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 .
DETAILED OFFICE ACTION
Status of Claims
Claims 1-12,28-31 and 45-48 are pending examination.
Claim 6 is cancelled.
Claim Objection
Claim 4 is objects due to the claim depending on itself. Claim should depend on preceding claim. Examiner request the Applicant amend claim 4 to depend on claim 1.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the nd 30 examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b) (2) (C) for any potential 35 U.S.C. 102(a) (2) prior art against the later invention.
1. Claims 1 ,3,12,13,14,15,18, 22,23,24,27,28,29 and 30 are rejected under 35 U.S.C 103(a) as being unpatentable over MacKinnon et al. (USPUB 20180182091) in view of Snekhalatha Umapathy et al. ( NPL DOC: "Computer Aided Diagnosis Based Hand Thermal Image Analysis:A Potential Tool for the Evaluation of Rheumatoid Arthritis," 30th September 2017, J. Med. Biol. Eng. (2018) 38,Pages 666-674.).
As per claim 1, MacKinnon et al. teaches A method for determining a parameter indicative of the degree of swelling and/or atrophy of a body part of a subject ( Paragraph [0056]- “…the ratio of the width of the fingers and the joints can be compared to the width of the finger between the joints to provide an index of the degree of swelling due to inflammation. The finger centerline can be analyzed in segments to determine the length of the finger segment between the interphalangeal joints. …”) , the method comprising the steps of:
(i) retrieving image of a body part of a subject ( FIG.1 teaches the image of body part of subject) , wherein the body part is capable of swelling and/or atrophy (Body part ( joint of hand) that capable of swelling taught within Paragraph [0004]- “… the early course of the disease that result in swelling and tenderness and this condition is sometimes referred to as inflammatory osteoarthritis. This swelling and tenderness manifests in the nerves, blood vessels and supporting matrix that supplies the synovial membrane that encapsulates the joint and produces…” AND Paragraph [0056]) ;
MacKinnon et al. does not explicitly teach (ii) determining the contrast of shadows on the skin of the body part on the image and/or the edge line of the body part on the image; and (iii) classifying the contrast of shadow on the skin of the body part on the image and/or the edge line of the body part on the image of step (ii) to determine the parameter indicative of the degree of swelling and/or atrophy from the image.
However, within analogous art, Snekhalatha Umapathy et al. teaches (ii) determining the contrast of shadows on the skin of the body part on the image and/or the edge line of the body part on the image ( Page 667- Col.2 – “…The edge based segmentation method detects the boundaries and outlines between the objects and background in the image and fails to detect the true edges in thermal images if the intensity is weak [17]. The active contour models are energy minimising deformable models which are influenced by certain constraints and internal and external image forces [18]. In that method, the initial parametric closed curve moves over the image speeding towards the feature of interest such as lines and edges….” AND Page 673- Fig.2-3 teaches the contrast shadows of skin within the body part( hand) ) ; and (iii) classifying the contrast of shadow on the skin of the body part on the image and/or the edge line of the body part on the image ( Page 666- Abstract – “…algorithm using a computer aided diagnostic tool for classification of rheumatoid arthritis (RA) and normal based on the feature extracted from the segmented thermal image….” AND Page 668- Col. 2- “…The classification is performed by minimising the sum of squares of distance between data and corresponding cluster centroids….”) of step (ii) to determine the parameter indicative of the degree of swelling and/or atrophy from the image ( Page 667- Col. 2- “…3. Inflammatory finger arthritis, 4. carpal tunnel syndrome, 5. thoracic outlet syndrome and 6. Raynaud’s phenomenon [14]. An interesting relationship between joint swelling measured by 3-dimensional imaging and increased temperature obtained by infrared thermography…”) .
One of ordinary skill in the art would have been motivated to combine the teaching of Snekhalatha Umapathy et al. within the modified teaching of the Method and system for imaging and analysis of anatomical features mentioned by MacKinnon et al. because the Computer Aided Diagnosis Based Hand Thermal Image Analysis:A Potential Tool for the Evaluation of Rheumatoid Arthritis mentioned by Snekhalatha Umapathy et al. provides a method and system for implementation of diagnosing and classification of rheumatoid arthritis.
Therefore, it would have been obvious for one in the ordinary skills in the art before the effective filing date of the claimed invention to implement the Computer Aided Diagnosis Based Hand Thermal Image Analysis:A Potential Tool for the Evaluation of Rheumatoid Arthritis mentioned by Snekhalatha Umapathy et al. within the modified teaching of the Method and system for imaging and analysis of anatomical features mentioned by MacKinnon et al. for implementing a system and method for diagnosing and classification of rheumatoid arthritis.
