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 .
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1, lines 5 - 9 recite, “at least one temperature-sensitive element… arranged to sense temperatures of different regions of a body part… by changing it colour proportionally…” but should read -- by changing its colour proportionally --.
Claim 1 recites, “at least one sensor device comprising a base… and at least one temperature-sensitive element provided on the first side of the base…” Claim 1 additionally recites “at least one camera,” but because of the formatting with the “-“ bullets and indentation, it is unclear if the “at least one camera” is intended to be a part of the overall system or specific to the sensor device. Examiner notes that in claim 12, which is directed towards “a sensor device”, only the “base” and “at least one temperature-sensitive element” are claimed as a part of the sensor device which is further supported by pages 2 - 3 of the Applicant’s specification, and is thus interpreting the at least one camera as a part of the system and not of the sensor device. Examiner also notes that the indentation of the “base” and the “at least one temperature-sensitive element” vary and should be updated to improve the clarity of claim 1 in regards to what positively claimed elements are a part of the sensor device versus the overall system.
Appropriate correction is required.
Claim Interpretation
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 following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
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) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(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) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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”), such as the recitations of “a tying means” and “a clamping means” in claims 11 and 16, are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 14 & 17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In regard to claim 14, lines 1 – 2 recite “the at least one temperature-sensitive material,” which lacks antecedent basis.
In regard to claim 17, line 9 recites, “the temperatures of different regions of the body part,” which lacks antecedent basis.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 12 - 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mousa (US 20190209019 A1 – Cited by Applicant).
In regard to claim 12, Mousa discloses a sensor device comprising a base having a first and second side (FIG. 3, component 100) with at least one temperature sensitive element (FIG. 3, components 116A, 116B, & 116C) that senses temperatures of different regions of the breast upon contact with the body part for a predefined time period by changing the color of each region or array (FIG. 3, component 304) proportionally to the temperature of each region of the body part (paragraph [0153]).
In regard to claim 13, Mousa discloses the invention of claim 12. Mousa additionally discloses that the sensor device comprises at least one temperature sensitive element comprising a well or recess with a thermographic or temperature-sensitive material disposed in each recess (paragraphs [0091] & [0153]; FIG. 3, components 120 & 216).
In regard to claim 14, Mousa discloses the invention of claim 12. Mousa further discloses that the temperature-sensitive material is a thermographic composition such as a dye comprising an azo compound (paragraphs [0106] – [0107]).
In regard to claim 15, Mousa discloses the invention of claim 12. Mousa further discloses that the body part is a breast and that the base of the sensor device has a hole (FIG. 3, component 106) surrounded by temperature sensitive elements (FIG. 3, component 304; paragraph [0153]).
In regard to claim 16, Mouse discloses the invention of claim 12. Mousa further discloses that the sensor device makes contact between the first side of the sensor device and the body part using an adhesive which allows the device to be releasably secured to the breast (paragraph [0158]; FIG. 3, component 108)
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.
14. Claims 1, 4, 8 – 11, & 17 are rejected under 35 U.S.C. 103 as being unpatentable over Mousa (US 20190209019 A1 - Cited by Applicant) in view of Ohnemus (US 20120201437 A1).
In regard to claims 1 and 17, Mousa discloses a system and method for determining a temperature in a body part comprising at least one sensor device with a first and second side (FIG. 3, component 100) with at least one temperature sensitive element (FIG. 3, components 116A, 116B, & 116C) that senses temperatures of different regions of the breast upon contact with the body part for a predefined time period by changing the color of each region or linear array (FIG. 3, component 304; paragraph [0009]) proportionally to the temperature of each region of the body part (paragraphs [0153] & [0157]). The colorimetric changes are analyzed after removing the sensor device from the skin (paragraph [0136]) where the temperature sensitive element is stable for at least several minutes up to several hours to allow for ease of reading and interpreting of results without haste (paragraph [0141]). While Mousa discloses that the sensor device is used to determine a temperature of a body part by reading the device and interpreting the results on the used device removed from the body (paragraph [0115]), they do not specify at least one camera configured to capture at least one image of the first side within a given time period from a time of removal of contact between the first side and the body part and a processor coupled to the camera wherein the processor is configured to identify at least one image segment representing the at least one temperature-sensitive element, recognize pixel value of pixels in the at least one image segment, and determine the temperature of different regions of the body part based on the pixel values of pixels in the at least one image segment.
