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 .
Response to Arguments
Applicant’s arguments, see Remarks at page 7, filed 15 January 2026, with respect to the objection to claim 13 for minor informalities have been fully considered and are persuasive. The objection has been withdrawn.
Applicant’s arguments, see Remarks at page 7, filed 15 January 2026, with respect to the rejections of claims 1-6, 8-13, 15, 16, and 18-20 under 35 U.S.C. 112(b) have been fully considered and are persuasive. The rejections have been withdrawn.
Applicant’s arguments, see Remarks at pages 7-8, filed 15 January 2026, with respect to the rejections of claims 1-6, 8-13, and 15 under 35 U.S.C. 101 have been fully considered but are moot. Upon further consideration of the claims in light of the amendments made in the response file 15 January 2026, the claims are eligible at Step 2A: Prong One of the subject matter eligibility analysis because the amended independent claims now include the selection of one of the “predefined images” that are provided or displayed by a “computing device”, as opposed merely selecting a patient baseline, as featured in the previous version of the claims, and further require identifying changes of the insertion site based on the selected predefined image(s) as in claims 1 and 12, or recording the selected predefined image as having similar skin tone to a patient as in claim 16. The claims were previously found to be directed to the abstract idea of managing personal behavior because the selection, under the broadest reasonable interpretation, encompassed a physician or other person’s decision to assess similarity as they view images of a patient’s catheter insertion site. However, the selection is no longer reasonably interpreted to be the person’s internal decision under the BRI of the claims, and thus the claims are no longer “directed to” the abstract idea. See MPEP 2106.04, subsection II; See also Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335, 118 USPQ2d 1684, 1688 (Fed. Cir. 2016) (“The ‘directed to’ inquiry, therefore, cannot simply ask whether the claims involve a patent-ineligible concept, because essentially every routinely patent-eligible claim involving physical products and actions involves a law of nature and/or natural phenomenon”). The rejection is withdrawn.
Applicant’s arguments, see Remarks at pages 8-10, filed 15 January 2026, with respect to the rejections of claims 1-6, 8-13, 15, 19 and 20 under 35 U.S.C. 103 have been fully considered but are not persuasive. Upon further consideration of the claims, and particularly upon further review of Dikeman, the previous ground of rejection is withdrawn and a new ground of rejection under 35 U.S.C. 102(a)(2) is provided based on Dikeman. Applicant’s arguments with respect to the cited reference(s) besides Dikeman are moot because they do not apply to the current rejections of the claims. With respect to Dikeman, Applicant argues on page 9 that Dikeman does not disclose the amended features including the displaying of a series of predefined images with skin tone similar to a patient skin tone around the catheter insertion site and/or dressing. Examiner respectfully disagrees.
As shown in FIG. 25 of Dikeman, calibrated images of a patient’s insertion site location over time are displayed. Dikeman discloses a healthcare provider using a mobile device with a camera to capture images of an insertion site over time for the same patient (See Dikeman at par. 101, “previous calibrated images 2508”). To make each image comparable, the images are color calibrated when they are acquired, including baseline images (See Dikeman at par. 53). The images in the displayed series of images are “predefined” because they have been previously calibrated and stored. Based on the calibrated series of predefined images, the healthcare provider may make an assessment of swelling or the computer may automatically determine swelling from the series of images (See Dikeman at par. 96). Thus, Dikeman teaches every feature of claims 1, 12 and 16. Accordingly, the claims remain rejected under 35 U.S.C. 103.
Claim Objections
Claim 8 is objected to because of the following informalities: in the last line, “changes in three-dimensional profile” should be changed to “changes in a three-dimensional profile” for clarity. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: in the last line, “generating” should be changed to “generate” to be consistent with the rest of the claim. Appropriate correction is required.
Claim Interpretation
According to the Federal Circuit’s decision in SuperGuide v. DirecTV, claim language of the type “at least one of … and …” creates a presumption that applicant intended the plain and ordinary meaning of the claim language to be a conjunctive list, unless the specification supports an interpretation of the claim language that rebuts the presumption.1
Claims 5, 8 and 16 recite limitations that raise the presumption of a conjunctive list per SuperGuide:
[Claim 5] The method of claim 1, wherein the site assessment rate is determined by the computing device using at least one of: catheter type and location; current medication; patient status; patient physiology; patient mobility; and history of vascular access complications.
