DETAILED ACTION
Status of Claims
This action is in reply to the application filed on 1 August, 2025.
Claim Objections
The numbering of claims is not in accordance with 37 CFR 1.126 which requires the original numbering of the claims to be preserved throughout the prosecution. When claims are canceled, the remaining claims must not be renumbered. When new claims are presented, they must be numbered consecutively beginning with the number next following the highest numbered claims previously presented (whether entered or not).
The claims include two (2) claims numbered as Claim “4”. The first instance depends from Claim 3, and the second instance depends from Claim 1. In order to prevent further mismatched dependencies, the first instance of misnumbered Claim 4, which depends from Claim 3, is renumbered Claim 21:
[[4]]21. The system of claim 3, wherein the server utilizes a machine learning model to analyze the first image, the second image, and/or the composite spectrum image to identify the set of treatment locations on the patient by:
identifying regions of the composite spectrum image or the thermal image having a human body;
mapping each pixel of the regions to a specific surface part of the human body; and
detecting areas on the composite spectrum image or the thermal image that are cooler than surrounding areas and assigning a location marker to each of the treatment areas, wherein the location marker maps to a portion of the human body.
Appropriate correction is required.
Claim 8 is objected to for minor informalities. Claim 8 includes the phrase “and hold the”, but there appears to be missing terms following. Appropriate correction is required.
Claims 1 – 21 are currently pending and have been examined.
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 .
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
The following rejection is formatted in accordance with MPEP 2106.
Claim 11 is representative. Claim 11 recites:
A method of documenting cryogenic therapy of a patient, comprising:
receiving a thermal spectrum image of a patient;
receiving a visible spectrum image of the patient;
aggregating the thermal spectrum image with the visible spectrum image to create a composite spectrum image;
identifying a set of treatment areas on the patient by analyzing the thermal spectrum image or the composite spectrum image;
analyzing the visible spectrum image to determine a location of each treatment area; and
transmitting the set of locations of the treatment areas to a medical record system to automatically document the locations on the patient in a medical record of the patient.
Claims 19 recites medium with instructions executed by a processor, and Claim 1 recites a system that executes the steps of the method recited in Claim 11, which varying degrees of functional specificity.
Claims 1 - 21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e. a law of nature, a natural phenomenon, or an abstract idea), and does not include additional elements that either: 1) integrate the abstract idea into a practical application, or 2) that provide an inventive concept – i.e. element that amount to significantly more than the abstract idea. The Claims are directed to an abstract idea because, when considered as a whole, the plain focus of the claims is on an abstract idea.
STEP 1
The claims are directed to a system, a method and non-transitory computer readable medium which are included in the statutory categories of invention.
STEP 2A PRONG ONE
The claims, as illustrated by Claim 11, recite limitations that encompass an abstract idea including:
identifying a set of treatment areas on the patient by analyzing the thermal spectrum image or the composite spectrum image;
analyzing the visible spectrum image to determine a location of each treatment area; and
document the locations on the patient in a medical record of the patient.
The claims, as illustrated by Claim 11, recite limitations that encompass an abstract idea within the “mental processes” grouping – concepts performed in the human mind including observation, evaluation, judgment and opinion.
The claims recite receiving a thermal image and a visible image of a patient; aggregating the images to form a composite image; analyzing the thermal image, (or the thermal component of the composite image), to identify treatment areas; analyzing the visible image to determine a location of each treatment area; and documenting the treatment areas in the patient’s medical record.
The specification discloses that thermal and visible image data is captured using conventional devices such as a FLIR™ camera and a visible spectrum camera. The images are analyzed to detect an area of interest such as a biopsy site, lesion site, treatment site or other site of interest. Analyzing images to detect a site of interest, is a process that, except for generic computer implementation steps, can be performed in the human mind. The specification gives an example where temperatures across the skin are compared to detect a treatment site. Comparing temperatures across the skin in a thermal image to detect a treatment site is a process that can be performed in the human mind.
Similarly determining the location of each treatment area is disclosed as mapping site coordinates to twenty-four distinct anatomical regions stored in a database. The specification discloses that conventionally, this is performed mentally.
Collecting information, including when limited to particular content, is within the realm of abstract ideas, and analyzing information by steps people go through in their minds, or by mathematical algorithms, without more, are mental processes within the abstract idea category (Electric Power Group v. Alstom S.A. (Fed Cir, 2015-1778, 8/1/2016).
