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 at page 7 of Remarks filed 5 June 2026, with respect to the objections to claims 8 and 12 for minor informalities have been fully considered and are persuasive. The objections have been withdrawn.
Applicant’s arguments at pages 7-8 of Remarks, with respect to the rejection of claims 1, 2, 4, 6, 8-12, 15, 16 and 18-20 under 35 U.S.C. 102(a)(2) have been fully considered but are moot.
As an initial matter, Examiner disagrees with the characterization of the prior Office action in the last paragraph of page 7 of Remarks. Applicant states that the Examiner’s characterization of Dikeman disclosing “a healthcare provider using a mobile device with a camera to capture images of an insertion site over time for the same patient” is equivalent to “all the images captured, calibrated, or otherwise in Dikeman are images of the actual patient.” This does not appear to be accurate based on Dikeman at paragraphs 54, 59, and 65 as well as Figure 4, which describe and/or illustrate how the system works with multiple patients, thereby producing images of multiple patients. The series of predefined images in the independent claims is considered to correspond to images acquired from one of the plurality of patients described by Dikeman.
Regarding the rejection under 35 U.S.C. 102, Applicant’s amendment necessitated new grounds of rejection. The independent claims are now rejected under 35 U.S.C. 103. Applicant’s arguments are directed to the claim language “are not images of the patient” which is not being asserted as explicitly disclosed by Dikeman, but is considered obvious based on other prior art applied in the rejection below. Therefore, Applicant’s arguments, including those with respect to the rejection of claim 5 under 35 U.S.C. 103, are considered moot because they are directed to Dikeman and subject matter that is taught by another reference.
Claim Interpretation
The Federal Circuit’s en banc decision in Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) expressly recognized that the USPTO employs the "broadest reasonable interpretation" standard:
The Patent and Trademark Office ("PTO") determines the scope of claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction "in light of the specification as it would be interpreted by one of ordinary skill in the art." In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364[, 70 USPQ2d 1827, 1830] (Fed. Cir. 2004). Indeed, the rules of the PTO require that application claims must "conform to the invention as set forth in the remainder of the specification and the terms and phrases used in the claims must find clear support or antecedent basis in the description so that the meaning of the terms in the claims may be ascertainable by reference to the description." 37 CFR 1.75(d)(1). MPEP 2111.
A Federal Circuit decision on claim construction considered the language “first means for storing at least one of a desired program start time, a desired program end time, a desired program service, and a desired program type”. See Superguide Corp. v. Direct TV Enterprises, Inc., 358 F.3d 870, 69 USPQ2d 1865 (Fed. Cir. 2004); see also claim 1 of U.S. Pat. No. 5,083,211. A key dispute concerned what “at least one of” modifies, whether the list of elements should be interpreted disjunctively or conjunctively. To resolve the dispute, the court interpreted the specific claim language before it according to ordinary English grammar and the intrinsic evidence including the specification and prosecution history.
The court determined that the plain and ordinary meaning of the disputed language supported the district court’s construction of “at least one of” as meaning “one or more”. The key issue however was over what “at least one of” modifies in the subsequently listed claim elements (categories) of the claim at issue. The court did not create a per se rule that claim language of the type “at least one of [one or more categories] ... and [category]” connotes a conjunctive list. Rather, the court decided that a conjunctive interpretation was one possible interpretation and since the specification only described embodiments supporting the conjunctive interpretation, there was nothing in the specification to rebut the presumption that the patentee intended the plain and ordinary meaning to be conjunctive. In other words, had there been one example of an embodiment supporting the disjunctive interpretation, the presumption may be rebutted.
The import of Superguide to the claims here is that in a context-specific review of a patent claim in light of the specification, the plain and ordinary meaning of “at least one of” may be conjunctive, but not in all cases. While claims 5, 8 and 16 recite limitations conforming to the format at issue in Superguide, the claims here are given their broadest reasonable construction in light of the specification as it would be interpreted by one of ordinary skill in the art.
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 a 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 of a patient, the system 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, wherein the series of predefined images are not images of the patient; 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 of the patient; 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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1, 2, 4-6, 8-12, 15, 16 and 18-20 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention.
Claims 1, 12 and 16 each recite “wherein the series of predefined images are not images of the patient”. Claims 2, 4-6, 8-11, 15 and 18-20 include this subject matter by virtue of dependency.
The amended claims now require the “series of predefined images” to specifically be images that are not images of the catheter site and/or dressing of the “patient”. The phrase “are not images of the patient” is not further described or explained in the claims. Accordingly, the plain meaning of “are not images of the patient” is the images do not include/depict/represent any part of the patient.
Turning to the Specification, there does not appear to be any explicit inclusion of the phrase “not images of the patient”, “not the patient” or the like. The closest disclosure to the subject matter added to the independent claims is found in sections that mention “a series of standardized images”. The claims notably recite a broader construction of standardized images: “predefined images”. A standardized image may be a predefined image, but a predefined image is not necessarily a standardized image.
