describe “any other person” and the patient is just a expected addition to the system in view of the references specification itself to allow a second party such as a trusted family member, to evaluate the image.
Claim 8.
The method of claim 1, further comprising:
providing to a caregiver an health or disease
state information. (References application, par. 0111)
Claim 19.
A system for managing one or more of irritable bowel disease, ulcerative colitis or Crohn's disease, comprising: (References application, claim 30, claim 33)
one or more data processors; (References application, claim 40, 42)
and
a non-transitory computer-readable storage medium containing instructions which, when
executed on the one or more data processors, cause the one or more data processors to perform operations including: (References application, Claims 40, 42)
receiving two or more images from one or more user devices, wherein a
first of the two or more images is captured prior to the second of the two or more images; (References application, claim 30)
determining, from stool in the two or more images, one or more stool
characteristics; (References application, claims 30-31)
generating a historical trend of the health or disease state via the two or more images,
wherein the historical trend shows a progression of the health or disease state over time based on the one or more stool characteristics; (References application, claim 30)
determining a risk of the health or disease state based at least in part on the historical
trend;( References application, claim 30)
and providing information of the health or disease state to at least one
of the user devices; (References application, claim 47
generating a corresponding report associated with a corresponding user device of at
least some of the plurality of user devices, wherein a corresponding ; ( References application, claim 54-55, par. 0081, 0096, and figure 9)
Kraus describes a system that compiles stool images and assessment data into a "Diary" or "History" view, specifically providing an Export Data function in Figure 9. Because Kraus explicitly includes images within these assessments (e.g., one or more photos relating to the stool), any exported "report" file would have a size proportional to the number of images selected for export.
and based on the corresponding file size
caregiver device. (References application, par. 0111)
While Kraus teaches sending alerts to a caregiver (the healthcare administrator), these alerts are triggered by clinical conditions, such as a "deteriorating stool condition" (a flare-up). Kraus does not disclose or suggest using "file size" or any technical data-storage metric as the threshold for triggering an alert.
Kim teaches the missing element, describing a mobile terminal that checks if image data size exceeds a predefined limit and takes action. Kim's system calculates the total size of the selected photos and checks whether the calculated size exceeds a transmittable size (referred to hereinafter as 'allowable size') (Kim, para. [0033]). If the size exceeds the allowable size, the mobile terminal outputs a message asking the subscriber whether to change the resolution (Kim, para. [0034]). It would have been obvious to a person of ordinary skill in the art to combine the teachings of References application with Kim because References application's system, by enabling the collection of multiple images over time, claim 30, creates a data management problem-the accumulation of data. A POSITA would have looked to the art to solve this problem and found an explicit solution in Kim, which is directed to managing image data size against a predefined limit. A POSITA implementing References application's system, which involves collecting multiple images over time ( References application, claim 30, fig. 9), would recognize the need to manage the resulting data volume, a problem explicitly solved by Kim's method of checking a first size of the at least one image against a transmittable size (Kim, Abstract). Applying Kim's size-management technique to References application's data collection system is a logical combination to address this data management issue.
Furthermore, a person of ordinary skill in the art would have been motivated to integrate the size threshold check from Kim into the alert system of References application to repurpose that size-management tool for the clinical benefit of automatically flagging potentially significant event patterns. A report file size exceeding a certain threshold would serve as a direct proxy for a high frequency of bowel movements, alerting a caregiver to a potential adverse event or that the patient upload all needed pictures. A POSI TA would have a high expectation of success because the modification only involves changing the consequence of the threshold check-from triggering Kim's resolution-change prompt to triggering References application's existing alert function-which is a routine and predictable programming adjustment.
Claim 20.
The system of claim 19, wherein the References application, claim 42-47, par. 0010, 0049, 0065, 0074, 0111, fig. 10)
The references application claims describe a device that uses a camara in communication of the processor.
However, the references application does not disclosed “plurality of client device”.