As such, the claims recite an abstract idea within the mental process grouping.
The claims, as illustrated by Claim 1, recite limitations that encompass an abstract idea within the “certain methods of organizing human activity” grouping –
fundamental economic principles or practices including hedging, insurance, mitigating risk;
commercial or legal interactions including agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations;
managing personal behavior or relationships or interactions between people including social activities, teaching, and following rules or instructions.
The claims recite receiving a thermal image and a visible image of a patient; aggregating the images to form a composite image; analyzing the thermal image, (or the thermal component of the composite image), to identify treatment areas; analyzing the visible image to determine a location of each treatment area; and documenting the treatment areas in the patient’s medical record.
This process is typical in medicine, in accordance with the specification, where a doctor documents each encounter involving cryogenic therapy in the patient’s record “to facilitate receiving reimbursement and recording the visit for compliance.” Conventional documentation systems include manual charting and dictation, including manually adding treated locations, diagnosis, and procedure details, and anatomical locations. (@ 0004 – 0007). Documenting treatment to facilitate reimbursement is a fundamental economic principle or practice that includes commercial or legal interactions, legal obligations or business relations. Documenting treatment to facilitate compliance includes following rules or instructions. As such, the claims recite an abstract idea within the certain methods of organizing human activity grouping.
STEP 2A PRONG TWO
The claims recite limitations that include additional elements beyond those that encompass the abstract idea above including:
receiving a thermal spectrum image of a patient;
receiving a visible spectrum image of the patient;
aggregating the thermal spectrum image with the visible spectrum image to create a composite spectrum image;
transmitting the set of locations of the treatment areas to a medical record system.
However, these additional elements do not integrate the abstract idea into a practical application of that idea in accordance with the MPEP. (see MPEP 2106.05)
The medical record system is recited at a high level of generality such that it amounts to no more than instructions to apply the abstract idea using a generic computer components. These elements merely add instructions to implement the abstract idea on a computer, and generally link the abstract idea to a particular technological environment.
Receiving images captured using conventional devices, and aggregating the images into a composite image are insignificant extra-solution activities – i.e. a data gathering step. Aggregating involves combining the images by “formation of calculation”, or overlapping them – i.e. “aligning identical points” of the two images using conventional techniques (MINIMA). Overlapping to images by matching points is conventionally known as image registration.
Nothing in the claim recites specific limitations directed to an improved technology or technological process. Similarly, the specification is silent with respect to these kinds of improvements. Rather, the specification discloses that the invention “reduces the reliance on manual documentation, reduces administrative burden, and enables systematic analysis” (although no analysis is performed). None of these are technological improvements. A general purpose computer that applies a judicial exception by use of conventional computer functions, as is the case here, does not qualify as a particular machine, nor does the recitation of a generic computer impose meaningful limits in the claimed process. (see Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 716-17 (Fed. Cir. 2014)). As such, the additional elements recited in the claim do not integrate the abstract documentation process into a practical application of that process.
STEP 2B
The additional elements identified above do not amount to significantly more than the abstract documentation process. Image capture and processing is a conventional technique, even according to the specification. For example, the specification discloses conventional devices for capturing image data. The disclosure of these techniques is at a high level of generality indicating that they are well-known in the art. Similarly, receiving information, for example over a network, is a well-understood, routine and conventional computer function – i.e. receiving or transmitting data over a network as in Symantec, TLI, OIP and buySAFE. Storing and retrieving information from memory is a routine and conventional computer function as in Versata and OIP Tech.
The additional structural elements or combination of elements in the claims, other than the abstract idea per se, amount to no more than a recitation of generic computer structure (i.e. a server/processor, medical record system, computer-readable medium thermal spectrum camera, visible spectrum camera). Each of the above components are disclosed in the specification as being purely conventional and/or known in the industry. Because the specification describes these additional elements in general terms, without describing particulars, Examiner concludes that the claim limitations may be broadly, but reasonably construed, as reciting well-understood, routine and conventional computer components and techniques. The specification describes the elements in a manner that indicates that they are sufficiently well-known that the specification does not need to describe the particulars in order to satisfy U.S.C. 112. Considered as an ordered combination the limitations recited in the claims add nothing that is not already present when the steps are considered individually. As such, the additional elements recited in the claim do not provide significantly more than the abstract documentation process, or an inventive concept.
