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 .
Notice of Reply
This communication is responsive to the amendment(s) and/or argument(s) filed 8/14/26. The previous ground(s) of objection and/or rejection is/are withdrawn. The following new and/or reiterated ground(s) of rejection is/are set forth hereinbelow.
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. Such limitations include at least the following:
“testing means” of claim 16;
“illumination means” of claim 16;
“acquisition means” of claim 16; and
“analyzing means” of claim 16.
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”) 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 § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 16-28 and 31 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gizewski (US 2008/0161661 A1).
For claim 16, Gizewski discloses a system for detection and metrology of an allergen skin reaction of an individual (Fig 3) ([0002, 0033-0051]), wherein said system comprises inter alia:
testing means (1000) (Fig 3) ([0033-0051]) configured to host a body part of said individual and to subject a skin surface area of said body part to an allergen skin reaction test ([0002, claim 19])) (Fig 3) ([0033-0051]);
illumination means (lights of 300) (Fig 3) ([0033-0051]), comprising a plurality of light sources (300), and configured to successively illuminate said skin surface area having been subjected to said allergen skin reaction test under a plurality of predetermined illumination angles with respect to a receiving direction along which acquisition means (imagers of 300) are positioned (Fig 3) ([0033-0051]); and
wherein said light sources are positioned under an angle larger than 40 degrees with respect to said receiving direction (Fig 3) ([0033-0051]);
said acquisition means fixedly positioned with respect to said skin surface area along said receiving direction (Fig 3) ([0033-0051]),
wherein said acquisition means is configured to image, for each of said predetermined illumination angles, said illuminated skin surface (Fig 3) ([0033-0051]); and
analyzing means (350, 360, 500) configured to determine one or more illumination-angle-dependent variations in light intensity imaged by said acquisition means (Fig 3) ([0033-0051]),
wherein said illumination-angle-dependent variations are caused by one or more wheals on said skin surface area (Fig 3) ([0033-0051]).
For claim 17, Gizewski discloses the system according to claim 16, wherein: said skin surface area extends along a longitudinal direction (Fig 3) ([0033-0051]); said acquisition means are fixedly positioned with respect to said skin surface area along said receiving direction traverse to said longitudinal direction (Fig 3) ([0033-0051]); said predetermined illumination angles are formed between said receiving direction and a lighting direction for each of said light sources of said illumination means (Fig 3) ([0033-0051]), wherein a light source tangentially illuminates said skin surface area along said lighting direction (Fig 3) ([0033-0051]).
For claim 18, Gizewski discloses the system according to claim 16, wherein said acquisition means are further configured to capture one or more images of said skin surface area for each of said predetermined illumination angles (Fig 3) ([0033-0051]), thereby generating a set of images of said skin surface area for said allergen skin reaction test (Fig 3) ([0033-0051]).
For claim 19, Gizewski discloses the system according to claim 18, wherein said analyzing means are further configured to process said set of images and to determine, from said set of images, one or more of the following: reflections generated from said illumination by said wheals on said skin surface area; shadows generated from said illumination by said wheals on said skin surface area; thereby determining said illumination-angle-dependent variations in light intensity imaged by said acquisition means (Fig 3) ([0033-0051]).
For claim 20, Gizewski discloses the system according to claim 16, wherein said analyzing means are further configured to determine a location of said wheal on said skin surface area using said illumination-angle-dependent variations in light intensity imaged by said acquisition means (Fig 3) ([0033-0051]).
For claim 21, Gizewski discloses the system according to claim 18, wherein said analyzing means are further configured to determine, from said set of images, a size and/or a shape of one or more of said wheals on said skin surface area (Fig 3) ([0033-0051]).
For claim 22, Gizewski discloses the system according to claim 17, wherein said acquisition means are positioned along said receiving direction traverse to said longitudinal direction to image said illuminated skin surface under each of said predetermined illumination angles (Fig 3) ([0033-0051]).