Paragraph 36 provides, “The system may provide a clinician with pre-defined images of sites for the clinician to simply pick the image that is closest to the site on the patient they are observing. This will allow images to be tied to a standard scale, and enable analytics to tie scale to outcome. This will further enable earlier intervention if it is found that certain types of site issues lead to negative outcomes (e,g. peeling of dressing). For example, one or more of the categories currently described in the EMR (e.g. dressing status as "clean, dry, intact" vs "clean, intact, with new drainage", etc., Phlebitis Grading Scale, infiltration) will have images to illustrate to the clinician what each subcategory grade is visualized as. To further enable this scale to standardize assessments, different images may be provided to illustrate different skin tones or placement on the body (e.g. placement on a patient's hand versus in the area of inflection on their elbow may look different).”
The description of the standardized images above or otherwise in the Specification does not disclaim or prohibit an interpretation where the standardized or predefined images include a series of images of the same person being scanned. A clinician having access to a series of patient images at different levels of the Phlebitis Grading Scale would have a valuable reference to compare with new scans of the patient. For example, a clinician may want to know if the patient is currently experiencing redness or inflammation at the same rate as in past instances. The Specification does not appear to further elaborate on what the standardization may entail regarding the respective patient(s) in each image, except for perhaps paragraph 45.
The last sentence of paragraph 45 describes how the series of images of a patient’s catheter insertion site taken prior to insertion and repeatedly thereafter can be used for comparison “with outcomes from other patients”. Subsequent paragraphs go on to describe using the various patient images for pattern recognition, machine learning and the like to identify trends.
Even assuming that the series of predefined images is a commonly used training data set used by many different parties in the same field of endeavor as the claimed invention to thereby make performance metrics between different models comparable, that does not necessarily mean that none of those images are of the same patient subject to the scanning recited in the independent claims.
Thus, while the Specification supports the series of predefined images as being standardized and/or including images of one or more additional or other patients, there is insufficient disclosure to demonstrate that at the time of filing, Applicant had possession of a method, program or product that deliberately ensures none of the standardized images include any images of the same patient being scanned, which is implied by the amended claims, i.e., “not images of the patient”.
The claims also require identifying changes “over a predetermined period of time, based on the selected patient baseline site location and skin tone.” This is accomplished by, for example, “colorimetric analysis”, “thermal analysis” or surface reflectance, which are types of image analysis. See, e.g., paragraph 55. Yet, claims 1 and 12 do not explicitly describe any particular images of the patient. At most, these claims set forth “scanning” the patient’s insertion site and/or dressing with “an image capture device”, leaving the quantity and type of images unspecified. An image of a dressing is an image of the dressing, not an image “of the patient”. Claim 16 requires capturing “at least one of a visible light, infrared, or thermal image of the insertion site and/or dressing”, but the recorded site assessment information is only “based at least in part on information from the one or more image capture devices and the one or more sensors”, which does not necessarily include any use of an image of the patient. Metadata, for example, is information obtained from an image capture device that is not an image.
Accordingly, how can the “one or more changes” (claims 1 and 12) of the patient’s insertion site and/or dressing be identified “based on the selected patient baseline site location and skin tone” when they are explicitly defined as not being images of the patient? And, why recite capturing images and determining one or more various sensor measurements related to image processing if they are not necessarily related at all given their disconnected description in claim 16, such that the automatic notification could be provided based on something entirely distinct from one of the captured images or determined sensor measurements? The Specification does not appear to contemplate detailed embodiments where captured images of the patient during scanning are not used to assess the patient’s insertion site and/or dressing.
Thus, there is insufficient disclosure to demonstrate that at the time of filing, Applicant had possession of a method, program or product that identifies one or more changes of the patient’s catheter insertion site and/or provides a notification based on images that are “not images of the patient” or based on information related to hardware that captures or processes images, but not necessarily any images of the patient’s insertion site and/or dressing.
Claim Rejections - 35 USC § 103
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 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.
Claims 1, 2, 4-6, 8-12, 15, 16 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Dikeman (U.S. Pat. Appl. Pub. No.20210016065) in view of U.S. Pat. Appl. Pub. No. 20210142882 (previously cited by Examiner) to Zhang et al. (hereinafter “Zhang”).
Regarding claim 1, Dikeman teaches a method for site assessments of a catheter insertion site of a patient (Dikeman, par. 55, “patient 200”) 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 of the patient (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 the 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 a 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.”), but does not teach that which is explicitly taught by Zhang.