[Claim 8] The method of claim 1, wherein the one or more changes of the catheter insertion site and/or dressing comprises at least one of: movement of the catheter or dressing; changes in temperature of the catheter insertion site; changes in color of the catheter insertion site; changes in stiffness of the catheter insertion site; changes in density of the catheter insertion site; changes in reflectance and refraction of light of the catheter insertion site; and changes in three-dimensional profile of the catheter insertion site and/or dressing.
[Claim 16] A system for site assessments of a catheter insertion site and/or dressing comprising: one or more image capture devices configured to capture at least one of a visible light, infrared, or thermal image of the insertion site and/or dressing; one or more sensors configured to determine at least one of density, reflectance of light, refraction of light, color calibration, and electrical impedance; ... assessment information.
Paragraph 49 of the specification provides a more detailed description of the list recited in claim 5, and ends with “and other factors identified based on trends of prior patients with similar parameters that are found to warrant extra monitoring.” This indicates that claim 5 is a non-exhaustive list of possible factors, any one or more of which may be associated with more frequent monitoring, where the list does not require each and every factor recited in the claim.
Paragraph 47 of the specification describes the pattern recognition used to determine the “changes” recited in claim 8 may be based on temperature and may perform a “similar colorimetric analysis ... to assess bruising.” Bruising is indicated by color, which is one of the listed elements of claim 8. Paragraph 47 thus discloses that temperature may be used, or temperature and colorimetric analysis may be used, which implies a disjunctive list. This indicates that claim 8 is a list of observed trends of the appearance of a catheter insertion site, any one or more of which may be used to assess changes of the site over time, but does not necessarily require each and every trend recited in the claim.
Paragraph 43 of the specification provides, “[the] system 10 may include the following: image capture (optical, thermal, depth, etc.); density/stiffness meter; capture of other parameters e.g. reflectance, refraction of light (to assess wetness); spectroscopic features which can be used for color calibration, or indicate infective or immune processes; stereoscopic imaging, radar, or other 3D depth techniques, to determine a three dimensional profile of the dressing, catheter insertion site, or area where the catheter is subdermal in order to, for example, detect inflammation, swelling or infiltration; electrical characteristics like impedance; and/or reactive dye that could be incorporated into dressing or applied to insertion sites.” (emphasis added). This indicates that the specific list of characteristics determined by the “one or more sensors” of claim 16 is a list of example characteristics, any one or more of which may be determined by the sensor(s), but does not necessarily require each and every characteristic recited in the claim.
Based on the specification, Applicant has rebutted the presumption of each of claims 5, 8 and 16 reciting a conjunctive list. Accordingly, the plain meaning of the lists in claims 5, 8 and 16 is that the lists are disjunctive.
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f):
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f). The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f). The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) because the claim limitations use a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited functions and the generic placeholders are not preceded by a structural modifier. Such claim limitations are:
“a series of predefined images provided by a computing device based on the scanning of the catheter insertion site and/or dressing” in claims 1, 2, 4-6 and 8-11. This limitation is equivalent to “a computing device that provides a series of predefined images based on the scanning of the catheter insertion site and/or dressing”. The phrase “that provides” is equivalent to “configured to provide”.
“one or more computing devices configured to: display a series of predefined images of patient baseline site locations and skin tones; record a selection from the series of predefined images of a predefined image with a skin tone similar to a patient skin tine around the catheter insertion site and/or dressing; record site assessment information based at least in part on information from the one or more image capture devices and the one or more sensors; and provide an automatic notification for a clinician to make a site assessment of the catheter insertion site and/or dressing based, at least in part, on the recorded site assessment information” in claims 16 and 18-20.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f), they are being interpreted to cover the corresponding structure described in the specification as performing the claimed functions, and equivalents thereof:
If applicant does not intend to have these limitations interpreted under 35 U.S.C. 112(f), applicant may: (1) amend the claim limitations to avoid them being interpreted under 35 U.S.C. 112(f) (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitations recite sufficient structure to perform the claimed functions so as to avoid them being interpreted under 35 U.S.C. 112(f).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 4, 6, 8-12, 15, 16 and 18-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by 20210016065 to Dikeman (hereinafter “Dikeman”).