The dependent claims add additional features including:
those that recite additional abstract ideas such as:
analyzing images to identify treatment locations (Claim 3);
identify regions in an image having a body, map regions to specific surface part, assign a location marker (Claim 21);
triggering image capture after a preset time (Claim 9, 14, 20);
detecting cooler areas and assigning a location marker (Claim 16);
those that recite well-understood, routine and conventional activity or computer functions such as:
update a medical record of the patient (Claim 2);
an actuator to trigger image capture (Claim 5, 6);
devices communicatively coupled (Claim 7);
medical notation API (Claim 10);
aligning identical point on two images (Claim 15);
transmitting/transferring location markers/images to a medical record system (Claim 17, 18);
those that recite insignificant extra-solution activities such as:
aggregate the first and second image (Claim 3);
capturing thermal/visible images with respective cameras (Claim 4);
or those that are an ancillary part of the abstract idea such as:
a housing to hold devices (Claim 8);
synchronous/simultaneous image capture (Claim 12, 13, 20).
The limitations recited in the dependent claims, in combination with those recited in the independent claims add nothing that integrates the abstract idea into a practical application, or that amounts to significantly more. As such, the additional element do not integrate the abstract idea into a practical application, or provide an inventive concept that transforms the claims into a patent eligible invention.
The apparatus claims are no different from the method claims in substance. “The equivalence of the method, system and media claims is readily apparent.” “The only difference between the claims is the form in which they were drafted.” (Bancorp). The method claims recite the abstract idea implemented on a generic computer, while the apparatus claims recite generic computer components configured to implement the same idea. Specifically, Claims 1 – 10 and 19 - 21 merely add the generic hardware noted above that nearly every computer will include. The apparatus claim’s requirement that the same method be performed with a programmed computer does not alter the method’s patentability under U.S.C. 101 (In re Grams). Therefore, the claims are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
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.
Claims 1 – 4, 10 – 13, 15 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Miyano et al. (US PGPUB 2001/0046316 A1) in view of Esham et al.: (US PGPUB 2006/0280287 A1).
CLAIMS 1 and 11
Miyano discloses an image synthesis apparatus that includes the following limitations:
a thermal spectrum camera configured to capture a first image; a visible spectrum camera configured to capture a second image; a server configured to receive the first image and the second image, (receiving a thermal spectrum image of a patient; receiving a visible spectrum image of the patient); wherein the server aggregates the first image with the second image to create a composite spectrum image; identify a set of treatment locations on the patient by analyzing the thermal spectrum image or the composite spectrum image; (Miyano Abstract, 0002, 0004, 0005, 0008, 0014, 0032 – 0037, 0045, 0046, 0048 – 0051, 0056, 0058, 0064, 0068, 0069, 0085, 0087).
Miyano discloses an image synthesis apparatus that includes an infrared (i.e. thermal) camera and a visible light camera configured to capture thermal and visible light images of a site of a human body, respectively. Images are transmitted to an image synthesis processing device (i.e. a server) where the thermal images and the visible light image are synthesized into a composite or overall image (i.e. aggregate). Aggregating includes matching respective points on each image to create an overlay of superimposed images. The composite image, and/or thermal image may be used to identify an area on the surface of a patient’s body having a temperature difference, for example, indicating the site on an inflammation, (i.e. a set of treatment locations), based on the thermal distribution displayed in the composite image. The respective areas may be color coded as a temperature distribution based on the detected temperature (i.e. red, green, yellow, blue) as is known in the art. The respective areas are mapped to a 3D coordinate system in a virtual space, based on the visible light image.
With respect to the following limitations:
A system for/A method of documenting therapy of a patient; (Esham Abstract);
wherein the server is further configured to transmit the set of treatment locations to a medical record system to automatically document the treatment locations on the patient in a medical record of the patient; (Esham Abstract, 0003, 0004, 0012 – 0015).
Miyano does not disclose storing treatment locations in a patient record, however, Esham does. Esham discloses a therapy treatment recording system that includes determining beam landing positions (i.e. treatment locations) on the surface of a human body, and storing information regarding the position at which treatment was delivered on the surface of the anatomy of the patient. Esham uses a visible light digital camera image overlaid with the positioning of the treatment to detect treatment areas. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing data of the claimed invention, to have modified the image synthesis apparatus of Miyano so as to have included storing cryogenic treatment locations in a patient record, in accordance with the teaching of Esham, in order to allow for effective planning of future treatments.