For claim 23, Gizewski discloses the system according to claim 16, wherein said acquisition means are positioned at a fixed predetermined receiving distance from said skin surface area for all of said predetermined illumination angles (Fig 3) ([0033-0051]).
For claim 24, Gizewski discloses the system according to claim 16, wherein each light source is configured to illuminate said skin surface area (Fig 3) ([0033-0051]); and wherein said system further comprises one or more mounting supports configured to hold said light sources (Fig 3) ([0033-0051]).
For claim 25, Gizewski discloses the system according to claim 22, wherein said system further comprises one or more mounting supports (light source mounting of [0033-0041]) configured to hold said light sources, wherein said light sources and/or said mounting supports are further configured to rotate around said body part in a plane comprising said receiving direction and traverse to said longitudinal direction such that said light sources illuminate said skin surface area under said plurality of predetermined illumination angles (Fig 3) ([0033-0051]).
For claim 26, Gizewski discloses the system according to claim 22, wherein said system further comprises one or more mounting supports (light source mounting of [0033-0041]) configured to hold said light sources, wherein said light sources and/or said mounting supports are further configured to rotate around said body part in a plane comprising said longitudinal direction of said body part and said receiving direction such that said light sources illuminate said skin surface area under said plurality of predetermined illumination angles (Fig 3) ([0033-0051]).
For claim 27, Gizewski discloses the system according to claim 16, wherein said testing means is configured to simultaneously deposit one allergen at a predetermined position on said skin surface area and incise said skin surface area of said individual at each of said predetermined positions (Fig 3) ([0002, 0033-0051, claim 19]).
For claim 28, Gizewski discloses the system according to claim 16, wherein an angular spread of said light sources within said illumination means is comprised between 35 degrees and 55 degrees (Fig 3) ([0033-0051]).
For claim 31, Gizemski discloses the system according to claim 16, wherein each of the predetermined illumination angles corresponds to a respective angle formed between the illumination means and the skin surface area of the individual (Fig 3) ([0033-0051]).
Response to Arguments
Applicant's arguments filed 8/14/26 have been fully considered but they are not persuasive, wherein Applicant argues the following:
Gizewski fails to disclose "illumination means, comprising a plurality of light sources, and configured to successively illuminate said skin surface area having been subjected to said allergen skin reaction test under a plurality of predetermined illumination angles with respect to a receiving direction along which acquisition means are positioned; and wherein said light sources are positioned under an angle larger than 40 degrees with respect to said receiving direction"
Gizewski fails to disclose that the sensory data unit 300 includes a plurality of light sources and further fails to disclose any particular orientation for the sensory data unit 300. Additionally, Gizewski fails to disclose "a plurality of light sources which are positioned under an angle larger than 40 degrees," as Gizewski is silent as to such a feature. The figures of Gizewski offer no disclosure in this regard, as they merely depict schematic block diagrams without showing any actual structure.
Moreover, Gizewski only describes a single white-light digital camera 312 which is "attached to the traversing head assembly of the horizontal and vertical digital image scanners." (para. [0035] of Gizewski), which fails to disclose the claimed feature of "acquisition means fixedly positioned with respect to said skin surface area along said receiving direction," as the acquisition means of claim 16 are "fixedly positioned," yet the white-light digital camera 312 is attached to a traversing head assembly. Moreover, as only the single white-light digital camera 312 is disclosed, Gizewski is wholly silent as to a plurality of lighting sources and a plurality of predetermined illumination angles as recited in claim 16.
Additionally, Gizewski fails to disclose at least "testing means configured to host a body part of said individual and to subject a skin surface area of said body part to an allergen skin reaction test" as recited in claim 16. The rejection refers to the system 1000, claim 19, Fig. 3, and paras. [0033-0051] of Gizewski as allegedly disclosing such a feature. However, nothing in Gizewski describes subjecting a skin surface area of a body part to an allergen skin reaction test.