As per claim 3, Combination of MacKinnon et al. and Snekhalatha Umapathy et al. teach claim
1,
MacKinnon et al. teaches wherein the determination of the parameter indicative of the degree of swelling, and/or atrophy from the image is further based on a clinical parameter of the subject ( Paragraph [0056]-“ …the ratio of the width of the fingers and the joints can be compared to the width of the finger between the joints to provide an index of the degree of swelling due to inflammation….”) .
As per claim 12, Combination of MacKinnon et al. and Snekhalatha Umapathy et al. teach claim 1,
MacKinnon et al. teaches wherein the body part is a hand and/or a foot of a subject ( FIG. 1 and FIG. 3 teaches image of hand) .
As per claim 13, Combination of MacKinnon et al. and Snekhalatha Umapathy et al. teach claim 12,
MacKinnon et al. teaches wherein the body part is a hand of the subject( FIG. 1 and FIG. 3 teaches image of hand).
As per claim 14, Combination of MacKinnon et al. and Snekhalatha Umapathy et al. teach claim 1,
MacKinnon et al. teaches wherein the body part comprises a proximal interphalangeal joint, an extensor tendon, a metacarpophalangeal joint, and/or a distal interphalangeal joint ( Paragraph [0013]- “… The analysis will identify key features of hand arthritis such as the presence and location of Heberden or Bouchard nodes, angular deviation of the phalanges at the interphalangeal and phalange-metacarpal joints and other characteristic features of osteoarthritis or inflammatory arthritis. Individuals may provide their personal physician, or other health providers, access to this information via their personal health record….”) .
As per claim 15, Combination of MacKinnon et al. and Snekhalatha Umapathy et al. teach claim 1,
MacKinnon et al. teaches wherein the body part comprises dorsal finger skin folds of the proximal interphalangeal joint, a skin fold of the extensor tendon, and/or the metacarpophalangeal joints ( Paragraph [0056]- “…Variation in finger thickness along the centerline can be analyzed to identify and label the interphalangeal joints [1020]. The width of the finger at the joints and other locations can be compared to normal physiological values to identify pathological changes that may indicate the presence of osteoarthritis, rheumatoid arthritis, or other disorders. For example, the ratio of the width of the fingers and the joints can be compared to the width of the finger between the joints to provide an index of the degree of swelling due to inflammation. The finger centerline can be analyzed in segments to determine the length of the finger segment between the interphalangeal joints….”).
As per claim 18, Combination of MacKinnon et al. and Snekhalatha Umapathy et al. teach claim 1,
MacKinnon et al. teaches wherein the parameter indicates whether arthritis ameliorates, halts, or deteriorates(Measurement of the arthritis change over time taught within Paragraph [0011]- “…the symptoms of arthritis to use their smartphone to collect information and to make measurements of their hands. This information can be analyzed to identify changes in the anatomy of the hand that are inconsistent with normal expectations and to track these changes over time. …”) .
As per claim 22, Combination of MacKinnon et al. and Snekhalatha Umapathy et al. teach claim 1,
MacKinnon et al. teaches wherein the method further comprises obtaining the image of the body part( FIG.1 teaches the image of body part of subject).
As per claim 23, Combination of MacKinnon et al. and Snekhalatha Umapathy et al. teach claim 1,
MacKinnon et al. teaches wherein the image is or was obtained by optical imaging, preferably using light as a source of light, wherein preferably the light is visible light ( The source light from mobile phone taught within Paragraph [0058] – “… collecting sensor information from the smartphone comprising at least one of geographic location, time and date, ambient light levels, smartphone camera settings and characteristics and correlating these with the measurements as part of the data set….”) .
As per claim 24, Combination of MacKinnon et al. and Snekhalatha Umapathy et al. teach claim 1,
MacKinnon et al. teaches wherein the image is or was obtained by a camera ( Camera for image obtaining taught within Paragraph [0047]- “…Both the hand and the paper must be within the field of view of the camera [130]. …user to orient the device until the camera is reasonably close to perpendicular to the middle finger axis of the hand ….”) .
As per claim 27, Combination of MacKinnon et al. and Snekhalatha Umapathy et al. teach claim 1,
MacKinnon et al. teaches A library of a parameter indicative of the degree of swelling and/or atrophy determined according to the method of claim 1( Storage/library of the parameters taught within Paragraph [0033] –“A ‘Cloud Database Server’ is a Cloud Server that functions primarily to store and retrieve data that can then be processed, analyzed or reviewed, typically after being transferred to another computer system….”) .