But in fig.10 clearly is include as part of the computer system the clinician application, in addition specification clarify that “systems and methods for determining and/or monitoring a stool condition for a subject….receives one or more images of a stool 104 from an image capturing device that is then used by a stool evaluation…captured by a first party (for example, the subject 102, a medical professional, or any other person…provided to a second party (for example, the subject 102, a medical professional, or any other person different from the individual operating the image capture device),”.
The missing elements in references claims are obvious variations, because an ordinary skilled person in the art, would find obvious because references describe in the claims the “device” more broad just to clarify that uses a camara and is in communication with the processor and configured to capture images, add that devices could be include plurality of client devices by showing that the caregiver’s hardware and the patient’s hardware are both defined as computing devices in a single networked ecosystem, designating them both as “client devices” is a minor, obvious variation of the disclosed architecture.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-18, 21-23, 25-27, and 29-30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Karlin - US 20200395124
Claim 1.
A method for managing one or more of irritable bowel disease, ulcerative colitis or Crohn's disease, the method comprising: (Karlin, “diagnostic efforts in following disease areas such as Crohn's disease”, par. 0103, par. 0006)
receiving two or more images from one or more user devices, wherein a
first of the two or more images is captured prior to the second of the two or more images; (Karlin, fig.3 “372, 272”, par. 0027, “time stamping of a data collection event”, par. 0081)
determining, from stool in the two or more images, one or more stool
characteristics; ( Karlin, fig. 5, “ obtain digital image of a stool sample…-> stool color…. Size… texture…”, fig. 3 “ 1.jpg, 2.jpg, 3…)
generating a historical trend of a health or disease state of a user based on the two or
more images, wherein the historical trend shows a progression of the health or disease state over time based on the one or more stool characteristics; (Karlin Paragraphs 0027 “improved long-term monitoring (e.g. over months or years, as in longitudinal studies) may be achieved”, 0086 “current clinical status of a patient—i.e., patient's diagnosis, stage, progression rate... “, 0098 “analyzed data on a timeline”, and 0099 “note physiological changes”, and fig. 3)
Karlin explicitly teaches the generation of a historical trend and the tracking of disease progression. Karlin’s system takes the analyzed stool data and places it on a "timeline," which is the functional equivalent of a "historical trend.
determining a risk of the health or disease state based at least in part on the historical
trend; (Karlin abstract “adverse clinical event from patient stool data”, Paragraphs 0002, 0006, 0020 “prediction analytics for adverse events” 0023, 0086, and 0107)
and generating and providing information associated with the determined risk
of the health or disease state to at least one of the one or more user devices. (Karlin, par. 0086 “suggestions of required immediate medical” ,par. 0079 “verify or change the prefilled stool monitoring information” par. 0097, par. 0084 ” clinical diagnostic tree 972 are configured to build up a process of disease and / or condition identification ( i.e. what disease ) , and disease and / or condition”, par. 0086 “, an output of this data interpretation layer is represented by patient information 990 about” for example (i) current clinical status of a patient”, par. 0036 “on-dive data … producing an output”)
Claim 2.
Karlin teaches, The method of claim 1, wherein the one or more stool characteristics include stool form, fuzziness, fragmentation, volume, stool color, blood, mucous, or any combination thereof. (karlin, fig. 5 “a stool color classifier model”).
Claim 3.
Karlin teaches, The method of claim 2, wherein the stool form is determined as the Bristol stool scale. (Karlin, par. 0027 “Bristol Stool”)
Claim 4.
Karlin teaches, The method of claim 1, wherein the client device includes a first device and a second device, the first device associated with a patient and configured to send the one or more stool images to the second device associated with a caregiver, and wherein the one or more stool images is received from the second device. (Karlin, par. 0006 “information obtained directly from the patient and / or the patient's caregiver”, par. 0087 “ computer systems , apparatus , and computer programs recorded on one or more computer storage devices , each configured to perform actions of methods described herein… any number of mobile devices “, par. 0021 “ information obtained directly from the patient and / or the patient's caregiver“)
Claim 5.
Karlin teaches, The method of claim 1, wherein the health or disease state information is referenced to a specific time period. (Karlin, par. 0027 “date and time stamping of a data collection event further enables data to be collected”)
Claim 6.