CLAIMS 2, 10 and 18
The combination of Miyano/Esham discloses the limitations above relative to Claims 1 and 11. Additionally, Esham discloses the following limitations:
wherein the server is further configured to automatically update a medical record of the patient in the medical record system to include information regarding the treatment locations; a medical notation API configured to interface the server with a database of the medical record system; transferring the thermal spectrum image and the visible spectrum image to the medical record system; (Esham Abstract, 0003, 0004, 0012 – 0015).
Miyano does not disclose storing treatment locations in a patient record, however, Esham does. Esham discloses a therapy treatment recording system that includes determining beam landing positions (i.e. treatment locations) on the surface of a human body, and storing information regarding the position at which treatment was delivered on the surface of the anatomy of the patient in a patient medical record. Esham uses a visible light digital camera image overlaid with the positioning of the treatment to detect treatment areas. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing data of the claimed invention, to have modified the image synthesis apparatus of Miyano so as to have included storing cryogenic treatment locations in a patient record, in accordance with the teaching of Esham, in order to allow for effective planning of future treatments.
CLAIM 3
The combination of Miyano/Esham discloses the limitations above relative to Claim 1. Additionally, Miyano discloses the following limitations:
wherein the server aggregates the first image with the second image to create a composite spectrum image; (Miyano Abstract, 0008, 0056, 0058); and
wherein the server is configured to analyze the first image, the second image, and/or the composite spectrum image to identify the set of treatment locations on the patient; (Miyano 0037, 0045, 0046, 0050, 0051, 0068, 0069, 0085, 0087).
The composite image, and/or thermal image may be used to identify an area on the surface of a patient’s body having a temperature difference, for example, indicating the site on an inflammation, (i.e. a set of treatment locations), based on the thermal distribution displayed in the composite image. The respective areas may be color coded as a temperature distribution based on the detected temperature (i.e. red, green, yellow, blue) as is known in the art. The respective areas are mapped to a 3D coordinate system in a virtual space, based on the visible light image.
CLAIM 4
The combination of Miyano/Esham discloses the limitations above relative to Claim 1. Additionally, Miyano discloses the following limitations:
wherein the thermal spectrum camera captures a thermal spectrum, and the visible spectrum camera captures a visible spectrum; (Miyano 0008, 0014, 0035 – 0037).
Miyano discloses thermal camera for capturing thermal images and visible light cameras for capturing visible light images of a patient’s skin.
CLAIMS 12 and 13
The combination of Miyano/Esham discloses the limitations above relative to Claim 11. With respect to the following limitations:
wherein the thermal spectrum image and visible spectrum image of the patient were taken synchronously; simultaneously triggering a thermal spectrum camera to capture the thermal spectrum image and a visible spectrum camera to capture the visible spectrum image; (Miyano 0057).
Miyano discloses acquiring the thermal and visible light images “at the same timing” – i.e. synchronously; simultaneously.
CLAIM 15
The combination of Miyano/Esham discloses the limitations above relative to Claim 11. With respect to the following limitations:
wherein the step of aggregating comprises aligning identical points of the thermal spectrum image with those of the visible spectrum image such that the images overlap relative to the patient; (Miyano Abstract, 0008, 0056, 0058).
Miyano discloses aligning identical reference point on the thermal and visible light images such that they overlap.
Claims 5 – 7 are rejected under 35 U.S.C. 103 as being unpatentable over Miyano et al. (US PGPUB 2001/0046316 A1) in view of Esham et al.: (US PGPUB 2006/0280287 A1) in view of Sheard et al.: (US PGPUB 2009/0102925 A1).
CLAIMS 5 - 6
The combination of Miyano/Esham discloses the limitations above relative to Claim 1. With respect to the following limitations:
an actuator configured to simultaneously trigger the thermal spectrum camera to capture the thermal spectrum in the first image and the visible spectrum camera to capture the visible spectrum in the second image; (Sheard 0002, 0012 – 0016, 0021);
an image capture device that comprises the thermal spectrum camera, the visible spectrum camera, and the actuator; (Sheard Figure 1A 0012 – 0016).