As per claim 28, Combination of MacKinnon et al. and Snekhalatha Umapathy et al. teach claim 1,
MacKinnon et al. teaches A storage device comprising computer readable program instructions for executing the method according to claim 1( Paragraph [0032]- “…A ‘Cloud Processing Server’ is a Cloud Server equipped with sufficiently powerful central processing units (CPUs) and available memory and that functions primarily to process or analyze information, for example, complex image processing….”).
As per claim 29, Combination of MacKinnon et al. and Snekhalatha Umapathy et al. teach claim 1 and 28 ,
Mackinnon et al. teaches A system for determining a parameter indicative of the degree of swelling, and/or atrophy determined according to the method of claim 1 ( Paragraph [0056]- “…provide an index of the degree of swelling due to inflammation. The finger centerline can be analyzed in segments to determine the length of the finger segment between the interphalangeal joints. …”) , comprising the storage device according to claim 28( Paragraph [0032]- “…A ‘Cloud Processing Server’ is a Cloud Server equipped with sufficiently powerful central processing units (CPUs) and available memory and that functions primarily to process or analyze information, for example, complex image processing….”) ; at least one processing device ( Processing device taught within Paragraph [0032]- “…A ‘Cloud Processing Server’ …”) and a capturing device ( Camera taught within Paragraph [0047]) .
As per claim 30, Combination of MacKinnon et al. and Snekhalatha Umapathy et al. teach claim 29,
Mackinnon et al. teaches at least one processing device, and a network connection for receiving data indicative of an image of a body part ( Paragraph [0043]- “… smart phone or tablet with Internet connectivity, a mobile application installed on the smart phone or tablet and software to process data provided from the smart phone or tablet to the processing software. …”) .
2. Claim 2 is rejected under 35 U.S.C 103(a) as being unpatentable over MacKinnon et al. (USPUB 20180182091) in view of Snekhalatha Umapathy et al. ( NPL DOC: "Computer Aided Diagnosis Based Hand Thermal Image Analysis:A Potential Tool for the Evaluation of Rheumatoid Arthritis," 30th September 2017, J. Med. Biol. Eng. (2018) 38,Pages 666-674.) in further view Ariane L. Herrick et al. ( NPL DOC: "New perspectives in the imaging of Raynaud’s phenomenon,"6th July 2020, European Journal of Rheumatology, 2020,S212-S218.).
As per claim 2, Combination of MacKinnon et al. and Snekhalatha Umapathy et al. teach claim 1,
Combination of MacKinnon et al. and Snekhalatha Umapathy et al. does not explicitly teach wherein the contrast of shadow on the skin of the body part on the image comprises level of contrast, width of contrast lines, length of contrast lines, angle of contrast lines and/or distance between contrast lines.
Within analogous art, Ariane L. Herrick et al. teaches wherein the contrast of shadow on the skin of the body part on the image comprises level of contrast, width of contrast lines, length of contrast lines, angle of contrast lines and/or distance between contrast lines ( Contrast of shadow on skin body part image taught within S217 Figure 3 g and h and the contrast lines, angle taught within Figure 3- c-d) .
One of ordinary skill in the art would have been motivated to combine the teaching of Ariane L. Herrick et al. within the combined modified teaching of the Method and system for imaging and analysis of anatomical features mentioned by MacKinnon et al. and the Computer Aided Diagnosis Based Hand Thermal Image Analysis:A Potential Tool for the Evaluation of Rheumatoid Arthritis mentioned by Snekhalatha Umapathy et al. because the Computer Aided Diagnosis Based Hand Thermal Image Analysis:A Potential Tool for the Evaluation of Rheumatoid Arthritis mentioned by Ariane L. Herrick et al. provides a method and system for implementation of disease progression analysis from body part images .
Therefore, it would have been obvious for one in the ordinary skills in the art before the effective filing date of the claimed invention to implement the Computer Aided Diagnosis Based Hand Thermal Image Analysis:A Potential Tool for the Evaluation of Rheumatoid Arthritis mentioned by Ariane L. Herrick et al. within the combined modified teaching of the Method and system for imaging and analysis of anatomical features mentioned by MacKinnon et al. and the Computer Aided Diagnosis Based Hand Thermal Image Analysis:A Potential Tool for the Evaluation of Rheumatoid Arthritis mentioned by Snekhalatha Umapathy et al. for implementing a system and method for disease progression analysis from body part images .
3. Claims 16 and 25 are rejected under 35 U.S.C 103(a) as being unpatentable over MacKinnon et al. (USPUB 20180182091) in view of Snekhalatha Umapathy et al. ( NPL DOC: "Computer Aided Diagnosis Based Hand Thermal Image Analysis:A Potential Tool for the Evaluation of Rheumatoid Arthritis," 30th September 2017, J. Med. Biol. Eng. (2018) 38,Pages 666-674.) in further view Jiang et al. ( USPUB 20200170564).