Instead, Gizewski describes a data analysis system 1000 configured to "utilize multiple abnormality detection technologies to sense and image skin disorders for capturing a significant number of different kinds of skin disorder characteristics." (para. [0022] of Gizewski). Thus, Gizewski describes a diagnostic system for already present skin disorders and is wholly silent about subjecting a skin surface to an allergen skin reaction test. Specifically, Gizewski only refers to allergies in claim 19 as being a "subject consideration" on which treatment options are based and does not ever describe the application of an allergen test; instead, the "allergies" are an already known feature of the subject for consideration in Gizewski.
The Examiner respectfully disagrees and in response notes the following:
The Examiner respectfully notes that as cited above, as broadly as claimed, absent any structural distinctions to the contrary, consistent with the plain meaning of the terms of the claims in light of the instant Specification, and absent any special definition upon which Applicant does not appear to rely, it is more than fair and reasonable to consider (i) the lights of Gizewski’s imagery and sensory data unit 300 to be at least the structural and/or functional equivalent of the claimed “illumination means” and (ii) Gizewski’s automated data analysis system 1000 to be at least the structural and/or functional equivalent of the claimed “testing means”.
The Examiner respectfully notes Gizewski’s multi-imaging modality capturing unit is explicitly concerned with mounting hardware and orientations for horizontal and/or vertical scanning [0034] that explicitly includes positioning a plurality of different light sources (white, fluorescence emission, and infrared) and necessarily includes an “under an angle larger than 40 degrees” when horizontally and vertically scanning with respect to the imaged body position. The Examiner notes the claimed plurality of illumination angles are only with “respect to a receiving direction” which may be relative to many desired different illumination planes or orientations.
In response to applicant's argument that Grizewski fails to disclose an illumination means that ”successively illuminate said skin surface area having been subjected to said allergen skin reaction test under a plurality of predetermined illumination angles with respect to a receiving direction along which acquisition means are positioned; and wherein said light sources are positioned under an angle larger than 40 degrees with respect to said receiving direction” and/or a testing means “to host a body part of said individual and to subject a skin surface area of said body part to an allergen skin reaction test”, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “application of an allergen test”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
The Examiner notes that Gizewski states inter alia the following (emphasis added):
[0002] Innumerable people, worldwide, suffer from skin disorders. These skin disorders can include burns, cuts, sores, dry skin, thinning skin, wrinkling, eczema, inflammations, itchy skin, infections, psoriasis, skin rashes, sunburn, parasites and many more. The reasons for these skin problems may be faulty diet, hormone imbalances, blood toxicity, ineffective cleansing, illness, disease, injury, exposure to an irritants or caustic substances, allergies, aging, excess or improper use of cosmetics or any other reason, causing an afflicted individual or subject discomfort or suffering. To relieve this suffering, the afflicted individual or subject needs to pursue: (1) a quick and accurate diagnosis; (2) identification and administration of an effective treatment; (3) monitoring the progression of the condition and the effectiveness of the treatment; (4) identify and implement of prevention, avoidance and/or mitigation strategies; and (5) long term surveillance.
[0033] Now, referring more specifically to FIG. 3, illustrated is the imagery and sensory data unit 300 of the data acquisition module 200. The imagery and sensory data unit 300 may include, but is not limited to, a stationary digital image scanner 310, a portable digital image scanner 320, and a digital camera 330. The imaging components of the imagery and sensory data unit 300 may be further communicatively coupled to the image selection and adjustment module 350 and the display module 900 in order to display and optimize the imagery data that is being acquired.
[0034] The stationary digital image scanners 310 may be divided into two configurations, namely, the horizontal digital image scanner (not shown) and the vertical digital image scanner (not shown). These devices are similar except the horizontal digital image scanner may be designed to image bodies lying in a horizontal position while the vertical digital image scanner may be designed to image bodies standing vertically or erect. The horizontal digital image scanner and the vertical digital image scanner may incorporate and use three or more uniquely different technologies that separately acquire images of particular characteristics of a skin condition or disorder. These technologies may include digital imagery white-light photographic, fluorescence spectroscopic imagery, and radiometric imagery.