Miyano discloses a signal that initiates the image synthesis process, but does not expressly disclose a trigger for capturing the images. Sheard discloses a handheld thermal and visible light imaging camera mounted in a housing that includes a trigger operated by the user to initiate imaging. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing data of the claimed invention, to have modified the image synthesis apparatus of Miyano so as to have included a actuator, and a housing for the thermal and imaging cameras and actuator, in accordance with the teaching of Sheard, in order to allow for single handed operation.
CLAIM 7
The combination of Miyano/Esham discloses the limitations above relative to Claim 6. With respect to the following limitations:
wherein the image capture device is communicatively coupled with the server; (Esham Abstract, 0003, 0004, 0012 – 0015).
Miyano does not disclose communicating with a server or another remote computer; however, Esham does. Esham discloses a therapy treatment recording system that includes communicating with a storage processor for storing location information in a patient record. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing data of the claimed invention, to have modified the image synthesis apparatus of Miyano so as to have included communicating with a server for storage, in accordance with the teaching of Esham, in order to allow for effective planning of future treatments.
Claims 16, 17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Miyano et al. (US PGPUB 2001/0046316 A1) in view of Esham et al.: (US PGPUB 2006/0280287 A1) in view of Van Snellenberg et al.: (US PGPUB 2019/0021649 A1).
CLAIM 19
The combination of Miyano/Esham discloses the limitations in Claims 1 and 11 as shown above. Claim 19 recites the same features, and are rejected on the same basis. Claim 19, however, recites the following addition features:
a non-transitory machine-readable medium having instructions stored thereon for execution by a processor to perform a method; (Miyano 0048);
aggregating, by aligning identical points of the thermal spectrum image with those of the visible spectrum image such that the overlapping images create the composite spectrum image; (Miyano Abstract, 0008, 0056, 0058);
assigning each of the areas a location marker based on its location relative to the patient using the processor and by analyzing the visible spectrum image; (Miyano 0016, 0048).
Miyano discloses a programmed computer that executes the method of Claim 11. Miyano discloses aggregating or synthesizing a composite image by matching respective reference points in the thermal and visible light images to generate overlapping images. Miyano assigns coordinates to areas identified in the images.
With respect to the following limitation:
detecting areas on the thermal spectrum image or the composite spectrum image that are cooler than surrounding areas using the processor; (Van Snellenberg 0033 – 0036).
Miyano discloses indicating areas of different temperature using color coding, including a blue color. While one of ordinary skill would know that blue typically represents areas that are cooler than other areas, Miyano does not expressly disclose detecting cooler areas in the thermal image. Van Snellenberg discloses a system and method for detecting skin problems that includes detecting areas on a patient’s skin that are cooler than the surrounding skin. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing data of the claimed invention, to have modified the image synthesis apparatus of Miyano/Esham so as to have included detecting cooler areas in a thermal image, in accordance with the teaching of Van Snellenberg, in order to allow for identification of skin abnormalities.
CLAIM 16
The combination of Miyano/Esham discloses the limitations above relative to Claim 15. Additionally, Miyano discloses the following limitations:
wherein the step of identifying the set of locations of the treatment areas comprises: assigning each of the treatment areas a location marker and determining an anatomic location on the patient; (Miyano 0016, 0048).
Miyano discloses assigning 3D coordinates to treatment areas identified in the images. With respect to the following limitations:
detecting the treatment areas on the composite spectrum image that are cooler than surrounding areas; (Van Snellenberg 0033 – 0036).
Miyano discloses indicating areas of different temperature using color coding, including a blue color. While one of ordinary skill would know that blue typically represents areas that are cooler than other areas, Miyano does not expressly disclose detecting cooler areas in the thermal image. Van Snellenberg discloses a system and method for detecting skin problems that includes detecting areas on a patient’s skin that are cooler than the surrounding skin. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing data of the claimed invention, to have modified the image synthesis apparatus of Miyano/Esham so as to have included detecting cooler areas in a thermal image, in accordance with the teaching of Van Snellenberg, in order to allow for identification of skin abnormalities.
CLAIM 17
The combination of Miyano/Esham/Van Snellenberg discloses the limitations above relative to Claim 16. Additionally, Miyano discloses the following limitations:
transmitting the location markers to the medical record system to automatically document the treatment locations on the patient in the medical record of the patient; (Esham Abstract, 0003, 0004, 0012 – 0015).