Regarding claim 1, Dikeman teaches a method for site assessments of a catheter insertion site comprising:
scanning the catheter insertion site with an image capture device and/or sensor (Dikeman, par. 53, “A healthcare provider may utilize a mobile device camera to take calibrated photographs and store associated calibrated images of the IVC site.”);
recording a baseline condition (Dikeman, par. 88, “a baseline measurement of lighting, color, skin tone, and hand and arm dimensions may be stored”) using [a] computing device (Dikeman, par. 50, “computer 102”);
determining a site assessment rate using the computing device (Dikeman, par. 57, “The application may also present a task 314 being performed. For example, the task 314 may be rounds, or a periodic check on patients or administration of a treatment such as bandage replacement, medicine administration, or an IVC assessment as indicated on the login screen 300. In some embodiments, the healthcare provider 210 directly enters the patient identification number 306. In other embodiments, the barcode 204 associated with the patient 200 is scanned and the application accesses the patient's EMR 214 from the stored database.”), the site assessment rate indicating a frequency with which the catheter insertion site is to be assessed (Dikeman, par. 57, “The application may also present a task 314 being performed. For example, the task 314 may be rounds, or a periodic check on patients or administration of a treatment such as ... an IVC assessment as indicated on the login screen 300.”);
prompting a site assessment of the catheter insertion site using the computing device (Dikeman, par. 57, “The application may also present a task 314 being performed. For example, the task 314 may be rounds, or a periodic check on patients or administration of a treatment such as bandage replacement, medicine administration, or an IVC assessment as indicated on the login screen 300.”);
selecting a patient baseline site location and a skin tone similar to a patient skin tone around the catheter insertion site (Under the broadest reasonable interpretation, the plain meaning of a baseline is: a point of comparison. Accordingly, a baseline may be compared to things that occurred before or after a point in time. Selecting a new calibrated image of a patient’s catheter insertion site exhibiting certain skin tone/color features to subsequently compare with “previously taken images” of the patient is a selection of a “patient baseline site location and skin tone”. See Dikeman at par. 96), wherein the patient baseline site location and skin tone are selected from a series of predefined images provided by [the] computing device based on the scanning of the catheter insertion site (Dikeman, par. 96, “By comparing the calibrated image 2000 with previously taken calibrated images and using the measurement chart 2202 provided on the mobile device display 216, the healthcare provider 210 may determine the condition of the IVC site 204.” Note: this limitation is addressed out of order compared to how it is presented by applicant in order to more easily understand the mapping between claim 1 and Dikeman. Claim 1 does not require the patient baseline selection step to occur before the recording, determining, and prompting steps.);
recording site assessment information in an electronic medical record using the computing device (Dikeman, par. 96, “Using the measurement chart 2202, the healthcare provider 210 may provide an indication of the level of swelling at the swelling measurement field 2206 and if the level is above a threshold value the application may provide an alert to the healthcare provider 210, administration, and/or emergency staff. ... In some embodiments, the application may automatically detect the swelling by comparing the calibrated image 2000 to other calibrated images and present the images along with suggested diagnosis and suggested treatments or actions. In some embodiments, the calibrated image 2000 may also be compared to calibrated images of known complications to determine if and which complication may be present.”);
the computing device identifying one or more changes of the catheter insertion site over a predetermined period of time (Instead of the healthcare provider comparing calibrated images to determine if there is swelling at the catheter insertion site, that comparison may be automatically performed by a computer. See Dikeman at par. 96, “In some embodiments, the application may automatically detect the swelling by comparing the calibrated image 2000 to other calibrated images and present the images along with suggested diagnosis and suggested treatments or actions. In some embodiments, the calibrated image 2000 may also be compared to calibrated images of known complications to determine if and which complication may be present.”), based on the selected patient baseline site location and skin tone (Dikeman, par. 96, “take a calibrated photograph of the IVC site 204 periodically based on the patient's condition, medication, or any other factor that may require periodic assessment. By comparing the calibrated image 2000 with previously taken calibrated images and using the measurement chart 2202 provided on the mobile device display 216, the healthcare provider 210 may determine the condition of the IVC site 204.”); and
the computing device generating a notification based on identifying the one or more changes (Dikeman, par. 94, “If it is determined that the color of the IVC site 204 in the calibrated image 2000 is different or outside a pre-defined standard error than the color in the baseline or previously taken images, the application may alert the healthcare provider 210 by providing an indication on the mobile device 212 or an alert may be sent to the healthcare provider 210, administration, and/or emergency staff. The application may also analyze the differences between the calibrated images and provide diagnosis and/or possible treatment suggestions.”).