As per claim 16, Combination of MacKinnon et al. and Snekhalatha Umapathy et al. teach claim 1,
Combination of MacKinnon et al. and Snekhalatha Umapathy et al. does not explicitly teach wherein the parameter is the shape of the skin folds, the contrast of the skin folds, the number of the skin folds, the length or thickness of the skin folds, the angle of skin folds, the distance between skin folds and/or the contour of the body part.
However, Jiang et al. teaches wherein the parameter is the shape of the skin folds, the contrast of the skin folds, the number of the skin folds, the length or thickness of the skin folds, the angle of skin folds, the distance between skin folds and/or the contour of the body part( Paragraph [0028]- “…a particular skin condition such as (but not limited to), nasolabial folds, variously located wrinkles; ptosis of the lower part of the face; sebaceous pores; whole face pigmentation; and vascular disorder…”) .
As per claim 25, Combination of MacKinnon et al. and Snekhalatha Umapathy et al. teach claim 1,
Combination of MacKinnon et al. and Snekhalatha Umapathy et al. does not explicitly teach wherein obtaining the image comprises using augmented reality or wherein the image was obtained by using augmented reality.
However, within analogous art, Jiang et al. teaches wherein obtaining the image comprises using augmented reality or wherein the image was obtained by using augmented reality( Paragraph [0095]- “…The image may be annotated such as via augmented reality or virtual reality techniques to highlight the region. By way of example, relevant pixels of a region in the image may be highlighted. A GUI may be provided showing the image (or normalized image)….”) .
4. Claim 34 is rejected under 35 U.S.C 103(a) as being unpatentable over MacKinnon et al. (USPUB 20180182091) in view of Ariane L. Herrick et al. ( NPL DOC: "New perspectives in the imaging of Raynaud’s phenomenon,"6th July 2020, European Journal of Rheumatology, 2020,S212-S218.).
As per claim 34, MacKinnon et al. teaches A method for determining a score indicative of the likelihood of a subject of having arthritis, scleroderma or Raynaud's phenomenon from an image of a body part ( Paragraph [0013]- “…. The analysis will identify key features of hand arthritis such as the presence and location of Heberden or Bouchard nodes, angular deviation of the phalanges at the interphalangeal and phalange-metacarpal joints and other characteristic features of osteoarthritis or inflammatory arthritis. Individuals may provide their personal physician, or other health providers, access to this information via their personal health record….” AND Paragraph [0056]) , wherein the method comprises the steps of:(i) determining from an image of a body part of a subject a parameter indicative of the degree of swelling and/or atrophy according(Body part ( joint of hand) that capable of swelling taught within Paragraph [0004]- “… the early course of the disease that result in swelling and tenderness and this condition is sometimes referred to as inflammatory osteoarthritis. This swelling and tenderness manifests in the nerves, blood vessels and supporting matrix that supplies the synovial membrane that encapsulates the joint and produces…” AND Paragraph [0056]) to (i) determining from an image of a body part of a subject a parameter indicative of the degree of swelling and/or atrophy according (ii) comparing the parameter determined in (i) to a distinguishing reference pattern ( Paragraph [0056]- “… Variation in finger thickness along the centerline can be analyzed to identify and label the interphalangeal joints [1020]. The width of the finger at the joints and other locations can be compared to normal physiological values to identify pathological changes that may indicate the presence of osteoarthritis, rheumatoid arthritis, or other disorders. For example, the ratio of the width of the fingers and the joints can be compared to the width of the finger between the joints to provide an index of the degree of swelling due to inflammation. The finger centerline can be analyzed in segments to determine the length of the finger segment between the interphalangeal joints. The lengths of these segments can be compared to expected physiological parameters to provide an index of finger curling or other indications useful for diagnosis. The angle of the centerline of each segment of a finger can be compared to the angles of the other segments of the finger to provide a diagnostically useful measure of joint breakdown causing deviation from the normal finger axis….”) ,
MacKinnon et al. does not explicitly teaches wherein the distinguishing reference pattern is obtained from at least three reference subjects, wherein at least one reference subject has arthritis, at least one reference subject has scleroderma and at least one reference subject has Raynaud's phenomenon; and(iii) identifying a score indicative of the likelihood of the subject of having arthritis, scleroderma or Raynaud's phenomenon based on the comparison in step (ii).