However, Ohnemus teaches a system and method for the remote analysis of microarrays (Abstract) that includes a camera (FIG. 5, component 504) and a computing device with a processor comprising a variety of modules (paragraph [0014]; FIG. 2) where the camera captures at least one image of the first side of the array (FIG. 5; paragraph [0083]), which exhibits a color change upon being exposed to a sample having predetermined properties (paragraph [0027]), and uploads the image to the processor (FIG. 1, component 105; FIG. 2, component 201; paragraph [0083]). The processor identifies a region or image segment representing the microarray based on calibration markings (FIG. 4, component 411; paragraph [0083]), recognizes pixel values of pixels in at least one image segment (paragraph [0070]), and compares each colored pixel and its intensity against data stored in the database where the data may be in the form of a look up table of colors. The analysis module correlates the color and intensity for a specific microarray reaction site and determines if a given medical condition is present in the sample based on the color and/or intensity of the color changing component of the array (paragraph [0070]). While Ohnemus discusses the system and method of microarray analysis to determine the presence of specific reactants or analytes, where the presence of an analyte causes a color change in the microarray, one of ordinary skill in the art would recognize that the same system and method could be applied to the microarray structure disclosed by Mousa to analyze the color changing arrays on the sensor device by comparing the color change caused by the temperature of the skin to a database that correlates the color or intensity to temperature.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method disclosed by Mousa, which includes a sensor device with a temperature sensitive array of elements that change color upon contact with the body that is analyzed after removing the sensor device from the body, with the teaching of Ohnemus, that includes the use of a system for processing microarray data using a camera to capture images of the microarray sensing device and a processor for assessing a color change of the microarray, because Ohnemus further teaches that the ability to image a microarray sensing device with a camera, and upload and remotely process the image allows an individual to discover any pressing health concerns without the necessity of scheduling an in-person appointment with a medical professional (paragraph [0008]).
In regard to claim 4, Mousa as modified discloses the invention of claim 1. Ohnemus further teaches that at least one user device, such as a phone (paragraph [0011]; FIG. 1, component 101), is communicably coupled to at least one processor (FIG. 1, component 105), wherein the at least one processor is configured to send an output to a remote analysis system with indication of the medical states indicated by the processed array (paragraph [0086]), which in this case would reasonably include the temperatures of different regions of the body part based on the color matching of pixels of the image of the array disclosed by Mousa.
In regard to claim 8, Mousa as modified discloses the invention of claim 1. Mousa further discloses that the system includes a first and second sensor device, where the first sensor device is applied to a first breast and the second sensor device is applied to a second breast (paragraph [0161]; FIGs. 5A & 5B) and the differential temperature of each region of the sensor are compared to compute a temperature differential between the two body parts (paragraph [0161]).
In regard to claims 9 & 10, Mousa as modified discloses the invention of claim 1. Mousa discloses that the body part is at least one breast (paragraph [0157]; FIG. 4, component 404) and that the base of the sensor device has a hole partially surrounded by temperature sensing elements (FIG. 3, components 106 & 116; paragraph [0164]).
In regard to claim 11, Mousa as modified discloses the invention of claim 1. Mousa additionally discloses that the contact between the first side of the sensor device and the body part is made of adhesive which allows the device to be releasably secured to the breast (paragraph [0158]; FIG. 3, component 108).
15. Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Mousa (US 20190209019 A1 - Cited by Applicant) in view of Ohnemus (US 20120201437 A1) as applied to claim 1 above, and further in view of Stepien (US 20090259139 A1).