Regarding claim 2, Dikeman teaches the method of claim 1, further comprising:
scanning a proposed catheter insertion site prior to insertion of a catheter with the image capture device and/or sensor (Dikeman, par. 88, “As depicted in the exemplary embodiment in FIG. 16A, the healthcare provider 210 may take the photograph to show the IVC site 204 prior to insertion. This may provide a baseline for measurements that may be used for assessment after the IVC 202 has been inserted.”).
Regarding claim 4, Dikeman teaches the method of claim 1, wherein the series of predefined images are displayed by the computing device (See images 2508 in FIG. 25 of Dikeman) based on the scanning of the catheter insertion site and/or dressing with the image capture device and/or sensor (Scanning images are displayed based on the images being previously scanned, calibrated and stored. See Dikeman at par. 101, “The assessment summary screen 2500 may also provide previous calibrated images 2508 along with dates and times such that the healthcare provider 210 may compare the calibrated images 2508. In some embodiments, the healthcare provider 210 may select the calibrated images 2508 for comparison and view the calibrated images 2508 side-by-side or overlaid with the calibrated image 2000. This may assist the healthcare provider 210 in comparing the calibrated images 2508 for any differences that may lead to potential complications.”).
Regarding claim 6, Dikeman teaches the method of claim 1, wherein prompting the site assessment of the catheter insertion site comprises selecting an image from a series of predefined images (The device may automatically prompt a healthcare provider to acquire a new calibrated image for evaluation of a catheter insertion site. After the image is acquired, the device may automatically determine swelling by comparison to a calibrated baseline image. See Dikeman at pars. 57 and 96).
Regarding claim 8, Dikeman teaches the method of claim 1, wherein the one or more changes of the catheter insertion site comprises changes in color of the catheter insertion site (Dikeman, par. [0053], “color variations”) and changes in stiffness of the catheter insertion site (Dikeman, par. [0053], “hardness”).
Regarding claim 9, Dikeman teaches the method of claim 1, further comprising:
placing a reference marker on or adjacent to the catheter insertion site (Dikeman, par. 55, “barcode 206”); and
scanning the reference marker with the image capture device and/or sensor (Dikeman, par. 55, “A healthcare provider 210 scans the barcode 206 using the mobile device 212 comprising display 216.”).
Regarding claim 10, Dikeman teaches the method of claim 9, wherein the reference marker comprises an information tag (Dikeman, par. 55, “The healthcare provider 210 may scan the barcode 206 associated with the patients EMR 214 and the patients EMR 214 is automatically accessed via the mobile device 212.”) and a series of predefined colors (Under the broadest reasonable interpretation of “color”, the plain meaning of “color” is: an attribute of an object that produces different sensations on the eye as a result of the way the object reflects or emits light.2 Tablet cameras, like camera 1600 (par. 86), acquire color images. The barcode 206 (par. 55) is a series of black lines separated by white spaces. Cameras simulate human visual perception. The physical barcode has two predefined colors: black and white. The resulting image of the barcode acquired by the camera has a color value at each pixel, e.g., RGB values (red, green, blue) or another color space to represent the complete pattern of the barcode. Even a binary image comprises multiple colors, i.e., black and white. Thus, the barcode 206 is a tag that encodes information, is adjacent to the catheter insertion site (FIG. 2), and comprises a series of predefined colors.).