[0035] The stationary digital image scanner 310 may incorporate an adjustable white-light digital camera 312 and suitable lighting, which may include a reticle projector and may be attached to the traversing head assembly of the horizontal and vertical digital image scanners, and may be remotely manipulated in multiple planes to permit optimized focusing, lighting and viewing. The white-light digital camera 312 may capture images, of areas-of-interest, either individually or by a streamed video. A scanning mode may be selected which automatically manipulates the white-light digital camera 312 to permit the scanning and imaging of an entire body or just a specific sector. The precise positioning and location of suspected abnormality may be digitally recorded in each of the photographic images by using fixed datum point triangulation using fixed landmarks and/or anatomical features. For the purpose of this invention, white-light or visible-light is electromagnetic radiation that has a wavelength in the range from about 4,000 (violet) to about 7,700 (red) angstroms and may be perceived by the normal unaided human eye. The white-light digital camera 312 may be designed to capture white-light images of high-resolution, high contrast-ratios and true color, and with high quality color saturation. These images may be precisely scaled in order to accurately depict precise dimensional characteristics that may delineate even minute differentiations in the manifestation of skin conditions and disorders. During a white-light digital camera scanning process, the captured imagery may continuously be screened in order to detect suspicious edges, shapes, colors, textures and other differentiating characteristics of a peculiar or unusual skin aberration. Once a suspected area-of-interest is detected, the white-light digital camera 312 typically focuses on the area with magnification typically ranging from 2.times. to 700.times.. For example magnification, in the range of 160.times., maybe used to detect pathogenesis associated with hair follicle mites. Magnification of greater than 700.times. may be available and utilized under unusual circumstances where high magnification, microscopic imaging is necessary. Images that have been photographed or videoed may be accurately scaled down to less that 1 mm at a magnification of 1.times.. Image quality may be reviewed and, if desired, manually optimized though the use of the image selection and adjustment module 350. In one embodiment, the magnified objects may be scaled accurate to less that 0.1 mm under higher magnification. The white-light digital camera 312 may be the lead or initial imagery technology that is applied, and may be responsible for establishing common or shared datum points that may be used to precisely locate objects within areas-of-interest.
[0036] A fluorescence spectroscope 314 may be used as a safe, noninvasive skin condition assessment or diagnostic tool that detects sizes and quantifies variances in the fluorescence landscapes and the presence of markers that may indicate a condition or tissue abnormalities. The emitter and detector, of the fluorescence spectroscope 314, may be mounted on the head assembly of the horizontal digital image scanner and/or the vertical digital image scanner and may include a reticle projector and may be positionable in the same manner as the white-light digital camera 312. Image quality may be reviewed and, if desired, manually optimized though the use of the image selection and adjustment module 350. The fluorescence spectroscope 314 may be used to scan the body's surface areas independently of other imaging devices as well as in collaboration with other imaging devices. For example, fluorescence spectroscope may scan the body for peculiarities and abnormalities without regard to areas-of-interest detected by other imaging devices and then focus the fluorescence spectra imaging on the areas-of-interest, it has detected, as well as areas-of-interest detected by the other imagers. In this way, the fluorescence spectroscope 314 may perform independent assessments as well as elaborate or expand on discoveries made by other imaging technologies.
[0037] A high-definition Infra Red (IR) imager 316 may be used to capture the sized digital radiometric images of the body's surface area and quantify minute variances in temperature by registering the radiometric values of each detector pixel. This permits the detection of hyperthermia, localized vasodialation, hypervacularization, discrete temperature variations, and other abnormalities that display unique temperature characteristics. The high-definition IR imager 316 may include a reticle projector and may be mounted on the head assembly of horizontal digital image scanner and/or on the vertical digital image scanner in the same manner as the white-light digital camera 312 and the fluorescence Spectroscope 314. Image quality may be reviewed and, if desired, manually optimized through the use of the image selection and adjustment module 350. The high-definition IR imager 316 may be used to scan the body's surface areas independently of other imaging devices and in collaboration with other imaging devices. For example, the high-definition IR imager 316 may scan the body for peculiarities and abnormalities without regard to areas-of-interest detected by other imaging devices and then focus the high-definition IR imaging on the areas-of-interest it has detected as well as areas-of-interest detected by the other imagers. In this way, the high-definition IR imager 316 may perform independent assessments as well as elaborate or expand on discovers made by other imaging technologies.