Karlin teaches, The method of claim 5, wherein the health or disease state information indicates a flare up over the time period. (Karlin, par. 0099 “note physiological changes associated with relapse”)
Claim 7.
Karlin teaches, The method of claim 6, further comprising:
providing to the client device an adjustment to a therapy associated with managing the flare up. (Karlin par. 0086 “suggestions of required immediate medical intervention or changes to continuous treatmen”)
Claim 8.
Karlin teaches, The method of claim 1, further comprising:
providing to a caregiver an alert associated with the health or disease
state information. (Karlin, par. 0097 “enables rapid communication of detected adverse events and potentially acute patient issues to a responsible party”)
Claim 9.
Karlin teaches, The method of claim 1, wherein the health or disease state information indicates ulcerative colitis or Crohn's disease state information. (Karlin, par. 0103 “The classification models derived from the method and system described herein may furthermore be used in (but not only restricted to) diagnostic efforts in following disease areas such as Crohn's disease, ulcerative colitis”)
Claim 21.
Karlin teaches, The system of claim 1, wherein the health or disease state comprises a gastrointestinal health or disease state. (Karlin, par. 0003 “gastrointestinal health monitoring”)
Claim 23.
The system of claim 1, wherein generating the historical trend of the health or disease state comprises generating a historical trend of one or more inflammatory markers. (Karlin, par. 0003, 0021, 0023, 0095, 0098, 0099)
Karlin et al. describes a system that collects data on blood in stool which is a primary clinical marker for inflammation in diseases like ulcerative colitis. The reference explicitly discloses using a "visualization engine" to place these observations on a "timeline". By plotting "warning signs" (the markers) over "long-term monitoring" periods to identify "relapse" (the disease state), Karlin et al. teaches the generation of a historical trend of inflammatory markers.
Claim 25.
Karlin teaches, The system of claim 23, further comprising determining a level of the one or more inflammatory markers of the user based on the one or more stool characteristics. (Karlin, abstract, par. 0006, fig. 1a,
Karlin et al. uses a "Machine Learning Algorithm" to do exactly this. Karlin's computer program analyzes the color, texture, and shape (the characteristics) to output a "predicted property" or "classification" (the level) of a medical event.
Claim 26.
Karlin teaches, The system of claim 25, wherein determining a level of the one or more inflammatory markers of the user comprises using a machine learning model trained on a plurality of stool images and associated levels of the one or more inflammatory markers. (Karlin, fig. 7, par. 0067 – 0072, 0078)
Karlin discloses a "Train Model Process" that uses "Image Data" (plurality of stool images) and "Annotations" (associated levels/patient-assessed information).
Note: Claims 1-9, 21, 23, 25-26 were used to reject claims 10-18, 22, 27, 29, 30 for being very similar.
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.
Claim(s) 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Karlin - US 20200395124 and further in view of Kim - US-20060128407-A1
Claim 19.
A system for managing one or more of irritable bowel disease, ulcerative colitis or Crohn's disease, comprising: (Karlin, “diagnostic efforts in following disease areas such as Crohn's disease”, par. 0103, par. 0006)
one or more data processors; (Karlin, fig. 1B)
and
a non-transitory computer-readable storage medium containing instructions which, when executed on the one or more data processors, cause the one or more data processors to perform operations including: (Karlin, fig. 1B)
receiving a plurality of images from each user device of a plurality of user devices, wherein a first of the plurality of images is captured prior to at least a second of the plurality of images from the each user device; (Karlin, fig.3 “372, 272”, par. 0027, “time stamping of a data collection event”, par. 0081, par. 0006 “information obtained directly from the patient and / or the patient's caregiver”, par. 0087 “ computer systems , apparatus , and computer programs recorded on one or more computer storage devices , each configured to perform actions of methods described herein… any number of mobile devices “, par. 0021 “ information obtained directly from the patient and / or the patient's caregiver“)
determining, from stool in the plurality of images, one or more stool characteristics
associated with the each user device; ( Karlin, fig. 5, “ obtain digital image of a stool sample…-> stool color…. Size… texture…”)