Miyano does not disclose storing treatment locations in a patient record, however, Esham does. Esham discloses a therapy treatment recording system that includes determining beam landing positions (i.e. treatment locations) on the surface of a human body, and storing information regarding the position at which treatment was delivered on the surface of the anatomy of the patient. Esham uses a visible light digital camera image overlaid with the positioning of the treatment to detect treatment areas. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing data of the claimed invention, to have modified the image synthesis apparatus of Miyano so as to have included storing cryogenic treatment locations in a patient record, in accordance with the teaching of Esham, in order to allow for effective planning of future treatments.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Miyano et al. (US PGPUB 2001/0046316 A1) in view of Esham et al.: (US PGPUB 2006/0280287 A1) in view of Van Snellenberg et al.: (US PGPUB 2019/0021649 A1) in view of Li et al.: (US PGPUB 2023/0065433 A1).
CLAIM 21
The combination of Miyano/Esham discloses the limitations above relative to Claim 3. Additionally, Miyano discloses the following limitations:
assigning a location marker to each of the treatment areas; (Miyano 0016, 0048).
Miyano assigns coordinates to areas identified in the images. With respect to the following limitations:
wherein the server utilizes a machine learning model to analyze the first image, the second image, and/or the composite spectrum image to identify the set of treatment locations on the patient; (Van Snellenberg 0010, 0022, 0035 – 0037, 0047);
identifying regions of the composite spectrum image or the thermal image having a human body; (Van Snellenberg 0035);
detecting areas on the composite spectrum image or the thermal image that are cooler than surrounding areas; (Van Snellenberg 0033 – 0036).
Miyano discloses indicating areas of different temperature using color coding, including a blue color. While one of ordinary skill would know that blue typically represents areas that are cooler than other areas, Miyano does not expressly disclose detecting cooler areas in the thermal image. Van Snellenberg discloses a system and method for detecting skin problems that includes detecting areas on a patient’s skin that are cooler than the surrounding skin. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing data of the claimed invention, to have modified the image synthesis apparatus of Miyano/Esham so as to have included detecting cooler areas in a thermal image, in accordance with the teaching of Van Snellenberg, in order to allow for identification of skin abnormalities. With respect to the following limitations:
mapping each pixel of the regions to a specific surface part of the human body; and wherein the location marker maps to a portion of the human body; (Li 0034, 0049, 0051 – 0057).
Miyano discloses indicating areas of different temperature and assigning coordinates in a 3D coordinate system to the area. Miyano does not disclose mapping pixels to a specific part of the human body. Li discloses an image processing system and method that includes mapping pixels in an image to a human body area. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing data of the claimed invention, to have modified the image synthesis apparatus of Miyano/Esham/Van Snellenberg so as to have included mapping pixels to human body parts, in accordance with the teaching of Li, in order to allow for identification of skin abnormalities.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Miyano et al. (US PGPUB 2001/0046316 A1) in view of Esham et al.: (US PGPUB 2006/0280287 A1) in view of Sheard et al.: (US PGPUB 2009/0102925 A1) in view of Ellman et al.: (US 6,905,496 B1).
CLAIM 8
The combination of Miyano/Esham/Sheard discloses the limitations above relative to Claim 6. With respect to the following limitations:
a housing configured to receive (i) the image capture device; (Sheard Figure 1A 0012 – 0016).
Miyano discloses image capture devices, but does not expressly disclose a housing. Sheard discloses a handheld thermal and visible light imaging camera mounted in a housing that includes a trigger operated by the user to initiate imaging. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing data of the claimed invention, to have modified the image synthesis apparatus of Miyano so as to have included an actuator, and a housing for the thermal and imaging cameras and actuator, in accordance with the teaching of Sheard, in order to allow for single handed operation. With respect to the following limitation:
a housing configured to receive a pressurized container configured to hold a cryogenic fluid; (Ellman Abstract, Figure 1, col. 1 line 35 – 55, col. 2 line 46 – 67, col. 3 line 11 – 54, col. 4 line 12 – 17).