[0038] The portable digital image scanner 320, also referred to as derma imager, may consist of a set of compact, lightweight devices used to capture various characteristics of skin conditions and skin disorders. There may be one or more portable digital image scanners 320 operationally subordinate to a user interface and display unit 100 configured to facilitate access, to the system 1000, by remotely located subjects who might otherwise not have access to the stationary digital image scanners 310. The portable digital image scanner 320 may include three imager configurations in its set or suite of components. These imagers may include: a derma imager WLP (White-Light Photographic) 322; a derma imager FS (Fluorescence Spectroscopy) 324; and a derma imager IR (Thermo-Graphic IR) 326. Each of these imagers is compact, light weight and may be comfortably operated by one hand. The portable digital image scanner's 320 suite of components also incorporates a portable ruggedized computer with a high-contrast, true-color, high-resolution touch-screen display with built-in ambient temperature/air quality/humidity/elevation sensors, stylus, mouse and high-speed modem (not shown), a cable set (not shown), a battery set and charger (not shown), adapters (not shown), miscellaneous spare components (not shown), a cleaning kit (not shown), a manual (not shown), software applications and training materials (not shown) and other supporting items, all stowed in one or more ruggedized carrying cases (not shown). Data captured by the portable digital image scanners 320 may be transmitted to the portable computer which thereafter may transmits the data, via the communication network, to the data analysis and reporting unit 500. This transmission may be either direct or through the user interface and display unit 100, to which the portable digital image scanner 320 is operationally subordinate. Alternatively, the portable digital image scanner 320 may be assigned to or managed by an independent third party. In this case, the portable digital image scanner 320 may directly forward the captured data to the data analysis and reporting unit 500.
[0039] The derma imager WLP 322 may be designed to capture individual and streamed digitized photographic/video images of a similar kind and for the same purposes as the stationary digital image scanner 310 but at a slower rate and smaller scale and with fewer automated functions. The components that may be built-into the derma imager WLP 322 may include a digital camera (not shown) with high-contrast, high-resolution, true color (high color accuracy) and high quality color saturation capabilities and features. The derma imager WLP 322 incorporates: magnification selections ranging between 1.times. to 700.times.; a reticle projection device; a light meter sensor; an adjustable light source; and an appended surface texture and thickness sensor. The reticle, projected onto the skin, is used for positioning the device correctly over the area-of-interest. The video image may be transmitted to the portable computer and displayed on the touch-screen monitor. The subject may adjust the derma imager WLP 322 until the lighting, focus and view are optimized. Once the desired image is suitably displayed, the subject initiates a capture sequence. Areas-of-interest, captured by the derma imager WLP 322, may be accurately scaled down to 1 mm or smaller, at a magnification of 1.times. which means the dimensional size (height and width) of objects in the images may be accurately gauged. Additionally, magnified objects (greater than 2.times.) may be scaled accurate to less than 0.1 mm. Additionally, the derma imager WLP 322 may be equipped with self-diagnostics and self-calibration devices which permit simplified maintenance and ensure high quality performance.
[0040] The derma imager FS 324 may consist of a fluorescence spectroscope (including an ultraviolet and/or infrared emitters and detectors), a digital camera with a light meter, adjustable light source, and a reticle projector. The fluorescence spectroscope and digital camera may generate a video, of the targeted area, which may be transmitted to the portable computer and viewed on its monitor. When a suitable view has been selected, the operator may initiate a capture sequence and the images will be captured and automatically transmitted to the user interface and display unit 100 or the data analysis and reporting unit 500. Both visual images (digital photographs/video) and the fluorescent spectra data may be captured along with location identification data. Additionally, the derma imager FS 324 can be equipped with self-diagnostics and self-calibration devices which permit simplified maintenance and ensure high quality performance.