generating a historical trend of the health or disease state of a user based on the plurality
of images, wherein the historical trend shows a progression of the health or disease state over time based on the one or more stool characteristics; (Karlin Paragraphs 0027 “improved long-term monitoring (e.g. over months or years, as in longitudinal studies) may be achieved”, 0086 “current clinical status of a patient—i.e., patient's diagnosis, stage, progression rate... “, 0098 “analyzed data on a timeline”, and 0099 “note physiological changes”, and fig. 3)
determining a risk of the health or disease state based at least in part on the historical
trend; (Karlin abstract “adverse clinical event from patient stool data”, Paragraphs 0002, 0006, 0020 “prediction analytics for adverse events” 0023, 0086, and 0107)
generating and providing information associated with the determined risk of the health or disease state to at least some of the plurality of user devices; (Karlin, par. 0086 “suggestions of required immediate medical”, ,par. 0079 “verify or change the prefilled stool monitoring information” par. 0097, par. 0084 ” clinical diagnostic tree 972 are configured to build up a process of disease and / or condition identification ( i.e. what disease ) , and disease and / or condition”, par. 0086 “, an output of this data interpretation layer is represented by patient information 990 about” for example (i) current clinical status of a patient”, par. 0036 “on-dive data … producing an output”)
generating a corresponding report associated with a corresponding user device of at
least some of the plurality of user devices, wherein a corresponding file size associated with the corresponding report is proportional to a number of images associated with the corresponding user device;(Karlin, fig. 3, par. 0035)
Karlin’s system collects and stores "Stool Images 1, 2, 3..." for each patient. By adding these images to the patient's record, the size of that record grows proportionally. Since Karlin already describes a database that stores an increasing number of images per user, the "proportional file size" is considered part of Karlin's system.
and based on the corresponding
caregiver device. (Karlin, par. 0097 “enables rapid communication of detected adverse events and potentially acute patient issues to a responsible party”)
35 U.S.C 103 Obvious Rational:
Karlin teaches all limitations above except
Kim teaches the missing element, describing a mobile terminal that checks if image data size exceeds a predefined limit and takes action. Kim's system calculates the total size of the selected photos and checks whether the calculated size exceeds a transmittable size (referred to hereinafter as 'allowable size') (Kim, para. [0033]). If the size exceeds the allowable size, the mobile terminal outputs a message asking the subscriber whether to change the resolution (Kim, para. [0034]).
It would have been obvious to one of ordinary skill in the art to combine the teachings of Karlin, which requires “uploading the digital image in a remote storage” (para. [0005]) over a “network interface 128” (para. [0026]), with Kim, which solves the problem of file transmission failure where “the size of the attached photos exceeds a transmittable size” (para. [0006]). A PHOSITA would be motivated to look to Kim because Karlin’s system relies on the “continuous patient monitoring” (para. [0020]) and longitudinal collection of images, which naturally leads to data volumes that can strain mobile network constraints. As Karlin notes that its system provides “suggestions of required immediate medical intervention” (para. [0086]), the PHOSITA would recognize that a report failing to reach a caregiver due to an unmonitored file size would defeat the medical purpose of the system. Therefore, the PHOSITA would naturally look to integrate Kim’s logic—where a system “calculates the total size of the selected photos and checks whether the calculated size exceeds a transmittable size” (para. [0033])—to ensure that the proportionally growing reports in Karlin trigger a threshold alert, ensuring the caregiver is notified before a transmission failure occurs.
A PHOSITA would have had a reasonable expectation of success because the integration involves routine software logic. Karlin utilizes a “Processor 322” and “Network Interface 328” (para. [0081]) and Kim utilizes a “processing unit 110” (para. [0043]) to perform size checks. Given that Kim specifically lists common resolution levels and sizes—such as “1280x960 (about 140K)” and a threshold of “400 Kbyte” (para. [0012-0013])—the technical integration of these concrete parameters into Karlin’s “server 310” (para. [0035]) is a matter of straightforward algorithmic implementation.