Regarding claim 11, Dikeman teaches the method of claim 9, further comprising:
capturing an image of the catheter insertion site using the image capture device (Dikeman, par. 53, “A healthcare provider may utilize a mobile device camera to take calibrated photographs and store associated calibrated images of the IVC site.”); and
calibrating the image based on the reference marker using the computing device (The calibration occurs after scanning the barcode. Therefore, the calibrating is based on the barcode because it is a subsequent step in a process begun by scanning the barcode. See Dikeman at pars. 112-113, “FIG. 37 presents an exemplary flow diagram presenting a method 3700 for calibrating IVC site images and assessing the IVC site 204 in embodiments described above. At Step 3702, the healthcare provider 210 accesses the patient's EMR 214 by entering security information and scanning indicia associated with the patient 200 identification number such as the barcode 206 as described in embodiments above. ... Upon access to the patient information via the patient's EMR 214, the healthcare provider 210 may select to assess the IVC site 204. ... At Step 3704, the calibrated image 2000 of the IVC site 204 may be created by taking a calibrated photograph of the IVC site 204 using the mobile device 212 as described in embodiments above. The healthcare provider 210 may use the mobile device 212 and take a calibrated photograph of the IVC site 204.”).
Regarding claim 12, Dikeman teaches a computer program product for site assessments of a catheter insertion site and/or dressing, comprising at least one non-transitory computer-readable medium including instructions (See Dikeman at pars. 50-51, e.g., “RAM, ROM, EEPROM”) that, when executed by a computing device (Dikeman, par. 50, “computer 102”), cause the computing device to:
scan the catheter insertion site with an image capture device and/or sensor (Dikeman, par. 53, “A healthcare provider may utilize a mobile device camera to take calibrated photographs and store associated calibrated images of the IVC site.”);
display a series of predefined images of patient baseline site locations and skin tones (Dikeman, par. 101, “The assessment summary screen 2500 may also provide previous calibrated images 2508 along with dates and times”; The calibrated image 2000 is also displayed. See Dikeman at par. 96.) based on the scan of the catheter insertion site with the image capture device and/or sensor (The displayed images are previously-acquired scan images of the same patient’s catheter insertion site. See Dikeman at par. 96, “By comparing the calibrated image 2000 with previously taken calibrated images and using the measurement chart 2202 provided on the mobile device display 216, the healthcare provider 210 may determine the condition of the IVC site 204.”);
record a baseline condition (A “baseline” is a starting point for a comparison. Generating an alert indicating a patient has a problem, such as a dangerous amount of swelling at the site, is a baseline condition for comparison to further development of the site. See Dikeman at par. 96.) using a computing device (Dikeman, par. 50, “computer 102”) based on a selection from the series of predefined images of a predefined image (The healthcare provider uses the screen 2500 to “review and edit the assessment information” and “may select the calibrated images 2508 for comparison and view the calibrated images 2508 side-by-side or overlaid with the calibrated image 2000.” See Dikeman at par. 101.) with a site location and a skin tone similar to a patient skin tone and the catheter insertion site, as acquired from the scan (Dikeman, par. 102, “In some embodiments, the application automatically opens the complications assessment screen 2600 when the application compares calibrated images 2508 and determines that there may be a complication with the IVC site 204. The complications assessment screen 2600 may provide the calibrated image 2000 in which it was determined that a complication is present.”), to tie the patient skin tone and the catheter site to a predefined scale (The computer or the provider selects the calibrated image 2000 from the series of predefined images based on a comparison with the other images of the series, thereby tying or relating the calibrated image 2000 to the same normalized scale used for each image. See Dikeman at pars. 94 and 101.);
determine a site assessment rate (Dikeman, par. 57, “The application may also present a task 314 being performed. For example, the task 314 may be rounds, or a periodic check on patients or administration of a treatment such as bandage replacement, medicine administration, or an IVC assessment as indicated on the login screen 300. In some embodiments, the healthcare provider 210 directly enters the patient identification number 306. In other embodiments, the barcode 204 associated with the patient 200 is scanned and the application accesses the patient's EMR 214 from the stored database.”), the site assessment rate indicating a frequency with which the catheter insertion site is to be assessed (Dikeman, par. 57, “The application may also present a task 314 being performed. For example, the task 314 may be rounds, or a periodic check on patients or administration of a treatment such as ... an IVC assessment as indicated on the login screen 300.”);
prompt a site assessment of the catheter insertion site (Dikeman, par. 57, “The application may also present a task 314 being performed. For example, the task 314 may be rounds, or a periodic check on patients or administration of a treatment such as bandage replacement, medicine administration, or an IVC assessment as indicated on the login screen 300.”);
record site assessment information in an electronic medical record (Dikeman, par. 96, “Using the measurement chart 2202, the healthcare provider 210 may provide an indication of the level of swelling at the swelling measurement field 2206 and if the level is above a threshold value the application may provide an alert to the healthcare provider 210, administration, and/or emergency staff. ... In some embodiments, the application may automatically detect the swelling by comparing the calibrated image 2000 to other calibrated images and present the images along with suggested diagnosis and suggested treatments or actions. In some embodiments, the calibrated image 2000 may also be compared to calibrated images of known complications to determine if and which complication may be present.”);