[0041] The derma imager IR 326 may consist of a thermo graphic imager or sensor, reticle projector, and a digital camera with a light meter, adjustable light source, and a reticle projector. The thermo graphic imager and the digital camera may generate a video, of the targeted area, which may be transmitted to the portable computer and viewed on its monitor. When a suitable view has been selected, the operator may initiate a capture sequence and the images will be captured and automatically transmitted to the user interface and display unit 100 or the data analysis and reporting unit 500. Both visual images (digital photographs/video) and the thermo graphic data may be captured along with location identification data. Additionally, the derma imager IR 326 can be equipped with self-diagnostics and self-calibration devices which permit simplified maintenance and ensure high quality performance.
[0042] Additionally, a standard, off-the-shelf, high quality, high-contrast, true color, high-resolution, digital camera 330, in combination with appropriate full-spectrum lighting, may be used to capture digitized photographic/video images of an object-of-interest. These images are typically not of the quality acquired by the stationary digital image scanners 310 or the portable digital image scanners 320 however, the image quality is frequently adequate to allow at least a preliminary automated analysis. This capability offers a significant advantage since digital images of derma abnormalities may be captured, by almost anyone, and electronically transmitted, over the communications network, to the data analysis and reporting unit 500 directly or through the user interface and display unit 100.
[0043] The data acquisition module 200 may incorporate a breath analyzer 340, which may be used to analyze the composition of the subject's breath in order to detect the presence and concentration of certain molecules or chemical compounds that provide markers of a physiological condition that can manifest it self in the form of skin disorders. The breath analyzer 340 is simple and easy to administer and produces near real-time and accurate assessments of the breath gasses. The subject breathes into the device through a disposable mouth-piece & cartridge assembly which may be inserted into the breath analyzer 340 housing. In one configuration of the breath analyzer 340, the breath analysis technology may utilize laser absorption spectroscopy. Near ultraviolet (UV) to near infrared (IR) wavelengths may be emitted into the gas and a spectrophotometer can be used to measure the absorption spectrum, which is recorded as a quantitative value. Absorption spectrums are unique to particular compounds and change with varying concentrations. Available technologies of breath analyzer 340, such as the gas chromatography-electrolyzer powered flame ionization detector (EFID) may also be used The output of the breath analyzer 340 may be transmitted to the data analysis and reporting unit 500 directly or through the user interface and display unit 100.
[0044] The data acquisition module 200 may incorporate a test and measurement unit 360 as a stationary and portable configuration. The test and measurement unit 360 may be used to capture quantitative physical characteristics and physiological characteristics of the subject, as well as test environment characteristics (including calendar day, time-of-day, and location). Additionally the test and measurement unit 360 is capable of importing outside laboratory results and test results.
[0045] The physical characteristics or features, captured by the test and measurement unit 360, include height, weight, body dimensions, body fat ratios, skin tone/shade, fingernail characteristics, eye color, hair color, and the like. The physical features may be captured for the purposes of developing a comprehensive physical description of the subject, including both their peculiar or unusual characteristics and their common or normal characteristics.
[0046] The physiological characteristics, captured by the test and measurement unit 360, include vital signs, bone density, muscular/skeletal strength and flexibility, arterial blood oxygen saturation, endurance, skin thickness, skin texture, skin translucence, skin elasticity, skin moisture content, skin sensitivity, vision, eye clarity, hearing, hair loss and hair condition, fingernail characteristics, hormone levels, and the like. The physiological characteristics may be captured for the purposes of developing a comprehensive physiological description of the subject, including both their common or normal characteristics as well as their abnormal or peculiar characteristics.
[0047] The test environment characteristics, captured by the test and measurement unit 360, include ambient temperature, air quality, humidity, elevation, air pollutants, geographical location, and calendar day and time of day. The test environment characteristics may be captured for the purposes of defining those influencing environmental factors that may affect test results.