Zhang teaches a series of predefined images are not images of the patient (A patient population, by definition, includes patients that are not the same. See Zhang at par. 22, “Peritoneal dialysis (PD) may use an access site that includes a PD catheter.”, par. 27, “computational models used by the access site analysis process may be trained using actual patient information and/or images of an individual patient and/or a patient population (for instance, of chronic kidney disease (CKD) and/or end-stage renal disease (ESRD) patients).”, par. 30, “Images in the repository may be catalogued and indexed by patient including key clinical information, demographics, medical history, and/or the like to be processed by the access site analysis system at a patient level and/or a population level.”, par. 61, “computational model 436 a may determine trends (for instance, increasing element size, increasing inflammation, decreasing redness, decreasing shininess, and/or the like), variances (for example, presence new abnormality, absence of previous condition, color changes, shape changes, and/or the like), and other determinations that may be made based on viewing a series of images taking at different times.”, par. 49, “population-based training may include 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. 63, “computational model 436 b may compare access site image 432 and/or access site information to any previous images or information associated with the access site to determine variations, trends, and/or the based on historical patient information.”, par. 66, “treatment recommendation 442 may include analytics information 454, for example, indicating outcomes, success rates, treatment types, and/or the like associated with other patients and/or populations of patients.”)
Dikeman discloses a system that monitors a catheter insertion site through image analysis. The system may be used to determine complications associated with a patient’s insertion site. See Dikeman at par. 96. Through an interface, a series of patient images may be displayed that depict the insertion site over time. The interface may also be accessed by a healthcare provider to review treatment recommendations, to display and review the patient’s images, as well as “images presenting known complications side-by-side or overlaid”. See id. at par. 115. While it is very likely that the “known complications” images depict patients that are not the same patient whose IVC site image is being currently assessed, Dikeman does not appear to explicitly state that such images do not include the specific patient being currently scanned and assessed. Thus, Dikeman shows that it was known in the art before the effective filing date of the claimed invention to display patient images together with images of known complications, which is analogous to the claimed invention in that it is pertinent to the problem being solved by the claimed invention, standardizing catheter site assessment. Zhang discloses a system that monitors a catheter insertion site through image analysis and a computational model that is trained on access site images of multiple patients indexed by the system including images depicting complications and trends over time. See Zhang at pars. 23, 27 and 30. The computational model is trained on images of different patients and is used to generate a treatment recommendation for one patient based on a population group comprising other patients. Thus, Zhang shows that it was known in the art before the effective filing date of the claimed invention to index images of more than one patient in the same system and provide an automated treatment recommendation based on images of other patients, which is analogous to the claimed invention in that it is pertinent to the problem being solved by the claimed invention, standardizing catheter site assessment.
A person of ordinary skill in the art would have been motivated to combine the side-by-side display of patient images and images of known complications depicting a trend over a period of time as disclosed by Dikeman with the indexed images of an entire patient population as disclosed by Zhang, to thereby select a series of predefined images from the population that are not images of the patient as the displayed images of known complications. 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 providing the healthcare provider or clinician with examples of complications in other patients to more comprehensively assess a given patient based on a comparison of their individual characteristics and known characteristics exhibited by other patients.
Regarding claim 2, Dikeman in view of Zhang 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 in view of Zhang 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 5, Dikeman in view of Zhang 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 of Dikeman in view of Zhang based on a patient’s medication and status as further 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.
Regarding claim 6, Dikeman in view of Zhang 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 in view of Zhang 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 in view of Zhang 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 in view of Zhang 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.1 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 in view of Zhang 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 of a patient, 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 of the patient 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
generate 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.”), but does not teach that which is explicitly taught by Zhang.
Zhang teaches a series of predefined images are not images of the patient (A population of different patients containing multiple series of insertion/access site images for each patient includes a series of images that are not of a particular patient of the population. Zhang, pars. 22, 23, 27, 30, 49, 61, and 63.)
The rationale for obviousness is the same as provided for claim 1.
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.
Therefore, claim 15 is rejected for same reasons of obviousness as provided for claim 1.
Regarding claim 16, Dikeman teaches a system for site assessments of a catheter insertion site of a patient, the system 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 of the patient (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.”), but does not teach that which is explicitly taught by Zhang.
Zhang teaches a series of predefined images are not images of the patient (A population of different patients containing multiple series of insertion/access site images for each patient includes a series of images that are not of a particular patient of the population. Zhang, pars. 22, 23, 27, 30, 49, 61, and 63.)
The rationale for obviousness is the same as provided for claim 1.
Regarding claim 18, Dikeman in view of Zhang 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.
Therefore, claims 19 and 20 are rejected for same reasons of obviousness as provided for claim 1.
Conclusion
Applicant's amendment necessitated the new grounds 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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/RYAN P POTTS/Examiner, Art Unit 2672
/SUMATI LEFKOWITZ/Supervisory Patent Examiner, Art Unit 2672
1 See https://web.archive.org/web/20191019182010/https://sensationalcolor.com/color-theory/color-terminology-glossary/#tab-con-24.
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