identify one or more changes of the catheter insertion site over a predetermined period of time (Instead of the healthcare provider comparing calibrated images to determine if there is swelling at the catheter insertion site, that comparison may be automatically performed by a computer. See Dikeman at par. 96, “In some embodiments, the application may automatically detect the swelling by comparing the calibrated image 2000 to other calibrated images and present the images along with suggested diagnosis and suggested treatments or actions. In some embodiments, the calibrated image 2000 may also be compared to calibrated images of known complications to determine if and which complication may be present.”), based in part on the selected predefined image (The above describes how the “predefined image” (calibrated image 2000) was created. Those operations are based on the image that is ultimately “selected” to generate the alert because they are how it came to be. The claim does not require the “identify” step to occur after the “record a baseline” step.); and
generating a notification based on identifying the one or more changes (Dikeman, par. 94, “If it is determined that the color of the IVC site 204 in the calibrated image 2000 is different or outside a pre-defined standard error than the color in the baseline or previously taken images, the application may alert the healthcare provider 210 by providing an indication on the mobile device 212 or an alert may be sent to the healthcare provider 210, administration, and/or emergency staff. The application may also analyze the differences between the calibrated images and provide diagnosis and/or possible treatment suggestions.”).
Claim 15 substantially corresponds to claim 11 by reciting a computer program product for site assessments of a catheter insertion site and/or dressing, comprising at least one non-transitory computer-readable medium including instructions (See Dikeman at pars. 50-51, e.g., “RAM, ROM, EEPROM”) that, when executed by a computing device (Dikeman, par. 50, “computer 102”), cause the computing device to perform the method of claim 11. Claim 15 differs from claim 11 in that intervening claim 9 is positioned between claims 1 and 11, but this does not affect how the cited art is applied to the claims.
Regarding claim 16, Dikeman teaches a system for site assessments of a catheter insertion site and/or dressing comprising:
one or more image capture devices configured to capture a visible light image of the insertion site (Dikeman par. 86, “a camera image 1600 provided by the camera of the mobile device 212 on the mobile device”);
one or more sensors (The camera includes a sensor. See Dikeman at par. 86, “a camera image 1600 provided by the camera of the mobile device 212 on the mobile device”) configured to determine color calibration (Dikeman, par. 94, “The calibrated image 2000 may be normalized using a known color of a calibration object in the calibrated image 2000.”); and
one or more computing devices in communication with the one or more image capture device and the one or more sensors (Dikeman, par. 125, “In some embodiments, the application is stored on or accessed via a computer, tablet, mobile device, smartphone, and a computer on wheels.”), the one or more computing devices configured to:
display a series of predefined images of patient baseline site locations and skin tones (The calibrated images 2508 are predefined. Any image is a baseline image that is used in a comparison to another image. See Dikeman at par. 101, “The assessment summary screen 2500 may also provide previous calibrated images 2508 along with dates and times such that the healthcare provider 210 may compare the calibrated images 2508. In some embodiments, the healthcare provider 210 may select the calibrated images 2508 for comparison and view the calibrated images 2508 side-by-side or overlaid with the calibrated image 2000. This may assist the healthcare provider 210 in comparing the calibrated images 2508 for any differences that may lead to potential complications.”);
record a selection from the series of predefined images of a predefined image with a skin tone similar to a patient skin tone around the catheter insertion site (The system records the healthcare provider’s selection and displays the selected images. Thus, the recorded selection is from the series of predefined images being selected for display. See Dikeman at par. 101, “In some embodiments, the healthcare provider 210 may select the calibrated images 2508 for comparison and view the calibrated images 2508 side-by-side or overlaid with the calibrated image 2000. This may assist the healthcare provider 210 in comparing the calibrated images 2508 for any differences that may lead to potential complications.”);
record site assessment information based at least in part on information from the one or more image capture devices and the one or more sensors (Dikeman, par. 96, “Using the measurement chart 2202, the healthcare provider 210 may provide an indication of the level of swelling at the swelling measurement field 2206 and if the level is above a threshold value the application may provide an alert to the healthcare provider 210, administration, and/or emergency staff. ... In some embodiments, the application may automatically detect the swelling by comparing the calibrated image 2000 to other calibrated images and present the images along with suggested diagnosis and suggested treatments or actions. In some embodiments, the calibrated image 2000 may also be compared to calibrated images of known complications to determine if and which complication may be present.”); and
provide an automatic notification for a clinician to make a site assessment of the catheter insertion site based, at least in part, on the recorded site assessment information (Dikeman, par. 94, “If it is determined that the color of the IVC site 204 in the calibrated image 2000 is different or outside a pre-defined standard error than the color in the baseline or previously taken images, the application may alert the healthcare provider 210 by providing an indication on the mobile device 212 or an alert may be sent to the healthcare provider 210, administration, and/or emergency staff. The application may also analyze the differences between the calibrated images and provide diagnosis and/or possible treatment suggestions.”).