The integration is the predictable application of Kim’s size-check functionality (para. [0009]) to Karlin’s diagnostic reporting system (para. [0086]). In both references, the underlying technical challenge is the movement of image-heavy files across a network. Karlin provides the medical context where reports increase in size based on “frequency of a patient's various bowel movements” (para. [0098]), and Kim provides the known technical mechanism for monitoring those sizes to trigger user notifications (para. [0034]). The resulting system predictably alerts a caregiver when the clinical data volume exceeds a predefined transmission or review threshold.
A PHOSITA would have had a reasonable expectation of success because the integration involves routine software logic. Karlin’s system uses a computer and a network connection, while Kim’s system uses a main computer part to check file sizes. Kim also gives clear examples of photo sizes and limits—like photos that are 140 kilobytes and a limit of 400 kilobytes Kim par. 0012-0013. Adding these simple rules to Karlin’s system is just regular programming.
Claim 20.
Karlin teaches, The system of claim 19, wherein the caregiver device is included in the plurality of client devices. (Karlin, par. 0026, 0081, 0087)
Karlin et al. describes a system (System 900) that utilizes "any number of mobile devices" acting as client units to interface with a server.
Claim(s) 24 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karlin - US 20200395124 and further in view of Clark- US11419560B2.
Claim 24.
Karlin teaches, The system of claim 23, wherein the one or more inflammatory markers comprises a
Karlin teaches monitoring a patient for a gastrointestinal condition, stating that its models and classifications may "be used in diagnostic efforts in following disease areas such as... inflammatory bowel disease" (para. [0103]). Karlin specifically identifies that its system can "note physiological changes associated with relapse and/or warning signs in gastrointestinal (GI) diseases" (para. [0099]). Regarding inflammatory markers, Karlin discloses the "late detection of acute complications (e.g. blood in stool)" (para. [0095]). Karlin further suggests integrating stool data with other clinical data to "add contextual value to other clinical measures, such as electronic PROs, medical history, socio-demographics, quality of life (mood, depression, stress, fatigue), and BMI" (para. [0101]). However, Karlin fails to disclose that the one or more inflammatory markers comprises a level of C-reactive protein (CRP).
Clark teaches the level of C-reactive protein (CRP), describing a system for monitoring the state of inflammatory bowel disease where the system utilizes inflammatory markers, stating "the CD subjects had significantly higher levels of inflammatory markers CRP and IL-6 compared to controls" (col. 1, ll. 40-42).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the teachings of Karlin with Clark because both references are directed to the field of monitoring inflammatory bowel disease (IBD) and improving diagnostic accuracy through the integration of multiple data streams. Karlin explicitly seeks to improve data quality for GI monitoring, stating "Better and more data, in turn, allow for improved diagnostic, improved prognostic analysis, [and] improved monitoring of disease progression" (para. [0023]). Clark provides the specific technical solution for providing "better data" by specifically identifying "C-reactive protein" (col. 1, ll. 37–45; col. 10, ll. 50–51). Combining the image-based classification of Karlin with the specific chemical marker level of Clark makes obvious the integration of the missing element to create a more robust clinical profile of the patient.
The combination makes the full limitation obvious because it bridges the gap between image-based stool assessment and systemic chemical inflammation indicators. A PHOSITA would integrate the level of C-reactive protein (CRP) into the system of Karlin to achieve the benefit of improved detection of disease flares, as Karlin teaches that its system is used for "early detection and prediction analytics for adverse events" (para. [0020]) and Clark teaches that "inflammatory markers [such as] CRP" are significantly higher in patients during disease progression compared to controls (col. 1, ll. 37–42).
A PHOSITA would have had a reasonable expectation of success because both Karlin and Clark utilize similar signal processing architectures. Karlin utilizes a "processor for interpreting health-monitoring data" (para. [0005]) and Clark utilizes a "signal processing circuit configured to process the patient condition signals" (col. 6, ll. 29–31). Integrating a numerical value representing a CRP level from a chemosensor into an existing clinical database is a routine data integration task that requires no undue experimentation.
Note: Claim 24 is used to reject claim 28 for being very similar.
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 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.
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/JOSHUA DAMIAN RUIZ/Examiner, Art Unit 3684
/Shahid Merchant/Supervisory Patent Examiner, Art Unit 3684