[0048] The test and measurement unit's capability to import laboratory test results and test results captured by external test equipment is provided for the purposes of including potentially important diagnostic data elements, developed outside of the system 1000. This enables the capability for ensuring the broadest practicable selection of test and measurement data is captured and made available to the data analysis and reporting unit 500 for analysis.
[0049] The data acquisition module 200 may be responsible for the acquisition of prescribed data elements as quantitative values. These data elements are derived from continuously evolving sets of tests, measurements and background queries and may comprise essential prerequisite source data for the high-speed automated analysis preformed by the data analysis and reporting unit 500. These data elements may include imagery data (or spectral data), sensory data, physical/physiological and environmental test and measurement data, and supportive data. Imagery data may be collected by the white light digital camera 312 (including but not limited to the dermatoscope and videomicroscope), fluorescence spectroscope 314, high-definition IR imager 316, derma imager WLP 322, derma imager PS 324, and the derma imager IR 326, and, additionally by the independently operated digital camera 330. These devices may be designed to detect and quantitatively register particular visual, florescent and/or thermal characteristics of skin conditions and skin disorders. For capturing the appearance, size, shape, color, edge characteristics, spectral characteristics, and density characteristics of skin conditions and disorders, other additional technological applications such as, ultrasonography and optical coherence tomography may also be used. Sensory data may be collected by the breath analyzer 340 which may include, but is not limited to, laser absorption spectroscopy and gas chromatography technologies. The breath analyzer 340 may be designed to detect and quantitatively register chemical compounds or markers, in the subject's breath, that correlate to certain known conditions, diseases, toxicity/poisoning, inflammation, or other types of disorders or abnormalities. The breath analyzers may also be used to detect evidence or indications of dietary/nutritional deficiencies, hormonal imbalances, drug and alcohol abuse, drug interactions/reactions, and the like. The test and measurement unit 360 may be designed to digitally acquire at least two categories of data which includes physical/physiological characteristics and test environment characteristics. The physical and physiological characteristics include information such as height, weight, body fat ratio, body dimensions, vital signs, vision performance, hearing performance, coordination, strength, flexibility, arterial blood oxygen saturation, blood type, skin texture, skin thickness, skin elasticity and the like. The test environment data includes ambient temperature, air quality, humidity, air quality, and elevation.
[0050] Additionally, data originating form other sources (i.e. laboratory reports, medical histories, skin tests, blood tests, biopsies, and the like) may also be imported into the user interface and display unit 100, through direct entry or the use of a communication network such as high-speed internet connection or the like. Once the key data prerequisites have been verified, the user interface and display unit 100 transmits the data, through the communication network, to the data analysis and reporting unit 500 for processing and subsequent analysis.
[0051] The digitized imagery, measurement, and sensory data, that have been captured by the imagery and sensory data unit 300, may be submitted to the image selection and adjustment module 350 where the data is processed for presentation by the display module 900. Once displayed, the subject or the operator may make image selections, modify or add references or data elements, verify dimensional data, verify area-of-interest location designators, modify or add narrative, adjust image quality, and perform a number of other material enhancement and equipment operational verification and maintenance tasks through the use of the user-interface devices (i.e. touch-screen display, stylus, key board, mouse, etc.) incorporated into the display module 900. Commands, entered through the display module 900 user-interface devices, may be routed to the image selection and adjustment module 350, which interprets the inputs, acts on the commands, and/or disseminates instructions to other modules or units including the imagery and sensory data unit 300, breath analyzer 340, test and measurement unit 360, and the supportive data unit 400.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jeffrey G. Hoekstra whose telephone number is (571)272-7232. The examiner can normally be reached Monday through Thursday from 5am-3pm EST.
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 A. 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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Jeffrey G. Hoekstra
Primary Examiner
Art Unit 3791
/JEFFREY G. HOEKSTRA/ Primary Examiner, Art Unit 3791