Regarding claim 18, Dikeman teaches the system of claim 16, wherein the one or more computing devices is configured to identify changes of the catheter insertion site over a predetermined period of time based on the site assessment information from the one or more image capture devices and the one or more sensors (Instead of the healthcare provider comparing calibrated images to determine if there is swelling at the catheter insertion site, that comparison may be automatically performed by a computer. See Dikeman at par. 96).
Claims 19 and 20 substantially correspond to claims 10 and 11 by reciting a system comprising one or more computing devices (Dikeman, par. 50, “computer 102”) configured to perform substantially the same methods as claims 10 and 11. Claims 19 and 20 differ in their dependencies from claim 16 as compared to claims 10 and 11, however, this does not affect how the cited art is applied to the claims.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Dikeman.
Regarding claim 5, Dikeman teaches the method of claim 1, wherein the site assessment rate is determined by the computing device (A periodic assessment of an IVC site assessment may be programmed into the mobile device to prompt a healthcare provider to take an assessment image, and the device may automatically determine if there is swelling. See Dikeman at par. 57, “the task 314 may be rounds, or a periodic check on patients or administration of a treatment such as ... an IVC assessment as indicated on the login screen 300.”), but does not explicitly teach the site assessment rate is determined by the computing device using at least one of: catheter type and location; current medication; patient status; patient physiology; patient mobility; and history of vascular access complications.
However, according to MPEP 2144.04, subsection III, “broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art”. In this case, Dikeman discloses the site assessment rate is determined by a healthcare provider using a patient’s medication and status (Dikeman, par. 96, “the healthcare provider 210 may take a calibrated photograph of the IVC site 204 periodically based on the patient's condition, medication, or any other factor that may require periodic assessment.”), but not determined by the computing device.
A person of ordinary skill in the art would have been motivated to replace the manual site assessment rate determination based on a patient’s medication and status as disclosed by Dikemen with a programmed/automated determination to thereby accomplish the same result of determining a specific assessment rate that corresponds to a specific patient characteristic, such as their current medication or status. Based on the foregoing, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made such modification according to known methods to yield the predictable results to have the benefit of giving time back to a healthcare provider to assess a patient.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US20210142882A1 is pertinent because it discloses “training a computational model 136 with access site images 132 of a particular population of patients (for instance, geographic region, disease state, condition, different skin tones, different types of access sites, different ages of access sites, and/or the like) and information indicating the condition, abnormalities, or other information that may be used to determine access site information 138 and/or a treatment recommendation 142.” (par. 49). A computational model trained to assess catheter insertion sites for different skin tones would be beneficial for automating other site assessment methods.
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/RYAN P POTTS/Examiner, Art Unit 2672
/SUMATI LEFKOWITZ/Supervisory Patent Examiner, Art Unit 2672
1 See Superguide Corp. v. Direct TV Enterprises, Inc., 358 F.3d 870, 69 USPQ2d 1865 (Fed. Cir. 2004).
2 See https://web.archive.org/web/20191019182010/https://sensationalcolor.com/color-theory/color-terminology-glossary/#tab-con-24.