However, within analogous art, Ariane L. Herrick et al. teaches wherein the distinguishing reference pattern is obtained from at least three reference subjects, wherein at least one reference subject has arthritis, at least one reference subject has scleroderma and at least one reference subject has Raynaud's phenomenon (Page S217 – Col. 2 – “…This technique allowed the recogni-tion of the now famous scleroderma pattern, characterized by capillary enlargement, areas of avascularity (capillary drop-out), distor-tion of the normal nailfold architecture, and hemorrhages and later subdivided into early, active, and late patterns…”) ; and(iii) identifying a score indicative of the likelihood of the subject of having arthritis, scleroderma or Raynaud's phenomenon based on the comparison in step (ii)( S214- Col. 3- “…There are several aspects to consider: reliability of qualitative image grading (e.g., early, active, and late); reliability of semi-quantitative and quantitative measures, including capillary density and apical width; presence of giant capillaries; and the reliability of image ac-quisition …” AND S216- Col. 2- “…examining an area rather than a single point in RP, was just emerging. Since then, LDI and more recently LSCI, also called laser speckle contrast analysis have been used to examine finger blood flow in pa-tients with RP, compare primary and second-ary RP, examine treatment response, and study SSc-related digital ulceration….”).
One of ordinary skill in the art would have been motivated to combine the teaching of Ariane L. Herrick et al. within the modified teaching of the Method and system for imaging and analysis of anatomical features mentioned by MacKinnon et al. because the Computer Aided Diagnosis Based Hand Thermal Image Analysis:A Potential Tool for the Evaluation of Rheumatoid Arthritis mentioned by Ariane L. Herrick et al. provides a method and system for implementation of disease progression analysis from body part images .
Therefore, it would have been obvious for one in the ordinary skills in the art before the effective filing date of the claimed invention to implement the Computer Aided Diagnosis Based Hand Thermal Image Analysis:A Potential Tool for the Evaluation of Rheumatoid Arthritis mentioned by Ariane L. Herrick et al. within the modified teaching of the Method and system for imaging and analysis of anatomical features mentioned by MacKinnon et al. for implementing a system and method for disease progression analysis from body part images .
It is noted that any citations to specific, pages, columns, lines, or figures in the prior art references and any interpretation of the reference should not be considered to be limiting in any way. A reference is relevant for all it contains and may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art. See MPEP 2123.
Allowable Subject Matter
5. Claims 4,5,7,8,9,10,11,17,19, 20,21,26,30,31,32 and 33 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
6. The following is an examiner’s statement of reasons for objecting the claims as allowable subject matter:
As to claim 4, prior art of record does not teach or suggest the limitation mentioned within claim 4: “wherein clinical parameter is at least one parameter selected from the group of age, gender, form of arthritis, grade of arthritis, form of scleroderma, grade of scleroderma, grade of Raynaud's phenomenon, type of Raynaud's phenomenon, body size, body weight, and skin color.”
As to claim 5, prior art of record does not teach or suggest the limitation mentioned within claim 5: “…(ii) comparing the parameter determined in (i) to a reference parameter; and (iii) identifying a score indicative of the state of arthritis based on the comparison in step (ii), in particular, wherein the score is indicative for an active state of arthritis, scleroderma and/or Raynaud's phenomenon if the parameter determined in (i) is above the reference parameter in step (ii).”
As to claims 8,9,10 and 11,20,21,26,30,31,32 and 33, The following claims depend objected allowable claim 5, therefore the following claims are considered objected allowable claims over prior art of record.
As to claim 17, prior art of record does not teach or suggest the limitation mentioned within claim 17: “wherein the parameter is (a) the edge line of the dorsal finger skin folds of the proximal interphalangeal joint,(b) the contrast of shadow of the dorsal finger skin folds of the proximal interphalangeal joint, (c) the contrast of the shadow of extensor tendon, and/or(d) the contour of the metacarpophalangeal relief.”
As to claim 19, prior art of record does not teach or suggest the limitation mentioned within claim 19: “ wherein the edge line of the dorsal finger skin folds of the proximal interphalangeal joint, the contrast of the shadow of dorsal finger skin folds of the proximal interphalangeal joint, the contrast of shadow of the extensor tendon, and/or the contour of the metacarpophalangeal relief is/are determined.”
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
7. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Refer to PTO-892, Notice of Reference Cited for a listing of analogous art.
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to OMAR S ISMAIL whose telephone number is (571)272-9799 and Fax # is (571)273-9799. The examiner can normally be reached on M-F 9:00am-6:00pm.
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
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David C. Payne can be reached on (571) 272-3024. The fax phone number for the organization where this application or proceeding is assigned is (571)273-8300.
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/OMAR S ISMAIL/
Primary Examiner, Art Unit 2635