In regard to claim 2, Mousa as modified discloses the invention of claim 1. While Mousa discloses obtaining a temperature distribution of different regions of a body part using a sensor device comprising temperature sensitive arrays and Ohnemus further teaches a system for capturing and analyzing sensor arrays, neither Mousa nor Ohnemus discuss determining whether a temperature of a region exceeds a threshold value or generating a thermal map of the body based on the differential temperature profile, where the thermal map indicates any region whose temperature exceeds the temperature threshold value.
However, Stepien teaches a system and method for detecting breast pathology in women based on differential temperatures measured by thermosensitive liquid crystals (Abstract) where the color scale of a response of the thermosensitive liquid crystals are analyzed and defined by multiple temperature thresholds, with each interval being 1° C in the range of 31° C - 36° C for hypothermal expression and four additional thresholds in the range of 36° C - 39° C for hyperthermal expression, where each threshold value is represented as a specific color on a thermal map of the body part (paragraph [0137]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method disclosed by Mousa as modified, which includes the thermal mapping of a body part based on a differential temperature profile, with the teaching of Stepien that regions exceeding a predefined threshold can be identified and labeled on a thermal map of the body part, because the color scaling of the thermally sensitive material allows a person to easily read the examination result and detect a direction of thermal anomaly shift of higher or lower temperature compared to surrounding tissue (Stepien, paragraph [0138]).
16. Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Mousa (US 20190209019 A1 - Cited by Applicant) in view of Ohnemus (US 20120201437 A1) as applied to claim 1 above, and further in view of Rogers (US 20180014734 A1).
In regard to claim 3, Mousa as modified discloses the invention of claim 1. Neither Mousa nor Ohnemus discuss the use of an infrared temperature measurement device configured to measure test temperatures of different regions of the body or that at least one processor is configured to receive the test measurements from the infrared device.
However, Rogers teaches a system and method that includes a tissue-mounted sensing device with colorimetric indicators that make up an array of pixels (paragraphs [0007] & [0022]) for monitoring thermal properties of a tissue (Abstract). Rogers additionally teaches the use of an infrared measurement device (FIG. 43; paragraph [0083]) configured to measure test temperatures of the different regions of the body part and wherein the at least one processor is further configured to receive the test temperatures from the infrared measurement device (paragraphs [0255]; paragraphs [0258], see “direct comparisons of spatio-temporal variations…”; FIG. 43).
It would have been obvious to one of ordinary skill in the art to have modified the system and method disclosed by Mousa as modified with the teaching of Rogers because Rogers teaches that direct comparisons of spatio-temporal variation in temperature using the infrared camera can be used to validate or show quantitative agreement the colorimetric indicators of the sensing device paragraph [0258], see “direct comparisons of spatio-temporal variations…”; FIG. 43).
17. Claims 5 & 6 are rejected under 35 U.S.C. 103 as being unpatentable over Mousa (US 20190209019 A1 - Cited by Applicant) in view of Ohnemus (US 20120201437 A1) as applied to claim 1 above, and further in view of Porter (US 20220101992 A1) and further in view of Cordero (US 6298255 B1 – Cited by Applicant as WO 0078213 A2).
In regard to claims 5 and 6, Mousa as modified discloses the invention of claim 1. Mousa further discloses that the at least one sensor device comprises a unique identifier (FIG. 6, component 330; paragraph [0156]) on the base, with at least one camera being configured to capture the identifier, which comprises a machine-readable QR code or barcode (paragraph [0156]) and Ohnemus teaches a processing device, such as a smart phone (FIG. 2, component 2), that one of ordinary skill in the art would recognize is capable of scanning and identifying a QR code. While Mousa teaches that the sensor device comprises a unique identifier which associates data such as the serial number of the device, production details, and other information which is used in communication with an electronic device to read the results with the unique identifier (paragraph [0156]; FIG. 6, component 330), they do not specify that the processor is configured to associate the temperatures of different regions of the body part to the unique identifier or that the processor is configured to either block or permit future interpretations of the sensed temperatures from the sensor device.