The combination of Miyano/Esham/Sheard discloses image capture devices in a housing, but does not disclose that the housing receives a pressurized container for cryogenic fluid. Ellman discloses a housing for an electrosurgical generator, where a container holding a cryogenic fluid is attached to the housing. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing data of the claimed invention, to have modified the image synthesis apparatus of Miyano/Esham/Sheard so as to have included a housing configured to receive a container of cryogenic fluid, in accordance with the teaching of Ellman, in order to allow for convenient operation of a routine cooling procedure.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Miyano et al. (US PGPUB 2001/0046316 A1) in view of Esham et al.: (US PGPUB 2006/0280287 A1) in view of Sheard et al.: (US PGPUB 2009/0102925 A1) in view of Ellman et al.: (US 6,905,496 B1) in view of Official Notice.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Miyano et al. (US PGPUB 2001/0046316 A1) in view of Esham et al.: (US PGPUB 2006/0280287 A1) in view of Official Notice.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Miyano et al. (US PGPUB 2001/0046316 A1) in view of Esham et al.: (US PGPUB 2006/0280287 A1) in view of Van Snellenberg et al.: (US PGPUB 2019/0021649 A1) in view of Official Notice.
CLAIMS 9, 14 and 20
Claims 9, 14 and 20 recite a common feature – triggering capture of thermal and visible light images after dispensing the cryogenic fluid, and in particular, at a present time after dispensing, as follows:
wherein the actuator is configured to trigger the thermal spectrum camera to capture the first image and the visible spectrum camera to capture the second image at a preset time after some of the cryogenic fluid is expelled from the pressurized container.
wherein the step of triggering occurs a preset time after dispensing of a cryogenic fluid on the patient.
simultaneously capturing the thermal spectrum image using the thermal spectrum camera and capturing the visible spectrum image using the visible spectrum camera a set time after cryogenic fluid is dispensed.
None of the cited references disclose triggering image capture at a time after cooling. Nonetheless, Examiner takes Official Notice that cryogenic treatments have a time to effect. Cryogenic treatments require the skin temperature to be brought to a specified temperature for a specified amount of time. Propagating cold (or heat) into the skin takes time, and one of ordinary skill would known this fact. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing data of the claimed invention, to have modified the image synthesis apparatus of Miyano/Esham/Sheard and Ellman, Van Snellenberg, so as to have included triggering images after a preset time, in accordance with the Official Notice taken, in order to allow the treatment to propagate into the skin.
CONCLUSION
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 6,157,854 A to Haber discloses a system and method for monitoring pain treatment with thermal imaging, where the image is captured a time after treatment.
US PGPUB 2008/0188840 A1 to Johnson et al. discloses a handpiece for dermatological treatments that includes a cryogenic liquid container.
US PGPUB 2010/0135550 A1 to Arnon discloses a system and method for thermography that includes acquiring thermal and visible light images simultaneously.
US PGPUB 2011/0278455 A1 to Choi et al. discloses detecting cooler regions in an thermal image.
US PGPUB 2012/0197657 A1 to Prodanovic discloses a system and method for documenting the site of a dermatological skin treatment, including cryotherapy, in a patient record. This reference is particularly relevant.
Any inquiry of a general nature or relating to the status of this application or concerning this communication or earlier communications from the Examiner should be directed to John A. Pauls whose telephone number is (571) 270-5557. The Examiner can normally be reached on Mon. - Fri. 8:00 - 5:00 Eastern. If attempts to reach the examiner by telephone are unsuccessful, the Examiner’s supervisor, Robert Morgan can be reached at (571) 272-6773.
Official replies to this Office action may now be submitted electronically by registered users of the EFS-Web system. Information on EFS-Web tools is available on the Internet at: http://www.uspto.gov/patents/process/file/efs/guidance/index.jsp. An EFS-Web Quick-Start Guide is available at: http://www.uspto.gov/ebc/portal/efs/quick-start.pdf.
Alternatively, official replies to this Office action may still be submitted by any one of fax, mail, or hand delivery. Faxed replies should be directed to the central fax at (571) 273-8300. Mailed replies should be addressed to “Commissioner for Patents, PO Box 1450, Alexandria, VA 22313-1450.” Hand delivered replies should be delivered to the “Customer Service Window, Randolph Building, 401 Dulany Street, Alexandria, VA 22314.”
/JOHN A PAULS/Primary Examiner, Art Unit 3683
Date: 21 August, 2026
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