However, Porter teaches a sensor patch and related monitoring systems that includes a sensor package for use in clinically monitoring a patient (Abstract). The sensor has a unique identifier (paragraph [0010]) that allows for the patch to be tied to a specific user and automatically uploads data to the correct subject file (paragraph [0021]). One of ordinary skill in the art would recognize that the same data processing and association with a unique identifier taught by Porter could be applied to the temperature data of different regions of the body part measured by the system disclosed by Mousa as modified.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method disclosed by Mousa as modified with the teaching of Porter, which includes associating data with a unique identifier and uploading the information to the correct location based on the unique identifier, because Porter further teaches that storing measured data associated with a unique identifier allows for the aggregation and tracking of sensor data over time (paragraph [0023]).
While Mousa teaches that the sensor device comprises a unique identifier which associates data such as the production details of the device, they do not specify that the processor is further configured to block or permit future interpretation of sensed temperatures from the sensor device.
However, Cordero teaches a smart sensor system for biosignals monitoring (Abstract), that includes a unique identifier that is associated with a usage count of a sensing device (Column 5, lines 5 – 14) where the processor will refuse further information from the smart sensor once the sensor is authenticated a preset maximum number of times, allowing for a limited amount of uses of the sensor (Column 5, lines 35 – 58).
It would have been obvious to one of ordinary skill prior to the effective filing date of the claimed invention to have modified Mousa as modified with the teaching of Cordero, which includes associating a unique identifier with a usage count of a sensing device and blocking future interpretations of sensed temperatures from the sensor device because Cordero further teaches that tracking the number of uses and blocking a sensor after a preset maximum number of uses allows for the reuse of a sensor device while maintaining quality of the sensor readings and preventing potential infections (Column 5, lines 35 - 58).
18. Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Mousa (US 20190209019 A1 - Cited by Applicant) in view of Ohnemus (US 20120201437 A1) as applied to claim 1 above, and further in view of Peters (US 20200066404 A1).
In regard to claim 7, Mousa as modified discloses the invention of claim 1. Ohnemus further teaches at least one camera (FIG. 5, component 504) and Mousa discloses that each sensor device includes instructions for proper alignment of each device on the body (paragraph [0157]), but neither Mousa nor Ohnemus discuss capturing at least one body image representing at least the body part of the user, wherein the at least one processor is further configured to identify features of the body, digitally superimpose at least one virtual object on the at least one body image, and sending the at least one body image to at least one user device.
However, Peters teaches a health monitoring system and method including instructions for the placement of a monitoring device where a user captures an image of their body (FIG. 14) and the processor is configured to superimpose a virtual object (FIG. 13, component 704) with representing the monitoring device onto the body image to instruct a user on the placement of the device (FIG. 13, see “Place here”) and displaying or sending the body image with the superimposed virtual object (FIG. 13, component 704) to the user device (FIG. 13, component 140).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method disclosed by Mousa as modified by Ohnemus with the teaching of Peters, that includes capturing a body image and superimposing at least one virtual object on the body image to guide a user in the correct placement of the sensor or monitoring device, because Mousa already discusses including instructions for placement of the sensor device on the body (paragraph [0157]) such that modifying Mousa as modified with Ohnemus with the guided placement taught by Peters would be considered combining prior art elements according to known methods to yield the predictable result of instructing a user to correctly place a sensor device on the body.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Van Pieterson (US 20090204100 A) discloses a wearable sensing device (FIG. 1) with temperature sensitive elements that change color based on a measured temperature (paragraph [0017]; FIGs. 5A & 5B).
20. Any inquiry concerning this communication or earlier communications from the examiner should be directed to SIENNA CHRISTINE PYLE whose telephone number is (703)756-5798. The examiner can normally be reached 8 am - 5:30 pm M - T; Off first Fridays; 8 am - 4 pm second Fridays.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor, II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIC F WINAKUR/Primary Examiner, Art Unit 3791
/S.C.P./Examiner, Art Unit 3791
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